Procedures for Establishing, Supplementing and Maintaining a Register of Patients Suffering from Certain Diseases

Issued in accordance with
Section 9, Paragraph one of the Medical Treatment Law

[27 December 2011]

I. General Provisions

1. This Regulation prescribes the procedures for establishing, supplementing and maintaining a register of patients who are suffering from certain diseases (hereinafter - the Register).

2. The Register is a State information system which contains data on patients who are suffering from certain diseases.

3. The manager and keeper of the Register shall be the Centre for Disease Prevention and Control (hereinafter - the Centre). The Centre shall ensure operation of the Register, and also shall enter into agreements with personal data operators for the processing and protection of personal data.

[22 May 2012]

4. The objectives for the establishment of the Register are as follows:

4.1. to establish a joint information database of patients who are suffering from certain diseases;

4.2. to ensure implementation of the official statistical programme;

4.3. to ensure implementation of international obligations regarding compilation and provision of statistical information.

[29 November 2016]

II. Provision, Entering, Processing and Use of the Information to be Included in the Register

5. The National Health Service shall once a month provide the Register with non-personal information from the unified electronic information system of the health sector regarding the following:

5.1. narcological patients;

5.2. patients diagnosed with tuberculosis;

5.3. patients diagnosed with diabetes mellitus;

5.4. patients diagnosed with oncological disease;

5.5. patients diagnosed with mental and behavioural disorders;

5.6. patients diagnosed with occupational disease;

5.7. patients diagnosed with multiple sclerosis;

5.8. patients diagnosed with congenital anomaly;

5.9. patients who have turned to a medical treatment institution for emergency medical assistance due to trauma, injury or poisoning.

[29 November 2016]

6. Inpatient and outpatient medical treatment institutions, as well as doctors' practices (hereinafter - the medical treatment institutions) shall enter and update information in the information system of the Register online regarding:

6.1. patients diagnosed with hepatitis C - pursuant to Annex 14 to this Regulation;

6.2. patients diagnosed with HIV infection or AIDS - pursuant to Annex 15 to this Regulation.

[8 January 2019]

7. On the basis of the information referred to in Paragraphs 5 and 6 of this Regulation, the Centre shall, once a year, draw up the following statistical information summaries:

7.1. regarding patients diagnosed with tuberculosis;

7.2. regarding patients diagnosed with diabetes mellitus;

7.3. regarding patients diagnosed with oncological disease;

7.4. regarding patients diagnosed with mental and behavioural disorders;

7.5. regarding narcological patients;

7.6. regarding patients diagnosed with occupational disease;

7.7. regarding patients diagnosed with multiple sclerosis;

7.8. regarding patients diagnosed with congenital anomaly;

7.9. regarding patients who have turned to a medical treatment institution for emergency medical assistance due to trauma, injury or poisoning;

7.10. regarding patients diagnosed with hepatitis C;

7.11. regarding patients diagnosed with HIV infection or AIDS.

[22 April 2014; 28 June 2016; 29 November 2016; 8 January 2019]

8. On the basis of the statistical information summaries referred to in Paragraph 7 of this Regulation, once a year the Centre shall draw up statistical reports of the health care sector.

[30 November 2009; 27 December 2011; 22 May 2012]

8.¹ Upon request the Centre shall provide statistical information regarding cases of poisoning (diagnosis codes T36.0-T65.9 in conformity with 10th version of the International Classification of Diseases referred to in Paragraph 9 of this Regulation) to the Clinic of Toxicology and Sepsis of the Riga East University Hospital and regarding cases of poisoning with pesticides (diagnosis codes T60.0-T60.9 in conformity with 10th version of the International Classification of Diseases referred to in Paragraph 9 of this Regulation) to the State Plant Protection Service.

[22 May 2012]

9. In statistical reports of the health care sector diseases and disease groups shall be grouped and coded in conformity with the International Statistical Classification of Diseases and Related Health Problems (the 10th revision of the International Classification of Diseases).

10. Information identifying a patient for the patients referred to in Paragraph 6 of this Regulation (the given name, surname, personal identity number, declared and actual place of residence of the patient) shall be stored in the data processing system in encrypted form, separately from other information included in the Register. The link between information identifying the patient and other information included in the Register shall be encrypted in the data processing system. The Centre and also the person, who is authorised by the data operator to enter and update information referred to in Paragraph 6 of this Regulation in the Register, has a possibility to identify a particular patient. Information identifying a patient for the patients referred to in Paragraph 6 of this Regulation shall be deleted after the death of the patient by 31 December of the following year. Information regarding a child born to an HIV infected mother who has not been diagnosed with HIV shall be deleted from Section VII "HIV infection in the antenatal and perinatal period" of his or her mother's HIV/AIDS patient form (from Paragraphs 39 to 46) until 31 December of the following year after the child in question has reached 18 months of age.

[30 November 2009; 27 December 2011; 22 May 2012; 29 November 2016; 12 June 2018; 8 January 2019]

11. The information included in the Register shall be kept in printed form until the time when the information is electronically entered in the database of the Register, however no longer than one year. The information included in the Register shall be kept electronically by ensuring personal data protection in accordance with the procedures laid down in the Personal Data Processing Law and Law on the Rights of Patients. The information included in the Register is restricted access information.

[18 December 2012; 17 December 2019]

12. The information referred to in Paragraph 6 of this Regulation which is included in the Register shall be compared in accordance with the following procedures:

12.1. with the Database of Causes of Death of Inhabitants of Latvia - once a day;

12.2. with the Register of Recipients of Health Care Services of the National Health Service and information regarding health care services provided to patients - when necessary;

12.3. with the Population Register of the Office of Citizenship and Migration Affairs - each time regarding each patient registered for the first time and when updating patient's data in the Register, and also once a year regarding all patients included in the Register;

12.4. with the State Infectious Diseases Surveillance and Monitoring System - once in 24 hours regarding each registered patient diagnosed with hepatitis C;

12.5. with the Register of Newborns:

12.5.1. once every 24 hours for each registered woman who has been diagnosed with HIV infection and, if a child has been born to the woman, information shall be provided from the Register of Newborns on the date of birth of the child, the time of birth of the child, and the personal identity number of the child (HIV/AIDS patient form Section VII "HIV infection in the antenatal and perinatal period" (Paragraphs 39 to 41).

12.5.2. information on the personal identity number of the mother of the child (Paragraph 20 of the HIV/AIDS patient form Section III, Most likely transmission route, analysing the information provided by a patient) shall be provided by the Register of Newborns once for every child for whom a case of the vertical transmission of HIV infection has been registered (mark has been made in Paragraph 19 of the HIV/AIDS patient form Section III, Most likely transmission route, analysing the information provided by a patient).

[22 April 2014; 28 June 2016; 29 November 2016; 8 January 2019; 17 December 2019]

13. The operation of the data processing of the Register shall be organised by complying with the general technical and safety requirements of the State information systems.

14. The information included in the Register shall be used in accordance with the procedures laid down in the Statistics Law, the Law on the Rights of Patients and the Personal Data Processing Law.

[18 December 2012; 29 November 2016; 17 December 2019]

15. [22 April 2014]

III. Closing Provisions

16. Cabinet Regulation No. 263 of 4 April 2006, Procedures for Establishing, Supplementing and Maintaining Register of Patients who are Ill with Certain Diseases (Latvijas Vēstnesis, 2006, No. 57), is repealed.

17. The medical treatment institutions, which may not ensure entering of the information to be included in the Register in online mode, shall, once a month, but not later than until 1 January 2010, submit information in printed form regarding patients who have had traumas and injuries (shall be submitted only by inpatient medical treatment institutions regarding hospitalised patients), regarding narcological patients and persons who are using substances causing addiction, regarding patients with mental and behavioural disorders, regarding patients who are suffering from diabetes mellitus, and also regarding patients who are suffering from oncological disease, and patients for whom malignant mesothelioma has been detected (Annex 1, 2, 3, 4, 5, 7, 8 and 9) to the National Health Service. The abovementioned institutions shall submit other information to be included in the Register once a month in printed form to the following data operators:

17.1. valsts aģentūra "Latvijas Infektoloģijas centrs" [State agency Latvian Centre of Infectious Diseases] - regarding patients who are suffering from tuberculosis (Annex 6);

17.2. valsts sabiedrība ar ierobežotu atbildību "Paula Stradiņa klīniskā universitātes slimnīca" [State limited liability company Pauls Stradiņš Clinical University Hospital] - regarding patients who are suffering from occupational diseases (also asbestosis) (Annexes 10 and 11);

17.3. valsts sabiedrība ar ierobežotu atbildību "Bērnu klīniskā universitātes slimnīca" [State limited liability company Children's Clinical University Hospital] - regarding patients who are suffering from congenital anomalies (Annex 12);

17.4. akciju sabiedrība "Latvijas Jūras medicīnas centrs" [joint stock company Latvian Maritime Medicine Centre] - regarding patients who are suffering from multiple sclerosis (Annex 13).

[30 November 2009; 27 December 2011; 22 May 2012]

18. Information, which is necessary for the establishment, supplementation and maintenance of the Register, shall be entered and updated in the Register in online mode:

18.1. until 1 January 2009 - Tuberkulozes un plaušu slimību valsts aģentūra [State agency Centre of Tuberculosis and Lung Diseases] (regarding patients who are suffering from tuberculosis) and sabiedrība ar ierobežotu atbildību "Rīgas Austrumu klīniskā universitātes slimnīca" [limited liability company Riga East University Hospital] (regarding patients who are suffering from oncological diseases, and patients for whom malignant mesothelioma has been detected);

18.2. until 1 January 2010 - the State stock company Pauls Stradiņš Clinical University Hospital (regarding patients who are suffering from occupational diseases (also asbestosis)), the State limited liability company Children's Clinical University Hospital (regarding patients with congenital anomalies) and the joint stock company Latvian Maritime Medicine Centre (regarding patients who are suffering from multiple sclerosis).

19. The medical treatment institutions, which cannot ensure entering of information to be included in the Register regarding patients who are suffering from tuberculosis (Annex 6) in online mode, shall submit it in printed form to the Centre once a month until 1 January 2014.

[18 December 2012]

20. The medical treatment institutions shall, by 31 May 2017, ensure that the Register is supplemented with the data regarding patients who, accordance with Annex 14 to this Regulation, in the time period from 1 January to 30 November 2016 have a confirmed infection of hepatitis C, an opinion of the doctors' council, or with regard to which treatment has been commenced, or treatment course has been completed/suspended.

[28 June 2016]

21. The medical treatment institutions which, in accordance with the procedures laid down in the laws and regulations regarding the unified electronic information system of the health sector, have failed to agree on the provision of data to the unified electronic information system of the health sector, shall, by 31 August 2017, enter and update the information included in Annexes 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12 and 13 to this Regulation in the information system of the Register online.

[29 November 2016]

22. The procedures for data processing laid down in Paragraphs 7, 8, 8.¹, 9, 10, 11, 12, 13 and 14 of this Regulation shall be applicable to the data included in the Register in accordance with Paragraph 20 of this Regulation.

[29 November 2016]

23. Until 31 July 2019, the Centre shall ensure that the Register is supplemented with data regarding patients who have been diagnosed with HIV infection or AIDS until 30 June 2019, using data from the State information system "State Register of HIV/AIDS Cases".

[8 January 2019]

Informative Reference to the European Union Directive

[27 December 2011]

This Regulation contains legal norms arising from Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides.

Prime Minister I. Godmanis

Minister for Health I. Eglītis

Annex 1
Cabinet Regulation No. 746
15 September 2008

Register Form of Traumas, Injuries and Cases of Poisoning

[1 September 2017. See Paragraph 3 of the amendments]

Annex 2
Cabinet Regulation No. 746
15 September 2008

Registration Form of a Narcological Patient

[1 September 2017. See Paragraph 3 of the amendments]

Annex 3
Cabinet Regulation No. 746
15 September 2008

Evaluation of the Medical Treatment Result of a Narcological Patient

[1 September 2017. See Paragraph 3 of the amendments]

Annex 4
Cabinet Regulation No. 746
15 September 2008

Patient Form of a Patient with Mental and Behavioural Disorders

[1 September 2017. See Paragraph 3 of the amendments]

Annex 5
Cabinet Regulation No. 746
15 September 2008

Registration Form of a Diabetes Mellitus Patient

[1 September 2017. See Paragraph 3 of the amendments]

Annex 6
Cabinet Regulation No. 746
15 September 2008

Tuberculosis Patient Form

[1 September 2017. See Paragraph 3 of the amendments]

Annex 7
Cabinet Regulation No. 746
15 September 2008

Oncological Patient's Registration Form

[1 September 2017. See Paragraph 3 of the amendments]

Annex 8
Cabinet Regulation No. 746
15 September 2008

[22 April 2014]

Annex 9
Cabinet Regulation No. 746
15 September 2008

Registration Form of the Treatment of an Oncological Patient

[1 September 2017. See Paragraph 3 of the amendments]

Annex 10
Cabinet Regulation No. 746
15 September 2008

Registration Form of the Patient of Occupational Diseases

[1 September 2017. See Paragraph 3 of the amendments]

Annex 11
Cabinet Regulation No. 746
15 September 2008

Voucher of the Patient of Occupational Diseases

[1 September 2017. See Paragraph 3 of the amendments]

Annex 12
Cabinet Regulation No. 746
15 September 2008

Registration Form of the Patient with Congenital Abnormalities

[1 September 2017. See Paragraph 3 of the amendments]

Annex 13
Cabinet Regulation No. 746
15 September 2008

Multiple Sclerosis Patient Form

[1 September 2017. See Paragraph 3 of the amendments]

Annex 14
Cabinet Regulation No. 746
15 September 2008

[12 June 2018; 8 January 2019]

Hepatitis C Patient Form

The Register shall be supplemented on a regular basis by entering data regarding the patients diagnosed with hepatitis C - after basic diagnosis, each time after the conclusion of the council, after an initiated treatment course if the treatment course has been completed or interrupted by assessing the efficacy of therapy, and in other relevant cases of the update of the treatment process.

I. Patient data

1. Medical treatment institution							-
				(name and code in the Register of Medical Treatment Institutions)
2. Personal identity number of the patient						-
2.1 Date of birth of the patient (dd/mm/yyyy)						.  .    .
3. Name of the patient1					4. Surname of the patient1
5. Gender of the patient1 (1 - M; 2 - F)
6. Declared place of residence1
			(street, house, village, rural territory, municipality, town/city, state, postal code)

7. Code of the administrative territorial unit of the declared place of residence1

8. Risk factors affecting the course of treatment
(1 - currently; 2 - in health history; 3 - none; 9 - unknown)
8.1. use of narcotic and psychotropic substances
8.2. excessive consumption of alcohol
8.3. receiving narcotic replacement therapy

II. Diagnosis

9. Case registered in the State Infectious Diseases Surveillance and Monitoring System2:
9.1. diagnosis of hepatitis C (code in accordance with the ICD-10)3	.
9.2. date of registration (dd/mm/yyyy)	.   .     .
10. Year of detection of hepatitis C		.
11. Infection of hepatitis C confirmed
11.1. HCV RNA
11.2. HCV cor Ag
12. Code of the basic diagnosis before treatment (code in accordance with the ICD-10)				.

13.1. stage of fibrosis upon initiating treatment4 (F0 - no fibrosis; F1 - portal fibrosis without septa; F2 - portal fibrosis with few septa; F3 - numerous septa without cirrhosis, F4 - cirrhosis)						F
13.2. method of detecting stage of fibrosis:
13.2.1. histology
13.2.2. elastography
13.2.3. cirrhosis of the liver proven by another method (specify)
14. HCV genotype (1; 1A; 1B; 2; 3; 4; 5; 6; 7 - combined; 9 - not specified)
14.1. if combined, specify types (1; 1A; 1B; 2; 3; 4; 5; 6)					;   ;
14.2. Year of the detection of HCV genotype					.
15. Medicinal products/treatment scheme code used in the ineffective treatment course administered until 31 December 20155 (if in health history)
Other (specify)

III. Treatment

17.	Etiotropic treatment course (to be filled in for each treatment course)
17.1.	medical treatment institution		-
			(code in the Register of Medical Treatment Institutions)
17.2.	medicinal products used in the treatment/treatment scheme code
	Other (specify)
17.3.	planned duration of treatment (specify the number of weeks)
17.4.	payment for the treatment course
	(1 - paid by the State; 2 - paid by the patient; 3 - partial co-payment by the patient; 4 - participation of the patient in a clinical trial; 5 - compassionate use of medicinal products)
17.5.	date of the initiation of treatment (dd/mm/yyyy)				.   .     .
17.6.	side-effects of treatment therapy

20. Monitoring of treatment efficacy
20.1. up to two months
20.1.1. HCV RNA6:	positive	negative	not examined
20.2. from three to five months
20.2.1. HCV RNA:	positive	negative	not examined
20.3. from six to eleven months
20.3.1. HCV RNA:	positive	negative	not examined
20.4. at least one year
20.4.1. HCV RNA:	positive	negative	not examined

Notes.

¹ Information is received from the Population Register.

² Information is received from the State information system State Infectious Diseases Surveillance and Monitoring System where it is entered by the Centre for Disease Prevention and Control.

³ International Statistical Classification of Diseases and Related Health Problems (ICD - 10th revision).

⁴ Stage of fibrosis is detected according to the METAVIR scoring system.

⁵ Appropriate combination of the chosen medicinal products may be selected online. In addition, the Centre for Disease Prevention and Control provides an explanation on its website at www.spkc.gov.lv.

⁶ HCV RNA is positive if its concentration exceeds the detection threshold of the used laboratory test.

⁷ Information is received from the Database of Causes of Death of Inhabitants of Latvia where it is entered by the Centre for Disease Prevention and Control.

Annex 15
Cabinet Regulation
15 September 2008

[8 January 2019; 17 December 2019]

HIV/AIDS patient form

The Register shall be supplemented on a regular basis following the receipt of updated epidemiological and/or clinical data by entering data on patients diagnosed with HIV infection or AIDS.

I. Patient data

II. Epidemiological health history

14. Infectious disease (indicate as appropriate)
(1 - currently; 2 - in health history; 3 - none; 99 - unknown)
14.1. tuberculosis
14.2. syphilis
14.3. gonorrhoea
14.4. chlamydia genitourinary infection
14.5. hepatitis B
14.6. hepatitis C

III. Most likely transmission route, analysing the information provided by a patient
(indicate as appropriate, including during subsequent appointments)

17. Use of injectable narcotic substances with shared injection accessories
18. Sexual contact with a person infected or possibly infected with HIV
18.1. heterosexual contact
18.2. homosexual contact
18.3. partner is the user of injectable narcotic substances
19. Vertical transmission
20. Mother's personal identity number			-
21. Other transmission route
		(indicate)

IV. Diagnosis

25. Date of confirmation of HIV infection in the National Microbiology Reference Laboratory
(dd/mm/yyyy)		.   .     .
26. Registration number of the sample of the National Microbiology Reference Laboratory
	/
27. Laboratory methods for diagnosis of HIV infection (indicate as appropriate)
27.1. a positive HIV antibody test confirmed by a more specific antibody test
(Immunoblot/Western blot)
27.2. a positive HIV combination (HIV antibodies and HIV p24 antigen) test, confirmed by a more specific antibody test (Immunoblot/Western blot) or by HIV p24 antigen test, including neutralisation response
27.3. positive results with two separate samples in the detection of HIV nucleic acid
27.4. a positive HIV test result using another method
				(indicate)
28. Type of an HIV virus (indicate as appropriate)
(1 - HIV-1; 2 - HIV-2)

29. Main reason for testing for HIV infection (indicate one)
29.1. requested by the patient/parents/guardians/trustees
29.2. in connection with the positive result of the rapid HIV test
(1 - at an HIV prevention point (if "1" is indicated in the first box, indicate in the second box the region where the HIV prevention point is located according to the code); 2 - by a medical practitioner; 3 - self-testing was carried out; 99 - other)
29.3. clinical indications (symptoms which suggest HIV infection)
29.4. contact person
29.5. screening of a patient with a sexually transmitted infection
29.6. blood/sperm/organ donor
29.7. during the period of pregnancy
29.8. examination of a child born to an HIV positive mother
29.9. in case of tuberculosis
29.10. in the place of imprisonment

V. AIDS

35. AIDS indicator diseases (indicate as appropriate)
35.1. bacterial infections, multiple or recurrent (in children < 6 years of age)
35.2. Burkitt lymphoma
35.3. cytomegalovirus infection excluding localisation in spleen, lymph nodes, liver
35.4. retinitis caused by cytomegalovirus
35.5. Herpes simplex: ulcers for more than one month, bronchitis, pneumonitis, oesophagitis
35.6. HIV-induced encephalopathy
35.7. HIV-induced fatigue syndrome
35.8. histoplasmosis, disseminated or extrapulmonary
35.9. immunoblastic lymphoma
35.10. invasive cervical carcinoma (in adults and children > 6 years of age)
35.11. chronic intestinal isosporiasis, for more than one month
35.12. candidiasis - of trachea, bronchi, lungs
35.13. candidiasis - oesophageal
35.14. Kaposi's sarcoma
35.15. coccidioidomycosis, extrapulmonary or disseminated
35.16. cryptococcosis, extrapulmonary
35.17. cryptosporidiosis with diarrhoea, for more than one month
35.18. Mycobacterium avium complex or Mycobacterium kansasii (or other Mycobacterium species) induced extrapulmonary or disseminated disease
35.19. Mycobacterium tuberculosis induced pulmonary disease (in adults and
children > 6 years of age)
35.20. Mycobacterium tuberculosis induced extrapulmonary disease
35.21. primary central nervous system lymphoma
35.22. pneumocystis pneumonia
35.23. pneumonia, repeatedly over a period of 12 months (in adults and children > 6 years of age)
35.24. sepsis/septicaemia caused by salmonella (recurrent)
35.25. cerebral toxoplasmosis
35.26. progressive multifocal leukoencephalopathy
35.27. others
	(indicate)

VI. Antiretroviral treatment

(Paragraphs 36.6 to 38 shall only be completed in respect of children who have been confirmed with HIV infection and who have been infected through vertical transmission)

VII. HIV infection during the antenatal and perinatal period
(to be completed for each child individually)

Information regarding the child

39. Date of birth of the child5	.   .     .
40. Time of birth of the child5	.
41. Personal identity number of the child5	-
42. The newborn has been diagnosed with HIV RNA (to be completed by the doctor of infectious diseases)
(1 - yes; 2 - no; 99 - unknown)
43. Date when the newborn was diagnosed with HIV RNA
(dd/mm/yyyy)	.   .     .
44. The newborn has received prophylactic treatment during the period of time until 72 hours
(1 - yes; 2 - no; 99 - unknown)
45. Type of prophylactic treatment received by the newborn
(1 - monotherapy; 2 - combination therapy; 99 - unknown)
46. HIV infection of the child is confirmed
(1 - yes (if "yes", then the HIV/AIDS patient form shall be completed); 2 - no (if "no", then information regarding the child shall no longer be visible); 99 - unknown)

VIII. Death of an HIV infected person or AIDS patient⁶

47. Date of death (dd/mm/yyyy)	.   .     .
48. Underlying cause of death (code according to ICD-10)	.

IX. Closing Provisions

Notes.

¹ Information is received from the Population Register.

² Code according to the standardised list of State and territorial codes available on the website of Eurostat (http://ec.europa.eu/eurostat/ramon/nomenclatures/index.cfm?TargetUrl=LST_NOM_DTL&Int CurrentPage=1&StrNom=CL_GEO&IntPcKey=41999324&StrLanguageCode=EN&StrLayoutCode=HIERARCHIC).

³ For first-time patients this shall be marked after 12 months of initiation of treatment and subsequently (for regular patients) at least once a year at the discretion of the physician.

⁴ Information is received from the Register of Medical Treatment Institutions.

⁵ Information is received from the Register of Newborns.

⁶ Information is received from the Database of Causes of Death of Inhabitants of Latvia where it is entered by the Centre for Disease Prevention and Control.

Translation © 2020 Valsts valodas centrs (State Language Centre)