The Republic of Latvia Cabinet of Ministers of 5 May 1998 rules no. 165 in Riga (nr. 23.11) medical certification order Issued by the authorities in accordance with article 56 of the law on the treatment of i. General questions 1. terms used in the rules: 1.1. certificate: a document stating the medical authorities or the compliance with the minimum requirements in the field in question;
1.2. minimum requirements: medical institutions or their departments requirements of high-quality health care.
2. Those rules shall determine the treatment of certification authorities (hereinafter certification).
II. Certification Authority certification authority has 3 Cabinet authorised certification bodies.
4. the competence of certification bodies for evaluation criteria and evaluation of the competence of certification bodies for personnel of the Commission shall be determined by the Minister of welfare.
5. upon certification authorities the Ministry of welfare assessment submitted to the Cabinet of Ministers proposals for the accreditation of certification bodies to perform certification.
6. The Cabinet of Ministers may withdraw the authorisation to carry out certification, if certification authority does not provide quality certification.
7. The Ministry of welfare and articulates the certification bodies and certified medical institutions ' registers.
8. certification authorities: 8.1 adopt medical certification application by the authorities, and concluded with the relevant contracts;
8.2. medical institutions assessed compliance with minimum requirements in accordance with the law on conformity assessment ";
8.3. the decision on the grant or refusal of the certificate of the grant of a certificate;
5.2. issue certificates;
8.5. stop the operation and the certificate renewed certificates;
8.6. revoke certificates;
8.7. in compliance with the certified medical institutions in the minimum requirements for supervision (hereinafter supervision of treatment);
8.8. every three months, publish in a newspaper "journal" to "list of treatment that have been issued certificates, as well as the list of treatment, which certificates are revoked or suspended certificate;
8.9. provide information on the minimum requirements and procedures for the certification of persons who will assess the conformity of the hospital's minimum requirements, as well as conformity assessment in the statement of expenditure and the hospital's surveillance spending estimates;
8.10. stores from medical authorities in the confidentiality of the information received in accordance with the procedure prescribed by law;
8.11. adopted from institutions of treatment charges associated with conformity assessment of treatment institutions and medical institutions.
III. Certification and certificate 9. for a certificate, the medical establishment: 9.1 shall provide the certification authority: 9.1.1. certification application;
9.1.2. hospital's staff training or formal qualifications;
9.1.3 treatment room, the property rights or lease the premises supporting documents;
9.1.4. other hospital's compliance with the minimum requirements of the supporting documents, if required by the certification authority;
9.2. the certification body provides seamless access to all objects and items necessary for conformity assessment;
9.3. conformity assessment by before you start making payments related to the hospital's conformity assessment.
10. The maximum amount of payment for treatment services for conformity assessment and the maximum payment amount of the supervision of treatment approved by the Minister of welfare.
11. certification authority launches hospital's conformity assessment within 30 days after receipt of the application for certification. Treatment services for conformity assessment and conformity assessment bodies of treatment involved in the person's medical establishment and certifi cation body i shall be set by mutual agreement.
12. The medical establishment in the written submissions in a reasoned is entitled to reject one, more or all of the persons carrying out the assessment of conformity. After receipt of the said application to the certifying authority shall submit to the institution of treatment proposals for other persons to assess the compliance of treatment.
13. Ten days after the end of the certification of the conformity assessment body shall take a decision on the award of the certificate and, if satisfied, issue a medical certificate of the authority stating: 13.1. treatment services or the name;
13.2. mandatory requirements which correspond to the medical establishment;
13.3. the areas of activity in which the medical authority allowed to work;
13.4. the period of validity of the certificate.
14. Where the conformity assessment is found in the course of non-compliance with the minimum requirements, within ten days after the end of the assessment of conformity certification authority shall provide a reasoned written opinion about the hospital's non-compliance with the minimum requirements. If the medical establishment within three months does not prevent non-compliance with the minimum requirements, the certification authority shall refuse certification.
15. the period of validity of the certificate in the outpatient treatment of a type of institutions is three years, hospitals — five years. The period of validity of the certificate shall automatically be extended accordingly for the next three or five years, supervision of compliance with the minimum requirements, it has been determined.
16. the certification body shall carry out the supervision of certified treatment bodies: 16.1. on its own initiative, inform the medical establishment;
16.2. the certified medical authority.
17. Treatment services once a year making payments related to medical institutions.
18. In the month following the end of conformity assessment of medical establishment is entitled to submit a complaint about the certification body in the conformity assessment. If the certification authority's response did not satisfy the medical establishment, it is entitled to submit a complaint to the Ministry of Welfare and the law courts.
19. certification authority maintain confidentiality with regard to their conformity assessment information obtained during that are commercial in nature or that the medical establishment is considered confidential.
IV. the refusal of certification certification is 20 refused, if:
20.1. the medical establishment, these provisions 9.1.1 9.1.2 9.1.3 9.1.4., and the documents referred to in (a) knowingly provided false information about its activities;
20.2. the medical establishment does not provide smooth access to all objects and items that match is evaluated;
20.3. the medical establishment has not taken the charges associated with the hospital's conformity assessment;
20.4. conformity assessment found inconsistencies in the minimum requirements is not resolved within three months.
V. certificate suspension and restoring 21. Certificate suspended, if the certification body treatment services during surveillance detected non-compliance with the minimum requirements and that the prevention of non-compliance with the time required is longer than two weeks. Certificate is suspended for a period of up to three months.
22. where a certificate has been suspended, certified therapeutic body can deal with medical treatment, but it may not be used for certificates for new contracts with the entities on cures for the provision of services or for promotional purposes.
23. certification authority 10 days after the end of supervision shall notify the authority of the medical certificate suspension.
24. the certification authority to renew the certificate after you prevent non-compliance with the minimum requirements.
Vi. withdrawal of the certificate the certificate shall withdraw 25. in the following cases: 25.1. if certified medical establishment is closed or eliminated;
25.2. the certified hospital's written request;
25.3. If the medical establishment that the certificate has been suspended, three months does not prevent non-compliance with the minimum requirements for the certificate in m. 26. cancellation of a certification authority shall take a decision, sent to hospital. Information about the cancellation of the certificate of the certification authority: Ministry of Welfare; 26.1.
26.2. the Central Health Insurance Fund;
2 6.3. The Registrar of companies;
26.4. The State revenue service;
26.5. the relevant municipality.
27. Medical authority within three days after receipt of the cancellation of the certificate, the certificate must pass the certification revoked.
28. The medical establishment is eligible within one month of the decision on the withdrawal or suspension of the certificate of receipt to submit the complaint to the certification authority on the withdrawal or suspension of the certificate. If the certification authority's response did not satisfy the treatment, it can be cold-g t the Ministry of welfare and the complaint to the Court in accordance with the procedure prescribed by law.
VII. Transition issues 29. Clinical medical laboratory evaluation of conformity in accordance with the standard EN EN 45001 "General requirements for the operation of testing laboratories" are equated with clinical diagnostic laboratory certification.
30. the treatment of certification authorities to the following time limits: 30.1. blood establishments and blood preparations chapter certification — up to 31 December 1998;
30.2. medical rehabilitation institutions of certification — up to 1 March 1999;
30.3. dental offices and dental technical lab certification — until June 1, 1999;
18.9. emergency medical certification of institutions — up to 1 august 1999;
5. the type of treatment ulator amb institutional certification — up to 1 October 1999;
19.0 hospital certification —. 1999 31 December.
31. the rules shall enter into force on 1 July 1998.
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