LIETUVOS RESPUBLIKOS SVEIKATOS APSAUGOS MINISTRAS



MINISTER OF HEALTH OF THE REPUBLIC OF LITHUANIA

ORDER

APPROVING THE DESCRIPTION OF PROCEDURES FOR THE PROVISION OF AND REIMBURSEMENT FOR LIVER TRANSPLANTATION

19 January 2010 No. V-47

Vilnius

Pursuant to part 6 of paragraph 9 of the Law of the Republic of Lithuania on Health Insurance (Official Gazette, 1996, No. 55-1287; 2002, No. 123-5512) and considering Resolution No. 7/4 of 22 December 2009 “Approving the Description of Procedures for the Provision of and Reimbursement for Liver Transplantation issued by the Compulsory Health Insurance Fund Council“:

1. I hereby approve the Description of Procedures for the Provision of and Reimbursement for Liver Transplantation (attached hereto).

2. I hereby delegate supervision of the execution of this order to a Deputy Minister within his area of authority.

MINISTER OF HEALTH ALGIS ČAPLIKAS

______________

APPROVED

by Order No. V-47

of 19 January 2010 issued by the Minister of Health of the Republic of Lithuania

DESCRIPTION OF PROCEDURES FOR THE PROVISION OF AND REIMBURSEMENT FOR LIVER TRANSPLANTATION

I. General provisions

1. The Description of Procedures for the Provision of and Reimbursement for Liver Transplantation Services (hereinafter referred to as “the Description of Procedures”) sets out the rules governing the provision of and reimbursement for liver transplantation services.

2. Liver transplantation services shall be provided in accordance with the provisions of the Law of the Republic of Lithuania on Donation and Transplantation of Human Tissues, Cells and Organs (Official Gazette, 1996, No. 116-2696; 2004, No. 55-1886).

3. Definitions in the Description of Procedures have the same meaning as set out in the Law of the Republic of Lithuania on Donation and Transplantation of Human Tissues, Cells and Organs.

4. Requirements for a personal healthcare institution which provides liver transplantation services (hereinafter referred to as “the institution providing transplantation services”):

4.1. An institution providing transplantation services is required to comply with general hygiene requirements for medical institutions set out in Hygiene Standard of Lithuania HN 47-1:2008 Healthcare Institutions. The Requirements for Sanitary and Epidemiological Control, approved by Order No. V-1270 of 24 December 2008 issued by the Minister of Health of the Republic of Lithuania “Approving the Hygiene Standard of Lithuania HN 47-1:2008. Healthcare Institutions. Requirements for Sanitary and Epidemiological Control” (Official Gazette, 2009, No. 4-107);

4.2. Devices used by the institution providing transplantation services must comply with the requirements for the safety of medical devices:

4.2.1. Medical Standard MN 4:2001. Technical Regulation for the Safety of Medical Devices and Medical Standard MN 100-2001. Technical Regulation for the Safety of Active Implantable Medical Devices approved by Order No. 101 of 8 February 2001 issued by the Minister of Health of the Republic of Lithuania “Approving the Medical Standard of Lithuania MN 4:2001. Technical Regulation for the Safety of Medical Devices and the Medical Standard of Lithuania MN 100:2001. Technical Regulation for the Safety of Active Implantable Medical Devices” (Official Gazette, 2001, No. 15-467);

4.2.2. Medical Standard MN 102:2002. Technical Regulation for the Safety of in Vitro Diagnostic Medical Devices approved by Order No. 679 of 29 December 2002 issued by the Minister of Health of the Republic of Lithuania “Approving the Medical Standard of Lithuania MN 102:2001. Technical Regulation for the Safety of in Vitro Diagnostic Medical Devices and Amending Order No. 176 of 15 March 2001 issued by the Minister of Health “Approving the Procedure for the Approval of Medical Devices in the Transition Period“ (Official Gazette, 2002, No. 9-323).

4.3. The institution providing transplantation services must have laboratory, endoscopy, radiology and functional diagnostics units providing 24-hour service and performing tests specified in this Description of Procedures.

4.4. The institution providing liver transplantation services must provide abdominal surgery, gastroenterology/paediatric gastroenterology, paediatric/adult resuscitation and intensive care in-patient tertiary level services and gastroenterology/paediatric gastroenterology and abdominal surgery outpatient tertiary level services.

4.5. The institution providing liver transplantation services must have a licence to provide organ (liver) transplantation services.*

4.6. The institution providing liver transplantation services must ensure that physicians involved in the liver transplantation process fulfil the following qualification requirements:

4.6.1. abdominal surgeons are required to hold a valid licence, to have at least 10 years of work experience and at least 5 years of experience in liver surgery (at least 10 liver resections (> 2 segments) per year) and in reconstructive bile duct surgery, and to have completed abdominal organ transplantation internships in clinics abroad;

4.6.2. blood vessel surgeons are required to hold a valid licence, to have at least 10 years of work experience and at least 5 years of experience in reconstructive vascular surgery and to have completed abdominal organ transplantation internships in clinics abroad;

4.6.3. gastroenterologists are required to hold a valid licence, to have at least 5 years of work experience and to have completed abdominal organ transplantation internships in clinics abroad;

4.6.4. paediatric gastroenterologists are required to hold a valid licence, to have at least 5 years of work experience and to have completed abdominal organ transplantation internships in clinics abroad;

4.6.5. anaesthesiologists-resuscitators are required to hold a valid licence, to have at least 5 years of work experience and to have completed abdominal organ transplantation internships in clinics abroad;

4.6.6. allergologists and clinical immunologists are required to hold a valid licence, to have at least 5 years of work experience in transplantation and to have completed abdominal organ transplantation internships in clinics abroad;

4.6.7. general nurses are required to hold a valid licence;

4.6.8. aesthetic and intensive care nurses are required to hold a valid licence.

5.

AMENDED :

by Order No V-471 of 25 May 2010 (as of 4 June 2010)

(Official Gazette, 2010, No. 64-3184)

Liver transplantation phases shall be as follows:

5.1. patient selection for liver transplantation;

5.2. periodic evaluation of the potential recipient in outpatient facilities;

5.3. preparation of the potential recipient for transplantation of the liver from a living/deceased donor;

5.4. selection and evaluation of the potential living donor;

5.5. selection and evaluation of the potential deceased donor;

5.6. liver retrieval;

5.7. liver transplantation;

5.8. post-transplant treatment and evaluation of the recipient in an in-patient facility;

5.9. post-transplant initial immunosuppressive therapy in an in-patient facility;

5.10. post-transplant monitoring and treatment of the recipient in outpatient facilities;

5.11. post-transplant treatment of the recipient in an in-patient facility for surgical complications;

5.12. post-transplant treatment of the recipient in an in-patient facility for other reasons;

5.13. post-transplant evaluation and treatment of acute transplant rejection;

5.14. post-transplant evaluation and treatment of steroid-resistant transplant rejection;

5.15. post-transplant tests to determine the status of and treatment for cytomegalovirus infection (CMV) and other infections;

5.16. post-transplant evaluation and treatment for hepatitis B virus (HBV).

II. PATIENT SELECTION FOR LIVER TRANSPLANTATION

6. Indications for liver transplantation:

6.1. end-phase liver cirrhosis;

6.2. acute or chronic liver failure;

6.3. liver tumours;

6.4. other acquired and inherited conditions with life-threatening extra-hepatic complications, when there is no effective alternative medical or surgical therapy.

7. Indications for urgent liver transplantation:

7.1. acute liver failure;

7.2. fast-appearing chronic liver failure (when the patient is treated in an in-patient facility);

7.3. hepatic trauma.

8. Contraindications to liver transplantation:

8.1. absolute contraindications:

8.1.1. systemic infections;

8.1.2. active chronic infectious diseases;

8.1.3. severe cardiac or pulmonary failure;

8.1.4. untreated extrahepatic malignancy (oncological criteria for a cure not met);

8.1.5. co-morbid conditions in diabetes mellitus;

8.1.6. active mental illness;

8.1.7. mental and behavioural disorders due to alcohol or psychoactive substance abuse;

8.1.8. persistent noncompliance by the patient with the physician‘s guidelines;

8.2. relative contraindications:

8.2.1. HIV infection;

8.2.2. aged 70 years or older;

8.2.3. cholangiocarcinoma;

8.2.4. diffuse portal vein and mesenteric blood vessel thrombosis;

8.2.5. severe or morbid obesity (BMI > 40).

9. Upon assessing the indications for and contraindications to liver transplantation, the treating physician (gastroenterologist/paediatric gastroenterologist, infectious disease physician, abdominal surgeon, clinical toxicologist, anaesthesiologist-resuscitator) shall refer the patient to an institution providing transplantation services for assessment of the eligibility for liver transplantation. In the referral (in the extract from medical records No 027/a), the physician shall provide the results of the following tests:

9.1. full blood count;

9.2. creatinine level;

9.3. albumin level;

9.4. aspartate aminotransferase (AST) activity;

9.5. alanine aminotransferase (ALT) activity;

9.6. alkaline phosphatase (ALP) activity;

9.7. gamma-glutamyl transferase (GGT) activity;

9.8. total bilirubin level;

9.9. direct-reacting bilirubin level;

9.10. prothrombin time/international normalized ratio (PT/INR);

9.11. abdominal ultrasound scan.

10. Upon assessing the patient and evaluating the results of tests provided in the extract from medical records No. 027/a, the gastroenterologist/paediatric gastroenterologist of the institution providing transplantation services shall organise a Panel of Consulting Physicians which includes gastroenterologists/paediatric gastroenterologists and/or abdominal surgeons. Having found indications for liver transplantation referred to in paragraph 6 of the Description of Procedures, the Panel of Consulting Physicians shall inform the patient or his legal representative (if the patient is a minor or incapacitated) of the indications for liver transplantation, risks associated with transplant surgery and rules for provision of services set out in this Description of Procedures.

11. After the patient or his legal representative became aware of the indications for liver transplantation, risks associated with transplant surgery and rules for provision of services, and signed the patient consent form approved by the head of the institution providing transplantation services agreeing to liver transplantation, the gastroenterologist/paediatric gastroenterologist of the in-patient facility shall order tests specified for the service for selection of patients for liver transplantation:

11.1. Laboratory tests:

11.1.1. full blood count;

11.1.2. blood group by presence of ABO antigens and Rh (D) factor;

11.1.3. albumin level;

11.1.4. total bilirubin level;

11.1.5. direct-reacting bilirubin level;

11.1.6. aspartate aminotransferase (AST) activity;

11.1.7. alanine aminotransferase (ALT) activity;

11.1.8. alkaline phosphatase (ALP) activity;

11.1.9. gamma-glutamyl transferase (GGT) activity;

11.1.10. prothrombin time/international normalized ratio (PT/INR);

11.1.11. fibrinogen level;

11.1.12. activated partial thromboplastin time (APTT);

11.1.13. urea level;

11.1.14. creatinine level;

11.1.15. uric acid level;

11.1.16. C-reactive protein (CRP);

11.1.17. sodium level;

11.1.18. potassium level;

11.1.19. chloride levels;

11.1.20. total cholesterol level;

11.1.21. high-density lipoprotein cholesterol level;

11.1.22. low-density lipoprotein cholesterol level;

11.1.23. triglyceride level;

11.1.24. serum (plasma) glucose level;

11.1.25. hepatitis A virus antibodies (anti-HAV);

11.1.26. hepatitis B virus surface antigen (HBsAg);

11.1.27. hepatitis B virus surface antibodies (HBsAg);

11.1.28. hepatitis B virus core antigen (anti-HBcor);

11.1.29. hepatitis C virus (HCV) antibodies;

11.1.30. cytomegalovirus Ig M (CMV IgM);

11.1.31. cytomegalovirus Ig G (CMV IgG);

11.1.32. Epstein-Barr virus Ig M (EBV Ig M);

11.1.33. Epstein-Barr virus Ig G (EBV IgG);

11.1.34. Herpes simplex virus 1/2 IgM (HSV 1/2 IgM);

11.1.35. Herpes simplex virus 1 IgG (HSV 1 IgG);

11.1.36. Herpes zoster virus IgM (HZV IgM);

11.1.37. Herpes zoster virus IgG (HZV IgG);

11.1.38. Toxoplasma Gondii Ig M (TOXO IgM);

11.1.39. Toxoplasma Gondii Ig G (TOXO IgG);

11.1.40. human immunodeficiency virus type 1 and type 2 (anti-HIV 1/2);

11.1.41. RPR test;

11.1.42. methicillin-resistant Staphylococcus Aureus (MRSA) in nasal and pharyngeal smears;

11.1.43. alpha-fetoprotein;

11.1.44. tumour marker CA 19-9;

11.1.45. carcinoembryonic antigen (CEA) test;

11.1.46. full urine test;

11.1.47. stool test;

11.1.48. pre-transplant immunologic evaluation.

11.2. Instrumental analysis:

11.2.1. 12-lead ECG, including description of the ECG findings;

11.2.2. echocardiography;

11.2.3. duplex scanning of the abdominal cavity and retroperitoneal space;

11.2.4. abdominal ultrasound scan;

11.2.5. diagnostic esophagogastroduodenoscopy;

11.2.6. chest X-ray;

11.2.7. pulmonary function tests;

11.2.8. computed tomographic angiography of the abdomen;

11.2.9. gynaecological (for women) or urological ultrasound (for men);

11.2.10. mammography test (for women aged 40 years and older);

11.2.11. colonoscopy (aged 50 years and older).

11.3. Consultations with medical specialists:

11.3.1. otorhinolaryngologist;

10.3.2. obstetrician-gynaecologist/urologist;

11.3.3. psychologist/psychiatrist;

11.3.4. dentist;

11.3.5. radiologist.

11.4. Additional consultations with medical specialists, and laboratory and instrumental consultations may be performed based on clinical indications, if appropriate.

12. Upon evaluating the results of tests and consultations referred to in paragraph 11 of this Description of Procedures and in the absence of any absolute contraindication, the gastroenterologist/paediatric gastroenterologist of the institution providing transplantation services shall submit a proposal regarding the organisation of a Panel of Consulting Physicians.

13. Following the positive decision taken by the consulting gastroenterologists/paediatric gastroenterologists and abdominal surgeons, the patient shall be included in the list of potential recipients waiting for liver transplantation (hereinafter referred to as “the Waiting List”). The gastroenterologist/paediatric gastroenterologist shall provide information about the potential recipient to the Register of Donors and Recipients of Human Tissues and Organs (hereinafter referred to as “the Registry”).

14. In the case of indications for urgent liver transplantation specified in paragraph 7 of the Description of Procedures, the Panel of Consulting Physicians, which includes the gastroenterologist/paediatric gastroenterologist, anaesthesiologist-resuscitator, and abdominal surgeon, may take a motivated decision to reduce the scope of tests set out in paragraph 11 of the Description of Procedures and perform only the laboratory tests specified in subparagraph 11.1, computed tomographic angiography of the abdomen, and, if there are no contraindications, liver biopsy and histological assessment of the biopsy specimen.

15. The decision of the Panel of Consulting Physicians shall be included in the Record of the Panel of Consulting Physicians for Liver Transplantation Indications (Annex 2). This Record should be kept along with completed medical documents (Inpatient Clinical Records – form No. 003/a or Outpatient Health Records – form No. 025/a).

16. The gastroenterologist/paediatric gastroenterologist of the institution providing transplantation services shall administer to the listed potential recipient the following vaccines against the infectious diseases and agents*hepatitis A and B, influenza, pertussis, diphtheria, tetanus, poliomyelitis, varicella, BCG against tuberculosis, rabies, measles, rubella, parotitis, Haemofilus influenzae, Str. Pneumoniae, N. Meningitidis.

III. PERIODIC EVALUATION OF THE POTENTIAL RECIPIENT IN OUTPATIENT FACILITIES

17. The gastroenterologist/paediatric gastroenterologist/abdominal surgeon of the institution providing transplantation services must periodically evaluate the health status of the potential recipient placed on the Waiting List, order tests and administer treatment of the potential recipient and notify the National Transplant Bureau (hereinafter referred to as “the Bureau”) of the following significant changes in his health status:

17.1. temporary not recipient, in the case of a stable improvement of liver condition over at least 3 months;

17.2. appearance of absolute contraindications to liver transplantation specified in subparagraph 8.1 of the Description of Procedures;

17.3. death.

18. The gastroenterologist/paediatric gastroenterologist of the institution providing transplantation services shall refer the potential recipient placed on the Waiting List for testing in outpatient facilities (periodicity as approved by the physician):

18.1. Laboratory tests:

18.1.1. full blood count;

18.1.2. total bilirubin level;

18.1.3. direct-reacting bilirubin level;

18.1.4. aspartate aminotransferase (AST) activity;

18.1.5. alanine aminotransferase (ALT) activity;

18.1.6. alkaline phosphatase (ALP) activity;

18.1.7. gamma-glutamyl transferase (GGT) activity;

18.1.8. albumin level;

18.1.9. prothrombin time/international normalized ratio (PT/INR);

18.1.10. creatinine level;

18.1.11. alpha-fetoprotein (at least 2 times per year).

18.2. Instrumental analysis:

18.2.1. abdominal ultrasound scan (at least 2 times per year);

18.2.2. diagnostic esophagogastroduodenoscopy (at least 1 time per year);

18.2.3. computed tomographic angiography of the abdomen (at least 1 time per year).

18.3. Depending on clinical indications, the gastroenterologist/paediatric gastroenterologist may administer other laboratory and instrumental tests to the potential recipient or refer him to medical specialists for treatment.

19. In the case of deterioration in the health status of the potential liver recipient (febrile, bleeding from the gastrointestinal tract, refractory ascites/hydrothorax, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatopulmonary syndrome/portopulmonary syndrome, hepatic encephalopathy (stages 3 and 4), hepatocellular carcinoma), the gastroenterologist/paediatric gastroenterologist or abdominal surgeon of the institution providing transplantation services shall refer the potential recipient to a gastroenterology unit, abdominal surgery unit or resuscitation and intensive therapy unit for treatment and testing.

20. Upon finding indications for urgent liver transplantation to the potential recipient referred to in paragraph 7 of the Description of Procedures, the treating gastroenterologist/paediatric gastroenterologist, abdominal surgeon or anaesthesiologist-resuscitator shall organise a Panel of Consulting Physicians, which includes medical specialists involved in the transplantation process. The Bureau should be immediately notified in writing regarding conclusions of the Panel of Consulting Physicians.

21. The Bureau's duty coordinator shall immediately notify institutions providing transplantation services, laboratory service and international organisations providing human liver donation and transplantation services about the potential recipient in need of liver transplantation.

22. In the case of indications for urgent liver transplantation to the potential recipient, the transplantation shall be performed without regard to the matching criteria of liver donor-recipient pair, assessment of mismatch status and the ABO/Rh incompatibility.

23. In the case of death of the potential recipient or new circumstances preventing the liver transplantation, the treating gastroenterologist/paediatric gastroenterologist, abdominal surgeon or anaesthesiologist-resuscitator must notify the Bureau within one hour, and the Bureau must stop the urgent search for a donor organ.

IV. PPREPARATION OF THE POTENTIAL RECIPIENT FOR TRANSPLANTATION OF THE LIVER FROM THE LIVING/DECEASED DONOR

24. When a donor is available, the Panel of Consulting Physicians, which includes gastroenterologists/paediatric gastroenterologists who periodically evaluate and treat potential liver recipients, shall select potential recipients for liver transplantation.

25. The potential recipient for liver transplantation from a deceased donor should be selected based on blood group, Rh, body height and weight of both the potential recipient and the potential donor. A completed liver donor-recipient pair selection form (Annex 3) should be provided to the Bureau.

26. In the selection of a potential recipient for liver transplantation, priority should be given to the patient with the most severe liver disease (with the higher MELD score * ) and who has waited longer for liver transplantation.

27. To receive a part of the liver from a living donor, the potential recipient must be related to the donor by blood or marriage, and provide supporting documents and copies.

28. The abdominal surgeon of the institution providing transplantation shall administer the following laboratory and instrumental tests and refer the potential recipient to medical specialists for consultation:

28.1. Laboratory tests (required for all potential recipients):

28.1.1. blood group by the presence of ABO antigens and Rh (D) factor;

28.1.2. full blood count;

28.1.3. full urine test;

28.1.4. urea level;

28.1.5. creatinine level;

28.1.6. potassium level;

28.1.7. sodium level;

28.1.8. chloride levels;

28.1.9. calcium level;

28.1.10. ionized calcium level;

28.1.11. total protein level;

28.1.12. albumin level;

28.1.13. total bilirubin level;

28.1.14. direct-reacting bilirubin level;

28.1.15. alanine aminotransferase (ALT) activity;

28.1.16. aspartate aminotransferase (AST) activity;

28.1.17. lactate levels;

28.1.18. alkaline phosphatase (ALP) activity;

28.1.19. gamma-glutamyl transferase (GGT) activity;

28.1.20. C-reactive protein;

28.1.21. alpha amylase level;

28.1.22. serum (plasma) glucose level;

28.1.23. prothrombin time/international normalized ratio (PT/INR);

28.1.24. fibrinogen level;

28.1.25. activated partial thromboplastin time (APTT);

28.1.26. blood gas and pH analysis;

28.1.27. donor-recipient lymphocytotoxicity cross-matching.

28.2. Instrumental analysis:

28.2.1. 12-lead ECG, including description of the ECG findings;

28.2.2. chest X-ray;

28.2.3. abdominal ultrasound scan.

28.3. Depending on clinical indications, the abdominal surgeon may administer other laboratory and instrumental tests and refer the potential recipient to medical specialists for consultation.

V. SELECTION AND EVALUATION OF THE POTENTIAL LIVING DONOR

29. The Law on Donation and Transplantation of Human Tissues, Cells and Organs of the Republic of Lithuania regulates the donation by living people of solid organs and tissues.

30. Contraindications to donation:

30.1. absolute contraindications to donation:

30.1.1. the living donor is under the age of 18 years;

30.1.2. severe coronary, pulmonary or renal failure;

30.1.3. chronic liver disease;

30.1.4. untreated cancer;

30.1.5. HIV;

30.1.6. systemic infections, sepsis;

30.1.7. active chronic infectious diseases;

30.1.8. addiction to alcohol or psychoactive substances;

30.1.9. severe or morbid obesity (BMI > 40);

30.1.10. pregnancy;

30.2. relative contraindications to donation:

30.2.1. incompatibility of blood groups by ABO antigens and Rh (D) factor;

30.2.2. prior history of thrombosis or thromboembolism;

30.2.3. defective clotting;

30.2.4. viral hepatitis B and viral hepatitis C.

31. A person willing to donate a part of his liver for transplantation should turn to a family physician at the primary healthcare institution, which he has chosen in line with the provisions of applicable law.

32. The family physician at the primary healthcare institution shall refer the person willing to donate a part of his liver for transplantation, i.e. potential living donor, for the following tests:

32.1. full blood count;

32.2. full urine test;

32.3. blood group by the presence of ABO antigens and Rh (D) factor.

33. The family physician at the primary healthcare institution shall refer the potential living donor to a gastroenterologist of the institution providing transplantation services for evaluation of his eligibility for liver donation (extract from medical records No. 027/a, ICD-10 diagnosis code: Z00.5 (Examination of a potential donor of organ and tissue). The referral should be accompanied by the following test findings and information:

33.1. age of the potential donor;

33.2. evidence of genetic (marital) relationship between the potential donor and the potential recipient;

33.3. motivation;

33.4. important medical history facts;

33.5. height and weight;

33.6. arterial blood pressure.

34. The potential living donor must deliver the referral and evidence, original and copies, of genetic (marital) relationship with the potential recipient.

35. The gastroenterologist of the institution providing transplantation services shall refer the potential living donor to outpatient facilities for laboratory and instrumental tests:

35.1. Laboratory tests:

35.1.1. full blood count;

35.1.2. blood group by the presence of ABO antigens and Rh (D) factor;

35.1.3. full urine test;

35.1.4. serum (plasma) glucose level;

35.1.5. creatinine level;

35.1.6. total cholesterol level;

35.1.7. triglyceride level;

35.1.8. total bilirubin level;

35.1.9. direct-reacting bilirubin level;

35.1.10. aspartate aminotransferase (AST) activity;

35.1.11. alanine aminotransferase (ALT) activity;

35.1.12. alkaline phosphatase (ALP) activity;

35.1.13. gamma-glutamyl transferase (GGT) activity;

35.1.14. prothrombin time/international normalized ratio (PT/INR);

35.1.15. activated partial thromboplastin time (APTT);

35.1.16. fibrinogen level;

35.1.17. D-dimer level;

35.1.18. C-reactive protein (CRP);

35.1.19. prostate specific antigen (PSA) (men aged 40 and older);

35.1.20. hepatitis A virus IgM antibodies (anti-HAV Ig M);

35.1.21. hepatitis B virus surface antigen (HBs Ag);

35.1.22. hepatitis B virus e antigen (HBe Ag);

35.1.23. hepatitis B virus e antigen antibodies (anti-HBe);

35.1.24. hepatitis B virus core antigen antibodies (anti-HBcor);

35.1.25. hepatitis B virus surface antigen antibodies (HBsAg);

35.1.26. hepatitis B virus surface antigen (HBsAg);

35.1.27. human immunodeficiency virus type 1 and type 2 (anti-HIV 1/2);

35.1.28. cytomegalovirus Ig M (CMV IgM);

35.1.29. cytomegalovirus Ig G (CMV IgG);

35.1.30. Epstein-Barr virus Ig M (EBV IgM);

35.1.31. Epstein-Barr virus Ig G (EBV IgG);

35.1.32. Toxoplasma Gondii Ig M (TOXO IgM);

35.1.33. Toxoplasma Gondii Ig G (TOXO IgG);

35.1.34. RPR test;

35.1.35. stool test;

35.1.36. human chorionic gonadotropin (women).

35.2. Instrumental analysis:

35.2.1. 12-lead ECG, including description of the ECG findings;

35.2.2. diagnostic esophagogastroduodenoscopy;

35.2.3. abdominal ultrasound scan;

35.2.4. chest X-ray;

35.2.5. liver-computed tomographic angiography and volumetric images.

35.3. Depending on clinical indications, the gastroenterologist may administer the potential living donor other laboratory and instrumental tests and refer him to medical specialists for consultation.

36. Upon assessing the results of tests of the potential living donor regarding eligibility for donation, the gastroenterologist of institution providing transplantation services shall refer to the Panel of Consulting Physicians.

37. The Panel of Consulting Physicians shall include: a gastroenterologist, abdominal surgeon performing liver transplantations and other medical specialists (if necessary). Conclusions produced by the Panel of Consulting Physicians shall be valid for 3 months from the date of signature.

38. If the Panel of Consulting Physicians finds no contraindications to liver donation and the potential living donor signs the informed person consent for retrieval of his tissues and/or solid organs while he is alive (form No. 139/a), the potential living donor shall be hospitalized at an institution providing transplantation services for the resection of the liver.

39. The gastroenterologist of the institution providing transplantation services shall send the original of informed person consent for retrieval of his tissues and/or solid organs while he is alive (form No. 139/a) to the Registry and its copy and the referral to hospital shall be given to the patient.

VI. SELECTION AND EVALUATION OF THE POTENTIAL DECEASED DONOR

40. Absolute contraindications to donation:

40.1. person's objection to donation of his tissues and/or organs for transplantation after his death (form No. 137/a);

40.2. HIV;

40.3. active systemic bacterial, fungal or viral infections;

40.4. any active cancer, except brain tumours, skin basal cell carcinoma and carcinoma in situ of the uterus without systemic spread.

41. Relative contraindications to donation:

41.1. the potential donor is 70 years old or older or under 1 year;

41.2. insulin-dependent diabetes mellitus;

41.3. acute or chronic liver failure;

41.4. chronic liver diseases;

41.5. acute liver diseases;

41.6. systemic diseases (collagenosis, vasculitis);

41.7. addiction to alcohol or psychoactive substances;

41.8. hepatic trauma;

41.9. intra-abdominal infection;

41.10. drug intoxication;

41.11. children from parents with HIV behavioural risk.

42. The Panel of Consulting Physicians, which includes an abdominal surgeon performing liver transplantations, gastroenterologist, Bureau's duty coordinator and physician preparing the donor.

43. Evaluation of the potential deceased donor shall be carried out in accordance with the provisions of the Requirements for the Provision of Services Related to Donation, Procurement, Evaluation, Processing, Preservation, Storage, and Distribution of Organs and Tissues from a Cadaveric Donor approved by Order No. V-7 of 4 January 2008 issued by the Minister of Health “Approving Donation, Procurement, Evaluation, Processing, Preservation, Storage, and Distribution of Organs and Tissues from a Cadaveric Donor” (Official Gazette, 2008, No. 7-251).

VII. LIVER RETRIEVAL

44. Retrieval of a part of the liver from the living donor shall be performed at the institutions providing transplantation services.

45. The abdominal surgeon responsible for the retrieval of a part of the liver from the living donor must complete the Retrieval Record: the original should be kept with the living donor medical records at the in-patient facility, and a copy thereof must be submitted to the Registry.

46. Retrieval of the liver from the diseased donor:

46.1. retrieval of the liver from the diseased donor shall be performed at the healthcare institution preparing the deceased donor;

46.2. retrieval of the liver shall be performed by a team of medical specialists fulfilling requirements set out in items 4.6.1 and/or 4.6.2 and 4.6.7, which was summoned by the Bureau's based on the rotas for doctors provided by institutions providing transplantation services.

47. Upon performing retrieval of the liver from the diseased donor, the retrieving physician must complete the Liver Retrieval Record (Annex 4): the original should be kept with the donor medical records at the in-patient facility, one copy thereof must be submitted to the Registry and one copy should be sent along with the organ.

VIII. LIVER TRANSPLANTATION

48. Transplantation of the liver from a living/diseased donor shall be performed at the institution providing transplantation services which complies with the requirements laid down in paragraph 4 of this Description of Procedures.

49. Transplantation of the liver should be performed by staff which meet the requirements laid down in paragraph 4.6 of this Description of Procedure.

50. The abdominal surgeon who took part in liver transplantation must complete forms regarding the transplantation, or, if the liver was not transplanted, regarding the disposal approved by the Bureau, to be submitted to the Registry.

IX. POST-TRANSPLANT TREATMENT AND EVALUATION OF THE RECIPIENT IN AN IN-PATIENT FACILITY

51. Following the transplantation, the recipient shall be treated at the resuscitation and intensive care unit (hereinafter referred to as “the RICU”) of the institution providing transplantation services:

51.1. Tests administered to the recipient (periodicity as approved by the treating physician):

51.1.1. cyclosporine/tacrolimus level;

51.1.2. full blood count;

51.1.3. automated urine test;

51.1.4. blood compatibility test;

51.1.5. total protein level;

51.1.6. albumin level;

51.1.7. creatinine level;

51.1.8. urea level;

51.1.9. glucose level (in capillary blood);

51.1.10. total bilirubin level;

51.1.11. direct-reacting bilirubin level;

51.1.12. potassium level;

51.1.13. sodium level;

51.1.14. chloride levels;

51.1.15. calcium level;

51.1.16. phosphorus level;

51.1.17. magnesium level;

51.1.18. intensive care laboratory indicators (blood gases, pH, oxymetric analysis, haemoglobin fractions, osmolarity, glucose level, lactate level);

51.1.19. aspartate aminotransferase (AST) activity;

51.1.20. alanine aminotransferase (ALT) activity;

51.1.21. alkaline phosphatase (ALP) activity;

51.1.22. lactate dehydrogenase (LDH) activity;

51.1.23. gamma-glutamyltransferase (GGT) activity;

51.1.24. lipase activity;

51.1.25. prothrombin time/international normalized ratio (PT/INR);

51.1.26. fibrinogen level;

51.1.27. activated partial thromboplastin time (APTT);

51.1.28. antithrombin III;

51.1.29. procalcitonin test;

51.1.30. C-reactive protein (CRP);

51.1.31. automated blood culture (for aerobic and anaerobic organisms);

51.1.32. microscopy of Gram stain from pathologic material;

51.1.33. antibacterial susceptibility by disk diffusion technique (12 disks);

51.1.34. MIC (mg/mL) of an antibacterial drug tested by an automated dilution system;

51.1.35. immunological tests.

51.2. Instrumental analysis:

51.2.1. chest X-ray;

51.2.2. CT of the chest, abdomen, and pelvis with/without intravenous contrast;

51.2.3. abdominal ultrasound scan;

51.2.4. duplex scanning of the abdominal cavity and retroperitoneal space;

51.2.5. ultrasound of the heart.

51.3. Depending on clinical indications, the treating physician may administer the recipient other laboratory and instrumental tests and refer him to medical specialists for consultation.

52. After the transplantation, the recipient shall be transferred from the RICU to the abdominal surgery unit of the institution providing transplantation services for further therapy:

52.1. Laboratory tests to be performed (periodicity as approved by the treating physician):

52.1.1. cyclosporine/tacrolimus level;

52.1.2. full blood count;

52.1.3. prothrombin time/international normalized ratio (PT/INR);

52.1.4. fibrinogen level;

52.1.5. activated partial thromboplastin time (APTT);

52.1.6. creatinine level;

52.1.7. urea level;

52.1.8. total bilirubin level;

52.1.9. direct-reacting bilirubin level;

52.1.10. lactate dehydrogenase (LDH) activity;

52.1.11. aspartate aminotransferase (AST) activity;

52.1.12. alanine aminotransferase (ALT) activity;

52.1.13. alkaline phosphatase (ALP) activity;

52.1.14. gamma-glutamyl transferase (GGT) activity;

52.1.15. albumin level;

52.1.16. potassium level;

52.1.17. sodium level;

52.1.18. chloride levels;

52.1.19. calcium level;

52.1.20. glucose level;

52.1.21. C-reactive protein (CRP).

52.2. Instrumental analysis:

52.2.1. abdominal ultrasound scan;

52.2.2. duplex scanning of the abdominal cavity and retroperitoneal space.

52.3. Depending on clinical indications, the treating physician may administer the recipient other laboratory and instrumental tests and refer him to medical specialists for consultation.

53. The post-transplant recipient shall be transferred from the abdominal surgery unit to the gastroenterology unit of the institution providing transplantation services for further therapy:

53.1. Laboratory tests to be performed (periodicity as approved by the treating physician):

53.1.1. cyclosporine/tacrolimus level;

53.1.2. full blood count;

53.1.3. prothrombin time/international normalized ratio (PT/INR);

53.1.4. creatinine level;

53.1.5. albumin level;

53.1.6. total bilirubin level;

53.1.7. direct-reacting bilirubin level;

53.1.8. aspartate aminotransferase (AST) activity;

53.1.9. alanine aminotransferase (ALT) activity;

53.1.10. alkaline phosphatase (ALP) activity;

53.1.11. gamma-glutamyl transferase (GGT) activity;

53.1.12. lactate dehydrogenase (LDH) activity;

53.1.13. full urine test with microscopy of urine sediment;

53.1.14. C-reactive protein (CRP).

53.2. Instrumental analysis:

53.2.1. duplex scanning of the abdominal cavity and retroperitoneal space.

53.3. Depending on clinical indications, the treating physician may administer the recipient other laboratory and instrumental tests and refer him to medical specialists for consultation.

54. Upon assessing the indications for liver transplantation, medical specialists involved in the liver transplantation process (abdominal surgeon, gastroenterologist/paediatric gastroenterologist, allergologist and clinical immunologist) shall administer the recipient a combined immunosuppressive therapy (corticosteroids, calcineurin inhibitors, antiproliferative drugs, lymphocyte membrane protein antibodies) just before the transplantation of the liver to prevent rejection of the transplant (at the abdominal surgery unit), which will be continued throughout the recipient’s life.

X. POST-TRANSPLANT INITIAL IMMUNOSUPPRESSIVE THERAPY IN AN IN-PATIENT FACILITY

55. The institution providing transplantation services shall provide initial immunosuppressive therapy services in its in-patient facilities.

56. Initial immunosuppressive therapy will be initiated before the liver transplantation, administered by one-time infusions following the immunosuppressive therapy protocol approved by the head of the institution providing transplantation services. Initial immunosuppressive therapy may applied during other liver transplant phases or the patient may be hospitalized specifically with the purpose of an immunosuppressive therapy course.

57. When the recipient is hospitalized once again for initial immunosuppressive therapy, the gastroenterologist/paediatric gastroenterologist shall administer the following tests:

57.1. Laboratory tests:

57.1.1. cyclosporine/tacrolimus level;

57.1.2. full blood count;

57.1.3. C-reactive protein (CRP);

57.1.4. creatinine level;

57.1.5. total bilirubin level;

57.1.6. direct-reacting bilirubin level;

57.1.7. aspartate-aminotransferase (AST) activity;

57.1.8. alanine aminotransferase (ALT) activity;

57.1.9. alkaline phosphatase (ALP) activity;

57.1.10. gamma-glutamyl transpeptidase (GGT) activity.

57.2. Instrumental analysis:

57.2.1. duplex scanning of the abdominal cavity and retroperitoneal space.

57.3. Depending on clinical indications, the treating physician may administer the recipient other laboratory and instrumental tests and refer him to medical specialists for consultation.

XI. POST-TRANSPLANT MONITORING AND TREATMENT OF THE RECIPIENT IN OUTPATIENT FACILITIES

58. The outpatient follow-up of the recipient will be ensured by the gastroenterologist/paediatric gastroenterologist of the institution providing transplantation services.

59. Frequency of outpatient tests administered to the recipient and consultations by the gastroenterologist/paediatric gastroenterologist: once every four weeks during one month after the discharge from the hospital and up to 6 months after the liver transplantation; once every month or two months during the period from 6 months to 12 months after the transplantation; at least once every three months after the first year following the transplantation.

60. The gastroenterologist/paediatric gastroenterologist shall administer laboratory and instrumental tests based on test frequency recommendations set forth in Tables 1, 2 and 3:

Table 1

TESTS TO BE PERFORMED DURING THE PERIOD UP TO 6 MONTHS AFTER THE LIVER TRANSPLANTATION

|Tests |Frequency |

| |(number of times per 6 months) |

|full blood count |6 |

|total bilirubin level |6 |

|direct-reacting bilirubin level |6 |

|aspartate-aminotransferase (AST) activity |6 |

|alaninamino-transferase (ALT) activity |6 |

|gamma-glutamyl transpeptidase (GGT) activity |6 |

|alkaline phosphatase (ALP) activity |6 |

|creatinine level |6 |

|serum glucose level |6 |

|full urine test |3 |

|C-reactive protein (CRP) |6 |

|cyclosporine/tacrolimus level |6/3 |

|duplex scanning of the abdominal cavity and retroperitoneal space |2 |

Table 2

TESTS TO BE PERFORMED DURING THE PERIOD FROM 6 MONTHS TO 12 MONTHS AFTER THE LIVER TRANSPLANTATION

|Tests |Frequency |

| |(number of times per 6 months) |

|full blood count |3 |

|total bilirubin level |3 |

|direct-reacting bilirubin level |3 |

|aspartate-aminotransferase (AST) activity |3 |

|alaninamino-transferase (ALT) activity |3 |

|gamma-glutamyl transpeptidase (GGT) activity |3 |

|alkaline phosphatase (ALP) activity |3 |

|creatinine level |3 |

|serum glucose level |3 |

|cyclosporine/tacrolimus level |6/3 |

|C-reactive protein (CRP) |3 |

|total cholesterol level |1 |

|high-density lipoprotein cholesterol level |1 |

|low-density lipoprotein cholesterol level |1 |

|triglyceride level |1 |

|full urine test |1 |

|abdominal ultrasound scan |1 |

|duplex scanning of the abdominal cavity and retroperitoneal space |1 |

Table 3

TESTS TO BE PERFORMED AFTER THE FIRST YEAR FOLLOWING THE TRANSPLANTATION

|Tests |Frequency |

| |(number of times per year) |

|full blood count |4 |

|total bilirubin level | 4 |

|direct-reacting bilirubin level |4 |

|aspartate-aminotransferase (AST) activity |4 |

|alaninamino-transferase (ALT) activity |4 |

|gamma-glutamyl transpeptidase (GGT) activity |4 |

|alkaline phosphatase (ALP) activity |4 |

|creatinine level |4 |

|serum glucose level |4 |

|cyclosporine/tacrolimus level |8/4 |

|C-reactive protein (CRP) |4 |

|total cholesterol level |1 |

|high-density lipoprotein cholesterol level |1 |

|low-density lipoprotein cholesterol level |1 |

|triglyceride level |1 |

|full urine test |2 |

|abdominal ultrasound scan |1 |

|duplex scanning of the abdominal cavity and retroperitoneal space |2 |

61. Depending on clinical indications, the gastroenterologist/paediatric gastroenterologist may administer the patient other laboratory and instrumental tests and refer him to medical specialists for treatment.

XII. POST-TRANSPLANT TREATMENT OF THE RECIPIENT IN AN IN-PATIENT FACILITY FOR SURGICAL COMPLICATIONS

62. In-patient treatment of the recipient for complications following the liver transplantation shall be carried out in the institution providing transplantation services:

62.1. in the case of complications (acute bleeding with unstable haemodynamics, blood vessel thrombosis, bile duct leakage, bowel ischemia/necrosis) right after the liver transplantation, additional surgeries shall be performed during the same hospitalization;

62.2. in the case of complications (blood vessel aneurysm/ stricture/thrombosis, bile duct stricture) some time after the liver transplantation, additional surgeries shall be performed during a later hospitalization.

63. The following tests should be administered to the recipient (the treating physician shall determine the frequency of testing):

63.1. Laboratory tests:

63.1.1. cyclosporine/tacrolimus level;

63.1.2. full blood count;

63.1.3. C-reactive protein (CRP);

63.1.4. prothrombin time/international normalized ratio (PT/INR);

63.1.5. creatinine level;

63.1.6. total bilirubin level;

63.1.7. direct-reacting bilirubin level;

63.1.8. aspartate-aminotransferase (AST) activity;

63.1.9. alanine aminotransferase (ALT) activity;

63.1.10. alkaline phosphatase (ALP) activity;

63.1.11. gamma-glutamyl transpeptidase (GGT) activity.

63.2. Instrumental analysis:

63.2.1. duplex scanning of the abdominal cavity and retroperitoneal space.

63.3. Depending on clinical indications, the treating physician may administer the recipient other laboratory and instrumental tests and refer him to medical specialists for consultation.

XIII. POST-TRANSPLANT TREATMENT OF THE RECIPIENT IN AN IN-PATIENT FACILITY FOR OTHER REASONS

64. If health status of the recipient deteriorated for other reasons, he should be treated in a in-patient facility of the institution providing transplantation services or in a personal healthcare institution providing specialist tertiary-level services.

65. Medical specialists at a treating institution shall administer immunosuppressive therapy based on recommendations given by the gastroenterologist/paediatric gastroenterologist/abdominal surgeon of the institution providing transplantation services.

66. Laboratory tests and instrumental analysis listed in paragraphs 63.1 and 63.2 of the Description of Procedures should be performed. In addition, the recipient may be administered other tests and referred to medical specialists for consultations because of clinical indications.

XIV. POST-TRANSPLANT EVALUATION AND TREATMENT OF ACUTE TRANSPLANT REJECTION

67. Services related to liver rejection diagnosis and therapy services shall be provided at the institution providing transplantation services.

68. If liver transplant rejection is suspected, percutaneous liver biopsy and histological examination of a biopsy specimen should be performed if there is no contraindication to liver biopsy. If rejection is confirmed by histological or clinical (in the case of contraindications to liver biopsy) findings, the recipient should be administered the methylprednisolone pulse therapy in parallel with the continued immunosuppressive therapy.

69. The following tests should be administered to the recipient (the gastroenterologist/paediatric gastroenterologist shall determine the frequency of testing):

69.1. Laboratory tests:

69.1.1. cyclosporine/tacrolimus level;

69.1.2. full blood count;

69.1.3. C-reactive protein (CRP);

69.1.4. procalcitonin test;

69.1.5. prothrombin time/international normalized ratio (PT/INR);

69.1.6. D-dimer test;

69.1.7. creatinine level;

69.1.8. total bilirubin level;

69.1.9. direct-reacting bilirubin level;

69.1.10. aspartate-aminotransferase (AST) activity;

69.1.11. alanine aminotransferase (ALT) activity;

69.1.12. alkaline phosphatase (ALP) activity;

69.1.13. gamma-glutamyl transferase (GGT) activity;

69.1.14. lactate dehydrogenase (LDH) activity;

69.1.15. serum glucose level;

69.1.16. full urine test.

69.2. Instrumental analysis:

69.2.1. duplex scanning of the abdominal cavity and retroperitoneal space;

69.2.2. abdominal ultrasound scan;

69.2.3. percutaneous liver biopsy and histological examination of a biopsy specimen (if there is no contraindication);

69.2.4. 12-lead ECG, including description of the ECG findings.

69.3. Depending on clinical indications, the treating physician may administer the recipient other laboratory and instrumental tests and refer him to medical specialists for consultation.

XV. POST-TRANSPLANT EVALUATION AND TREATMENT OF STEROID-RESISTANT TRANSPLANT REJECTION

70. Services related to steroid-resistant liver rejection diagnosis and therapy services shall be provided at the institution providing transplantation services.

71. Steroid-resistant liver rejection should be confirmed by histological findings (if there is no contraindication to liver biopsy). If there is no clinical improvement within 3 to 5 days after the methylprednisolone pulse therapy for acute transplant rejection, liver biopsy should be performed once again. If steroid-resistant transplant rejection is confirmed by histological or clinical (in the case of contraindications to liver biopsy) findings, the recipient should be administered a treatment with monoclonal or polyclonal immunoglobulins in parallel with the continued immunosuppressive therapy.

72. The following tests should be administered to the recipient (the gastroenterologist/paediatric gastroenterologist shall determine the frequency of testing):

72.1. Laboratory tests:

72.1.1. cyclosporine/tacrolimus level;

72.1.2. full blood count;

72.1.3. C-reactive protein (CRP);

72.1.4. procalcitonin test;

72.1.5. prothrombin time/international normalized ratio (PT/INR);

72.1.6. creatinine level;

72.1.7. total bilirubin level;

72.1.8. direct-reacting bilirubin level;

72.1.9. aspartate-aminotransferase (AST) activity;

72.1.10. alanine aminotransferase (ALT) activity;

72.1.11. alkaline phosphatase (ALP) activity;

72.1.12. gamma-glutamyl transferase (GGT) activity;

72.1.13. lactate dehydrogenase (LDH) activity;

72.1.14. full urine test;

72.1.15. stool test.

72.2. Instrumental analysis:

72.2.1. duplex scanning of the abdominal cavity and retroperitoneal space;

72.2.2. abdominal ultrasound scan;

72.2.3. percutaneous liver biopsy and histological examination of a biopsy specimen (if there is no contraindication);

72.2.4. chest X-ray;

72.2.5. 12-lead ECG, including description of the ECG findings.

72.3. Depending on clinical indications, the treating physician may administer the recipient other laboratory and instrumental tests and refer him to medical specialists for consultation.

XVI. POST-TRANSPLANT TESTS TO DETERMINE THE STATUS OF AND TREATMENT FOR CYTOMEGALOVIRUS INFECTION (CMV) AND OTHER INFECTIONS

73. If there is an active cytomegalovirus or other systemic infection (Herpes simplex, Herpes zoster, Epstein-Barr and other viral, bacterial and fungal infections), the recipient should be treated at the institution providing transplantation services.

74. The following tests should be administered to the recipient (the treating physician shall determine the frequency of testing):

74.1. Laboratory tests:

74.1.1. cyclosporine/tacrolimus level;

74.1.2. full blood count;

74.1.3. C-reactive protein (CRP);

74.1.4. prothrombin time/international normalized ratio (PT/INR);

74.1.5. creatinine level;

74.1.6. total bilirubin level;

74.1.7. direct-reacting bilirubin level;

74.1.8. aspartate-aminotransferase (AST) activity;

74.1.9. alanine aminotransferase (ALT) activity;

74.1.10. alkaline phosphatase (ALP) activity;

74.1.11. gamma-glutamyl transferase (GGT) activity;

74.1.12. cytomegalovirus Ig M (CMV IgM);

74.1.13. cytomegalovirus DNR (CMV DNR);

74.1.14. Candida antigen (mannan);

74.1.15. Aspergillus antigen (galaktomannan);

74.1.16. full urine test with microscopy of the urine sediment;

74.1.17. urine culture;

74.1.18. stool test.

74.2. Instrumental analysis:

74.2.1. duplex scanning of the abdominal cavity and retroperitoneal space;

74.2.2. chest X-ray.

74.3. Depending on clinical indications, the treating physician may administer the recipient other laboratory and instrumental tests and refer him to medical specialists for consultation.

XVII. POST-TRANSPLANT EVALUATION AND TREATMENT FOR HEPATITIS B VIRUS (HBV)

75. Prevention, evaluation and treatment of viral hepatitis B reactivation in the transplant after the liver transplantation should be applied to the recipient if he received the liver from a donor with hepatitis B virus (anti HBcor “+”) or he himself had viral hepatitis B.

76. For prevention of the reactivation of hepatitis B virus in the transplant (in recipients who have no previous history of viral hepatitis B but received the liver from a donor with hepatitis B virus (anti HBcor “+”)), a onetime dose of immunoglobulin against human hepatitis B virus should be administered during the liver transplantation.

77. Recipients who were diagnosed with viral hepatitis B before the liver transplantation should be treated with immunoglobulin hepatitis B against human hepatitis B virus throughout his life.

78. The therapy with immunoglobulin hepatitis B against human hepatitis B virus should be initiated during transplantation surgery and continued in an in-patient facility after the liver transplantation following the viral hepatitis B therapy protocol approved by the head of institution providing transplantation services.

79. Supportive therapy with immunoglobulin hepatitis B against human hepatitis B virus should be administered lifelong (every 4 or 6 weeks), depending on hepatitis B surface antibody (anti-HBs) titres.

80. The following tests should be administered to the recipient (the gastroenterologist/paediatric gastroenterologist shall determine the frequency of testing):

80.1. cyclosporine/tacrolimus level;

80.2. total bilirubin level;

80.3. direct-reacting bilirubin level;

80.4. hepatitis B virus surface antigen (anti-HBs);

80.5. aspartate-aminotransferase (AST) activity;

80.6. alaninamino-transferase (ALT) activity;

80.7. alkaline phosphatase (ALP) activity;

80.8. gamma-glutamyl transpeptidase (GGT) activity.

XVIII. RULES FOR REIMBURSEMENT

81. Territorial Health Insurance Fund (hereinafter referred to as “the THIF”) shall reimburse for liver transplantation services by phases (Annex 1) within the limits of funding allocation for liver transplantation from the budget of the Compulsory Health Insurance Fund Council (hereinafter referred to as “the CHIFC”) allocated for reimbursement of ordinary expenses in the framework of the Human Cell, Tissue and Organ Transplantation Programme.

82. Outpatient services (phases II, IV, and X) provided by the gastroenterologist (paediatric gastroenterologist) shall be reimbursed, if instrumental tests specified in the Description of Procedures as necessary or other laboratory and/or instrumental tests within the competence of the gastroenterologist (paediatric gastroenterologist) have been performed and recorded in the Outpatient Health History Form No. 025/a (outpatient case-record, inset) during consultation of the patient. Consultation services delivered by other medical specialists during Phases II, IV or X shall be reimbursed from funds of the CHIFC allocated for services.

83. The following number of services shall be reimbursed from the budget of the CHIFC:

83.1. Phase II – up to 6 services per year;

83.2. Phase IV – 1 service for one potential donor;

83.3. Phase X:

82.3.1. the first 6 months after transplantation – up to 6 services;

83.3.2. the next 6 months after transplantation – up to 3 services;

83.3.3. the next year and following years after transplantation – up to 4 services per year.

84. Outpatient liver transplantation services shall be reimbursed at fixed base prices if all evaluation and treatment measures set out in the applicable chapter of the Description of Procedures and other evaluation and treatment measures specified in the patient's treatment plan have been performed.

85. 50% of the fixed base price shall be reimbursed in the following cases:

85.1. for Phases VIII, XIII, XIV or XV, if the duration of service provision was less than 50% of the standard therapy duration;

85.2. for Phase VIII.II, if a Phase XI service was delivered during the same hospitalization;

85.3. for Phase XV, if active CMV infection (or other systemic infections) was diagnosed during Phase VIII or Phase XI.

86. Liver transplantation services shall not be reimbursed in the following cases:

86.1. For Phase III, if Phase I and Phase VII services were provided for the patient during the same hospitalization;

86.2. For Phase XIII, if acute transplant rejection was diagnosed and treated during Phase VIII, Phase XI or Phase XV.

87. For the initial immunosuppressive therapy applied before the liver transplantation and within the first month after the liver transplantation shall be reimbursed once at a base price of Phase IX.I. If, following the initial immunosuppressive therapy protocol, the immunosuppressive therapy was applied in the second month, each therapy course shall be reimbursed (if the therapy was applied during the provision of other liver transplantation services, it shall be reimbursed at the base price of Phase IX.II, and each therapy applied during the next hospitalization shall be reimbursed at the base price of Phase IX.III).

88. Prevention of and treatment for viral hepatitis B shall be reimbursed at the base prices of Phase XVI.I, Phase XVI.II and Phase XVI.III, respectively, if these services were provided at the same time as other liver transplantation services. If the recipient was hospitalized for long-term supportive therapy against the hepatitis B virus (HBV), the service shall be reimbursed at the base price of Phase XVI.IV.

89. If the recipient was treated in an in-patient facility for other reasons (the services were not related to the liver transplantation services), the tests specified in the paragraph of the Description of Procedures and immunosuppressive therapy shall be reimbursed at the base prices of Phase XII.

90. After the end of the reporting month, the institution providing transplantation services must submit a Statement of Services to the THIF by the 10th day of the next month in line with the procedure set forth by the Order No. 74 of 21 July 1998 issued by the Director of the National Health Insurance Fund.

91. After the end of the reporting month, the institution providing transplantation services must submit a report (in a free form) on completed phases specified in Annex 1 of the Description of Procedures to the Bureau by the 10th day of the next month.

92. Accounting of funds allocated for the Human Cell, Tissue and Organ Transplantation Programme should be carried out in a special account of the institution providing transplantation services.

93. Upon obtaining a licence to provide liver transplantation services in line with the procedure set out by the legislation the institution shall be entitled to provide transplantation services, it must draw up the estimate of human cell, tissue and organ transplantation costs based on the Classification of Costs approved by the Ministry of Finance and keep accounting for liver transplantation costs based on the structure of costs in the institution. After the end of the reporting quarter, the institution must submit the Budget Expense Estimate Report to the THIF by the 10th day of the next quarter.

94. After the end of the reporting year, the institution providing transplantation services must transfer allocated funds not used for human cell, tissue and organ transplants back to the CHIFC budget account of the National Health Insurance Fund.

XIX. FINAL PROVISIONS

95. Legal and natural entities providing liver transplantation services shall be held legally responsible for the compliance with the requirements of the Description of Procedures, provision of true and correct information, and all their decisions and conclusions.

______________

Annex 1 to the

Description of Procedures for the Provision of and Reimbursement for Liver Transplantation

NEW EDITION as of 01/01/2012

(Official Gazette, 2011, No. 162-7691)

BASE PRICES FOR LIVER TRANSPLANTATION SERVICES

|Phase |Service description |Standard therapy |Base prices in |Notes |

| | |duration in bed days |scores | |

|I |Patient selection for liver transplantation |12 |5767 | |

|II |Periodic evaluation of the potential recipient in outpatient| |184 |Up to 6 patient visits |

| |facilities | | |per year |

|III |Preparation of the potential recipient for transplantation |1 |1592 | |

| |of the liver from a living/deceased donor | | | |

|IV |Selection and evaluation of the potential living donor | |907 |Up to 1 service to one |

| | | | |potential donor |

|V |Selection and evaluation of the potential deceased donor | | |Reimbursement based on |

| | | | |a report of the |

| | | | |National Health |

| | | | |Insurance Fund |

|VI |Liver retrieval |VI. I |From a living donor | |8450 | |

| | |VI. II |From a deceased donor | |8972 | |

| | |VI. III |From a deceased | |6917 | |

| | | |multi-organ donor | | | |

|VII |Liver transplantation | | | |19477 | |

|VIII |In-patient |VIII. I |At the resuscitation |14 |59363 | |

| |post-transplant | |and intensive therapy | | | |

| |treatment and | |unit | | | |

| |evaluation of the | | | | | |

| |recipient | | | | | |

| | |VIII. II |At the abdominal |7 |6774 | |

| | | |surgery unit | | | |

| | |VIII. III |At the gastroenterology|14 |9189 | |

| | | |unit | | | |

|IX |In-patient initial |IX. I |Treatment courses | |11476 |Treatment applied |

| |immunosuppressive | |within the first month | | |during other phases of |

| |therapy | |after LT (during the | | |LT |

| | | |same hospitalization) | | | |

| | |IX. II |Treatment courses in | |3735 |Treatment applied |

| | | |the second month | | |during other phases of |

| | | |(during the same | | |LT |

| | | |hospitalization) | | | |

| | |IX. III |Treatment courses |3 |5802 |Treatment applied |

| | | |applied during the next| | |during the next |

| | | |hospitalization | | |hospitalization |

|X |Outpatient post-transplant monitoring and treatment | |316 |Within the first 6 |

| | | | |months, up to 6 patient|

| | | | |visits. |

| | | | |Within the first 6 |

| | | | |months, up to 3 patient|

| | | | |visits. |

| | | | |In the second and |

| | | | |following years, up to |

| | | | |4 patient visits per |

| | | | |year. |

|XI |In-patient post-transplant treatment of the recipient for |12 |17561 | |

| |surgical complications | | | |

|XII |In-patient post-transplant treatment of the recipient for |12 |1805 | |

| |other reasons | | | |

|XIII |Post-transplant evaluation and treatment of acute transplant|14 |8274 | |

| |rejection | | | |

|XIV |Post-transplant evaluation and treatment of |21 |50590 | |

| |steroid-resistant transplant rejection | | | |

|XV |Post-transplant evaluation of and treatment for |14 |9346 | |

| |cytomegalovirus infection (CMV) and other infections | | | |

|XVI |Post-transplant |XVI. I |Prevention of viral | |40320 |Prevention measures |

| |evaluation of and | |hepatitis B during the | | |applied during LT |

| |treatment for | |liver transplantation | | | |

| |hepatitis B virus | | | | | |

| |(HBV) | | | | | |

| | |XVI. II |In-patient | |81514 |4-week treatment |

| | | |post-transplant | | |applied during other |

| | | |treatment for viral | | |phases of LT |

| | | |hepatitis B | | | |

| | |XVI. III |Post-transplant | |8064 |Treatment applied |

| | | |long-term supportive | | |during other phases of |

| | | |treatment for viral | | |LT |

| | | |hepatitis B | | | |

| | |XVI. IV |Post-transplant |1 |8531 | |

| | | |long-term supportive | | | |

| | | |treatment for viral | | | |

| | | |hepatitis B | | | |

______________

Annex 2 to the

Description of Procedures for the Provision of and Reimbursement for Liver Transplantation

RECORDS OF THE PANEL OF CONSULTING PHYSICIANS FOR LIVER TRANSPLANTATION INDICATIONS

Patient

(first name and surname, national identification number)

with (comprehensive diagnosis with the evaluation of liver function by Child-Pugh and MELD scores, and complications):

There are no/There are indications for a scheduled/urgent liver transplantation (Please underline as appropriate).

Members of the Panel of Consulting Physicians:

1.

(first name, surname, and signature)

2.

(first name, surname, and signature)

3.

(first name, surname, and signature)

I have read and understood the conclusions of the Panel of Consulting Physicians:

(patient’s (parent’s or guardian’s) first name, surname, and signature)

Date __________________

______________

Annex 3 to the

Description of Procedures for the Provision of and Reimbursement for Liver Transplantation

LIVER DONOR-RECIPIENT PAIR SELECTION FORM

Institution which carried out the initial selection

Liver donor-recipient pair selection date ____________

Donor identification No. _______________ Male ( Female (

Age _______ ABO _________ Rh (D) _________ Weight ________ Height _________

| |ABO |Rh (D) |

| | | |

|Cardiac arrest: |yes/no |........./....... (duration............. minutes) |

Applied drugs dosage

Antibiotics:

Diuretics:

Antidiuretics:

Vasopressors: dopamine μg/kg/min

dobutamine μg/kg/min

adrenaline (epinephrine) μg/kg/min

noradrenalin (norepinephrine) μg/kg/min

Blood transfusions:

Plasma replacements:

Other drugs

Laboratory tests:

Urine test: Microscopy

Glucose:

Proteins:

Culture: positive/negative

Urea: ALT bilirubin

Creatinine AST amylase

Na LDH lipase

K γGT glycaemia

Hb:

Leukocytes:

CK:

CK MB:

HbA1C:

Sputum culture: positive/negative

Blood culture: positive/negative

Organ preservation:

Heparin:............... IU................... hour Aorta cross-clamped:............... hour

Start of aortic perfusion..................... hour Perfusion of V. portae/SMA....... hour

Preservation solution: HTK/UW/other:......................

Record completed by:

(first name, surname, and signature)

______________

*057Ÿ8H¾Ï/

2

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|ÂxyOÈѹÁWXN"W"X"Œ"?"ðßðÎðßðßð½¯?‘¯‘†¯‘†ð†ð†ð†ðuðuðh†\†\†h>5Ãh¤O&6?mH sH h>5Ãh¤O&0Jv[pic]mH sH h>5Ãh¤O&6?B*[pic]mH phsH h>5Ãh¤O&m This provision shall come into force following the addition of liver transplantation services to the List of Licensable General Personal Healthcare Services approved by Order No. V-364 of 14 May 2004 issued by the Minister of Health of the Republic of Lithuania “Approving Lists of Licensable Personal Healthcare Services“ (Official Gazette, 2004, No. 86-3152; 2008, No. 106-4053).

* The list of vaccines may be adjusted taking into account previous diseases and vaccination history on medical records of the potential recipient:

* MELD (Model of End-Stage Liver Disease) system is a scoring system for assessing the need for a liver transplant.

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