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RS 810.212.41 DFI Ordinance of 2 May 2007 on the allocation of organs for transplantation (DFI Ordinance on the allocation of organs)

Original Language Title: RS 810.212.41 Ordonnance du DFI du 2 mai 2007 sur l’attribution d’organes destinés à une transplantation (Ordonnance du DFI sur l’attribution d’organes)

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810.212.41

DFI Guidelines on the Assignment of Organs for Transplantation

(DFI Organ Assignment Ordinance)

2 May 2007 (State 1 Er June 2015)

The Federal Department of the Interior,

Having regard to the order of 16 March 2007 on the allocation of organs for transplantation (Organ allocation order) 1 ,

Stops:

Chapter 1 Definitions

Art. 1

For the purposes of this order:

A.
Adequate quality organs Organs which, because of their condition, can only be attributed to a restricted circle of recipients;
B. 1
Preformed anti-HLA antibody : endogenous antibodies present in the blood which are directed against exogenous human cells and which can, in the case of transplantation, lead to the destruction of the organ transplanted;
C.
HLA locus The genetic location of tissue characteristics.

1 New content according to the c. I of the DFI O of 23 May 2012, in force since 1 Er Jul. 2012 ( RO 2012 3139 ).

Chapter 2 Allocation Criteria and Priorities

Section 1 General provisions

Art. 2 Blood group compatibility

An organ may be assigned to a newborn or to a young child whose blood group is not compatible if the legal representative gives his or her consent.

Art. 3 Calculating latency

1 The wait time is calculated from the date on which the wait list is entered. It is determined in days.

1bis If the registration on the waiting list was not made in due time for reasons beyond the control of the patient, the waiting time is calculated from the day on which the conditions of registration are met. The competent transplant centre shall communicate the date to the national authority. 1

2 If the use of a patient against a non-listing decision on the waiting list is accepted, the waiting time is calculated from the day on which the transplant centre issued the non-registration decision.

3 If the use of a patient against a decision to remove the waiting list by the transplant centre is accepted, the waiting time shall include the length of time since its cancellation.

4 If a patient is required to undergo a new transplant, the waiting time is calculated from the day on which the patient is re-listed on the waiting list.

4bis If a patient is required to undergo a new transplant within 90 days of a kidney transplant, the entire length of time that the patient waited for a kidney transplant is taken into account. 2

5 The length of time the patient is temporarily unable to be transplanted into the calculation of waiting time.

6 The waiting time taken into account for the assignment of a heart is up to two years.

7 For patients in medical emergency, only the time they waited for a transplant in this situation is taken into account.

8 For patients without medical emergency, the whole time they waited for a transplant is taken into account.

9 The waiting time abroad shall be counted from the date of entry on the list established in the country concerned, if the patient produces a written attestation from the competent body of that country certifying the duration of the waiting period. 3


1 Introduced by ch. I of the O of the DFI of 3 Nov 2010, in force since 1 Er Dec. 2010 ( RO 2010 5073 ). See also disp. And trans. Of this mod. At the end of the text.
2 Introduced by ch. I of the O of the DFI of 17. 2008, effective since October 15. 2008 ( RO 2008 4469 ).
3 Introduced by ch. I of the O of the DFI of 17. 2008, effective since October 15. 2008 ( RO 2008 4469 ).

Section 2 Assigning a heart

Art. 4 Medical emergency

1 The patient is considered to be at risk of immediate death:

A.
Who is in the intensive care unit and who is responsible for administering high-dose positive inotropic drugs or equivalent vasoactive substances;
B.
Suffers from complications due to the method of imploring a ventricular assist system;
C.
Who had an acute rejection of a cardiac transplant;
D.
That does not meet the criteria set out in the let. A to c, but for which a transplant is required because of a vital prognosis.

2 The medical emergency is 14 days. It is extended every 14 days when confirmed by the competent transplant centre.

Art. 5 Effectiveness of Transplantation from a Medical Perspective

Where there is no medical emergency, the following order of priority applies:

A.
If the donor is under 16 years of age, the heart is assigned to a patient under 16 years of age;
B.
If the heart cannot be assigned in accordance with the let. A or if the donor is 16 years of age or older, the heart is assigned to a patient:
1.
The weight of which differs from that of the donor at a maximum of 25 %, and
2.
The age of the donor is not less than 15 years of age.
Art. 6 Attribution in the presence of identical priority degrees

1 When the priority is the same for several patients, the heart is assigned:

A.
In the first place to a patient for whom a multiple transplant is indicated, in accordance with Art. 11 of the order on the allocation of organelles;
B.
Then to a blood group 0 or B patient, if the donor is a blood group 0;
C.
Finally, to the patient who has been waiting for the transplant for the longest time.

2 When there is medical emergency for several patients within the meaning of s. 4, para. 1, the heart is assigned to the patient for whom the medical emergency is the largest. When the medical emergency is the same for several patients, the heart is assigned according to the order of priority defined in para. 1.

Section 3 Assigning a lung

Art. 7 Medical emergency

1 In particular, the patient is considered to be at risk of immediate death for which an invasive, invasive, intensive care unit ventilation is required.

2 The medical emergency lasted 28 days. It is extended every 28 days when confirmed by the competent transplant centre.

Art. 8 Effectiveness of Transplantation from a Medical Perspective

1 When there is no medical emergency, the optimum quality lung is assigned:

A.
In the first place to a patient for whom a combined joint-lung transplant is required;
B. 1
Second to a patient with pulmonary hypertonia;
C. 2
Third place to a patient under 40 years of age, if the donor is under 40 years of age;
D. 3
Fourth place to a patient with pulmonary fibrosis.

2 The correct quality lung is attributed to:

A. 4
First to a patient under 40 years of age, if the donor is under 40 years of age;
B.
Second to a patient with pulmonary fibrosis. 5

1 New content according to the c. I of the O of the DFI of 17. 2008, effective since October 15. 2008 ( RO 2008 4469 ).
2 New content according to the c. I of the O of DFI of 1 Er Jul. 2011, effective from 1 Er August 2011 ( RO 2011 3377 ).
3 Introduced by c. I of the O of the DFI of 17. 2008, effective since October 15. 2008 ( RO 2008 4469 ).
4 New content according to the c. I of the O of DFI of 1 Er Jul. 2011, effective from 1 Er August 2011 ( RO 2011 3377 ).
5 New content according to the c. I of the O of the DFI of 17. 2008, effective since October 15. 2008 ( RO 2008 4469 ).

Art. Attribution in the presence of identical priority degrees

1 When the priority is the same for several patients, the lung is assigned:

A.
In the first place to a patient for whom a multiple transplant is indicated, in accordance with Art. 11 of the order on the allocation of organelles;
B.
Second to a patient in intensive care, placed under oxygenation by extracorporeal membrane and under invasive mechanical ventilation;
C.
Third place to a blood group 0 or B patient, if the donor is a blood group 0;
D.
In fourth place to the patient who has been waiting for the transplant for the longest time. 1

2 When there is medical emergency for several patients within the meaning of s. 7, para. 1, the lung is assigned to the patient for whom the medical emergency is the largest. When the medical emergency is the same for several patients, the lung is assigned according to the order of priority defined in para. 1.


1 New content according to the c. I of the O of DFI of 1 Er Jul. 2011, effective from 1 Er August 2011 ( RO 2011 3377 ).

Section 4 Liver allocation

Art. 10 Medical emergency

1 In particular, the patient is considered to be at risk of immediate death:

A.
Within eight days after transplantation, a non-functioning of the liver transplant, either primary or due to thrombosis of the hepatic artery;
B.
Has a severe acute hepatic failure;
C.
Which is affected by a fulgurant hepatolenticular degeneration (Wilson's disease).

2 The medical emergency lasts for a maximum of six days. It is extended every two days when confirmed by the competent transplant centre.

3 If a body cannot be attributed to a patient whose blood group is identical to that of the donor or compatible with the donor's group, the liver may be assigned to a patient whose blood group is not compatible, if the patient gives his or her Consent.

Art. 11 1 Point system allocation for donors under 18 years of age

1 If the patient is not exposed to immediate risk of death within the meaning of s. 10, para. 1, and if the donor is under 18 years of age, the liver is allocated:

A.
First to a patient under 12 years of age;
B.
Second to a patient in the age range of 12 to under 18 years;
C.
Third to an 18 year-old or older patient.

2 If the donor is blood group 0, the liver, within the priorities defined in para. 1, is assigned:

A.
In the first place to patients in the blood group 0 who obtained the most points, but at least 20, according to the system set out in Annex 1;
B.
Second to patients in blood group B who received the most points, but at least 20, according to the system set out in Appendix 1;
C.
In the third place to patients in the A or AB blood group who received the most points, but at least 20, according to the system set out in Annex 1;
D.
In fourth place to patients who received the most points, but less than 20, according to the system set out in Appendix 1.

3 If the donor is of a different blood group than group 0, the liver, within the priorities defined in para. 1, is assigned to the patient who received the most points according to the system set out in Appendix 1.


1 New content according to the c. I of the DFI O of 12 May 2015, in force since 1 Er June 2015 ( RO 2015 1429 ).

Art. 11 A 1 Point system allocation for donors 18 to 49 years of age

1 If the patient is not exposed to immediate risk of death within the meaning of s. 10, para. 1, and the donor is between 18 and 49 years of age, the liver is first attributed to the patient with a body weight of less than 25 kilograms.

2 If the donor is blood group 0, the liver, within the priorities defined in para. 1, is allocated according to the priorities defined in Art. 11, para. 2.

3 If the donor is of a different blood group than group 0, the liver, within the priorities defined in para. 1, is assigned to the patient who received the most points according to the system set out in Appendix 1.


1 Introduced by ch. I of the DFI O of 12 May 2015, in force since 1 Er June 2015 ( RO 2015 1429 ).

Art. 11 B 1 Point system allocation for donors aged 50 years or older

If the patient is not exposed to immediate risk of death within the meaning of s. 10, para. 1, and the donor is 50 years of age or older, the liver is assigned:

A.
For blood group 0 donors: according to the priorities defined in art. 11, para. 2;
B.
For donors of a different blood group than group 0: to the patient who received the most points according to the system set out in Appendix 1.

1 Introduced by ch. I of the DFI O of 12 May 2015, in force since 1 Er June 2015 ( RO 2015 1429 ).

Art. 12 Attribution in the presence of identical priority degrees

When the priority is the same for several patients, the liver is assigned:

A.
In the first place to a patient for whom a multiple transplant is indicated, in accordance with Art. 11 of the order on the allocation of organelles;
B.
Then to a patient whose blood group is identical to that of the donor;
C.
Finally, to the patient who has been waiting for the transplant for the longest time.

Section 5 Renal allocation

Art. 13 Medical emergency

In particular, it is considered to be at risk of immediate death for the patient who cannot or can no longer be dialysed.

Art. 13 A 1 Blood group compatibility and age adequacy

1 If there is no medical emergency within the meaning of s. 13 and that the donor is 60 years of age or younger, the kidney is assigned in the second priority:

A.
First to the patient under 20 years of age, if the patient's blood group is identical to that of the donor;
B.
Second to the patient under 20 years of age, if the blood group is compatible with that of the donor;
C.
Third, if the patient is 20 years of age or older, if the blood group is identical to that of the donor;
D.
Fourth, if the patient is 20 years of age or older, if the blood group is compatible with that of the donor.

2 If the donor is over 60 years of age, the kidney is allocated:

A.
First to the patient aged 20 or older, if the patient's blood group is identical to that of the donor;
B.
Second to the patient 20 years of age or older, if the patient's blood group is compatible with that of the donor;
C.
In third place to the patient under 20 years of age, if the blood group is identical to that of the donor;
D.
In the fourth place to the patient under 20 years of age, if his blood group is compatible with that of the donor.

1 Introduced by ch. I of the O of the DFI of 17. 2008, effective since October 15. 2008 ( RO 2008 4469 ).

Art. 14 1 Tissue compatibility

1 The kidney is assigned the third priority to the patient:

A.
With no specific anti-HLA antibody to the donor; or
B.
Has a number of donor-specific anti-HLA antibodies that does not exceed the number granted by the national authority service.

2 The National Allocations Service only allows donor-specific anti-HLA antibodies:

A.
If their average fluorescence is less than 10,000; or
B.
If they do not present a high risk of causing rejection of the graft.

3 The authorised number of donor-specific anti-HLA antibodies must be calculated in such a way that each patient can benefit from an organ supply of at least 2 % of the potential donors in his case. The calculation shall be carried out on the basis of all available donor data.

4 The allowable number of donor-specific anti-HLA antibodies is calculated upon listing on the waiting list. It must be recalculated at the beginning of each calendar year, or when new data regarding a patient's HLA antibody are available.


1 New content according to the c. I of the DFI O of 23 May 2012, in force since 1 Er Jul. 2012 ( RO 2012 3139 ).

Art. 15 1 Infectious status

If the donor has obtained a negative test for the Epstein-Barr virus, the kidney is assigned the fourth priority to the patient who also obtained a negative test for the Epstein-Barr virus.


1 New content according to the c. I of the DFI O of 23 May 2012, in force since 1 Er Jul. 2012 ( RO 2012 3139 ).

Art. 15 A 1 Point system allocation

The kidney is assigned the fifth highest priority to the patient who obtains the most points according to the system defined in Appendix 2.


1 Introduced by ch. I of the O of the DFI of 17. 2008 ( RO 2008 4469 ). New content according to the c. I of the DFI O of 23 May 2012, in force since 1 Er Jul. 2012 (RO 2012 3139).

Art. 16 Attribution in the presence of identical priority degrees

When the priority is the same for several patients, the kidney is assigned:

A.
In the first place to a patient for whom a multiple transplant is indicated, in accordance with Art. 11 of the order on the allocation of organelles;
B.
And then the patient who has been waiting for the transplant for the longest time.

Section 6 Pancreatic or pancreatic islet allocation

Art. 17 Priorities

A pancreas for islet islet transplantation is attributed to:

A.
First to a patient who, in the year following an islet transplant, needs an additional islet transplant;
B.
Then to a patient who is waiting for a first islet transplant or who needs an additional islet transplant more than one year after islet transplantation.
Art. 18 1 Combination of pancreatic or pancreatic islet and kidney

A patient who requires only one kidney is a priority in relation to the patient for whom the transplantation of pancreatic or pancreatic islets and a kidney is indicated:

A.
If there is a medical emergency for him alone; or
B.
If the percentage of its preformed anti-HLA antibodies according to Annex 2 is at least 90 %.

1 New content according to the c. I of the DFI O of 23 May 2012, in force since 1 Er Jul. 2012 ( RO 2012 3139 ).

Art. 19 Attribution in the presence of identical priority degrees

1 When the priority is the same for several patients, the pancreas or pancreatic islets are allocated:

A.
First, to a patient for whom a multiple transplant is indicated, in accordance with s. 11 of the Organ Assignment Ordinance, with the exception of a combined pancreas or pancreatic islet and kidney transplant;
B.
Second, to a patient whose blood group is compatible with that of the donor within the meaning of para. 3;
C.
Third, to the patient who has been waiting for transplantation for the longest time;
D.
Fourth, to the patient whose tissue characteristics best correspond to those of the donor.

2 The compatibility of the tissue characteristics shall be evaluated on the basis of the point system defined in Annex 2 A . 1

3 Blood group compatibility is provided if:

A.
The donor is blood group A and the patient is:
1.
Blood group A, or
2.
The AB blood group and has been on the waiting list for more than a year;
B.
The donor is blood group 0 and the patient is:
1.
Blood group 0, or
2.
Blood group B and has been on the waiting list for more than a year;
C.
The donor and patient are blood group B.

1 New content according to the c. I of the DFI O of 23 May 2012, in force since 1 Er Jul. 2012 ( RO 2012 3139 ).

Section 7 Allocating a small intestine

Art. Medical emergency

In particular, it is considered to be at risk of immediate death for the patient who cannot or can no longer be fed parenterally.

Art. Attribution in the presence of identical priority degrees

1 When there is a medical emergency for several patients, the small intestine is allocated:

A.
First, to a patient for whom a multiple transplant is indicated, in accordance with s. 11 of the order on the allocation of organelles;
B.
And then the patient who has been waiting for the transplant for the longest time.

2 When several patients do not have a medical emergency, the small intestine is allocated:

A.
First, to a patient for whom a multiple transplant is indicated, in accordance with s. 11 of the order on the allocation of organelles;
B.
Then to the patient who received the most points according to the point system defined in Appendix 3;
C.
Finally, to the patient who has been waiting for the transplant for the longest time.

Chapter 3 Entry into Force

Art.

This order shall enter into force on 1 Er July 2007.

Transitional provisions of the amendment of 3 November 2010 2

1 Art. 3, para. 1 Bis , also applies to patients on the waiting list at the time this amendment enters into force.

2 In the point system according to Annex 2, up to the entry into force of this amendment, a point is assigned per month waiting prior to the start of dialysis for patients on the waiting list or whose registration has not been Conducted in a timely manner within the meaning of s. 3, para. 1 Bis .


Annex 1 1

(art. 11 to 11 B )

Point system for assigning a liver

1.
For patients 12 years of age or older, the number of decisive points for the allocation of a liver according to art. 11 to 11 B Is calculated on the basis of data obtained for three biological parameters, namely serum creatinine, serum bilirubin, and the International Normalized Ratio (INR).
2.
When the results for these three parameters are less than 1.0, they are calculated to be 1.0 for the calculation. The serum creatinine is a maximum of 4.0 mg/dl. It is 4.0 mg/dl for dialysis patients.
3.
The number of decisive points is calculated as follows:
0.957 × log E (creatinine mg/dl) + 0.378 × log E (bilirubin mg/dl) + 1.120 × log E (INR) + 0.643.
The calculated total is multiplied by 10, rounded to the nearest whole and limited to a maximum of 40.
4.
The number of points calculated is updated as follows:

Points

Refresh After

Scan results not going back more than

≥25

7 days

48 h

24 to 19

1 month

7 days

18 to 11

3 months

14 days

≤10

12 months

30 days

5.
For patients with prolonged oral anticoagulation, the number of decisive points according to art. 11 to 11 B , independently of the International Normalized Ratio (INR), is calculated as follows:
11.76 × Ln (creatinine mg/dl) + 5.11 × Ln (bilirubin mg/dl) + 9.44
The calculated total is rounded to the nearest integer and is limited to a maximum of 40.
6.
Patients who first obtained 20 points at least according to the c. 3 and 5 above shall receive a monthly payment of 1.5 additional points from the month following the calculation.
7.
Patients under 12 years of age and those who have one of the following conditions in particular receive 14 points:
A.
Hepatocellular carcinoma (CHC), cholangiocellular carcinoma (CCC), neuroendocrine tumour and other rare tumours;
B.
Heporenal syndrome
C.
Pulmonary hypertension;
D.
Metabolic liver disease.
This total is increased monthly by 1.5 percentage points from the first allocation.
8.
For patients mentioned in c. 7, the number of points is calculated in addition to the c. 3 or 5. For the assignment of a liver, it is the number of the highest points according to the c. 3 and 5 to 7 which is decisive.
9.
If the number of points calculated according to the c. 3 to 8 does not correctly reflect the urgency of transplantation, the national remit service calculates it on a case-by-case basis, after consultation with experts.

1 New content according to the c. II al. 1 of the DFI O of 12 May 2015, in force since 1 Er June 2015 ( RO 2015 1429 ).


State 1 Er June 2015

Annex 2 1

(art. 15 A And 18)

Point system for the assignment of a kidney

Criteria

Points

For each HLA-DR-level compatibility

12

For each compatibility at the HLA-B locus

4

For each compatibility at the HLA-A locus

4

Wait times (per month) upon registration on the waiting list and before dialysis begins

0.75

Wait times (per month) upon entry on the waiting list and after dialysis begins

1.5

1 For each patient, calculate the percentage of all donors registered in the National Service Data Bank against which it has preformed anti-HLA antibodies (calculation of the percentage of reactive antibodies On the panel).

2 For each patient, a number of points should be calculated according to the following formula, based on the percentage of reactive antibodies on the panel:

Number of points = 84 × x 2 (x = percentage of reactive antibody on panel).


1 New content according to the c. II al. 1 of the DFI O of 23 May 2012 ( RO 2012 3139 ). Update as per c. II al. 2 of the DFI O of 12 May 2015, in force since 1 Er June 2015 (RO 2015 1429).


State 1 Er June 2015

Annex 2a 1

(art. 19, para. 2)

System of points for the allocation of pancreas or pancreatic islets

Criteria

Points

For each HLA-DR-level compatibility

6

For each compatibility at the HLA-B locus

4

For each compatibility at the HLA-A locus

1


1 Introduced by ch. II al. 2 of the DFI O of 23 May 2012, in force since 1 Er Jul. 2012 ( RO 2012 3139 ).


State 1 Er June 2015

Annex 3

(art. 21, para. 2, let. (b)

System of points for determining bowel insufficiency

Criteria

Points

Hemopathy:

-
No liver disease

0

-
Biopsy + without biological sign

1

-
Biopsy + "transaminite" and/or bilirubin 25-30 M Mol/l

2

-
Biopsy + bilirubin > 30 M Mol/l

3

Infections:

-
No history of severe infection

0

-
Multi-resistant germs infection

1

-
1-2 episodes of severe infection

2

-
More than 2 episodes of severe infection

3

Central venous access:

-
No thrombossed access

0

-
Loss of adult access

1

-
Loss of child access or two adult access

2

-
Loss of more than one child access or more than two adult access

3

Hail Intestine:

-
No short bowel syndrome

0

-
Ultra-short intestine in adult continuity

1

-
Ultra-short intestine not connected to adult

2

-
Bowel syndrome in children or congenital enteropathy with malabsorption

3


State 1 Er June 2015