Sunday 17 October 2021  

1 Criteria for establishment of a kidney transplant center

The SCOT through its specialized committees has laid down certain criteria for establishment of kidney transplant centers in Saudi Arabia. They include:

 

1.1 Working staff:

1.1.1 Consultant kidney transplant surgeon.

One consultant kidney transplant surgeon with at least one year’s experience from a recognized kidney transplant center.

1.1.2 Consultant nephrologists.

At least one nephrologist with a minimum of one year’s experience from a recognized kidney transplant center.

1.1.3 Nursing staff.

They must be highly experienced in caring for the patients during and after kidney transplantation.

1.1.4 A transplant coordinator.

This individual must have adequate experience in order to perform the previously mentioned duties. The coordinator can also be appointed from the above-mentioned staff.

1.1.5 A dietitian.

1.1.6 A social worker.

 

1.2 Technical facilities required:

1.2.1 The hospital in which a kidney transplant center will be established must have the following departments:

Cardiology, gastroenterology (with endoscopy), chest (with endos-copy), radiology, hematology, pathology laboratory, biochemistry laboratory, nephrology with hemodialysis unit (preferably containing portable dialysis machines), and ICU.

1.2.2 At least two operating rooms must be available.

1.2.3 There should be at least two rooms for management of post-transplant patients.

 

1.3 Support services:

1.3.1 Laboratory.

All routine investigations necessary for the patients either before or after the transplantation must be available. Facilities to perform tissue typing, cytotoxic antibodies, and blood levels of drugs including cyclosporine or similar drugs should be available.

1.3.2 Radiology.

Conventional X-ray, ultrasound, radioisotope scanning, and computerized axial tomography must be available in the hospital.

 

1.4 Drugs:

The following drugs must be continuously available in the center:

1.4.1 Immunosuppressive drugs.

· Cyclosporine,

TACROLIMUS (FK 506)

· Azathioprine,

MYCOPHENOLATE MOFETIL (MMF)

· Prednisolone,

· Sirolimus,

(RAPAMYCIN)

· Other similar drugs.

1.4.2 Drugs for treating rejection episodes such as methylprednisolone, and anti-lymphocyte or anti-thymocyte globulin, anti-thymus globulin and monoclonal antibodies.

1.4.3 Solution for perfusing the organs such as Eurocollins solution or Wisconsin University solution or HTK solution.

1.4.4 Drugs for treating bacterial, viral, fungal, or parasitic infections.

 

2 Criteria for continuity of kidney transplant centers

2.1 Application of the criteria relevant for the establishment of new transplant centers, as mentioned previously.

2.2 The number of kidney transplants performed in the center should be not less than 10 per year.

2.3 The center must contribute to the training activities to the staff and help in the management of brain-dead cases in the ICUs attached to it in collaboration with the SCOT and report to it about these activities.

2.4 The transplant center should satisfy its entire obligations towards the citizens and expatriates by conducting meetings concerning all aspects of organ transplantation and brain death and must submit regular reports about these activities to the SCOT.

2.5 A detailed scientific annual report about the results of transplantation performed in each center must be forwarded to the SCOT. It should include the following points:

2.5.1 The condition of the transplanted patients.

2.5.2 The state of transplanted kidneys.

2.5.3 The rate of complications.

2.6 All transplantation centers will be evaluated every three years by the national kidney transplant subcommittee attached to the SCOT. An ad-hoc committee should be appointed by the national committee and has the right to visit any kidney transplant center whenever it is judged necessary to examine the pace of work in the respective center.

2.7 The Kidney Transplant Committee should meet annually to review all the reports from different transplant centers, including mortality rate, incidence of organ rejection, and complications of transplantation, as well as the reports submitted by the ad-hoc committee. If it appears that one of these centers is not applying these regulations and/or the success rate of transplants performed is not satisfactory, the ad-hoc committee shall visit the center in order to explore the reasons and obstacles preventing this center from carrying out its functions properly. The center will be given three months to improve its performance, following which the kidney transplant committee will re-evaluate the center with the right to close center if no improvement occurs. A two-thirds majority is needed for the decision of the committee with at least 70% of its members present.

2.8 These criteria apply to all kidney transplant centers currently existing as well as to the centers, which will be opened in future.

 

3 Criteria for deceased kidney transplantation

Patients are included in the local and national waiting lists for kidney transplantation according to the following criteria:

3.1 Patients should have end-stage renal disease (ESRD).

3.2 The patients should not have any other significant organ disease (e.g., active tuberculosis, active peptic ulcer, malignancy, or active acute or chronic infection).

3.3 The results of all investigations done on this patient must be within normal limits (see appendix 15 for the non-diabetic ESRD patients and appendix 16 for diabetic patients).

3.4 The patient must be between 3 and 70 years old and age and body weight should be matched between donor and recipient for transplantation.

3.5 The patient must be psychologically stable and compliant to therapy.

3.6 The patient must be human immuno-defiency virus (HIV) negative.

3.7 The patient must be hepatitis B negative. If he/she is hepatitis B positive, liver biopsy must be normal.

3.8 Patients who are positive for anti-glomerular basement membrane anti-bodies, anti-DNA antibodies, or antineutrophil cytoplasmic autoantibodies must turn negative before they are put on the waiting list.

3.9 Under special circumstances concerning hepatitis serology, the following is to be noted:

3.9.1 Hepatitis B Antigen (HBsAg) positive patients and hepatitis B immune patients can be transplanted with kidneys from HBsAg positive deceased donors.

3.9.2 Hepatitis C positive carriers can be transplanted with hepatitis C positive deceased kidneys.

 

4 Criteria for living kidney transplantation

4.1 The donor should be blood-related or must be the breast feeding mother or her children or relatives-in-law. This must be confirmed by official specialized institutions. Also, emotionally related and non-directed non-commercial donation can be accepted.

 

4.2 Paired kidney donation can be carried in the following situations:

4.2.1 If a family has candidate recipient for kidney transplantation and none of his family members is an appropriate donor (un-matching blood groups).

4.2.2 Another family has a similar situation, but some of the candidate donors match with the candidate recipients in the first family and vice versa; then in the appropriate medical setting, the donors and recipients can be exchanged in these families as follows:

4.2.2.1 A clear consent and agreement should be signed by both families of donors and recipients. There should be no request of compensation in case of graft failure in any of the patients.

4.2.2.2 All cases to be registered at the SCOT.

 

4.3 General rules for living donation:

4.3.1 The act of donation must be without any coercion and the donor must be fully convinced.

4.3.2 The donor should be completely healthy both physically and psychologically (appendix 17).

4.3.3 The donor age must be at least 18 years and not more than 60 years.

4.3.4 The donor’s blood group should be compatible with that of the recipient.

4.3.5 The cross-match should be negative.

4.3.6 The donor must be HBsAg, HCV antibodies, and HIV negative.

4.4 Contraindications for kidney transplantation:

4.4.1 Patients with incurable malignant disease

4.4.2 Patients with primary oxalosis (except if the patients will undergo a combined kidney and liver transplant).

4.4.3 Patients addicted to narcotics and other similar drugs.

4.4.4 Non-compliant patients.

4.4.5 Patients with organic diseases such as:

4.4.5.1 Liver Cirrhosis.

4.4.5.2 Periportal fibrosis with advanced esophageal varices.

4.4.5.3 End-stage heart failure, Class IV not responding to treatment.

4.4.5.4 End-stage respiratory failure, which restricts the patient’s daily activities.

4.4.5.5 Progressive vascular disease.

4.4.5.6 Chronic active hepatitis.

 

5 Priority criteria for kidney transplantation

The kidney transplant committee has laid down priority criteria for kidney transplantation as follows:

5.1 If the patient has life threatening vascular access problems, he has absolute priority for transplantation wherever he is, and as soon as a suitable kidney is available on the condition that the decision is made by the kidney transplant center to which the patient is wait-listed after officially informing the SCOT by the transplant center.

5.2 For patients who do not have vascular access problems, the priority level is based on the points given as follows:

5.2.1 Cytotoxic antibodies 1 for each 10% more than 50%

5.2.2 Age: 3 to 5 years 3 points

6 to 10 years 2 points

11 to 45 years 1 point

5.2.3 Period on dialysis 0.1 point per each month on dialysis

5.2.4 Previously failed LRD Tx. 2 points

5.2.5 Human leukocyte antigen (HLA) match 1 per each antigen match

5.2.6 Identical blood group 3 points

5.2.7 Identical age-group 2 points

 

5.3 Distribution of the recovered kidneys will be as follows:*

5.3.1 The first kidney will be transplanted to a suitable patient in the national waiting list and according to priority. The patient should be brought to the transplant center that has recovered the kidneys, except for patients wait-listed in another organ transplant center. In such cases, the kidney will be sent to that center for transplantation.

5.3.2 The second kidney will be transplanted to a patient from the local waiting list according to the priority that is set by the transplant center. If possible and according to priority levels, the kidney in the kidney transplant center should be transplanted to a patient from the donor hospital as possible.

5.3.3 The kidney should be transplanted to patients whenever a suitable patient is available. If there is no suitable national patients anywhere, and after obtaining consent, the kidney may be transplanted to a non-national patient with priority for residents followed by visitors. Moreover, kidneys could be exchanged with other countries according to an agreement established between the SCOT and similar institutions in other countries.

5.3.4 Pediatric patients should be allocated 20% of the standard donated kidney allografts.

5.3.5 Some extended criteria donated kidneys can be used for certain recipient groups after their consent.

*Appropriate patient is the one who has fulfilled the criteria for priority and medical conditions.