Patient search request procedure

Version date
2019-02-27

 Cooperation Transplant Center Application

  1. Purpose: To ensure that bone marrow donated via Tzu Chi stem cells center has legally performed the transplant operation and the medical institute that perform such operation has qualified techniques and experience.
  2. Document: Application for participation as a transplant center.
  3. Qualification of the medical institute:
    1. The transplant center must be a certified Medical Institute approved by local Health Authorities.
    2. Bone marrow transplant case of autologous and allogenic donor marrow source within the past 2 years. (including disease names and survival rate)
    3. The qualification and experience of such transplant unit person in charge and the transplant medical profession team.
    4. Approval documents of bone marrow transplant issued by government authority.
  4. Notice points: Tzu Chi stem cell center solely supply donor’s bone marrow to the cooperative transplant center. In case of the institute has yet to establish the cooperation partnership, Tzu Chi stem cell center is willing to accept the application while patient has found a match and undergoing a HLA matching confirmation exam. This may be more efficient for patient’s sake of receiving the transplant. 

Important Notes for Transplant Center/ Registry to apply an unrelated search request for the patient

  1. Preliminary Matching Stage
    1. Informal Matching：
      1. Aim: To assist the applicant gaining the initial understanding of the quantity of potential matching donors from our center with the patient.
      2. Application Requirements: Anyone can file a preliminary matching request.
      3. Application Documents: Examination report of the patients HLA examination, which must contain A, B and DR three locus, regardless of resolution.
      4. Application Methods: Please put down the applicants name and contact information, and sent the above-mentioned examination reports through e-mail or fax to Tzu Chi Stem Cells center.
    2. Formal Matching：
      1. Aim: To provide the patients doctor with unrelated donors HLA typing and its matching result for further matching process.
      2. Application Requirements: Application either from the registry or the doctor of the transplant center once the patient and his doctor confirmed to proceed the unrelated stem cells transplantation.
      3. Application Documents: Patients Preliminary Search Request form, letter of authorization for research and related documents.
      4. Application Methods: Please fax all above-mentioned documents to our center. (Please see Note)。
      5. Points of Attention: The standards of the center on providing stem cells are as below: Stem cells donors HLA low resolution must reach 5/6 matched with the patients. HLA low resolution of umbilical cord blood matching must reach 4/6.
    3. Requirement for Second Application for Matching: even though a patient has ever registered with BTCSCC, the patient or the patient’s attending physician may request, in writing, BTCSCC to perform matching anew.
  2. Initiating Donors Matching Process
    1. Aim: Contact the donor and ensure donors willingness on donation. Extracting second blood sample has to be done after the health screening for the Confirmatory Test (CT) and test of Infectious Disease Markers (IDMs).
    2. Application Requirements: The registry or the doctor of the transplant center can initiate the matching process.
    3. Application Documents：
      1. Returning the preliminary results and indicating donor ID, typing to be tested as request.
      2. When request blood samples shipping to transplant center's cooperative lab, please fill out Sample Shipment Request Form, which states the donors ID, locus of examination and designated HLA examination laboratory.
    4. Application Methods: Please e-mail or fax all the documents to our center.
    5. Points of Attention：
      1. The CT of the donor processed by BTCSCC is a High Resolution examination of HLA-A, B, DRB1 three locus, plus the test of IDMs.
      2. A Sample Shipment Request Form must be filled out if the donors blood sample is to be sent to the designated HLA laboratory, and the testing result must be returned to BTCSCC by the transplant center. The total collection of CT blood samples is limited to 30 ml.
      3. The validity of IDMs is 30 days.
  3. Donors Health Check-Up Procedure
    1. Aim: After receiving donors CT and infectious disease makers (IDMs) report, if the doctor decided to choose this donor for SC donation, then the donor must be arranged for a health check-up in order to ensure the donor is in a good condition.
    2. Application Documents：
      1. Work-up Request Form.
    3. Application Methods: Patients doctor is asked to prepare and fill in all the forms and send to our center by e-mail or fax upon completion.
    4. Points of Attention：
      1. The Medical Director of BTCSCC will have the right of final approval on whether or not the donor is suitable for donation.
      2. Regardless to donors health check-up results on the suitability of SC donation, all the expenses generated from the health check-up must be paid by the patient.
      3. When a female donor undergoes health check-up, a blood serum pregnancy test will also be done. The earliest possible date of donation will be drawn up and reply to TC immediately if the donor is pregnant.
      4. The health check-up report issued by Tzu Chi Stem Cells center is valid for 6 months. We will inform the TC one month before the validity expired, and inquire if TC want to continue this case. If TC did not reply in that month, we shall close the donor case in order to provide for other patients.
  4. Procedure of collecting donors stem cells
    1. Aim: Collecting donors stem cells for transplant to the patient.
    2. Application Documents：
      1. ① Donor Final Clearance Donor Final Clearance Report
      2. ② Prescription for Mobilized Stem Cells Collection
        Prescription form for bone marrow or mobilized stem cells product
    3. Application Methods: After receiving the health check-up report of the donor from BTCSCC, the registry or the transplant center can initiate the donation procedure for the qualified stem cells donors. The registry or the transplant centers doctor must complete the above-mentioned 2 documents, and sent to our center by e-mail or fax.
    4. Tzu Chi Stem Cells Centers Collection Standards：
      1. Bone Marrow: The body weight is based on the lighter of weight of the donor or the bone marrow recipient. If the patients body weight is less than 30 kg, 30kg will be used as criterion. Standard total Nucleated Cells counts is based on the body weight(kg) x 20 x 0.22.
      2. PBSC: Recipients body weight (kg) x 5 x 10^6 is the standard for requesting PBSC CD34 + cells count.
    5. Picking up marrow: Please provide the itinerary of the courier after picking up date and the transplanting date have been confirmed, so we can arrange the collecting schedule. Search Unit staff will prepare all clearance documents for the courier to pick up the marrow.
    6. Points of Attention：
      1. The maximum pre-collection blood sample is limited to 100ml. Should the transplant center need special blood samples during the collection of HSC, such as plasma, please make a special note on the Prescription form.
      2. Total blood samples at time of collection are limited to a maximum of 20ml.
      3. All hematopoietic stem cell transplantation operations should follow the international stem cell transplantation standard operating procedures to respect the donor's love. The donated hematopoietic stem cells can only be used to treat the fatal diseases of the recipients and can be imported into the patients within 48 hours after stem cell collection. Do not apply to research or other non-therapeutic uses.
  5. Recipient post-operation follow-up
    1. Aim: To understand the recovery status of the recipient after HSC transplantation, while checking if the quality of our Marrow meets the International Standard and the requirement of the HSC transplantation in both domestic and overseas TC.
    2. Use the form “Stem Cell Transplantation Follow-up” as post-operation follow-up periodically after transplant.
    3. Follow-up period: 100 days, 1 year, 2 years, 3 years, 5 years, and 7 years.
    4. Points of attention in the process：
      1. Each follow-up report should be completed within 1 month starting from the day the form was received.
      2. Ask the Physician of the TC to confirm the completeness after filling up the form, then fax or e-mail back to us.
  6. Subsequent donation
    1. Purpose: to elevate the patient’s transplant success rate when the attending physician assesses that the recipient requires a subsequent donation from the donor.
    2. Documents and method for initiating a subsequent donation：
      1. The attending physician shall complete the "PREVIOUS TRANSPLANT HISTORY and FORMAL REQUEST for SUBSEQUENT STEM CELL COLLECTION" in detail and send it to the Center by e-mail or fax.
      2. The Center’s medical director will determine if the donor is suitable for the subsequent donation, then the staff from the Donor Center will inquire the donor for agreement to do the subsequent donation, and will reply the answer to the transplant center within two days.
    3. The Center’s criteria for subsequent donations is as follows: 

Second Donation
First Donation
Marrow
First Donation
PBSC
Marrow
12 weeks
4 weeks
PBSC
4 weeks
not allowed
DLI
4 weeks
4 weeks
  • Please note：
    1. Both recipient and donor must meet the Center’s criteria for subsequent donations.
    2. If the date for the subsequent donation is over 6 months from the date of the donor’s last work-up, then the donor will undergo another work-up. A statement for the cost of this work-up will be sent to facilitate payment by electronic fund transfer.
  • Policy for Donor Subsequent Donation: 
    1. A donor may contribute to a maximum of three donations in a lifetime, regardless of the categories of the first donation and the second donation, but PBSC only once in a lifetime.
    2. A donor may donate Bone Marrow (BM) only twice in a lifetime.
    3. If the second donation is for another recipient, then the donation must be at least 1 year apart. If the third donation is for another recipient, then the donation must be at least 3 years apart from the second donation.
  • Subsequent donations must be an immediate and urgent need for the recipient to be transplanted, and the application must be submitted in writing to the Center's database and administrative group. If it is for research or other non-therapeutic purposes, it will not be accepted.
  • If the donor is Poor Mobilizer and the number of cells after the stem cells are too low to be re-donated, it must be more than two weeks before asking the donor to donate again.

 Cord blood matching

  1. Purpose – the Center not only provides matching results for unrelated bone marrow donors, but also matching results for cord blood for the transplant hospital’s option.
  2. Application method: bone marrow registry or participating transplant centers need only to specify the need for cord blood matching report on the application form. The matching process for cord blood is similar to that for hematopoietic stem cells, where they differ is that no health check is needed for cord blood, because the cord blood’s HLA typing needs only to achieve at least a 4/6 match with the patient, and the transplant center need only to reply to the Center with the expected time for the cord blood bank to provide the cord blood.
  3. Forms required for cord blood matching: Patient Status Report and Prescription for Cord Blood Unit:this may be completed by the attending physician so as to initiate the Confirmatory Test on Cord Blood Unit to ascertain the cord blood’s HLA typing.
  4. Important information：
    1. Bone marrow registry or participating transplant centers may request to have the cord blood sampling sent to a specified HLA laboratory to conduct HLA typing test.
    2. Cord Blood Summary Report: provides blood sampling test results on the infant and birth mother donating the cord blood. It can aid attending physicians in determining whether the bag of cord blood has been infected. When participating transplant centers or bone marrow registry submit a request for cord blood typing test, the Center will provide a Summary Report.
    3. When the bone marrow registry or participating transplant center has ascertained its intention to use the said cord blood, it shall reply to the Center with the expected cord blood transplantation date and the date it wishes the cord blood to be sent.
    4. The transplant center may specify a desired courier service, or the Center will provide the contact information of a courier service it uses to facilitate the arrangement for the cord blood’s delivery.

 Donor Reservation Principle

  1. Purpose – the donor reservation principle is the Center’s way of protecting the transplant center’s right to reserve the donor during the matching process, in case the matching process cannot be implemented smoothly due to complications in the patient’s condition or treatment.
  2. Definition and principle of implementation: the reservation can be done after the transplant center requests to initiate the donor CT test, at the following stages of the process, but with a 6 months maximum limitation.
    1. from the time the donor’s CT report is received, until the time transplant center requests a work-up for the donor.
    2. from the time the donor’s work-up results is received, until the time transplant center requests collection of the donor’s hematopoietic stem cells.
    3. The maximum reservation time for cord blood matching is also 6 months, the same as bone marrow.

 Fees & Payment

  1. Fees are collected according to the Center’s published schedule.
  2. Fee collection method: collection is done on a monthly basis for marrow registries, and pre-pay for transplant centers.
  3. When paying via electronic fund transfers, please specify patient’s name and ID number.

Buddhist Tzu Chi Stem Cells Center

E-mail: btcscc@tzuchi.com.tw
 Tei: +886-3-8561825#13518
Address: 707 Sec. 3, Chung Yang Rd., Hualien, Taiwan 970, R.O.C.
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