• Reimbursements
  • QA Procedures
  • Broadcasting Islet Offers
  • Administrative
There are five criteria necessary to receive a reimbursement for the islets shipped through the IIDP:
          a) The IIDP website must be used to broadcast the available islets
          b) The number of islets shipped cannot surpass your center’s distribution cap as listed in your subcontract
          c) The purity must be greater than or equal to 50%
          d) The viability must be greater than or equal to 80%
          e) The preliminary and final quality assessments for sterility must be negative for contamination, forms completed, and submitted
Your center can ship as many islets you’d like via the IIDP website, but you will not be reimbursed for the islets that surpass your center’s islet cap. A running total of islets shipped per contract year is displayed when you create an islet offer. If your center is also a CIT center, then both the IIDP and CIT caps will be displayed. [Reference: the Subcontractor agrees to produce up to but not exceeding two million (2,000,000) IEQs for basic science distributions from an IIDP center and seven hundred fifty thousand (750,000) islets from a CIT center. (Per Exhibit B of Subcontract)]
50% [Reference: Human islet preparations must contain ≥80% for “most pure” and ≥50% for “impure” islet tissue as determined by dithizone staining and light microscopy. (Per Exhibit E of Subcontract) IEQs of less than 50% purity will not be reimbursed by the IIDP.]
80% [Reference: Human islet preparations must consist of ≥ 80% viable islet particles as determined by fluorescence microscopy. Viability testing should be preformed post culture; prior to shipping. (Per Exhibit E of Subcontract)]
48 hours recommended with cold shipping; minimum acceptable, 18 hours. (See SHP-005 Attachment 8.1 Tips for Determining Islet Quality for Shipment)
There is not a maximum culture time allowable but be aware that in most cases the quality of islet degrades over an extended time. Also many recipients would prefer to have islets that are somewhat fresh so you may have a harder time having islets accepted the longer they are held in culture.
You may flash freeze islets that are >80% pure, 5,000 IEQs/ vial and up to 50,000IEQs (10 vials) per isolation. [Reference: On those occasions when not all IEQs can be placed from an isolation, the Subcontractor may flash freeze the IEQs, if the IEQs are > 80% pure, according to the Standard Operating Procedure (SOP) found on the IIDP website and will be paid at the standard reimbursement rate for these islets. The center may only freeze up to 50,000 IEQs per isolation (10 vials) and a maximum of 50,000 IEQs per subcontract year. The flash frozen islets will be counted against the Subcontractor’s annual cap. (Per Exhibit B of Subcontract)]
Within 10 days of the islet offer’s shipment date. [Reference: Testing for microbial (both aerobic and anaerobic) and fungal contamination must be performed on the final preparation. Preliminary results must be supplied to the IIDP within 10 days of shipping. Final results must be supplied within 30 days of shipping. (Per Exhibit E of Subcontract)]
Within 10 days of the islet offer’s shipment date. [Reference: Testing for microbial (both aerobic and anaerobic) and fungal contamination must be performed on the final preparation. Preliminary results must be supplied to the IIDP within 10 days of shipping. Final results must be supplied within 30 days of shipping. (Per Exhibit E of Subcontract)]
Within 30 days of the islet offer’s shipment date. [Reference: Per Exhibit E of Subcontract, see above.]
Although the optional islet assessments are not required, the recipients consider these to be incredibly valuable. As such, reporting as much information as possible will improve recipient satisfaction and center status with the IIDP. [Reference: Although optional, documentation of any additional quality assessments that a subcontractor normally performs on their preparations and is willing to share with the islet recipients and the IDCC is encouraged. These assessments should be entered into the IIDP database under Optional Assessments in the Quality Assessments section of the database and will be shared with the recipients who accepted islets from that broadcast. (Per Exhibit E of Subcontract)]
If the required forms have not been submitted by the end of the quarter, then those shipments will not be reimbursed at that time. However, if the forms are submitted and all other reimbursement criteria have been met during the following quarter; those shipments will be reimbursed at the conclusion of the following quarter.
The minimum time recommended by the IIDP is 30 minutes so that the offer recipients have a full open offer. However, 2 hours or more would be ideal. More than 2 hours is recommended for large islet offers in particular (i.e. offers of 200,000 IEQs or more).
The IIDP recommends the use of post-culture counts so that the broadcasted information is as accurate as possible and the recipients have a true understanding of the quality and quantity of the islets. This should be performed within 10 hours of broadcast. .[Reference: Dithizone-staining, cell size and enumeration evaluation using light microscopy with visual examination by 2 qualified personnel (or double counting by one individual of a duplicate sample.)
If the final islet quality and/or quantity prevent you from shipping your entire batch of islets, then you may cancel all shipments by entering “0” under “Amount to be Shipped by Center” and “No” under “Islets Shipped?” on the Confirm Recipient screen. If only a few shipments need to be cancelled due to reduced yield, then cancel the shipments starting from the bottom of the list since the recipients are listed in descending order of priority (i.e. the best matches are listed at the top and the worst matches are listed at the bottom).
When you offer islets and not all are accepted by IIDP investigators, you may either re-offer the islets using a slightly modified UNOS ID (i.e. ABC123A vs. ABC123) or you may flash freeze up to 50,000 IEQs of the leftovers and post them in the IIDP Flash Frozen Islet Inventory.
When an islet offer goes to an open offer, the offer recipients are given the full amount of time (until your offer’s deadline) to respond. Once the deadline is reached, the IIDP algorithm will assess the responses and provide a final list of recipients. This can take up to 5 minutes post your offer deadline.
If a system error occurs during a broadcast, Please contact the City of Hope Helpdesk at (626)256 – 4673, extension 64357. Please identify yourself as part of the IIDP, and give the Helpdesk your contact information. Let the Helpdesk technician know that an error has occurred that prevents you from using the IIDP web-based islet distribution system to complete your broadcast. If the problem cannot be immediately resolved by the Helpdesk technician, someone at the IIDP Coordinating Center will contact you as soon as possible. If the problem cannot be resolved with the automated system by the CC in a short time, the CC will do a manual broadcast of the islets by contacting the appropriate investigators by phone and email. Your islets will not go to waste.
To create access for a new staff member at your center, your center’s lab manager or their designee will need to contact either Barb Olack (bolack@coh.org) or James Cravens (jcravens@coh.org) and provide the name, email address, and phone number of the new staff member.
The IIDP’s SOPs are displayed within the secured access website (https://iidp.coh.org/secure/). Once you have logged in, the SOP link is listed under “Documentation” on the right side of the screen.
The IIDP tracks the amount of shipping supplies that should be used for every shipment by each center however special circumstances (breakage, contamination, etc) could cause the tracking to be completely reliable. You should contact Barbara Olack at (bolack@coh.org) any time you are concerned with any of your shipping supplies.