ABO policy modifications take effect June 23, 2016
Published on: Tuesday, April 26, 2016
Frequently asked questions
All Transplant professionals
Topics: policy, deceased vs. living donation, electronic verification, international, laboratory, laterality, programming, qualified health care professional, source documents, TransNetSM, two blood draws, verification
Transplant Hospital staff
Topics: deceased vs. living donation, documentation, general anesthesia vs. continuous sedation, laterality, organ check-in, pediatrics, pre-transplant verification, source documents, subtype, surgeon, templates, titer values, two blood draws, vessels
Living donor hospital staff
Topics: living donor verification, pre-recovery verification, subtype
OPO staff
Topics: OPO pre-recovery verification, subtype, template, two blood draws
More resources
Webinar Recordings
The following webinar recordings are available:
- ABO typing and subtyping training module available (UNetSM login required) (6/2016)
- ABO Town Hall recording (5/2016)
- ABO webinar recording: Compliance with upcoming changes (3/2016)
- ABO webinar recording (12/2015)
As of June 2, 2016, UNOS Connect is your new resource for educational webinars for transplant professionals. Go to UNOS Connect and sign in to access webinar recordings.
About UNOS Connect
- UNet Users: If you have access to UNOS Secure EnterpriseSM systems: UNet, WaitlistSM, DonorNet®, Tiedi®, KPDSM and other UNOS-developed transplant applications, your account is already set-up and there is no need for you to register. Access UNOS Connect with your UNet username and password. This will allow you full access to the site to view system training recordings, register for policy webinars and view materials.
- Other Users: The first time you visit UNOS Connect, you will need to complete a brief, online form to register for the site. After that, you will have access to a wide range of UNOS instructional offerings and materials, except system training.
Frequently asked questions (from December, March and May webinars)
all transplant professionals
Policy
What is the effective date for the new ABO policy modifications?
The new ABO policies are in place as of June 23, 2016.
Deceased vs. living donation
What are the differences in the requirements between deceased and living donation?
The differences between deceased and living donor transplant ABO requirements are on the donor side. Transplant hospital recipient requirements are the same, whether they are transplanting a deceased or living donor organ. The December 8, 2015, webinar walks you the different requirements between deceased and living donors. The webinar is available at https://unosconnect.unos.org.
Electronic verification
What are your suggestions for electronic verification?
The OPTN does not specify whether documentation must be recorded on paper or in an electronic medical record (EMR). Use of the EMR to record ABO verifications is growing. Use of either paper or electronic documentation is acceptable as long as the documentation and process meets all of the policy requirements. If you are planning to program an ABO verification form in your EMR, you might want to read suggested EMR data fields.
International
Will these changes be instituted nationally and internationally?
Since the OPTN does not have jurisdiction over transplant hospitals or organ procurement organizations outside of the U.S. or international transplants, we will only institute these changes in the U.S.
Laboratory
Do we need to ensure that two separate staff in the lab verify samples?
This policy does not cover laboratory protocols, which are governed under different regulations. When entering ABO results into UNetSM, two staff members designated by the OPO or transplant hospital as qualified health care professionals will each have to use two ABO results from the source documents they received from the laboratory.
Laterality
Define the term laterality, which was used multiple times during the webinar.
We use the term "laterality" to distinguish between the right and left organ. For example, right kidney or left kidney and right lung or left lung.
Programming
What system changes are in place?
Please see: https://www.unos.org/news/system-changes-related-to-abo-verification-policy-change-are-now-in-place/.
Qualified Health Care Professional
Can the surgeon be the qualified health care professional that performs the pre-transplant verification if surgery starts before organ receipt?
Yes, the surgeon can be one of the qualified healthcare professionals that performs the pre-transplant, if surgery starts before organ receipt. The surgeon is not required for this verification, but the surgeon must participate in the final pre-transplant verification conducted upon organ receipt in the operating room.
What is considered to be two qualified healthcare professionals to report blood typing? What does OPTN/UNOS consider as a "qualified healthcare professional"?
Your OPO or transplant hospital defines "qualified health care professional" in your protocol.
Source Documents
What are acceptable source documents for showing compliance with OPTN ABO policies?
Source documents and acceptable sources are not the same. Source documents are one type of an acceptable source. There are other types of acceptable sources that can be used when performing pre-recovery or pre-transplant verifications depending on the data element being verified.
“Source document” is now defined in OPTN policy as: “An original record of results, or a photocopy or digital copy of the original record.”
A source document is the only acceptable source to use when reporting ABO for donors and candidates in UNet.
A hospital's electronic medical record (EMR) can be a source document for lab results when the performing lab's results are directly uploaded into the EMR. Other source documents may be a paper or fax copy of the blood type results from the performing lab.
For pre-surgical verifications (either pre-recovery or pre-transplant) other references or sources specified in the policy verification tables can be used for some elements. In many places, data elements can be verified using the OPTN computer system. This means any data available in UNet including, but not limited to, the organ verification link designed to help with ABO verifications.
Should our internal policies include the specific source documents that we will use to report and verify ABO?
OPOs and transplant hospitals can include the specific source documents that will be used in their internal protocols but it is not required.
Keep in mind that the following definition for source document was approved in policy.
OPTN Policy 1.2 (Definitions)
Source document: An original record of results, or a photocopy or digital copy of the original record.
TransNetSM
What does OPTN-approved electronic method mean?
The current OPTN-approved electronic method is TransNet.
TransNet, a service of the OPTN, is a new system that uses barcode scanning technology at the point of organ recovery to help label, package and track organs and other biologic materials being shipped for transplantation. This comprehensive electronic solution also allows us to ensure that donated organs are matched correctly and efficiently with the identified recipient.
How can TransNet help?
TransNet will provide significant assistance in reducing labeling errors and ensuring right person/right organ. TransNet produces barcode and printed human readable labels for deceased donor organs as well as all the materials sent with organs (e.g. blood specimens, nodes, spleen, vessels, biopsy, and paper documentation). Users attach an identification band to the donor and scan the donor ID band to start recording all items packaged and shipped by organ.
OPTN policy requires all OPOs to start using TransNet by June 1, 2017.
For transplant hospitals, beta testing is underway using TransNet to conduct organ check-in and ABO verification in the operating room once the organ has arrived.
The Committee will continue collaborative efforts in developing TransNet to help members comply with policy.
Two Blood Draws
Please provide a clear definition of "two separate draws."
Two separate draws means two separate phlebotomy procedures (two sticks). For patients who are having their blood obtained through a different means (e.g. central line), then you need to complete two distinct procedures. Completing one draw and filling up two tubes would not the meet the policy requirements.
Can two ABO typings be performed on a patient on the same day if two separate phlebotomies are performed?
Yes, you may perform two ABO typings on the patient on the same day, as long as your perform two separate phlebotomy (blood draw) procedures.
UNet System Permissions
What do UNet site administrators need to do to allow members to view the organ verification link in a match in DonorNet?
For users who are not responsible for receiving and responding to organ offers, but still need access to view the match, the Site Administrator needs to assign VIEW OFFER ATTACHMENTS or ORGAN OFFER VERIFICATIONS permissions under DonorNet.
These users will not see organ offers displayed on their DonorNet page; they will have to search for the donor record using the donor ID and match ID.
Verification
What are acceptable sources for verification? Do they have to be source documents?
Source documents and acceptable sources are not the same. Source documents are one type of an acceptable source. There are other types of acceptable sources that can be used when performing pre-recovery or pre-transplant verifications depending on the data element being verified.
“Source document” is now defined in OPTN policy as: “An original record of results, or a photocopy or digital copy of the original record.”.A source document is the only acceptable source to use when reporting ABO for donors and candidates in UNet.
For each pre-recovery or pre-transplant verification, there is a chart in policy that contains a list of the acceptable sources that can be used for each data element of the verification. In a couple of cases, one of the listed sources is specifically “source documents." Source documents are very specifically defined in policy as “an original record of results, or a photocopy or digital copy of the original record."
For example, when looking at the pre-transplant verification upon organ receipt, there are two options for acceptable sources to verify recipient blood type – 1) recipient blood type source documents, and 2) recipient medical record. However, when you look at donor blood type in that same chart, the only acceptable source is donor blood type source documents. For the donor, you would have to have either an original or a copy of the original results. But for the recipient, you could either have the source documents or have something else that was included in their medical record and listed their blood type.
transplant hospital staff
Compliance
Do I need to print out every source used during the verifications to demonstrate compliance?
No. If the acceptable source is something you can pull up on a screen, then you can just pull it up and look at the screen during the verification. However, UNOS site surveyors will expect you to follow your own protocol. If you put in your protocol that you will use all paper documents, they will expect to see paper documents. In addition, if your protocol is that staff will verify using the organ verification link in UNet, but there is no access to it in the OR, then this could be questioned.
For more information on compliance, see the OPTN evaluation plan.
Deceased vs. living donation
For living donor recipient, if the surgery is started before the organ is in the room, do the same rules apply as for a deceased donor when the organ is not in the room?
The rule is the same for the both living donor and deceased donor recipients. If surgery starts before the organ arrives, a verification must be conducted before general anesthesia is administered. Another verification must be completed once the organ arrives in the room and before the first anastomosis.
Documentation
In regards to the recipient patient, should we place the pre-recovery ABO source documents on the recipient medical record?
The donor’s source documentation does not have to be in the recipient’s medical record.
Is the organ check-in documentation expected in the recipient's chart or a log? Are there specific requirements regarding documentation of organ check-in?
Other than requiring that the organ check-in be documented, there are no specific requirements as to how it should be done or where documentation is kept. Each individual transplant hospital must have its own protocol addressing organ check-in documentation procedures.
Do I have to document what source was used on each verification?
This needs to be covered in your protocols, but does not need to be documented on each record. In your protocol, you could say “Donor ID will be confirmed by checking the organ verification link.” Then the verification form could have a check box for “donor ID verified”. You would not be required to indicate on the form that it was verified using the organ verification link.
General anesthesia vs. continuous sedation
What is the definition of “induction of general anesthesia?"
OPTN policy does not have a definition for induction of general anesthesia. The interpretation of the induction of general anesthesia will be based on the Center for Medicaid and Medicare Services (CMS) interpretive guidelines (IG) used for 42 CFR 482.52 Conditions of Participation (CoP): Anesthesia Services available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2011-Transmittals-Items/CMS1254508.html
The IGs state the following: “General anesthesia: a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory support is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired… General anesthesia is used for those procedures when loss of consciousness is required for the safe and effective delivery of surgical services.”
See CMS guidance for more information.
If a medication such as Versed is given prior to general anesthesia, the administration of the Versed would not be considered the induction of general anesthesia.
What is the definition for continuous sedation?
OPTN policy does not have a definition for continuous sedation. The interpretation of the continuous sedation will be based on the CMS Interpretive Guidelines used for 42 CFR 482.52 Conditions of Participation (CoP) for Anesthesia Services available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2011-Transmittals-Items/CMS1254508.html
This would fall under the CMS definition for monitored anesthesia care (MAC) for deep sedation/analgesia.
Deep sedation/analgesia is described as “a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation”.
In addition, “Because of the potential for the inadvertent progression to general anesthesia in certain procedures, it is necessary that the administration of deep sedation/analgesia be delivered or supervised by a practitioner as specified in 42 CFR 482.52(a).”
See CMS guidance for more information.
The intent of the OPTN policy is to provide guidelines for recipients who may be receiving continuous sedation in the ICU prior to transplant surgery.
Laterality
How do we verify the laterality of the expected organ when this information is not included on the UNOS match run?
The expected organ laterality can be documented in the recipient medical record and this can be used as an acceptable source.
The “Organ Verification Link” available on the match results page in DonorNet might also be a source. The laterality will appear once the OPO has entered organ acceptance.
Organ check-in
Aside from the information written on the box’s external label, what source does the transplant center use to verify the organ check-in?
The transplant program will determine that in their written protocol. Acceptable sources could be a copy of the match run, or the operating room schedule log if it contains the expected donor ID.
Does the organ check-in have to be performed by 1 or 2 qualified professionals?
Policy does not specify who must conduct the organ check-in. The policy states "Transplant hospitals must develop and comply with a written protocol to perform organ check-ins…” The transplant hospital can determine who can perform the organ check-in as part of their protocol.
If one of the transplant center's procurement surgeons is personally delivering the organ to the operating room and bypassing the front desk, is the organ check-in process required? If our transplant hospital recovers the organ, do we still need to do an organ check-in? Can we combine the organ check-in with the pre-transplant verification if the organ goes directly into the recipient’s room?
The organ check-in is required only when the organ is being transported from an outside facility. If your transplant hospital team travels to an outside facility to recover the organ, you must complete the required check-in.
This check-in can be combined with the pre-transplant verification if the organ goes directly into the intended recipient's operating room when it arrives at the hospital.
What if the surgery is already started and the pre-transplant verification is already done?
You would still need to complete the organ check-in to make sure the correct organ has arrived.
Who can perform an organ check-in? For example, in our hospital, the ER charge nurse receives the organ from the courier and verifies all appropriate items. Can we continue to do this?
Yes. If the transplant hospital defines this as the process in their organ check-in protocol, then it will be acceptable to continue this practice. The organ check-in is an organization-specific process with certain elements that must be verified using the OPTN external label prior to opening the package.
What are the differences in the requirements for organ check-in, and pre-transplant verification before organ receipt?
The check-in confirms that we have “received” the correct expected organ at our facility.
The pre-transplant verification before organ receipt confirms that we have “accepted” the correct organ for the correct patient. It makes sure that a recipient does not undergo unnecessary risk of anesthesia or incision until we have verified the expected donor organ information.
What is specifically required of the transplant hospital regarding organ check-in?
Organ check-in is required for any organ arriving from outside your facility. Your transplant hospital must develop and comply with its own protocol that specifies how you will accomplish the check-in. You must document the check-in.
Make sure your protocol contains the following details:
- When must the check-in occur?
When the organ arrives at the transplant hospital and before you open the external transport container. - What information is being checked?
The transplant hospital must use the OPTN external organ label to confirm that the label contains the expected:- 1. Donor ID
- 2. Organ type and laterality (if applicable)
- What if the information is wrong?
If the transplant hospital determines that the donor ID, organ type or laterality label information conflicts with the expected information, then notify the host OPO as soon as possible, but within one hour. The transplant hospital can individualize its protocol including elements such as who will perform the check-in, what documents will be used to confirm it is the expected organ, and where the organ check-in will be documented.
Pediatrics
Are there any changes in ABO incompatible for pediatric patients?
There are no changes in this policy that impact how ABO incompatible organs are allocated to pediatric populations. All transplant hospitals will have to follow the new rules for ABO determination, reporting, and verification for all transplant procedures. Whether the donor and recipient ABO blood types are compatible or intended incompatible will be a standard part of the pre-transplant verification for every recipient.
The OPTN/UNOS Board of Directors did approve changes to pediatric lung allocation policy, including policy changes for ABO incompatible lungs in December 2015. These policy changes have not gone into effect yet and you can view that policy notice here.
Pre-Transplant Verifications
Can the pre-transplant verification take place outside the recipient OR at the nurses’ station prior to the surgeon scrubbing in?
No, OPTN policy requires that both recipient pre-transplant verifications take place in the OR.
Do we need to do two verifications for every recipient?
No, it depends on when surgery will start on whether you will do one or two verifications. A pre-transplant verification prior to organ arrival is required if surgery starts before organ receipt (arrival). This verification is done prior to giving general anesthesia.
Every recipient must have a pre-transplant verification upon organ receipt (when the organ arrives in the operating room).
For the pre-transplant verification prior to organ receipt, it states we should be verifying donor and recipient ABO before we initiate anesthesia. In pediatric thoracic patients, anesthesia typically begins before we see the organ at the donor facility. Does this process need to change?
The transplant verification process would need to change. You would need to verify the expected donor organ information before the recipient receives anesthesia to ensure the organ offer you accept is appropriate. We use the word expected since when you verify the organ receipt, the information could potentially not match, which would result in the organ not being used for transplant for this recipient.
Can you clarify the ABO verification process if the transplant surgery starts before the organ has arrived, and the correct timing of the ABO verification during the surgery process?
If surgery starts before the organ is received (arrives) in the operating room, then a pre-transplant verification must be conducted before general anesthesia is administered. This step verifies the expected donor ID, expected organ, and expected donor blood type and subtype (if used for allocation). You can verify these elements using documentation in the OPTN computer system (e.g. the match run page, the organ verification link, and/or blood type source documents uploaded to DonorNet). You can also verify the expected donor ID and expected organ information using the recipient medical record.
Once the organ arrives then you conduct the verification upon organ receipt.
For the pre-transplant verification, can you define "organ arrival"? Is that when it arrives in the operating room?
Yes, organ receipt (often referred to as organ arrival) means the time the organ arrives in the operating room. We use the term "organ receipt" in the pre-transplant verification policies. This terminology is consistent with CMS.
When the recipient is in the OR for a liver transplant, where does the donor information come from? Where would the nurse find this? Would the surgeon bring this information?
The donor information is available in DonorNet®. There is an “Organ Verification Link” available on the match run results page that provides donor and recipient information. If the nurse does not have DonorNet access, the transplant coordinator or surgeon can access and print the information. Paper copies of the donor’s ABO source documents will also arrive with the organ.
What additional elements will have to be recorded, if any, during the compatibility verification pre-transplant, post organ arrival?
The elements are specified in the policy. They include: donor ID, organ (and laterality if applicable), donor blood type and subtype (if used for allocation), recipient unique identifier, recipient blood type, donor and recipient are blood type compatible (or intended incompatible), and that the correct donor organ has been identified for the correct recipient. No additional data elements must be verified beyond what is contained in the policy.
For heart and lung donor organs that arrive on a Transmedic OCS device, is the initial ABO verification when the organ arrives on the device in the OR? For import kidneys, sometimes our OPO will put the kidney on the pump for us before it ever arrives at our hospital. How will this change the organ arrival verification?
If heart and lung donor organs are arriving on a Transmedic OCS device and the recovery took place outside of the transplant hospital facility, then an organ check-in is required. The organ check-in can be combined with the final pre-transplant verification upon organ arrival in the OR.
When a kidney is received by an import OPO, then the transplant hospital should work with the import OPO to ensure that the kidney is packaged and received in a way that will allow the transplant hospital to perform the required organ check-in.
CMS requires that ABO verification be performed once the organ and patient are in the room. OPTN policy is still the organ and patient ABO verification be performed after the organ arrive in the OR. Is this correct?
Both OPTN and CMS require that the pre-transplant verification occur with the organ and intended recipient present in the operating room. The verification must be performed prior to anastomosis of the first organ.
If the organ has arrived, but has not been checked in, should we continue to do the verification prior to organ arrival?
The pre-transplant verification required when surgery will start before organ arrival is based on the time the organ will arrive in the OR. If organ check-in will not occur before surgery starts and the organ will not be present in the OR when surgery starts, then this verification must be performed.
It should be noted that the organ check-in could be combined with the final pre-transplant verification upon organ receipt conducted with the organ and recipient present in the OR.
Source documents
Will transplant hospitals be expected to document which specific source documents they used for each verification?
No, it is not necessary to document which source documents were used, but it is necessary to document that the acceptable source was used in accordance with policy.
Is transcription of donor ABO from DonorNet into an EMR acceptable as source documentation? If the donor and recipient EMRs allow "linking" of donor organs and pulls the ABO to the recipient EMR may this serve as an acceptable source (recipient medical record) for verification if surgery starts prior to organ arrival?
If the electronic medical record (EMR) is pulling the data directly from a source document (e.g. laboratory data feed) then this would serve as an acceptable source for the donor ABO that could be stored or accessed in the recipient medical record. The recipient medical record could then be used as an acceptable source for the donor ABO.
Transcription of any information does not meet the OPTN policy definition as a source document. A pdf of source documentation of ABO blood type (original lab report) could be used. Remember not all data elements require that a source document as defined in policy be used.
In many cases, an acceptable source such as the OPTN computer system, can be used. See OPTN policies for specifics.
Subtype
Do transplant hospitals have to report or verify subtype for candidates?
Transplant hospitals do not have to perform or report subtyping on candidates. Subtyping results for candidates do not impact match run results. Only donor subtype results possibly expand allocation opportunities for candidates. Some transplant hospitals do report subtype, however, and in those situations second user verification is now programmed in UNet.
Surgeon
Can you explain who can perform ABO verification particularly with regards to the surgeon?
One of the licensed healthcare professionals participating in the pre-transplant verification if surgery starts before organ arrival can be the surgeon. The surgeon is not required for this verification. The surgeon, however, must participate in the final pre-transplant verification conducted once the organ has been received in the operating room prior to first anastomosis.
What is your suggestion when the surgeon is scrubbed in at the time when the verification occurs? The surgeon participates but is not able to sign the form at the time of the verification.
One way to handle this situation is to have the licensed healthcare professional pull up the required sources and do the documentation at the time of the verification, and have the surgeon participate by visually verifying the information before anastomosis, but signing an attestation afterward.
If the attending surgeon is scrubbed in when the organ arrives, but the organ is brought into the OR by another staff transplant surgeon can that surgeon perform the verification with a nurse?
Yes. An alternative would be to have the attending surgeon perform a visual verification as described above.
Can you clarify if for combined organ transplants, must each of the transplant surgeons complete the ABO verification before the first organ is implanted?
Policy states that verification must occur after the organ has arrived and before it is implanted. There is not a requirement that all verifications occur before the surgery can start. If there are different surgeons for each organ, then each surgeon must complete ABO verification before they implant that organ.
Templates
Will you be updating the donor form and recipient ABO verification form (templates) that currently exist?
Updated living donor and recipient OR verification template forms are available on-line. UNOS and CMS collaborated to update the forms. They can be modified to meet your institution's needs.
Titers
For A2 to B Recipients, does UNOS plan on making a policy as to whether the required titer value should be an Anti-A1 or Anti-A2 titer?
Currently no committees are proposing that we specify whether the required titers for A, non-A1 to B recipients should be Anti-A1 or Anti-A2.
Two blood draws
For pre-transplant blood type determination, should the candidate have their blood drawn on two different days or can it be drawn on the same day at different sites and at different times in 2 separate tubes?
You can perform two blood draws on a candidate on the same day as long as there are two different draws (two different phlebotomy procedures must be done). There should be two instances where the correct patient was identified. For auditing purposes, the two blood draws would need to be at least one minute apart.
Vessels
Are there any differences in how you document blood type verification for external donor vessels as opposed to an organ?
Policies 16.6.C (Blood Type Verification Prior to Transplant of Deceased Donor Vessels) and 16.6.E (Blood Type Verification Prior to Transplant of Living Donor Vessels) explain vessels blood type verification requirements. These policies include verification of additional elements such as infectious disease testing results. Policy states that vessels (deceased and living donor vessels) verifications must be documented and maintained in the recipient medical record. While not required, a transplant hospital could combine documentation of both organs and vessels as long as the requirements for both the organ and vessels verification policies are met.
living donor program staff
Living donor verification
You mentioned the Living Donor feedback form in the webinar. Is this new or Paired Exchange specific?
The OPTN living donor feedback form is used to register all living donors in Tiedi.
Pre-recovery verification
Our living donor grafts are recovered off site at another hospital. Will the pre-recovery ABO verification process for living donors be their responsibility? What will the recipient transplant hospital be responsible for?
The living donor recovery hospital must complete the pre-recovery verification for the living donor. The recovery surgeon and another licensed health care professional must participate in the verification.
The recipient hospital must complete the pre-transplant verifications.
For living donor pre recovery verification, is the donor ID source document the living donor UNOS ID or the patient’s hospital ID?
The living donor UNOS ID.
In Policy 14.7 Living Donor Pre-Recovery Verification, how can you verify the living donor organ type and laterality using the acceptable source (OPTN computer system) listed in policy?
The organ type (including laterality if applicable) is entered on the Living Donor Feedback Form when registering the living donor in UNetsm prior to donation. This information would be available on the Living Donor Feedback Form in the OPTN computer system.
For policy 14.7, Living Donor Pre-Recovery Verification-- the donor identification band is listed as a source for verifying the Donor ID. Our donor identification band doesn’t have the UNOS Donor ID on it, only the Donor’s name, DOB and medical record number. How can we do this part of the verification?
The donor identification band is listed as the acceptable source since it is necessary to ensure the identification of the correct donor present for donation. Hospital patient identification bands might not have the UNOS Donor ID printed on them. In that situation, it would be necessary to use an additional document, as identified in your protocol, to link the UNOS Donor ID with the other identifying information on the donor’s ID band.
In some institutions, additional identifiers can be printed on the hospital identification band. If this is the case in your institution, then it may be more efficient to start adding the UNOS Donor ID to the identification band for living donors.
For living donors, can the pre-recovery verification be done in the pre-operative area?
OPTN policy does not specify where the living donor pre-recovery verification takes place.
Subtype
Does subtyping need to be done twice?
Any subtyping that you report to the OPTN will need to be performed twice.
OPO staff
What are the anticipated changes for OPOs?
Determine ABO blood type and subtype
- OPOs need to ensure that two separate draws have been completed to determine deceased donor blood type. We’ve removed the option to draw blood at one time and send to two different labs. Historical blood type results can be used for one of the typings if source documentation is available.
OPOs must develop and include a process in their written protocols for how they will handle conflicting primary blood type results.
Report ABO blood type and subtype
- OPOs must complete blood type reporting to UNOS based on at least two blood type determinations. For deceased donors, the initial report and second user verification must be completed before the match run for deceased donors.
A qualified health care professional (defined in your OPO protocol) must be used to report all blood types and subtypes.
Match run
- If an organ has not been accepted on a match run and the transplant hospital updates data after the OPO notifies them, then the OPO must re-execute the match run before allocating the organ.
Pre-recovery verification
- OPOs must verify the donor ID; donor blood type and subtype (if used for allocation), and organ type (with laterality, if applicable) to be recovered on all deceased donors before incision. A qualified health care professional from the OPO and the recovering surgeon must complete this verification.
- When the intended recipient is known, the OPO must verify the intended recipient’s unique identifier, intended recipient’s blood type, and that the donor and intended recipient are blood type compatible or intended incompatible. Two qualified health care professionals, one of whom must be an OPO staff member, must conduct this verification.
- OPOs must use acceptable sources, as defined in the policies, to verify each data element.
Miscellaneous
- OPOs may or may not label additional red top blood tubes sent with the organ with the ABO blood type.
OPO pre-recovery verification
Do transplant centers need to create new ABO verification forms for pre-recovery verification of the deceased donor?
It is the OPO’s primary responsibility, not the transplant hospital’s, to ensure that pre-recovery verification is done according to its protocol. The recovering surgeon must participate in the verification. If the surgeon is from the intended recipient's transplant hospital, then the surgeon would participate but the OPO must develop the process and maintain the documentation.
Is a pre-recovery check required, even if the OPO doesn’t know yet who will accept the right vs left kidney?
Every organ recovered requires a pre-recovery verification, including the donor ID, organ (and laterality, if applicable), donor blood type, and subtype (if used for allocation).
If the OPO does not know who will accept the right versus the left kidney then the intended recipient is not known before organ recovery. The donor information stated above is all that needs to be verified in this situation.
Can you clarify what is meant by verifying recipient information before OR recovery?
If the intended recipient is known before deceased donor recovery, then you must verify the following information: the intended recipient unique identifier, intended recipient blood type, and that the donor and intended recipient are blood type compatible (or intended incompatible). You can get this information from the OPTN computer system match run.
For the deceased donor pre-recovery verification, if a surgeon is procuring an organ on behalf of another transplant hospital, will that surgeon be expected to sign the verification of recipient ABO? Recovery surgeons are not required to verify intended recipient information as part of the deceased donor pre-recovery verification requirements. The individual OPO may require this as part of their individual OPO protocol but it is not required by OPTN policy.
Does each surgeon need to sign off on the deceased donor pre-recovery verification for multiple organ procurements? Yes, each surgeon performing organ recovery will need to sign off on the deceased donor pre-recovery elements for donor ID, donor organ(s) and laterality if applicable to be recovered, and donor ABO.
For deceased donor pre-recovery verification, can the verification for intended recipient information be done by two OPO staff members? Yes, the verification for intended recipient information can be done by two OPO staff members as long as each of them meets the OPO’s individual requirements to be considered a qualified health care professional.
If the intended recipient changes after the OPO completes verification during the deceased donor pre-recovery verification, is there any requirement of further documentation of donor-recipient compatibility by the OPO? Verification of intended recipient information is performed using the information available at the time of verification. If the intended recipient changes, the OPO is not required to perform further verification or documentation. OPTN policy places the ultimate responsibility for donor-recipient compatibility with the transplant surgeon.
Policy 2.15.B Table 2-1 requires that one qualified healthcare professional be the recovery surgeon. If they are not local surgeon, is the host OPO responsible for training them or verifying their "qualified" status? How do we know they were trained? OPOs already have requirements in place to verify qualifications of recovery surgeons. The second person serving as the OPO qualified health care professional participating in the pre-recovery verification can provide information specific to the OPO’s protocol as needed.
How can an OPO obtain the source document for the intended recipient ABO? OPTN policy lists acceptable sources that can be used to verify information elements. For example, the organ verification link in DonorNet can be used to verify intended recipient ABO. While this is not a source document as defined in policy, it is an acceptable source to verify this information as part of the deceased donor pre-recovery verification.
Subtype
Is a second subtype required when the initial blood type is determined to be A1 or A1B?Since A1 and A1B are not used for allocation, you are not required to repeat the test and report to the OPTN (enter the result into DonorNet). OPOs, however, must maintain keep documentation showing that they performed subtyping for all primary A blood types. If you report the subtype result to the OPTN (enter the result into DonorNet), then it is necessary to complete a second subtype and have both tests showing the same result.
For OPOs, if we have a donor that has already received packed red blood cells (PRBCs) before our involvement, how can we obtain 2 separate pre-transfusion specimens for ABO subtyping?It may not be possible to obtain pre-transfusion specimens. In that situation, you must not perform subtyping and then document the reason why.
Can you say more about blood group A subtyping and accepted designation of A1-lectin negative type? Policy uses the term A, non-A1 for any subtype that is not A1. The OPTN will not be changing labels in UNet systems. The labels will still read A2. There is explanatory text that A2 is used as shorthand for any blood type A subtype other than A1 (i.e. non-A1, negative for A1). A2B is used as shorthand for any blood type AB subtype other than A1B (i.e. non-A1B, negative for A1B).
When blood type is reported as non-A1, do you register the donor as A2? If documentation doesn't match A2, will that cause issues? Yes, you would register as A2 (provided you tested according to policy requirements) and that would not cause an issue for documentation. We will not be changing labels in UNet systems. The labels will still read A2. Explanatory text is posted stating that A2 is used as shorthand for any blood type A subtype other than A1 (i.e. non-A1, negative for A1) and A2B is used as shorthand for any blood type AB subtype other than A1B (i.e. non-A1B, negative for A1B).
Do you have to draw subtyping samples on separate occasions as well? For example: if the only pre-transfusion sample is from the lab (one tube), can it be separated and sent to 2 different labs, or must you find another tube or not subtype all together?
Yes, subtyping specimens must be from two separate draws. You are not allowed to use one sample from one draw and send it to two different laboratories. If a second specimen from a different blood draw cannot be located then the subtyping must not be performed. The OPO should document why they could not complete the subtyping.
Does subtyping need to be done twice?
Any subtyping that you report to the OPTN will need to be performed twice.
Template
Is a template for deceased donor pre-recovery verification being developed and published? Yes, a template for deceased donor pre-recovery verification is posted on-line.
Two Blood Draws
Can you explain the lab draw changes for 2 ABOs? In order to align with CMS regulations, the OPTN no longer allows one draw with blood tubes sent to two different labs for deceased donor blood typing. Only two separate blood draws are allowed. Policy does not specify whether one or two labs must be used. This choice is up to the individual OPO.
Does the OPO have to draw both ABO samples or is it appropriate to utilize a hospital drawn sample for the first ABO type? It is OK to use the hospital sample for the first ABO type as long as the source document from those results is available to use when entering data into UNet.
Explain how to document that the individual OPO's protocol was followed for ABO determination and reporting prior to listing in DonorNet? This will be part of the individual OPO’s protocol. For example, your organization’s qualified health care professionals who review the ABO source documentation may initial, date, and time the lab results as the required documentation that source documents were consulted.