Taba Kheradmand | 8/9/2018

I support having two level entry for verification and not allowing progress if one entry does not match the other. It might be a little more challenging to monitor if the raw data vs the data entered have been reviewed thoroughly and it still can leave room for the wrong manual entry not being caught/corrected.

CarlLudwig FischerFroehlich | 8/10/2018

Dear Colleagues, Thank you for the opportunity to comment.  Double data entery is a challenging workload for a single Person which may not always result in avoiding 'typing' errors. In my country (Germany) HLA-Labs enter the typing via the IT-Software of the national OPO (one for the whole Country). This is linked to Eurotransplant (for organ match run). In order to increase safety we controll the data entry in the Background by IT automatically (with translation of the 'PCR-typing' into 'serological match-euqivalents' as agreed on by the Eurotransplant member states). Always a second person must verify the data by reading them again in the screen and signing them electronically before the data are released for the match rund. Also all donor tissue typing labs must be certified according to EFI standards. By random some recipient centers perform retyping of the donor on their own discretion - so we have random quality control beyond standards of mandatory interlaboratory tests, During work for relaunch of our IT-database we identified that the quality of the IT design to enter the data is a risk factor too. Tiny items may be the cornerstone to expose the user to the risk of incorrect data entry inadequately. This must be re-checked too in case of policy release. During this relaunch period our laboratories reported that they keep the records of the system entry and controll them against their internal data. Whether exchanging orginial records beyond this might be a national decision - at least one mechanism exist to validate the entry in the system agianst the own results measured. The control Loops must be defined and re-cecked durign certification of the lab. This policy is the other way around then suggested by the policy commented. We just have to make sure that somebody cecks and how this is done. An addtional safety feature could be to make data entry of Bw4/Bw6 and DR51/DR52/DR53 mandatory - as most people may read the screen and use their knowledge of HLA and to enter the data. This may help too - it  may 'cost' working time, but your eyes may detect a problem. Direct connection of laboratory equipment to the IT System will be challenging due to the Interface issue. This must be considered well - if easy to handle this is an option. Another issue to be considered is, that some HLA-Typing kits commercially available do not cover perfectly all needs for correct typing in all populations. Then difficulties arise regarding virtual crossmatch: we need a policy on how to proceed with a 'maybe result' of the initial typing (which is at a high probability not correct, but most likely without harm to any recipient) as time consuming retyping  becomes mandatory. Then retyping might reveal a slightly different result (e.g. homozygot or not). This issue should not be flagged as 'incorrect tpying' but flagged as 'unprecise typing due to technical limitations of the kit'. Unfortunately I do not know whether ever somebody went through all donor typings to check for such problems systematically too? Such technical limitations may require that the user develops a solution and forces him or her to enter 'some data' into the System....so we do not loose organs. (this issue came to the light when we started with our SAE/SAR system) Please appologize my lousy English    Kind regards  Carl-Ludwig Fischer-Froehlich.

Andrew Rivard | 8/19/2018

The OPTN Committee is proposing changes to reduce the number of manual HLA data entry errors in UNetSM. These changes fail to address the problem of uploading data electronically and continue to rely upon manual data entry which can have inherent problems of human (transcription) error. The proposal should instead focus on the root cause of the problem which is the lack of digital transmission of the HLA data directly from the HLA laboratory to the UNet. Use of manual data entry transfers the burden of labor from UNOS' IT department to individual transplant centers and HLA laboratories. Every effort to upload HLA lab data electronically should be exhausted by UNOS first prior to proposing overly burdensome activities to reduce system inefficiencies.  Steps that UNOS should take to accomplish this task include standardization of HLA reporting by HLA laboratories and cooperation with manufacturers to produce reports in a specific format. 1) When HLA data is entered manually into UNet, it must be entered twice (by the same person) for verification of accurate data entry. Response: This is double data entry and is doubly burdensome on the laboratory personnel and with addition of additional HLA allele reporting (DP) this will make the time to enter all the HLA antigens 2x as long as currently done. 2) When HLA data are uploaded directly into UNet, the member must have a process for verifying that the data are accurate. Response: This should be done by using electronic verification using rules based comparison to the latest equivalency tables for HLA-A, -B, -DR, and DQ. 3) Raw HLA typing must be attached in the system for verification of lab results. Response:  This requirement further burdensome and time consuming on top of double data entry of HLA antigens.Manual data entry into web based forms should be eliminated and replaced with electronic submission of HLA data in a compatible format (XLS, comma delineated, etc). In summary, UNOS should work with ASHE and equipment manufacturers to determine standard reports that can be automatically imported into UNet. This will effectively eliminate human error from manual data entry in the transcription process. The advantage of this automated process is the freeing up of additional time for HLA laboratory personnel to concentrate their effort on other vital transplantation tasks.

Randee Bloom | 8/25/2018

I support this and similar policy efforts that seek to reduce the known causes of documentation errors, especially critical in the correct analysis and allocation of precious donated organs. The collected and clearly reported findings, reported herein as 'donor HLA discrepancies' and 'discrepant typing' are appreciated, while possibly alarming. Given the fallibility of even well-trained professionals, I wonder about the potential gain when permitting one individual to repeat their own data input, and possibly their own mistake, rather than the recommended but more expensive and time consuming requirement of having a team of two individuals. Additionally, I suggest consideration be given to including within this policy's implementation plans for requiring members to participate in a re-education reflective of these actual error occurrences. Also, I ask for consideration of a means in the program to alert UNOS to compute and track the record number of event alerts from un-matched data entry.

Region 4 Vote | 8/30/2018

19 strongly support, 5 support, 0 abstentions/neutrals, 0 oppose, 0 strongly oppose

Anonymous | 8/31/2018

This is an issue that needs to be addressed and fixed. Incorrect HLA data could lead to multiple complications including, but not limited to, a recipient missing out on a transplant, an HLA mismatch being transplanted, organ rejection, and the development of more HLA antibodies in recipients.

Anonymous | 9/1/2018

This proposal is something that obviously needs to be completed and implemented. It appears that once errors were being observed, the need for a proposal was warranted; thus, the creation of this solution. This solution is appropriate, and pertinent to the topic at hand. It's straightforward but seems to be exactly what is needed. The proposal was easy to understand, follow, and SUPPORT! Especially with no tweaking from my standpoint. 

Suzanne Conrad | 9/3/2018

I am in support of this proposal because it will improve patient safety. More important than double entry of the HLA typing is the directive to upload source documents. In that way, even if an HLA technologist is working alone in a lab at night, there will be at least one OPO person able to view source documents to verify accuracy.

Anonymous | 9/4/2018

I agree that preventing HLA errors is extremely important.  Having a measure in place that prevents these and double checks the information entered is a good idea.  I wonder why it doesn't pass through a second set of eyes once the data has been cleared for the second entry.

Sarah Sampsel | 9/5/2018

I participated in a review and comment workgroup as part of the PACC, and also participated in a discussion of the proposal at the PACC meeting in August.  While I certainly support reducing errors, especially those that may impact patient safety and organ viability, there seems to be a need for more information on the actual impact of the proposed 'fix' to the data entry system.

Laura DePiero | 9/7/2018

I support having two level entry for verification and not allowing progress if one entry does not match the other. It might be a little more challenging to monitor if the raw data vs the data entered have been reviewed thoroughly and it still can leave room for the wrong manual entry not being caught/corrected.

AOPO | 9/10/2018

AOPO supports the Committee's proposal to reduce the potential for manual data entry errors in UNet through the addition of requirements to enter information twice to ensure accuracy of entry and for the requirement to attach raw HLA results to system to allow verification of results.  Several OPOs operate HLA labs for their communities and a straw poll of these organizations indicates that these practices are already in place at these laboratories. Given the potential consequences of HLA data entry errors and relative ease of implementing these changes to eliminate the potential for these type of errors, AOPO feels their addition as a requirement is appropriate.

Region 3 | 9/11/2018

Region 3 Vote: 15 strongly support, 10 support, 2 abstentions/neutrals, 0 oppose, 0 strongly oppose

The region supported the proposal as written. There was a programming suggestion to blind the initial manual entry of HLA data and hide it from the user when they enter the data the second time.  This would force the user to refer to the original source of the information, rather than what has already been entered in UNet.

No comments.

Region 8 | 9/12/2018

Region 8 Vote: 16 strongly support; 5 support; 0 abstentions/neutrals; 0 oppose; 0 strongly oppose

No comments.

Darnell Waun | 9/12/2018

This is a patient safety issue and any potential risk to safety should be addressed with whatever is needed to mitigate.

Region 5 | 9/14/2018

Region 5 Vote: 8 strongly support, 15 support, 2 abstentions/neutrals, 0 oppose, 0 strongly oppose

The region supported the proposal as written. There was some concern raised that antigen level typing errors would not be fixed by with this policy change.

Carolyn Light | 9/19/2018

This seems like a reasonable safeguard to ensure accurate data entry.

Region 1 | 9/17/2018

Region 1 Vote: 8 strongly support, 3 support, 3 abstentions/neutrals, 0 oppose, 0 strongly oppose

Anonymous | 9/20/2018

Why has there not always been a two stage confirmation process??? You literally have our lives in your hands!! One person should enter and A SECOND PERSON should verify. No one should ever verify their own entry

Denise Neal | 9/24/2018

This was an issue that needed to be addressed and resolved due to the potential for transplants to occur with incorrect HLA matching due to the incorrect entry of HLA data.  This policy also addressed the technical issue that allowed HLA data to be changed by anyone looking at the record. The will be a mechanism to lock this data so it cannot be inadvertently changed.

Deanna Santana | 9/24/2018

Creating the safest possible processes will lead to the best outcomes for these gifts.

Anonymous | 9/24/2018

I appreciate the work to ensure accuracy in data entry.

Region 2 | 9/26/2018

Region 2 Vote: 19 strongly support, 9 support, 1 abstentions/neutrals, 0 oppose, 0 strongly oppose

The region supported the proposal as written. It was noted that with the prevalence of uploading capabilities into UNet that manual entry of HLA should not be an option.  If interested the committee could collaborate with the Operations and Safety committee to look into this.  Another member expressed the desire for a more formal process to handle HLA discrepancies than what is currently in OPTN Policy.

OPTN/UNOS Patient Affairs Committee | 9/27/2018

The OPTN/UNOS Patient Affairs Committee commends the Histocompatibility Committee on their efforts to improve patient safety by proposing data entry safeguards to mitigate human error.

The PAC asked the following questions:
Q: With regard to the setup of HLA data in DonorNet, where a user can unknowingly change a donor’s HLA information prior to the match run, is there a way to “lock” this field so it cannot be edited?
A: The Histocompatibility Committee is working with UNOS IT on a system enhancement that will lock data fields to prevent mistakes like these. This issue will be addressed.

Q: What is the frequency with which these HLA mismatches occur?
A: 1-2% critical discrepancies a year over the past several years. But at least 50% of those match runs were repeated with corrected HLA typing. But in the 50% that weren’t, the OPTN doesn’t have data to ascertain what happened in those cases. Just because typing is incorrect, doesn’t necessarily mean there would be an issue, unless the patient doesn’t have antibodies against that donor HLA type.

Q: Did the Histocompatibility consider requiring “refresher” education, in addition to any education that will be developed for implementation of these changes?
A: This could be considered after implementation if the Histocompatibility Committee continues to see these specific reporting errors.

Q: Did the Histocompatibility Committee consider programming that would record the error (on a field-level) real-time for data collection purposes, and then incorporate pop-up warnings or messages to notify the user incorrect data was entered?
A: The Histocompatibility Committees reviews errors retrospectively on a quarterly basis. The presenter wasn’t sure if there were ways for UNOS to visually customize fields identified as problematic. The Histocompatibility Committee does review the data for patterns.

Q: Is there a way to have the raw patient data running in the background and “prompting” a user when they enter the wrong data?
A: The raw patient information is uploaded to UNet, not entered manually, nor does the testing instrumentation communicate with UNet. There is no link between the raw data and UNet itself.

From a patient perspective, the proposal was very technical and challenging to understand. The average patient would likely support this proposal, however, they are unlikely to understand the content. Although the proposed improvements may result in additional administrative burden for staff; there seems to be nothing but positive implications for patients. The PAC supports this proposal.

OPTN/UNOS Organ Procurement Organization Committee | 9/27/2018

The OPO Committee met by teleconference on 09/24/2018 to discuss the Addressing HLA Typing Errors proposal. The Committee supported this proposal to ensure the accuracy in data entry.

Anonymous | 9/27/2018

Our HLA Laboratory have been utilizing these practices for some time now. We feel that its addition as a requirement is beneficial.

American Nephrology Nurses Assiciation | 10/01/2018

ANNA supports.

American Society of Transplantation (AST) | 10/01/2018

The American Society of Transplantation is supportive of this proposal in concept and believes that it will reduce the number of HLA data entry errors in UNet and promote safety for both living and deceased donor transplantation, but offers the following comments:  • We support dual entry of the HLA data into UNet  • For HLA data uploaded directly into UNet, we believe that minimum criteria for data verification will strengthen this proposal if added to the policy.  • We recommend clear working to ensure that uploaded donor HLA typing data is labeled with the UNOS ID and stripped of other identifiers to comply with HIPAA regulations.  • Would suggest that HLA typing verification be performed by HLA laboratories independent of how the HLA data was entered into UNet- manually or automatic upload. This is routinely done at some laboratories as part of their QA process. We would suggest the UNOS considers incorporating this step of HLA typing verification by the HLA laboratories into the process and having a method of documentation of such review (within a short period, 30-60 days).  • We agree with attaching Raw HLA typing to the system for verification of the lab results  • There is a comment somewhere in the process of entering HLA data that states 'at least one HLA antigen must be entered for each locus.' We believe this statement should be changed. If there is only one HLA antigen identified at a particular locus, the person entering the data should be required to enter something into the second field to acknowledge that only one HLA antigen was identified at that locus. For example, if patient is homozygous for A2, the person performing the data entry can enter A2, A2 or A2, 'no second antigen'. The system should not allow the person performing data entry to enter A2 in the first box and nothing in the second box and move onto the next locus. The basis for this comment is the fact that we have seen discrepancies between UNet HLA data entry and our laboratory data based on the requirement that 'only one antigen entry is mandatory.'  • We believe that an online education tutorial for 'HLA data entry for Transplant Programs' will be valuable to the community. The AST would be happy to work with the OPTN/UNOS on this project if it is implemented.

Region 9 Vote | 10/01/2018

The Region 9 vote is as follows:

9 strongly support, 10 support, 0 abstentions/neutrals, 1 oppose, 0 strongly oppose

American Society of Transplant Surgeons | 10/2/2018

The American Society of Transplant Surgeons (ASTS) appreciates the opportunity to comment on the current OPTN/UNOS public comment proposal to address HLA typing errors. ASTS supports this proposal as written to ensure the safety and integrity of the organ allocation process. The requirement to accurately enter and validate HLA and tissue typing is a minimal requirement for all OPOs, taking additional steps to improve the process is recommended.

Region 11 | 10/2/2018

Region 11 Vote: 10 strongly support, 9 support, 0 abstentions/neutrals, 0 oppose, 0 strongly oppose

The region supported the proposal as written.  One member noted that HLA typing is changing and advancing; however, allele typing in UNet does not always have serological equivalents.  The member was in favor of the changes to correct clerical errors, but does not address issues with interpretation. 

The American Society for Histocompatibility and Immunogenetics (ASHI) | 10/2/2018

The American Society for Histocompatibility and Immunogenetics (ASHI) supports this proposal and unequivocally favors policies designed to reduce clerical errors prior to reporting deceased donor typings. ASHI believes this proposal will not negatively impact laboratories in either immediate or long-term budgetary issues.

ASHI believes that direct transmission of data from laboratory databases directly into UNet is the best way to eliminate clerical errors. ASHI is hopeful that discussions with UNOS IT at an upcoming workshop  during the annual ASHI meeting will lead to actionable items that promote  seamless data transmission to UNet and other UNOS systems (Tiedi, etc.) seamlessly.  ASHI has requested the two largest vendors of HLA laboratory information systems, SystemLink and HLA Data Systems, to provide input for this proposal. Both vendors believe that APIs for inputting donor typings and recipient typings and unacceptable antigens in real-time through electronic submission of appropriate files formats could be accomplished in a manner similar to what is already being done with HLA laboratory data submissions to the National Marrow Donor Program.

ASHI also believes that any clerical errors responsible for HLA typing discrepancies will be reduced by this proposal; such discrepancies will still not be totally eliminated. OPTN/UNOS must recognize that HLA typing is undergoing a revolution due to an increasing number of labs performing next-generation sequencing (NGS).  While NGS is unlikely to be a factor in initial deceased donor typing, confirmatory donor typing will often be done by NGS, leading to potential discrepancies. While in most cases, Most-low resolutions HLA typing, done initially for deceased donor, typings focuses on a limited number of exons (exons 2 and 3 of class I; exon 2 of class II), NGS can sequence the entire gene and identify polymorphisms that were not resolved by low-resolution typing.  Furthermore, complicating HLA typing discrepancies arising between low-resolution typing and next-generation sequencing may occur due to the, is a large number of HLA alleles are based on with  incomplete or outdated sequence data.  This is being addressed by the International Histocompatibility and Immunogenetics Workshops, the next one which is being scheduled for 2020 in the Netherlands in 2020.

A larger issue for ASHI and OPTN/UNOS to consider is that while HLA typings are being revolutionized by next-generation sequencing, there has been little to no progress made to determine the 'serological equivalents' of these new HLA alleles.  A major scientific effort, to assign serological equivalents to new alleles and, perhaps, foster a change in mindset from considering mismatched HLA 'antigens' to mismatched HLA 'epitopes' is needed and will likely require national/international funding and effort.

Elizabeth Rubinstein | 10/3/2018

Anytime you have manual entry of data with no transcription cross checks, mistakes happen unknowingly and in HLA matching this has serious consequences. The proposal action is a start but there does need to be source educational training and a two person verification method implemented prior to data entry and afterwards just as patients and family members witness when a unit blood match is verified prior to administration. This is an additional solution to compliment the proposal.  Any time we can have an IT solution to help eliminate these common entry errors that occur more often then we would like to acknowledge, it should be implemented.  It would be interesting to track and review what our current faulty data entry rates are now and trace source data entry points to enforce education efforts of staff. But the proposal should go one step further to get to a true absolute solution to address the root cause of the problem which is the lack of digital transmission of the HLA data directly from the HLA laboratory to UNet. When data has to be transferred literally from one source to another in any redundant manual fashion, mistakes happen. Why not address the root cause and provide a more reliable long term resolution, reduce labor costs and safe guard accurate reporting? Overall, I support the proposal but we need to do more in this area of safeguarding accurate data entry and reporting.  Protecting our patients in the transplant matching process should be our number one priority and this proposal is a solid step in assuring we are meeting that standard behind the scenes.

Anonymous | 10/3/2018

It seems to me this proposal is a 'no brainer.'  In fact, I wonder why there was a need to present the proposal for comment. I can see where reducing typing errors will greatly improve outcomes without any risk.  How many typing errors occurred between the time this issue was identified and adoption?  I suggest there be a fast track option where the impacts of adoption result in improved patient safety.

National Kidney Foundation | 10/3/2018

As the Histocompatibility Committee highlights, while human leukocyte antigen (HLA) typing errors occur infrequently even one error can be catastrophic and result in death of the recipient, failed transplant, and organ wastage due to inappropriately matched donors. The National Kidney Foundation appreciates the recommendations of the Committee for a two-step authentication of HLA type. We support this proposal as an interim step to reduce future errors.  However, we recognize that human error will continue and that the only way to prevent HLA typing errors is to improve technology by allowing for interoperability of software programs from the labs to UNET and transplant programs so that data can be automatically uploaded.  We recognize not all transplant programs are using the same software package, and we call on OPTN to work with the transplant community to take immediate steps towards automatic uploading of HLA type to reduce this significant risk to patient safety and lost organs.

Luis Mayen | 10/3/2018

I support the Histocompatibility Committee's effort to enhance patient safety.  Double verification and attaching the raw data are reasonable requirements with minimal impact on current operational practice.

Region 6 | 10/3/2018

Region 6 Vote: 19 strongly support, 15 support, 0 abstentions/neutrals, 5 oppose, 0 strongly oppose

It was noted that it might help improve accuracy if two people were required to enter HLA data.

Region 7 | 10/3/2018

Region 7 Vote: 22 strongly support, 1 support, 0 abstentions/neutrals, 1 oppose, 0 strongly oppose

OPTN/UNOS Living Donor Committee (LDC) | 10/3/2018

The OPTN/UNOS Living Donor Committee (LDC) commends the OPTN/UNOS Histocompatibility Committee’s efforts to improve safety and accuracy through its HLA typing proposal. The LDC offers its consensus support for improving accuracy of HLA typing.  While the source documentation at issue is intended for deceased donor transplants, in the LDC’s view, the proposal’s focus on increasing accuracy in data entry and thus reporting is important to improving safety in transplantation in general.

The LDC’s views were informed by the Histocompatibility Committee presentation on the proposal in September 2018. The LDC asked questions about the proposal’s impetus, form changes, extent of where HLA typing entry changes occur (i.e., for all candidates, deceased donors and living donors), source documentation, and expected implications on transplant hospital staff compliance time. The LDC considered the dialogue and concluded that the proposal is an appropriate, constructive and low-effort means to increase safety.

The LDC thanks the Histocompatibility Committee for presenting to the LDC and its work to spotlight and improve safety in data entry.

Marc Schecter | 10/3/2018

I support having two level entry for verification and not allowing progress if one entry does not match the other. It might be a little more challenging to monitor if the raw data vs the data entered have been reviewed thoroughly and it still can leave room for the wrong manual entry not being caught/corrected.

Region 10 | 10/3/2018

Region 10 Vote: 11 strongly support, 10 support, 0 abstentions/neutrals, 0 oppose, 0 strongly oppose

A member asked how double entry would work for those programs that use an uploading software.  It was noted that the program would need to make sure that the information entered was accurate, and that the center would need to determine their own protocol for ensuring accuracy.