1. CTA, CVDR, & TCSA Sue Logan Feb 21, 2019
There are no conflicts of interest to disclose.

2. Three Key Components Consecutive Transplant Audit (CTA)
Center Volumes Data Report (CVDR)
Transplant Center Specific Analysis (TCSA)

3. What is the value?
Patients and their families strongly desire to understand what to expect from HCT
They need an unbiased, reliable source of information about:
Anticipated results of HCT (aggregate vs. individual)
By disease and other relevant factors
Centers with experience for the disease in question
Centers’ performance

4. Source of truth (Center Database)
HRSA Report Cycle
Source of truth (Center Database)
Accurate CIBMTR Data
CVDR
TCSA
CTA*
CIBMTR Studies
This is just to give you an idea of where the Consecutive Transplant Audit fits into the overall cycle of the HRSA reports. You’ll notice that we’ve represented the timeline without a beginning or end here, since with the three components together, its more of a continuous effort than a process with a distinct beginning and end. The reports themselves obviously have cutoffs, as we’ve discussed before, but the work involved in reporting and cleaning the data in always ongoing.
So, at the close of a calendar year, your center will now be expected to submit a list of the transplants performed in the previous year (by March). This gives a few months to finish registering patients and reporting transplants before the CVDR Data review cycle begins. And as the CVDR data reviews come to a close, we begin the TCSA data clean-up process, which will hopefully be greatly reduced due to the CTA and exclusion rules for CVDR.

5. Consecutive Transplant Audit (CTA)

6. Consecutive Transplant Audit (CTA)
CTA Process Overview
What we need from you
Consistent formatting
Accurate reporting
Discrepancy resolution
The CIBMTR has developed a process to audit consecutive HCT reporting by US centers. Consecutive reporting of HCTs is important to ensure the continued epidemiological integrity of the CIBMTR outcomes registry and to meet our obligations to provide the US government with an accurate assessment of transplant activity.

7. CTA Timeline
Centers were notified about CTA process and deadlines on Jan 14, 2019
Spreadsheet listing all patients transplanted between 1/1/2018 – 12/31/2018 due by March 15
Unregistered patients must be registered by Apr 30
CIBMTR flags discrepancies and returns list by Aug 1
Corrections due by Aug 31
Annual reporting of consecutive transplants is required for CPI. 
For this cycle, starting January 14, 2019, we are requesting you submit a list of all HCTs that have occurred at your center between the dates of January 1, December 31, 2018.  This includes patients with one to multiple transplants. 
Providing this information will allow us to confirm patients reported to CIBMTR are representative of all patients transplanted. 
8/1 deadline for corrections is to give us time to process the corrections before the end of the trimester, in case they create new errors.

8. Spreadsheet Formatting correctly will save time Data elements include:
CRID – (if applicable); provided in a NUMBER format
DOB – must be formatted as a DATE FIELD, preferably (yyyy-mm-dd)
Sex – M, F (M indicating Male, F indicating Female)
Date of HCT – must be formatted as a DATE FIELD, preferably (yyyy-mm-dd)
HCT Type – Allo_R, Allo_U, Auto (provided in this format)
Please do not include “MUD”; “MRD”; “Cord”, etc.
Case Sensitive
Consistent formatting will help us save time by ensuring that the data is in the correct format that we need it to be in to quickly compare it the way data is stored in CIBMTR databases. If your list does not contain the required variables in the requested way, your CRC will contact you and request you to fix the original copy. While there is some leeway, mostly in the dates, which can be easily re-formatted using tools in Excel, having your center do this will avoid any further questions that will slow down the process for your center to receive and review any discrepancies that may be found.
The preferred & required formats are shown here.
If you perform, but do not report autologous HCTs to CIBMTR, please do not include them in your list of HCTs.
Do not include patient names
Contains PHI so send securly

9. Accurate Reporting
HRSA reports and CIBMTR Studies rely on what is reported in FormsNet
Which relies on accurate reporting to CIBMTR
Refer to your center’s medical records when putting your list together
Check with your BMT Program or IT Department
Register any missing patients right away
So while correct formatting is appreciated ….it won’t be enough if the data you report is not ACCURATE.
Those of you familiar with reviewing CVDR & TCSA data will remember the large excel sheets of data for your to review. This effort will use similar lists, but in this case we need you to provide lists from your center’s records, rather than CIBMTR creating the lists. Using FormsNet as a source to generate this list is not acceptable, as this effort is to validate the FormsNet data. Similarly, completing the list from memory is not acceptable.
This will reduce the number of basic transplant and patient discrepancies overall, which will speed up the process for CVDR and TCSA (and studies) and allow us to spend more time focusing on the more complicated data checks later.
Larger transplants centers or for those of you who have been around enough, may already have a consecutive list of transplants performed at your center, so try checking with your department or IT group to see if one is already available. If you noticed any transplants that you did not register or report at the time of transplant, its best to register these as you prepare your list, so that they can be included in the initial check. This will lessen the burden when it comes to resolving any discrepancies.
Get a good jump on the upcoming years & start making consecutive lists!

10. Discrepancy Resolution – DOB
You will receive a file back that lists identified discrepancies
As mentioned before, any discrepancies between the list you provide and the data stored in FormsNet 3 will be flagged and provided to you. Here is a general idea of how the information will be passed along to your center.
The file will have 11 columns; showing the information you provided to us through the audit and what you provided to us through FormsNet Reporting. Discrepancies will be highlighted with a short description in the last column. As you can see in this example for the first CRID, it looks like the DOB was off by just a day.

11. Discrepancy Resolution – HCT Date
The second CRID has two completely different transplant dates with differing types. These are the things we would like to resolve!
These types of errors impact the inclusion/exclusion criteria for CVDR and TCSA, so an error like this could change whether that record is included
Transplant Type impacts where a form is counted for CPI as well.

12. Discrepancy Resolution
Your CRC will help you in the resolution of any discrepancies that exist
Resolution is required for CPI Goals (by Sept 1st Report)
Missing infusions and HCT type mismatches are critical
All eligible patients at your center require a CRID
Edit Patient DOB and sex with CRID Edit Tool
Once grid is updated, data checks will be run on all forms to ensure that they are also correct
Addressing any discrepancies found in the data provided from your consecutive transplant list and what was originally reported in FormsNet 3 will require investigation and action taken on your [center’s] behalf. Failure to address said discrepancies will impact your CPI standing starting September 1st, 2019.
Missing transplants and HCT type mismatches are critical and are both part of TCSA and CVDR and can also effect how forms are counted for CPI. These will be and will be required top priority Most other demographic information (DOB, sex), are editable with the CRID Editor tool
Once we’ve confirmed all of the core data that displays in the GRID is accurate, then we’ll be running checks for all of the places where those fields are also reported on forms to ensure that all of the forms are also accurate. Those will be sent as a second round of discrepancies – but you shouldn’t feel like you need to wait to make updates if you know they are needed.
Confirming the discrepancy and working to fix it with your CRC will be a required part of this process.

13. Center Volumes Data Report (CVDR)

14. Center Volumes Data Report (CVDR)
What is CVDT?
Annual report required by HRSA
A count of all transplants performed at each US center over a 5 year period
Why we do this?
To provide meaningful data to the public and others about HCT
How often is a person with my disease transplanted?
Which centers perform these transplants?

15. CVDR Timeline Inclusion Criteria
Data points collected from CIBMTR forms
Recipient Demographics
Transplant characteristics
Disease data
Exclusion Criteria
Best Practices
CIBMTR Portal Access
Quick look at the inclusion criteria
As Dr. Rizzo showed you the CVDR report published on HRSA website. I will be covering in detail regarding accessing the reports on CIBMTR Portal. Show how the reports look on this website. Talk about data points collected from the forms for each table
Starting this new year some of the CRIDs were excluded from the reports as there was data discrepancies
Highlight on some of the best practices for CVDR

16. CVDR Timeline
CIBMTR prepares dataset for all HCTs performed in prior calendar year
Includes all transplants performed in
Portal opened for 1st round of review Oct 31 – Nov 15, 2018
Changes to be made in FN
CIBMTR prepares refreshed dataset
Portal opened for further review (any center who submitted “data pending correction” after 1st review) Nov 28 – Dec 7, 2018
Finalize data for HRSA posting

17. Available center status options
Option 1 – Data Complete/Correct – Publish All Data
Option 2 – Data Complete/Correct – Publish ALLO data and NOT Auto Data
Option 3 – Data Pending Correction – Will update FN
Option 4 – Data Incomplete/Incorrect – DO NOT Publish Data for the Center
All 4 options are available at 1st review
Option 3 not allowed at final review
Any changes made to data in FormsNet during the first round is now reflected within the tables on the portal. 
If, during the first round of review (ended November 15th), you submitted your status as “Data Complete/Correct – Publish All Data”, then no action is required on your part.  You may view your refreshed data if you wish to.
·         If, during the first round of review, you submitted your status as “Data Pending Correction”, you now have the opportunity to login to the Portal and view your refreshed data.  During that time, you need to submit your status as option 1, 2 or 4 below. 
·         If, during the first round of review, you did not respond or submit a status – this is your final chance to do so.  If we do not hear anything, or your center has not submitted your center’s status during this round – your data will be published with a disclaimer – see FAQ Q4 on the CVDR Portal for details.

18. CVDR: Data/Variables Included and Source Forms
Transplant Characteristics
Patient Characteristics
Indication Form 2814
Indication
Cell Therapy vs. HCT
Transplant Date
Transplant Type (related, unrelated, autologous)
Product Type
PreTED Form 2005
Patient-Donor HLA match
Pre-TED Form 2400
Age
Race/Ethnicity
Sex
Disease Form 2402 and 20xx
Disease Subtype
Disease Status

19. Inclusion Criteria Transplant Cellular Therapies
Autologous and Allogeneic transplants
Transplants occurring between 2013 to 2017
Performed at a US Transplant Center
With pre-transplant forms completed
Cellular Therapies
Form 4000
All allogeneic transplants that were performed at a US transplant center and with pre-tx forms completed are included in CVDR.
Also all the Autologous transplants with consent = No and no forms due
Performed at a US transplant center and with a Form 4000 started in FormsNet.

20. Additional Data Points Collected…
For HCT
Form 2400/2000
Recipient Demographics – Ethnicity
Form 2400 and/or pre-HCT disease form
Disease status at transplantation
For Cellular Therapies (Form 4000)
Cellular Therapies characteristics – Donor, Product
Recipient Demographics – Gender, DOB
These are some additional datapoints that are collected and displayed in the Excel file that can be downloaded from the website

21. Exclusion Criteria Transplants excluded from dataset
Identify data discrepancies early on
Improve
Data completeness
Data Quality
Patients are excluded if data discrepancies were identified that have not been resolved after the final review deadline.

22. Exclusion Criteria – Data Quality
Transplant characteristics
Donor missing
Product missing
Recipient Demographics (Form 2400/2000)
Date of birth missing or mismatch
Race mismatch
Ethnicity mismatch
Disease
Primary disease or sub-disease classification missing
Mismatch NHL or CLL disease classification for Richter’s transformation
There were 7 data discrepancies introduced – Birthdate missing/mismatch; primary disease and/or subdisease missing; race mismatch and ethnicity mismatch. We have seen a huge data quality improvement and thank you to all the centers who helped us with this.
CVDR also flags the patients when CLL – NHL transformation is reported but the sub-disease reported doesn’t seem right.
When Richter’s transformation is reported CVDR is looking for
Diffuse, large B-cell lymphoma - NOS (107) under NHL
Chronic lymphocytic leukemia (CLL), NOS (34) under other leukemia
Chronic lymphocytic leukemia (CLL), B-cell/small lymphocytic lymphoma (SLL) (71) under other leukemia
some of the criteria that we will be working on are sub-disease mismatch and pre-transplant disease status mismatch.

23. CVDR Best Practices
Register your patients (obtain CRID) and complete Indication form as soon as possible after transplant has happened
This will make sure CIBMTR is aware of the infusion and get the Pre-TED on your forms due list
Complete PreTED (F2400) as soon as possible, ideally within 30 days of transplant
Ensures that your Forms Due list is as complete as possible, facilitating workflow planning
Provides maximum amount of time for CIBMTR data reviews to catch errors before CVDR cycle closes
Report subsequent transplants/infusions within 30 days of infusion to ensure CIBMTR is aware of infusion and forms due are updated
These are general CIBMTR best practices, but impact these reports specifically. The data, as corrected in FN, are used by CIBMTR for Research Studies as well as for additional HRSA reporting like TCSA.

24. CVDR Best Practices
Keep CIBMTR notified of staff changes so that Portal permissions are up to date
Respond to CIBMTR queries within requested time frame, ideally responding to first request
Some changes may generate additional queries that would also need to be resolved for report to be accurate
Inform CIBMTR if concerns about data leading to request not to post certain data

25. Public Posting: HRSA Transplant Activity Report
Transplant Activity Report provides reports about the number of transplants performed at transplant centers in the United States. These data include all types of transplants, including autologous, related allogeneic and unrelated allogeneic as reported by transplant centers. The tables provide annual transplant numbers by:
Age of patient
Cell source (bone marrow, peripheral blood stem cells (PBSC), and umbilical cord blood)
Disease
Donor type (autologous, unrelated allogeneic, and related allogeneic)
Gender
Race
State of transplant center
Year

26. Transplant Center Specific Analysis (TCSA)

27. What is TCSA? Why we do this? Also referred to as Center Outcomes
Provide an equitable, balanced, scientific performance measurement tool(s) that can be used by the profession to define and improve quality.
Be a resource to support the HCT community
FACT Accreditation
Also referred to as Center Outcomes

28. Transplant Center Specific Analysis
Timeline
Inclusion Criteria
Data points collected from CIBMTR forms
Best Practices
Data Quality
So, once we’ve validated the transplant activity with CVDR, we move on to the next phase of data review, which involves preparing the dataset for TCSA. We’ll go over the details of that dataset in more detail, including best practices for quality data.

29. TCSA Timeline
Queries on Recipient and Donor demographics Dec 2018 – Jan 2019
Raw data distributed to centers Feb 15
Queries on pre-HCT variables Feb – March
1 yr forms due Apr 30
Queries on survival status and contact date Apr – May 10
Report sent to HRSA Sept
Final report sent to centers Dec

30. Center Outcomes Report 2018
3 year rolling time window -
Outcome: 1 year survival
Multivariate analysis adjusts for ‘risk factors’
Full data on HCT Comorbidity Index (Sorror, et al)
Reports for 2018 sent to centers Dec 2018
Additional univariate descriptive reports for centers accompany report
2018 Reports also sent directly to payers Dec 2018
Reports available on NMDP website

31. TCSA Inclusion Criteria
Center Inclusion Criteria
Actively Reporting to CIBMTR
Sufficient Follow-up reported on at least 90% of allogeneic transplants
Transplant Inclusion Criteria
First Allogeneic Infusions for a patient
Given at a US Transplant Center
With at least one year of follow-up (or death reported)
Doug covered some of this, but to reiterate,

32. TCSA: Data/Variables Included
All CVDR Variables
Plus
Transplant Date
Donor Type
Product
Patient Age
Patient Sex
Patient Race/Ethnicity
Disease Subtype
Disease Status
Transplant History
Donor Demographics
Comorbid Conditions (HCT-CI)
CMV Status
Post-Transplant Follow-up
Survival Status
Date of Contact

33. New variables in 2018 Zip code History of mechanical ventilation
Cytogenetics for AML, ALL, MDS
Labs to calculate IPSS for MDS
ISS, serum beta2-macroglobulin, and serum albumin for PCD

34. Raw Data Files
Raw Data Files will include all allogeneic HCTs, not just those that appear to be the “first” allogeneic transplant
Helps us to identify issues related to reporting transplant history
Presents all data issues concurrently
If patient had multiple donors, there will be a row for each donor
If patient was multi-racial, there will be a row for each race
Separate spreadsheets for each disease

35. Product
Re-confirm product information with additional sources (NMDP) to ensure that appropriate validation
Common issues
Cross-Form inconsistencies
Disagreement with NMDP

36. A Word about NMDP RID REQUIRED for all NMDP products
Used to map to NMDP databases to get data not expected for “NMDP Products”
ONLY captured on CRID form
Must be manually added if NMDP infusion is not the first (i.e., prior auto)
You’ve already heard about this once today, and probably will again while you are here and its because its so critical. Providing complete and accurate IDs is crucial and we are continuously monitoring this

37. Transplant History
Used to determine whether transplant is the first allogeneic for that recipient
Look at previous tx type, chronological HCT #
Common issues
Post-TEDs not matching PreTED
PreTED not counting prior autos, especially if there was no consent or the center doesn’t report autos

38. Donor Demographics Review PreTED and Infusion form Common Issues
Race/Ethnicity
DOB
Sex
Donor pregnancies
Common Issues
Declined on one form, provided on other
Multiple reported on one, single on the other
Donor DOB vs Age
Mismatch between 2400 and 2006

39. HLA Match If NMDP donor, we will get the HLA data from NMDP
If related donor or non-NMDP unrelated donor, must complete 2005 HLA forms
Common Issues
Missing NMDP RID
Incomplete HLA
Invalid HLA Reported
Discrepancy between serology and DNA typing
Submit lab report so we don’t query you

40. HCT-Comorbidity Index (HCT-CI) and History of Malignancy
Sorror Co-morbidity Score (HCT-CI)
Dr. Sorror has published a paper reviewing how he assesses comorbidities and CIBMTR has guidelines
CIBMTR does not need the entire medical history of the patient reported in the other specify field
Conditions reported in the specify field are not used to calculate the HCT-CI score
Common Data Issues
Reporting a comorbidity in the specify field instead of the correct form field.
Reporting non-malignant conditions in the prior hematologic malignancy specify field
Symptoms/Conditions that are related to the primary disease for transplant will have a more appropriate place to report than the specify field.

41. Comorbidities Arrhythmia (1) Obesity (1) Cardiac (1) Peptic ulcer (2)
Cerebrovascular (1)
Psychiatric disturbance (1)
Diabetes (1)
Pulmonary, moderate (2)
Heart valve disease (3)
Pulmonary, severe (3)
Hepatic, mild (1)
Renal, moderate / severe (2)
Hepatic, moderate/severe (3)
Rheumatologic (2)
Infection (1)
Solid tumor (3)
Inflammatory bowel disease (1)
Other specify (0)

42. Solid Tumors Breast cancer
Central nervous system (CNS) malignancy (e.g., glioblastoma, astrocytoma)
Gastrointestinal malignancy (e.g., colon, rectum, stomach, pancreas, intestine, esophageal)
Genitourinary malignancy (e.g., kidney, bladder, ovary, testicle, genitalia, uterus, cervix, prostate)
Lung cancer
Melanoma
Oropharyngeal cancer (e.g., tongue, buccal mucosa)
Sarcoma
Thyroid cancer
Notice there is no Other Specify field. Check Yes to parent Q and No to all the tumors

43. Prior Hematologic Malignancy
History of malignancy (hematologic or non-melanoma skin cancer)
Acute myeloid leukemia (AML/ANLL)
Other leukemia, including ALL
Clonal cytogenetic abnormality without leukemia or MDS
Hodgkin disease
Lymphoma or lymphoproliferative disease
Other skin malignancy (basal cell, squamous)
Myelodysplasia (MDS)/myeloproliferative (MPN) disorder
Other prior hematologic malignancy
History of malignancy (hematologic or non-melanoma skin cancer) other than the primary disease for which this HCT is being performed?
PCD should go in the other specify

44. Comorbidity Reporting Example 1
Which of the following comorbidities should be reported in the other comorbidities specify field?
An infection that has resolved prior to day 0 of the patient’s transplant with no current therapy
A pulmonary embolism that occurred 10 years prior to the patient’s transplant with no current therapy
A pulmonary comorbidity due to an abnormal FEV1 test despite the DLCO test being normal
Splenomegaly that is associated with the patient’s disease that resulted in a splenectomy
Tell them how to report a solid tumor if it's not on the list of solid tumors on the They forgot to include an other_solid_tumor_specify field when the form was revised. Don't put it in the other_specify field or the won't get any points on the HCT-CI. And don't put it in the hematologic malignancy specify field. They should answer Yes to the parent solid tumor Q, then No to all the child questions. That way they'll get 3 points on the HCT-CI

45. Comorbidity Reporting Example 2
Which comorbidities can be reported if the patient’s history shows multiple syncope episodes due to aortic stenosis and ventricular tachycardia as well as diabetes that has been controlled through diet alone?

46. Comorbidity Reporting Example 2
Centers should not report a cardiac or diabetes comorbidity in this example because only a history of coronary artery disease, a myocardial infarction, or congestive heart failure are valid reasons. Also, diabetes that is controlled through diet alone with no insulin injections does not need to be reported.

47. What is “Sufficient” Follow-up?
Center Inclusion Criteria requires that each center have reported one year follow-up on at least 90% of allogeneic patients transplanted in three-year window
90% of related, 90% of unrelated, 90% overall
Patients who are Lost to follow-up earlier than one year will count against completeness
Subsequent transplants within the first year will shift forms due deadlines, but not Center Specific expectations; patient must have at least one year’s follow-up reported to be included
1 yr survival does not mean 1 yr form is CMP. It means the contact date is at least 365 days after the transplant.
To meet 90% completeness LCD can be up to 30 days prior to 1yr. But contact date must be at least 365 days after the transplant to count at surviving 1 year.

48. How is 1 year survival calculated?
1 Year survival does not mean the 1 year form has been completed.
The contact date must be at least 365 days after the HCT date
Cases reported with most recent contact date more than 30 days prior to one-year anniversary have not met 1 year survival but do count towards 90% completeness
1 yr survival does not mean 1 yr form is CMP. It means the contact date is at least 365 days after the transplant.
To meet 90% completeness LCD can be up to 30 days prior to 1yr. But contact date must be at least 365 days after the transplant to count at surviving 1 year.
LTF pts count towards total pts but don’t count to 1y surv if LFT prior to 1y
If no post-HCT forms done, is not included in analysis

49. Survival and Last Contact
One-Year survival is the only endpoint for this analysis
Common data Issues
Contact dates too early
Dates not matching between follow-up and 2900 death form
Death and subsequent transplant reported on same follow-up visit

50. TCSA Best Practices
Report follow-up as soon as information is known, but within visit expectations
100 day report contact date should be within 15 days of day 100 anniversary
1 year contact date should be within 30 days of one year anniversary
Respond to queries as soon as possible after first request
Develop processes for consistently reporting critical variables like HCT-CI and disease status
Later data for one year is better

51. Final Reports

52. CIBMTR Portal
To access the CVDR you will have to register to the portal using a google account.
CVDR reports are provided for each transplant year and the link for each year are in the left panel on the home page. There are 9 different summary reports that are provided for each year based on the transplants reported by the center

53. CIBMTR Portal (Table 1)

54. Data Points Used for Table 1
Transplant Characteristics
Form 2814
Indication – Cellular Therapy Vs HCT
Form 2400/2000
Transplant date
Transplant type – Autologous, Unrelated, Related
Patient–Donor HLA match
Disease
Primary disease and sub-disease classification
When multiple donors are reported – Unrelated has highest precedence, then HLA matched sibling, Related and Autologous
If the event date has been updated on the indication form then reprocess the transplant date on 2400

55. CIBMTR Portal (Table 2)

56. Data Points Used for Table 2
Transplant Characteristics
Form 2814
Indication – Cellular Therapy Vs HCT
Form 2400/2000
Transplant date
Product type
For multiple products – CBU > PBSC > BM
Disease
Primary disease and sub-disease classification
When multiple products have been reported – CBU has the highest precedence, then PBSC and then BM

57. CIBMTR Portal (Table 3)
Age is calculated from the difference between the Date of Birth and transplant date
Patients will be put into the next age group only when they reach a specific age group. For example, if a patient is 50 years + 1 day (when the data set was pulled), the patient will be classified in age group.

58. Data Points Used for Table 3
Transplant Characteristics
Form 2814
Indication – Cellular Therapy Vs HCT
Form 2400/2000
Transplant date
Product type
For multiple products – CBU > PBSC > BM
Recipient Demographics
Date of Birth
When multiple products have been reported – CBU has the highest precedence, then PBSC and then BM
Age is calculated from the difference between the Date of Birth (DOB) reported on form 2400 and transplant (HCT) date reported on form If DOB has been updated using the CRID tool then please reprocess the 2400 to update the date

59. CIBMTR Portal (Table 4, 5 and 6)
Table 4 – displays the number of transplants by sex. If sex is updated using the CRID tool then remember to reprocess the 2400 to update the sex information
Table 5 – displays the number of transplants by race. Patients with multiple race will be counted only under one race category. If one of the race reported is White then the patient will be counted under White Category. The race precedence is:
White
Black or African American
Asian
American Indian or Alaska Native
Native Hawaiian or Other Pacific Highlander.
Table 6 – displays the number of transplants per month

60. Data Points Used for Tables 4–6
Transplant Characteristics
Form 2814
Indication – Cellular Therapy Vs HCT
Form 2400/2000
Transplant date
Recipient Demographics
Gender
Race and Race detail
If more than one race is reported then the patient is counted only under one race category.
All the allogeneic and autologous transplants with pre-transplant forms completed are included under tables 1-6.
In the next two slides I will talk about tables 7-8 which include the Autologous transplants with consent =No and no forms have been completed. The internal group will be meeting soon to update the CVDR code to capture all the Autologous no consent under these tables as now the form completion rule has changed for Auto no consents.

61. CIBMTR Portal (Table 7 and 8)
AUTO with Research consent = No and no forms completed
The reason for separating these from tables 1-6 is because we have very limited information.

62. Data Points Used for Tables 7–8
Transplant Characteristics
Indication – Cellular Therapy Vs HCT
Transplant date
Transplant type – Autologous
Disease
Primary disease

63. CIBMTR Portal (Table 9)
Table 9 represents all the Cellular therapies performed at your center

64. Data Points Used for Table 9
Cellular Therapies Characteristics
Form 2814
Indication – Cellular Therapy Vs HCT
Form 4000
Transplant date
Disease
Primary disease and sub-disease classification

65. Reporting Results - Centers
Detailed report that includes overview, methods, descriptive tables and
Results of risk adjustment model:
Odds ratios (95% CI’s) for one year survival (>1 means better survival)
For each center, we include a table with
Number of tx
Observed survival
Predicted survival
95% prediction interval
Current performance indication
Historical performance

66. Reporting Results

67. Reporting Results

68. Reporting Results - Public
Results are posted online annually in January and accessible through
HRSA website
Be the Match
CIBMTR Portal
Public reports are text-based single center descriptions of outcome vs ‘expected’
Formats changing to better represent the data and more understandable to public
Reports are also provided to payers

69. We include the Center Specific Analysis along with other information about the center so it can be used in conjunction with other information about the center:
Total number of transplants,
Number of transplants by cell source, by age, by disease and
Other relevant information about the center.
This helps patients look at the outcomes in context of a bigger picture.

70. TC Directory – Patient Survival
In the section that displays the Center Specific Analysis we emphasize how the center performs compared to the expected rate based on transplants for similar patients by putting this information first. The center is noted as performing below, similar to or above the expected rate.
The next piece of information tells the viewer what is included in the analysis – the years included, that it is only the first all transplant at a US center and that the patients’ follow-up information was reported to the CIBMTR
And the number of patients from this center that were included in the analysis
Finally, we provide the actual survival rate and the expected range for similar patients. We put this last because we don’t want patients to focus on the number. We need to emphasize that this number can’t be used to compare one center to another because the different patients they treat.