Handouts 4/5/2016. BCA Members willing to genotype your samples on Immucor PreciseType HEA

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1 BCA Members willing to genotype your samples on Immucor PreciseType HEA Community Blood Center - Dayton Blood Bank of Delmarva Indiana Blood Center LifeServe Blood Center LifeShare Blood Centers LifeSouth Community Blood Center Mississippi Valley Regional Blood Center Blood Center of New Orleans Oklahoma Blood Institute QualTex Laboratories San Diego Blood Bank SunCoast Communities Blood Bank Rhode Island Blood Center South Bend Medical Foundation. Leading Blood Centers into the Future PreciseType HEA and Beyond: Immucor s Advances in Molecular Immunohematology (mih) Tools and Services for Blood Centers and IRLs Jayanna Slayten, MS, MT(ASCP)SBB cm IRL Manager and SBB Education Coordinator Indiana Blood Center Elizabeth Hopkins, MT(ASCP)SBB CM Director, Reference Laboratories Mississippi Valley Regional Blood Center Anthony Gatherum, MT(ASCP), SBB CM, MBA Molecular and Specialty Business Manager Immucor Joel DeJesus Sr. Director, Government Affairs & Payer Relations Immucor Handouts 1

2 Handouts Continuing Education PACE, California DHS Florida BPR Contact Hours Each attendee registers at: Continuing Education Each attendee must register Registration deadline is April 19, 2016 Certificates will be sent via only to those who have registered by May 3,

3 Other Session will be recorded No CE issued for participating in recording Please mute yourselves Do not put your phones on hold Q&A following session Unmute yourself to ask a question PreciseType HEA is a registered trademarks of Immucor, Inc. Course content is for information and illustration purposes only. Immucor makes no representation or warranties about the accuracy or reliability of the information presented, and this information is not to be used for clinical or maintenance evaluations. The opinions contained in these presentations are those of the presenters and do not necessarily reflect those of Immucor. Immucor Molecular Platform A Brief Introduction Anthony Gatherum MT ASCP SBB (CM) MBA Molecular & Specialty Business Manager 9 3

4 Molecular BioArray Founded in 1996, BioArray pioneered the development of a molecular diagnostic system using DNA analysis to enable rapid and comprehensive antigen determination (genotyping) for blood donors and patients requiring transfusions BioArray is headquartered in New Jersey and was acquired by Immucor in 2008 Proprietary BeadChip platform uses proprietary encoded microparticles ( beads ) to perform quick and reliable molecular analysis of red blood cells and platelet antigens for transfusion diagnostics Interface between Serological and Molecular Immunohematology Serological methods remain the Gold Standard for quick, routine ABO typing, RHD typing and antibody screening Hemagglutination and other serologic methods have been proven and well understood for many years Molecular immunohematology is rapidly emerging as a critical tool to complement serology with the potential to improve lab productivity and enhance patient safety Source: (1) Reid, Applications and Experience with PCR-Based Assays to Predict Blood Group Antigens, Transfusion Medicine and Hemotherapy, 2009;36: RHCE, RHD, HPA ARE FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES. BioArray Molecular Product Line To-date, a million BeadChip tests have been completed by 65+ customers worldwide Four products include: HEA for red cell typing FDA Approved RhD and RhCE for Rh variant analysis HPA for platelet typing HEA, RhD and HPA are currently CE marked for sale in Europe. HPA, RHCE and RHD are Research Use Only (RUO) in the United States

5 RHCE, RHD, HPA ARE FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES. Research Use Only Molecular Tests RHCE and RHD BeadChips Identifies RH variants using emap technology RHD 75+ variant alleles RHCE 35+ variant alleles 48 tests complete within 5 hours post-extraction with 1 hour of hands-on time HPA Beadchip Detects 22 platelet antigens in a single test Complete HPA protocol in less than 5 hours post extraction Obtain DNA analysis results for extended platelet antigen typing within a single shift All results generated from these assays must be confirmed with licensed reagents The first and only FDA approved in-vitro diagnostic for molecular typing of red blood cell antigens Rapidly detects genotypes for accurate prediction of phenotypes Simplifies the identification of rare antigens As Test of Record, confirmation with antisera is not required Enables routine characterization of donor units for the most relevant antigens Identifies 35 red blood cell antigens and 3 phenotypic variants from 11 blood groups simultaneously Detects 24 gene mutations and one polymorphism associated with hemoglobinopathies (HgbS)* *HgbS is not intended for diagnosis of sickle cell disease

6 Run 96 samples in a single work shift Automated read, interpretation, and reporting Provides 96 tests in two formats: - 8 chip slides (12) - 96-chip microplate Immucor PreciseType Improving Efficiency in the IRL 4/5/16 Jayanna Slayten, MS, MT(ASCP)SBBcm IBC IRL Manager and SBB Educ. Coord. 6

7 Outline IBC Experience and Applications Past Current Future 4/5/2016 indianablood.org 19 Indiana Blood Center Experience We adopted BioArray Solutions HEA for donor screening and patient testing in 2007 In 2008 with BioArray Solutions DxBot, we implemented an interim database which allowed for review and release of phenotyped results from BASIS to SafeTrace indianablood.org 20 IBC Experience Continued In , BioArray HEA testing was moved to a dedicated IRL Molecular Lab 2015 PreciseType TM was implemented at IBC Without DxBot or Immulink 2016 the interface initially developed at is available after re-validation 4/5/2016 indianablood.org 21 7

8 Interim Database Initial Database Past HEA Testing completed DxBot/BASIS extract files to the Interim Database Review the testing, and release the results to Safetrace Release into historical donor record, not test of record Any discrepancies are flagged by the system and each investigated Future: What changed in 2016 PreciseType BASIS data is converted to Excel. The Excel worksheet is entered into the interim database, results reviewed and transferred to ST Long-term solution Immulink with a new BECS 4/5/2016 indianablood.org 22 Data Management how has it helped? Estimated Time to Completed Manual Approximately 5 min per donor, with a second step of entry verification before release of results We have tested approximately 25,000 donors Estimated time for manual entry = 125,000 min or 2083 hours Estimated Time for Use of the Interface Approximately 15 min per run of donors to review the testing and release to SafeTrace We have 25,000 donors and most were 96 well plates Estimated time for use of interface 260 plates x 15 min = 3900 min or 65 hours 4/5/2016 indianablood.org 23 Why is molecular done? Donors: Easy to mass screen full phenotypes to increase rare donor pool Able to identify unusual rare alleles such as hr B -, Jo(a-), Hy, Co(a-) Routinely find high frequency antigen negative donors while screening for full phenotype (i.e. k-, U-) Increase number of donors with historical low frequency antigen typing when antiserum is unavailable (i.e. Lu a -, Js a -) 24 8

9 What we have found at IBC 4/5/2016 indianablood.org Units Shipped vs Imported Units Year 2007Year 2008Year 2009Year 2010 Year 2011 Yr 2012 Yr 2013 Yr 2014 Yr 2015 Total Imported Total Units Provided by Year 26 Volume of Patient Samples Tested Perecentage of IRL Cases with New Molecular Testing Yr 08 Yr 09 Yr 10 Yr 11 Yr 12 Yr 13 Yr 14 Yr 15 4/5/2016 indianablood.org 27 9

10 Why Molecular Is Tested Samples as part of Case Genotype Requested only Yr 08 Yr 09 Yr 10 Yr 11 Yr 12 Yr 13 Yr 14 Yr 15 4/5/2016 indianablood.org 28 Why is molecular done? Donors: Able to do other tasks while molecular testing is happening IBC now has over approximately 25,000 donors with molecular results accounting for approximately 2/3 of our daily rare unit inventory The molecular typing becomes the historical typing for the donor so that results are available upon repeat donation 29 Most Useful for Future Type of Units Discovered with Implementation of Molecular Screening in High Incident 1% Misc 19% R1 33% rr 29% Ro 13% R2 5% 30 10

11 Application of Standard Must have a process for Stnd To ensure evaluation and concordance of test results from two previous donations This must be completed prior to labeling unit as antigen negative. Tested x 2 if sent out Tested x 1 if sent out Donation 1 Antigen Tested Donation 2 Antigen Tested All additional donations do not have to be antigen confirmed 31 The Future IBC IT Specialist has developed a database to aid with this applying Data is available SafeTrace Antigen Data Serology BioArray Antigen Data RUO Molecular Results PreciseType Antigen Data Licensed Molecular Results With this tool Typing by two methods, or two donations 32 The Future With validation of this created tool, we will be able to use the molecular data to the best advantage Repeat confirmation testing will no longer be necessary Decreased TAT for customers by having not testing time Increased volume of units available 33 11

12 In Closing Use of HEA at our Donor Center IRL Improved the use of phenotyped donors locally Increased the volume of units shipped annually through the IRL Improved availability of genotype matched units. 34 In Closing, cont. Decreased time and cost of troubleshooting since information available with molecular information Decreased dependence on imports for phenotyped units 35 Thank you for this opportunity to share our experience

13 Going Beyond HEA Elizabeth Hopkins, MT(ASCP)SBB CM Director, Reference Laboratories MVRBC Reference Laboratories Davenport, IA o AABB accredited Transfusion Service o Immunohematology Reference Lab Services o HEA Molecular Typing Springfield, IL o AABB accredited Immunohematology Reference Lab (IRL) o Molecular Typing (HEA, HLA, HPA, RHD Variant) o Platelet antibody testing St. Louis, MO o Immunohematology Reference Lab Services o Support a Sickle Cell Program HLA / HPA Testing Algorithm 13

14 HPA Molecular Type HPA BioArray TM Beadchip TM Assay Performed IF HPA antibody is detected Detects 22 human platelet antigens HLA Molecular Type LifeCodes HLA Assay on Luminex Determines molecular HLA phenotype MVRBC only tests for HLA Class I (HLA-A, HLA-B) HPA / HLA Molecular Cost Containment Multiple tests using the same testing platform o HPA utilizes the same testing platform as HEA o HLA utilizes the Luminex which is used for HLA antibody testing as well. Fill in runs with platelet donors o Builds HPA / HLA antigen donor database HPA / HLA matched or mismatched products o Allows for larger runs to be performed More cost effective 14

15 MVRBC HLA / HPA Typed Donors Platelet Crossmatching Immucor Capture-P XM o Solid Phase Adherence Test o Provide XM platelets if the PRA is manageable o Quick turn around time Impact to Platelet Inventory Crossmatching Platelets: o Impact is minimal o Testing performed BEFORE products released o Suitable products identified and saved for hospital o Incompatible products released o Double / triple products Decreases number of donors patient is exposed to Allows for multiple products to be located if warranted 15

16 HLA / HPA Matched Products Cumbersome process compared to crossmatching Locate products if in inventory Schedule matched donor to donate Tagged at donation to alert lab / PMD of special nature of product Time consuming for multiple departments Currently, a very manual process Impact to Platelet Inventory o Minimal impact to inventory o Product may impact expiration rate or excess if not handled well Hospital discontinue request Sits on shelf tagged for hospital too long Special Platelet Products Matched / Mismatched Platelet Crossmatches

17 RHD Variant Implemented in July 2015 o Simple implementation due to current methodology currently in lab with HEA / HPA Performed ON o Requests from hospitals o Internal investigations Cost Containment o Small runs of RhD Try to build volume of samples o Fill in runs with donors o Working to build interest in testing to increase RHD workload RHD Variant, continued Pregnant patients o Several Weak D Type 1 o Weak D Type 2 o RHD Deletion Weak Rh Result / Rh Discrepancies o Weak D Type 2 o RHD Deletion o DIVb / DIIIa o Weak D Type 4.0 or 4.3 o DAR / DIIIa Thank you Elizabeth Hopkins, MT(ASCP)SBB CM ehopkins@mvrbc.org 17

18 Reimbursement Molecular Immunohematology: HEA Joel de Jesus Sr. Director, Government Affairs & Payer Relations 52 Disclaimers Contents of this presentation are specific to the PreciseType HEA test which is an FDA approved (IVD) diagnostic test. The information contained in this presentation is provided to help you understand the reimbursement process, and is neither intended to tell you how to bill or code your claims, nor to suggest any manner in which you can increase or maximize reimbursement from any payer. All billing, coding, reimbursement, and appeals decisions must be made exclusively by the billing health services provider. The information in this presentation is for informational purposes only, and represents no promise, commitment, statement or guarantee by Immucor concerning proper billing or coding practices or levels of reimbursement, payment or charges. All Current Procedural Terminology (CPT ), Healthcare Common Procedural Coding System (HCPCS), Ambulatory Payment Classifications (APCs) or National Drug Classification (NDC) codes are provided for your information only and Immucor does not represent that these codes are or will be appropriate or that reimbursement will be made if using them or any other codes. CPT codes and descriptions only are copyright by the American Medical Association. CPT, APC and other codes do not include fee schedules, relative values or related listings. The Centers for Medicare & Medicaid Services (CMS) updates coding and coverage information frequently, and it is the responsibility of each health service provider to confirm the appropriate billing required by the local Medicare contractor The information provided in this guide is based on publicly available Medicare reimbursement information gathered from the Center for Medicare and Medicaid Services (CMS) and is subject to change. For additional Medicare information, you should consult directly with your local Medicare Administrative Contractor. We recommend that you consult with your private payer organizations and state Medicaid programs with regard to their reimbursement policies. Immucor expressly disclaims any and all liability or responsibility for the billing, coding and claims submission of any third party that may choose to use this guide. 53 All Content Immucor, Inc. U.S. Coverage Medicare Coverage Medicaid Coverage 54 All Content Immucor, Inc. 18

19 Reimbursement Policy Key information needed to submit or code for HEA reimbursement CPT code to state procedure Z-code or descriptor for test used ICD-10 code to show medical necessity Medicare, and other payers, may cover pre-transfusion molecular testing using the PreciseType HEA assay for the following categories of patients: Long term, frequent transfusions anticipated to prevent the development of alloantibodies Fetal red cell genotyping to evaluate hemolytic disease of the fetus/newborn (HDFN) in alloimmunized mothers Autoantibodies or other serologic reactivity that impedes the exclusion of clinically significant alloantibodies Suspected antibody against an antigen for which typing sera is not available; and Laboratory discrepancies on serologic typing 55 All Content Immucor, Inc. Contact Information: Joel de Jesus 56 Q&A

20 Continuing Education Each attendee must register for CE at: Registration deadline is April 19, 2016 Certificates will be sent via only to those who have registered by May 3, 2016 No registration for CE will be accepted after May 3, 2016 Thank you! 20