The Fear Before and the Excitement After Implementation of PreciseType HEA. Hackensack UMC Experience

Transcription

1 The Fear Before and the Excitement After Implementation of PreciseType HEA Hackensack UMC Experience

2 Objectives Discuss impetus for implementing molecular testing in blood bank Discuss different molecular platforms available Describe how needs were assessed to ensure successful implementation of molecular testing Discuss key issues to consider during implementation, validation, and accreditation

3 Perspective: Medical Director Dave Chow, MD

4 HackensackUMC

5 HackensackUMC Blood products 35k prbc 20k Plts 11k FFP, Cyro 4k

6 Red Cell Usage Adult Onc Internal Medicine Other Cardiac Surg Peds Onc Trauma Crit Care Ortho Neph General Cardiology

7 HackensackUMC Hematologic oncology Acute leukemia Lymphoma Bone marrow transplant Multiple myeloma

8 Daratumumab

9 Daratumumab CD38 Red cells Leukocytes B-cells T-cells NK-cells Interference in antibody testing

10 Daratumumab FDA approved (Nov. 2015) Janssen/Genmab

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12 Daratumumab CD38 Red cells Leukocytes B-cells T-cells NK-cells Phase 2 (LYM001) Non-Hodgkin lymphoma: DLBCL Mantle cell lymphoma Follicular lymphoma

13 Send Out

14 HackensackUMC Sickle Cell Anemia 80 patients (stable) 5-10 BMT 10 new patients / year

15 Sickle Cell Anemia Current Phenotype Rh, Kell, Duffy, Kidd, MNS Future Phenotype Rh only Genotype Transfusion (prbc) Routine Rh and Kell Exchange Rh, Kell, Duffy, Kidd

16 Antibody Workup Warm Auto Ab Difficult Ab 1-2 (new) per month 3-5 (new) per month

17 Medical Need Daratumumab Sickle cell anemia Warm Auto-Ab Difficult Ab 200 ~ 265 total cases

18 Red Cell Genotyping Methods

19 Red Cell Genotyping Methods Immucor PreciseType HEA Progenika ID Core Agena Biosci Hemo ID Platform Proprietary Luminex MassArray Technical Skills Easy Moderate Difficult Regulatory FDA approved RUO RUO Flexibility Fixed Open Open

20 Red Cell Genotyping Methods Immucor PreciseType HEA Progenika ID Core Agena Biosci Hemo ID Platform Proprietary Luminex MassArray Technical Skills Easy Moderate Difficult Regulatory FDA approved RUO RUO Flexibility Fixed Open Open

21 Doubts Cost Can we justify? Who will perform? Molecular laboratory Blood bank

22 Doubts Cost Can we justify? Who will perform? Molecular laboratory Blood bank

23 Cost / Reimbursement CPT Code: Limited coverage guidelines for reimbursement (Novitas) Reimbursement coverage determinations established in other MAC s Immucor is actively working with NJ Medicaid Bill from send-out = Cost of in-house testing Cost neutral (assume no reimbursement) Finance was on-board

24 Doubts Cost Can we justify? Who will perform? Molecular laboratory Blood bank

25 Doubts Cost Can we justify? Who will perform? Molecular laboratory Lab relocation Blood bank New skills

26 Perspective: Supervisor Pilar Brahim, MS, MT(ASCP)BB

27 Personnel Selection Methodology Sample Stability, Repeatability and Reproducibility Validation Accreditation

28 Skills requirements Clean and organized Contamination is an issue! Manual technique Pipette very small volumes Willingness to learn Read and interpret complex documents Understand new concepts Important for troubleshooting We identified two blood bank techs who fulfilled these requirements

29 Methodology New skills Pipetting techniques Multichannel pipettes Operate PCR Immucor Provided full training Manual techniques Troubleshooting afterwards

30 Stability, Repeatability & Reproducibility 5 samples (whole blood). DNA was extracted on day 1 and tested. In addition 3 aliquots from each sample was made and froze at -20C. Subsequent parallel testing (fresh and frozen samples) were done on day 7, 14, 21, and 28. Samples were sent to the NYBC for HEA testing as well.

31 Results Results for frozen and fresh samples obtained and HUMC were compared to those performed by the NYBC. One out of the 5 samples extracted from whole blood on day 28 expressed false positive Kpa phenotype. All other results correlated 100%. Fresh samples were also tested at 35 and 42 days (no frozen sample available) and all results were compared and no discrepancies found.

32 Some Issues Contamination Meticulous cleaning with DNase away Pipetting skills Spurious Kp(a)+ result Not enough Clean Up reagent Listed as a cause of false Kp(a)+ result Repeat testing was Kp(a)- Low signal Not enough Clean Up reagent Repeated

33 Validation 20 samples (including the 5 samples used for testing stability, repeatability and reproducibility) Validation sample pool included 11 Daratumumab patients, 2 sickle and 3 with warm autoantibodies. All samples were also sent to the NYBC for HEA testing. All results matched those obtained by the NYBC.

34 So where are we now? Currently awaiting for the NJSDOH approval of our letter of intent. Patient testing will start in January 2017 Longevity of whole blood sample to be used up to 30 days old to match our PAT protocol. Once tested frozen DNA to be kept up to 6 months.

35 Accreditation CAP Molecular is not addressed in Blood Bank checklist Separate Molecular checklist AABB 2 years NJ State Letter of intent List of required documents

36 Blood Bank Technicians Organized + clean Manual techniques Willingness to learn Common issues Contamination Manual skills Accreditation What do I need to do for CAP AABB State Things to consider

37 Questions?