Starting from Scratch: Experiences with a Focused Apheresis Service

Transcription

1 Starting from Scratch: Experiences with a Focused Apheresis Service University of Virginia Tamila Kindwall-Keller, DO, MS September 21, 2018 Disclosures Medical Monitor for BMT CTN 1301 Back Up Medical Monitor for BMT CTN

2 Background University of Virginia Stem Cell Program Inception September prior programs Starting from scratch Apheresis Facility Director Cytotherapy Medical Director Associate Clinical Director Background Therapeutic Apheresis Nephrology Plasma exchange Leukocytoreduction Red cell exchange Thrombocytopheresis 2

3 Background Stem Cell Apheresis Stem Cell Transplant 1 st Apheresis collection February 2012 Disease Indications Autologous Donors MM, NHL, HL, Other Allogeneic Donors Related Donors (AML, ALL, MDS) Haploidentical Matched related NMDP collection center (Future State) D'Souza A, Fretham C. Current Uses and Outcomes of Hematopoietic Cell Transplantation (HCT): CIBMTR Summary Slides, Available at: 3

4 D'Souza A, Fretham C. Current Uses and Outcomes of Hematopoietic Cell Transplantation (HCT): CIBMTR Summary Slides, Available at: D'Souza A, Fretham C. Current Uses and Outcomes of Hematopoietic Cell Transplantation (HCT): CIBMTR Summary Slides, Available at: 4

5 D'Souza A, Fretham C. Current Uses and Outcomes of Hematopoietic Cell Transplantation (HCT): CIBMTR Summary Slides, Available at: Background Commercial CAR-T Novartis, KITE Cancer Research 6 Cancer research trials BATS trials Pancreas, Breast, Glioblastoma, Neuroblastoma KITE Pharma CAR T cell therapy for ALL, DLBCL Basic Science Vaccine trials Volunteer Donors Volunteer donors for basic science research 5

6 Background 460 Apheresis Collections on 285 donors over 6 years Average of 1.6 collections per patient 14 Apheresis Collections on 13 allogeneic donors in 2017 Average of 1.0 collection per patient Background Donor per disease 47% Plasma cell disorders 26% Lymphoma 14% Related donor 10% Research 3% Other 6

7 2 chairs 2 machines Background Plan for photopheresis machine GVHD Cutaneous T cell lymphomas 2.5 nurses UVA Focused Stem Cell Transplant Apheresis Unit 7

8 Background Approximately 30 SOPs 1 Quality supervisor with apheresis experience 1 Medical Director 1 Facility Director Resources Developing a Focus People / Staffing Location Equipment Quality Management Standard Operating Procedures Regulatory Organizations 8

9 Resources Developing a Focus People / Staffing Location Equipment Quality Management Standard Operating Procedures Regulatory Organizations Developing a Focus Provide all apheresis procedures available Health system or Hospital Therapeutic apheresis Plasma Platelets RBC Leukocytes 9

10 Developing a Focus Patients in a healthcare facility Medical condition requiring apheresis Often unforeseen Inpatient / outpatient After hours / weekend call Developing a Focus Expert care in one or a few areas Selective procedures for a specific program Peripheral blood stem cell collection Thrombocytopheresis for blood services program Extracorporeal photophoresis Research 10

11 Developing a Focus Collection of a cellular component Planned in advance Donor for stem cells Platelet donation Research More predictable Resources Developing a Focus People / Staffing Location Equipment Quality Management Standard Operating Procedures Regulatory Organizations 11

12 People / Staffing Facility Director Medical degree or degree in relevant science 2 years post-graduate training / experience Technical procedures Collection procedure Supervision of staff Administrative operations QMP 12

13 People / Staffing Medical Director Medical degree 2 years experience performing/supervising procedure Medical care of donors Pre-collection evaluation Management of complications Quality Manager People / Staffing Maintain systems to review, modify and approve SOPs Monitor compliance 13

14 People / Staffing Determine staffing needs 24 hour coverage / weekend coverage Scheduled or unplanned procedures Vacation schedules Illness / Sickness Flexibility when volumes are high People / Staffing Apheresis Machine / Apheresis Nurse Ratio Adequate number of trained personnel per number procedures performed Minimum 1 with trained back up Nurses running more than 1 procedure at a time Apheresis Techs PCAs Patient acuity 14

15 People / Staffing Qualifications of staffing Current job description for all staff Initial qualifications for hire New employee orientation Initial training and retraining Certifications if applicable Competency evaluations minimum annually Continuing education Resources Developing a Focus People / Staffing Location Equipment Quality Management Standard Operating Procedures Regulatory Organizations 15

16 Location Apheresis Collection Facility Must meet regulatory standards FACT-JACIE Standards Adequate size to prevent mix-ups, cross-contamination Parameters and Environment shall be controlled to protect safety / comfort of patients, donors, and personnel Temperature Humidity Minimize risks to health / safety of employees, patients, donors, visitors, volunteers 16

17 Location Adequacy of site Suitable space for donor examination and evaluation Adequate lighting, ventilation, sinks Document cleaning and sanitation Adequate equipment and materials Written safety manual Exposure to communicable disease Chemical, biological, radiological hazards Resources Developing a Focus People / Staffing Location Equipment Quality Management Standard Operating Procedures Regulatory Organizations 17

18 Equipment I do not endorse any particular piece of equipment or apheresis system including photopheresis. All equipment decisions and purchases should be made in the context of the apheresis program needs. Equipment Number of apheresis machines Number of patients per week Number of sessions per week Back up if machine malfunctions Number of photopheresis machines Number of patients per week Number of sessions per week Back up if machine malfunctions 18

19 Vitals signs Telemetry monitor Smaller equipment Heat sealer Blood warmer Blanket warmer UPS Power back up Other Other Equipment Resources Developing a Focus People / Staffing Location Equipment Quality Management Standard Operating Procedures Regulatory Organizations 19

20 Quality Management Program (QMP) Maintain a written QMP Organizational chart of key positions How positions interact to implement QMP Report quarterly to staff Annually review effectiveness of QMP 20

21 Quality Management Program (QMP) Document control policy with list of all active critical documents SOPs and policies Worksheets Forms Labels Quality Management Program (QMP) Document control policy with system for archive Retraction of obsolete documents Establish and maintain written agreements with third parties 21

22 Quality Management Program (QMP) Plan for analysis of product safety, efficacy, and/or clinical outcome Time to engraftment Micropositive products Indicator Range How Established % MNC % Ranges for HSC quality indicators were changed on July 1, 2017 to reflect data from the Spectra Optia CD34% % using the CMNC procedure. Data points from 100 collections were analyzed to determine the mean %HCT % and 2 standard deviations from the mean for each indicator. 22

23 Quality Management Program (QMP) Audits annually at a minimum Donor eligibility determination prior to procedure External sites met critical contracted services 23

24 Quality Management Program (QMP) Policies for errors, accidents, product deviations, serious adverse events Detection Investigation Documentation Reporting Corrective / preventative action 24

25 Quality Management Program (QMP) Policies for tracking / tracing products Procedures in case operations are interrupted Qualification of critical reagents, supplies, equipment and facilities Quality Management Program (QMP) Validation / verification of critical procedures Achieve expected end-points Viability of cells Cellular therapy product characteristics 25

26 Resources Developing a Focus People / Staffing Location Equipment Quality Management Standard Operating Procedures Regulatory Organizations Standard Operating Procedures Policies / procedures Critical aspects of operations and management Donor consent, screening, testing Procedure itself Labeling Product storage Transportation / shipping Recall of equipment 26

27 Resources Developing a Focus People / Staffing Location Equipment Quality Management Standard Operating Procedures Regulatory Organizations Regulatory Organizations Foundation for the Accreditation of Cellular Therapy (FACT) Food and Drug Administration Institutional Review Board Pharmaceutical Companies Clinical Trials Sponsors 27

28 Clinical Trials CAR-T cell therapy (Novartis, KITE, Juno, Bluebird) Children with ALL Adults DLBCL Multiple myeloma BiSpecific Activated Armed T Cells (BAATS) Things I Learned Do your homework Think positively Stay focused Be open to new possibilities Be prepared It is all about teamwork Work hard 28

29 References Fact Standard Seventh Edition, Version 7.0 Circular of Information for use of human blood and blood components (FDA) UVA Stem Cell Apheresis Annual Report 2017 Prepared by Opal Preston, Quality Manager Thank you 29