MANAGEMENT OF A CORD BLOOD BANK. Riccardo Saccardi Banca Toscana di SCO AOU Careggi, Firenze

Transcription

1 MANAGEMENT OF A CORD BLOOD BANK Riccardo Saccardi Banca Toscana di SCO AOU Careggi, Firenze Milano. November 2008

2 Cord Blood Banking: Quality, Safety and Cost Effectiveness The worldwide increase of CB as source of HSCs results in a constant growth of Banking activity CB Banks need to increase both the quality of stored Units and the size of their inventory CB Transplantation Programmes need to ensure the quality of the Units selected by joining International programmes aimed to enable accepted standards

3 Quality and Safety: Internazional Standards and accreditation of CB Banks

4 FACT Standard PART A: CORD BLOOD BANK QUALITY MANAGEMENT PART B: CORD BLOOD BANK OPERATIONAL STANDARDS PART C: CORD BLOOD DONOR MANAGEMENT AND COLLECTION STANDARDS PART D: CORD BLOOD PROCESSING STANDARDS PART E: CORD BLOOD SELECTION AND RELEASE STANDARDS

5 Selection donor SOPs Donor evaluation Procurement and Processing Procurement Ser ious Adver se Reaction or Event Biological validation Processing Registration/ Traceability Storage Distribution Transplantation FOLLOW UP

6 STAFF

7 CBB management: Training of midwives A specific training program is developed on both theory and practical issues. The CBB software associates the quality of collected Units to the operators A report about efficency of Collection Units is yearly circulated, including an analysis of single operators acivity

8 Piano di Formazione Ostetrica Parte Teorica Inizio addestramento Parte Pratica Dimostrazione prelievo (almeno 1 raccolta) Prelievo (almeno 3 in affiancamento con personale esperto) Operatore idoneo? NO Prolungare o ripetere l addestramento SI Qualifica

9

10

11 What is required? Adequate space, design Adequate equipment Clean and Orderly Security

12 EQUIPMENT Cleaning Maintenance Standardization and calibration (SOP) Sterilization documented

13 SOPs

14 RECORDS

15 Process control through the DB

16 DATA ENTERING HLA is entered by 2 operators with a reciprocal check

17 Jacie ISBT 128

18 TEMPERATURE MONITORING

19

20 Cord Blood Banking: Volume reduction and Cost Effectiveness Concentration of Units is moslty aimed to the reduction of LN 2 consumption System must be closed and reproducible It must ensure high cellular recovery and viability Fully automation of the process results in both safety and time saving of the operators

21 Volume reduction methods The procedure can be improved by the use of optic sensors which detect the different fractions of the product Semi automated Fully automated manual top&bottom variabile Vol. Rotor

22 Systems Comparison

23 Systems Comparison

24 Karandish et AL, AABB meeting 2007

25 Karandish et AL, AABB meeting 2007

26 Manual Plasma Removal (n = 1 72; February April 2002) Median Range Initial Volume (ml) 97 (61-202) Final Volume (ml) 57 (35-122) TNC Init (x 10 6 ) 1556 ( ) TNC final (x 10 6 ) 1422 ( ) TNC Recovery(%) 92 (53-100)

27 Manual Buffy- Coat (n = ; March 2000 May 2001 ) Mediana Range Initial Volume (ml) 96 (57-195) Final Volume (ml) 30 (30-42) TNC init (x 10 6 ) 1731 ( ) TNC final (x 10 6 ) 1238 ( ) TNC Recovery (%) 72 (45-97)

28 Automated Buffy- Coat (n = 41 5; June 2001 February 2006) Median Range Initial Volume (ml) 97 (54-202) Final Volume (ml) 38 (34-40) TNC Init (x 10 6 ) 1171 ( ) TNC Final (x 10 6 ) 1425 ( ) TNC Recovery(%) 83 (60-100)

29 (HES) AUTOMATED SEDIMENTATION Non- HES sedimentation (Sepax- UCB v 1 91 ) Final volume 20 ml

30 HES Sedimentation (n = 1 0) Median Range FinalVolume (ml) 20,5 (20-21) TNC Recovery 89% (76-97) MNC Recovery 99% (82-102) CD34 + Recovery 99% (89-100) HTC post (%) 39 (16-48)

31 CB VOLUME REDUCTION Deplasmazione BC auto HES auto UCB Volume Post (ml)

32 TNC RECOVERY Deplasmazione BC auto HES auto UCB Recupero WBC %

33 Model of cost effectivenes Cryo-Bags number DF700: 168 DF200: 336 PALL/CryoSC: 1376 Average annual LN2 cost AIM: 1400 CB Units storage

34 UNSEPARATED (2 DF700/Unit) 2800 DF Tanks Storage SYstem LN Resulting and 16,7 tanks

35 PLASMA REMOVAL (1 DF700/Unit) 1400 DF tanks Storage System LN Resulting And 8.3 tanks

36 MANUAL BUFFY COAT (1 DF200/Unit) 1400 DF Tanks Storage System LN Resulting in and 4,2 tanks

37 AUTOMATED BUFFY COAT (1 DF200/Unit) 1400 DF Tanks Storage System LN Kits Sepax Resulting in and 4,2 tanks

38 LOW VOLUME SEDIMENTATION (1 Pall/CryoSC BAG/UNIT) 1400 Kits Pall/CryoSC Tank Storage System LN Sepax Other materials Resulting in and 1 Tank

39 VOLUME REDUCTION COST EVALUATION Analysis to be finalized Evaluation of time saving Improvement of safety Inclusion of barcode tracking Stepwise costs Automation of volume reduction improves safety and is cost effective

40 Management strategies Italian inventory by Dec 2007 Caratterizzate Non caratterizzate Pescara Reggio Calabria Napoli Bologna Roma S. Eugenio Roma Umberto I Roma Gemelli Genova 6628 Milano Pavia Centro Nazionale Sangue Banche di sangue di cordone ombelicale Report 2007 Torino Pisa Firenze Padova Treviso

41 Management strategies INDICE DI RILASCIO indice rilascio indice rilascio totale dall'inizio attività 1 0 Firenze Torino Milano Pavia Lazio* Padova Bologna Pescara Treviso fonte: dati IBMDR, luglio 2008

42 MANAGEMENT OF A CORD BLOOD BANK The management of a Cord Blood Bank must be perfectly harmonized with the collection programme and the external labs Quality and Safety of the Process must be managed according to the evolution of Cellular Therapyassociated technologies The automation of the process allows: To increase the quality of the product To compensate investments and running costs To reduce costs when associated to volume reduction The activity of a CB Bank needs a careful planning of investment and resources

43 CORD BLOOD Bank Firenze, Careggi