# Presentation: 743890

## Blood Products Advisory Committee17 – 18 March 2005Impact of Changing Practices in Freezing and Storage

**G. Michael Fitzpatrick, Ph.D.**
**Chief Operating Officer**
**gmfitzpatrick@americasblood.org**

## America’s Blood Centers (ABC)

- A national network of locally controlled, non-profit community blood centers that provide half of the U.S. blood supply from volunteer donors.
- 76 members operate in 45 states and the Province of Québec, Canada.
- ABC’s total blood collections exceeded 8 million donations in 2004.
- Every year, ABC members ship over 250,000 liters of plasma from volunteer donors for manufacture into plasma therapeutics.

## Surveyed Blood Centers andTheir Hospital Customers

- About current practices for the production and storage of FFP, plasma frozen (PF), cryoprecipitate (cryo) and recovered plasma (RP)
- Blood centers were asked:
- To identify which plasma products they produce and/or store and
- To describe the time frames, equipment, and temperatures at which they freeze and store those products
- Hospitals were asked:
- What products they have on hand and their storage temperatures
- Both were asked:
- Whether they would need to modify current temperature settings or purchase new freezer(s) if the rule becomes effective
- To estimate the cost of such changes

## Responses

- 52 blood centers
- 68% of ABC’s membership and
- 75% of ABC supply of 5.7 million units of WB
- 168 hospitals and other medical facilities
- Of approximately 3,300 facilities that obtain blood from ABC members

## Results – Blood CentersBlood Products Manufactured

**Notes:**
FFP - 100 % of respondents (52) 
RP - 90 % (47)
Cryo - 81 % (42)
PF - 40 % (21)
31 % (16) also manufacture other products

(EACH RESPONDENT MIGHT BE INCLUDED IN MORE THAN ONE CATEGORY)

## Results – Blood Centers Placed in freezer (X) hours after collection

**Notes:**
FFP:
69 % (36)within eight hours
12 % (6) within six hours
8 % (4) within four hours
RP: 96 % (50) freeze RP.
40 % (21) within 24 hours
13 % (7) within 12 hours
10 % (5) within 72 hours
37 % (19) answered “other” or “N/A” – mostly centers that produce several types of recovered plasma.  

(Each respondent might be included in more than one category)

## Results – Storage Practices

|  | - 18 oC | - 25 oC
 | - 80 oC
 | Other |
| --- | --- | --- | --- | --- |
| Blood Centers | 52% (27) | 54% (28) | 0 | 40% (21)
(Blast freezers at -30) |
| Hospitals (as reported by blood centers) | 67% (35) | 19% (10) |  |  |
| Hospitals
(Direct Survey) | 22% (37) | 68% (113) | 7%    (11) | 8%    (14) |

**Notes:**
Centers
52 percent (27) store FFP and other blood products in freezers that are capable of -18 degrees C or lower
54 percent (28) store in freezers capable of -25 degrees C and below (Note: disparity result of respondent entering in more than one category).
40 percent (21) use blast freezers at -50 degrees C
36 percent (19) use mechanical freezers (21 percent are -25 degrees C capable; 15 percent are -18 degrees C capable)   

Storage Conditions Hospitals
68 % (113) indicated that they store blood products (fresh frozen plasma, plasma frozen, and cryoprecipitate) in -25 degrees C-capable equipment.
22 % (37) store blood products in -18 degrees C-capable equipment.
7 % (11) store blood products in -80 degrees C-capable equipment.
8 % (14) responded “other.”

## $ Impact of Alarm Resetting

|  | Blood Centers | Hospitals |
| --- | --- | --- |
| Yes 
by Manufacturer | 69% (36) | 41% (69) |
| NO | 27% (14) | 48% (81) |
| Not Sure | 4% (2) | 11% (18) |
| Cost | 25% (13) Responded $500 to $1,000
Avg - $16,744 | 6% (17) Responded $200 to $5,000
Avg - $1,087 |

**Notes:**
Alarm Resetting:
69 % (36 centers) said that if the FDA requires storage of FFP at -25 degrees or below, the maintenance contractor would have to change the alarm settings on their freezer equipment.
27 % (14) said no resetting would be necessary
4 % (2) were not sure.
Alarm Resetting Cost: 
25 % (13 centers) provided a cost estimate
The average cost was $16,744, with a range of between $500 and $100,000, depending on the size of their operation and the number and types of freezers.
Alarm Resetting
41 % (69) said they would need to change their alarm settings if the rule became effective.
48 % (81) indicated they would not have to change their freezer alarm settings. 
11 % (18) said they were unsure
Resetting cost:
17 provided an estimate of the resetting cost (those who were unsure of the cost were asked to skip the question).  
The average alarm resetting cost estimate was $1,067, with a range of $200 to $5,000.

## $ Impact of Freezer Purchase

|  | Blood Centers | Hospitals |
| --- | --- | --- |
| Yes 
 | 40% (21) | 19% (32) |
| NO | 40% (21) | 67% (114) |
| Not Sure | 20% (10) | 14% (23) |
| Cost | 41% (20) Responded $2,000 to 280,000
Avg - $75,571 | 25% (41) Responded $3,000 to $30,000
Avg - $8,803 |

**Notes:**
40 % (21) said they would have to purchase new freezer equipment
40 % (21) said they would not
20 % (10 centers) were not sure
40% (21) provided a cost estimate
The average new equipment cost was $75,571, with a range of between $2,000 and $280,000, depending on the size of their operation and the number and types of freezers they use.
The Responses ranged from:
At the high end New York Blood Center ($280,000) 
Which in 2003 reported 473,100 collections, or 6 % of the total collected by ABC members.
 At the low end Texoma Regional Blood Center ($2,000)
Which in 2003 reported 9,222 collections New Freezer Equipment:
Hospials 
67 % (114 ) responded that they would not need new freezer equipment if the FDA proposal took effect.
19 % (32 ) responded that they would need new freezer equipment.
14 % (23 ) were unsure.
New equipment cost:
Of the 41 respondents who answered a question “What would be the economic impact or cost to your hospital of replacing freezer equipment?” 
The average cost was $8,803, with a range of $3,000 to $30,000.
The answers ranged from, Jersey Shore University Medical Center ($30,000) to Greenwood Leflore Hospital ($2,000)

## Surveys SummaryBlood Centers

- About half store plasma products in freezers capable of -18 oC
- Half store in freezers capable of -25 oC
- Most respondents freeze RP between -20 oC and -24 oC
- 69% said that if the FDA requires storage of FFP at -25 oC or below, maintenance contractor would have to change freezer alarm settings
- 27% (14) said no resetting necessary
- Cost estimates for resetting alarms:  $500 – $100,000, with an average of $16,744
- 40% would have to purchase new freezer equipment; 40% would not; about 20% not sure.
- Cost estimates for new equipment: $2,000 – $280,000, with an average of $75,571

## Surveys SummaryHospitals 

- Of 168 respondents, 68% store FFP, PF, and cryo in -25 oC-capable equipment
- 41% would need to change alarm settings if rule became effective; 48% would not have to change alarm settings
- Cost estimates for alarm resetting: $200 – $5,000, with an average of $1,067
- 67% would not need new freezer equipment if FDA proposal took effect; 19% would need new equipment; 14% unsure.
- Of 41 respondents who estimated cost of new equipment, the average was $8,803, with a range of $3,000 – $30,000.

## Acknowledgements

- I want to thank the ABC members and hospitals that responded and
- Jane Starkey, Robert Kapler, and Karen Edwards for their help in preparing, distributing, collating and analyzing the surveys

## Thank you!

**gmfitzpatrick@americasblood.org**