Blood

AssuranceSOURCE PLASMA PROGRAM

Choosing Equipment

Aurora selected Good relationship with

Fresenius Kabi - we use Alyx already

Aurora has Alyx Brain

staff are familiar with the

Alyx Icons

Easy to operate

Blast Freezer Model Number

XBF40MD selected

Size

Cost

Familiar with Thermo Scientific

Plasma Freezer Model Number

JDL430A for storage

Size

Cost

Familiar with Thermo Scientific

Recruitment Plan Educate Donors and Staff

1. Shock

2. Burns

3. Adult Respiratory Distress

4. Cardiopulmonary Bypass Surgery

5. Immune Deficiency Diseases

6. COPD

7. Bleeding Disorders

Give realistic information on donation time

Blood Types

Gender

History

1. Have they given plasma within the last 28 days

2. Can’t be first time donor; need 1 set of test results

Donor Target

B+ and A+ blood types

Women that are HLA Class I/II positive

Woman who use to give Apheresis but can’t

anymore due to HLA Class I/II positive test

Blood types based on inventory and demand

OP ON AP AN BP BNABP/

ABN ?

MALE and

FEMALES that

have never

been pregnant

or tested

negative HLA

class I/II

1st PPA or PTA 1st DRA 1st PPA or PTA 1st PPA or PTA 1st PPA or PTA 1st DRA 1st PPA 1st PPA or PTA

2nd PRA 2nd PRA 2nd DPA 2nd DPA 2nd PTA 2nd PPA or PTA 2nd DPA 2nd WBD

3rd DRA or WBD 3rd WBD 3rd WBD 3rd DRA 3rd SAP 3rd WBD 3rd WBD 3rd N/A

FEMALES that

have been

pregnant or

HLA untested

1st DRA 1st DRA 1st WBD 1st DRA 1st SAP 1st DRA 1st WBD 1st WBD

2nd WBD 2nd WBD 2nd SAP 2nd WBD 2nd WBD 2nd WBD 2nd N/A 2nd N/A

3rd SAP 3rd N/A 3rd N/A 3rd SAP 3rd N/A 3rd SAP 3rd N/A 3rd N/A

Patient Needs Collection Grid

SAP = Source

PPA/PTA/PRA = Platelets/Plasma/RC DRA = Double Alyx RC

WBD = Whole Blood DPA = Double Alyx Plasma

Timeline For Facility Collections

and Trends

Started Collecting Source Plasma November 12th, 2015 in Chattanooga

North River Started Collecting Source Plasma February, 2016

Tullahoma Started Collecting Source Plasma March 25th, 2016

Cleveland Started Collecting Source Plasma April, 2016

23

82

115

139

179

147

88

162

80

48

6354

157

Trend Collecting All Positive Blood Types

At first, to get the staff familiar with the

equipment, they were collecting all

positive blood types

Trend showing collections of

targeted blood types based

on inventory

113

93

99

75

65

106

66

22

JANAURY FEBRAURY MARCH APRIL MAY JUNE JULY AUGUST

Trend Collecting B+ and A+

SOURCE PLASMA PRODUCTION

2015

August September October November December

23

70

23

58

0 0 0

20

56

23

70 3 2

Prepared Shipped Discarded

SOURCE PLASMA

DISCARDS 2015

VALIDATION/TRAINING ERRORS

CLERICAL ERRORS (NOT DOCUMENTING TIME IN

AND OUT OF FREEZER)

BROKEN AFTER FREEZING

POSITIVE TEST RESULTS

SOURCE PLASMA

PRODUCTION 2016

114

139

178

146

83

161

73

48

63

54

92

70

110

132

161

136

60

121

67

46

61

49

84

65

4 7

1710

23

40

62 2 5 8 5

Prepared Shipped Discarded

SOURCE PLASMA

DISCARDS 2016

BROKEN AFTER FREEZING

FROZEN TOO LATE

NO PARVO TUBE DRAWN

POSITIVE TEST RESULTS

CLERICAL ERRORS (NOT DOCUMENTING TIME IN

AND OUT OF FREEZER)

SOURCE PLASMA

PRODUCTION 2017117

96 97

75

65

105

66

107

9295

74

63

100

58

104 2 1 2

52

Prepared Shipped Discarded

SOURCE PLASMA

DISCARDS 2017

BROKEN AFTER FREEZING

CLERICAL ERRORS

NO TUBES DRAWN

POSITIVE TEST RESULTS

ISSUES Getting FDA Source Plasma License (ISBT labels, SOP’s, validations)

Label software version would not print FDA approved labels

New Blast Freezer delivered with dents in Chattanooga. Sent back for new one

New Blast Freezer delivered to North River didn’t work correctly. Sent back for new

one

Staff forgetting to draw Parvo tube

Staff not checking unit out from blast freezer, no time out recorded

Packing and transporting Frozen Plasma; very breakable

Blast Freezer not monitored: can’t collect after 12 pm or on weekends

1. Temperature monitoring system will be installed on all equipment in the near future