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Quality assurance of Blood safety:
Laboratory implication
Tasanee Sakuldamrongpanich
National Blood Center, Thai Red Cross Society
18072015, HIV EQA provider, NIH
Quality Assurance in Blood Transfusion service
Quality assurance deals with the maintenance of a system
to ensure that the performance in all blood bank ‘s
processes is of the required quality in order to provide
safe unit of blood and if any errors are identified, these
should be corrected.
It is the term used for all of the measures from recruitment
of the donor to transfusion of the blood/blood product to
ensure that product are of the quality required for their
intended use, and that laboratory results are reliable.
Blood Donor Screening for blood safety
Donor selection - Donor self screening (Questionnaire) - Pre-donation counseling by blood bank staff Laboratory screening - Transfusion Transmitted Infection Testing - Blood group serology
QA in laboratory –The right result,
at the right time
on the right specimen.
QA in blood bank laboratory
• Premises
- the organization should provide a safe & healthy
workplace for all employees, visitors – donors, patients
& others.
- all premises should be
- constructed in away that suits the
activities to be carried out.
- designed to allow effective cleaning.
- designed to provide a safe working
environment.
- control temperature
QA in blood bank laboratory
• Staff
Qualified personal, training of staff,
assessment of staff capability, continue
education. Individual job description.
• SOPs - provision of standard operating procedures, including documentation. Record keeping of all test’s results.
• Specification and quality control of reagents, techniques, and equipments.
Specimen collection
Collection sample from diversion Pouch
Avoid contamination of collected sample.
Avoid contamination of collected sample.
NAT sample is collected last
Avoid abnormal samples
Lipemic samples Hemolyse samples
Maintain the transport temp
appropriate for testing
Avoid Labeling error for
donor unit & sample tube
check unit No., sample tube match with donor registered form
21 May 2013
9 May 2008
Avoid Labeling error for donor unit & sample tube
Event No of
hospitals No of
samples
-Labeling error for donor
units/specimens 14 19
-Contamination in sample
collection 3 4
Occurrence of undesirable events at RBCs
(Dec 2013 – May 2014)
Pimol chiewsilp
Laboratory session
• Laboratory areas
- separated from processing area & restricted to authorized
personnel.
- enable the work to proceed in a logical sequence, allow for
effective cleaning & maintain
- Waste disposal area shall be designated for safe disposal of
waste.
9 May 2008
Donor testing laboratories
QA and QC of testing laboratory
1. Used reagents & materials from approved
suppliers that meet the documented requirements
& specifications .
2. Lab procedures shall be validated before used.
3. IQC – to monitor the reliability of the test
performance
4. Participate in proficiency testing- EQA .
Medical Device Control in Thailand
• Regulatory Authority: Medical Device Control Division, Thai
FDA
• Current Law: Medical Device Acts 2008
• All medical devices as defined in Medical Device Acts 2008
requires to be registered to obtain import license before
importing for sale in Thailand.
.
17
Medical Device Registration
Medical Device Registration Medical device can be classified into 3 groups
• Licensing Medical Device: Requires to do clinical evaluation
and submit technical specifications dossier for review and
approval e.g. HIV test kit, HIV NAT etc.
• Notification Medical Device: Same as licensing medical device
but not require to do clinical evaluation e.g. Blood bag etc.
• General Medical Device: Requires a Free Sale Certificate
(FSC) from manufacturing site or product owner country to
register for approval. (> 90% of medical devices) e.g.
- HBsAg, Anti-HCV, Syphilis , Ferritin, ABO, Rh Grouping
antibody Screening, CBC, Hb testing
18
Laboratory testing procedures
All laboratory procedures shall be validated before
used.
Validation of laboratory procedure
9 May 2008
Validation Result page.3.of3
Validation Protocol No….016………………………. Subject being validated: การใชเครองตรวจหมโลหตอตโนมต QWALSE3
Section / RBC: ภาคบรการโลหตแหงชาตท 2 จงหวดลพบร
Date of validation: 16ภมภาพนธ -30 เมษายน 2555
Refer to: SP/WI … G2WI 001, G2WI 002 Objective; เพอประเมน ความไว (Sensitivity) และ ความจ าเพาะ ( Specificity) และ ความแมนย า ( Precision)ของเครองตรวจหมโลหตอตโนมต QWALSE3
Scope: ครอบคลมการตรวจ หมโลหตระบบ ABO , Rh, Antibody Screening (Coombs’ test) ในโลหตบรจาค Validator: นางสาวพชรากร กร ากระโทก Criteria for approval of validation: ความไว ( Sensitivity) 100% ความจ าเพาะ (Specificity) 100% ส าหรบผลการตรวจ ABO Rh
ความไว ( Sensitivity) > 98% ความจ าเพาะ ( Specificity) >98% ส าหรบผลการตรวจ Antibody Screening (Coombs’ test)
List of equipment used: 1.ใชตวอยางโลหตบรจาคทตรวจดวยวธเดม microplate technique แลวน ามาตรวจดวยเครอง QWALYS3 เปรยบเทยบผลการตรวจตาม Criteria ทตงไว จ านวน 100 ตวอยางประกอบดวย หมโลหต A 20 ราย หม B 35 ราย หม O 35 ราย หม AB 10 ราย 2.ใชตวอยางโลหตบรจาคททราบผล Antibody screening จ านวน 100 ราย น ามาตรวจดวยเครอง QWALYS3 เปรยบเทยบผลการตรวจตาม Criteria ทตงไว 3. ตวอยางทมประวต subgroup จ านวน 12 ราย ประกอบดวยหม A2 2 ราย A3 2 ราย B3 1 ราย A2B 3 ราย A3B 2 ราย A1B3 2 ราย และตวอยางหมโลหต Rh (D) positive จ านวน100 ราย Weak D จ านวน 2 ราย และ Rh (D)
negative จ านวน 5 ราย น ามาตรวจดวยเครอง QWALYS3 เปรยบเทยบผลการตรวจตาม Criteria ทตงไว 4.ตวอยางแอนตบอดททราบชนดแลว จ านวน 19 ราย ประกอบดวย Anti-D 2 ราย Anti-E 3 ราย Anti-Lea 2 ราย Anti-Leb 2 ราย Anti-Lea+b 3 ราย Anti-P1 3 ราย Anti-M 2 ราย Anti-N 2 รายและAnti-c 1ราย (ถาสามารถหาได) น ามาตรวจดวยเครอง
QWALYS3 เปรยบเทยบผลการตรวจตาม Criteria ทตงไว
Process Validation Result : ( ตามเอกสารแนบ)
1. ผลการตรวจหมโลหต ABO , Rh ตรงกนกบตวอยาง 100% (Sensitivity) 100% , (Specificity) 100%
2. ใหผลการตรวจ Antibody Screening (Coombs’ test) ตรงกนกบตวอยาง 100% (Sensitivity) 100% (Specificity) 100%
Conclusion: ผลการทดสอบผาน ตาม Criteria for approval of validation
Accepted Unaccepted Revalidate
Recommendation …………………………………………………………………………….………..
Chief of section / RBC …………………………………………..……. Date ……………………….
Approved Unapproved Revalidate
Recommendation ……………………………………………………………………………………..
Quality management representative ……………………………………. Date: ……………………
Validation of laboratory procedure
Laboratory testing for TTIs
Screening for infectious markers
1. Each donation - tested for HBsAg, anti-HCV, HIVAg/Ab,
syphilis.
2. A single reactive screened, the original sample be tested in
duplicate, also with segmented from blood bag.
3. Repeatedly reactive sample - HBsAg confirmatory test,
HIV rapid test (ICS) & Serodia as supplementary test.
4. Only serology negative (HbsAg, Anti-HCV, HIV Ab/Ag )
samples tested by NAT
Quality Control for TTIs serology testing
1. Assay Calibration : New lot reagent
2. Daily Quality Control :
2.1 Reagent Kit Control
2.2 EQC samples - EM5 (HbSAg, HIV ag/Ab, anti-HCV)
& In house Syphilis Quality Control
( plot Levey-Jennings graph for both each day)
3. When new Lot of control & reagents were used, parallel
run QC (EM5) with both reagents – to adjust the L-J
graph.
1. Assay Calibration
• Cal Curve Details
2. Daily Quality Control
2.1 Kit Control
Using kit control run each day of testing.
- Follow the manufacturer’s instructions.
Results - Plot LJ graph
2.2 EM5 & In house Syphilis Quality Control
Using QC samples run each day of testing at the
beginning & end of a shift.
Results - Plot LJ graph
2. Daily Quality Control
2. Daily Quality Control
2. Daily Quality Control
Out of range
2. Daily Quality Control
Should be Exclude And add comment
3. Reagent Parallel Run New lot of control & Reagent should be analyzed in parallel
with the control in current use.
Parallel Study Reagent Parallel Run
Continue to run current lot as usual
Run new lot twice per day for 5 days
Mean for 10 runs is used as the target mean for the new
lot
Mean must fall within assay sheet range
3. Reagent Parallel Run
3. Reagent Parallel Run
New Lot Reagent
Old Lot Reagent
Daily Quality Controls
Roche cobas® TaqScreen MPX Controls Kits, v2.0
The controls are covers 5 critical viral targets (4 vials):
• Negative Control
• Multi-Positive Control includes the HIV-1 M, HBV and HCV Positive Control.
• HIV-1 O Positive Control
• HIV-2 Positive Control
Vials are loaded onto the HAMILTON Pipettor and extracted together with samples
on Cobas AmpliPrep.
In house Quality Control
In-house Quality control (IQC)
IQC ( prepared from pool of HBV DNA, HCV RNA & HIV RNA reactive plasma) is
performed daily. CT value plot LJ graph
Quality control for NAT testing
QC of NAT testing
• result
9 May 2008
Laboratory testing for blood group
serology
Blood Group Serology Testing
1. Test for ABO, Rh & screening for RBC antibody.
2. First time donor- ABO group Rh(D– test twice.
3. RBC antibody screen: saline RT, 37C papain, AHG
4. If any discrepancy is found, blood should not be
released until discrepancy is resolved.
Quality control for Blood group serology
Daily quality control of reagents
Run QC samples at the beginning and end of working
day on automatic blood group analyzer.
- Blood group A, B, O, AB, Rh(D) negative
- 2 samples of weak antibodies positive
eg. Anti-D & anti-P1
QC of blood grouping testing
IQC Blood Group
Sample Sample
IQC Blood Group
IQC antibodies (anti-D, anti-Fya , anti-E, negative)
EQAS in donor screening laboratory
Test Provider
1 HIV, HBV, HCV, Syphilis serology NRL/Australia
2 HIV serology(HIV Ag/Ab Combi, anti-HCV
Dept of Medical Science, MOPH
3 HBsAg, Syphilis EQAI, Mahidol Iniversity
4 MP6 NAT EQAP Italy
5 ABO/Rh/antobody screen & identification
Dept of Medical Science, MOPH
6 CBC Dept of Medical Science, MOPH, RIQAS
EQAS for special laboratory
Test Provider
1 Red cells serology Reference lab - Dept of Medical Science, MOPH
- Royal College of Pathologists of Australia (QA program)
2 HLA Asia Pacific Histocompatibility and Immunogenetics Association
3 Platelet antigen/antibody NIBSC,UK
4 Low level Leukocyte Enumeration UK, NEQAS
5 CD34+ Stem Cells Enumeration
UK, NEQAS
EQA HIVAg/Ab combo (NRL)
EQA HIVAg/Ab combo (NRL)
EQA Syphilis (NRL)
การรายงานผล โรงพยาบาลทใชโปรแกรมศนยฯ โรงพยาบาลทไมใชโปรแกรมศนย
1. สงขอมลผบรจาคและผล โดยโปรแกรม Data transfer จะไดเปน text file แลวสงใหทาง email
1. Scan ใบรายงานผลเปน PDF file สงใหโรงพยาบาลผานทาง email
2. Scan ใบรายงานผลเปน PDF file สงใหโรงพยาบาลผานทาง email
2. กรณไมสามารถรบผลทาง email จะสง Fax ให (กรณ internet มปญหา)
3. กรณไมสามารถรบผลทาง email จะสง Fax ให (เชน กรณ internet มปญหา)
3. เมอมาสงตวอยางครงตอมา จะสงรายงานผลฉบบจรง คนให โรงพยาบาล
4. เมอมาสงตวอยางครงตอมา จะสงรายงานผลฉบบจรง คนให โรงพยาบาล
Program Data Transfer
ตวอยาง รายงานผล จาก PDF file
Table 4 Repeat donation of previous positive infectious marker blood donors
Year HIV HBV HCV Total
Donor Unit Donor Unit Donor Unit Donor Unit
2006a 8 10 120 132 50 56 178 198
2007b 15 15 233 264 102 115 350 394
2008b 8 9 214 253 99 112 321 374
2009b 14 15 233 266 119 137 366 418
2010b 11 14 253 295 112 126 376 435
Total 57 63 1,052 1,210 483 546 1,591 1,819
a: repeat donation from previous positive detected in 2006 only
b: repeat donation from previous positive detected in the same year and the year before
Blood Donor Screening in Thailand
3/34
BTS network Composes of
BKK,
- 1 NBC and 6 branches BS in the hospital.
Province,
- 12 RBCs has been set up throughout the
country.
- 161 branches BS in the provincial H,
Central general H, university H.
( hospital based BBs)
~ 200 HBBs in BKK and 800 in the provinces.
Total population : app. 65 M
Provinces : 77
Phuket
Blood Transfusion services network
Annual blood collection in Bangkok VS in the province fiscal year 2009–2013 (Oct–Sep)
Fiscal Year 08/09 09/10 10/11 11/12 12/13
Whole country 1,836,513 1,925,568 2,023,489 2,097,868 2,205,043
% of collection /population
2.9% 3.0% 3.2% 3.3% 3.4%
Collection in BKK 662,790 693,944 709,796 723,328 772,760
% of collection /population
11.6% 12.2% 12.5% 12.7% 13.6%
6 Branches& few HBBs
123,697 122,759 121,043 126,212 130,050
At NBC 539,093 571,185 588,753 597,116 642,710
Collection in provinces
1,173,723 1,231,624 1,313,693 1,374,540 1,432,283
% of collection/ population
2.0% 2.1% 2.2% 2.3% 2.4%
At HBBs 1,156,114 1,192,639 1,227,768 1,257,424 1,270,878
At RBCs 17,609 38,985 85,925 117,116 161,405
Historical of blood donation screening at NBC, TRC
• 1952 Syphilis
• VDRL, RPR, TPHA [PK7200], CMIA
• 1972 HBsAg
• CIEP, RPHA, ELISA, Chemiluminescence
• 1987 Anti-HIV
• ELISA, Chemiluminescence
• 1990 Anti-HCV
• ELISA, Chemiluminescesnce
• 1991 HIV-p24 Antigen
• ELISA
• 2002 NAT
• HIV/HCV
• HIV, HBV, HCV 4/34
Prevalence of TTI serological markers (%) in blood donations in Thailand (2002/03 – 2012/13)
2002/03 2003/04 2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 2011/12 2012/13
Syphilis 0.61% 0.58% 0.60% 0.57% 0.57% 0.40% 0.35% 0.35% 0.37% 0.34% 0.29%
HBsAg 2.44% 2.31% 2.19% 2.06% 1.96% 1.69% 1.51% 1.29% 1.11% 1.01% 0.84%
anti HCV 0.74% 0.65% 0.60% 0.60% 0.62% 0.60% 0.51% 0.49% 0.43% 0.39% 0.32%
HIV Ag/Ab 0.34% 0.27% 0.34% 0.34% 0.29% 0.28% 0.24% 0.21% 0.16% 0.17% 0.14%
0.00%
0.50%
1.00%
1.50%
2.00%
2.50%
3.00%
Fiscal year 2005
total 2.56%
Fiscal year 2006
total 2.15%
Fiscal year 2007
total 1.93%
Fiscal year 2008
total 1.65%
Fiscal year 2009
total 1.51%
Fiscal year 2010
total 1.27%
Fiscal year 2011
total 1.14%
Fiscal year 2012
total 1.05%
Fiscal year 2013
total 1.09%
Fiscal year 2014
total 0.99%
Syphilis 0.75 0.44 0.40 0.28 0.23 0.21 0.23 0.21 0.21 0.16
HBsAg 1.31 1.26 1.14 1.01 0.96 0.79 0.65 0.57 0.60 0.52
HCV-Ab 0.31 0.26 0.23 0.19 0.18 0.13 0.15 0.14 0.12 0.11
HIV Ab/Ag 0.19 0.19 0.16 0.15 0.15 0.13 0.12 0.12 0.16 0.20
0.00
0.20
0.40
0.60
0.80
1.00
1.20
1.40
%
Prevalence of serological markers (%) in blood donors at NBC in 2005 - 2014
Fiscal year 2009 total 3.51%
Fiscal year 2010 total 1.82%
Fiscal year 2011 total 2.35%
Fiscal year 2012 total 2.31%
Fiscal year 2013 total 1.99%
Fiscal year 2014 total 0.99%
Syphilis 0.54 0.52 0.45 0.39 0.32 0.30
HBsAg 1.99 1.73 1.43 1.44 1.20 1.07
HCV-Ab 0.47 0.43 0.36 0.35 0.35 0.27
HIV Ab/Ag 0.15 0.14 0.11 0.13 0.12 0.12
0.00
0.50
1.00
1.50
2.00
2.50
%
Prevalence of serological markers (%) in blood donations from RBCs from 2009 - 2014
7/34
National Blood Policy in Thailand
2010
Serology
• Syphilis
• Anti-HIV 1,2
• HIV Ag (p24 Ag)
• HBsAg
• Anti-HCV
with a sensitive technique eg. EIA
• Nucleic Acid Testing (NAT)
8/34
534,168 566,815 584,830 597,350 636,037
631,756
35,234 41,595
53,884 53,776
66,215 71,637
569,402 608,410
638,714 651,126
702,252 703,393
0
100,000
200,000
300,000
400,000
500,000
600,000
700,000
800,000
2009 2010 2011 2012 2013 2014
Total sample tested at NBC;TRC and Hospital BBs in Bangkok
Oct 2009 – Sept 2014
NBC TRC BB Hospital Total
10/34
0
200,000
400,000
600,000
800,000
1,000,000
1,200,000
2009 2010 2011 2012 2013 2014
75,157
201,622
422,315
607,651
768,304
1,013,996
Number of NAT tested at RBCs, TRC from 2009 – 2014 (Oct – Sep)
11/34
RBC Provincial hospital Blood
Bank (Already NAT Testing)
Provincial hospital
Blood Bank (Non NAT Testing)
Tested at NBC 3 3
RBC 2 Lopburi 7 7
RBC 3 Chonburi 7 6
RBC 4 Rachaburi 7 7
RBC 5 Nakornrachasima 5 5
RBC 6 Khon Kaen 10 10
RBC 7 Ubonrachathani 6 5
RBC 8 Nakornsawan 5 5
RBC 9 Pitsanuloke 6 2 + 1*
RBC 10 Chiangmai 6 5 +1*
RBC 11 Nakornsri. 5 5
RBC 12 Songkla 5 5
RBC Phuket 4 4
Total 76 71 (2*)
NAT Testing of provincial Blood Banks
* Tested only new donors 12/34
Year No. of
Samples tested
NAT Reactive Samples (sero-negative )
HIV HCV HBV
2009 534,168 7 (1:76,300) 0 179(1:2,980)
2010 566,815 6(1:94,500) 1 193(1:2,930
2011 584,830 6(1:97,500) 1 182(1:3,210
2012 597,350 1(1:597,350) 1 176(1:3,390)
2013 636,037 5(1:127,200) 2 169(1:3,760)
2014 631,756 14(1:45,000) 2 147(1:4,300)
Total (NAT yield)
3,550,956 39
(1:91,000) 7
(1:507,000) 1,046
(1: 3,400)
NAT reactive samples from NBC,TRCS
Oct 2009-Sep 2014
13/34
Index sample No.
Date Sex Risk
behavior Donation
time Donation
site
NAT cobas s
201 (Ct)
F/U sample shown
Seroconvert after
(Month)
1 10/13 M MSM 9 mobile 33.6 3*
2 12/13 M N/A 1 NBC 27.7 N/A
3 12/13 M MSM 8 mobile 31.5 4*
4 12/13 M N/A 40 mobile 23.7 N/A
5 12/13 F N/A 4 mobile 33.5 N/A
6 12/13 F N/A 4 mobile 32.1 N/A
7 3/14 M MSM 2 mobile 29.9 3*
HIV-1 NAT reactive samples at NBC FY 2014
* follow up sample shown seroconvert by Architect, Determine and GPA 14/34
Index sample No.
Date Sex Risk
behavior Donation
time Donation
site
NAT cobas s
201 (Ct)
F/U sample shown
Seroconvert after
(Month)
8 5/14 M MSM 5 mobile 27 2*
9 5/14 M MSM 7 NBC 28.1 2*
10 6/14 M N/A 2 mobile 29.2 N/A
11 8/14 F N/A 21 mobile
31.4
N/A
12 8/14 M N/A
1 mobile 33.3
N/A
13 9/14 M N/A 5 mobile 29.8 N/A
14 9/14 M MSM 1 mobile 38.5 2*
HIV-1 NAT reactive samples at NBC FY 2014
* follow up sample shown seroconvert by Architect, Determine and GPA 15/34
Year No. of
Samples tested
NAT Reactive Samples (sero-negative)
HIV HCV HBV No plasma
sample to be confirmed
2009 35,234 0 0 15 8
2010 41,595 1 0 21 16
2011 53,884 0 1 17 15
2012 53,776 0 0 12 73
2013 66,215 0 0 15 21
2014 71637 1 0 10 -
Total (NAT yield)
322,341 2
(1: 160,000) 1
(1:322,000) 75
(1:4,300) 112
NAT reactive samples from hospital BBs in BKK
Oct 2009-Sep 2014
16/34
Year No. of
Samples tested
NAT Reactive Samples (sero-negative)
HIV HCV HBV No plasma
sample to be confirmed/VTR
2009 59,591 2(1:29,800) 1 48 (1:1,240) 0
2010 201,622 1(1:201,600) 2(1:100,000) 143(1:1,400) 40
2011 422,315 4(1:105,000) 3(1:140,000) 240(1:1,760) 66
2012 607,651 6(1:101,000) 1 263(1:2,300) 124
2013 768,304 11(1:70,000) 5(1:154,000) 323(1:2,400) 212
2014 1,013,996 13(1:78,000) 8(1:127,000) 454(1:2,200) -
Total (NAT yield)
3,073,479 37
(1:83,000) ) 20
(1:150,000) 1,471
(1:2,100)
NAT reactive samples from HBBs in the provinces Oct 2009-Sep 2014
17/34
• In 2014, blood donation samples tested at NBC and RBCs cover
about 75% of whole country blood collection.
• The prevalence rates of serological markers for Syphilis, anti-
HCV, HIV Ag/Ab gradually declined yearly where as HBsAg
declined significantly.
However there was a rising trend of HIV prevalence rate at NBC.
• Number of NAT window cases increased yearly as number of
NAT testing increased. In 2014, the NAT yield rates for HIV
(1:45,000) at NBC hit the highest rate.
18/34
• Thus, combination of serology and NAT testing in screening of
blood donations would significantly reduce the TTID and provide
the highest level of safe blood to the patient.
• Moreover, a better & strictly donors selection will be significantly
improved the blood transfusion safety.
19/34