the appendix is an integral part of certificate of ... · 818 -haematology laboratory activated...

The Appendix is an integral part of Certificate of Accreditation No. 668/2017 of 16. 11. 2017

Accredited entity according to ČSN EN ISO 15189:2013:

Institute of Hematology and Blood Transfusion (ÚHKT) ÚHKT Laboratories

U Nemocnice 1, 128 20 Praha 2

Medical laboratory locations: 1. Workplace No. 1

2. Workplace No. 2

1. Workplace No. 1

U Nemocnice 2094/1, 128 08, Praha 2

U Nemocnice 499/2, 128 08, Praha 2

The Laboratory has a flexible scope oj accreditation permitted as detailed in the Annex.

Updated list oj activities provided within the required flexible scope oj accreditation is available jrom the Laboratory Quality Manager.

Examinations:

1.

2.

3.

4.

5.

6.

7.

Examination procedure name

Examination procedure identification

818 - Haematology Laboratory

Activated partial thromboplastin 105 SOP 08 O 1 time of plasma on ST A-R analyzer using STA-PTT A kit [ APTT-time, APTT-ratio]

Prothrombin time of plasma by 105 SOP 08 02 ST A-R analyzer using ST A-Neoplastine kit. [Prothrombin time, Prothrombin time-ratio]

Immunoturbidimetric determination of amount-ofsubstance concentration ofDdimer in plasma by STA-R analyzer using STA-LIATEST D-Di kit [D-dimers]

105 SOP 08 03

Quantitative determination of 105 SOP 08 04 fibrinogen in plasma by Clauss method by ST A-R analyzer using DG-FIB L Ruman reagents [Fibrinogen]

Determination of amount-ofsubstance concentration of D-Dimer in plasma by ELFIA analyzer by VIDAS kit D-Dimer Exclusion [D-Dim (ELISA) (VIDAS)]

Reserved

Spectrophotometric determination of free haemoglobin in plasma [Free haemoglobin in plasma]

105 SOP 08 06

of-l)l -

Examined object

Plasma

Plasma

Plasma

Plasma

Plasma

Blood

The Appendix is an integral part of Certificate of Accreditation No. 668/2017 of 16.11.2017


Ordinal number

8.

9.

10.

11.

12.




Cul ture examination of the number ofhaematogenic progenitor cells from bone marrow or peripheral blood (CFU-GM+BFU-E) [CFU-GM+BFU-E]

Peripheral blood smear analysis - leukocyte count and morphological description of cells

Quantitative spectrophotometric determination of G-6-PDH by TRINITY BIOTECH kit, Procedure No. 345-UV [G-6-PDH]

Quantitative determination of A2, F and S haemoglobins by capillary electrophoresis method on MINlCAP system EHbA2, HbF, HbS] Measurement ot blood count parameters (WBC, RBC, HGB, Hct, PLT) on Sysmex XNlO, XN20 haematology analyzers

Measurement of absolute number of reticulocytes (RET)


304 SOP 08 01

113 SOP 14 05

117 SOP 11 02

117 SOP 12 01

113 SOP 16 19

113 SOP 16 20 - - -

Examined object

Bone marrow, apheresis product, peripheral blood

Blood

Blood

Blood

Blood

Blood

13. on

14.

15.

Sysmex XN20 haematology analyzer

Determination of differential Leukocyte count on analyzers Sysmex XNIO, XN20 (NEUT#, LY#, MO#, EO#, BASO#, NEUT¾, LY%, MO%, EO%, BAS0%)

Determination of blood count parameters (leukocytes, erythrocytes, haematocrit, haemoglobin, thrombocytes) on haematology analyzer Sysmex XS l000i [Hb, Htk, Ery, Leu, Trambo]

113 SOP 16 21 Blood

206 SOP 08 01 Peripheral blood



Ordinal number

16.

17.-99.

100.

101.-104.

105.

106.

107.

108.

109.

110.



Examination procedure Examination procedure name identification Examined object

Determination of blood count 206 SOP 08 02 - -Peripheral blood parameters (leukocytes,

erythrocytes, haematocrit, haemoglobin, thrombocytes) on haematology analyzer Nihon Kohden Celltac E [Hb, Htk, Ery, Leu, Trombo]

Reserved

222 - Transfusion Medicine

Lymphocytotoxic test for the 233 SOP 08 01 Blood - -

determination of HLA class I antigens and lymphocyte cross-match [HLA serotyping, Lymphocytotoxic crossmatch]

Reserved

Identification of thrombocyte 203 SOP 14 02 Serum - -antibodies by PakLx Screening of irregular 203 SOP 10 04 Serum, plasma - - -antibodies against erythrocytes by column agglutination method in DG Gel cards [Ser prot DG Gel] Identification of irregular 203 SOP 10 05 Serum, plasma antibodies - - -

against erythrocytes by column a8glutination method in BioRa (DiaMed) cards [Id prot DiaMed] Examinat10n oťblood group 203 SOP 11 01 Blooa ABO Rh D by agglutination - - -

method on Galileo system [KS] Examination of erythrocyte 203 SOP 11 02 Blood antigens C c E e K Cw by - - -

agglutination method on Galileo system [Phenotype Rh, K]

Screening of lgG irregular 203 SOP 11 04 Blood - - -antibodies against erythrocytes by solid phase .,,-method on Galileo system Ň~ \1ro afrr. v ~ $~· [Ser prot donor] .4 ,~ ~

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The Appendix is an integral part of Certificate of Accreditation No. 668/2017 of 16.11.2017


Ordinal number

111.

112.

113.

114.

115.

116.-199.

200.

201.



Examination procedure Examination procedure name identification Examined object

Direct Coombs test (PAT) by 203 SOP 12 07 Blood - - -column agglutination method in DG Gel cards [PAT DG Gell

Compatibility test by LISS Blood NAT column agglutination 203 SOP 12 09 - - -method in BioRad cards [DiaMed] "LISS/Coombs" [zkgDM]

Detection of HIT II 203 SOP 13 01 Blood - - -

antibodies (anti-heparin/PF4 IgG class) on AcuStar system [AcuStar IgG]

Lymphocytotoxic test for 203 SOP 13 02 Blood - -

screening and identification of anti-HLA antibodies [HLA antibodies LPC]

Genotyping of HP A antigens 203 SOP 14 06 Blood - - -by BLOODchip IDHP AXT method [HP A BLOODchip ID]

Reserved

816 - Medical Genetics Laboratory

Examination of cellular NRL 01 SOP 14 01 Biological material - -chimerism after allogeneic containing human nuclear HSCT by electrophoretic DNA analysis of sequence polymorphisms8

[Examination of cellular chimerism after allogeneic HSCT - elpho]

Examination of genotype of NRL 05 SOP 14 01/ Biological material - -

main histocompatible system procedure A containing human nuclear of human being - HLA by DNA PCR-SSP method 9

[Examination of HLA-PCR-SSP method]

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I.Pes) .b i) -~

Pa= ~í

- -- -- -- ----------- ----- - ----- --- - -------



Ordinal number

202.

203 .

204.

205.

206.

207.

208 .




Examination of genotype of main histocompatible system ofhuman being-HLA by direct sequencing method 9

[Examination ofHLA-SBT method] Examination of genotype of main histocompatible system of human being - HLA by real-time PCR9 method [Examination of HLA -qPCR method] Examination of genotype of main histocompatible system ofhuman being- HLA by massive parallel sequencing method 9

[Examination of HLA - NGS method]

Examination of genotype of main histocompatible system of human being - HLA -quality and concentration of isolated DNA. [Examination of HLA -DNA isolation] Examination of cellular chimerism after allogeneic HSCT by real-time PCR analysis of sequence polymorphisms 10

[Examination of cellular chimerism after allogeneic HSCT qPCR]

Diagnostic examination of BCR-ABL fusion gene by multiplex RT-PCR method 11

[Diagnostic examination of BCR-ABL]

Examination of the level of BCR-ABL transcript by realtime RT PCR method 12

[Monitoring of BCR-ABL]


NRL 05 SOP 14 01/ procedure B

NRL 05 SOP 14 01 procedure C

NRL 05 SOP 14 01 / Procedure D

NRL 05 SOP 14 01/ Annex 01

NRL 07 SOP 14 01

NRL 03 SOP 14 01

NRL 04 SOP 14 01/ procedure A

Examined object

Biological material containing human nuclear DNA





Biological material containing human RNA

Peripheral blood, bone marrow

~------------------------- -- -- -



Ordinal number

209 .

210.

211.

212.

213.

214.

215 .

216.

217.

218.



Examination procedure Examination procedure Examined object name identification

Examination of mutations in NRL 04 SOP 14 01/ Peripheral blood, bone - - - -kinase domain ofBCR-ABL procedure B marrow by direct sequencing method [Mutations in kinase domain ofBCR-ABL] Examination of the number NRL 02 SOP 14 01 Biological material - - - -

oftranscripts of WTl gene containing human RNA by means of real-time RT-PCR at patients with acute leukemia and MDS Examination of mutations in NRL 06 SOP 14 01 Biological material - - - -

HBB gene (Haemoglobin containing human nuclear beta) by direct sequencing DNA method Examination of the presence NRL 09 SOP 14 01 Biological material - - - -of mutations in NPM 1 gene containing human RNA by direct sequencing method Examination of the number NRL 10 SOP 14 01 Biological material - - - -

of transcripts of mutated containing human RNA NPMl gene by real-time RT-PCR method at patients with AML Examination of the presence NRL 11 SOP 14 01 Biological material - - - -of mutations in CEBP A gene containing human nuclear by direct sequencing method DNAandRNA Examination of mutations in NRL 12 SOP 16 01 Biological material - - - -HBAl and HBA2 genes by containing human nuclear u-Globin StripAssay kit DNA [Detection of mutations in HBAl and HBA2 genes]

Detection of JAK.2 gene 114 SOP 08 01 Bone marrow, peripheral - -V 617F mu tati on in peripheral blood blood and bone marrow by RT-PCR method [Result of RT-PCR examination of JAK.2 V617F mutation] Genotyping of erythrocyte 203 SOP 16 01 Blood - - -antigens by RBC-FluoGene vERYfy method 13

Genotyping of thrombocyte 203 SOP 16 02 Blood - - -antigens by HP A FluoGene method 14

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Ordinal number

219.

223.-299.

300.

301.

302.

303.

304.-399.

500.

501.




Examination of the presence 105 SOP 15 01 Blood - -of thrombophilic risk factors by PCR and fluorogenic target-specific hybridization [Thrombophilia]

Reserved

802 - Medical nůcrobiology

Detection of human 318 SOP 08 01 Smears - - -

papillomavirus (HPV) by Hybrid Capture 2 method (HC2) [Hybrid Capture] Detection of human 318 SOP 08 02 Smears, oral cavity lavage, - - -

papillomavirus by reverse bronchoalveolar lavage, hybridization method (RLB) aspirate, exploratory biopsy, I [PCR] paraffin fixed tissue

Examination of markers of LPVN SOP 09 01 Serum - -blood-bome infections (HIV, HBV, HCV, Treponema pallidum) by ELISA method [HIV Ab/Ag, HBsAg, HCV Ah/Ag, anti-Treponema pallidum] Examination of markers of LPVN SOP 11 01 Serum - -hepatitis B virus (HBsAb, HBcAb, HBeAb, HBeAg) and cytomegalovirus infection by ELISA method [anti-HBs, anti-HBc, anti-HBe,HBeAg, anti-CMV IgG]

Reserved

813 - Allergology and Immunology Laboratory

Determination of lymphoid 116 SOP 08 01 Peripheral blood - -subpopulations in peripheral blood by flow cytometry 2

Determination of CD34+ 116 SOP 08 02 Peripheral blood, umbilical - -stem cells in peripheral blood, blood marrow, blood, umbilical blood, blood apheresis products marrow and apheresis

~ ~íO «3,4-,,_ť:) products by flow cytometry --~..;:; . ~-

single platform ISHAGE 'či t"'!:

protocol 3 s i. ,;,,;, - o :t:. ~()[JHl,l,KJ:IE~AČH\ORGAH •

l.fl0. .b ;?i .C.,

ge 7_qJJ l

-----~-~ - -



Ordinal number

502.

503.

504.

505.

506.

507.

508.-599.




Determination of PNH 116 SOP 16 03 Peripheral blood - -erythrocytes and granulocytes in peripheral blood by flow cytometry: diagnostics of paroxysmal nocturnal hemoglobinuria 4

Imunophenotyping of 116 SOP 08 04 Peripheral blood, bone - -leucocytes from peripheral marrow, lymph node, blood sample, bone marrow cerebrospinal fluid, aspirate, lymph node, malignant exudate cerebrospinal fluid, malignant exudate by flow cytometry 5

Determination ofVASP 116 SOP 08 05 Peripheral blood - -phosphorylation of thrombocytes by flow cytometry: monitoring of therapy of P2Y12 receptor ADP antagonist 6

Quantitative determination of 116 SOP 08 06 Peripheral blood - -CD64 expression on neutrophil granulocytes in peripheral blood by flow cytometry 7

Determination of minimal 116 SOP 16 07 Peripheral blood, bone - -residua! disease in patients marrow with chronic lymphocytic leukemia (B-CLL) by multicolor flow cytometry 15

Determination of minimal 116 SOP 16 08 Peripheral blood, bone - -residual disease in patients marrow with acute B-lymphoblastic leukemia (B-ALL) by multicolor flow cytometry 16

Reserved





4) 116 SOP 16 03: Examíned markers: FLAER, CD15, CD45, CD59, CD64, CD157, CD235a.

s) 116-SOP-08-04: Examíned markers:

Lineage B-lymphoíd lineage

T-lymphoíd lineage

Myelomono cytary líneage

Plasma líneage

Prímary reagents CD5,CD10,CD19,CD20, CD45,kappa, lambda

CD2, CD3,CD4,CD5,CD7, CD8,CD45,CD56

CD7, CD1lb,CD13,CD14, CD 15,CDl 6,CD33,CD34,C D45,CD56,CD117,HLADR CD19, CD38, CD45, CD56

Secondary reagents CD9,CDl lc,CD15,CD22,cCD22,CD23,CD25,CD13,CD33, CD34,CD38,CD43,CD58,cCD79a,CD79b,CD103,FMC7,B cl-2,kappa, lambda,cMPO,TdT,ZAP-70, slgm

CD 1 a, cCD3,CD1 0,CDl 6,CD25,CD26,CD30,CD34,CD 45RA,CD45RO,CD57,TCR-a!3, TCR-yo,cMPO,cTIA, T-beta chain beta chain isoforms, TdT

CD2, cCD3,CD4,cCD22,CD25,CD36,CD38,CD41,CD61,cCD61, CD64,CD71,cCD79a,cMPO,CŮ123,CD163,CD235a

CDl0, CDl 17, CD138,cyt. kappa, cyt. Lambda

6) 116 SOP 08 05: Examíned markers: 16C2, CD61.

7> 116-SOP-08-06: Examíned markers: CD45, CD64. S) NRL_Ol_)OP_14_01 examined polymorphisms: VNTR: ApoB, MCTl 18 (D1S80), YNZ22 (Dl 7S5), Col2Al, PAH, HVR-Ig, TPO, Amelogenín gene AMG, Y-specífic sequence DYZl, DYZ3/DXZ1.

STR: AMG, LPL, FESFPS, F13B, F13A01, D16S539, D7S820, D13S317, D5S818, D3S1358, D21S11, D18S51 , Penta E, D8S1179, FGA, Penta D, Penta C, CSFlPO, TPOX, THOl, vWA, D22S1045, D2S1338, D19S433, D2S441, D10S1248, D1S1656, D12S391 and SE33.

DIP: AM X, AM Y, HLD106, HLD70, HLD84, HLD103, HLD104, HLDl 16, HLDl 12, HLD307, HLD310, HLDl 10, HLD133, HLD79, HLD105, HLD140, HLD163, HLD91, HLD23, HLD88, HLD101, HLD67, HLD301, HLD53, HLD97, HLD152, HLD128, HLD134, HLD305, HLD48, HLDl 14, HLD304, HLD131, HLD38, HLD82.

9) NRL_05_SOP _14_01 tested genes:

Procedure A and B: Class I HLA: loci A, B, C Class II HLA: loci DRB 1, DQA, DQB 1, DPB 1, presence of DRB3-5 KIR genes: presence of 2DL1 , 2DL2, 2DL3, 2DL4, 2DL5, 2DS1, 2DS2, 2DS3, 2DS4, 2DS5, 3DL1, 3DL2, 3DL3, 3DS1, 2DP1, 2DP2. Procedure C Presence ofHLA-B*57. Procedure D:

0 Class I HLA: loci A, B, c v\. 9í 8 kr6> Class II HLA: loci DRBl, DQA, DQBl, D , . ~-NGS = next-generation sequencing. .S

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-2-

of 11



Institute of Hematology and Blood Transfusion {ÚHKT) ÚHKT Laboratories


10> NRL_07 _SOP _14_01 tested specific sequence polymorphisms: S01 (ITGA2B), S04 (DBH), S07 (UXT/ZNF81), S08 (PAPPA2/ASTN1), S10 (LTBPl), S11 (DLG2) - each system has A and B variant, S0SB (EIF2S2), GAPDH, SMCY (AF273841).

11> NRL_03_SOP _14_01 detected alterations: b2a2 (e13a2), b3a2 (b14a2, b), ela2, e19a2 + rare

alterations. 12> NRL_04_SOP _14_01 detected alterations: a) alterations b2a2 (e13a2) a b3a2 (b14a2, b), c)

ela2. 13> 203_SOP _16 _01 tested genes coding:

D, C,c,E,e,Cw erythrocyte antigens and Kell, Kidd, Duffy, MNS and Dombrock system antigens Dweak erythrocyte antigens, D variant erythrocyte antigens, molecular basis of AB0 system antigens.

14>203_SOP _16 _02 tested genes coding thrombocyte antigens HPA-1,-2,-3,-4-, -5,-6,-9,-15. 15>116_SOP_l6_07:CD3, CD5, CD19, CD20, CD43, CD79b, CD81, RORl, lgkappa, Iglambda. 16>116_SOP_16_08:CD10, CD19, CD20, CD22, CD34, CD38, CD45, CD58, CD66c, CD73, CD81,

CD123, CD304, HLA-DR.

Annex: Flexible scope of accreditation

Examination procedure ordinal numbers

200-215 The Laboratory is allowed to modify the examination procedures listed in the Annex within the specified scope of accreditat10n provided the measuring principie is observed.

The flexible approach to the scope of accreditation cannot be applied to the examinations not included in the Annex.

Primary sampling:

Ordinal Primary sampling Primary sampling number l) procedure name procedure identification Primary sample

400. Venous blood sampling 206 SOP 10 03 Blood - -

401.-Reserved 499.

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- - ----------------------------





2. Workplace No. 2

Examinations:

Ordinal Examination procedure Examination procedure Examined object number name identification

816 - Medical Genetics Laboratory

Analys i s of karyotype by SOP-UKBLD-CNC-1 Bone marrow, penpheral

conventional cytogenetic blood

220. method [Conventional cytogenetic analysis]

Analysis of chromosomal SOP-UKBLD-CNC-2 Bone marrow, peripheral anomalies by fluorescent in blood

221. sítu hybridization (FISH) [Analysis of chromosomal anomalies by FISH method]

Analysis of chromosomal SOP-UKBLD-CNC-3 Bone marrow, peripheral deviations by multi-coloured blood fluorescent in-sítu hybridization (mFISH)

222. method and high resolution multicolor banding technique (mBAND) [Analysis of chromosomal deviations by mFISH/mBAND method]

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the appendix is an integral part of certificate of ... · 818 -haematology laboratory activated...

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