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Fungsi BDRS adalah sebagai pelaksana dan penanggung jawab pemenuhan kebutuhan darah untuk transfusi di rumah sakit sebagai bagian dari pelayanan rumah sakit secara keseluruhan.
Mutu pelayanan darah di rumah sakit sangat penting.
OUTPUTOUTPUTINPUTINPUT
Struktur dibuat sehingga akan dapat menerapkan sistem mutu dengan efektif.
“Quality consciousness” dalam organisasi diusahakan untuk terwujud.
Quality is everybody’s responsibility, quality starts with me.
Tempat kerja harus aman dan sehat untuk pegawai maupun donor, pasien / keluarga dan lainnya.
Area kerja harus cukup luas, ventilasi baik, suhu dapat terkontrol, bebas suara bising.
Fasilitas keamanan umum mis. listrik, pemadam kebakaran, dan kemungkinan terjadinya bencana harus dipertimbangkan.
Pemeliharaan, perawatan dan kalibrasi dilakukan secara reguler dan tercatat.
Sebelum digunakan secara rutin, reagen harus dievaluasi sehingga dengan kondisi yang ada dapat berfungsi optimal.
Semua prosedur dibuat dalam SOP untuk menghindari error.
SOP dilakukan review secara reguler dan diupayakan selalu up to date.
Dokumentasi/pencatatan yang komplit dalam setiap step memungkinkan dilakukan penelusuran di waktu mendatang.
“If it isn’t written down, it didn’t happen !!”
▪ Tujuan: memastikan bahwa transfusi darah atau komponen darah dilakukan secara aman dan efektif.
▪ Dirancang guna menjamin suplai darah dengan efikasi maksimal dan risiko minimal bagi pasien dan donor.
▪ Meliputi: edukasi, identifikasi, skrining dan seleksi donor; pengambilan darah; preparasi komponen; pemeriksaan lab; penyimpanan, transportasi, identifikasi pasien serta dokumentasi.
QA terkait dengan pemeliharaan sistem untuk memastikan bahwa performance keseluruhan merupakan kualitas yang dikehendaki, dan untuk mendeteksi kecenderungan perubahan kualitas produk / service.
QC merupakan procedur yang dilakukan bersamaan dengan tes/ pemeriksaan untuk memberikan informasi bahwa hasil tes bersifat valid.
ISO Akreditasi Lainnya
Sistem kualitas harus dievaluasi secara reguler.
Pengembangan secara kontinyu merupakan salah satu tujuan utama sistem kualitas.
HO is a quality tool for continous improvement of quality and safety in blood transfusion
Dilakukan dengan:•Review managemen.•Audit : Internal & Eksternal.
QC dilakukan untuk menjamin efikasi dan keamanan produk darah.
Contoh : QC whole blood dan trombosit.
(Recommendation No R(95) 15 ) Council of Europe Publising 13th ed. 2007 http://book.coe.int
Platelet concentrates Platelet concentrates minimal QC minimal QC
Volume : all units Platelet count : 40 - 50% or allLeukocyte count : 1 - 2%Red cells : 1 - 2%Swirling effect : all units At issue : presentpH (outdated) : 5%Bacterial screening : all units At issue : negative
Council of Europe GuideSanquin Blood Bank North-West
Variables affecting platelet Variables affecting platelet quality: storage quality: storage
Storage bag◦ Material :◦ Size :
Storage medium◦ Plasma :◦ PAS/plasma
Volume ◦ Single unit :◦ Pool or apheresis :
Recommendation
gas permeable foiladapted to volume
minimum 30% plasma
35 - 70 mL150 - 400 mL
Platelet concentration◦ Plasma :◦ PAS/plasma :
Residual leukocytes : Residual red cells : Agitation : Temperature :
Recommendation
0.8 - 1.4 x 109/mL0.8 - 1.1 x 109/mL< 1 x 106
not visibly redhorizontal 20 - 24°C
Variables affecting platelet Variables affecting platelet quality: storage quality: storage
Right test, right sample, right results.
Error dapat disebabkan karena kesalahan teknis serologi atau karena proedur yang in-adekuat sehingga menyebabkan kesalahan identifikasi sampel, kesalahan transkripsi, mis-interpretasi.
Penggunaan SPOTraining stafPenilaian periodik kompetensi
stafDokumentasi dan validasi teknikValidasi reagen dan alatValidasi prosedur
Validation: Red cells reagents
Appearance No hemolysis or turbidity in the supernatant by
visual inspection
Each lot
Reactivity and specificity
Clear-cut reaction with selected reagents against
declared RBC antigens
Each lot
Validation: ABO-typing reagentsAppeearance No precipitate, particles or gel-formation by visual
inspectionEach
new lotReactivity and
specificityNo immune hemolysis, rouleaux formation or prozone
phenomenon.Clear-cut reactions with RBC bearing the weakened expression of the corresponding antigen(s), no false
reaction.
Each new lot
Potency Undiluted reagent should give a 3 to 4 plus reaction in saline tube test using a 3% RBC suspension at room
temperature.For polyclonal reagents, titres should be of 128 for anti-A, anti-B and anti-AB with A and B cells, 64 with A2 and
A2B cells.
Each new lot
Validation: Rh-typing reagentsAppeearance No precipitate, particles or gel-formation by visual
inspectionEach
new lot
Reactivity and specificity
As for ABO-typing reagents Each new lot
Potency Undiluted serum to give a 3 to 4 plus reaction in the designated test for each serum and a titre of 32 for anti-D and of 16 for anti-C, anti-E, anti-c, anti-e and anti-CDE
using appropiate Heterozygous red blood cells
Each new lot
Validation: Antiglobulin serum
Appearance No precipitate, particles or gel-formation by visual inspection
Each lot
Reactivity and specificity
No hemolytic activity; no agglutination of RBC of any ABO group after incubation with compatible serum.
Agglutination of RBC sensitized with anti-D serum containing not more than 10 nanograms/mL antibody
activity ( 0.05 IU/mL antibody activity).
Agglutination of RBC sensitized with a complement-binding alloantibody (eg anti-Jka) to a higher titre in the
presence than in the absence of complement or agglutination of RBC coated with C3b and C3d.
Each lot
Each lot
Each newlot
Pemantapan Mutu InternalPenggolongan Darah
1) ABO-grouping Test twice in using two different reagents. Use of two different reagents: monoclonal anti-A and anti-B from different clones; human antisera anti-A, anti-B and anti A,B from different batch
One blood sample of each of the following types: O, A, B
Each test series or at least once a day provided the same reagents are used throughout
2) ABO reverse- groping
Use of A and B cells Each test series or at least once a day provided the same reagents are used throughout
Pemantapan Mutu InternalPenggolongan Darah
3) RhD - grouping
Testing twice in using two anti-D reagents
from different clones or batchs; use of the indirect anti-globulin
test for weak D. it must be ascertained
that the system recognises the most important D variants (notably D variants category VI) as RhD
positive.
One RhD-pos, one RhD-neg sample
Each test series or at least once a day provided the same reagents are used
throughout
Pemantapan Mutu InternalPenggolongan Darah
4) Rh and other blood
group system phenotyping
Use spesific reagents
Positive control: RBC with tested antigen in single
dose.Negative control:
RBC without tested antigen.
Monoclonal antibodies and human antisera
once a day
5) Antiglobulin testing tube technique
Washing the cells at least 3 times before antiglobulin is added
Addition of sensitized blood cells to negative
test
Each negative test
Pemantapan Mutu InternalPenggolongan Darah
6) Testing for irregular
alloantibodies
Use at least the indirect antiglobulin
test manual or automated testing
with equivalent sensitivity and
homozygous RBC for the main clinically
important antigens
Serum samples with known RBC-
alloantibodies
Occasional input by the supervisor of the laboratory and participation
in external proficiency testing
exercises
7)Compatibility testing
Use at least the indirect antiglobulin
test manual or automated testing
with equivalent sensitivity
Serum samples with known RBC-
alloantibodies
Occasional input by the supervisor of the laboratory and participation
in external proficiency testing
exercises
Pemantapan Mutu InternalPenggolongan Darah
8) Type and Screen
Typing as 1,2,3,4With at least
antiglobulin test, against a panel of
cells chosen to provide
homozygosity for important antigens
Serum samples with known RBC-
alloantibodies
Each test series but at least daily
Sampel darah “NORMAL” dan”PROBLEM” didistribusikan oleh laboratorium rujukan kepada peserta paling tidak 2 kali setahun.
Pemeriksaan yang dilakukan adalah Compatibility Testing (penggolongan darah ABO, Rh-typing dan phenotyping, deteksi alloantibodi).
Berisi 4-6 sampel meliputi kompatibel maupun inkompatibel.