Strategi Operasional BDRS

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


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


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


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


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


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


alloantibodies

Occasional input by the supervisor of the laboratory and participation

in external proficiency testing

exercises


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


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.

Strategi Operasional BDRS

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