KORELASI. Standard Technical Manual. Rekod Pindaan / Semakan. Pindaan 1 : Pindaan pada pengenalan. Pindaan pada tatacara no
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1 Hospital Universiti Sains Malaysia KORELASI Disediakan oleh: Disemak oleh: Disahkan oleh: En. Mohd Iman Hafiz Ibrahim Date : 3/10/2016 Dr. Noor Suryani Mohd Ashari Date: 3/10/2016 Date: 3/10/2016 Rekod Pindaan / Semakan No Versi. Tarikh Pindaan Muka Surat Huraian Pindaan Disemak Oleh Disahkan Oleh / 6 5 / 6 Pindaan 1 : Pindaan pada pengenalan. Pindaan pada tatacara no 7.
2 Muka Surat 2 / 6 KORELASI ISI KANDUNGAN : 1. Pengenalan 2. Objektif 3. Skop 4. Tanggungjawab 5. Tatacara 6. Rujukan En. Mohd Iman Hafiz Ibrahim Tarikh Efektif
3 Muka Surat 3 / 6 Pindaan 1 1. Pengenalan Ujian kolerasi perlu dilakukan setiap 2 tahun sekiranya menggunakan dua atau lebih alatan penganalisa untuk ujian yang sama. Ujian kolerasi juga perlu dijalankan sekiranya: 1. Menggunakan alatan penganalisa baru atau kaedah ujian yang baru. 2. Sekiranya terdapat perubahan atau pembaikian yang besar terhadap alatan penganalisa yang sedia ada. Beberapa faktor yang perlu diambil kira adalah: 1. Bilangan sampel: Minima 20 sampel diperlukan. Paras sampel yang digunakan perlu merangkumi julat rujukan yang penting untuk diagnosis klinikal. 2. Sampel: Material yang boleh digunakan: larutan standard, sampel kawalan mutu, atau sampel pesakit. 3. Masa penganalisaan: Minima lima hari diperuntukan untuk ujian ini. 4. Sampel perlu dianalisa dalam masa kurang dari dua jam di antara dua alatan penganalisa. En. Mohd Iman Hafiz Ibrahim Tarikh Efektif
4 Muka Surat 4 / 6 2. Objektif Untuk mengesahkan prestasi ujian seperti yang dinyatakan oleh pengeluar dan memastikan kaedah dan alatan penganalisaan yang digunakan mempunyai keupayaan untuk mencapai piawaian yang ditetapkan. 3. Skop Untuk diguna pakai bagi semua analit yang termasuk dalam skop akreditasi di Makmal Imunologi. 4. Tanggungjawab 4.1 Pengarah makmal 4.2 Pakar Imunologi 4.3 Pegawai Sains 4.4 Semua staf makmal En. Mohd Iman Hafiz Ibrahim Tarikh Efektif
5 Muka Surat 5 / 6 Pindaan 1 5. Tatacara 1. Kenal pasti 20 sampel yang sesuai merangkumi keseluruhan julat klinikal. 2. Paras sampel yang digunakan perlu merangkumi keseluruhan julat klinikal. 3. Analisa sampel dilakukan dalam masa melebihi lima hari 4. Analisa sampel bagi kedua-dua instrumen dilakukan dalam masa kurang dari dua jam. 5. Buang data bagi kedua-dua instrumen sekiranya terdapat outlier* 6. Sekiranya terdapat outlier, kenal pasti kemungkinan ralat yang berlaku dan troubleshooting perlu dijalankan. Analisa sampel tersebut perlu dilakukan semula bagi kedua alatan penganalisa. 7. Masukkan data dalam excel / SPSS / program lain yang setara dengannya dan analisa menggunakan kaedah korelasi. 8. Nilai r yang disasarkan ialah Sekiranya nilai r kurang daripada 0.90, ulang ujian dengan sampel tambahan. *Outlier salah satu atau kedua nilai tersasar jauh dari nilai sebenar atau kedua- dua instrumen memberikan nilai yang jauh berbeza. r - Korelasi En. Mohd Iman Hafiz Ibrahim Tarikh Efektif
6 Muka Surat 6 / 6 6. Rujukan 6.1 MS ISO 15189:2014, Medical Requirements for Quality and Competence (second revision) 6.2 JAMES O. Westgard (2008). Basic Method Validation, 3 rd Edition En. Mohd Iman Hafiz Ibrahim Tarikh Efektif
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