Laboratuvarımızda çalışılan kalsiyum metabolizma testlerinin analitik performansının altı sigma medodu kullanılarak değerlendirilmesi ve ölçüm belirsizliklerinin saptanması
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Dosyalar
Tarih
2021
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Yayıncı
Trakya Üniversitesi Tıp Fakültesi
Erişim Hakkı
info:eu-repo/semantics/openAccess
Özet
Tıbbi laboratuvarlar verdikleri test sonuçlarıyla bir hastalığa tanı koyma, prognozunu belirleme, tedaviyi yönetmekte doktorlara dolayısıyla da hastalara yardımcı olur. Laboratuvarlarda bu önemin farkında olarak en güvenilir ve en doğru test sonuçlarını vermeye çalışırlar. Bu yüzden klinik laboratuvarlar performanslarını sürekli olarak değerlendirmelidirler. Bu çalışmada analitik kalite performansının değerlendirilmesi için kalsiyum metabolizma testlerinin (kalsiyum, fosfor, magnezyum, parathormon ve 25(OH) Vitamin D) ölçüm belirsizliği ve sigma skorlarının hesaplanması amaçlandı. Ölçüm belirsizliğini NORDTEST klavuzuna göre ?yukardan aşağı? yaklaşım modelini baz alarak hesaplandı. Sonuçlar CLIA (Clinical Laboratory Improvement Amendments) ve RCPA (The Royal Collage of Pathologists of Australasia) total izin verilebilir hata limitleri üzerinden karşılaştırıldı. CLIA’a göre fosfor testi hariç diğer testlerimiz hedef limitlerini aşmamıştır. RCPA’a göre sadece magnezyum testimizin düşük seviyesi hedef limitinin altında olup geriye kalan bütün testlerimizin hedef limitlerini aştığı saptandı. Testlerimizin analitik süreç sigma seviyelerini hesaplarken CLIA ve RCPA total izin verilebilir hata limitleri kullanıldı. CLIA hedef limitlerine göre fosfor testinin ikinci analizör ikinci seviye performansı hariç, diğer tüm test performansları 2 sigma değerinin üzerinde bulundu. RCPA hedef limitlerine göre magnezyum testinin ikinci analizör birinci seviyedeki performansı hariç, diğer tüm test performansları 2 sigma değerinin altında bulundu. Kalsiyum metabolizma testlerinin analitik performanslarını altı sigma metodolojisiyle değerlendirilmesi bu testlerin performansına uygun kontrol kurallarının ve kontrol sıklığının belirlenmesinde yardımcı olacaktır. Bu da hatalı kontrol reddini engelleyip hem mali hem de zaman açısından tasarruf sağlayacaktır. Aynı zamanda bu testlerin ölçüm belirsizlik değerlerini belirlemek ve gerektiğinde bunu sonuç raporuna ekleyerek hekimin bilgisine sunmak, test sonuçlarını daha kullanılabilir ve değerli bir hale getirecektir. Sonuç olarak laboratuvara duyulan güven artacaktır.
Medical laboratories help doctors in making the diagnosis, determining the prognosis, leading the treatment strategies with the results they produce as well as the patients. Being aware of this importance in laboratories, they try to give the most reliable and accurate test results. Therefore, the clinical laboratories must continuously evaluate their performance. In this study, it was aimed to calculate the measurement uncertainty and sigma scores of calcium metabolism tests (calcium, phosphorus, magnesium, parathormone and 25 (OH) Vitamin D) to evaluate the analytical quality performance. Measurement of uncertainty was calculated based on the ?top-down? approach model according to NORDTEST guidelines. The results were compared over CLIA (Clinical Laboratory Improvement Amendments) and RCPA (The Royal Collage of Pathologists of Australasia) total allowable error limits. Except for the phosphorus test, our other tests did not exceed the target limits, according to CLIA. According to RCPA, only the low level of our magnesium test was below the target limit. It was determined that all of our remaining tests exceeded the target limits. CLIA and RCPA total allowable error limits were used while calculating the analytical process sigma levels of our tests. Except for the second analyser and second level performance of the phosphorus test according to CLIA target limits, all other test performances were above two sigma. According to the RCPA target limits, except for the second analyser and first level performance of the magnesium test, all other test performances were below two sigma. Evaluating the analytical performance of calcium metabolism tests with the six sigma methodology will help to determine the appropriate performance control rules and control frequency of these tests. This will prevent false control rejection and save both money and time. At the same time, determining the measurement uncertainty values of these tests, adding of them to the result report whenever it necessary, and presenting it to the physician's information will make the test results more usable and valuable. As a result, confidence for the laboratory will also be increased.
Medical laboratories help doctors in making the diagnosis, determining the prognosis, leading the treatment strategies with the results they produce as well as the patients. Being aware of this importance in laboratories, they try to give the most reliable and accurate test results. Therefore, the clinical laboratories must continuously evaluate their performance. In this study, it was aimed to calculate the measurement uncertainty and sigma scores of calcium metabolism tests (calcium, phosphorus, magnesium, parathormone and 25 (OH) Vitamin D) to evaluate the analytical quality performance. Measurement of uncertainty was calculated based on the ?top-down? approach model according to NORDTEST guidelines. The results were compared over CLIA (Clinical Laboratory Improvement Amendments) and RCPA (The Royal Collage of Pathologists of Australasia) total allowable error limits. Except for the phosphorus test, our other tests did not exceed the target limits, according to CLIA. According to RCPA, only the low level of our magnesium test was below the target limit. It was determined that all of our remaining tests exceeded the target limits. CLIA and RCPA total allowable error limits were used while calculating the analytical process sigma levels of our tests. Except for the second analyser and second level performance of the phosphorus test according to CLIA target limits, all other test performances were above two sigma. According to the RCPA target limits, except for the second analyser and first level performance of the magnesium test, all other test performances were below two sigma. Evaluating the analytical performance of calcium metabolism tests with the six sigma methodology will help to determine the appropriate performance control rules and control frequency of these tests. This will prevent false control rejection and save both money and time. At the same time, determining the measurement uncertainty values of these tests, adding of them to the result report whenever it necessary, and presenting it to the physician's information will make the test results more usable and valuable. As a result, confidence for the laboratory will also be increased.
Açıklama
Anahtar Kelimeler
Ölçüm belirsizliği, Nordtest, Altı sigma, Analitik performans değerlendirmesi, Measurement uncertainty, Nordtest, Six sigma, Analytical performance evaluation
