Faktor-faktor yang Mempengaruhi Hasil Pemantapan Mutu Eksternal pemeriksaan Glukosa, Kolesterol dan Trigliserida Laboratorium Klinik Mandiri di Indonesia Tahun 2011

Abstract

Abstract
The results of the National Program on External Quality Control (EQC) for clinical chemistry were
collected from Independent Clinical Laboratories (ICL) in Riset Fasilitas Kesehatan Laboratorium Klinik
Mandiri (Risfaskes - Health Facility Reseach on Independent Clinical Laboratories) 2011 carried out by the
National Institute of Health Research and Development Ministry of Health. To reveal the factors affecting the
EQC results of glucose, cholesterol and triglyceride measurements which become more increasing demands in
the epidemiologic transition era, an indepth analysis was done on a subset of Rifaskes data.There were 782 ICL
throughout Indonesia that met the inclusion criteria of Rifaskes, while ICL who participated in EQC for glucose,
cholesterol and triglyceride were 421 (53.8%), 411 (52.6%) dan 402 (51.4%) respectively. For each analyte,
very good results were 23.8%, 24.1% dan 21.9%, and good results were 62.2%, 61.8% dan 61.7%. Furthermore
the estimatedaverage percentages of the accuracies were 77.6%, 77.7% dan 76.6% subsequently, and the
estimated average percentages of errors were 22.4%, 22.3% and 23.4% accordingly. The factors that had
moderate and slightly weak association with EQC for glucose measurements were Internal Quality Control
(IQC) evaluation (Somers’d 0.346), air conditioning in the measurement room (Somers’d 0.232), refrigerator
maintenance (Somers’d 0.224), refrigerator temperature record (Somers’d 0.259), calibration of micropipette 10
uL (Somers’d 0.249), calibration of micropipette 1000 uL (Somers’d 0.263), manual of micropipette 10 uL
(Somers’d 0.209), working room temperature record (Somers’d 0.269), participating regularly in EQC
(Somers’d 0.246), EQC evaluation (Somers’d 0.296) dan internal audit (Somers’d 0.227). The factors that had
slightly weak association with EQC for cholesterol measurements were IQC evaluation (Somers’d 0.288),
refrigerator maintenance (Somers’d 0.231), calibration of micropipette 10 uL (Somers’d 0.261), calibration of
micropipette 1000 uL (Somers’d 0.274), reagent room (Somers’d 0.212), participating regularly in EQC
(Somers’d 0.224), EQC evaluation (Somers’d 0.242), internal audit (Somers’d 0.279) and EQC audit (Somers’d
0.287). The factors that had moderate and slightly weak association with EQC for triglyceride measurements
were calibration of micropipette 1000 uL (Somers’d 0.302), IQC evaluation (Somers’d 0.295), refrigerator
(Somers’d 0.200), refrigerator maintenance (Somers’d 0.201), calibration of micropipette 10 uL (Somers’d
0.264), MOU of laboratory supplies (Somers’d 0.201), EQC evaluation (Somers’d 0.249), participating
regularly in EQC (Somers’d 0.272), SOP for specimen (Somers’d 0.229), specimen evaluation (Somers’d
0.218), internal audit (Somers’d 0.253) and EQC audit (Somers’d 0.260). Other factors such as levels of ICL,
regional location, directors’ specialties, ownership, photometer or automatic instruments had weak or very weak
association with Somers’d < 0.200 on EQC results. In conclusion, the estimated average percentages of errors
for glucose and cholesterol still exceeded 10%, but for triglyceride was already slightly less than 25% of
Recommended Total Allowable Error Limits, while the main factors that affected the EQC results were audit,
calibration, temperature, IQM evaluation and regularly participating in EQC.

Key words : External Quality Control, clinical chemistry, affecting factors, Independent Clinical
Laboratories, Rifaskes

Abstrak
Hasil Program Nasional Pemantapan Mutu Eksternal (PME) kimia klinik telah dikumpulkan dari
Laboratorium Klinik Mandiri (LKM) dalam Riset Fasilitas Kesehatan Tahun 2011 yang dilaksanakan oleh
Badan Litbangkes Kemenkes RI. Untuk mengungkapkan faktor-faktor yang mempengaruhi hasil PME
pemeriksaan glukosa, kolesterol dan trigliserida yang makin menjadi kebutuhan umum dalam era transisi
epidemiologi ini, dilakukan analisis lanjut terhadap subset data Rifaskes. Ada 782 LKM di seluruh Indonesia
yang memenuhi kriteria inklusi Rifaskes, selanjutnya yang mengikuti PME pemeriksaan glukosa 421 (53,8%),
70 Jurnal Biotek Medisiana Indonesia . Vol.5.1.2016:69-84
kolesterol 411 (52,6%) dan trigliserida 402 (51,4%). Untuk masing-masing analit, hasil sangat baik 23,8%,
24,1% dan 21,9%, dan hasil baik 62,2%, 61,8% dan 61,7%. Kemudian persentase ketepatan rata-rata estimasi
berturut-turut adalah 77,6%, 77,7% dan 76,6%, sehingga persentase kesalahan rata-rata estimasi adalah 22,4%,
22,3% dan 23,4%. Faktor-faktor yang memiliki hubungan positif sedang dan agak lemah dengan hasil PME
pemeriksaan glukosa adalah evaluasi Pemantapan Mutu Internal (PMI) (Somers’d 0,346), AC ruang
pemeriksaan (Somers’d 0,232), pemeliharaan lemari es (Somers’d 0,224), pencatatan suhu lemari es (Somers’d
0,259), kalibrasi mikropipet 10 uL (Somers’d 0,249), kalibrasi mikropipet 1000 uL (Somers’d 0,263), petunjuk
mikropipet 10 uL (Somers’d 0,209), pencatatan suhu ruang kerja (Somers’d 0,269), rutin PME (Somers’d
0,246), evaluasi PME (Somers’d 0,296) dan audit internal (Somers’d 0,227). Faktor-faktor yang memiliki
hubungan positif agak lemah dengan hasil PME pemeriksaan kolesterol adalah evaluasi PMI kimia klinik
(Somers’d 0,288), pemeliharaan lemari es (Somers’d 0,231), kalibrasi mikropipet 10 uL (Somers’d 0,261),
kalibrasi mikropipet 1000 uL (Somers’d 0,274), gudang reagen (Somers’d 0,212), rutin PME (Somers’d 0,224),
evaluasi PME (Somers’d 0,242), audit internal (Somers’d 0,279) dan audit PME (Somers’d 0,287). Faktorfaktor
yang memiliki hubungan positif sedang dan agak lemah dengan hasil PME pemeriksaan trigliserida
adalah kalibrasi mikropipet 1000 uL (Somers’d 0,302), evaluasi PMI kimia klinik (Somers’d 0,295), lemari es
(Somers’d 0,200), pemeliharaan lemari es (Somers’d 0,201), kalibrasi mikropipet 10 uL (Somers’d 0,264),
MOU bahan habis pakai (Somers’d 0,201), evaluasi PME (Somers’d 0,249), rutin PME (Somers’d 0,272), SOP
spesimen (Somers’d 0,229), evaluasi spesimen (Somers’d 0,218), audit internal (Somers’d 0,253) dan audit
PME (Somers’d 0,260). Faktor-faktor lainnya seperti kelas LKM, wilayah lokasi, penanggung jawab dan
pemilik LKM, alat fotometer atau otomatik berpengaruh lemah atau sangat lemah dengan Somers’d < 0,200
terhadap hasil PME.Sebagai kesimpulan, persentase kesalahan rata-rata estimasi untuk glukosa dan kolesterol
masih melebihi 10%, namun untuk trigliserida sudah sedikit di bawah 25% dari Recommended Total Allowable
Error Limits, kemudian faktor-faktor utama yang berpengaruh positif terhadap hasil PME adalah audit,
kalibrasi, suhu, PMI evaluasi dan PME rutin.
Kata kunci : PME, kimia klinik, faktor yang mempengaruhi, LKM, Rifaskes