Current Challenges in

Haemostasis Laboratory

z
Mansyur Arif
Departemen Ilmu Patologi Klinik
Fakultas Kedokteran Universitas Hasanuddin
MaCPLAM, 12 Juli 2019
 Sumber: Riset Kesehatan Dasar 2018
Potret Kesehatan Indonesia 2018

The 5th Makassar Clinical Pathology and

Laboratory Medicine Annual Meeting
 Do we aware?

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Laboratory Medicine Annual Meeting
The 5th Makassar Clinical Pathology and
Laboratory Medicine Annual Meeting
 The balance of haemostasis

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 Hemostasis Components

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 Primary Haemostasis
Hemostasis Primer & Sekunder

Secondary Haemostasis

The 5th Makassar Clinical Pathology and

Laboratory Medicine Annual Meeting
 Current Medicinal Chemistry 12(4):397-417
Paradigma baru hemostasis

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MAIN ENDOGENOUS INHIBITORS OF BLOOD COAGULATION
AND FIBRINOLYSIS

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Laboratory Medicine Annual Meeting
G. Lippi, EJ. Favaloro. J Lab Precis Med 2018;3:67
 Pemeriksaan Hemostasis

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Algorithm to assist the diagnosis of Hemostasis Disorders

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G. Lippi, EJ. Favaloro. J Lab Precis Med 2018;3:67
Hierarchic classification of tests for the screening, diagnosis and
therapeutic monitoring of hemorrhagic and thrombotic disorders

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Laboratory Medicine Annual Meeting
G. Lippi, EJ. Favaloro. J Lab Precis Med 2018;3:67
Current Challenges in Hemostasis Test in Indonesia

Knowledge

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• Inadequate knowledge of hemostasis in health and disease

Laboratory Medicine Annual Meeting

• Heterogenicity of available guidelines for diagnosis and therapeutic

Standardization among laboratories

• Variation in pre-analytical, reference range, result interpretation

• External quality assurance

Limited available test

• Lack of advance diagnostic tools for specific diagnosis of hemostasis disorders
• Limited technology and human resources

Budget limitation in JKN Era

• Setback to unspecific test method (manual clotting time)
• Short reagents lifetime
Penyebab Tes Hemostasis Rendah

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 Laboratorium (SDM, Alat, Logistik)

Laboratory Medicine Annual Meeting

 External Lab (Jumlah tes yang kurang, JKN)
 Permintaan Pemeriksaan Hemostasis di
Lab RSUP Dr. Wahidin Sudirohusodo Makassar

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Laboratory Medicine Annual Meeting
Parameter Pemeriksaan
Jumlah test 2017 Jumlah test 2018
Hemostasis
PT 33.262 33.715
APTT 33.558 33.698
Fibrinogen 814 944
D - Dimer 1.747 1.989

Sebagian besar pemeriksaan Hemostasis umumnya ada di PT dan

APTT
 Permintaan Pemeriksaan Hemostasis di
Lab RSUP Dr. Wahidin Sudirohusodo Makassar

The 5th Makassar Clinical Pathology and

Laboratory Medicine Annual Meeting
33262 33715 33558 33698

814 944 1747 1989

PT APTT FIBRINOGEN D-DIMER

2017 2018
The 5th Makassar Clinical Pathology and
Laboratory Medicine Annual Meeting
Tuntutan dan Tantangan Kesehatan di Indonesia

The 5th Makassar Clinical Pathology and

Laboratory Medicine Annual Meeting
Adaptasi seringkali dilakukan dengan
menekan biaya
 penurunan kualitas
 Hubungan Faktor Kontribusi Terhadap Biaya Pemeriksaan Hemostasis

The 5th Makassar Clinical Pathology and

Pengulangan Analisa

Laboratory Medicine Annual Meeting

Reagen rusak Presisi akurasi sistem ↓↓
sebelum habis

Stabilitas reagen rendah

Penyimpanan tidak memadai Interferensi sampel
Kondisi Pre-
Volume terlalu besar alami
sampel analitik

Harga Beli Efisiensi

Kurang pemahaman ttg hemostasis Biaya ↓

Masih dgn metode lama

Sulit Pembatasan permintaan

mengubah
paradigma
Faktor lainnya Permintaan rendah
Bagaimana pengaruhnya terhadap

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Laboratory Medicine Annual Meeting
keputusan klinis & patient outcome

“~25% of Laboratory errors are affecting patient outcome.”

Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem 2007 Jul;53(7):1338-42.
 Apa yang dapat ditingkatkan oleh Lab dari kondisi yang ada?

The 5th Makassar Clinical Pathology and

Pengulangan Analisa

Laboratory Medicine Annual Meeting

Reagen rusak Presisi akurasi sistem ↓↓
sebelum habis

Stabilitas reagen rendah

Penyimpanan tidak memadai Interferensi sampel
Kondisi Pre-
Volume terlalu besar alami
sampel analitik

Harga Beli Efisiensi

Kurang pemahaman ttg hemostasis Biaya ↓

Masih dgn metode lama

Sulit Pembatasan permintaan

mengubah
paradigma
Faktor lainnya Permintaan rendah
 Algorithm to assist the diagnosis of Hemostasis Disorders

Pre-analitik Analitik Post-analitik

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Pre-analitik

Laboratory Medicine Annual Meeting

Carraro P, Plebani M.
Errors in a stat laboratory: types and frequencies 10 years later.
Clin Chem 2007 Jul;53(7):1338-42.

menyumbang 62% 15% 23%

> 60% kesalahan Goswami B1, Singh B, Chawla R, Mallika V.
Evaluation of errors in a clinical laboratory: a one-year experience.

pada pemeriksaan
Clin Chem Lab Med. 2010;48(1):63-6. doi: 10.1515/CCLM.2010.006.

77% 15% 8%
Hemostasis Plebani M
Errors in clinical laboratories or errors in laboratory medicine?
Clin Chem Lab Med. 2006;44(6):750-9.

46-68% 19-47%
Masalah pre-analitik hemostasis
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The 5th Makassar Clinical Pathology and

Plebani M.
Errors in clinical laboratories or errors in laboratory medicine.

Laboratory Medicine Annual Meeting

Clin Chem Lab Med 2006;44: 750-759

According to the College of American Pathology Q-probe survey, it

[hemolysis] occurs five-fold (54%) more frequently than insufficient
specimens (21%).

Lippi G, Plebani M, Favaloro E.

Interference in coagulation testing: Focus on Spurious Hemolysis, Icterus and Lipemia.
Semin Throm Hemost 2013;39:258-266

[…] In the coagulation laboratory, spurious hemolysis is by far the leading

source of interference in plasma samples (40%), prevailing over pre-analysis
clotting (29%), inappropriate filling of primary blood collection tubes (28%),
contamination from infusion routes (2%), lipemia and hyperbilirubinemia (both
approximately 1%) […]
 Dampak Kesalahan Pre-analitik
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Sampel Hemolisis Sampel Underfilled

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Sampel clotting

Laboratory Medicine Annual Meeting

TEST Effect TEST Effect Test Effect
PT ↑
PT ↑
PT ↓ APTT ↑↑
APTT ↑
FIBRINOGEN ↓
APTT ↓
Fibrinogen ↓↓↓ Factor VIII ↓
Factors ↓↑ D-dimer ↑ APCR ↑

E.J. Emmanuel, et al. Pre-analytical

S. Kitchen. Pre-analytical variables Lippi G , et al. Preanalytical quality
Variables in Coagulation Testing Associated
in haemostasis. Bad samples are bad improvement: in quality we trust.
With Diagnostic Errors in Hemostasis,
for patients. 2014 Clin Chem Lab Med 2013; 51(1): 229–241
LabMedicine. 2012:43, 1-10

“~25% of Laboratory errors are affecting

patient outcome.”
Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem 2007 Jul;53(7):1338-42.
 Apa yang dapat dilakukan untuk permintaan yang rendah?

The 5th Makassar Clinical Pathology and

Pengulangan Analisa

Laboratory Medicine Annual Meeting

Reagen rusak Presisi akurasi sistem ↓↓
sebelum habis

Stabilitas reagen rendah

Penyimpanan tidak memadai Interferensi sampel
Kondisi Pre-
Volume terlalu besar alami
sampel analitik

Harga Beli Efisiensi

Kurang pemahaman ttg hemostasis Biaya ↓

Masih dgn metode lama

Sulit Pembatasan permintaan

mengubah
paradigma
Faktor lainnya Permintaan rendah
Overcoming
z the Challenge

The 5th Makassar Clinical Pathology and

Standardization among laboratories

Laboratory Medicine Annual Meeting

• PDS PATKLIN initiated hemostasis guideline for national standard in hemostasis
laboratory practice

Limited available test

• Referral system to make advanced test within reach

Budget limitation in JKN Era

• Involvement of clinical pathologist in establishing clinical pathway and budget

allocation
TAKE HOME MESSAGE
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• Tes hemostasis di Indonesia masih relatif terbatas dan oleh karena itu peluang

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dikembangkan dengan membuat pusat-pusat rujukan

Laboratory Medicine Annual Meeting

• Berkembangnya ilmu pengetahuan dan konsep hemostasis yang dikenal dengan
paradigma baru dalam hemostasis memungkin pemeriksaan hemostasis yang lebih
tepat

• Optimalisasi pemeriksaan hemostasis perlu melibatkan manajemen dan klinisi

dengan tetap memperhatikan Kendali Mutu Kendali Biaya (KMKB)

• Paket Ina CBG TIDAK BISA MENJADI ALASAN untuk menurunkan mutu layanan

• Laboratorium / PDS Patklin berperan sentral dalam menjaga kualitas tes-tes

hemostasis
z

The 5th Makassar Clinical

Pathology and Laboratory
Medicine Annual Meeting