Dr. Joko Widodo, M.

Kes
PELAPORAN HASIL DIAGNOSTIK
LABORATORIUM YANG KRITIS

MUNAS PATELKI
Dr. JOKO WIDODO, M.Kes SURABAYA, 18 MEI 2017
 Outlines

• Pendahuluan
• Dasar Penetapan Kebijakan Nilai Kritis
• Prosedur Pelaporan Nilai Kritis
• Pengulangan Pemeriksaan Pada Nilai
Kritis
• Penilaian Pelaporan Nilai Kritis
• Ringkasan
 Definisi Nilai Kritis

“Hasil laboratorium yang menunjukkan

keadaan patofisiologis yang berbeda
dengan kondisi normal yang memiliki
risiko terhadap kehidupan pasien kecuali
jika segera diambil tindakan.”

Lundberg GD, Med Lab Obs,1972;4:47-54

 NOTIFICATION OF CRITICAL LABORATORY RESULT

• An important aspect of patient safety.

• Failure to report critical lab results in a timely
and reliable way is a threat to patient safety
and healthcare quality.
• For Accreditation purpose, all Labs must have
a list of critical limits, formulate notification
procedures, document critical results and
notify clinicians immediately.

Piva E, Sciacovelli L et al ,Am J Clin Pathol. 2009; 131: 432-41

 Outlines

• Pendahuluan
• Dasar Penetapan Kebijakan Nilai Kritis
• Prosedur Pelaporan Nilai Kritis
• Pengulangan Pemeriksaan Pada Nilai
Kritis
• Penilaian Pelaporan Nilai Kritis
• Ringkasan
 U.S Regulatory (Examples)
• CLIA ’88
Written procedure or critical value result reporting
• The Joint Commission National Patient Safety Goals
Documention and Read Back
Define Critical Value
• CAP Checklist
Procedure, Documentation, read back, turn
around time
 Indonesia Regulatory

Tidak ada daftar standar nilai kritis dalam literatur medis,

institusi lab wajib menyusun daftar nilai kritis pemeriksaan
masing-masing.
Permenkes Rl No 1691/Menkes/Per/VIII/2011 ttg Keselamatan Pasien Rumah
 Outlines

• Pendahuluan
• Dasar Penetapan Kebijakan Nilai Kritis
• Prosedur Pelaporan Nilai Kritis
• Pengulangan Pemeriksaan Pada Nilai
Kritis
• Penilaian Pelaporan Nilai Kritis
• Ringkasan
 Prosedur Pelaporan Nilai Kritis

• Menetapkan daftar nilai kritis yang

harus dilaporkan
• Mekanisme komunikasi nilai kritis
• Penetapan waktu pelaporan (TAT) nilai
kritis
• Dokumentasi

Howanitz PJ, Steindel SJ, Heard NV. Laboratory critical values policies and procedures: a College of
American Pathologists Q-Probes Study in 623 institutions. Arch Pathol Lab Med. 2002
 Proses Penetapan Kebijakan Nilai Kritis

• Bagaimana seharusnya laboratorium

menetapkan tes mana yang harus dimasukkan
dalam daftar nilai kritis?
• Bagaimana menentukan batasan nilai kritis yang
harus ditetapkan?

Tanggung jawab pimpinan laboratorium, harus

dilakukan komunikasi dan koordinasi dengan
dokter pengguna layanan laboratorium, dan
dewan peninjau medis dari institusi tersebut
Howanitz JH,et al, Arch Pathol Lab Med. 2002
Proses Penetapan Kebijakan Nilai Kritis

Howanitz JH,et al, Arch Pathol Lab Med. 2002

https://www.aruplab.com/testing/critical-values
Contoh Penentuan Batasan Nilai Kritis

Howanitz JH,et al, Arch Pathol Lab Med. 2002

Of the 111,545 sodium results occurring during the study, 615 (0.6%) were
critical. By using criteria of 120 mEq/L (120 mmol/L) or less and 155
mEq/L (155 mmol/L) or more, we found 166 critically low results
and 447 critically high results.

Howanitz JH,et al, Am J Clin Pathol. 2007

Howanitz JH,et al, Am J Clin Pathol. 2007
 Critical values
in Hematology

McFarlane A,et al. Critical values in Hematology.2014

Critical values in Microbiology

Howanitz JH,et al, Arch Pathol Lab Med. 2002

LABORATORY PROCEDURE FOR NOTIFICATION and COMMUNICATION
OF CRITICAL RESULTS
MLT
Results entered into VALIDATE CRITICAL
RESULT
LIS
CHECK RESULT
CHECK SAMPLE
ANY CRITICAL CHECK QC
LIMIT? VERIFY CRITICAL
RESULT

LAB TEST
ORDERS

REFER CRITICAL DOCUMENTATION

VALUE LIST THE NOTIFICATION
AND RELEVANT
MLT atttempt to INFORMATION INTO
contact doctor RECORD BOOK
VERIFY THE OR LIS
RESULT
RECORD:
WHAT TO PHONE
CHECK FOR INFORMER
INFORM? ELECTRONIC
PRE-ANALYTICAL, SMS
NAME &
ANALYTICAL & POST MANUAL DISPATCH DESIGNATION
REPEAT ANALYTICAL FACTORS PATIENT ID
OR & NAME
INFORMER NAME
NO? CHECK RECORD FROM TEST NAME &
DESIGNATION
RECORD BOOK/LIS PATIENT ID &LOCATION RESULT
TEST NAME&RESULT INFORM RESULT AND SAMPLE
SAMPLE DATE &TIME ASK FOR READ BACK DATE & TIME
RECIPIENT
NAME
Adapted from : Howanitz PJ et al,Laboratory critical values policies and procedures, 2002
 Turn Around Time of Critical Value

Intervals between development and correction of a critical abnormality.

Median
Time
? 48 7 1.8h 12h
Valenstein et al , Notification of Critical Results, Arch Pathol Lab Med,2008
Kuperman GJ, et al. How promptly are inpatients treated for critical laboratory results? J Am Med Inform Assoc
The Process of Reporting a Critical Value

Wagar EA, et al. Arch Pathol Lab Med. 2007

DOCUMENTATION
NOTIFICATION VIA TELEPHONE
• Informer name and
designation
• Confirm patient location
• Patient ID : name, MRN
• Sample date & time
• Test name & result
• Result read back by
recipient
• Document recipient
name & designation
• Document date & time
of notification

Hanna Doris et al,Vol 31 No 2,2005

FAIL SAFE PLAN NOTIFICATION

Hanna Doris et al,Vol 31 No 2,2005

 FORM REPORT CLR (Critical Laboratory Result)
Identitas Pasien PROSES LABORATORIUM
Tgl/jam terima spesimen :
Nama : Tgl/jam selesai pemeriksaan :
No. Id : Validasi hasil
No. Lab : jam :
Tgl Periksa : petugas :
Jenis Pemeriksaan : Jam Informasi Nilai Kritis :

HASIL LABORATORIUM

1. Pemeriksaan :
Hasil :
2. Pemeriksaan :
Hasil :
3. Pemeriksaan :
Hasil :
PENERIMA INFORMASI DAN HASIL NILAI KRITIS

1. Petugas penerima informasi via telephon :

2. Petugas penerima salinan hardcopy hasil nilai kritis :
3. Tanggal dan jam penerimaan informasi :

Tandatangan TLM yang bertugas :

(………………………………)
 Outlines

• Pendahuluan
• Dasar Penetapan Kebijakan Nilai Kritis
• Prosedur Pelaporan Nilai Kritis
• Pengulangan Pemeriksaan Pada Nilai
Kritis
• Penilaian Pelaporan Nilai Kritis
• Ringkasan
 REPEAT CRITICAL VALUE
• Another common problem in critical value
reporting is how a laboratory should handle
repeat critical values
• Approximately 70% of surveyed laboratories
have a policy on repeat critical values.
• For those that do not, one is strongly
recommended because it will clarify laboratory
technologist responsibility and establish
consistency in performance.

Genzen JR,et al. Pathology Consultation on Reporting of Critical Values. Am J Clin Pathol. 2011
REASONS FOR REPETATIONS :
OVER THE RANGE
QC not within acceptable limit
Critical Values (CV)
Early Notification (EN)

• The results
showed 97.6%
agreement
between initial
and repeat values
• Only 14 values
out of 580 fell
outside
recommended
limit.

Chima HS,et al. Is it Necessary to Repeat Critical Values in the Laboratory? Lab Med. 2009
Conclusion
• It was clear that modern analyzers are precise and repeating critical

values did not yield better accuracy

• This change has improved our laboratory’s efficiency and TAT in critical

cases and improved our patient care

Chima HS,et al. Is it Necessary to Repeat Critical Values in the Laboratory? Lab Med. 2009
 ORIGINAL ARTICLES
Does Routine Repeat Testing of Critical Values Offer Any Advantage
Over Single Testing?
Adam D. Toll, MD; Jennifer M. Liu, MD; Gene Gulati, PhD; Eric M. Behling, MD; William D. Kocher, MD

Conclusion : Routine repeated testing of critical

values does not offer better accuracy
and, hence,is unnecessary.
Adam D Toll,et al, Am J Clin Pathol. 2011
 Outlines

• Pendahuluan
• Dasar Penetapan Kebijakan Nilai Kritis
• Prosedur Pelaporan Nilai Kritis
• Pengulangan Pemeriksaan Pada Nilai
Kritis
• Penilaian Pelaporan Nilai Kritis
• Kesimpulan
REPORTING ASSESSMENT CRITICAL VALUE

• Laboratories are responsible for reporting CLR to

healthcare providers, as well as monitoring and
improving the time of reporting and receiving critical
values.
• Quality indicator in the critical value policy is the
response time, defined as the time elapsed from when
the laboratory first knew the critical result to the time
when caregiver accepted the result .

Valenstein et al , Notification of Critical Results, Arch Pathol Lab Med,2008

Quality Indicator of Critical Value

Valenstein et al , Notification of Critical Results, Arch Pathol Lab Med,2008

Greatest Obstacle Faced by Laboratory

Anand S. Dighe et al, 2008

Bagaimana dengan notifikasi otomatis?

CRITICAL TEST RESULTS MANAGEMENT (CTRM)

physician
orders lab tests

Lian Kah Ti et al,BMJ Qual Saf,2012

Lian Kah Ti et al,BMJ Qual Saf,2012
THE CHALLENGE:
TIME TO DELIVER CRITICAL LAB RESULTS

Results entered into LIS

physician physician
orders lab tests accepted lab
tests
REFER CRITICAL MLT attempt to
VALUE LIST contact Dr.

TIME TO COMPLETE THE 20 MINUTES

START PROCESS:

Lian Kah Ti et al,BMJ Qual Saf,2012

THE CHALLENGE:
SPEEDING CRITICAL LAB RESULTS WITH
CTRM (CRITICAL TEST RESULTS MANAGEMENT)
Results entered into LIS
• Results sent directly
to physician's device
• Alert message is
transmitted securely

• Results can be sent

physician to multiple devices
orders lab tests and multiple
caregivers
(CTRM)
REFER CRITICAL • Alert will escalate in
VALUE LIST 15, 30, 60 min if the
loop is not closed
• Escalation period can
be configured by the
Electronic Medical Record(EMR)
hospital

TIME TO COMPLETE THE 3 MINUTES

STAR PROCESS:
T
Lian Kah Ti et al,BMJ Qual Saf,2012
 Outlines

• Pendahuluan
• Dasar Penetapan Kebijakan Nilai Kritis
• Prosedur Pelaporan Nilai Kritis
• Pengulangan Pemeriksaan Pada Nilai
Kritis
• Penilaian Pelaporan Nilai Kritis
• Ringkasan
 QUICK GUIDE

LABORATORIUM
TLM

IDENTIFIKASI VALIDASI SEGERA DOKUMENTASIKAN

HASIL HASIL LAPORKAN PELAPORAN
NILAI KRITIS NILAI KRITIS NILAI KRITIS NILAI KRITIS

KONFIRMASI HASIL NILAI

KRITIS
CHECK HASIL
CHECK SAMPEL
CHECK QC
 KESIMPULAN

• Penetapan kebijakan pelaporan nilai kritis yang efektif

menjadi dasar untuk perawatan dan keselamatan pasien.
• Perlunya komunikasi yang efektif mulai tingkat
laboratorium sampai klinisi yang bertanggungjawab
menangani pasien.
• Indikator keberhasilan adalah jumlah dan waktu respon
mulai teridentifikasinya nilai kritis sampai informasi kepada
dokter yang merawat atau tim yang bertanggung jawab
untuk mengambil tindakan untuk pasien.
• Berkembangnya metode pelaporan berbasis komputerisasi,
prosedur komunikasi baru akan muncul dan waktu
pelaporan nilai kritis akan menjadi lebih cepat dan akurat.
 TERIMA KASIH
SEMOGA BERMANFAAT
DAFTAR PUSTAKA
1.Genzen JR, Tormey CA. Pathology Consultation on Reporting of Critical Values. Am J Clin Pathol. 2011 Apr.1;135(4):505–13.
2.Lippi G, Giavarina D, Montagnana M, Luca Salvagno G, Cappelletti P, Plebani M, et al. National survey on critical values reporting in a cohort
of Italian laboratories. Clinical Chemical Laboratory Medicine. 45(10).
3.Lundberg GD. When to panic over abnormal values. MLO Med Lab Obs 1972;4:47–54
4.Howanitz PJ, Steindel SJ, Heard NV. Laboratory critical values policies and procedures: a College of American Pathologists Q-Probes Study
in 623 institutions. Arch Pathol Lab Med. 2002; 126: 663-9
5.International Organization for Standardization. ISO 15189:2007: medical laboratories: particular requirements for quality and competence
[items 5.5.3; 5.8.7, and 5.8.8] [Internet]. Available at: www.iso.org
6.The Joint Commission Accreditation Program. Laboratory, national patient safety goals (NPSG.02.03.01) [Internet]. Available at: http://www.
jointcommission.org/
7.College of American Pathologists. Laboratory general checklist [components GEN.41320, GEN.41330, and GEN.41340] [Internet]. Available
at: www.cap.org
8.Permenkes Nomor 1691/MENKES/PER/VIII/2011 tentang Keselamatan Pasien Rumah Sakit
9.Doering TA, Plapp F, Crawford JM. Establishing an Evidence Base for Critical Laboratory Value Thresholds. Am J Clin Pathol. 2014
Oct.15;142(5):617–28.
10. Mayo Foundation for Medical Education and Research. DLMP critical values/critical results list [Internet]. Available at: http://www.
mayomedicallaboratories.com/articles/criticalvalues/view.php?name=Critical+Values%2FCritical+Results+List.
11.Icahn School of Medicine at Mount Sinai. Critical value notification list [Internet]. Available at: http://icahn.mssm.edu/static_files/
MSSM/Files/Research/Labs/Clinical%20Pathology%20Laboratory/ CriticalValuesTable.pdf
12. Wagar EA, Stankovic AK, Wilkinson DS, Walsh M, Souers RJ. Assessment monitoring of laboratory critical values: a College of American
Pathologists Q-Tracks Study of 180 institutions. Arch Pathol Lab Med. 2007; 131: 44-9
13. Liebow EB, Derzon JH, Fontanesi J, Favoretto AM, Baetz RA, Shaw C, et al. Effectiveness of automated notification and customer service
call centers for timely and accurate reporting of critical values: A laboratory medicine best practices systematic review and meta-analysis.
Clinical Biochemistry. 2012 Sep.;45(13-14):979–87.
14. Piva E, Plebani M. Interpretative reports and critical values. Clin Chim Acta. 2009; 404: 52-8
15. McPherson RA, Pincus MR. Postanalysis: medical decision making. In: Henry’s clinical diagnosis and management by laboratory methods.
Elsevier Saunders. 2011; 7: 81-90
16. Howanitz JH, Howanitz PJ. Evaluation of total serum calcium critical values. Arch Pathol Lab Med. 2006; 130: 828-30
17. Howanitz JH, Howanitz PJ. Evaluation of Serum and Whole Blood Sodium Critical Values. Am J Clin Pathol. 2007 Jan.1;127(1):56–9.
18. Yang D, Zhou Y, Yang C. Analysis of Laboratory Repeat Critical Values at a Large Tertiary Teaching Hospital in China. Willson RC, editor.
PLoS ONE. 2013 Mar.14;8(3):e59518.
19. Piva E, Sciacovelli L, Zaninotto M, Laposata M, Plebani M. Evaluation of Effectiveness of a Computerized Notification System for Reporting
Critical Values. Am J Clin Pathol. 2009 Mar.1;131(3):432–41.
20.Plebani M, Sciacovelli L, Marinova M, Marcuccitti J, Chiozza ML. Quality indicators in laboratory medicine: A fundamental tool for quality and
patient safety. Clinical Biochemistry. 2013Sep.;46(13-14):1170–4.
21.Valenstein PN, Wagar EA, Stankovic AK, Walsh MK, Schneider F. Notification of critical results: a College of American Pathologists Q-
Probes Study of 121 institutions. Arch Pathol Lab Med. 2008; 132: 1862-7