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REPORTING FLOW / EQAS

What are the NRLs? NRL-SACCL?

The National Reference Laboratories

NRL-East
Avenue Med
Center
(Toxicology)

NRL-RITM
(Microbiology
/ Testing for
donors)

NRL-NKTI
(Hematolo
gy)

NRL-SACCL
San Lazaro
Hospital
(HIV/AIDS,
Hepatitis,
and other
STIs)

NRL-Lung
Center of
the
Philippine
s

NRL-SACCL

NRL-SACCL (National
Reference Laboratory
STD AIDS
Cooperative Central
Laboratory), San
Lazaro Hospital,
Manila
- NRL for HIV and other
STIs

NRL SACCL Functions/Mandates


1. To provide
laboratory referral
services (e.g.
confirmatory testing,
surveillance,
research)

3. To maintain a
quality assurance
program for
laboratory tests- in
coordination with
BHFS-DOH

2. To train laboratory
personnel

4. To evaluate test kits and


reagents-in coordination with
BFAD (FDA) and BHDT -DOH

Referral System

What do we test in the laboratory?

SEE

GROW
REACT with chemicals/reagents

CHECK for the Antibody

Antigen foreign body

Antibody substance
produced by the body
against the antigen

Antibody testing is still the


most widely used.
The need for a
confirmatory test.
Why? Concentration in
serum, practicality, and
high level of specificity

Basic serologic course


Antibody

Level

window period

Seropositive
Antigen
Threshold
for detection

Seronegative
w e e k s

m o n t h s

Time frame

What are the types of tests?

Screening tests
-Initial test/s done
-Must be sensitive
-HIV proficient RMTs
-If reactive, proceed
to confirmatory

Confirmatory tests
-A more specific test
-No biological false +
-Trained personnel
-Results must be
correlated to
screening tests and
clinical findings

Monitoring tests
-Test/s done after a
POSITIVE
confirmation
-To monitor disease
progression and
treatment response
- ARVs
- CD4 / Viral load
- Nucleic acid tests
- DNA sequencing

RBC

Mono

Lym

Neu

Eos

Baso

HIV tests
Screening:
Particle agglutination
ELISA
Immunochromatography
Confirmatory:
Western Blot
Immunofluorescence
Assay
Monitoring:
CD4 (flowcytometry)
Viral Load (NAT)

Hepa C tests
Screening:
EIA, Rapid tests

Hepa B
tests :
Screening
ELISA /
Immunochromatography
Confirmatory:
Neutralization Assay
Monitoring
NAT

Tests for Syphilis


Screening:
RPR (Rapid Plasma Reagin)
Immunochromatography
ELISA

Confirmatory:
SIA (e.g. RIBA,LIA), HCV
RNA(Qualitative)

Confirmatory:
TP Particle Agglutination (TP-PA)
TP Heme Agglutination (TP-HA)
Fluorescent Treponemal Antibody
Absorption (FTA-Abs)

Monitoring
HCV RNA (Quantitative)

Monitoring:
RPR Quantitative

Standardized Reporting
Serology (HIV, Hepatitis, and Syphilis)
Screening tests
REACTIVE
NONREACTIVE
Inconclusive
Confirmatory tests
POSITIVE
NEGATIVE
Indeterminate

STI Microbiology Reporting


N. gonorrhoeae (presence or absence of GNID,
GNED + positive culture)
Trichomonas vaginalis (positive or negative)
Candida albicans (positive or negative - culture)
BV (BV, intermediate, Normal)
Chlamydia trachomatis (positive or negative PCR)

What are the 2 types of surveillances?

PASSIVE surveillance a system in which initially HIV


reactive samples are referred by hospitals/clinics to the
national confirmatory center / national reference lab.

medical
technologist
patient

Laboratory
(screening)

doctor
result

DOH-NEC
(AIDS Registry)

NRL-SACCL
(confirmatory)

ACTIVE surveillance DOH personnel do field testing.

DOH team

NRL-SACCL
(Screening &
Confirmatory)

Social Hygiene
Clinics (SHC)

DOH-NEC

result

How does a lab refer an HIV sample?

Steps in referring HIV samples


STEP 1 Write data

STEP 2 Transfer

NEW!

STEP 3 Pack
Absorbent material
Ice gel / cold dog

Primary container

Styrobox
Secondary container

STEP 4 Send

- Place forms on an envelope and attach it outside the styrobox.


- For laboratories within Metro Manila, send package to NRL-SACCL.
- For laboratories outside Metro Manila, send through the local courier.

External Quality Assessment Scheme

NRL SACCL Functions/Mandates


1. To provide
laboratory referral
services (e.g.
confirmatory testing,
surveillance,
research)

3. To maintain a
quality assurance
program for
laboratory tests- in
coordination with
BHFS-DOH

2. To train laboratory
personnel

4. To evaluate test kits and


reagents-in coordination with
BFAD (FDA) and BHDT -DOH

AO 2007-27 Revised Rules and Regulations


Governing the Licensure and Regulation of
Clinical Laboratories In the Philippines
VI.B.ii Specific Guidelines on QAP
ii. The clinical laboratory shall participate in an
EQAP administered by designated NRL or in other
local and international EQAP approved by DOH

Quality assurance is the total process that


gurantees that the final results reported by a
laboratory are as accurate as possible.
Quality control (QC) measures that must be
included during each test run to verify that the test is
working properly.
Quality assessment is a means of determining the
quality of results.
- usually an external evaluation of a laboratorys
performance using proficiency panels.

WHY IS EQA IMPORTANT?


PRIMARY Objectives:
1. to assess the quality of
laboratory performance
on a nationwide basis;
2. to provide assurance to
consumers (physician and
patients), that laboratory
results are reliable.

SECONDARY:
1. to identify common errors and recommend
corrective measures;
2. to encourage good laboratory practice, using
standardized procedures, appropriate
definitions and high-quality reagents;
3. to encourage the implementation of quality
assurance and control measures in the
participating laboratories;

SECONDARY:
4. to stimulate information exchange and
networking among laboratories at the national
and/or international level;
5. to provide updated information on new
developments in HIV diagnostics and related
matters.

EQA Methods
Proficiency
Proficiency
Testing
Testing
On-site
On-site
Evaluation
Evaluation
Re-checking/
Re-checking/
Re-testing
Re-testing

EQA Methods
Proficiency
Proficiency
Testing
Testing
On-site
On-site
Evaluation
Evaluation
Re-checking/
Re-checking/
Re-testing
Re-testing

Panels of specimens are sent


to multiple test sites by
reference laboratory
Test sites perform tests and
report results
Results indicate quality of
personnel performance and
test site operations
Results are often compared
across several testing sites

EQAS Methods
Proficiency
Proficiency
Testing
Testing
On-site
On-site
Evaluation
Evaluation
Re-checking/
Re-checking/
Re-testing
Re-testing

Periodic site visits to systematic


assessment of lab practices
Focuses on how the lab
monitors its operations and
ensures testing quality
Provides information for
internal process
improvement

EQAS Methods
Proficiency
Proficiency
Testing
Testing

On-site
On-site
Evaluation
Evaluation
Re-checking/
Re-checking/
Re-testing
Re-testing

The process by which a


random selection of specimens
are collected from the routine
workload at the test site and
sent to the reference laboratory
for validation
Used to detect errors

EQA Should Lead to


Corrective Actions

EQA
EQA

Identify
Identify
Problems
Problems

Take
Take
Corrective
Corrective
Action
Action

Corrective Action
An action taken to correct a problem or deficiency
Examples:
Production of an incorrect result
Not following procedures

NEQAS FLOWCHART
NRL sends invitation
for participation

Participant submits
registration form
with payment

NRL sends sample


to participants

Participants tests samples


submit results to NRL
(or DigitalPT)

Analysis of results
NRL provides results to participants
NRL issues certificate of participation
to participants
NRL provides BHFS list of participating
laboratories

www.doh.gov.ph/saccl
nrl_saccl@yahoo.com