April 11, 2007
ADMINISTRATIVE ORDER
No. 2007 – 0019
GUIDELINES FOR THE
IMPLEMENTATION OF THE QUALITY ASSURANCE SYSTEM ON DIRECT SPUTUM SMEAR
MICROSCOPY (DSSM)
I. RATIONALE
Tuberculosis
(TB) is one of the deadliest infectious diseases affecting the world today; it
is the sixth leading cause of morbidity and mortality in the Philippines (DOH,
2004). The Philippines ranks eight among the 22 high–TB burden countries in the
world, and third in the Western Pacific Region (WHO, 2005). The estimated number
of TB cases in the country is over 241,000 (WHO, 2005), and the majority of
these cases come from the economically productive age groups. In 2006, the
Philippines reached the TB control global targets of 85% treatment success
rate, and 70% case detection rate at 90% and 75%, respectively.
The
strategy endorsed by the World Health Organization (WHO) to control TB in
countries with a high TB burden is called Directly Observed Treatment Short
Course (DOTS). A key element of DOTS is the availability of, and access to,
quality microscopy services provided through a laboratory network within the
National TB Control Program (NTP). Direct sputum smear microscopy (DSSM) is the
primary tool for case detection and for follow–up of cases under treatment. The
TB laboratory service is an essential, but less supported, part of the National
Tuberculosis Control Program (NTP). Poorly functioning laboratories can give
rise to erroneous microscopy results and to undetected TB cases that would
remain infectious and further fuel the TB epidemic. Hence, the quality of TB
laboratory services must be ensured to protect the public from misdiagnosis.
The
Quality Assurance System (QAS) for DSSM using blinded rechecking was
established under the NTP in 1989 to ensure accuracy and reliability of
results. In 1996, the QAS was strengthened with the adoption of DOTS in the
Philippines. In 2002, the QAS was modified based on the general methods and
guidelines developed in 2001 by experts from the International Union Against
Tuberculosis and Lung Disease (IUATLD), World Health Organization (WHO), Japan
anti–tuberculosis association (JATA), Royal Netherlands Tuberculosis Foundation
(KNVC), Centers for Disease Control and Prevention (CDC) and the Association of Public Health
Laboratories (APHL). The modified QAS was pilot tested in Cebu province with
the assistance of the Japan International Cooperation Agency (JICA). In 2003,
the “Manual of Quality Assurance for Sputum Smear Microscopy” was developed by
the NTP through the National Tuberculosis Reference Laboratory (NTRL) of the
Department of Health (DOH), with technical support from JICA and WHO, to serve
as the guide in implementing the new QAS. The system was officially adopted by
the country in 2004 and was then implemented in phases. Capability building for
the nationwide implementation of QAS started in 2004 and completed in December
2006. Observations made from monitoring visits and program reviews during the
phased implementation of QAS revealed several problems including (1) variable
manner of implementation; (2) constraints related to organization,
infrastructure, funds, and human resources; and (3) limited coverage of QAS
policies and guidelines.
II. POLICY STATEMENTS
A. The National Objectives for Health, 2005 – 2010 aims
to reduce morbidity and mortality from Tuberculosis in support of the
attainment of the MDGs, of which, one of the strategic thrusts is the
“Implementation of quality assurance measures in the implementation of DOTS and
DOTS PLUS, with emphasis on laboratory diagnosis, to improve TB control program
efficiency.”
B. Tuberculosis is one of the diseases included under the
Programs Projects and Activities (PPA) intensified disease prevention and
control under the Health Service Delivery component of the FOURmula One for
Health strategy for implementing health reforms. DOH is mandated to ensure that
public health services and goods are of good quality including TB laboratory
services.
C. A national Quality Assurance System (QAS) for TB
sputum microscopy services must be established in accordance to international
standards and practices to ensure that services are of acceptable quality to
support the pursuit of the goals of the NTP.
D. All public and private TB microscopy laboratories in
the country shall be covered by the national QAS for TB sputum microscopy; the
National Tuberculosis Reference Laboratory (NTRL) shall lead in the development
and overall management of the QAS.
E. Local government units (provincial or chartered city),
in collaboration with NTRL and Regional TB Laboratories, shall establish a QA
center in their areas of jurisdiction and shall ensure the continuous
implementation of QAS in their respective localities. The implementation of QAS
shall be according to the operating guidelines contained in the Manual of
Quality Assurance for Sputum Smear Microscopy (2003).
F. DOH offices, particularly the National Center for
Disease Prevention and Control, the NTRL, and the Centers for Health
Development, shall provide technical and financial support for the sustained
implementation of QAS.
G. Trainings on basic sputum smear microscopy shall be
performed only by trainers certified by NTRL, and shall be conducted only in
NTRL certified training facilities to ensure that such trainings are in
accordance to national and international standards.
III. OBJECTIVES
A. To define policies , and broadly describe the
implementation of QAS for DSSM;
B. To defined the roles and functions of each level of
the TB laboratory network, health facilities including health personnel;
C. To describe the system for participation of other TB
laboratories including the private sector; and
D. To describe policies governing training on QAS.
IV. SCOPE
This
issuance shall cover all agencies/units, whether public, particularly the local
government units, private, including non–governmental organizations, that are
supporting and implementing the QAS, performing DSSM, and involved with the
implementation of the NTP.
V. DEFINITION OF TERMS
A. Directly
observed treatment short course (DOTS)
– refers to the main strategy to control TB and is one of the most cost–effective
health strategies. It has five elements namely (1) diagnosis by quality assured
bacteriology (including QA DSSM), (2) supply of anti–TB drugs with efficient
drug management, (3) supervised intake of short course chemotherapy and patient
support, (4) monitoring and evaluation including impact measurement, and (5)
political commitment with sustained financing.
B. Quality
Assurance System (QAS) – refers to
the system designed to continuously improve the proficiency of laboratory
services.
C. External
Quality Assessment (EQA) – refers to
the process of periodic and independent measurement of laboratory performance
in collaboration with a competent external laboratory; its components include
on–site evaluation to review quality control procedures and on–site re–reading of
smears, blinded slide re–checking and panel testing.
D. Quality
Control (QC) – refers to the
systematic internal monitoring of working practices, technical procedures,
equipment and materials including quality of stains.
E. Quality
improvement (QI) – refers to the process
by which the various components of the sputum microscopy services are analyzed
to find ways to permanently remove obstacles to success. The elements of QI
include data collection, data analysis and problem solving. The process
involves continuous monitoring and identification of problems followed by
remedial action to prevent a recurrence of the problem. It often relies on
effective supervisory visits.
F. Laboratory
Network – refers to the different
levels of TB laboratories under the NTP and includes the central, intermediate,
and peripheral; each level with their respective functions and working in close
coordination with each other.
G. Central Laboratory – refers to the National TB Reference Laboratory
(NTRL)
H. Intermediate
Laboratory – refers to the Regional
TB Laboratory and Provincial TB Laboratory or Quality Assurance Centers,
located in the level of administrative regions and provinces.
I. Peripheral
Laboratory – refers to the microscopy
centers or laboratories located in primary care rural health units (RHU), city
health centers (CHC), government and private hospitals, and private clinics
that provide TB sputum smear microscopy services.
VI. THE QUALITY ASSURANCE SYSTEM FOR TB LABORATORIES
Quality
Assurance System (QAS) for TB sputum microscopy is a system designed to
continuously improve and maintain the proficiency of the laboratory services.
The QAS aims to ensure the reliability of the laboratory services by detecting
deficiencies in microscopy work that can be attributed to events within or
outside the laboratory.
The
objectives of QAS are to:
(1) Ensure the accuracy of sputum microscopy results,
(2) Identify practices that could be potential sources of
error, and
(3) Ensure that corrective actions are initiated within a
reasonable short period of time.
QAS
has three components, namely: quality control (QC), external quality assessment
(EQA) and quality improvement (QI). The activities of these components are
implemented by the NTPs network of laboratories through its three
organizational levels, namely: central (NTRL), intermediate (Regional TB
laboratories; Provincial/City Quality Assurance centers), and peripheral
(microscopy laboratories). The QAS will cover all TB microscopy laboratories in
public primary care units (RHU/HC), private clinics and laboratories,
government and private hospitals, as well as those in non–government
organizations. Ensuring the quality of the microscopy services requires a
well–functioning QAS that monitors all aspects of laboratory operations. The
commitment and support of all stakeholders are required to sustain its
implementation.
VII. GUIDELINES AND PROCEDURES
A. Establishment
of the NTP Laboratory Network
A
country requires a network of TB laboratories to meet the global targets of TB
control. International experts recommend that the TB laboratory network in
populous countries like the Philippine should have a tri–level organizational
structure namely: central, intermediate and peripheral. In general, the central
laboratory (NTRL) develops policies and standards and fulfills the overall
manager’s role; the intermediate level laboratories (regional and provincial TB
laboratories) work with the central level in implementing the policies, while
the peripheral level (microscopy laboratories) provides the sputum microscopy
services.
The
functions of each laboratory level are the following:
1. Central
Laboratory
The
central TB laboratory is the National Tuberculosis Reference Laboratory (NTRL)
located at the Research Institute of Tropical Medicine in Alabang, Muntinlupa.
The main functions of the NTRL include the development of policies, technical
guidelines and standards that are in consonance with existing NTP policies;
exercise overall technical supervision of the TB laboratory services; provide
technical advice; research; and surveillance. A number of AFB sputum microscopy
examinations, cultures and drug susceptibility testing (DST) shall be performed
at the NTRL to maintain the central staff’s skill on training, supervision, and
quality assurance. The specific functions of the NTRL are the following:
· Develop, update
and disseminate policies, standards, and guidelines on laboratory procedure for
quality assured TB bacteriologic diagnosis;
· Develop a
national strategic plan for TB laboratory services in collaboration with the
NTP;
· Provide technical
advice to the NTP on laboratory matters including requirements of laboratory
supplies and equipment;
· Develop technical
specifications or standards for TB laboratory equipment and facilities,
reagents, consumables, and other laboratory supplies; and monitor compliance to
the standards;
· Develop and
disseminate guidelines on the care and maintenance of microscopes and other
laboratory equipment;
· Monitor,
supervise, and evaluate the nationwide implementation of QAS and overall
laboratory performance, especially in areas where there are no Regional NTP
Medical Technologist Coordinators;
· Provide technical
and managerial support to intermediate level laboratories;
· Conduct training
on quality assurance and other laboratory support activities (training,
supervision, laboratory safety, and equipment maintenance) for intermediate
level staff, i.e., regional laboratory staff, provincial/city controllers, and
NTP coordinators;
· Perform EQA for
microscopy examinations done at regional TB laboratories, PTSI Central
Laboratory, and specialty hospitals in the National Capital Region;
· In special
situations, designate a QA center for TB Laboratories in collaboration with NTP
to fill any gaps in QAS; and
· Conduct
operational researches related to laboratory services and QAS
2.
Intermediate
Laboratories
a. Regional
TB Laboratory
The
Regional TB Laboratory covers an administrative region in the country and is
administratively under the DOH Centers for Health Development, with technical
supervision from the Regional NTP Medical Coordinator. A number of sputum
microscopy examinations may be done at the regional TB laboratories to maintain
the regional staff’s skills in training, supervision, and quality control.
The
functions of the Regional TB Laboratory are:
· Prepare a
strategic plan for the region’s TB laboratory services in collaboration with
the Regional NTP Coordinators;
· Assist the
central laboratory in the development and dissemination of TB laboratory
policies;
· Provide advocacy
and technical , and administrative support for the establishment and operation
of QA centers in each province/city;
· Monitor,
supervise and evaluate the implementation of QAS in the region.
· Perform as
necessary, EQA on microscopy examinations done at the provincial/city TB laboratories
and QA centers;
· Collate and
analyze data on EQA and laboratory activities from the provincial and
peripheral laboratories;
· Submit quarterly
and annual reports on EQA and laboratory activities to NTRL within the
prescribed timeline;
· Conduct training
on DSSM as endorsed by the NTRL; and
· Assess the
quality of reagents that we distributed in the field
b. Provincial
and City TB Laboratory (QA Centers)
The
Provincial or City TB laboratory under the local government serve as the
Quality Assurance (QA) center for the province and chartered city respectively
under the technical supervision of the NTP Coordinator. The provincial/city
laboratory (QA Center) will cover the TB microscopy laboratories located in
their corresponding area. This will include the RHU/CHC; Public–Private Mix
DOTS clinics; provincial and district hospitals; private hospitals and clinics;
DOH–retained, specialty, and regional hospitals; and the PTSI microscopy
laboratories. A number of microscopy examinations may be done at the provincial
laboratory to maintain the provincial staff’s skills on training, supervision
and quality assurance.
The principal functions of the QA Centers are the following:
· Implement QAS
activities including determination of sample size, collection of sample slides
(Note: collection of sample slides should not be done by the Controller to ensure
blindedness), blinded re– checking of slides, provide feedback to
microscopists, perform on– site assessment of laboratory activities
(supervisory visits), and provide technical or managerial support to the
peripheral microscopy laboratories in implementing corrective actions for
quality improvement;
· Collate and
analyze data on EQA and laboratory activities to identify problematic
microscopy centers;
· Submit quarterly
and annual reports on EQA and laboratory activities to the Regional TB
Laboratory within the prescribed timeline; and
· Provide technical
advice to LGUs on procurement of laboratory equipment and supplies to ensure
that these conform to NTP standards.
3. Peripheral
Laboratory
The
Peripheral Laboratories are TB microscopy laboratories located in rural health
units and city health centers (RHU/HC), those in PPMD units, and in public and
private hospitals under the supervision of the head of the clinic/unit. The
laboratory should have at least one binocular microscope, and at least one NTP
trained microscopist covering a population of about 100,000 or less, provide
that the daily workload is adequate to maintain the staff’s proficiency.
The
principal functions include:
· Perform sputum
smear microscopy for diagnosis, and follow up of TB patients on therapy using
the Ziehl–Neelsen technique.
· Ensure quality
control in the laboratory
· Store sputum
slides for EQA
· Receive feedback
from QA center and take corrective action as needed
· File EQA results
and feedback sheets from the QA center;
· Record and report
TB laboratory data
B. Training
1. Categories
of Staff for Training on Quality Assurance
The
following staff must undergo the standard training on QAS at the NTRL and/or
its designated laboratory, e.g. Cebu Tuberculosis Reference Laboratory (CTRL),
prior to their involvement in the implementation of QAS:
a. Controllers at QA center
b. Provincial/City NTP Coordinators
c. Regional NTP Coordinators
d. Regional NTP Medical Technologists
Controllers
at the QA center and the Regional Medical Technologists should also have been
trained in DSSM.
The
Provincial/City NTP Team and QA staff must conduct an orientation on the new
QAS for the staff of Rural Health Units/Health Centers, PPMD units, and other
TB Laboratories. They should also ensure that each unit or laboratory has a
copy of the Manual on Quality Assurance for Sputum Smear Microscopy (DOH,
2004).
VIII. QUALITY ASSURANCE (QA) CENTER
The
provincial or city government, with assistance from the regional TB laboratory
and/or NTRL, shall be responsible for the establishment of the QA center and to
start and manage its operations. The QA center is under the administrative
supervision of the provincial or city government; it is responsible for the
effective implementation of QAS in the area. The requirements for a QA center
to perform its functions are:
A. Location
There
must be at least one QA center per province or city preferably located in
sufficient proximity to the Provincial/City NTP office. If the local NTP
Coordinators deem that one microscopy laboratories, another one may be
established after consultation with the provincial/city and regional teams, and
the NTRL.
B. Staffing
There
should be at least one, preferably two, Controller(s) in the QA center. The
Controller should be a Registered Medical Technologist who has completed the
basic and/or refresher course on sputum microscopy, and QAS training provided
by the NTRL or CTRL.
C. Facilities
and Necessary Equipment/Supplies
The
QA center ideally should have a quiet and comfortable working environment with
the necessary laboratory and office equipment and supplies to allow the
efficient conduct of its functions. For the specific requirements and physical
set – up of a QA center; refer to the Manual on Quality Assurance for Sputum
Smear Microscopy.
D. Funding
and Logistical Support
The
establishment, operation and maintenance of the QA center are the
responsibility of the respective LGUs (province/city). This also includes
providing adequate funds for salaries and benefits of staff, equipment, forms,
supplies and funds for field supervisory visits for on–site evaluation and
feedback to the peripheral laboratories. Assistance from DOH, international and
local partners, may be mobilized to strengthen the QA center. In addition, QA
centers may develop and implement financing schemes to sustain the
implementation of QAS in accordance to existing laws and policies, and without
jeopardizing access to TB laboratory services especially for the poor.
E. Specific
Activities
The
following are the major activities performed by the QA centers; these are
described in detail in the Manual for Quality Assurance for Sputum Smear
Microscopy
The
specific activities to implement EQA are:
a. Determine sample
size per microscopy center using the LQAS.
b. Collect sample
slides from peripheral laboratories on a quarterly basis (in some situations as
approved by the Provincial/City NTP Coordinators, peripheral laboratories may
bring the slides to the QA center)
c. Perform blind re–checking
and smear assessment of slides,
d. Analyze and
interpret results of blind rechecking,
e. Perform on–site
assessment of laboratory activities using the standard checklist,
f. Provide feedback
of EQA results to the peripheral laboratories, and
g. Monitor
compliance to recommendations.
Consolidate,
analyze and report data on EQA and other TB laboratory activities
Perform
on–the–job training and/or re–training of microscopists in collaboration with
the regional TB laboratory and/or NTRL.
F. Reporting
and Feedback Schedule
Quarterly
reports of QA activities must be submitted to the provincial/city health office
through the NTP Coordinators, and to the Regional TB Medical Technologists
Coordinator. Regional TB Laboratories should then send the collated reports
with a corresponding analysis to NTRL on a quarterly basis.
Timelines
will be as follows:
· Feedback from the
QA center to the microscopy center should be done within 10 days after
detecting a major error,
· Report from
Provincial/City TB laboratories to Regional TB Laboratory: end of the second
month following the assessed quarter
· Report from
Regional TB Laboratory to NTRL: end of the third month following the assessed
quarter
· Report from NTRL
to the NTP (NCDPC) during the semi–annual NTP Laboratory Management Workshop
IX. SPECIFIC PROCEDURES FOR QAS
The
detailed procedure to implement QAS is contained in the Manual for Quality
Assurance for Sputum Smear Microscopy (DOH, 2004). The manual has been disseminated
to different end–users to serve as the Standard Operating Procedures in the
implementation of QAS at each level of the laboratory network.
X. EFFECTIVITY
FRANCISCO T. DUQUE, MD,
MSc.
Secretary of Health
No comments:
Post a Comment