NTP LABORATORY NETWORK ASSESSMENT (2016)
Arthur B. Lagos MD Lynette P. Adorio-Arce MD Marlon L. Bayot RMT
March 2017
Disclaimer: This document is a draft and is provided for information only. The information contained herein is subject to change and does not commit USAID, SIAPS, MSH and the authors. The final version of the report will be published as soon as adopted.
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NTP LABORATORY NETWORK ASSESSMENT (2016)
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Table of Contents
List of Acronyms Preface Executive Summary Page 1 Introduction Page 7 Findings Page 7 I. Laboratory Services Page 7 1. TB sputum microscopy Page 13 2. Xpert MTB/RIF Assay Page 21 3. Culture and DST Page 28 4. Line Probe Assay Page 29 5. External Quality Assurance Program Page 34 II. Laboratory systems Page 34 1. Human resources Page 34 2. Training and supervision Page 36 3. Financing Page 37 4. Information management Page 38 5. Supply chain management Page 39 6. Equipment, facility (physical plant) and infrastructure Page 41 7. Monitoring and evaluation system Page 41 8. Leadership and management of the lab network Page 42 9. Biosafety Page 42 10. Infection control Page 42 11. Waste management Page 43 12. Laboratory health promotion and education Page 45 Recommendations Page 48 References Page 51 Annex A. Summary results of smear quality assessment Page 52 Annex B. Types of inconclusive test results in Xpert testing Page 53 Annex C. List of facilities included in the assessment Page 54 Annex D. List of persons interviewed
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List of Acronyms
Biomed Biomedical Department (RITM) BHMC Barangay Health Management Council BHS Barangay Health Station BSC Biological Safety Cabinet CHO City Health Office CTRL Cebu TB Reference Laboratory CXR Chest X-ray DOH Department of Health DSSM Direct Sputum Smear Microscopy DR drug resistant DST Drug susceptibility testing EPTB Extra-pulmonary tuberculosis EQA External Quality Assurance Program / External Quality Assessment EVRMC Eastern Visayas Regional Medical Center HC Health center HIV Human Immunodeficiency Virus IC Infection control ILW Informal laboratory worker ITR Inconclusive test result LCP Lung Center of the Philippines LED-FM Light emitting diode – Fluorescence Microscopy LNW Laboratory Network LPA Line Probe Assay LTBI Latent TB Infection MDRTB Multiple Drug-resistant Tuberculosis MTB Mycobacterium tuberculosis NGO Non-governmental organization NTM Non-tuberculous Mycobacteria NTP National TB control Program NTRL National TB Reference Laboratory NR No result (from an Xpert test) PCR Polymerase Chain Reaction PhilPACT Philippine Plan of Action to Control Tuberculosis PPE Personal Protective Equipment PTC Presumptive TB Cases RHU Rural Health Unit RITM Research Institute for Tropical Medicine RR An Xpert test result: MTB detected, Rifampicin resistant
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RSS Remote Smearing Station PMDT Programmatic Management of Drug Resistant Tuberculosis PTSI Philippine Tuberculosis Society, Inc. QAC Quality Assurance Center SIAPS Systems for Improved Access to Pharmaceuticals and Services SLH San Lazaro Hospital T An Xpert test result: MTB detected, Rifampicin susceptible TAT Turnaround time TI An Xpert test result: MTB detected, Rifampicin resistance indeterminate TML TB microscopy laboratory XDRTB Extremely drug resistant tuberculosis ZN Ziehl-Neelsen
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Preface
Draft version - please do not quote or circulate
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Executive Summary
Draft version - please do not quote or circulate
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Introduction
I. The Philippines
The Philippines is an archipelago composed of 7,107 islands located at the southeast coast of Asia with a total land area of approximately 343,448.32 km2. The country’s three major island groups and their land areas are: Luzon, covering 147,947.63 km2; Visayas with 59,873.84 km2; and Mindanao with 135,626.85 km2. The country has a diverse terrain consisting of high mountains, volcanoes and extensive valleys and plateaus that are surrounded by bodies of water such as rivers and lakes.
The Philippines is a tropical country with an average temperature of 27°C. There are two seasons experienced each year: wet and dry1. The dry season can be divided into the cool dry season from December to January; and a hot dry season extending from March to May2. The highest temperatures recorded in the period of 2014 to 2016 were recorded in Tuguegarao City, Cagayan Province and in Metro Manila with temperatures exceeding 40 degrees Celsius3,4,5.
The country is divided into 18 administrative regions with the addition of the newly established Negros Island Region (NIR) in mid-2016. NIR includes the provinces of Negros Occidental and Negros Oriental and Bacolod City. The population in 2015 was almost 101 million with an average annual population growth rate of 1.72% from 2010 to 2015 (Census and Housing Population, Philippine Statistics Authority). Region 4-A (CALABARZON) had the biggest population with 14.41 million, followed by the National Capital Region (NCR) with 12.88 million, and Region 3 (Central Luzon) with 11.22 million. The combined population of these three regions accounted for about 38.1 percent of the Philippine population in 2015.
The Philippines is composed of 81 provinces and 144 cities, 1,490 municipalities and 42,036 barangays6. The country has 33 highly urbanized cities (HUCs), 4 of which have a population of over 1 million, these are Quezon City (2.94 million), City of Manila (1.78 million), Davao City (1.63 million), and Caloocan City (1.58 million)7. There are 1,489 municipalities in the Philippines.
Cavite province (Region 4-A) is the most populous province in 2015 with a population of 3.68 million; followed by Bulacan in Region 3 (3.29 million); and Laguna in Region 4A (3.04 million). Batanes province has the smallest population size with 17,246 persons. Two other provinces had a population of less than 100,000 namely, Siquijor (95,984) and Camiguin (88,478).
1 Philippine Statistics Authority (PSA). A view of the Philippines. Geography. 2010. 2 Philippine Atmospheric, Geophysical and Astronomical Services Administration (PAGASA). Climate of the Philippines. 2016. 3 Corrales, N. Inquirer.Net. Tuguegarao City records hottest temperature–Pagasa. 2014 4 Locsin, J. GMA News. PAGASA: Highest temperature of 2015 so far recorded in Cagayan on Sunday. 2015. 5 Santos, E. PAGASA: Election day records hottest temperature of 2016 so far. 2016. 6 Philippine Standard Geographic Codes (PSGC). List of regions. 2016. 7 Philippine Statistics Authority (PSA). Highlights of the Philippine Population 2015 Census of Population. 2016
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There are three municipalities with big populations, namely: Rodriquez (pop: 369,222); Cainta (pop: 332,128); and Taytay (pop: 319,104), these are all located in Rizal province (Region 4A). The municipality of Kalayaan in Palawan province (Region 4B) has the smallest population with 184 persons. The population in urban areas is 41.9 million, while the rural population is 50.5 million which translates to an urban to rural population ratio of 0.83 (2013).
The Philippine population is characterized by the rapid growth of the working age groups, and the slowly but steadily increasing elderly population. From 1970 to 2010, the proportion of the older age group (65 years and older) had increased faster than the younger age group (0-14 years and 15-64 years age group). However, the younger age group still has the bigger part of the population8.
There were more males than females in the age groups 0 to 54 years (2010), but there were more females than males in the older age groups of 55 years and over9. The gender proportions are 50.4% males and 49.6% females. This pattern of age and gender distribution is also observed for 2016 based on population estimates. Life expectancy of Filipinos in 2015 is lower in males (65 years) than in females (72 10 years).
In 2013, the literacy rate among Filipinos aged 15 to 24 remained high at 98.1% with women having a slightly higher literacy rate than men. One of every 10 Filipinos aged 6 to 24 years were out-of-school, which translates to about 24 million Filipinos in the country (2010). ARMM had the highest out-of-school population at 14.4% which is higher than the national average of 10.6%.11 The country is classified as a lower middle income country. The poverty incidence is 26.3% and the proportion of Filipino families in 12 extreme poverty was estimated at 9.2% in the first half of 2015.
The country has a developed transport infrastructure but services are still inadequate due to lack of sustainable financing. There were modest improvements in the country’s transport services but large parts of the road network remain in poor which is largely due to poor and inadequate maintenance and is linked closely to weak transport sector governance. Significant developments were made in water transport with the upgraded Roll on – Roll off (ro-ro) ferry services as an alternative to the traditional inter-island shipping services. However, serious capacity limitation for air transport is anticipated as domestic and international air traffic grows.
The urban transport system is mainly composed of buses, mass transport system (trains in Metro Manila), jeepneys, taxis, tricycles and pedicabs.13 From 2007 to 2013, motorcycles and tricycles
8 Castro, L.V. Efforts of the Philippine Statistical System (PSS) in Compiling Statistics on Population Ageing. 2015. 9 Philippine Statistics Authority (PSA). The Age and Sex Structure of the Philippine Population. 2012. 10 World Health Organization (WHO). Philippines Statistics. 2016. 11 Rodriguez, F. In numbers: #PHvote and PH education. 2016. 12 Philippine Statistics Authoriry (PSA). Poverty incidence among Filipinos registered at 26.3%, as of first semester of 2015 – PSA. 2016. 13 Asian Development Bank. Philippines: Transport Sector Assessment, Strategy and Road Map. 2012.
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comprised the highest proportion of type of vehicle used and has contributed significantly to road and traffic congestion.14 Telecommunications in the Philippines consist of telephones (landlines) and mobile phones, digital subscriber lines (DSL), cable networks, cellular sites and communication devices. These have improved communications capabilities for Filipinos. More Filipinos are now using cellular (mobile) phones as communication devices in place of the traditional landlines. The use of smart phones mobile 15 computers also increased due to the improved internet access.
Epidemiology of TB in the Philippines
The Philippines belongs to two of the three global high TB burden country lists. It is one of the world’s top 20 high TB burden (in absolute numbers) countries of the world, and one of the top 20 countries with a high MDR-TB burden.16 The trend of case notification is increasing since 2009, and may have been 17 due to the increased case finding efforts.
Table 1. Estimated TB incidence by age and sex (thousands) 2015 (source: WHO Global TB Report, 2016)
0-14 yrs >14 yrs Total Females 14 (6.4-22) 100 (64-135) 114 (71-156) Males 17 (11-23) 194 (152-236) 211 (163-259) Total 31 (22-40) 294 (266-322) 324 (279-373)
Table 2 shows data from the 2016 WHO Global TB Report where a total of 286,544 cases were notified in the Philippines in 2015; of these, 276,672 were new and relapse cases, 97% of whom are pulmonary TB (PTB) cases. However, only 36% of the notified PTB cases have bacteriologic confirmation of their disease. In addition, only 20% of the total new and relapse cases were tested with the new rapid diagnostic tests (RDT).
Table 2. TB case notifications, Philippines 2015 (source: WHO Global TB Report 2016)
Total cases notified 286,544 Total new and relapse 276,672 - % Tested with RDTs at time of Dx 20% - % known HIV status 13% - % PTB 97% - % Bacteriologically confirmed PTB 36%
14 Philippine Statistics Authority. Philippine Yearbook: Transportation. 2013. 15 Philippine Star Online. More Filipinos use cellphones as 'mobile computers': study. 2013. 16 WHO Global TB Report, 2015. World Health Organization. 17 Yamada N. Epidemiology Review, Philippines NTP Joint Program Review; 2016.
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The epidemiology review by Yamada for the 2016 JPR showed that the trend in the number of presumptive TB cases (PTC) who were tested with smear microscopy has been increasing since 2005. However the number of smear positive cases has not increased significantly and the trend in smear positivity rates has been declining. The latter observation is common seen when case finding efforts are intensified (Yamada, 2016).18 There has been a sharp increase in the number of smear negative cases in recent years.
The declining diagnostic smear positivity rates lead to an increasing proportion of PTCs who are smear negative (SN-PTC). However, the proportion of SN-PTCs who proceeded to the next level of diagnosis – underwent chest X-ray (CXR) - appear to be low. Limited data from Quezon City BHMCs indicates that only an estimated 18% to 22% of SN-PTCs had CXRs after the microscopy examination; the rest are 19 assumed to have dropped out of the NTP diagnostic process.
This scenario is a reflection of patients’ limited access to CXR due to limited availability and accessibility, and relatively high cost for poor patients. We believe that a significant proportion of patients who dropped out of the diagnostic process belong to the pool of the so-called “missing TB cases” (Figure 1). In addition, the issue of diagnostic quality emerges given the sharp increase in the number and proportion of smear negative PTB cases despite the patients’ limited access to CXR.
Recent NTP policy changes in case finding provide that patients with negative diagnostic smears, but have CXR findings suggestive of PTB, are eligible to be tested with Xpert. However, data is not available at this time to describe these patients.
18 Yamada N. Epidemiology Review, Philippines NTP Joint Program Review; 2016. 19 Lagos AB, Adorio-Arce LP. Quezon City BHMC workshop notes. Philippines; 2014.
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The NTP Laboratory Network
The country is currently developing its strategic plan for TB elimination. To support the country TB Elimination Plan, the NTP is expanding its laboratory services to improve access to reliable TB diagnosis.
The NTP has established a network of laboratories to provide the bacteriologic basis for TB diagnosis, for monitoring treatment response, and support TB surveillance. The NTP laboratory network (LNW) has adopted a variety of technologies using mainly sputum as the test specimen. These technologies include sputum smear microscopy, Xpert MTB/RIF assay (GX), TB culture, drug susceptibility test (DST) and line- probe assay (LPA). The services are generally free of charge particularly in public primary care facilities for eligible patients under the TB control program.
However, diagnostic tests such as chest X-ray (CXR) and other imaging procedures, as well as serologic tests to detect TB infection, and histologic examination to detect disease particularly extra-pulmonary TB (EPTB), are not part of the NTP’s free diagnostic services. This has negative consequences on the results of case finding activities because they form part of the entire diagnostic process. For example, the detection of active PTB among smear negative patients may be reduced; furthermore, the quality of clinical diagnosed PTB may be compromised without the CXRs. Without support to tests for non- pulmonary specimens, the diagnosis of EPTB will remain low.
NTP laboratory facilities are generally provided by the institutions hosting the laboratory. Peripheral TB microscopy (TMLs), and some Xpert laboratories, are lodged in primary care units (e.g. RHUs/HCs) that are owned and managed by LGUs, non-profit NGOs, private-for-profit and other non-health government facilities. Essential laboratory equipment and supplies are provided mainly by the government, external partners and donors (e.g. The Global Fund).
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The other intermediate level facilities are the Quality Assurance Centers (QAC). These centers are managed by the local governments and implement the quality assurance (QA) program for TB microscopy. Some of the QACs also perform other lab services including TB microscopy and/or Xpert.
Remote Smearing Stations (RSS) are located in barangay health stations (BHS) that are owned and managed by the LGUs and/or Barangays. The Remote Smearing Stations continue to provide services in remote areas functioning as sputum collection and smear preparation facilities.
Framework for the fully functional NTP diagnostic services
In order for the laboratory network to support the attainment of the country’s TB strategic objectives in terms of providing effective, reliable and sustainable services, the NTP is working within a framework that aims to strengthen the TB diagnostic services and ensure that these are fully functional20.
Figure 1: Framework for the fully functional TB diagnostic services in the National TB Control Program of the Philippines2 (Source: Philippines NTP Laboratory Leadership and Management Development Program Workshop, Strengthening Pharmaceutical Systems Project, Management Sciences for Health, 2010)
Inputs 1. Infrastructure 2. Equipment 3. Consumables
4. Transport Outcomes: Clinical & Public 5. Staff Health Impact 6. Money 1. Rapid diagnosis and treatment Measurable Outputs 1. Proficient staff 2. Increased TB case detection 2. High quality and reliable 3. Early & increased detection of National policy, test results drug resistance standards and 3. Accredited laboratories 4. Reduction of initial defaulters legal regulatory 4. Service efficiency 5. Early detection of treatment framework 5. Increased clinician adherence problems and confidence on lab results treatment failures Systems & Processes 6. Patient satisfaction 6. Decreased morbidity & mortality 1. Leadership 2. Management 3. Planning 4. Laboratory organization (networks & referral systems) 5. Quality management 6. Supply chain management 7. Equipment management 8. Logistics management 9. Information management 10. Human resource management 11. Supervision 12. Monitoring and evaluation 13. Infection control 14. Waste management 15. Health promotion
20 NTP Laboratory Network Strategic Plan 2013 – 2016. DOH; Philippines, 2013.
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The framework includes the following elements: (a) national policies and standards that form the legal regulatory framework; (b) human, financial and material inputs to enable the effective and sustainable delivery of services; and (c) the systems and processes that support the staff in providing the services (Figure 1). Working together, these elements will generate measurable outputs such as proficient staff, high quality test results, accredited laboratories, service efficiency, increased clinician confidence on lab results and patient satisfaction. These are expected to lead to program outcomes that have clinical and public health impact
About the assessment
Case finding in the NTP needs to improve in order to achieve the country’s vision of TB elimination. Finding all TB cases in the community, providing them with effective treatment and getting them cured are basic interventions to stop ongoing transmission of TB, and to reduce TB morbidity and mortality. A fully functional TB diagnostic network is essential for finding the TB cases in the community.
The laboratories are an important part of the diagnostic services. The laboratories must always be functional in order to provide the needed services to find the TB cases. The assessment was done to gather information regarding the performance of the NTP lab network. This information will be useful for NTP, NTRL and sub-national program managers to guide them in developing the strategies and plans for strengthening the lab networks in their respective areas of jurisdiction.
The description of NTP-LNW performance was based on the analysis and interpretation of routinely reported indicator-based data, as well as other data using custom indicators for this study. Review of relevant reports and other documents (published and unpublished), interviews, field observations, and group discussions were done to come up with the study findings. The study adopted a systems approach to identify and organize the findings and develop recommendations.
A total of 33 laboratories located in 8 regions were assessed for this study (Box 1). The study laboratories include (a) culture labs at the central (n=1) and intermediate levels (n=11), all of which also function as Xpert labs, and 3/11 labs performing DST; (b) 8 full-time quality assurance centers (QAC), 3 of which provide DSSM services; (c) 4 RHU/HC based laboratories performing DSSM, but are also functioning as QACs, with 3/4 also performing Xpert tests; (d) 8 TMLs based in RHU/HC that provide DSSM and other lab services for their patients and for patients referred by other RHU/HCs; and (e) 1 Xpert laboratory located in a PMDT treatment center (TC).
Data collection was started in March 2016 and lasted till August 2016. Data management and analysis was from September to December 2016; report writing was started in December 2016.
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Box 1: Laboratories for this study in 8 regions, total: 33 Central level . 1 national reference laboratory (NTRL) Intermediate level . 11 culture labs: 1/11: regional reference lab: culture, DST 3/11: culture and DST 8/11: culture only 11/11: with Xpert; . 8 QACs 3/8 provide DSSM services; 5/8 are for QA only Peripheral level . 4 HC labs with TML and other services 4/4: function also as QACs 3/4 TML/QACs: with Xpert services . 8 TMLs in RHU/health center 8/8 perform other lab tests (e.g. CBC, urinalysis, blood chemistry) 8/8 serve other RHU/HCs . 1 TC with Xpert
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Findings:
I. Laboratory Services
1. TB sputum microscopy
TB smear microscopy is currently the initial bacteriologic test under the NTP and the test is still used to monitor bacteriologic response to treatment. The NTP will gradually replace sputum microscopy with Xpert as the initial test for all PTCs to diagnose active PTB.
TB smear microscopy is still considered an important laboratory test in the country’s TB control program for case finding and for monitoring treatment response. This is despite the use of GeneXpert, with its higher sensitivity, specificity, short turnaround time, and ability to detect resistance to Rifampicin. Microscopy laboratories, however, are still more available and accessible particularly in the remote, or difficult to reach areas, such as in island or mountain barangays and municipalities, and in many urban poor settlements.
The 2013 mapping survey done by NTRL reported that there were 2,561 TMLs in the country, 85% of which are in the public services, and the remaining 15% are in the private sector. However, this number has not been updated since the time of the survey. Additionally, the survey did not include the remote smearing stations (RSS) that have been established in the country since 2007. LED-Fluorescent Microscopy (LED-FM) was introduced in 2014 in selected laboratories in regions 3 (Central Luzon), 4A (Southern Tagalog) and NCR (Metro Manila). As of June 2016, 59 TMLs were equipped with LED- Fluorescent microscopes, most of which are in NCR.
In the Philippines, most peripheral public health laboratories provide other services aside from TB sputum microscopy such as, CBC, HIV testing, newborn screening, hepatitis screening, urinalysis, and in some, including the recently adopted GeneXpert tests. All of the peripheral laboratories assessed are providing a range of laboratory services to a number of referring facilities, both public and/or private, ranging from 5 to 11 referring health centers. A number of TMLs are also functioning as QA centers for the TB microscopy EQA program. In our study labs, 4 of the 12 TMLs (33%) are QACs.
In addition, Med Techs in 4 of 8 study TMLs (50%) are also functioning as part-time EQA Controllers in their respective province or city. Many of the “part-time controllers” were not trained adequately due to the limited availability of training opportunities. These multi-tasking arrangements have increased staff workload considerably and have resulted to the reduction in workers’ efficiency and effectiveness, and loss of motivation.
TB laboratory case finding data in the study showed that 69,379 presumptive TB cases (PTCs) underwent diagnostic DSSM from 2013 to 2015 wherein 10,073 smear-positive cases were identified (Table 1). The
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3-year average smear positive rate in this group is 15%, which is higher than the national average of 13%, but within the range of 10% to 20% that is expected in areas with a high TB burden21. However, the number of PTCs tested increased, but the number of smear positive cases detected, did not change significantly.
Table 3. TB Microscopy Laboratory performance in study sites, 2013-2015
No. of PTCs Smear (+) Smear (-) Year examined No. No. % No. % 2013 21,560 3,334 15% 18,226 85% 2014 24,575 3,321 14% 21,254 86% 2015 23,244 3,418 15% 19,826 85% Total 69,379 10,073 15% 59,306 85%
A related finding is that among the PTCs who were smear negative (SN-PTCs), information is not available on how many of them were able to proceed to the next round of diagnostics, usually a chest X- ray (CXR), as this is not included in the regular reporting system.
Our observations in Quezon City BHMCs showed that only an estimated 18% to 22% of the smear negative PTCs were able to have a CXR in 2014, diagnosed with reasonable accuracy, and given the appropriate treatment22. In succeeding years with LGU interventions, the proportion of SN-PTCs with CXRs increased to 64% among whom around 74% were X-ray PTB+ (SN-PTCs/CXR-PTB+). This resulted to an 84% increase in the number of TB cases found and treated that contributed to an increase in CDR All Forms.23 This is an area in the case finding process that needs to be strengthened to find some of the so- called “missing cases”.
The policy of 2-specimen collection for diagnosis was introduced by NTP in 2012 to improve patients’ convenience and with the expectation that patients’ compliance to the diagnostic protocol will improve. Health facilities were given the option to collect both specimens on the same day (spot-spot) with an interval of one hour, or within 2 days: spot + early morning (EM) specimen. Data on 2-specimen collection was available only in 9 study TMLs. Only 4 of the 9 TMLs were able to collect 2 specimens from all PTCs tested (Table 2); overall, an average 88% of PTCs submitted 2 specimens.
Discussions with field health workers and lab staff revealed variable specimen collection practices in the field. The following are examples of these patterns:
1. 2 spot-specimens collected with 1-hour interval under supervision at the health facility on day of consultation;
21 Department of Health. NTP Case Finding and Case Holding Report. 2015. 22 Lagos AB, Adorio-Arce LP. BHMC Planning Workshop Notes. SIAPS, Philippines; 2014. 23 See KG, Lagos AB, Adorio-Arce. Improved case finding in Old Balara. Quezon City; 2016.
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2. 1 spot specimen on day of consultation, 1 EM specimen submitted on the following day; 3. 2 EM specimens collected at home (day after consultation); 4. 1 EM specimen collected at home (day after consultation), and 1 spot collected upon submission of the first EM specimen
Table 3. Number of PTCs with 2 specimens for diagnostic TB microscopy in selected laboratories, 2013-2014
No. No. w/ % PTCs 2-sp. San Lazaro Hosp. 9,125 7,043 77% Kamuning SHC 982 982 100% Sindalan RHU 366 349 95% Batangas Med Ctr. 1,036 1,021 99% Batangas Health Ofc. 3,155 3,154 100% Naic RHU 1,660 1,656 100% Tacloban City Health Ofc. 1,461 1,396 96% EVRMC 3,636 2,965 82% Carmen RHU 2,753 2,753 100%
It was observed that the collection of 2-specimens was more efficient in labs that strictly implemented the one-day collection process (Pattern 1) compared to those that used the other patterns. Many health workers implement patterns 2, 3 and 4 to enable the collection of early morning specimens - which they perceive are of better quality and will yield more positive results24. However, the evidence is insufficient to support this theory. Field observations also suggest that specimens collected at home tend to have lower quality compared to specimens collected under supervision at the health facility25.
Data from selected QA centers in 2014 and 2015 show that only 79% of slides assessed under the EQA program had acceptable specimen quality (Annex A. Summary of Smear Quality Assessment in study LGUs, 2014-2015). Health workers reported several issues in the specimen collection process that contribute to poor specimen quality, these include:
1. Inadequate instruction and supervision of sputum collection which is often attributed to: . Timing and location of sputum collection process that cause inconvenience to patients (e.g. spot versus early morning; at the facility versus at home; schedule of sputum collection at the facility); . Weak capacity of HWs, especially non-professional lab staff, to provide correct instruction and/or adequately supervise the collection process; this matter is related to the quality of training and supervision that they received;
24 Lagos AB. DOH-JICA QTBCP Field Notes. Philippines; 2003. 25 Ibid
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. Inadequate time for health staff to instruct and supervise patients; this is claimed to be due to their high workload. 2. Unacceptable physical conditions of the sputum collection area (e.g. inadequate privacy, uncomfortable, inadequate ventilation and light). Sputum collection areas that are poorly ventilated increases the risk of infection among other people / patients without TB. 3. Poor conditions during storage after collection, and/or transport, of specimens to the TML. Some examples are: placement of specimen in areas exposed to heat and/or sunlight; leakage of specimens due to improper packaging for transport (usually in plastic bags packed with ice), and in some cases, the use of non-screw type specimen containers; seepage of water from melted ice into the specimen container; and exposure to heat during transport. In one study RHU, as much as 30% of specimens brought to their labs had some form of spillage.
Health workers also expressed dismay since expenses for the packaging and transport of specimens are shouldered either by them or by patients – both of whom have limited financial resources. In a few instances, funds generated by the health center through clients’ donations are used for this purpose.
The use of sub-standard packaging contributes to the poor quality of the specimen for TB microscopy once it reaches the laboratory. For example, due to the unavailability of standard specimen transport boxes, health workers resort to using plastic bags packed with ice to transport specimens that usually leads to seepage of water into the specimen container when the ice melts.
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EQA data for smear quality showed that majority of the slides assessed did not reach acceptable levels (at least 90%) in four of the six assessment points, including specimen quality, smear thickness, size and evenness (Figure 2).
Some of the operational factors that contributed to this situation include poor quality of training; lack of supervision; work space inadequacies; high workload; poor quality and/or expired stains; inadequate equipment; sub-standard specimen containers; and weak implementation of EQA activities.
In our study sites, stock-outs of Ziehl-Neelsen (ZN) stains were experienced in the past year and this led to the use of expired stains. The same was reported in places where LED-FM was deployed. Stock-outs of the auramine stain was frequent which forced lab staff to revert back to the use of ZN stains; the lab staff shifted back to Fluorescence Microscopy when auramine stain became available26.
26 Lagos, A.B. Notes from EQA Policy Workshop. SIAPS, Philippines; 2016.
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The occurrences of slide reading errors, particularly major errors, were infrequent and at a low level in the study labs. Blinded slide rechecking results showed that the proportion of slides with reading errors is only 3% in 2014 and 2015; major err ors constitute less than 1% of the total error slides. However, issues regarding EQA program implementation, discussed in another section of this report, tend to cast some doubts to these results.
Data for diagnostic microscopy turnaround time (TAT) is limited since this is not routinely recorded and monitored in the study labs. Available data showed TATs that varied from 1 to 3 days; diagnostic tests usually take 3 days, while follow-up examinations take 2 days on average. However, data for RHUs that are referring to other TMLs was not available. We noted that in other areas (e.g. Quezon City), results for DSSM from referral TMLs are usually obtained after about 5 working days27.
Microscopy test results were released to patients, rather than to the clinic staff, in more than 50% of our study sites; the rest forwarded the results to the clinic nurse or midwife in charge. For referring units, patients were usually asked to get the lab results using their own money for transport. There are areas where lab results were collected by health workers from the referring units using their facilities’ funds. The practice of releasing diagnostic lab results to patients is not always good because there had been instances in the past, although poorly documented, wherein these patients are lost in the diagnostic process28.
27 Lagos, A.B., Adorio-Arce LP. Quezon City BHMC Workshop Notes. SIAPS Project. Philippines; 2014-2015. 28 Lagos, A.B. Field Notes. TB LINC Project. Philippines; 2008.
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2. Xpert MTB/RIF Assay
The use of XPERT-MTB/RIF assay (Xpert) was introduced in the NTP lab network in the last quarter of 2011 with 16 laboratories providing the test. The Xpert network continued to grow, and by 2016, a total of 188 functional Xpert laboratories are functional out of the 207 that have been established. Xpert testing was done mainly for patients suspected of having DRTB, specifically MDRTB. In 2014 the use of Xpert was extended to other types of patients including EPTB, and smear-negative PTCs with CXR findings suggestive of active TB.
Recent policy discussions indicate that NTP will use Xpert as the initial diagnostic test for all PTCs, with the view of replacing smear microscopy as the initial diagnostic test. Xpert has shown a higher level of test sensitivity and specificity, and is capable of detecting Rifampicin-resistance (Rr), the presence of which is currently used as a proxy indicator for the presence of multi-drug-resistant TB (MDR-TB).
In this assessment, we gathered data from 16 study Xpert labs for the period 2013 to 2015. Data was available in only 6, 10 and 16 functional laboratories for 2013, 2014 and 2015, respectively. Again, this reflects the problem of reporting in the Xpert services.
The issues regarding sputum collection, packaging and transport described previously for TB microscopy were also seen in peripheral Xpert labs. These issues include the inadequate instruction and supervision of health workers on sputum collection; poor physical condition of sputum collection areas; and improper packaging of specimens.
The quality of specimen storage after collection, and the conditions during transport to the Xpert lab are also in need of improvement. Some examples of these practices include: placement of collected specimen in areas exposed to heat and/or sunlight (near windows, or underneath air condition units); leakage of specimens due to improper packaging for transport (usually in plastic bags packed with ice); seepage of water from the melted ice into the specimen container due to poorly capped specimen containers; and exposure to heat during transport in motorcycles.
In one i-DOTS center in Quezon City, poor communication and coordination between referring facilities and Xpert laboratories, as well as the unclear procedures for lab referrals, are causing confusion and frustration among patients and health workers. It prolongs the testing process, increases the patients’ costs and inconvenience due to the repeated going back-and-forth to different health facilities, and contributes to delays in diagnosis and treatment. At the health center level, the cost of transporting specimens to the Xpert laboratories is shouldered mostly by patients.
A total of 33,724 drug-resistant presumptive TB cases (DR-PTCs) were tested in the 3-year period (Table 3). Of these patients, 4,418 (13%) were classified as New; 12,395 (37%) as Relapses; 16,491 (49%) as Other Retreatment; and 420 (1%) were reported as Unknown. The patients tested were still reported as DR-PTCs; no data was available for EPTB and non-DR (DS) PTCs such as the smear negative PTCs with CXR findings suggestive of PTB.
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The trend in the proportions of the various types of patients showed that those classified as New and Relapses, were increasing while the Other Retreatment and Unknown were decreasing from 2013 to 2015 (Table 3). This is likely to be due to an improvement in the health workers’ ability to classify patients.
Table 4. Number and proportion of tests by type of patients in study Xpert laboratories, 2013-2015 PTC type No. PTC Year New Relapse Other Ret. Unknown tested No. % No. % No. % No. % 2013 4,711 97 2% 670 14% 3,770 80% 174 4% 2014 12,778 1,365 11% 4,010 31% 7,157 56% 246 2% 2015 16,274 2,956 18% 7,715 47% 5,564 34% 0 0% Total 33,763 4,418 13% 12,395 37% 16,491 49% 420 1%
Table 4 shows test results of New DR-PTCs: MTB was positive in 1,051 (24%), and among these cases, 13% were Rifampicin-resistant (Rr) and considered MDRTB cases; 85% were Rifampicin susceptible (T) and 2% showed indeterminate results for Rifampicin resistance (TI).
Table 5. Xpert test results of New DR-PTCs in study Xpert laboratories, 2013-2015
No. MTB (+) MTB (-) Year Rr T TI tested No. % No. % No. % No. % No. % 2013 97 37 38% 11 30% 26 70% 0 0% 56 58% 2014 1,365 285 21% 41 14% 239 84% 5 2% 1,070 78% 2015 2,956 729 25% 80 11% 632 87% 17 2% 2,224 75% Total 4,418 1,051 24% 132 13% 897 85% 22 2% 3,350 76%
Among Relapse (Table 5) and Other Retreatment PTCs (Table 6), results were MTB positive in 29% and 42%, respectively. Rifampicin resistance was found in 37% of MTB+ Relapse cases, and 34% of MTB+ Other Retreatment cases.
In all three types of patients tested, MTB detection as well as Rifampicin resistance rates, were higher in Relapses and Other Retreatment patients compared to New DRTB presumptive cases. We noted that the majority of MTB+ cases were Rifampicin susceptible at 85% for new cases, 61% for Relapse cases, and 64% for Other Retreatment cases.
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In addition, the majority of the three types of patients tested showed MTB negative results (MTB not detected). However, it is useful to remember that it is possible for some TB patients to show negative Xpert results even in the presence of active disease. This may be due to instances where the bacillary load in the specimen is too small to be detected by the machine (e.g. some HIV+ TB patients, smear negative TB)29. Issues that diminish specimen quality may also lead to negative results.
Table 6. Xpert results of Relapse DR-PTCs in study Xpert laboratories, 2013-2015
No. MTB (+) MTB (-) Year tested Rr T TI No. % No. % No. % No. % No. % 2013 670 399 60% 168 42% 230 58% 1 0% 265 40% 2014 4,010 1,385 35% 538 39% 819 59% 28 2% 2,631 66% 2015 7,715 1,763 23% 614 35% 1,119 63% 30 2% 5,914 77% Total 12,395 3,547 29% 1,320 37% 2,168 61% 59 2% 8,810 71%
Table 7. Xpert results of Other Retreatment PTCs in selected Xpert laboratories, 2013-2015
No. PTCs MTB (+) MTB (-) Year Rr T TI tested No. % No. % No. % No. % No. % 2013 3,770 1,723 46% 587 34% 1,110 64% 26 2% 1,920 51% 2014 7,157 3,008 42% 999 33% 1,946 65% 63 2% 4,079 57% 2015 5,564 2,165 39% 763 35% 1,374 63% 28 1% 3,596 65% Total 16,491 6,896 42% 2,349 34% 4,430 64% 117 2% 9,595 58%
Inconclusive Xpert test results (ITR)
Xpert tests also generate inconclusive test results (ITR) due to a wide range of operational issues. The five leading Xpert labs in our study with the highest proportion of ITRs over the 3-year period are: NTRL, LCP, Batangas Medical Center, San Lazaro Hospital and PTSI (Table 7). We also noted 25 types of ITRs in the Xpert tests (see Annex H. Types of ITRs).
29 Cepheid. Xpert MTB/RIF insert manual. 2010.
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Table 8. List of top 5 Xpert labs by frequency of ITRs, 2013-2015 PTCs tested ITRs
No. No. % 1 NTRL 3,027 277 9% 2 LCP 6,359 500 8% 3 Batangas Medical Center 1,458 112 8% 4 SLH 2,904 186 6% 5 PTSI 10,253 384 4%
Data from 11/16 Xpert study labs showed the number and proportions of ITRs per year 656 (14%), 608 (5%) and 695 (4%) out of the total tests made in 2013, 2014 and 2015, respectively (Table 8). The national averages for ITRs based on NTRL reports for the same years are: 6%, 6% and 5%, respectively. The table shows that the three most frequent ITRs in the study labs from 2013 to 2015 are Errors, followed by Invalid, and No Result; the table also shows the respective values compared to standards set by the manufacturer. In 2015, the ITR type No Result (NR) went down at 0.44% and met the standard; Invalid Result (IR), however, remained at 1% which is still over the standard.
Table 9. Frequency of three leading ITRs in study Xpert labs from 2013 to 2015
2013 2014 2015 No. % No. % No. %
No. tests No. tests No. tests 30 Standards 4,711 12,778 16,274 Errors* 614 13% Errors* 433 3% Errors* 401 2.5% Less than 3% NR 31 0.66% IR 88 1% IR 223 1% Less than 1% IR 11 0.23% NR 87 1% NR 71 0.44% Less than 1% Total 656 14% Total 608 5% Total 695 4%
Table 10 shows the 10 most frequent ITRs out of the 25 types of ITRs that occurred from 2013 to 2015; these accounted for more than 90% of the total ITRs recorded. For practical reasons, we focused on the 5 most frequent ITRs in 2014 and 2015 which accounted for more than 80% of the total. These include: INVALID; Error 5007; Error 5011; No Result (NR); and Error 2127. These accounted for 88% and 82% of the total error results in 2014 and 2015, respectively. In 2013, Invalid (IR) was not among the top 5 GX- ITRs.
30 Ibid
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Table 10. Ten most frequent Xpert inconclusive test results (GX-ITR), 2013 to 2015
2013 GX-ITR 2014 GX-ITR 2015 GX-ITR No. % No. % No. % 1 5007 175 49% 1 5011 135 23% 1 INVALID 223 33% 2 2008 71 20% 2 5007 121 21% 2 5007 149 22% 3 5011 35 10% 3 INVALID 88 15% 3 5011 77 11% 4 NR 31 9% 4 2127 87 15% 4 NR 71 11% 5 5006 13 4% 5 NR 80 14% 5 2127 35 5% 6 INVALID 11 3% 6 5006 23 4% 6 5006 33 5% 7 2014 10 3% 7 2008 20 3% 7 1001 32 5% 8 2127 6 2% 8 1001 12 2% 8 1002 26 4% 9 1001 4 1% 9 1002 9 2% 9 2014 17 3% 10 1002 3 1% 10 2037 9 2% 10 2005 11 2% Total 359 100% Total 584 100% Total 674 100%
Table 11 describes the possible reasons for the occurrence of the ITRs. The occurrence of ITRs can be attributed to issues related to: 1. People (staff, patients) 2. Training 3. Supervision 4. Supplies (e.g. Xpert cartridges, buffer solutions) 5. Equipment (Xpert machine, software,) 6. Processes (machine installation, sputum collection and transport, sample preparation, supply storage) 7. Infrastructure (e.g. power supply stability) 8. Environment (temperature).
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Table 11. Description of Xpert inconclusive test results (ITRs)
Possible reasons for ITR occurrence ITRs 31 Authors’ remarks: possible underlying reasons (Source: Cepheid Xpert Users’ Manual )
Sputum viscosity and/or wrong sample Poor sample preparation practices – related to lab Error volume, or cartridge reaction tube worker performance due to gaps in training 5007 improperly filled, contains bubbles, or probe effectiveness, inadequate supervision, lack of proper integrity issues detected. measuring equipment (e.g. graduated measuring cup)
Loss of tube pressure because the cartridge Poor sample preparation practices related to poor Error tuben is ot airtight, or cartridge valve is not quality of cartridge can be due to improper storage; 5011 working right. gaps in lab worker performance; gaps in training effectiveness; inadequate supervision.
Power supply issue (main power or UPS Unstable power supply and recurrent power outages; Error fluctuations); Ethernet cable between PC and improper machine installation. 2127 GX instrument; Communication cable between gateway and GX Module.
Error Sample is too viscous; The filter is clogged by Poor sample preparation practices – related to lab 2008 debris in sample; Pressure sensor failed. worker performance due to gaps in training effectiveness; inadequate supervision.
Error An incorrect amount of reagent was inserted Poor sample preparation practices; poor quality of 5006 into the cartridge; The reagent is bad; Fluid reagent can be due to improper storage; defective transfer failed. machine.
Error Environment temperature is too warm; Fan High environment temperature; improper machine 1001 Failure placement; defective machine
Error The difference between the temperatures of High machine temperature 1002 the two thermistors has exceeded the acceptable difference of 5 °C.
Error The heater A/heater B/module’s/optical High machine temperature 2014 block thermistor failed.
PCR was inhibited due to inhibitors (pus, Poor specimen quality - can be due to inadequate Invalid food particles) instruction to patients on sputum collection; poor training of HWs in sputum collection.
No Windows or Software freeze; Power failure; Computer-related bugs; power interruption; Result STOP TEST function has been activated premature termination of test (e.g. during close of (accidentally or deliberately) office at 5:00 pm).
31 Cepheid. GeneXpert Dx System Operator Manual. 2012.
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Issues related to people are often linked to process-related problems such as: specimen collection, specimen quality, poor sample preparation, machine installation, and on some occasions, the premature termination of testing procedure. These can be attributed to gaps in training quality and effectiveness, and the lack of effective supervision of health workers.
Specimen quality problems can be connected to the inadequate supervision of patients during specimen collection, to storage of specimens, and to the packaging and transport of specimens. These apply to all of the diagnostic technologies that use sputum as the test specimen.
Issues related to the condition of the supplies (e.g. cartridges and buffer solutions) used for the tests reflect poor supply management procedures and practices. As examples, we saw storage areas with room temperatures exceeding 35 Celsius (note that the heat index can even be higher especially during the summer months). In many places, the storage areas are air-conditioned but these are turned off after office hours and during weekends and holidays. Temperature monitoring is not routinely done.
On the other hand, machine related problems can be due to procedures and practices related to storage conditions and handling prior to installation; and the operators’ use, care and maintenance of the machine and related equipment. This also reflects the measures taken by the laboratory managers to protect the machine from environmental and infrastructure related issues such as very hot weather and unstable power supply.
The occurrence of ITRs requires repeat testing which is not always easy to do because patients may not return to submit another specimen. Repeat testing due to errors and inconclusive test results increases the financial, material and opportunity costs related to testing. While the proportions of ITRs seem small, the absolute number of affected patients is substantial.
We have no information on how many of the patients were retested in these labs, as these are not routinely reported. However, we have to keep in mind that patients who are supposed to be retested but were not, have the potential of being lost in the diagnostic process and may not receive appropriate treatment. If they are active TB cases, whether drug susceptible or drug-resistant, they are at risk of developing complications and dying from TB. Moreover, they continue to be sources of infection for other people.
Turnaround time (TAT) for the labs covers the time from receipt of specimen to the time test results are released to a person designated to collect the result (driver, courier, clinic staff, or in some cases, patients themselves). Data for TAT is limited because these are not routinely recorded, monitored and reported. We were able to gather TAT data from 11 Xpert study labs which showed the following TATs for release of results are: 1 day (36%), 2 days (18%), and 3 days (46%). Peripheral level facilities had shorter TATs (i.e. 1 day) presumably due to the lower workload compared to intermediate and central level laboratories.
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Xpert test results were released to the relevant clinic staff in 83% (10/12) of labs; on the other hand, results are transmitted by commercial courier or by a PMDT assigned transport driver to PMDT facilities (i.e. treatment center and/or satellite treatment centers). However, since courier pick-up schedules are not on a daily basis, results are initially transmitted by SMS, email or phone calls, at the lab staff’s expense, to facilitate the transmittal process. One lab is using ITIS to send lab results using an off-facility internet café for this purpose.
Other peripheral health facilities such as RHU/HCs collect the results through their own clinic staff when they go out for other tasks such when picking up medical supplies. On the other hand, 17% (2/12) of labs released Xpert results to patients who are then expected to submit these to their attending clinical staff (doctors or nurses). As mentioned previously in the microscopy section of this report, releasing results directly to patients entails some risks.
3. Culture and DST
TB culture and drug susceptibility test (DST) is used mainly for Xpert MTB+/Rifampicin resistant patients who are under PMDT treatment, to identify the individual patient’s drug-resistance pattern which will help the clinicians make drug regimen adjustments. Culture/DST is also used to monitor bacteriologic response during treatment, and for drug resistance surveillance.
Most of the NTP’s TB culture laboratories are located in DOH regional laboratories, tertiary hospitals or medical centers, and several private medical facilities. These culture laboratories receive financial and operational support from The Global Fund, while technical supervision and support is provided mainly by NTRL. The NTP planned to have 28 functional culture labs by 2016. However, progress has been slow in operationalizing the laboratories with only 22 functional culture laboratories in 2014, 23 in 2015 and 25 in mid-2016 (Table 11). The slow progress has been attributed to various factors such as delays in infrastructure improvements that were due to bureaucratic processes; issues related to procurement of equipment, services and supplies; technical issues related to facility standards32.
Seven DST centers were expected to be functional by 2015, but only three are functional by end of 2016 namely, NTRL, CTRL and DTRL. The status of the culture/DST laboratory expansion as of 2016 is shown in Table 12.
In NTRL, liquid culture using the Mycobacterial Growth Inhibitor Tube (MGIT) is utilized for baseline PMDT tests, while solid culture is used for the follow-up tests among MDR-TB patients. DSTs, either for first-line drugs (FLD) or second-line drugs (SLD), are performed in selected regional TB reference laboratories and at the National TB Reference Laboratory (NTRL).
32 Bayot, M.L. Interview notes with NTRL-PSQM. 2016.
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NTRL sees the broader use of liquid culture in the NTP. WHO’s recommendation on the adoption of liquid culture is that this “should be taken in a step-wise manner and integrated into a country specific comprehensive plan for laboratory capacity strengthening and addressing the following key issues related to appropriate biosafety level; staff training; maintenance of infrastructure and equipment; customer plan with details of manufacturers’ commitments and guarantees; quick transport of specimens from peripheral health facilities; and rapid transmission of results”33.
Given the findings of this study on matters regarding laboratory network support systems, such as leadership and management; training; supervision; biosafety; waste management; specimen transport; referral system; facility and equipment maintenance, it is likely that the broader use of liquid culture may not be forthcoming in the short term.
Table 11. List of functional TB culture laboratories in NTP lab network, 2016 (NTRL, March 2016) LUZON Public (n=9) Private (n = 4) 1. National TB Reference Laboratory (NCR) 1. De La Salle Health Sciences Institute (Reg. IV-A) 2. Sorsogon Medical Mission Group of Hospital and 2. DOH-Region II TB Laboratory (Reg.II) Health Services Cooperative (Reg.V) 3. DOH- Region III TB Laboratory (Reg.III) 3. Philippine Tuberculosis Society Inc. (NCR) 4. Dagupan Doctors Villaflor Memorial Hospital 4. Batangas Medical Center (Reg. IV-A) (Reg. I) 5. Bicol TB Regional Laboratory (Reg. V) 6. Baguio General Hospital and Medical Center (CAR) 7. Lung Center of the Philippines (NCR) 8. San Lazaro Hospital (NCR) 9. UP PGH Medical Research Laboratory (NCR) VISAYAS Public (n=3) Private (n =1) 1. Western Visayas Medical Center (Reg. VI) 1. Dr. Pablo O. Torre Memorial Hospital (Reg. VI) 2. Cebu TB Reference Laboratory (Reg. VII) MINDANAO Public (n=5) Private (n =3) 1. Zamboanga City Medical Center (Reg. IX) 1. Jamelarin Hospital (Reg. IX) 2. Northern Mindanao TB Reference Laboratory 2. CDO Polymedic Medical Plaza (Reg. X) (Reg. X) 3. Davao TB Reference Laboratory (Reg. XI) 3. Dr. Arturo Pingoy Medical Center *(Reg. XII) 4. Davao Regional Hospital (Reg. XI) 5. CARAGA Culture laboratory (CARAGA)
33 World Health Organization. 2007.
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Table 12. Culture and DST Laboratories under NTP laboratory network, 2016
Region Status NTRL NCR Functional; performing FLD & SLD DST LCP NCR Non-functional; awaiting completion of proficiency requirements. PTSI-QI NCR Functional; performing FLD DST ITRMC I Non-functional; awaiting completion of ventilation and AC systems CTRL VII Functional; performing FLD & SLD DST NMTRL X Non-functional; Lab. Staff still for DST Training DTRL XI Functional; performing FLD DST; will start SLD by April
A major weakness of the culture lab network is recording and reporting. We observed that recording and reporting forms are not standardized, records are not updated, reporting is frequently delayed, and the quality of data needs improvement. These issues indicate that caution is needed when doing data analysis and interpretation.
In 2014, only 8 of the 23 (35%) functional culture laboratories submitted reports and only 19 of 23 (83%) laboratories in 201534. There is no official set of standard indicators in place for monitoring the culture laboratories’ performance. Data from culture laboratory reports are rarely analyzed or used at the national and sub-national level. Additionally, the staffs responsible for culture lab data and information management and use are not well equipped to perform the tasks. Supervision of the recording and reporting process is inadequate.
The formulas used by laboratory staff to compute and report the culture lab performance indicators varied across the different culture labs. To standardize the computation for the performance indicators for this assessment, we used the study labs’ raw data and our staff performed the computation. On the other hand, we used NTRL’s own reported data to assess their culture lab performance. Due to the paucity of available data, only the following indicators were used for this assessment: (1) culture positivity rate; (2) contamination rate; and (3) culture recovery rate.
Culture positivity rates (Table 13): The standard for this indicator is from 10% to 15%; it is population dependent, and baseline values are needed to establish a trend to develop a standard level that is appropriate for a particular region. Data for this indicator are incomplete as shown in the blacked out portions of table 13 and reflects the problems in reporting. The available data show wide variation in Culture (+) rates among the study laboratories and may reflect the variations in the characteristics of their region, population and types of patients.
Contamination rates (Table 14): The acceptable range for contamination rate is from 3% to 5% of culture tubes using solid media, and 8% to 10% using liquid media (MGIT). The values seen in our study labs are fluctuating from high to low suggesting inconsistent quality of performance. The contamination rates for
34 National TB Reference Laboratory. TB culture laboratories report 2014-2015.
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liquid culture in NTRL for 2014 and 2015 also showed wide shifts in quarterly trend: high during quarters 1 and 2, and falls within acceptable levels during quarters 3 and 4. Note that contamination is always a problem in the use of liquid culture.
Table 13. Culture positivity rates in study laboratories 2014-2015
2014 2015 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 NTRL* 79% 73% 74% 67% LCP 62% 59% Batangas MC 44% 19% 50% 46% DOH-Region 3 42% 39% 56% 29% 36% 53% 49% 31% CTRL 57% 81% 65% 74% 76% 72% 64% 77% NMTRL 91% 85% 63% 38% 34% 35% 59% 63% *Liquid culture.
Contamination rates may be influenced by the type of population under study, by specimen collection, and by the laboratory’s level of proficiency in specimen processing35. High contamination rates can be attributed to administrative and technical factors related to culture processing, such as: incomplete processing; and use of contaminated media, reagents or equipment. On the other hand, contamination rates below the minimum level indicate the use of harsh decontamination reagents, and/or excessive processing times36.
Table 14. Contamination rates for solida and liquidb culture in selected TB culture labs, 2014-2015 2014 2015
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 NTRL* 20% 21% 7% 6% 13% 26% 6% 3% LCP 2% 2% 2% 3% 2% 2% 6% 2% BGHMC 0% 14% 4% 6% 3% 3% 2% 0% DOH-Region 3 11% 16% 7% 8% 3% 1% 2% 2% Batangas Med. Ctr. 0% 2% 4% 1% CTRL 1% 11% 3% 2% 3% 8% 5% 5% NMTRL 5% 1% 5% 3% DTRL 3% 3% 4% 6% 5% 7% 4% 3% a Contamination rate for solid culture: 3-5%; b Contamination rate for liquid culture: 8-10% *NTRL uses liquid culture.
35 Association of Public Health Laboratories (APHL). Performance Indicators for the Laboratory. 36 McCarthy K. Division of Tuberculosis Elimination. CDC. Laboratory Performance Indicators. 2007.
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Culture recovery rate: The acceptable range for culture recovery rate for solid culture is at least 85% to 90% of smear positive cultures; and 95% to 98% for liquid culture. A number of factors can influence culture recovery rates and may include the following: type of population tested (TB suspects versus confirmed TB cases); type of facility performing the tests such as intermediate (e.g. hospital) versus reference labs; seasonal variations; contamination of specimens during collection; cross-contamination inside the laboratory; procedural problems; sub-optimal reagents; and poorly performing equipment37. The culture recovery rates shown (Table 15) are generally low; for NTRL, the culture recovery rate using liquid culture are high except in quarters 3 and 4 of 2015.
Table 15. Culture recovery rates in study labs, 2014-2015
2014 2015 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 NTRL* 98% 99% 96% 97% 97% 93% 84% 78% LCP 74% 95% BGHMC 100% 100% 100% 100% 73% DOH-RO3 culture lab 90% 80% 65% 38% 77% 69% 68% 58% Batangas MC 9% 12% 14% 13% 100% 100% 63% 62% CTRL 61% 88% 69% 80% 82% 79% 65% 80% NMTRL 90% 85% 71% 82% 77% 78% 88% 86% DTRL 100% 92% 92% 91% 73% 86% 94% 93% *Liquid culture
Drug susceptibility testing
In 2016, drug susceptibility tests (DST) for TB is available in three NTP culture laboratories; these are: the National TB Reference Laboratory (Muntinlupa City, NCR), Cebu TB Reference Laboratory (Cebu City, Region 7) and Davao TB Regional Laboratory (Davao City, Region 11).
Most of the patients with DST are previously treated cases including the Other retreatment cases (average, 46%); with a smaller proportion of relapses, 24% on average, and 27% consisting of retreatment patients with no specific categorization (Table 16).
Drug susceptibility results of DR cases were reported by NTRL, LCP and CTRL for 2014; while in 2015, DST reports came from NTRL, CTRL and DTRL only. LCP temporarily stopped performing DST for NTP patients in 2015 due to procedural issues that remain unresolved.
37 Revised National TB Control Program (RNTCP). New Delhi. Training Manual for Mycobacterium tuberculosis Culture and Drug Susceptibility Testing.
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Table 16. Types of patients with DST in study laboratories, 2013-2015 (n=4)
No. Pts Other Retreatment New Relapse Unknown Year w/ DST Retreatment only* No. No. % No. % No. % No. % No. % 2013 2,832 3 0% 266 9% 2115 75% 0 0% 448 16% 2014 2,657 19 1% 361 14% 694 26% 52 2% 1531 58% 2015 3,378 102 3% 1491 44% 1269 38% 86 3% 430 13% Total 8867 124 1% 2118 24% 4078 46% 138 2% 2409 27% *Retreatment only - patients classified as retreatment case without specific category
The vast majority of (77%) of those tested for FLD/DST showed drug resistance with most showing multi- drug resistant (MDR-TB) patterns, while an average 13% showed other resistance patterns (e.g. mono- resistance and poly-resistance). A small proportion, average of 17%, had drug-susceptible patterns (Table 17).
Table 17. Results of First line DST in study DST laboratories (n=4), 2013-2015
Other Drug- No. of Pts Drug-Resistant MDR Year resistance Susceptible No. No. % No. % No. % No. % 2013 2,563 1651 64% 1,239 75% 412 25% 936 37% 2014 1,442 1229 85% 1,090 89% 139 11% 28 2% 2015 1,930 1674 87% 1,639 98% 35 2% 30 2% Total 5,935 4,554 77% 3,968 87% 586 13% 994 17%
Table 18 shows the results of SLD/DST in the study laboratories. On average, 14% of patients showed drug resistance patterns, among which 4% were with XDR-TB. An average 86% showed drug susceptible patterns.
Table 18. Second line DST performance in selected laboratories, 2013-2015 (n=3) No. Pts Drug-Resistant XDR Other resistance Drug-Susceptible Year No. No. % No. % No. % No. % 2013 269 20 7% - 0% 20 100% 249 93% 2014 1,215 147 12% 11 7% 136 93% 1,055 87% 2015 1,448 238 16% 6 3% 232 97% 1,219 84%
Total 2,932 405 14% 17 4% 388 96% 2,523 86%
Observations on the collection, storage and transport of sputum specimens for culture/DST reflect the same issues encountered in TB microscopy and Xpert services. These include the improper packaging of specimens for transport, lack of standard packaging materials and supplies, and variable procedures for
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specimen packaging. In addition, the supplies of packaging materials are also inadequate particularly the primary, secondary and tertiary containers (with “cold dogs”) despite funding support from The Global Fund.
Specimens for TB culture were packed mostly by health workers at treatment facilities who are not well versed on proper specimen packaging procedures; appropriate packing is also affected by the lack of packing materials. In these instances, health workers improvise, and because they pay for the packaging costs, the improvisation is often inappropriate to limit their expenses.
Some lab workers mentioned that contamination rate is higher when they receive samples that have packaging issues that result to specimen spillage or leakages. Specimens for culture were transported mainly by commercial couriers and are paid for by The Global Fund. There is no monitoring or evaluation of specimen integrity as it goes through the transport system.
The TAT for TB culture from the study labs was from 8 weeks to 16 weeks using solid media. Some of the study culture labs (i.e. PTSI, NMTRL, SLH) visited exceeded the TAT standard due to the following: a. Pooling of specimens before processing b. Delay in recording results due to shortage of encoders c. Identification of culture growth is done in another lab leading to delayed result
The TAT was not monitored in all study labs because this is not required by the program. Besides, no standard TAT is implemented on the culture lab network, both for solid and liquid culture (using MGIT).
The standard TAT for solid culture is 3-8 weeks on average38; however, the TAT for culture among study labs using solid media is 9 weeks (NTRL, LCP, DOH-RO3 culture laboratory, Batangas MC). Culture results are expected to be reported from 3 to 8 weeks but this covers only the time required for incubating inoculated culture tubes. This does not include administrative procedures for recording and reporting, as well as the release and transmittal of results. It takes an additional week after 8 weeks of incubation (total of 9 weeks) before releasing the final culture result (NTRL, LCP, DOH-RO3 culture laboratory, Batangas MC). A turnaround time of 9 weeks seems to be more realistic.
NTRL’s TAT for liquid culture (MGIT) is 6 weeks; this is longer than the average TAT of 2 weeks39. However, detection may be delayed by factors such as harsh specimen processing, tightened caps during the first week of incubation, incorrect temperature and low bacterial load such as in smear- negative specimen40.
38 Siddiqi, S.H., and Rüsch-Gerdes, S. MGIT procedure manual. Geneva, FIND. 2006. 39 Association of Public Health Laboratories (APHL). Mycobacterial Culture. 40 Association of Public Health Laboratories (APHL). Mycobacterial Culture.
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Most of the patient types who had DSTs were the Other Retreatment (46%), relapses (24%), and the unclassified retreatment cases (27%). Observed TAT for solid DST and liquid DST (MGIT) at NTRL is seven weeks; this is longer than the standard TAT of 4 weeks for solid DST and around 2 weeks for liquid DST41.
Prolonged TAT may be due to batching of specimens, use of conventional identification and DST methods, suboptimal use of technology and use of national or other reference laboratories42. Delay in the transmittal of results is due to problems in the courier’s pick-up schedule (as seen in RO3, NMTRL, NTRL), previously unsettled courier payment by DOH (in PTSI), and delayed encoding of results in ITIS software (in Batangas MC).
4. Line Probe Assay
Line-Probe Assay (LPA) to detect MDR and XDR-TB is currently used mainly for patients under treatment with new SLDs including Bedaquiline and Delamanid; and for patients under the pilot implementation of the new 9-month MDR-TB regimen. Currently, there is only one functional Line Probe Assay (LPA) laboratory in the country which is at the NTRL. Delays in making additional LPA labs functional were due to delays in procurement of equipment (thermocycler), and lack of competent staff to perform the procedure.
Table 18 below describes the results of LPA tests for 1st line anti-TB drugs (FLDs) in 2013. Of 276 MTB detected specimens, 78 (28%) were MDR-TB, 13 (5%) were with rifampicin (R) mono-resistance and 33 (12%) with INH mono-resistance. More than half of specimens, 152 (55%), were drug susceptible.
Table 18. LPA First line DST results, NTRL 2013 No. % MTB detected 276 R resistant and H resistant (MDR) 78 28% R resistant and H susceptible 13 5% R susceptible and H resistant 33 12% R susceptible and H susceptible 152 55%
On the other hand, the LPA tests for SLD/DST (3rd quarter of 2015 up to 3rd quarter of 2016) for 537 specimens showed the following results: 369 (69%) were MTB detected; 116 (22%) MTB not detected; and 49 (9%) had Invalid results. Among the 369 specimens with MTB-detected results, 332 (90%) were susceptible to both Fluoroquinolones (FQ) and second-line injectable (SLI) drugs. Only 1 specimen had extensively drug-resistant strains (XDR-TB), or resistance to both FQ and SLI.
41 Association of Public Health Laboratories (APHL). Drug Susceptibility Testing for M. tuberculosis complex 42 McCarthy, K. Division of Tuberculosis Elimination. CDC. Laboratory Performance Indicators. 2007.
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Table 19. LPA Second line DST results, NTRL Q3 2015- Q3 2016
No. % No. of specimens processed* 537
MTB detected 369 69% FQ resistant and SLI resistant (XDR) 1 0.3% FQ susceptible and SLI resistant 24 6.5% FQ resistant and SLI susceptible 12 3.2% FQ susceptible and SLI susceptible 332 90% MTB not detected 116 22%
Invalid 49 9% *3 specimens are unaccounted NTRL’s turnaround time for LPA is five days. The NTRL’s TAT is longer than GLI’s standard TAT of 1-2 days. TAT may still be longer if batching of tests is done43. Of the 534 specimens tested from Q3-2015 to Q4-2016, 507 (95%) were within the 5-day TAT (Table 20).
Table 20. LPA Turn-Around Time in NTRL (Q3 2015 - Q3 2016)
No. % Number of samples processed 534 Number of samples released within TAT 507 95%
Number of samples released beyond TAT 27 5%
5. Laboratory External Quality Assurance Programs
The NTP has implemented an EQA program for TB smear microscopy but not for the other diagnostic technologies. The program was implemented since the 1990s, and underwent revision in 2004. The revision involved the following changes: (1) use of the lot quality assurance system (LQAS) for collection of sample slides for rechecking replacing the 100% smear (+) / 10% smear negative rule; (2) the lab network was organized for the implementation of EQA activities; (3) new procedures for EQA were developed and published and disseminated as a new manual44; and (4) passage of a national policy to support the implementation of the microscopy QA program45.
The guidelines and procedures of the new EQA program were based on international recommendations46. The new guidelines aimed to strengthen the implementation of EQA activities which include quarterly (1) on-site assessment and supervision; (2) blinded slide rechecking; and (3) panel testing. Panel testing is currently not implemented in the country because of its inherent
43 Global Laboratory Initiative. Training package on LPA. 2012. 44 Department of Health. Quality Assurance for Sputum Smear Microscopy, Philippine National TB Program. 2004. 45 Department of Health (DOH). Administrative Order no. 2007-0019. Guidelines for the Implementation of the Quality Assurance System on Direct Sputum Smear Microscopy. Philippines; 2007. 46 Association of Public Health Laboratories. External Quality Assessment for AFB Smear Microscopy; 2002.
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limitations and challenges. However, there are no country guidelines or procedures for the external quality assessment of fluorescence microscopy (FM) slides at this time.
We collected data for 2014 and 2015 (recorded data for 2013 was not complete) from 12 QA centers (QAC) to assess the implementation of the EQA program. We looked into the management of EQA implementation and its results. EQA program results were measured through the trend in the level of quarterly participation (coverage) of all TMLs in the local NTP lab network, and the trend in the level of quarterly microscopy performance (reading proficiency). This is in contrast to the current NTRL practice of reporting the annual national average level of performance that do not reflect realities on the ground.
To obtain a more realistic picture of the state of EQA implementation in the study areas, the following ind icators were used for this assessment:
1. High EQA participation (coverage): “At least 95% of all TMLs in the LGU’s NTP laboratory network are participating quarterly in the EQA program”. 2. High EQA performance (reading proficiency): “At least 95% of all TMLs in the LGU’s NTP laboratory network have less than 5% major errors per quarter”.
Of the 12 QACs, 8 (67%) are located at the intermediate level (provincial/city health offices) while 4 (33%) are peripheral main health centers that were designated to implement EQA in addition to their regular function of providing health services and managing public health programs. Three of the eight provincial QACs are also providing sputum microscopy services. Three of the four (75%) peripheral QA centers are providing public health and clinical services including laboratory tests such as TB microscopy, Xpert tests, HIV testing, CBC, urinalysis, blood chemistry, among others.
Table 21 shows the number of microscopy laboratories in the respective LGUs’ in 2014 and 2015; note that 8 of the 12 LGUs (67%) showed an increase in the number of laboratories in their areas as a result of the NTP’s drive to expand the availability and accessibility of microscopy laboratories. This led to an increased workload for the QA teams.
The QA teams enumerated a number of operational problems that affected the implemented of EQA activities. Among the 12 QA teams in the study, 84% reported transport problems as barriers to perform on-site assessment, slide collection, feedback and supervision; 33% have insufficient funds for travel to conduct supervisory visits; and 25% have no dedicated budget for EQA activities.
In addition, 84% have shortages of staff including controllers and MD/Nurse coordinators; in 17% of the QA teams, the nurse and doctor of the QA team are not trained; almost all have inadequate skills and knowledge to perform on-site assessment, identify performance problems, and provide technical support to TMLs and help them solve their performance problems. Facility and equipment issues were also mentioned with 42% of QA teams needing infrastructure improvements in their QA centers; and 17% lacked microscopes for slide rechecking use.
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Table 21. Number of TMLs in local lab network in study LGUs, 2014-2015 % 2014 2015 increase 1 Quezon City 40 54 35% 2 Baguio City 9 9 0% 3 Angeles City 9 10 11% 4 Pampanga 48 54 13% 5 Batangas 39 48 23% 6 Cavite 43 43 0% 7 Cebu City 5 5 0% 8 Tacloban City 5 5 0% 9 Leyte 45 46 2% 10 Misamis Oriental 27 29 7% 11 Davao City 46 48 4% 12 Davao del Norte 29 30 3%
Table 22 below shows the trend in the level of EQA participation in the study LGUs. In both years, there are more low performers than the high performers in terms of EQA coverage. Only 33% of the LGUs in the study achieved a high level of quarterly EQA participation (coverage) in 2014; this improved to 42% in 2015. The operational problems described previously account for this situation. Most notable among these is the lack of operational support to enable the QA teams to travel for slide collection.
Table 22. Trend of quarterly EQA participation (coverage) in study LGUs, 2014-2015
2014 2015 No. No. LGU Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 TMLs Level TMLs Level % % % % % % % % Angeles City 9 89 89 89 89 Low 10 100 100 100 100 High Baguio City 9 89 89 67 44 Low 9 67 67 67 22 Low Batangas Province 39 90 92 95 95 Low 48 85 88 90 79 Low Cavite Province 43 98 98 88 77 Low 43 100 100 100 100 High Cebu City 5 100 100 100 100 High 5 100 100 100 100 High Davao City 46 98 98 100 100 High 48 100 96 94 96 Low Davao del Norte 29 97 97 97 97 High 30 97 97 97 97 High Leyte Province 45 91 95 91 91 Low 46 93 91 98 98 Low Misamis Oriental Prov. 27 89 74 89 93 Low 29 89 93 96 97 Low Pampanga Province 48 73 69 81 90 Low 54 94 90 92 94 Low Quezon City 40 100 100 100 100 High 54 100 100 100 98 High Tacloban City 5 0 20 20 20 Low 5 60 60 60 60 Low Total 2014 High: 4 (33%); Low: 8 (67%) 2015 High: 5 (42%); Low: 7 (58%)
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The data, however, provides evidence that it is feasible for LGUs to implement quarterly EQA activities as stated in the NTP policy and manual for sputum microscopy quality assurance. The data further show that LGUs can achieve a high level of coverage if there is adequate support. However, this level of performance can also quickly change over time (i.e. quarter to quarter, year to year) if support is not sustained.
In the LGUs that performed well, the improvements in coverage were achieved mainly through better coordination and planning of slide collection activities, and by adopting modified approaches in slide collection as seen in 64% of the QA teams. Examples of modified slide collection methods seen in this study are: (1) slide collection during monthly staff meetings or quarterly DQC activities; (2) RHU staff brings the slides to the QA center for selection and collection (either monthly or quarterly); and (3) slides are selected at the RHUs by RHU staff and brought to the QA center for the rechecking process. The last method, however, may be problematic because it can introduce bias in the slide selection process.
Table 23 shows the trend of quarterly level of EQA performance (proficiency) in the study LGUs. The number of high performers in 2014 is higher than in 2015. The low level of performance for TMLs in the study LGUs can be attributed to the human resource problems especially the lack of controllers to perform slide rechecking; and the lack of the QA teams’ capacity to conduct field visits, and the capability to provide feedback and supportive supervision.
Table 23. Trend of EQA performance (proficiency) in study LGUs, 2014-2015
2014 2015 No. No. LGU Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 TML Level TML Level % % % % % % % % Angeles City 9 89 89 89 78 Low 10 100 100 100 100 High Baguio City 9 89 89 67 44 Low 9 67 67 67 22 Low Batangas Province 39 87 92 95 90 Low 48 85 83 88 77 Low Cavite Province 43 98 95 88 74 Low 43 100 88 91 100 Low Cebu City 5 100 100 100 100 High 5 100 100 100 100 High Davao City 46 98 98 100 98 High 48 100 94 94 96 Low Davao del Norte 29 90 93 97 93 Low 30 97 97 93 93 Low Leyte Province 45 91 91 89 89 Low 46 93 89 91 98 Low Misamis Oriental Prov 27 85 70 81 81 Low 29 81 89 89 83 Low Pampanga Province 48 65 67 79 90 Low 54 92 86 92 93 Low Quezon City 40 100 95 95 100 High 54 93 98 100 94 Low Tacloban City 5 0 20 20 20 Low 5 60 60 60 60 Low Total 2014 High: 3 (12%); Low: 9 (75%) 2015 High: 2 (17%); Low: 10 (83%)
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The data further show that performance can quickly vary over time (i.e. from quarter to quarter, year to year). This is why the continuous assessment, monitoring and provision of technical support to address problems in performance are necessary to achieve and sustain high levels of performance.
To address the increasing EQA workload and shortage of controllers, 75% of the QA teams used “part- time controllers” (i.e. microscopists from the peripheral TMLs) to help perform blinded rechecking of slides. However, the use of “part-time controllers”, who are also the subject of the slide rechecking process, has some issues that may affect the EQA results. This includes the potential bias in the rechecking of their colleagues’ slides; as well as the uncertain level of proficiency in slide assessment of part-time controllers. In addition, the slide rechecking done by “part-time controllers” usually have long turnaround times, as long as three months in some cases, and contributes to delays in reporting. Moreover, the added task is adversely affecting the part-time controllers’ regular work in their official workplaces.
Among the QA teams, the general perspective of EQA is still the identification of individual slide errors or the validation of individual patient diagnosis, rather than on the identification of laboratories that may have serious problems. There is also inadequate focus on identifying the root causes of these problems and on addressing them to improve their performance.
The capacity of the QA teams to manage and implement EQA activities is variable. Majority of the QA teams (67%) have no comprehensive plans for EQA implementation. In those with plans, the quality of their plans is often low, and does not focus on addressing the priority problems or challenges. Budgetary support for these plans is usually inadequate.
The level of technical support and supervision to QA teams from the regional and/or national level after EQA training is also inadequate. Monitoring, supervision and evaluation of EQA implementation from the higher level is relatively weak. In addition, there is still no mechanism to assess the competencies of the QA teams as they perform EQA functions. Some QA staff felt that they have been neglected in terms of technical support from the higher level.
EQA data management and use
The EQA program generates huge quantities of data based on routine program indicators. These data are used primarily to create and submit reports in raw form. At regional and provincial/city level, it is not easy to come by documents that provide information based on the comprehensive analysis of EQA data, from staff meetings, or from periodic DQC activities. One program manager mentioned that they generally do not analyze data because this is not “required for reporting”. It was suggested by some interviewees that the national level is expecting only consolidated data from the lower levels.
Qualitative information from the field is not well documented. This is not a priority for the QA Teams because this is not required for reporting. It was observed that most of the QA teams’ appreciation of, and their capacity to gather and analyze, qualitative data is inadequate. The QA teams expressed the need for more skills in data analysis and interpretation.
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II. Laboratory support systems
1. Human resource system
Human resources are the most important resource of any organization. The shortage of appropriate staff in the laboratory network is a continuing problem. Task shifting has been tried in some areas at various levels of the network to address the human resource shortage particularly in the use of informal laboratory workers for smearing and microscopy work in TB microscopy in difficult to reach areas; there are instances where non-med tech professional are utilized to perform Xpert testing. The effectiveness of this intervention has not been assessed, however.
Issues related to organizational positions, compensation, benefits, lack of clear career development, as well as poor workplace conditions remain. These persist as important factors that deter laboratory professionals from working in the NTP laboratory network whether as laboratory staff, supervisors or laboratory network managers.
Most staffs in the specialized NTP laboratories (i.e. Xpert, culture/DST) are project-hired contractual employees whose salaries and benefits are lower than the permanent staff in the same laboratories. The contractual (temporary) employment and lower compensation tend to drive project-hired laboratory workers to leave and seek employment elsewhere.
The use of health center/TML microscopists as part-time EQA controllers is a multi-tasking arrangement which helped QA centers cope with their workload. However, this does not increase the controllers’ effectiveness, efficiency and motivation; this has even contributed to the weakening of the laboratory service because their regular work is adversely affected by their EQA activities.
2. Training and supervision
Training and supervision are essential for the optimal performance of the NTP laboratories. Training is a unique service that has to be provided regularly as new technologies are adopted and new personnel are recruited. Effective training and post-training supervision are costly activities, but these investments are necessary in order to ensure that trained workers have the competencies required to perform lab procedures correctly and safely.
Formal training courses are available for all diagnostic technologies employed in the NTP. The conduct of microscopy training has been devolved to regional and some LGU level trainers while trainings for Xpert, culture/DST and LPA remained as NTRL responsibilities centrally.
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The scale-up of Xpert use in the country, and the turnover of Xpert operators, as well as the presence of new EQA staff in many places, has raised the demand for training to a point where NTRL could no longer respond to the demand adequately. This has limited the pace in the conduct of Xpert trainings, and may have contributed to the slowdown in the expansion of Xpert laboratories. The limited availability of EQA trainings has reduced the capability of some LGUs to implement the EQA program due to the lack of trained EQA teams.
The quality and effectiveness of the current laboratory trainings has not been thoroughly evaluated. Competency assessment in the laboratories is not routinely performed after the formal training. The training curricula for microscopy and EQA have not been updated since these were developed in the early part of the last decade. Other teaching methods (e.g. mentoring, online learning) have not been fully utilized in appropriate circumstances. In addition, training materials and job aids need to be updated and improved.
Though relatively new, the Xpert training course has not been evaluated as well. In addition, Most of the Xpert trainings conducted in recent years are for operators; clinic staff (doctors and nurses) who refer patients and use the results for patient diagnosis and management were not trained. When Xpert results are not straightforward (e.g. R-resistance indeterminate, or MTB not detected in the presence of symptoms signs and other tests that suggest TB), clinicians may find it difficult to make decisions related to treatment.
Supervision is limited for all types of laboratory workers including sub-national lab network managers. A supervisory program for the laboratory network is not yet fully developed and organized. For the culture laboratories, most supervisory visits facilities were done by NTRL staff during the initial mentoring phase at the start of their operations. The supervision component of microscopy EQA is not adequately performed.
In 2016, activities were implemented to start the decentralization process for the implementation and management of trainings for EQA and Xpert to the regional level. This intervention is expected to have long term and more permanent improvements in NTP’s capability to provide laboratory trainings. Building organizational capacity at the sub-national level is ongoing under the laboratory training decentralization strategy (LTDS). It is a long term process that is being led by NTRL and which requires substantial financial, political and technical support. When fully implemented, the decentralization process will enable the regional, including most provincial and city health offices, to organize and implement selected laboratory trainings to meet the NTP’s training needs.
Another measure that was implemented by the program managers to address the unmet training demand for Xpert operators is to conduct “informal trainings” (also called on-the-job training). These are shortened (one or two days) versions of the formal course and are conducted by newly trained lab implementers (not trainers). On the job trainings were also resorted to for workers in some TMLs, QA centers and culture laboratories.
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The informal trainings are generally unstructured, and not standardized in terms of its content, and are lacking in training aids. These trainings are basically a “demo-return demo” activity which does not ensure that trainees will acquire the minimum competency requirements to perform laboratory procedures correctly and safely. This makes “informally trained” workers potentially at risk as they work inside the laboratory.
Sub-national (i.e. regional, provincial) support to training management, implementation and conduct of supervision is limited because the capacity and mandates at these levels have not been developed to enable them to perform these functions effectively. Furthermore, sub-national training facilities and equipment that meet the standards are few; this is another barrier to effective training.
Currently, training courses for trainers and training managers are only for Basic TB Microscopy, and none for EQA and Xpert trainers; laboratory training courses are designed with only the laboratory operators and EQA supervisors in mind. There are no courses in place to help lab network managers enhance their leadership and management capabilities.
The relatively high level of inconclusive test results (e.g. errors) from Xpert tests, inconsistent performance of the culture laboratories, and low proficiency seen in the study TMLs, as well as some unsafe laboratory practices that were observed, reflect the sub-optimal level of training effectiveness, and the consequences of the lack of supervision. In this scenario, the benefits and impact of the diagnostic technologies may not be fully achieved by the NTP, its stakeholders and beneficiaries despite the high level of investments to modernize and strengthen the laboratory services.
3. Financing
The establishment and operations of the laboratory network’s specialized technologies are financed with funds from donors, by the national government through the regional offices of DOH and the private sector. On the other hand, the devolved microscopy services, EQA activities, and peripheral Xpert labs are financed by LGUs and private sector. Capacity building activities to strengthen the services are financed in large part with donor money. Most of the equipment and consumables for the scale-up of new diagnostic technologies are financed with donor support.
Strengthening the laboratory systems is necessary to ensure that the diagnostic services are effective and are sustained in the long term. However, this will require higher levels of government funding. Identifying and mobilizing new domestic sources of financing will be important.
4. Information management
Information is an important resource that can empower leaders and managers in the laboratory network. A number of gaps in laboratory information management exist including data quality, delayed reporting, limited feedback and sharing of information, and the inadequate use of information to
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improve the laboratory services. The causes are varied and reflect weaknesses in the laboratory information system elements such as staff, procedures, equipment, communications capacity and skills. Underscoring these gaps is the lack of adequate financing that can be traced to a low level of political support to strengthen the information system. In addition, opportunities for training are lacking; and supportive supervision from the higher levels is inadequate.
The quality of laboratory records and reports needs improvement. Data quality issues, particularly its correctness, have made data collection for this study difficult. There are many instances wherein laboratory records are not updated; and errors are quite common particularly in culture laboratory performance reports. The set of indicators to monitor the performance of culture laboratories is not yet standardized. In addition, there is some confusion regarding the formulas for computing the values of these indicators. The frequent changes in culture recording and reporting forms in the past years instituted by NTRL also caused confusion among implementers.
Personnel dedicated to perform encoding, recording and reporting tasks are lacking. In the usual scenario, the updating of records and writing of reports are performed by the medical technologists who are already burdened by their heavy laboratory workload. Procedures for data management are not clearly defined; lab workers and managers are in need of guidance that will help them perform data management tasks properly including feedback to the data generators, and sharing of information with stakeholders.
Access to essential equipment such as computers, printers and/or copiers especially in the peripheral level is still limited. The transmittal of reports is still a problem especially in rural areas. In these places, internet use to strengthen communications capacity is limited because of connectivity problems. An information management tool, the ITIS (laboratory module), is not yet available in most peripheral laboratories. Text messaging has become an important tool for transmitting information and has contributed to the strengthening of the lab services’ communications capability. However, the cost of using this technology is often shouldered by the laboratory workers themselves.
Laboratory information management skills, particularly among laboratory network managers, needs improvement. Knowledge and skills on data management, analysis, interpretation, use and information sharing generated by routine laboratory data are inadequate. The continued practice of reporting consolidated raw data do not provide the opportunity, and compelling reason, to analyze and interpret data to be used as basis for the improvement of laboratory operations.
Operational difficulties in the laboratory services also contributed to reporting delays. A good example is the delay in EQA reporting wherein the delays in sample slide collection, and prolonged duration of the slide rechecking cascades into a delay in the reporting and feedback processes.
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The level of support for the information system is lacking in terms of finance; mandates; staff; equipment; infrastructure; training; supervision; work spaces; information flow particularly in terms of feedback and information sharing; and M&E of the information system.
5. Supply chain management
The effective management of supplies is necessary to ensure that services are provided continuously in an effective manner. We observed that, in general, laboratory supply chain management is weak and needs more attention at all levels. Gaps in supply management practices seen in this study have led to service interruptions due to stock-outs of supplies, and contributed to problems in test results. The functioning of some newly established laboratories was delayed because of supply related problems.
There are stock outs of the following laboratory supplies in some of our study laboratories:
1. For sputum microscopy: sputum containers, applicator sticks, ZN and auramine staining kits (Batangas CHO), immersion oil (Naic RHU), slide boxes, alcohol, disinfecting solutions 2. For EQA: ZN staining kits, immersion oil (Cavite PHO), slide boxes (Leyte PHO) 3. For GeneXpert: cartridges (EVRMC), non-powdered gloves, disinfecting solutions (LCP) 4. For culture: conical tubes (DOH-RO3 culture laboratory), culture media, sodium hydroxide, respirator, gloves, disinfecting solutions (SLH, LCP), hand soap (LCP), lab gowns (DOH-RO3
culture laboratory) and lab registers (NMTRL)
Reasons for stock outs include: (1) inadequate quantities of requested supplies (DOH-RO3 culture laboratory, Batangas MC); (2) delayed delivery of requested supplies; and (3) unforeseen referrals of specimens for culture (SLH, PTSI).
TMLs using LED-FM had to revert to ZN staining when stocks of auramine ran out. Stock outs of sodium hydroxide (NaOH) stopped the processing of specimens for TB culture for up to 10 working days (SLH, Batangas MC). The stock outs of laboratory materials led to inefficiencies in service delivery and inaccuracies of test results. This also led to out-of-pocket expenses among patients and lab staff as they had to buy supplies while waiting for supply replenishments to arrive. Laboratory biosafety practices are also compromised because of the inadequate quantities (and in some cases, incorrect concentration) of disinfecting solutions and the lack of personal protective equipment (e.g. N95 mask). Some Xpert operators used powdered gloves despite this being not recommended; this is because the non- powdered gloves were not supplied (LCP).
There were instances wherein the expiry dates of auramine written on the box are different from those printed on the bottles (Batangas CHO). Culture media tubes delivered by NTRL to the culture/DST labs had no manufacturing date and expiration date (DTRL). The sub-standard quality of sputum containers remains an issue in two TMLs (Carmen RHU, Kamuning SHC) as specimen leakages occurred in these settings. One regional TB laboratory (NMTRL) reported overstocks of ZN stains and sputum containers. Buffer stocks are generally not available in TMLs.
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Ogawa culture media for use by the NTP culture/DST laboratories are prepared by NTRL. Three other culture labs (LCP, PTSI, CTRL) are also preparing media (Ogawa, Lӧwenstein-Jensen) for their own use. There is no quality assurance program in place to ensure that these are prepared according to standardized procedures and are meeting quality standards.
In addition, there were instances wherein commercially bought eggs were used instead of the required organic eggs, because of supply problems, for the preparation of egg-based media (NTRL, LCP, PTSI, CTRL). A major concern is that commercially available eggs may contain antibiotics and this might cause false negative culture results especially among patients with low bacterial load.
Ogawa media tubes are transported via courier from NTRL to sub-national laboratories. Problems encountered in the distribution process are: (1) breakage of media tubes during transport and; (2) media tubes getting uncapped during transport (Batangas MC), both of which rendered them unfit for use. The number of broken media tubes received in study labs ranged from 5 tubes (Batangas MC) to 20 tubes (NMTRL).
Improper storage of lab supplies (e.g. Xpert cartridges) was observed (Lourdes Sur HC, Cebu CHO). These can compromise test results such as when Xpert cartridges and/or buffer solutions are subjected to hot temperatures well above the manufacturer’s recommendations.
In 2015, one culture laboratory (SLH) received laboratory supplies and equipment (such as beakers, cryovials, Erlenmeyer flasks, beaded tubes) which were not requested for their operations. The reason for the delivery of these supplies to this lab was not clear.
6. Equipment, facility (physical plant) and infrastructure
Facilities, equipment and infrastructure are necessary elements for the development of the capacity of the laboratory network in order to provide its services. In general, the study laboratories are fully equipped, with dedicated laboratory spaces and adequate supply of water and electricity. Laboratory arrangement and administration is generally good among study culture labs; workflow is logical and efficient for TB culture processing. The certification and maintenance of newly established culture labs are performed by the Biomed Services of RITM.
However, some of the study labs have ventilation design flaws that pose hazard to both the laboratory worker and the persons within the vicinity of the laboratory.
Communications capability is variable although the minimum requirements are met with either landlines or personal mobile phones. Internet connectivity is present but does not always have the desired strength.
In TMLs, the minor maintenance of microscopes is performed by microscopists. All TMLs visited had functional microscopes but only one (Sindal an RHU) had yearly microscope calibration. In the study
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Xpert labs module calibration is performed annually. In culture laboratories, BSC certification is performed annually. Three culture labs (NTRL, SLH, Batangas MC) were regularly monitoring their lab equipment. All study culture labs have service records for equipment on file.
The laboratory equipment and facility maintenance program is not well organized at this time. Problems related to equipment and facility maintenance and other support systems have led to downtimes in the laboratories. For example, two culture laboratories (LCP, DRH) were rendered non-functional because of malfunctioning air handling units and staff problems. Table 24 below shows the length of downtimes in our study laboratories. A total of 408 days downtime occurred in 2015. Equipment maintenance issues caused the longest downtime (LCP = 220 days, DRH = 60 days).
Table 24. Facility downtime in sample TB laboratories, 2015 No. Type Laboratories Working Causes Days TML Naic RHU 7 Staff attendance to meetings and trainings; leave of absence Carmen RHU 14 Staff attendance to whole day weekly meeting Xpert XU-CHCC 2 Rotating brown-outs (2.5 hours); no generator Culture/DST LCP 220 Malfunctioning air-handling unit SLH 10 Stock-out of NaOH for TB culture processing Region 3 TB Lab 10 Delay in renewal of employment contract
15 Staff attendance to meetings and trainings Batangas MC 10 Due to stock-out of NaOH for TB culture processing DRH 60 Malfunctioning air-handling unit 60 No med tech Total 408
In XU-CHCC, one Xpert module is not functional. The staff reported that their Xpert unit experienced frequent breakdowns but the number of downtime days was not tracked. In Cebu CHO, the biosafety cabinet used for processing specimens and the biological refrigerator for storage of cartridges are non- functional.
In NTRL, the delay in certifying BSCs is due to HEPA filters not meeting the required standard specifications. There are no SOPs for culture equipment maintenance. Delays in facility renovations have contributed to the slow progress in the expansion of culture laboratory services. The imminent pull out of Biomed Services of RITM in 2017 will further delay the certification and maintenance of culture laboratories.
7. Monitoring and evaluation
Monitoring activities are implemented by the laboratory network managers / coordinators at all levels. However, these are not well planned and not adequately supported with funds, time and logistics.
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Monitoring is not well appreciated and not used as a management tool. Monitoring skills need to be enhanced, especially at the national, regional and provincial level. Findings from monitoring activities are not analyzed and shared with the stakeholders.
Evaluation of laboratory network performance is hardly implemented. This is largely due to the lack of skills and resources among the laboratory network managers at all levels to perform evaluation.
8. Leadership and management of the lab network
The strategic direction of the laboratory network was set by the NTP in consultation with NTRL, technical partners and regional coordinators. Policies and guidelines on the use of microscopy, Xpert, culture and LPA have been developed and are aligned with NTP diagnostic algorithms. Coordination of laboratory activities and services are led by regional and provincial coordinators. Strategic planning for the laboratory network was led by NTRL. Annually, NTRL develops plans in consideration of the needs of the laboratory network.
In 2016, NTRL resumed the regional consultative workshop to ensure alignment of regional priorities and activities with regard to the laboratory network. During the regional workshop, technical areas for capacity building were identified by the regions to support lab expansion, improvement of service delivery and scale up of adoption of new diagnostic technologies.
However, the participation of the medical technologist in planning activities at the regional and provincial levels is limited. Laboratory network plans lack the necessary focus to address the local needs. Most of the planned activities are on training and monitoring visits.
Leadership and management capacities of the regional and provincial teams need enhancement; organizational capacities at the regional and provincial levels must be strengthened in order to perform their leadership and management mandates.
9. Biosafety
Biosafety is an important laboratory element that helps ensure the safety of the lab staff and other individuals who come in contract with the laboratory and its vicinity through the application of safety practices inside the laboratory. The NTRL/RITM has developed the National Biosafety Guidelines for the NTP laboratory network. However, these guidelines have not been widely disseminated and implemented.
Laboratories in the study do not have biosafety plans. Biosafety is not given enough emphasis during trainings. Monitoring and supervision of safe laboratory practices is inadequate. None of the study laboratories has a manual on safe laboratory practices. The study lab staffs do not strictly adhere to safe laboratory practices. For example, staffs perform procedures in poorly ventilated laboratory with non-
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functioning BSC (Cebu City Xpert lab) and the SLH medical technologist performs procedures using a non-certified BSC. In two laboratories, ventilation apparently does not conform to published biosafety standards. These scenarios increase the risk of laboratory workers’ exposure to the TB bacilli which may lead to an infection and subsequent disease.
10. Infection control
Infection control is a set of activities aimed to prevent TB infection within the facility including TB laboratory. This is complemented by laboratory biosafety. Almost all (92%) study labs are implementing restricted access to laboratories as part of administrative control. The national infection control guidelines were approved in 2010 but these are not well disseminated or implemented.
Laboratory specific risk assessment was not performed and there are no local IC plans in the study facilities. Most study laboratories do not have spill kits. Respirator fit testing is not regularly done at the subnational level. Screening of laboratory workers for TB infection and/or disease is not regularly done at all levels.
The lack of biosafety SOPs, use of malfunctioning equipment (e.g. BSC); problems in facility design (poor ventilation); as well as issues on supply management of PPEs, contribute to risk of exposure to TB bacilli in addition to the poor biosafety practices of laboratory workers.
11. Waste management
The laboratory services generate a huge amount of waste materials in the course of conducting diagnostic procedures. As new technologies are adopted and more laboratories are established, waste generation increases. When the laboratory waste is not managed properly, it can impact on the environment negatively and pose threats to public health.
The NTP laboratory waste management system is not well developed. National guidelines on hospital waste management exist but are not well disseminated. The implementation of laboratory waste management is not adequately supported with plans, budget, policies and procedures. Standard operating procedures are not available or unclear at all levels.
Laboratory waste management practices show significant gaps and need improvement. In one laboratory, waste is placed in an unlined carton box. It takes a long time before the laboratory waste is disposed because of the delayed collection by a third party medical waste collector. Laboratory staffs do not have information on the final disposal of sputum cups, culture tubes and Xpert cartridges. Monitoring of laboratory waste management is not routinely done.
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Good health governance dictates that leaders should be accountable for the state of the environment. Appropriate and responsible laboratory waste management must be practiced at all levels of the laboratory network to protect people and the environment.
12. Laboratory health promotion and education Laboratory health promotion is important to ensure that health workers and patients are informed so they can better understand the use of TB diagnostic procedures.
In general, information on TB diagnostics is provided only to the laboratory workers and clinic staff. Information provided to patients is often limited to specimen submission. Information on new TB diagnostic technologies is inadequate for the clinic staff. Training for clinic staff on GeneXpert is not done.
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Recommendations
The results of the assessment showed that the full functionality of the NTP diagnostic network is determined by the presence and interaction of the various elements of the laboratory system working synergistically in order to provide quality assured services, and to achieve the desired NTP outputs and outcomes. The following are the recommendations based on the study findings:
1. Human resource system Review and update the staffing pattern, roles, functions and qualifications to meet the needs of the lab network at all levels. Address issues on workplace conditions, disparities in compensation and benefits between contractual and regular employees. Develop a rewards system to acknowledge good performance and significant contributions to the program. Assess task shifting initiatives; expand task shifting coverage where appropriate and effective. Limit multitasking initiatives to a minimum to preserve efficiency and effectiveness of the
staff (e.g. part time EQA controllers from RHUs).
2. Training and supervision Build capacity of the regional and provincial/city staff to implement training decentralization for microscopy, Xpert and EQA; this should include acquisition of competencies on various teaching methods. Standardize the existing training courses and on-the-job trainings. Monitor and evaluate training quality and effectiveness. Develop a course that will enhance the leadership and management capacity of lab network managers. Develop and implement a post-training supervisory program.
3. Financing Explore alternative sources of financing for the laboratory network Implement mechanisms to mobilize LGU resources for laboratory maintenance and operations including training, monitoring and supervision.
4. Information management Enhance the laboratory information system considering mandates, staff, funds, procedures, equipment, supplies, communications capacity and skills.
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Develop the capacity of the regional, provincial/city levels to manage the laboratory information system including planning, monitoring, supervision and evaluation.
5. Supply chain management Increase the capacity to manage laboratory supply chain management cycle at all levels to prevent stock-outs / overstocking, use of expired supplies and ensure quality of supplies according to specifications. Strengthen quality assurance of laboratory supplies.
6. Equipment, facility (physical plant) and infrastructure Develop a maintenance program for equipment, facility and infrastructure. Develop the capacity of peripheral lab workers (e.g. microscopists) through the provision of SOPs, job aids and supportive supervision.
7. Monitoring and evaluation Enhance skills for monitoring and evaluation at all levels Develop M&E plan and secure funds and other resources for its implementation Provide venue for discussions and ensure sharing of monitoring and evaluation results.
8. Leadership and management of the lab network Enhance the planning process to produce evidence based and focused plans Support organizational strengthening at the regional and provincial/city levels to increase the capacity of these levels according to mandates. Develop a framework for effective vertical and horizontal coordination, cooperation and collaboration in the laboratory network.
9. Biosafety Develop a biosafety program for the lab network. Ensure biosafety plans are developed and implemented at all levels. Develop laboratory safe practices manual for all technologies at all levels. Strengthen biosafety component in laboratory trainings Strengthen monitoring and supervision of safe laboratory practices
10. Infection control Develop an Infection control program for the lab network. Develop and implement infection control plans in all facilities at all levels. Monitor the implementation of IC plans
11. Waste management Develop a laboratory waste management program at all levels Develop waste management plans, SOPs at all levels
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Monitor and supervise the implementation of plans and adherence to SOPs at all levels
12. Health promotion Capacitate the lab staff in providing information to patients regarding the importance of TB diagnostics Develop job aids for TB diagnostics to be used for information dissemination Develop and ensure the provision of appropriate training to clinic staff on TB diagnostics
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Annex A Summary of smear quality assessment in study LGUs, 2014-2015
Table A1. Summary of smear quality assessment results in study areas Slides Smear Quality Assessment Points
Actually Specimen LGU Staining Cleanness Thickness Size Evenness Taken Quality No. No. % No. % No. % No. % No. % No. % Quezon City 5,630 4,754 84% 5,289 94% 5,149 91% 5,258 93% 5,185 92% 5,094 90% Baguio City 616 351 57% 521 85% 565 92% 409 66% 508 82% 452 73% Angeles City 1,054 760 72% 920 87% 913 87% 736 70% 744 71% 840 80% Pampanga 5,130 4,601 90% 4,459 87% 4,839 94% 4,236 83% 4,300 84% 4,027 78% Batangas 3,930 2,760 70% 3,758 96% 3,580 91% 2,664 68% 2,303 59% 1,862 47% Cavite 5,289 4,401 83% 4,693 89% 4,771 90% 4,145 78% 4,087 77% 3,805 72% Cebu City 654 516 79% 639 98% 632 97% 442 68% 498 76% 461 70% Leyte 5,060 3,329 66% 4,248 84% 4,201 83% 3,360 66% 3,260 64% 2,456 49% Tacloban City 144 127 88% 136 94% 142 99% 124 86% 123 85% 130 90% Davao City 2,905 2,677 92% 2,779 96% 2,807 97% 2,407 83% 2,553 88% 2,468 85% Davao del Norte 3,211 3,027 94% 3,196 100% 3,154 98% 2,770 86% 3,025 94% 2,873 89% Misamis Oriental 3,064 1,612 53% 2,481 81% 2,531 83% 2,090 68% 1,317 43% 1,117 36% Overall 36,687 28,915 79% 33,119 90% 33,284 91% 28,641 78% 27,903 76% 25,585 70%
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Annex B Types of Inconclusive Test Results (ITR) in Xpert testing among study laboratories
Table A3. Types of inconclusive Xpert test results among study laboratories, 2013-2015
ITR type and 2013 2014 2015 3-Year Total error codes No. % No. % No. % No. % 5007 175 48% 121 20% 149 21% 445 27% Invalid 11 3% 88 14% 223 32% 322 19% 5011 35 10% 135 22% 77 11% 247 15% NR 31 9% 80 13% 71 10% 182 11% 2127 4 1% 87 14% 35 5% 126 8% 2008 71 20% 20 3% 3 0% 94 6% 5006 13 4% 23 4% 33 5% 69 4% 1001 6 2% 12 2% 32 5% 50 3% 1002 3 1% 9 1% 26 4% 38 2% 2014 10 3% 8 1% 17 2% 35 2% 2005 1 0% 5 1% 11 2% 17 1% 2037 1 0% 9 1% 0 0% 10 1%
1018 0 0% 6 1% 1 0% 7 0% 2022 0 0% 0 0% 5 1% 5 0% 1004 0 0% 0 0% 3 0% 3 0% 4017 0 0% 0 0% 3 0% 3 0% 5001 1 0% 0 0% 2 0% 3 0% 2012 0 0% 2 0% 0 0% 2 0% 4009 0 0% 0 0% 2 0% 2 0% 4012 0 0% 2 0% 0 0% 2 0% 2006 1 0% 0 0% 0 0% 1 0% 2025 0 0% 1 0% 0 0% 1 0% 2034 0 0% 0 0% 1 0% 1 0% 4010 0 0% 0 0% 1 0% 1 0% 4015 1 0% 0 0% 0 0% 1 0% Total 364 100% 608 100% 695 100% 1667 100%
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Annex C List of facilities included in the assessment
Region TB Laboratories NCR 1. National TB Reference Laboratory (NTRL) 2. Lung Center of the Philippines – National Center for Pulmonary Research (LCP-NCPR) 3. Philippine Tuberculosis Society, Inc. – Quezon Institute (PTSI-QI) 4. San Lazaro TB Culture Laboratory 5. Quezon City Quality Assurance (QA) Center/ 6. Kamuning Super Health Center CAR 7. Baguio City Health Office QA Center 8. Baguio General Hospital and Medical Center (BGHMC) 3 9. Region 3 TB Culture Laboratory 10. Pampanga Provincial Health Office (PHO) QA Center 11. Lourdes Sur RHU Main (Angeles City QA Center) 12. Sindalan Rural Health Unit (RHU) 4A 13. Cavite Provincial Health Office (PHO) QA Center 14. Batangas Provincial Health Office (PHO) QA Center 15. Batangas Medical Center 16. Batangas City Health Office (CHO) 17. Naic Rural Health Unit (RHU) 7 18. Cebu TB Reference Laboratory (CTRL) 19. Cebu City Health Office (CHO) QA Center 20. Parian Health Center 21. Mabolo Health Center 8 22. Region 8 TB Culture and Xpert Laboratory 23. Leyte Provincial Health Office (PHO) QA Center 24. Tacloban City Health Office (CHO) QA Center 25. Eastern Visayas Regional Medical Center (EVRMC) 10 26. Northern Mindanao TB Reference Laboratory 27. Misamis Oriental Provincial Health Office (PHO) QA Center 28. Carmen Rural Health Unit (RHU) 29. Xavier University Community Health Care Center (XU-CHCC) Xpert laboratory 11 30. Davao TB Reference Laboratory 31. Davao City QA Center 32. Davao del Norte Provincial Health Office (PHO) QA Center 33. Davao Regional Hospital (DRH)
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Annex D List of persons interviewed
National Capital Region (NCR)
National TB Reference Laboratory (NTRL) o Ms. Cristina Villarico – Head, Laboratory Services Unit o Ms. Catherine Ann Sacopon – Medical Technologist o Ms. Maria Althea Sabrina Perez – Science Research Specialist o Mr. Dionisio Cabanela – Laboratory Technician o Mr. Mar Alrey Jumarang – Laboratory Aide
Lung C enter of the Philippines – National Center for Pulmonary Research (LCP-NCPR) o Mr. Randolf Leppago – Medical Technologist o Ms. Maria Theresa Remaneses – Medical Technologist o Mr. Cyryll Castillo – Medical Technologist
Philippine Tuberculosis Society, Inc. – Quezon Institute (PTSI-QI) o Ms. Emily Datoy – Chief Medical Technologist o Ms. Lirio Borlongan – Medical Laboratory Technician o Mr. Ian Paul Resabal – Medical Technologist o Mr. Jerson Hortillosa – Medical Technologist o Ms. Rowena Madres – Medical Laboratory Technician
San Lazaro TB Culture Laboratory o Dr. Arlan Lopez – Laboratory Supervisor o Ms. Ma. Cecilia Belo – Head, Microbiology Department o Ms. Mayline Kong – Medical Technologist o Ms. Ashley Cynna Ong – Medical Technologist o Ms. Mary Joy Nalangan – Medical Technologist
Quezon City Quality Assurance (QA) Center o Mr. Bernard Yumang – City NTP Medical Technologist Coordinator
Kamuning Super Health Center o Ms. Ma. Jesusa Chua – Medical Technologist o Ms. Niña Jamille Guerrero – Microscopist o Ms. Elena Escoriaga – Laboratory Aide
Cordillera Administrative Region (CAR)
DOH CAR Regional Health Office o Mr. Clint Ildefonso – Regional NTP Coordinator
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Baguio City Health Office QA Center o Ms. Ruby Magsino – City NTP Controller
Baguio General Hospital and Medical Center (BGHMC) o Mr. Andrew Sib-aten – Medical Technologist o Ms. Chris Diane Somera – Medical Technologist
Region 3 – Central Luzon
Region 3 TB Culture Laboratory o Ms. Catherine Toledo – Regional NTP Medical Technologist Coordinator o Ms. Michelle Bautista – Medical Technologist
Pampanga Provincial Health Office (PHO) QA Center o Dr. Maria Imelda Labrador-Ignacio – Provincial NTP Medical Coordinator o Mr. Nickson Manlutac – Provincial NTP Nurse Coordinator o Ms. Catherine Zapanta – Provincial NTP Med Tech Controller
Lourdes Sur RHU Main (Angeles City QA Center) o Ms. Femie Pangilinan – Controller o Ms. Lourdes Pinpin – NTP Nurse Coordinator
Sindalan Rural Health Unit (RHU) o Dr. Emerito Mercado – Medical Officer o Mr. Richard Puno – Medical Technologist o Ms. Lolita Mabalay – Public Health Nurse
Region 4A - CALABARZON
DOH Regional Office 4A (CALABARZON) o Ms. Myla Velgado – Regional NTP Medical Technologist Coordinator
Cavite Provincial Health Office (PHO) QA Center o Ms. Rosemarie Gomez – Provincial Lab Coordinator o Ms. Minda Lingan – Provincial NTP Nurse Coordinator
Batangas Provincial Health Office (PHO) QA Center o Ms. Maria Lourdes Soriano – Medical Technologist o Ms. Viviane Hernandez – Provincial NTP Nurse Coordinator
Batangas Medical Center o Ms. Dessa Joy Bacay – Medical Technologist o Ms. Mary Ann Cuartero – Medical Technologist o Ms. Maria Angelica Castillo – Medical Technologist
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Batangas City Health Office (CHO) o Ms. Catherine Moral – Chief Medical Technologist o Mr. Edwin Chavez – Medical Technologist o Ms. Marie Jane Lumanglas – Medical Technologist o Ms. Vicky Atienza – City NTP Nurse Coordinator
Naic Rural Health Unit (RHU) o Ms. Jennifer Casamar – Medical Technologist
Region 7 – Central Visayas
Cebu TB Reference Laboratory (CTRL) o Ms. Cresilda Cases – Regional NTP Medical Technologist Coordinator
Cebu City Health Office (CHO) QA Center o Mr. Norman Capaning – NTP Medical Technologist Coordinator o Ms. Laurean Jo Cabase – Medical Technologist
Parian Health Center o Mr. Joselito Manubag – Medical Technologist o Ms. Loreta Canencia – Laboratory Aide
Mabolo Health Center o Mr. Owen Joshua Briones – Medical Technologist
Region 8 – Western Visayas
DOH Regional Office 8 o Mr. Flor Jimenez – Regional NTP Medical Technologist Coordinator
Region 8 TB Culture and Xpert Laboratory o Mr. Brendon Sanilla – Medical Technologist o Ms. Raquel Espina – Laboratory Aide
Leyte Provincial Health Office (PHO) QA Center o Ms. Joline Ariza – Provincial NTP Medical Technologist Coordinator o Ms. Evelyn Pacheco – Controller o Ms. Karena Cleofe de Veyra – Controller o Ms. Medly Lou Dimzon – Provincial NTP Nurse Coordinator
Tacloban City Health Office (CHO) QA Center o Dr. Danilo Ecarma – NTP Medical Coordinator o Ms. Imelda Labarda – NTP Medical Technologist o Ms. Nilda Cantay – NTP Controller
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Eastern Visayas Regional Medical Center (EVRMC) o Ms. Ma. Merlina Vistal – Head, Microbiology Section o Ms. Reyna Ann Peques – Medical Technologist
Region 10 – Northern Mindanao
Northern Mindanao TB Reference Laboratory o Ms. Jenny Alabado – Regional NTP Medical Technologist Coordinator o Ms. Perla Sanchez – Laboratory Supervisor o Ms. Rene Fleur Clutario – Medical Technologist o Ms. Irene Abejuela – Medical Technologist o Ms. Marian Paguidopon – Laboratory Aide
Misamis Oriental Provincial Health Office (PHO) QA Center o Ms. Maria Carmela Ditona – Controller o Ms. Stephanie Bolos – Project Associate
Carmen Rural Health Unit (RHU) o Ms. Leah Yvette Pelaez – Medical Technologist o Ms. Juvy Madarang – Medical Technologist
Xavier University Community Health Care Center (XU-CHCC) Xpert laboratory
o Ms. Cheerwind Agcito – Medical Technologist
Region 11 – Davao Region
Davao TB Reference Laboratory o Ms. Sonia Dapitanon – Regional NTP Medical Technologist Coordinator o Mr. Jordan Kintanar – Medical Technologist
Davao City Chest Center (QA Center) o Dr. Ashley Lopez – City NTP Medical Coordinator o Ms. Maria Theresa A. Bien – City NTP Medical Technologist Coordinator o Ms. Cynthia Garcia – City NTP Nurse Coordinator o Ms. Viluz Dimatulac – City NTP Controller (Main Laboratory) o Ms. Melody Maghari – City NTP Controller (Main Laboratory) o Ms. Marites Saco – City NTP Controller (Main Laboratory)
Davao del Norte Provincial Health Office (PHO) QA Center o Ms. Ruby Rosal – Provincial NTP Medical Technologist Coordinator o Ms. Glomerlina Laag – Provincial NTP Nurse Coordinator o Ms. Gemma Nadine Eustaquio – Provincial NTP Controller o Mr. Raymundo Rosales I – Provincial NTP Controller o Ms. Rea Mae Navigar – Provincial NTP Controller o Mr. Reynaldo Rala – Provincial NTP Controller
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o Mr. Lougie Depra-Provincial NTP Controller o Ms. Leona Olila- Provincial NTP Controller
• Davao Regional Hospital (DRH) o Mr. Jenry Mibato-Medical Technologist
Draft version - please do not quote or circulate
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