JOINT REVIEW OF THE NATIONAL TUBERCULOSIS PROGRAMME OF

LEBANON

Carried out by the World Health Organization, International Organization for

Migration and the Ministry of Health of Lebanon

1 – 6 November 2015

Report

Acronyms and abbreviations

AIDS Acquired immunodeficiency syndrome COPD Chronic obstructive pulmonary disease CXR Chest X-ray DALY Disability-adjusted life years DOTS A brand name for the WHO-recommended strategy for TB control; it constitutes the foundations for the Stop TB Strategy and End TB StrategyDST Drug susceptibility test/testing EMR Eastern Mediterranean Region EMRO WHO Office for the Eastern Mediterranean RegionEPTB Extra-pulmonary tuberculosisFNSR Foreigners who are Not Syrian RefugeesGDP Gross domestic product gross domestic product GF Global Fund HIV Human immunodeficiency virusIOM International Organization for Migration IPT Isoniazid preventive therapy MDR-TB Multidrug-resistant tuberculosis MOPH Ministry of Public Health NAP National HIV/AIDS Program NGO Nongovernmental organization NRL National reference laboratory NSP National strategic plan NTP National Tuberculosis Programme PAL Practical approach to lung health PHC Primary health care PLHIV People living with HIV PMDT Programmatic management of drug-resistant tuberculosis SOP Standard operating proceduresSNPTB Smear-Negative Pulmonary Tuberculosis SPPTB Smear-Positive Pulmonary TuberculosisSR Syrian Refugee TB TuberculosisTST Tuberculin Skin Test UNHCR United Nations High Commissioner for Refugees UNRWA United Nations Relief and Works Agency for Palestine Refugees in the Near EastWHO World Health Organization

INTRODUCTION AND BACKGROUND INFORMATION Lebanon is located in Middle-East and has a size of 10,400 squared kilometres. It has a border of 709 kilometres with Syria in North and East, Israel in South and Mediterranean Sea in West. The size of its population is 6.2 million inhabitants who belong to more than 15 religious entities. There are also 1.1 million UNHCR-registered Syrian refugees and nearly 500,000 Palestinian refugees; in addition, it is believed that there are 500,000 other Syrian refugees who are not registered. The national territory of Lebanon is administratively divided into six governorates which, all together, include 26 districts. Each district is also divided into sub-districts or municipalities. Eighty eight percent of the total population lives in urban areas and approximately one third in the Capital City Beirut. The gross domestic product (GDP) is estimated at 18,100 US$ (2014 estimates). Approximately 25% of the population is aged less than 15 years, 42% less than 25 and 44% between 25 and 54; the median age is 29.4 years. The population growth rate is estimated at 0.9% in 2015. The crude mortality rate is 4.9 deaths per 1,000 population per year (2015 estimate). The maternal mortality is 15 deaths per 100,000 live births while the infant mortality 7.8 deaths per 1,000 live births (2015 estimates). The life expectancy is 80 years regardless of gender; it is 82 years in females and 78 in males (2015 estimates). Lebanon has a long tradition of free-market economy and does not restrict foreign investment. The Lebanese economy is service-oriented with strong banking and tourism sectors. The 1975-90 civil war seriously damaged Lebanon's economic infrastructure, cut national output by half, and derailed Lebanon's position as a Middle Eastern banking hub. Following the civil war, Lebanon rebuilt its infrastructure by borrowing heavily, mostly from domestic banks, which resulted in an important national debt. The ongoing conflict in the neighboring country of Syria has led to an influx of Syrian refugees, an increase in internal tension and a slow economic growth to the 1-2% range in 2011-13, after a four-year growth of 8% per year on average. Chronic fiscal deficits have made Lebanon’s debt-to-GDP ratio the third highest in the world. It is estimated that approximately 28% of Lebanese population lives under poverty level. The Government has developed and implemented since 2006 actions to alleviate poverty in the framework of programs, such as the National Poverty Targeting Program.

POPULATION HEALTH STATUS Lebanon is in epidemiological transition. Communicable diseases have been decreasing for the last 20 years but still remain relatively frequent in socially disadvantaged groups of population, migrants and refugees. The data of the Ministry of Public Health (MOPH) established for the year 2011 showed that the morbidity related to: i) water- and food-born illnesses was only 0.04% (31% of the cases were associated with viral hepatitis A), ii) vaccine-preventable diseases 0.06% (74% of them were viral hepatitis B) and iii) the other infectious diseases 0.07% (meningitis accounted for 52% of them). Non communicable diseases constitute a major problem of public health in the country. Nearly 10,000 cases of cancer are identified

every year through the services of the existing health care system; the incidence of cancer is estimated at 197 cases per 100,000 population for the year 2014. Mental health issues are one the main causes of demand of care; the lifetime prevalence of at least one mental disorder is estimated at approximately 25%. Among people aged more than 18 years, the prevalence of diabetes is estimated at 13% and that of high blood pressure at 22%. Thirty seven percent of Lebanese aged more than 15 years are tobacco smokers (44% among males and 30% among females). Obesity is high; 27% of adults aged 25 years and above are obese. Road accidents contribute significantly to the burden of health problems in Lebanon. According to the Lebanese Red Cross, 11,161 car accidents, needing first-aid interventions, occurred in 2011. The data collected in 2010 by Internal Security Forces suggest that there were 1.4 injury per accident which resulted in a case fatality rate of 8.4%. World Health Organization (WHO) estimates the number of physically disabled persons at approximately 277,000; nearly 45% of them are aged between 6 and 34 years and 30% between 35 and 65. The age-adjusted rates of mortality from communicable diseases, non communicable diseases and injuries in 2011 were respectively 30, 385 and 41 deaths per 100,000 population. Therefore, death from non communicable diseases is 13 and 9 times more likely to occur than from communicable diseases and injuries respectively. The proportional mortality rates established for the year 2012 (WHO) shows that ischemic heart diseases accounted for 31% of deaths, strokes for 9% and road injuries for 4%; most of the other leading causes of deaths are chronic illnesses such as cancer, diabetes and chronic obstructive pulmonary disease (COPD). Chronic diseases have the highest disability-adjusted life years (DALY); among them, cardiovascular diseases rank first. Infectious illnesses, including tuberculosis (TB) have the lowest DALYs.

HEALTH SYSTEM DESCRIPTIONIn 2013, the total expenditure on health was estimated at 1,092 US$ per capita and accounted for 7.2% of GDP. The Government expenditure on health accounts for nearly 11% of the total Government expenditure. Lebanon has significant geographic discrepancies in health care, but the recent health sector reform has focused on trying to balance access to healthcare across the country and to provide universal health care services through the use of public funds. The MOPH has revised the national health policy after the 2006 war. The goal of this policy is to “improve the health status of the population by: i) ensuring equitable accessibility to high quality health services through fairly financed universal coverage and ii) addressing economic and social determinants of health through trans-sectorial policies”.To this end, a National Health Plan was established in 2007 with the following six objectives: i) reducing the regional discrepancies, ii) improving the overall quality of health service delivery, iii) sustaining health care financing reform, iv) providing and rationalizing cost-effective prescription of quality-assured medicines, v) strengthening national health programs and vi) strengthening the regulation

capability of MOPH. Most of the health work is decentralized at governorate, district and sub-district or municipality levels. This decentralization allows for responsibility and oversight to be spread and places primary authority for inspections and health programs’ implementation as local activity. There are, in Lebanon, 168 hospitals with all together nearly 13,000 beds and among which 28 public hospitals. Most of the hospitals are private and run by charitable or religious organizations, or private physicians’ groups. The MOPH is the only accrediting body for hospitals. It also contracts with hospitals (public and private), creating annual budget with a fixed financial ceiling. The contract is based on quality and accreditation, therefore placing incentive on performance and sound investment practices. Despite the MOPH maintaining financial control, public hospitals have some degree of autonomy via autonomous administration boards. The utilization of public hospitals by population, in the recent years, has increased and attracted more than 40% of hospitalized patients. In addition, there are 960 dispensaries and primary health care (PHC) centres among which 216 are accredited by the MOPH and constitute a PHC network. Seventy PHC facilities are operated by the Ministry of Social Affairs, 47 by MOPH and the rest by NGOs. There are more than 320 laboratories, which are either hospital-based or free-standing. Approximately half of the free-standing laboratories are licensed by the MOPH. Most of the laboratories are concentrated in urban areas, contributing to the unequal distribution of access to health care. The MOPH controls the pricing of pharmaceutical drugs. Lebanon has seven medical schools; four of them are in Beirut. Various categories of health professionals are available in the country. In order to practise, all health professionals need to have a working permit from the MOPH and be registered in their National Order or Professional Union. Besides several categories of health workers such as physiotherapists or laboratory and radiology technicians, there are, in Lebanon, approximately 11,200 registered physicians, 7,400 nurses and 9,950 pharmacists. The majority of physicians and dentists practice in the Greater Beirut Area making the distribution of these categories of health professionals unequal across the national territory. Also, it is important to highlight that nearly 70% of physicians are specialists.Slightly less than 50% of the population is covered by a health insurance in Lebanon. Many Government not-for-profit and private for-profit financing schemes are available. The most important are the National Social Security Fund which covers mainly the employees of private sector and their family members and the Civil Servants Cooperative which covers the regular government employees and their families. The National Social Security Fund covers the employees during their employment period only and not during their retirement. The Government allocates in the budget of the MOPH special allotments to cover the uninsured population with the aim of ensuring universal access to health services. Therefore, the MOPH covers persons who have no health insurance; they account for slightly over 50% of the population. Despite these efforts, the share of out-of-pocket represents nearly 40% of total health expenditure (2012). Formal refugee camps or field hospitals are not currently allowed to be established for Syrian refugees in Lebanon. As a result, the Syrian refugees must use the health care system that exists in Lebanon. They have access to health centres run by

nongovernmental organizations (NGO) partners of United Nations High Commissioner for Refugees’ (UNHCR) and the Ministry of Social Affairs. Given the high costs of medical care in Lebanon and the lack of funding for UNHCR, the Syrian refugees have limited access to secondary and tertiary health care services. The Syrian refugees may use the 27 PHC centres of United Nations Relief and Works Agency (UNRWA) located in 12 Palestinian refugees. There are also health centres which have their own funding. These health facilities may be funded by private donors, charitable groups or beneficiaries not registered with UNHCR. Refugees may only receive secondary or tertiary care from these centers if they have a referral from a UNHCR registered PHC centres.In order to meet the needs of the refugees and work with Lebanon’s health care system, the International Organization for Migration (IOM) in collaboration with the Al-Kayan Foundation has launched the mobile medical unit. The unit includes a doctor, nurse and assistants. The team travels to remote communities where access healthcare is limited and provides free consultations and medications to the patients.

EPIDEMIOLOGY OF TUBERCULOSIS IN LEBANON

Lebanon is a low burden TB country. The last WHO estimates highlighted that 920 persons were newly affected by TB in 2014 while the incidence was 16 new episodes of TB per 100,000 population for the same year. The prevalent number of TB cases was estimated at 1,200 and the prevalence at 21 TB cases per 100,000 population. According to WHO, 89 people died of TB in 2014, which resulted in a mortality rate of 1.6 deaths from TB per 100,000 population. The incidence, prevalence and mortality rate, as estimated by WHO, steadily and sharply declined from 1990 to mid-2000s; since then, the WHO estimates suggest, in contrast, a slight increase in these three indicators. TB care and control are organized in the framework of the National TB Programme (NTP). The NTP adopted the WHO DOTS Strategy in 1998 and established an information system that has generated useful data on TB epidemiology and TB control. The number of TB cases, all forms, notified between 2010 and 2014 increased from 513 to 676 (32% increase). In fact, the number of notified TB patients who are Lebanese remained more or less stable between these 2 years (300 to 340). The increase of notified TB cases was at the expense of patients who are foreigners. Indeed, the number of TB cases increased until 2012 among foreigners who are not Syrian refugees (FNSR) and among Syrian refugees (SR); in 2013 and 2014, the number of FNSR with TB declined slightly but that of SR with TB increased significantly (see Graph 1). Among notified TB cases, the proportion of Lebanese with TB declined from 66.7% in 2010 to 49.4% in 2014, that of FNSR with TB oscillated between 31 and 41% (41.1% in 2012) and that of SR with TB increased from 1.6% in 2010 to 16% in 2014 (see Graph 2).

Among the 676 TB cases (regardless of the nationality) notified in 2014, 46.2% had a smear-positive pulmonary TB (SPPTB), 18.7% a smear-negative pulmonary TB (SNPTB), 35.2% an extra-pulmonary TB (EPTB) and 0.9% a TB relapse. This distribution varies according to the nationality. The proportion of EPTB is much higher among Lebanese while that of SPPTB is significantly higher in FNSR (see Table 1). In 2014, 59.3% of the 676 notified TB cases were females. However, this proportion varies in function of the form of TB and the nationality status of the patient. The proportion of females accounted nearly for 86% in FNSR with any form TB and even more (91%) in those with EPTB (Table 2). This high proportion may be explained by the high number of women among migrant workers.

It is important to highlight that among all the women notified with any form of TB in 2014, 50.1% were FNSR; among women with SPPTB, 61.2% were FNSR (versus only 39.4% for EPTB). Table 1: Distribution, in percent, of the form of TB by nationality status of patient Form of TB Regardless of

the nationality status

Lebanese Foreigners who are not Syrian refugees

Syrian refugees

SPPTBSNPTBEPTBTB relapse

46.2%17.8%35.2%0.9%

36.4%20.5%41.6%1.5%

57.3%13.2%28.6%0.9%

48.6%20.0%31.4%0.0%

Overall 100.0% 100.0% 100.0% 100.0%SPPTB: smear-positive pulmonary tuberculosis;SNPTB: smear-negative pulmonary tuberculosis;EPTB: extra-pulmonary tuberculosis;TB: tuberculosis.

Table 2: Proportion of females among notified cases by form of TB and nationality statusForm of TB Regardless of

the nationality status

Lebanese Foreigners who are not Syrian refugees

Syrian refugees

Any for form of TB

59.3% 44.9% 85.9% 46.7%

By form of TB SPPTB SNPTB EPTB TB

relapse

58.7%50.8%65.1%

33.3%

38.0%39.7%53.6%

40.0%

83.6%87.1%91.0%

50.0%

43.1%33.3%60.6%

------SPPTB: smear-positive pulmonary tuberculosis;SNPTB: smear-negative pulmonary tuberculosis;EPTB: extra-pulmonary tuberculosis;TB: tuberculosis.

The average of age of TB cases notified in 2014, irrespective of the form of TB and the nationality status, was 33.2 years. However this average varies according to the gender and the nationality status; women are younger in all the nationality groups. Lebanese are the eldest (37.4 years on average with 35.1% years for females and 39.2 years for males) while FNSR are the youngest (28.6 years on average with 27.6 for females and 34.9 years for males). The 2014 data show that 78% of notified TB cases were aged less than 45 years and 86% less than 55 years. However, these percentages vary according to gender and the nationality status of patient. They are higher in females than in males regardless of the nationality status. These percentages are much higher for FNSR and SR than for Lebanese (Table 3); for instance, among female FNSR with TB, 56.6% were aged 25-34 years and 99% were less than 45 years (see Graph 3). It is important to highlight that still more than 70% of Lebanese who developed TB in 2014 are aged

less than 55 years. This suggests that TB is affecting persons who belong to the productive age groups of the Lebanese population.

Table 3: Proportion of TB patients aged less than 45 years and less than 55 years according to the nationality status and gender in Lebanon, 2014

Nationality status of patients

< 45 years < 55 years

Regardless of the nationality status:

Males and females Males Females

78.3%66.8%86.1%

85.8%79.9%89.9%

Lebanese: Males and females Males Females

62.7%60.0%66.0%

73.4%72.8%74.1%

FNSR: Males and females Males Females

96.5%80.0%99.0%

98.7%93.3%99.5%

Syrian refugees Males and females Males Females

87.2%81.0%94.1%

96.3%94.8%98.0%

TB: tuberculosisFNSR: foreigners who are not Syrian refugees.

Lebanon has a very low HIV/AIDS burden; UNAIDS estimates, for the year 20014, the prevalence of HIV infection at less than 0.1% in population aged 15 to 49 years and the number of deaths from AIDS at less than 100. Among the 109 new HIV/AIDS

cases reported to the National HIV/AIDS Program (NAP) in 2011, 93% were males and 28% associated with travel to or migration from endemic areas.

Conclusion: Lebanon has a low TB burden. However, TB notification significantly increased to more than 670 cases in 2014 (32% increase since 2010). This increase was made at the expense of foreigners in whom TB detection significantly progressed, including among Syrian refugees. The number of Lebanese identified with TB remained stable around 340 every year and accounted for approximately 50% of TB cases notified across the country. Women who are FNSR constituted a significant proportion of notified TB cases particularly among SPPTB patients. TB is still affecting the most productive age groups in Lebanese population since 70% of TB cases notified in 2014 are aged less than 55 years. Given that HIV/AIDS burden is low in the country, HIV infection is unlikely to contribute, for the time being, to fuelling TB transmission in general population.

ORGANIZATION OF TUBERCULOSIS CONTROL IN LEBANON There is a NTP in charge of organizing TB control in Lebanon. Its role is to implement TB prevention, care and control interventions and activities and to ensure the coordination with the relevant stakeholders such as the private medical sector, the NAP or the hospital network. The NTP adopted DOTS Strategy in 1998 and Stop TB Strategy in 2006 as national policies to fight TB in the country and deployed efforts to implement the programmatic management of drug-resistant TB (PMDT) and to initiate the practical approach to lung health (PAL). However, the NTP does not establish national strategic plans (NSP) to develop and implement strategic interventions and activities to achieve clear goal(s) and objectives.

The NTP is included in the Directorate of Preventive Health Care of the MOPH. It has, at national level, a Central Unit headed by a manager who is medical officer. This unit is responsible for the organization, implementation, supervision, monitoring and evaluation of TB prevention, care and control activities as well as for the management of NTP resources. The Central Unit is assisted by a National TB Committee in: i) developing national guidelines, ii) supervising, monitoring and evaluating NTP activities and iii) facilitating the coordination with the key stakeholders and partners. TB prevention, care and control interventions and activities are developed and implemented through a network of eight TB centres located in the six governorates. Four governorates have one TB centre each (Beirut, Mount Lebanon, North and Nabatiyeh) and the remaining two governorates two each (Bekaâ and South). Each TB centre is under the responsibility of a chest physician who supervise a team including one to three nurses, clinical workers, a laboratory technician in charge of TB sputum smear microscopy, DOT workers; the TB centre equipped with X-ray machine has an X-ray technician. The NTP Central Unit is located in the TB Centre of Beirut (Karantina Centre) and the NTP manager is also responsible for the care activities undertaken in this centre.

Patients are referred from the private medical facilities, PHC centres or hospitals (public and private) to the TB centres for the provision of TB diagnosis and treatment services. Each TB centre covers a part or the totality of a governorate, depending on the number of TB centres available in the governorate. All the TB centres are assumed to ensure chest X-ray (CXR) and sputum smear examinations to the patients with presumable TB who are referred. All TB patients who need hospitalization in Lebanon are hospitalized in Armenian Azounieh Sanatorium. The treatment of patients with multidrug-resistant (MDR) or extensively drug-resistant TB is initiated and monitored in this health facility. The Sanatorium has a TB laboratory ensuring sputum smear microscopy and X-ray equipment. The laboratory network of the NTP includes the TB microscopy laboratories of chest centres and a National Reference Laboratory (NRL) hosted at the Bacteriology Laboratory of American University Beirut Medical Centre. Culture, Xpert testing and drug susceptibility tests (DST) are performed in the NRL. Xpert testing is also carried out in the Karantina TB centre of Beirut. In addition, seven Xpert machines are available in the private health sector. Besides the NRL, DST is performed in two other laboratories: one public and one private. The NTP has adopted the WHO requirements for the implementation of its information system regarding TB epidemiology and control in Lebanon. A case-based data set has been developed and is hosted in the NTP Central Unit. TB prevention, care and control activities are fully funded by the MOPH through the Directorate of Prevention Health Care. However, no budget is specifically allocated to the NTP per se. NTP activities have been recently supported by Global Fund (GF) funding through IOM; this support focuses on improving and strengthening TB care and control services for Syrian refugees. NTP developed a network of partners mainly from universities, medical professional associations and societies and private health sector. According to the WHO estimates, 73% of incident TB cases that appear in Lebanon population were detected in 2014 and only 71% of TB patients, who were put on treatment, were successfully treated in 2013.

OBJECTIVES OF THE REVIEW The joint review of the NTP of Lebanon was undertaken by the MOPH, IOM and WHO-Eastern Mediterranean Region (EMR). The objectives of this review were:

to assess the level of development and implementation of the approaches adopted by the NTP to control TB in the country, including those targeting Syrian refugees;

to evaluate the managerial capacities and the strategic orientations of the NTP;

to provide guidance to strengthen TB prevention, care and control services; to recommend strategic actions in order to accelerate the decrease in TB

burden toward the elimination of TB in Lebanon.

DESCRIPTION OF THE REVIEW IMPLEMENTATION

The review was undertaken on 2 to 6 November 2015. It was carried out by one team which included four international TB experts, one international and one national staff from IOM Office in Lebanon, one international staff from the WHO Office in Jordan, one senior epidemiologist from Lebanese University and the NTP manager of Lebanon. After briefing meetings held in the WHO Office of Lebanon and NTP Central Unit, the review team made field assessments and met relevant staff and stakeholders in 14 sites across the six governorates. The field visits took place in a PHC facility, TB centers, Syrian refugee communities, hospitals and laboratories; a full session was devoted to meet the board of the Lebanese Pulmonary Society during the review.

OBSERVATIONS MADE IN THE REVIEW

1. Political commitment1.1. Strengths A national program for TB control was established few decades ago and has been maintained to date despite other competing health priorities such as chronic diseases that constitute a major problem of public health in Lebanon. TB prevention, care and control services are financed with public funds through the general budget allocated by the Government to the MOPH. The public funding covers the anti-TB drugs’ supply, some equipment and running costs. All TB patients, including foreigners, are treated and followed free of charge all over the national territory. The NTP is structured; it has: i) a Central Unit whose role is to organize the implementation of TB control interventions and ii) TB centres which ensure the provision of TB prevention, care and control services to population across national territory. The salaries of all the staff of the Central Unit and TB centres are covered by the budget of MOPH.

1.2. Challenges Because of the demographic and epidemiologic transitions, many chronic diseases are emerging in Lebanon. Some of these illnesses, such as cardiovascular diseases, diabetes, cancer or COPD, are major problems of public health. Chronic diseases constitute the first cause of death and, therefore, have received significant attention from health policy makers. Interventions to control the burden of these diseases and conditions, such as smoking and obesity, are presently included in the top priorities of the national health policy and are promoted and politically supported by various and powerful medical professional associations as well as by academies. Given the important burden of chronic diseases and their high visibility within the medical communities of Lebanon, much more attention may be given, in terms of funding and priority in the national health agenda, at the expense of TB control. As matter of fact, in the last National Strategic Health Plan developed in 2007, TB control is not specifically mentioned among the interventions to meet the Objective 5 entitled “Strengthen the MOPH Preventive Programs” while Enlarged Program of Immunization, NAP, Non-Communicable Disease Program and registries for cancer and heart diseases are clearly identified.

There is no earmarked budget allocated to the Central Unit of NTP to cover the costs of training, supervision, monitoring missions and meetings. The role of the PHC network in TB care and control services’ provision is not defined.

2. Management of NTP2.1. Strengths The managerial functions of the Central Unit of the NTP focus on: i) the establishment of the national policy to prevent and control TB in Lebanon, ii) the development of norms and standards for TB prevention, care and control at national level, iii) the implementation of strategic interventions and activities in line with these norms and standards, iv) the management of TB drugs, vi) the coordination with the eight existing TB centres, the Armenian Azounieh Sanatorium and the NRL, v) the monitoring of the implementation of NTP interventions and activities and the evaluation of their outcomes, vi) the collaboration with the other health sectors, especially with the private medical sector and vii) the coordination with the TB National Committee as well as with national and international partners, such as Lebanese Respiratory Society, IOM, UNHCR or UNRWA. There are TB Centres available in all the six governorates. They are the referral facilities for patients who need to be assessed and managed for TB. Therefore, they constitute the main providers of TB prevention, care and control to population. They ensure a communication and relation with the PHC network, the private medical sector, hospitals and the other health sectors. TB centres are the health facilities where information on TB epidemiology and control is collected for the NTP. The NTP adopted DOTS strategy in 1998 and Stop TB Strategy in 2006. In collaboration with the TB National Committee, the NTP developed treatment guidelines in 2006 and PAL guidelines in 2009. More recently, a new TB guidelines’ document has been prepared and is in process of finalization in collaboration with TB National Committee and Lebanese Respiratory Society. The NTP has developed an adequate work relation with IOM; this has created a good momentum which focuses on the provision of TB services for Syrian Refugees.

2.2. Challenges The Central Unit of NTP, which is hosted in Karantina TB Centre of Beirut, is staffed with 11 health professionals under the leadership of the NTP manager. Most of their work deals with the provision of TB diagnosis and treatment services to patients who are referred from the private and public health facilities located in Beirut Governorate. The Central Unit does not devote enough time to the programmatic management of TB control in Lebanon; only the NTP manager, the monitoring and evaluation officer and the pharmacist are ensuring, on part time basis, some managerial activities for the NTP. The existing TB treatment guidelines were developed 10 years ago; they are outdated and not available for the staff working in the health facilities visited during the review (as highlighted above, new guidelines’ document is in the process of finalization).

The Central Unit is not used to establish work plans; therefore, the NTP has no NSP with clear goal(s) and operational objectives which should be targeted by strategic interventions. The NTP has no training modules and programs for the health workers who should be involved in TB prevention, care and control. In fact, there is no budget line for training on TB prevention, care and control. The role of the PHC system in the development and implementation of NTP activities is not well defined. The NTP did not develop standard operating procedures (SOP) which can be used on routine basis by PHC workers. Some sensitization sessions are organized on ad hoc basis for health staff practising at PHC level. The supervision of NTP activities’ development and implementation is not organized and not undertaken at any level. There is no national guidelines nor checklist to carry out a supervision visit. In addition, there is no budget line for supervision activities. There is no quality control for TB laboratory activities organized and carried out on routine basis under the supervision of the NRL. Except for collecting data on TB detection, notification and treatment, the TB centres are not developing nor involved in any programmatic activities for NTP such as the establishment of annual operational plans for their governorate or the capacity building of the health professionals practising in the PHC network. 3. Management of patients with TB symptoms and TB detection3.1. Strengths Patients with presumptive TB are usually identified in the private medical sector, PHC facilities or hospitals and referred to the TB centres of Governorates for TB assessment; some of the patients are directly referred to Armenian Azounieh Sanatorium. The process of TB assessment usually includes CXR and tuberculin skin testing (TST) as a first step; if there is any radiological lesion, three sputum smears are examined by microscopy. Significant number of patients with EPTB are also identified in TB centres; the diagnosis of EPTB is based most often on histopathological evidence. TB patients are also identified through TB contact investigation and systematic screening of Syrian refugees. All retreatment TB cases who are identified are assessed for drug-resistant TB through Xpert testing and DST.

3.2. Challenges In practice, there is no working definition of presumptive TB which can be used by health workers to identify the patients who need to be evaluated for TB. The interviews of health workers during the review showed that they use confusing and non standardized definitions. In addition, the definition of presumptive TB is not clearly identified in the national treatment guidelines’ document, even in the new one which is on the process of finalization (see “Recommendations” in paragraph “X” entitled “Diagnosis of TB”). In the draft of the new guidelines’ document, the process of diagnosis TB is confusing, not in line with the WHO guidelines and not clearly prescriptive. Most of the TB centres are not equipped with X-ray machine (ex.: TB Centres of Tripoli and Zahlé) and, therefore, CXRs are made in hospitals or in private medical

sector and for which the patients should pay at least 10 US$. In not all TB centres (ex.: TB centre of Zahle), TB laboratories are not functioning and, therefore, sputum smear microscopy is carried in private sector or hospital and for which patients should pay. These payments (CXR and smear microscopy) in private sector or hospital are directly made by Lebanese while it is ensured by IOM for Syrian refugees. It is not clear to which extent the PHC facilities are contributing to the identification of patients with presumptive TB. Most of the health workers practicing in this category of health facilities have not been trained on the identification and management of patients with symptoms compatible with TB. For instance, the PHC facility called Taal Abaya Health Center (Zahle), visited during the review, which usually deals on average with 2,000 care seekers every month has nearly no linkages with the local TB centre. There are no data collected systematically on the process of identification and management of patients with presumptive TB, except for those specified in the TB microscopy registers. NTP data for the year 2014 show that bacteriological confirmation by smear microscopy was 64, 71 and 81% for pulmonary TB in, respectively, Lebanese, SRs and FNSRs. These percentages may suggest that the process of TB diagnosis is unequal according to the nationality. The high percentage of smear-positive cases among FNRSs may indicate that foreign workers may have more extensive pulmonary lesions than Lebanese; this may also suggests that FNSRs have some obstacles to access TB diagnosis services. In addition, the smear microscopy confirmation of pulmonary TB is relatively low in Lebanese citizens. This observation points out that the clinically established diagnosis of TB might be doubtful in some of these patients. Like many other countries of WHO EMR, the proportion of EPTB cases among notified TB patients is high, especially among Lebanese (41%); however, the NTP has not yet defined and standardized procedures to establish the diagnosis of EPTB.

4. TB laboratory The private sector ensures a significant proportion of TB laboratory services, including microscopy, conventional culture, DST and tests using molecular methods (ex.: Xpert testing). Functional TB microscopy laboratories are currently available in five TB centers and in Armenian Azounieh Sanatorium (for hospitalized patients). In line with the NTP policy, specimens taken from all previously treated patients and selected new patients (people living with HIV (PLHIV), prisoners, MDR contacts, patients from high MDR countries, patients who are still smear-positive at the end of intensive phase of treatment, history of treatment with unknown quality drugs) are sent to Karantina TB Centre of Beirut for Xpert testing and, if needed, culture and DST. Liquid culture and first-line DST are conducted in the NRL (American University of Beirut) in line with an outsourcing agreement. An Xpert machine has been recently implemented in Karantina TB Centre of Beirut where samples are tested for preliminary evaluation.

4.1. Strengths

There is a functional microscopy laboratory network with a centralization at Karantina TB Centre. Effort has been made to increase the number of microscopy laboratories within NTP network. The procurement of equipment and supplies are under the responsibility of and ensured by the NTP Central Unit. There are appropriate capacities to detect TB and resistance to rifampicin using molecular technology are available in country (ex.: Xpert testing). The transportation system of specimens taken from patients is ensured across the country. There is a policy established by the NTP to initiate Xpert testing and conventional culture/DST. 4.2. Challenges In general, the sputum smear examinations are carried out in poor conditions in the existing microscopy laboratories. There is no standardized TB laboratory registers. There is nearly no external quality assurance system for smear microscopy. External quality assurance procedures are occasionally proceeded in some workshops. NTP needs of culture and DST are ensured by one site only at the national level. There is no linkages with a supra-national reference laboratory. There is no attempt of bacteriological confirmation of EPTB using Xpert testing and/or culture. Sustainability of laboratory services is of special concern as six of the ten laboratory technicians are recruited under the GF grant through IOM.

5. TB treatment5.1. Strengths The TB treatment regimens used in the NTP network are in line with the WHO recommendations. Most of the TB treatments are prescribed in the TB centres of NTP. The indications of the treatment regimens tend to be respected by the physicians of TB centres; most of the physicians of TB centres are chest specialists. Treatments are provided to patients in TB centres only. In some TB centres, the TB drugs’ intake is directly supervised for pulmonary TB during the intensive phase of chemotherapy; this supervision is ensured by a health staff called “DOT Worker”. The TB medicines are provided to patients on regular basis (ex.: weekly basis) during the continuation phase of treatment and when patients are treated for EPTB. In some TB centres, the TB treatment is regularly monitored, during its continuation phase, using CXR and sputum smear microscopy (ex.: Tripoli TB centre; monitoring every 1-2 months). Some of the patients are hospitalized and treated in Armenian Azounieh Sanatorium, their treatment is directly supervised by health staff on daily basis and their sputa are examined with microscopy every week; they are discharged from hospital when they become smear-negative at the microscopy examination. It is important to highlight that some patients are also treated in the private medical sector in coordination with the relevant TB centre. The treatment of Syrian refugees is, whenever possible, directly supervised by volunteers in the refugee shelters. In some settings, mobile phones are used by health workers to strengthen TB treatment adherence. All TB patients, including migrant workers and refugees, are diagnosed, treated and followed free of charge. The migrants workers who developed TB are not deported outside the country.

TB drugs are appropriately and closely managed by NTP from the Karantina TB Centre of Beirut; a pharmacist is appointed to ensure all the necessary tasks. There has been no shortage of TB drugs for the last 12 months. The presentations, formulations and dosages of TB medicines used in the NTP network are in line with the WHO and Global Drug Facility requirements; paediatric fixed-dose combinations are available and provided through NTP services. TB drugs are available in the private pharmacies but not sold without any medical prescription.

5.2. Challenges The indications of TB treatment regimens may not be in line with the WHO recommendations in some TB centres (ex.: Zahle TB Centre). The treatment regimens included in the draft of the new TB treatment guidelines document are not prescriptive enough; in many instances, they are not clearly specific for the duration of treatment. In addition, the description of the retreatment TB cases’ management in this draft is not in line with the WHO recommendations. Challenge TB treatment is used to establish the diagnosis of TB in some TB centres (ex.: Tripoli TB Centre); therefore, the diagnosis of TB may not be established on bacteriological and/or clinical evidence. The provision of TB treatment is not decentralized in the PHC facilities which are the closest health units to patients in their communities. The TB treatment services are still centralized in the TB centres of governorates; this may constitute an obstacle for TB patients to access treatment services. In many TB centres, the direct supervision of TB treatment is not implemented; the conditions under which it needs to be undertaken are not clear. Also, the monitoring process of TB treatment administration during the continuation phase is often not in line with the WHO recommendations. In one TB centre visited during the review, the monitoring is quasi absent. In addition in the draft of the new treatment guidelines document, there is no clear indications on how to ensure the monitoring of TB treatment in patients. The TB treatment success rate was 71% only in 2013, which is far below the 85% minimal rate required by WHO.

6. Information system6.1. Strengths The NTP has developed and implemented a standardized information system. TB treatment registers are available in the health facilities (Governorates’ TB Centres and Armenian Azounieh Sanatorium) where the diagnosis and treatment are undertaken. Treatment cards are widely available. The definitions of TB cases and treatment outcomes are adequately used by health staff in some of the TB centres visited during the review. The information on the bacteriological monitoring and follow-up of TB patients is available and included in the TB treatment registers in some of the TB centres. In some TB centres, the registers and the treatment cards are appropriately completed and the information they include is consistent.

Each governorate TB centre sends, every month, to the NTP Central Unit the list of TB patients who have been newly registered in the TB treatment register as well as follow-up information on TB patients who are already treated. The lists received from all the Governorate Coordination Units are compiled in the NTP Central Unit. All the information on each TB patient is entered in a data set using a computer programme. The collection and compilation of the information on the treatment outcome of each patient follow the same process.

6.2. Challenges There is no standardized information system on the identification and management of patients with presumable TB. Therefore, the data on the process of TB detection are not systematically collected nor analysed in TB centres and NTP Central Unit. In contrast to other TB centres, the definitions of TB cases and treatment outcomes are not correctly used and TB treatment registers appropriately completed in some of the TB centres visited. Some on the physicians working in the TB centres do not have a full knowledge of the WHO definitions and TB treatment regimen categories. In addition, the definitions of TB cases and treatment outcomes, the description of the NTP information system and the instructions on how to use this information system are not clearly specified in the draft of the new treatment guidelines’ document of NTP. In some TB centres, there is a discrepancy between the data registered in the TB register and the data forwarded to the NTP Central Unit. Given that data are forwarded to the NTP Central Unit every month, no quarterly reports are established in the Governorates’ TB centres; no data analysis is carried out on quarterly basis to assess the progress made in TB detection and treatment outcomes. The cohort analysis of the patients “transferred in” is not carried out at national level; therefore, its integration in the overall cohort analysis, is missed. Furthermore, there is no information system on TB contact investigation activities well established in the NTP network. The information available on the contribution of TB contact investigation to TB detection is not quite reliable. The draft of the new treatment guidelines’ document includes a section on this intervention but does not specify any indications on how to monitor its implementation and evaluate its outputs. The case-based data set established in the NTP Central Unit is not usually analysed in depth; in general, the analysis made at this level is not well focused. Moreover, the case-based data set does not include further information on social, behavioural, environmental and health factors that are inherent to TB patient. The available data are not used to raise hypotheses for operational research to help NTP improve its performance. No annual report on TB epidemiology and TB control situation in Lebanon is prepared and produced by NTP Central Unit to inform decision and policy makers and partners. 7. TB/HIV collaborative activities7.1. Strengths

The HIV/AIDS control in Lebanon is organized in the framework of a national program: the NAP. TB patients who are identified HIV-positive are referred to NAP sites for the provision of HIV care package. All co-infected TB/HIV patients are treated and followed for their TB in the governorates’ TB centres. Isoniazid preventive therapy (IPT) in PLVIH is included in the national policy.

7.2. Challenges In the draft of the new NTP guidelines’ document, there is no description of the measures that must be taken through the NTP services for HIV. There is still no clear coordination body established between the NTP and the NAP that would facilitate the integration of activities of the two programmes.It seems that most of TB patients identified in the TB centres are not systematically screened for HIV infection. For instance, there is almost no information on HIV screening of TB patients in the treatment registers of TB centres visited during the review. There is no information on the systematic TB screening in PLHIV as well as on IPT in PLHIV with no active TB. There are almost no data available on TB/HIV collaborative activities in the TB centres visited during the review.

8. Multidrug-resistant tuberculosis8.1. Strengths WHO estimates the number of patients with MDR TB at 10 among notified pulmonary TB and retreatment TB cases for the year 2014. The laboratory capacities to identify MDR TB are available in the country, namely nine Xpert machines (one in Karantina TB Centre of Beirut, one in the NRL and seven in private laboratories) and DST in two laboratories. The indications to undertake Xpert testing are clearly specified in the national policy. All MDR-TB cases identified through NTP network are treated free of charge. Indeed, the treatment with 2nd line anti-TB drugs was initiated for 5 patients within the year 2014. All patients with MDR TB are hospitalized and receive their medications in Armenian Azounieh Sanatorium until they become bacteriologically negative; then, there are discharged and referred to the relevant TB centre where their treatment is continued. On the day of the review visit to Armenian Azounieh Sanatorium, three MDR TB patients were hospitalized and on treatment with 2nd line anti-TB medicines.

8.2. Challenges There is no clear strategy to develop and strengthen the capacities of the NTP to manage MDR-TB patients. There is no clear guidance on how to identify potential MDR-TB cases during the monitoring of TB cases who are administered 1 st line anti-TB drugs. There is no clear guidelines on how to manage patients with MDR-TB.

9. Infection control9.1. Strengths Nearly all the TB centres visited are well ventilated; many of them are well designed for air-flow. The renovation of laboratories (Hermel, Zahle and Saida), that were dilapidated, has been initiated and is presently ongoing; this renovation includes the

installment of hood with exhaust fan. The process of construction of the new TB centre of Halba is progressing and taking into account the administrative measures of airborne infection control. Isolation measures are applied in Armenian Azounieh Sanatorium where TB and MDR-TB patients are usually hospitalized. Most of the TB laboratories have hoods with exhaust fans. All the required health workers have access to personal protective equipment. WHO-recommended sputum collecting cups are available in most of health facilities visited during the review. Plastic bags and ice boxes are used for the transport of specimens to the NRL.

9.2 ChallengesThe NTP has not yet developed a national guide on TB infection control; therefore, no clear infection procedures are available for health workers and no training has been undertaken for them. There is no focal person within the NTP Central Unit team for TB infection control. Hand washing facilities are not easily accessible to health staff in most of the TB laboratories and centres visited. The disinfectant used by health workers is not internationally recommended. In most of the TB laboratories (except for that of Armenian Azounieh Sanatorium), there are no clear procedures applied for waste management. The ventilation system with exhaust fans is weak and not well adapted to some health settings; for example, the ventilation is not sufficient in the MDR TB ward of Armenian Azounieh Sanatorium and in the TB centre of Tripoli. The personal protective equipment is not widely used by health staff of TB centres visited. The health staff has no clear knowledge on how to use respirators. In some health facilities, sputa are collected from patients under sub-opitimal conditions in inappropriate environment.

10. TB contact investigation 10.1. Strengths TB contact investigation is included in the national policy to control TB. A specific chapter is devoted to this intervention in the draft of the new NTP guidelines’ document. TB case index and contacts who need to be systematically and actively screened are clearly identified in this chapter and are consistent with the WHO recommendations. TB contact investigation is assumed to be implemented in all the chest centres visited in the review. The contacts are systematically screened by CXR and TST, regardless of the presence of symptoms. Contacts who have radiological lesions are, then, assessed by sputum smear microscopy. Contacts with active TB are registered and treated in line with the NTP policy. In principle, children, PLHIV and persons with immune-deficiency who have no active TB receive IPT. The dosage of isoniazid and duration of IPT are in line with the WHO recommendations. 10.2 Challenges There are no clear national guidelines for TB contact investigation with clear SOPs and algorithm to carry out TB contact investigation (even in the draft of the new NTP guidelines’ document). The index cases for whom TB contact investigation should be undertaken are different across the TB centres; for instance, TB index cases are: i) in Tripoli TB

Centre, those who have any form of TB and ii) in Zahle TB Centre, those who have pulmonary TB. In all TB centres visited during the review, it seems that not all index TB cases, as defined locally, are investigated. There is no clear information system on TB contact investigation activities carried out in the NTP network. No indicators to monitor and evaluate this intervention are identified in the draft of the new NTP guidelines document. The dosage, duration and indications of IPT vary across the TB centres. There is no information on IPT; as a result, the number of contacts who are treated with IPT is unknown and the number of those who completed it is unknown as well.

11. Involvement of all care providers11.1 Strengths It is estimated that 60 to 80% of notified TB cases in Lebanon are identified through the private medical sector. Some TB patients are treated and followed by private physicians; the NTP supplies these physicians with anti-TB drugs to ensure the treatment administration of TB patients. In general, there is a good collaboration between the NTP and the private sector, NGO and faith-based organizations. The NRL belongs to the private sector (American University of Beirut) and ensures many laboratory activities for the NTP such as culture, DST or genotyping. In addition, the Lebanese Pulmonary Society closely collaborates with the NTP in: i) developing national guidelines, ii) promoting NTP strategy in the curricula of the medical schools and post-graduate courses, iii) devoting special sessions on TB prevention, care and control in professional conferences and iv) participating actively in the events organized every year on World TB Day.

11.2 ChallengesEven though significant efforts are made to inform the private physicians, the process of identifying and managing patients with presumable TB in the private medical sector is not fully known. It is still not known to which extent the private physicians are following NTP guidelines when they manage TB patients.

12. TB care and control in Syrian Refugees12.1 Strengths TB prevention, care and control services for Syrian refugees are fully supported by a specific GF grant through IOM. IOM shows a strong commitment to organize and ensure, in close collaboration with the NTP and UNHCR, these services for the Syrian Refugees. Tremendous support is provided by IOM, through its network, to ensure TB diagnosis and treatment for all Syrian refugees who are residing in 1,748 shelters or living in communities. IOM hired four health staff and involves many TB volunteers who are dealing with Syrian refugees on daily basis. In addition, IOM is: i) ensuring the salaries of 29 newly recruited staff who are working, as clinicians, laboratory technicians or nurses, in the NTP network and ii) equipping with digital X–ray machines the TB centres of Beirut (Karantina), Tripoli and Zahle. Adequate linkages have been established between IOM and the NGOs and faith-based organizations that are ensuring health care services to Syrian refugees. All costs inherent to TB care and management for Syrian refugees, such as hospitalization and CXR in private sector, are covered by IOM. IOM with its staff and volunteers initiated

important actions of systematic screening for TB and acute flask paralysis in Syrian refugees using a questionnaire; the refugee who reports any symptom compatible with TB is then assessed for TB through CXR and, if needed, sputum smear microscopy. Between June and October 2015, 70,000 Syrian refugees were actively screened for TB symptoms and, among them, 17 patients with active were identified (0.02%). Approximately 15% of TB cases that are notified in Lebanon are detected among Syrian refugees.

12.2 Challenges The outstanding work that has been undertaken in TB care and control in Syrian refugee settings and the significant support provided to NTP by IOM depend substantially on GF funding. Tremendous efforts were made to identify 17 TB cases among 70,000 Syrian refugees using a questionnaire and then further evaluation; this means that the number of refugees needed to be screened to identify one TB cases was 4,117. 13. Operational research13.1. StrengthsThere are many academic institutions in Lebanon which can develop operational research for programmatic purpose in order to guide NTP towards TB elimination.

13.2 ChallengesGiven the weak capacities of the NTP to undertake in depth analysis of the data collected, the information system of the NTP does not generate hypotheses for operational research that would help the NTP address TB control issues identified through the analysis of the data.No plan has been yet established for operational research regarding TB prevention, care and control in Lebanon.

RECOMMENDATIONSThese recommendations aim at: i) strengthening the visibility of TB prevention, care and control among the national health priorities of Lebanon, ii) addressing the managerial and programmatic issues identified in the NTP services during the review and iii) paving way to implementing a sound national policy to eliminate TB in Lebanon. The recommendations specified below are intended to the MOPH, NTP, IOM and WHO/EMRO.

Recommendations to the Ministry of Public Health

TB elimination should be included in the political health agenda of the MOPH. The political commitment to control TB in Lebanon needs to be strengthened.

The MOPH should continue to fund the NTP.

In addition, the funding needs to be significantly increased in order to develop and implement a policy to eliminate TB in Lebanon.

TB control needs to be promoted and included in all the governorate and national initiatives to alleviate poverty, especially in the National Poverty Targeting Program, Community Social Development Program and the local programs established by Social Development Centres.

TB prevention, care and control services should remain free of charge, including for foreign workers and refugees, as it is presently.

TB care services’ provision should remain free of charge, even in any process of health insurance implementation and during the retirement, particularly for those who were ensured through National Social Security Fund.

A specific budget should be allocated to the NTP Central Unit to undertake and organize activities such as training, supervision, monitoring, partnership building or ensuring a strong collaboration and coordination with important stakeholders, especially with the private medical sector.

Recommendations to the National TB Programme

1. Overall management The role of the Karnatina TB Centres of Beirut, as Central Unit of NTP must be

clearly defined regarding the programmatic management of TB control. Its role in ensuring TB care services for the population of Beirut Governorate needs to be clearly specified and separated from its managerial role.

The job description of the staff working in the NTP Central Unit and TB centres should be clearly defined in order to avoid confusion and overlapping in the assignments to carry out tasks for the programmatic management of TB control and TB care services.

The draft of the new TB guidelines document of NTP needs to fully revised in line with the various new WHO recommendations and finalized. These new guidelines should be widely distributed and their utilisation by the health workers promoted and evaluated.

The NTP Central Unit must develop a NSP for TB prevention, care and control for the coming years (ex.: 2016-2020). This new NSP should focus, besides maintaining sound TB care services, on: i) improving the managerial and programmatic activities of NTP and ii) initiating interventions for TB elimination in Lebanon. To this end, the NSP should have well defined goals and operational objectives and include consistent strategic interventions along with their inherent activities; in addition, it should include a well-established budget, a clear description of the process of monitoring and evaluation, a description of how the plan will be operationalized and an identification of the technical assistance needs. The NSP should also include a preparedness plan.

Based on the NSP, the NTP Central Unit should issue an operational plan for every year in order to specify the interventions and activities that will be undertaken during that year. This operational plan must be shared with the

relevant departments of the MOPH, the Health Directors of Governorates, the heads of TB centres and the relevant partners.

A staff should be appointed within the NTP Central Unit to appropriately organize and monitor training and supervision activities to be undertaken for TB control across the country.

The NTP central Unit should develop a standardized training material in order to strengthen basic TB care and control services in TB centres and PHC facilities. It should be widely distributed and used in the training sessions organized in the Governorates.

Education and training of all doctors, nurses and other health professionals practising in PHC and general hospital outpatient clinics need to be undertaken and carefully planned in order to reach a high degree of awareness and increase the identification of patients with presumptive TB. This training should target selected general practitioners and chest physicians of the private sector.

The annual budget of NTP must include the cost of the training that will be undertaken.

The staff knowledge on TB prevention, care and control should be regularly assessed.

The NTP Central Unit should clearly define the procedures that need to be undertaken to carry out supervision visits at governorate level and in each category of health facility. A supervision checklist needs to be established and a model of report on supervision visit prepared. The observations included in the supervision reports need to be compiled and analysed to orient the trainings programs and agendas established by NTP.

A team of national supervisors should be established by the Central Unit. The cost of the supervision visits that will be planned and undertaken must

be estimated and included in the budget of NTP. The NTP Central Unit needs to establish an information system to monitor

and evaluate the training and supervision activities carried out in the Governorates.

NTP Central Unit must organize, for the staff working in the Governorate TB centres, a training course on the management of a TB control programme, including operational planning, in a governorate. The cost of this training must be included in the budget of NTP.

The NTP Central Unit must work with the NRL to establish a functional external quality control system for TB laboratory activities.

2. Management of patients with TB symptoms The definition of presumptive TB must be clearly specified and identified in

the new guidelines’ document of NTP. A significant emphasize must be given to the utilisation of the presumptive TB

definition in the training sessions that will be organized for health staff working in TB Centres and PHC facilities.

Specific SOPs and algorithms on the identification and management of patients with presumptive TB should be developed and implemented specifically in PHC facilities.

All TB centres must be equipped with digital X-ray and Xpert machines; their access for all patients attending TB centres must be free of charge.

The cost of CXR and sputum examinations, still carried out in private sector for Lebanese patients who have no health insurance, must be covered by National Poverty Targeting Program, Community Social Development Program or the local programs of Social Development Centres.

The NTP should collect data on the number of patients with presumptive TB who are identified and assessed for TB in the TB centres. In the supervision, the process of identification and management of patients with presumptive TB must be evaluated through the TB centre register, CXR register and TB laboratory register.

Physicians practising in TB centres need to meet on regular basis the health staff working in the PHC facilities of their governorates to promote NTP services and provide technical assistance.

TB identification services must be promoted in the health departments dealing with migrant workers.

Algorithms need to be established in order to use Xpert testing in improving the quality of TB diagnosis.

NTP Central Unit should define standardized procedures to establish the diagnosis of EPTB, including when histopathological evidence is used.

3. TB laboratory 3.1. Microscopy laboratories Laboratory facilities should be upgraded. An extensive rehabilitation program is

planned in Halba; it is supervised and financially supported by IOM through the GF grant. However, other laboratory facilities need refurbishment to provide a clean environment with renovated masonry and new painting of room walls. These laboratories should have easy-to-clean benches and chairs adapted to bench work.

The supervision of microscopy laboratories must be strengthened. During NTP supervision visits that will be carried out in TB Centres, more time should be given for laboratory issues. The supervision should highlight and correct irrelevant practices such as the utilization of non-adequate containers for sputum collection while suitable containers are available.

Laboratory registers must be implemented and laboratory technicians trained on their utilization. The importance of laboratory results for a better management of TB patients must be clearly explained. Staff should evaluate their own data and make monthly calculations of number of smears, positivity rate, positive cases detected. These indicators provide an early warning of problems and signal the need for corrective actions. They contribute to staff motivation and self-reliance.

Refreshment training in microscopy must be organized for staff. Even though, the NRL holds a one-day workshop on microscopy with lectures and hands-on training (IOM-sponsored), additional refreshment training needs to be organized with a focus on microscopy techniques and on the optimal use of standard laboratory registers.

As highlighted above, quality assurance of microscopy must be implemented in line with the WHO guidelines. First, provide internal quality control using positive and negative control slides. Control slides should be included in each day's reading and read before patient smears. Second, implement a closer external quality control with blind rechecking of all the smear-positive slides and 10% of the smear-negative slides.

3.2. Culture and DST A new culture/DST laboratory needs to be implemented in North Lebanon. North

Lebanon is the region with the most important population of Syrian refugees and is, therefore, likely the area where more DSTs will be needed. The establishment of a second laboratory performing culture and DST in this region will contribute to minimizing the time of specimens’ transportation which is a key for optimal recovery of TB bacilli and high yield of culture positivity. It has to be noted that for the last 27 DST results released by NRL, 13 were not interpretable due to absence of growth for 6 samples and contamination of the 7 others. The Lebanese University of Tripoli offers a platform with a high technological level (Biosafety cabinets, MGIT automate for liquid culture, Xpert testing) with extensive experience in culture and DST. Moreover, the director of the University is willing to create a containment room to meet the WHO biosafety recommendations.

A tender should be organized to identify the cheapest supplier for the best services and reduce the costs of DSTs. The cost is expected to raise with the increase in number of requests. The present outsourcing agreement should be revised to anticipate the cost increase. If a facility other than the NRL located in the American University of Beirut is identified, particular attention should be paid to safety conditions.

Linkages need to be established with a supra-national reference laboratory for the quality control of DST and supervision. The NRL of American University of Beirut is accredited by the College of American Pathologists. However, the mycobacteriology survey organized by this College does not meet the WHO standards for external quality control of DSTs. The two centers covering the North and South Lebanon should participate in external quality assurance of DST that will be organized by the supra-national reference laboratory of WHO-EMRO.

The indications of Xpert testing must be clarified with respect to the indications of conventional DST.

The quality control of molecular tests should be implemented in order to check the quality of the results of Xpert tests carried out in the NTP facilities (Karantina and the 2 culture/DST centers). This quality control needs to be undertaken in collaboration with the supra-national reference laboratory.

Systematic bacteriological investigation (culture/molecular testing) of extra-pulmonary specimens needs to be undertaken to establish a bacteriological confirmation of EPTB. The NTP should forward, to (hospitals, surgeons, laboratories of the private sector, guidelines addressing the logistics (conditions of collection of specimens, quality of specimens, transportation conditions, etc) for a successful culture.

4. TB treatment The treatment regimen categories and their indications must be clearly

specified, identified and prescriptive in the new TB guidelines document of NTP. They should be in line with the WHO recommendations.

The training that will be undertaken should emphasize these regimen categories and their indications.

The challenge treatment to set the diagnosis of TB must be totally banned; this issue needs to be clearly highlighted in the new TB guidelines’ document of NTP.

TB treatment provision to TB patients, who are not hospitalized, needs to be progressively extended to the network of PHC facilities. PHC workers need to be trained on ensuring the direct supervision of TB treatment for the patients whose anti-TB drugs’ intake needs to be directly observed.

TB treatment should be also provided to patients through the existing network of social workers whenever and wherever possible to improve the direct supervision of anti-TB drugs’ intake.

The monitoring process of TB treatment administration must be carefully and appropriately described in the new TB guidelines’ document of NTP. This monitoring process must be urgently applied in the TB centres.

The cohort analysis must be carried out in every TB centres; this analysis must be done also separately for Lebanese and non Lebanese patients. The NTP must identify why the treatment success rate is below 85% (defaulting?, death?...), where it is low and in which category of TB patients.

5. Information system The new TB guidelines’ document must clearly describe the information

system used by NTP in Lebanon. This document must include the definitions of TB cases and treatment outcomes.

The training sessions that will be organized must emphasize the utilization of the NTP information system.

The supervision visits, that will be organized, should monitor the quality and comprehensiveness of the data collected.

As highlighted above, the NTP should organize the collection of data on the process of identification and management of patients with presumable TB. These data will be collected in the TB centres and compiled in the Central Unit. The following indicators need to be monitored to evaluate this process: i) number of patients referred to TB centres for TB evaluation, ii) number of patients assessed through CXR, iii) number of patients for whom sputum examination was performed and iv) the number of TB cases diagnosed.

On quarterly basis, the number of presumptive TB patients identified should be compared to the number of patients who were assessed for TB through the registers of CXR and TB laboratory.

On quarterly basis, the proportion of patients registered in the TB treatment register should be calculated among the patients who were assessed for TB.

The number of smear microscopies, Xpert tests and cultures performed for TB diagnosis out should be properly recorded, compiled and monitored.

The proportion of patients who have bacteriologically confirmed TB among pulmonary TB cases should be evaluated on quarterly basis and monitored over time.

The quarterly reports on TB declaration, TB conversion at the end of the intensive phase of treatment must be established at Governorate level.

The treatment outcomes should be assessed every quarter, using cohort analysis, in all the Governorate TB Centres.

The TB Centres should forward to the NTP Central Unit the information on the treatment outcome of every TB patient who was “transferred in” in the Governorate. The Central Unit will integrate this information in the national case-based data set.

The NTP Central Unit must establish an information system for TB contact investigation, including clear definitions of the relevant indicators.

Data on TB contact investigation activities must be collected and analysed at all levels. On quarterly: i) the number of contact investigations needs to be compared to the number of TB index cases registered, ii) the proportion of contacts screened and assessed for TB among the number of identified contacts should be evaluated and iii) the proportion of TB cases identified in contacts needs to be calculated among TB patients registered in TB treatment register. In addition, the number contacts who received IPT should be registered and the proportion of those who completed their IPT course evaluated.

Information on demographic, social, environmental and health factors needs to be collected for each TB patient who is registered. The NTP Central Unit will compile this information in the national case-based data set.

The national case-based data set established in the NTP Central Unit must be analysed in depth in order to identify more specific high risk groups for TB (other than TB contacts and PLHIV) as well as areas where TB is more prevalent. This will help to identify target populations or regions for innovative approaches to prevent and control TB. These innovative approaches will need to be defined, designed, implemented and monitored.

The in-depth analysis of the national data will help raise hypotheses for operational research.

The NTP Central Unit needs to prepare and issue an annual report on TB epidemiology and on TB care and control activities’ results. This report will be forwarded to those who need to be informed, namely health workers involved in NTP activities, decision makers and partners.

6. TB/HIV collaborative activities

NTP Central Unit must develop in collaboration with the NAP a national guidelines document on the collaborative TB/HIV activities in Lebanon.

The new TB guidelines’ document of NTP must highlight specifically the joint TB/HIV activities that need to be undertaken.

A functional coordination mechanism must be established at ministerial level between NTP and NAP. This mechanism will help create communication channels, at all levels, between the two programmes and will facilitate the integration of their inherent activities.

The information system of NTP must collect data on HIV activities carried out within the NTP network.

All TB patients who are identified must be tested for HIV infection. All co-infected TB/HIV must receive antiretroviral treatment and co-

trimoxazol. In collaboration with the NAP, the NTP should collect data on: i) the number

of TB/HIV who received antiretroviral treatment and co-trimoxazol, ii) the number and proportion of PLHIV, followed in the NAP sites, who were systematically screened for TB and iii) the number and proportion of PLHIV with no active TB who were treated with IPT.

7. Multidrug-resistant tuberculosis National guidelines for PMDT must be prepared in line with the last WHO

recommendations. The PMDT activities undertaken in Armenian Azounieh Sanatorium should be

maintained and fully supported by the NTP Central Unit. Psycho-social support needs to be provided to MDR-TB patients who are on

treatment with 2nd line anti-TB drugs. The new TB guidelines’ document of NTP should briefly describe the PMDT

component of the national strategy to control TB. In the new TB guidelines’ document, the utilization of Xpert testing, culture and

DST must be clearly described in the process of the monitoring of treatment regimens using 1st line anti-TB medicines.

The NTP Central Unit should establish a routine monitoring system on the process of identification of MDR-TB cases; this system needs to be closely linked to the monitoring system of culture and Xpert testing requests.

A national drug resistance survey needs to be undertaken in order to assess accurately the burden of MDR-TB in Lebanon.

The NTP Central Unit should explore, in collaboration with the NRL, the feasibility of continuous drug resistance surveillance.

8. Infection control National guidelines and SOPs on TB infection control must be established. Training of health workers on infection control procedures should be organized. Dedicated focal person for infection control needs to be assigned within the NTP

Central Unit and in the main health facilities dealing with TB and MDR TB patients.

Air ventilation needs to be maximized in indoor waiting areas using exhaust fans or open window.

TB Centres need to be supplied by hand washing facilities or, as substation, alcohol rub.

Windows should be opened in TB centres and laboratories to maintain ventilation.

Specimen collection area should be carried out outdoor in open air.

9. TB contact investigation and IPT

National guidelines on TB contact investigation must be developed in line with the WHO recommendations and widely distributed to the users. These guidelines should clearly define the index cases and contacts, specify the process of TB screening and assessment in contacts and appropriately define the indicators to monitor and evaluate TB contact investigation activities.

An information system to monitor and evaluate TB contact investigation activities needs to be established in line with the national guidelines. TB contact investigation needs to be included in the training program of

health workers. The possibility of carrying out TB contact investigation activities from PHC

facilities as well as of ensuring IPT in this health facility category should be explored and evaluated.

A specific register on IPT should be designed and implemented in the health facilities. The outcome of IPT needs to be monitored and regularly evaluated.

10. Involvement of all care providers The existing mechanisms of collaboration between the NTP and the private

medical sector and Lebanese Respiratory Society must be maintained and strengthened.

The NTP should promote of NTP policy in the curricula of medical schools and post-graduate courses and in the programs of the conferences of professional medical associations and societies.

The new TB treatment guidelines document of NTP needs to be promoted in seminars that will be organized for private general practitioners and chest specialists in collaboration with the relevant professional associations or societies.

The NTP should monitor the contribution of the private medical sector to TB case detection in Lebanon and regularly evaluate the level of adherence of the physicians belonging to this sector to the NTP guidelines.

11. TB care and control in Syrian refugees The efforts to ensure TB care and control services for Syrian refugees must be

maintained. The successful coordination mechanism between IOM and NTP must be

maintained. The experience on the provision of TB care and control services to Syrian

refugees must be analysed in depth, documented and published to inform international community.

The cost-benefit of the approach to systematically screen Syrian refugees using questionnaire needs to be studied and evaluated.

IOM, WHO and other partners should mobilize funds to maintain the existing momentum.

12. Operational research

The operational research must be oriented towards problem-solving for the NTP.

The in-depth analysis of the data collected by the NTP should identify hypothesis for operational research.

The NTP Central Unit should establish, in collaboration with the existing national research institutions and academies, a national agenda for TB prevention, care and control, with a focus on TB elimination in Lebanon.

The innovative interventions that will be designed will be tested and evaluated through operational research studies.

The programmatic implementations of these interventions will be monitored and assessed through the information system of NTP.

13. Other recommendation The NTP needs to establish linkages with the National Diabetes Program in

order to promote TB care provision in diabetes settings and improve care services in diabetic patients with TB.

Recommendation to the International Organization for Migration IOM should maintain its successful collaboration with NTP, UNHCR, WHO and

the other partners. IOM should help in fund raising for TB control in Syrian refugees.

World Health OrganizationWHO/EMRO Stop TB Unit should:

1. Support NTP to define and establish a national policy to eliminate TB in Lebanon; this policy will define and design innovative approaches, including strategic interventions for active TB case-finding and chemoprophylaxis in specific groups.

2. Technically assist NTP to develop a new multi-year NSP to address the managerial and programmatic issues and initiate actions for the implementation of TB elimination strategy in Lebanon.

3. Provide the technical support to develop the relevant guidelines and training material and to address the managerial and programmatic issues through the mobilization of the required technical assistance.

4. Contribute to providing a technical support to improve the activities to be carried out in the laboratory network of Lebanon.

5. Organize the external monitoring of the multi-year NSP implementation as well as the evaluation of the outcomes of this plan.

ANNEXES

Review team and sites visited

Review team members:

National reviewer Dr Mary Deeb, Epidemiology Department, Lebanese University, Beirut, LebanonDr Abdallah Mkanna, Emergency public health specialist, IOM Office, Beirut, LebanonDr. Hiam Yaâcoub, NTP manager, Beirut, Lebanon

International reviewersDr. Mohamed Abdel Aziz, RA STB EMRO, Cairo, EgyptDr. Novera Ansari, Project coordinator for Jordan and Lebanon Global Fund grant, Emergency Support Team, WHO, Amman, Jordan Dr Kaisa Kontunen, Health Coordinator, IOM Office, Beirut, LebanonDr. Salah-Eddine Ottmani, WHO consultant, Geneva, SwitzerlandDr. Amal Salah, Infection Control consultant, Cairo, EgyptDr. Veronique Vincent, TB laboratory consultant- HEALEXPERT, Paris, France.

Sites visited NTP Central Unit/Karantina TB Centre of Beirut National Reference Laboratory (American University of Beirut) Plage Noor Shelter (Syrian refugee setting) TB Centre of Tripoli Shelter of Camp1 Minieh (Syrian refugee setting) Office of the Lebanese Pulmonary Society (meeting with the National Board) Armenian Azounieh Sanatorium Taal-Abaya Health Center, Tahle TB Centre of Zahle TB Centre of Halba (infection control assessment only)

TB Centre of Beiteddine (infection control assessment only) TB Centre of Saida (infection control assessment only) TB Centre of Nabatieh (infection control assessment only) TB Centre of Tyre (infection control assessment only).

WHO Recommendations for laboratory waste

Waste management:- To minimize the risk from waste, all infectious materials should be

decontaminated, (an approved decontaminant or bleach should be added to sputum cups before discarding).

- Incinerated in an incinerator, or autoclaved.- Discard bags should be used to segregate waste, broken glasses and sharps

should be discarded in safety boxes up to two third.- Decontamination by proper disinfectant for TB :

Phenol:- Used in concentration of 5% in water- Used for decontamination of equipment and single use items prior to disposal.- Disadvantage: highly irritant to skin, mucous membrane and eyes, because of its toxicity and odor phenol derivatives are used.

Chlorine:- Sodium hypochlorite (domestic bleach) contains 50g/l.- diluted to 1: 50 or 1: 10 in water, should be prepared daily- Stored in well ventilated, dark area.- used as general disinfectants, soaking of contaminated materials- Because it is highly alkaline it can corrode metals.Alcohols:- Ethanol or isopropyl alcohol are used at 70% solution- Used for routine decontamination of BSC- Used as hand rub when hand is decontaminated followed by thorough hand wash with soap and water.- Disadvantage: alcohol is volatile; flammable should not be used near flames, andwell labeledPer acetic acid:- Used at 2% conc. Solution stable for 48 hours- It has a rapid action against all microorganisms.- It lacks harmful decomposition product, enhance removal of organic materials and leaves no residue.

Reference: Tuberculosis Laboratory Biosafety Manual 2012

N.B : Azonieh sanatorium is the ideal way for waste storing which should be followed

“To incinerate hazardous waste properly requires an efficient means of controlling the temperature, and a secondary burning chamber. Many incinerators, especially those with a single combustion chamber, are unsatisfactory for dealing with infectious materials or plastics. If this type is used, such materials may not be completely destroyed, and the effluent from the chimney may pollute the atmosphere with microorganisms, toxic chemicals and smoke. However, there are many satisfactory configurations for combustion chambers. Ideally the temperature

in the primary chamber should be at least 800°C, and in the secondary chamber at least 1000°C. In order to achieve the required temperatures, the incinerators must be properly designed, operated and maintained.(page 18 Tuberculosis Laboratory Biosafety Manual 2012)”

Specification of UVGI 1- UV-c lamps of wave length 254 nm (253.7nm) 2- The upper-air UV beam protected with pure medically approved stainless

steel, could be used in the presence of patients and staff3- 8000 working hours 4- covers from 35/75 m²

Special considerations for installing UVGI:

- Using ceiling fans with low speed to ensure the germicidal effect of UV rays as hot air rises upwards due to its low density and replaced by cold air.

- The room ceiling should be more then 2.4m high- The lamp should be installed at 2.10 m high so people cannot look into the

lamp.- The lamp should be of 30w / 18-20m. Square - Cleaning of the lamp should be done every week by 70% alcohol and annual

maintenance is needed or replacement as the lamp works up to 8000hours- Efficacy of UV lamp decrease if humidity is around 70%, this should be put in

consideration

Reference - Riley, R.L., and E.A. Nardell. 1989. Clearing the air-The theory and application

of ultraviolet air disinfection. Am. Rev.Resp. Dis. 139: 1286-1294.- First M.W., Nardell E.A., Chaisson W., Riley R. 1999 Guidelines for the

Application of Upper Room UVGI for Preventing transmission of Airborne Contagion. Part I and II. ASHRAE transactions 105