Status of implementation of recommendations for section Case-finding and diagnosis
| Recommendations | Status | Implementation | Institution responsible for implementation | Deadlines |
| Case-finding and diagnosis | ||||
| General recommendations | ||||
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1. Only defined risk groups should be targeted for TB case-finding by fluorography, and the funds saved should be redirected towards other needs of the NTP. TB screening with fluorography is done extensively and includes population groups that are not at special risk of TB disease. The criteria for TB screening should be revised based on their cost-effectiveness and documented by quality-checked data. Financial incentives for TB screening should be carefully reconsidered. |
Not implemented
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State Service
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31.12.14
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| Special recommendations | ||||
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2. TB screening should be optimized by: (i) analysing the yield for each group screened, and (ii) identifying the risk groups to screen based on the higher yields. |
Implemented
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The recommendation is taken into account in the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis”, which is approved with the Order of the Ministry of Health of Ukraine dated 21.12.2012 No. 1091. (Annex 1., page 118) |
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3. A proper diagnostic algorithm should be followed for sputum smear-negative patients, including the use of a broad-spectrum antibiotic and excluding any fluoroquinolone. |
Partially
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In accordance with the applicable Order of the Ministry of Health of Ukraine dated 03.07.2006 No. 433 the protocol of medical aid to patients with community-acquired pneumonia stipulates that fluoroquinolones therapy may be prescribed as an alternative treatment regimen. Proper diagnostic pattern is specified in the unified clinical protocol of primary, secondary (specialized) and tertiary (highly specialized) medical care “Tuberculosis”, which is approved with the Order of the Ministry of Health of Ukraine dated 21.12.2012 No. 1091. (Section А 3, Diagnosis and Treatment Stages, page 55). This pattern, in its turn, must be reflected in local protocols in all regions across Ukraine. |
MOH
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31.12.14
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4. In the absence of a rapid molecular test, the diagnosis of TB should always be confirmed with bacteriological investigation. |
Partially
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Percentage of lung TB diagnosis (category 1-3) confirmed with bacteriological technique totalled: |
UCDC
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On an ongoing basis |
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5. A working group should be set up to develop a strategy for optimizing the national laboratory network, based on a countrywide analysis of the needs of: (i) laboratory services according to population coverage, geographic access and the epidemiological burden of TB; (ii) an upgrading of the laboratories (civil work renovation, purchase of new equipment); (iii) human resources. |
Implemented
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Interagency working group on improvement of laboratory network activity in microbiological TB diagnosis was organized in 2012 and, based on its work results, guidelines “Ways to Optimize Laboratory Network Activity in Bacterioscopic TB Diagnosis in Ukraine” were issued the same year. Developing institution: state-owned institution “F.G. Yanovsky National Institute of Phthisiology and Pulmonology of the National Academy of Medical Sciences of Ukraine”. |
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6. The National Tuberculosis Reference Laboratory should be officially designated, with clear responsibilities and dedicated human and financial resources and located within the National Institute of Tuberculosis and Pulmonology (under a contract with the Ministry of Health) or in another facility. |
Implemented
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The Order of the Ministry of Health of Ukraine dated 02.08.2011 No. 457/70 “On Ensuring Operation of the Central Reference Laboratory of the Ministry of Health and Laboratory Network for Microbiological TB Diagnosis”. |
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7. The quality of laboratory services should be ensured by external quality assurance. |
Partially
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Until 2012, the system of external quality assurance for II level laboratories had not been implemented in Ukraine. In 2012 and 2013, all 27 civilian sector laboratories of the III level successfully passed external quality control (100%). Laboratories subordinating to the penitentiary system had not been included to external quality control until 2013. In 2013, 50% (5 of 10) penitentiary laboratories successfully passed external quality control. Draft Order of the Ministry of Health of Ukraine “On Assurance of Bacteriological Assays Quality Control” is pending approval with the structural divisions of the Ministry of Health of Ukraine. The schedule for quality control assurance in 2014 for microbiological TB laboratories of level III were developed and coordinated with the head of Central Reference Laboratory of the Ministry of Health of Ukraine, including the laboratories subordinated to Penitentiary Service Department of Ukraine. Pursuant to latest update from the Ukrainian Centre for Socially Dangerous Diseases Control, 663 of 777 microbiological TB laboratories of level 1 were subject to external quality control in 2013, which accounts for 85.3%. |
UCDC
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On an ongoing basis |
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8. New tools should only be introduced, such as the rapid diagnosis of TB, when testing results are proven reliable and all new cases detected can be treated with a full course of second-line TB drugs. |
Implemented
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In 2012, rapid molecular DNA diagnostic methods recommended by WHO were implemented in 12 regions of Ukraine. Since 2013, all 27 regions of Ukraine are provided with access to rapid diagnostic methods. In the course of equipment installation across the regions, installation trainings were held by a maintenance engineer at all laboratories. The responsible experts made two monitoring visits to each region in the course of launching rapid diagnostic methods in order to ensure on-the-job training. In 2011 patients with sensitive TB had the limited access to the first-line TB drugs. In 2012-2013, availability of first-line drugs was 100%. In 2011 patients with MDR-TB were provided with second-line drugs for 79%, in 2012 – for 95%, in 2013 – for 102%.* |
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9. The criteria for defining a TB suspect should be improved and promoted widely. |
Implemented
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In accordance with the applicable Order of the Ministry of Health of Ukraine dated 21.12.2012 No. 1091, the unified protocol sets forth the criteria for the identification of TB-suspects and such criteria comply with the WHO recommendations (Section А.3.1.1, page 55). The diagnosis pattern and criteria by which a TB-suspect is identified are also reflected in local protocols on regional and district levels. Since 2012, outreach activities are being carried out, within the framework of All-Ukrainian Awareness Campaign of “Stop Tuberculosis in Ukraine” program (GF) among the population masses and risk groups, concerning major TB symptoms and importance of timely visit to a doctor. Community awareness is ensured with public service announcements (interlinking) broadcast by the national and regional TV-channels and radio stations, awareness-raising posters (interlinking) in public places, distribution of specialized materials among the risk groups etc. |
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10. Sputum smear microscopy should be improved by: (i) teaching patients how to expectorate better; (ii) organizing the transport of sputum samples in rayons and oblasts; and (iii) implementing the front-load method (two sputum samples on the spot) to ensure that at least two samples are available for investigation. |
Partially
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a) Under the awareness campaign of “Stop Tuberculosis in Ukraine” program, awareness-raising posters “Sputum Sampling Rules” (interlinking) were developed and distributed in 2011-2013 among first aid facilities and specialized TB institutions. b) Unified guidelines on development of local treatment protocols for healthcare facilities in Ukraine clearly specify how the patient’s clinical route should be specified. In accordance with these guidelines the patient’s route, sputum smear transportation routes and schedules should be specified in each local protocol. Considering that the percentage of bacteriologically-confirmed new cases of TB in 2011 totalled 34, in 2012 (cohort 1-3) - 39, such low rate may witness of incompliance with the protocol requirements and with sputum smear transportation pattern and conditions. c) Recommendation is not valid, whereas the divisibility of sputum smear sampling according to the unified clinical protocol should total 2. |
UCDC
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On an ongoing basis |
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11. The National Tuberculosis Reference Laboratory should be officially tasked to: (i) prepare national manuals with standard operating procedures for bacteriology and biosafety; (ii) prepare and coordinate the implementation of a training plan and training materials for laboratory procedures; and (iii) provide consultation and supervision on standard operating procedures. |
Implemented
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The applicable Order of the Ministry of Health of Ukraine and the National Academy of Medical Sciences of Ukraine dated November 22, 2013 N 995/102 “On Ensuring Operation of the Central Reference Laboratory for Microbiological Tuberculosis Diagnosis of the Ministry of Health of Ukraine” sets forth that the national reference laboratory is authorized to perform all functions listed in this recommendation. The administrative and maintenance support (equipment and consumables) is not provided from the state-budget of the National Reference Laboratory. Starting January 2013, under the project named “Support to the National Reference Laboratory, the Charity Foundation “Development of Ukraine” finances administrative costs, approbation of new methods. In September 2013, the Foundation supplied equipment to the training room and in July 2013 supplied equipment for rapid TB diagnosis and other laboratory equipment. |
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12. Supportive supervision and quality assurance in the laboratory network should be improved by the establishment of strong level III laboratories in each oblast and the provision of transport for regular supervisory visits. |
Partially
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a) Efficient laboratories of level III were opened in civilian sector in all 27 regions of Ukraine and successfully passed the external quality control in 2012 and 2013. However, 50% (5 of 10) laboratories of level ІІІ which are subordinated to the penitentiary system successfully passed external quality control in 2013. b) Under “Stop Tuberculosis in Ukraine” program (GF), starting 2012 monitoring visits from the national level (reference laboratory) to the regional level and from the regional level to the district level have been financed (since 2013 monitoring visits in 17 regions have been financed with the round 9 grant of the Global Fund, 10 regions have been financed with Chemonics project). |
UCDC
Regional healthcare departments
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On an ongoing basis |
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13. Certification of the appropriate functioning of biosafety cabinets should be carried out urgently and repeated annually. Sanitary–epidemiological service units should be included in training in biosafety principles. |
Not implemented
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For the regular certification of appropriate functioning of laminar flow biosafety cabinets, legal framework should be accordingly amended by Ukrmedderzhstandart (State medical standard of Ukraine) which would regulate this process. |
UCDC
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On an ongoing basis |
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14. A collaborative agreement should be established between the Ministry of Health and the State Department for the Enforcement of Sentences, including who will pay for what, and supervision of the prison level III laboratories ensured by the Ministry of Health oblast level III laboratory. |
Implemented
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The agreement on cooperation between the Ministry of Health of Ukraine (state-owned institution Ukrainian Centre for Socially Dangerous Diseases Control of the Ministry of Health of Ukraine) and the State Penitentiary Department was concluded in December 2013 within the framework of the grant of The Global Fund. Starting 2013, supervision over the laboratories of level ІІІ which join the penitentiary system has been realized by the National Reference Laboratory with the financial support of The Charity Foundation “Development of Ukraine” under the project ”Support to the National Reference Laboratory”. |
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In accordance with the applicable Order of the Ministry of Health of Ukraine dated 17.05.2008 No. 254 ”On Approving of the Guidance for Periodicity of Chest X-Ray Examinations for Certain Population Categories in Ukraine”, preventive X-ray examinations are made twice a year starting the age of 18. Screening examinations, pursuant to this Order, are carried out on a large scale and include those social groups which do not join any groups of TB high risk.