BackAlpha-1-antitrypsin deficiency is an overlooked problem
If a problem is not talked about, it does not mean that it does not exist. Unfortunately, a similar situation exists in our region with the lack of diagnostics of alpha-1-antitrypsin enzyme deficiency. The study of this pathological condition in Western countries is gaining momentum, but in CIS countries this problem is only beginning to be discussed.
So, alpha-1-antitrypsin (A1AT) is a liver protein, the deficiency of which is manifested by lung dysfunction due to the destruction of structural units of the organ - alveoli, resulting in the development or progression of COPD.
COPD is a chronic lung disease characterised by a decrease in lung function and an increase in "dead" air space (emphysema).
Symptoms of COPD:
- Dyspnoea
- Production of abnormal sputum (mixture of saliva and mucus)
- Chronic cough with choking attacks
- Difficulty with physical activity
- Wheezing
According to the Salauatty Otan Medical Association, there are at least 200,000 people in Kazakhstan suffering from chronic obstructive pulmonary disease (COPD). This disease is particularly prevalent in Kostanay, Kyzylorda, Almaty and South Kazakhstan regions. At the Euro-Asian Respiratory Society it was noted:
"COPD is the only disease among all diseases whose mortality rate continues to rise!"
There are two causes of A1AT deficiency:
- A defect in the gene encoding A1AT occurs in an average of 1 in 2,000 patients
- Liver damage resulting in a reduced ability of the liver to synthesise proteins
In any case, the result is a decrease in blood concentration of A1AT protein and impairment of its ability to inactivate specific proteins-proteases destroying lung tissues.
Thus, A1AT deficiency is an important pathogenetic link in the development of COPD, which, unfortunately, is not taken into account when prescribing treatment in Kazakhstan today.
Why is it necessary to know the A1AT level in the blood?
Firstly, if a patient does not have risk factors for lung disease (under 45 years of age, smoking, working at a hazardous workplace, etc.), but has symptoms of COPD (see above), then A1AT levels in the blood may be an indication for therapy aimed at increasing this protein in the blood. This will help to significantly reduce the rate of disease progression.
Secondly, if a patient already suffering from COPD has concomitant liver disease, it worsens the course of lung disease. If A1AT deficiency is detected in the blood, liver function will need to be restored for effective COPD treatment.
In conclusion, it is worth noting that the development of the scientific and practical sector of medicine in Kazakhstan does not stand still, but is actively developing and adopting the best traditions of the World Health Standards. The recent introduction of the A1AT study in OLYMP CDL has become another step towards improving the quality of life of COPD patients!Attention! Diagnostics of alpha-1-antitrypsin deficiency is available in any treatment room of the OLYMP CDL branches.
Interview of E.M. Suleimenov, General Director of OLYMP branches, to Ulagatty Meditsina magazine
ULAGATTY MEDITSINA
4 (6) AUGUST-SEPTEMBER 2014
Text: Madina Nurgaliyeva
The OLYMP independent clinical diagnostic laboratory was the first in Kazakhstan to be internationally accredited according to the requirements of the International Association of Accredited Laboratories, thereby raising the overall quality of services in the industry. We talk to Yerlan Suleimenov, General Director of OLYMP CDL, about this and much more.
- The "Salamatty Kazakhstan" programme for 2010-2014 ends this year. What are your assessments of the implementation of this programme?
- This year, within the framework of the implementation of the "Salamatty Kazakhstan" state programme for 2010-2014, there have been no significant changes that would affect the development of the private health sector at the system level. Rather, we are talking about individual measures that have been implemented. For example, private haemodialysis centres have opened, a centralised laboratory OLYMP in Karaganda, etc. In the future, we expect a continuation of the Ministry of Health's consistent policy without any surprises, without sudden changes in the tariff rate retroactively.
- How do you feel about the idea of transferring screening programmes to private players with networks throughout the country? For example, for tuberculosis, etc.?
- As for tuberculosis, I would say that most likely, private players will not be allowed to participate in this process, as the problem of tuberculosis is very urgent, and today it is very seriously controlled at the state level. In addition, there are also international players, the DOTS programme has been introduced, so there is a special situation in tuberculosis screening. When it comes to cancer screening, hepatitis screening, or other screenings, there is a different option. But the public sector is not yet ready and cannot fully operate at the republican level, and among private players there are only a couple of such players who can actually realise this and fully provide these services on the scale of the republic. In my opinion, a systemic measure would be to introduce ratings of heads of medical departments in the regions. Now more and more powers are being transferred to the regional level, so it would be logical to transfer responsibility to them as well. This rating should be created based on the achievement of the goals of the state programme for the development of medicine, and specifically private healthcare: development of PPPs, involvement of private players in the implementation of the state order, etc. The test can be carried out based on the results of the current programme and the new stage for the next 5 years. The fact is that in some regions the heads of health departments have taken a tough stance, preventing the private sector from developing. Chief physicians are afraid to work with us for the simple reason that the first head simply "cuts" and restricts the private sector. This can be easily monitored from the list of subcontractors, which shows the extent to which the private sector is present in the process under discussion. This is a serious problem that contradicts the President's policy of developing the private sector in health care.
- You represent a large domestic company in the medical sector. What is your attitude to public-private partnerships (PPPs) in medicine?
- I have a favourable attitude, but to be frank, we are not trying to get involved in this process. There are many things not spelt out in the legislation, there are no specific rules to work by. And it is possible to work successfully only when there are clearly defined rules. It is important for any investor or private investor to participate in PPPs, but as long as the healthcare policy itself is not clearly defined, I think it is inexpedient. Here is one of the clear examples: the April changes of the tariff rate without coordination with entrepreneurs, in my opinion, are not quite legal, because they were not justified by calculations and were not coordinated even with the National Chamber of Entrepreneurs, i.e. the price/tariff policy is not stable. This entails high risks, although PPPs stipulate that tariffs cannot change. Hence the reserved attitude towards such projects. It should also be taken into account that the medical business is a tidbit not only for private companies, but also for state officials who see themselves as managers in the future. Therefore, there is very tough competition even for current chief physicians who know their medical centre well. I believe that it is difficult for a private person who is not in the general health care system to get involved in a project related to the privatisation of health care facilities, especially in connection with PPPs. It is not for nothing that they say that good officials are excellent businessmen. That is why we, having experience in our medicine, a network across the country, and partners who would like to participate in this process, are not going into a PPP for the management of some state hospital.
- How do you assess the results of this year for the market of non-dependent clinical diagnostic laboratories in the Republic of Kazakhstan?
- The market is growing in all directions. For example, a large Kazakhstani company GEM merged with the Russian INVITRO, Azerbaijani investors entered our market with AQUALAB, etc. Kazakhstani companies have started to enter foreign markets more actively. Small urban laboratories are developing rapidly, they have started to position themselves more clearly on the market, expand and compete more boldly. At the same time, there is a qualitative development of the market - in depth. For example, our company alone has introduced more than 20 new highly informative laboratory tests aimed at diagnosing liver pathology, rare infectious diseases, autoimmune processes, oncopathology and allergies.
- How would you characterise this year for your company?
- We are in the trend - we are developing in all areas. As I mentioned above, we are expanding our product line with highly informative and unique tests for our country. We increased the number of outlets across the country by about half, concluded direct contracts for the purchase of reagents from European manufacturers (which allowed us to reduce the cost of reagents by about 20% and more easily "bear" the devaluation of the tenge and price reductions in public procurement), we are entering the Russian market (Omsk), and others. However, the most important thing we focused on this year was the qualitative development of the company, bringing business processes to the international level. In 2014, our laboratory was internationally accredited according to ISO 15189:2012 "Medical laboratories". Specific quality and competence requirements". I consider this to be a great achievement both for the clients and partners of "Olymp" CDL and for our team. Now the results of our tests are recognised in any clinic in the world, which is guaranteed by the ILAC-MRA (ILAC - International Association of Accredited Laboratories) mark on the result form. In conditions when our compatriots are often treated abroad, it is convenient and saves time and money. In addition, it is the completion of a whole stage in the organisational development of the company that lasted several years. At the initial stage, we took training courses and started to implement this standard with the help of specialists. Then we attracted a specialist from Lithuania - Ms Gorina, we concluded a contract with her regarding the preliminary assessment of our laboratory. She audited us according to the 15189 standard in two laboratories - in Astana and Karaganda. More than 80 discrepancies were identified, most of them minor and insignificant, but there were a few critical ones that we corrected. When in 2012 we were ready to be certified according to the 2008 version, the updated 2012 standard came out, which required significant changes.
- What are the differences between the 2007 version and the 2012 version? How significant are they?
- The key thing, perhaps, is that the main emphasis is on raising quality standards, high requirements for working with patients, and the focus on making any procedures we have in the laboratory transparent, easily verifiable at every stage. In 2012, these standards were revised in the direction of tightening. It was necessary to strengthen them by making it mandatory to record the time of biomaterial collection. Accordingly, from that moment it was necessary to record the time of delivery to the laboratory, which cannot be violated. We have such standards, where the delivery time should be 4 hours from the time of collection of biomaterial to the time of its arrival at the laboratory. It is important to see this process at every stage, for each client, for each collection. Everything is recorded - which nurse performed the collection, how it happened, the time of arrival at the laboratory. In order to achieve these requirements, certain costs and efforts were required, ranging from the development of software for laboratory information systems to increasing the number of laboratories, material collection points, etc. These moments are not visible, they take place inside and are unnoticeable to the average person, but they are achieved by significant efforts of the staff. Another important factor to take into account. We have our own region of the world, our own diet - somewhere they eat more meat, somewhere they eat more flour, etc. All this affects the norms, which should be monitored and special norms should be made for the results of tests applicable specifically for Kazakhstan. For this purpose it is necessary to have good laboratories. Like liver tests. There are people who are not sick, they are fine. When a certain number of these healthy people and their indicators according to the results of tests are collected, a norm - our, Kazakhstan's norm - is drawn up. Today we use materials from European manufacturers, and they recommend us these norms. But they always have a caveat that in the territory of your locality you have to get your own values, which you have to implement and use. We do not have this yet. But if we make joint efforts, it would be good to realise this in the future. I think we can also help in this, participate in this process to get and create our own norms. Another change is related to our measuring instruments - these are scales, pipettes, etc., and they need to be checked in special calibration laboratories that have been accredited by the ILAC (International Laboratory Accreditation Cooperation) network. There is no testing laboratory in our country that could ensure fulfilment of the ILAC requirement to the level of traceability of measuring instruments. Therefore, we had to check our equipment in another country, which means time and additional costs.
- Which technical or human issues were more difficult to resolve in the process of preparing for accreditation?
- Strange as it may seem, everything went more smoothly on the technical side, as we had been preparing for this for a long time and our task was to move to this level from the very beginning. Our main goal is high quality, i.e. we set and solved these issues right from the start. We have a special laboratory product, the Laboratory Information System (LIS), and this allows us to build the technological process correctly, i.e. all the stages in laboratories and treatment rooms are marked and organised, everyone knows what to do and how to do it. As for the human factor - this is, from my point of view, the most difficult moment. The work of preparing staff for accreditation is difficult, as people do not know what it is, do not have an understanding and idea of the standards that exist and what is required of them. We had to put a lot of effort to prepare them. And now we have revised their motivation, included additional payment to our staff for accompanying them in preparing the ISO, for its specific application, so that they keep it up to date and use it all the time. If something suddenly happens for some reason, they will lose this motivation. In general, if any medical personnel in our country understood what accreditation is and followed all the procedures, we would be world champions.
- Was the implementation of ISO 15189 worth the "gamble"?
- Absolutely, yes. First of all, for us it is an increase in responsibility and control. For example, each accredited test requires a monthly external quality assessment, a daily internal one, which we carry out in a regulated manner, as well as the costs associated with improving logistics, tightening delivery deadlines, etc. But on the one hand, we have had significant expenses on the quality of services before, and on the other hand, competition is growing, and if we want to remain market leaders, we need to be one step ahead of our competitors. And, of course, there is the important aspect of influencing industry standards. Due to the fact that we have started to implement this standard, many private and public laboratories, especially in Astana, are now forced to pull up to our level with international accreditation. I think it is right: there should be a special laboratory as a reference point, which we can look up to. The game is worth the candle!
- How did you choose a company for accreditation?
- We had two criteria. The first was that the company should be on the official list on the ILAC website and have experience of accreditation not only in Europe. The second, no less important, was that the auditors should be fluent in Russian, so that we could understand each other as clearly as possible and make the most of their knowledge and experience. According to these two criteria, the Slovak National Accreditation Service, which has more than 20 years of experience, proved to be the most suitable.
- Did accreditation affect the work of biomaterial collection points?
- Of course, in particular, time fixation, improvement of the quality of service, etc. In addition, we have designated 2014 as the "Year of High Service". Among other things, this included the introduction of a new format of biomaterial collection points - "Megaprocedure rooms". "Megaprocedure room" is a high-service room, which allows using special technology to serve a large number of people (up to 200 people) in a short time. It's an electronic queue, order, no nervousness. Why is this necessary? We see from our clients that often, when doing some tests, a person does not want others to hear about it. To make customers feel comfortable, we are introducing new technologies and service standards. So far, we have been practising them in Astana and Karaganda, and then we will replicate the positive experience.
- What are the plans for next year?
- There are quite a lot of plans. To date, we have accredited the laboratory only in Astana. According to the plan, there are 5 more laboratories to be accredited. We have a special department that monitors these processes, develops special standards, prescribes procedures, as each laboratory has its own technological features (equipment, purpose, etc.), i.e. different procedures. Given these requirements, it is important to analyse them properly and determine whether any changes are required or whether it is possible to leave things as they are. Then prescribe them. Here, of course, we will widely involve employees of the laboratory in Astana, which has already passed accreditation, to replicate their experience and knowledge among other laboratories. In general, we want to switch to the standard 15189 in all our laboratories, and we have them in all regional centres. Next year will tentatively be either a year of High Efficiency or Efficiency. This is currently under discussion. The question is to make everything transparent, which means minimising our expenses and bringing them to optimal figures. We have already started this process by concluding direct contracts with manufacturers of equipment and reagents (SIEMENS, ROCHE), eliminating intermediaries and reducing costs. Another area is the service department. For example, we joined forces with an educational institution and entered into an agreement with them to train engineers in medical equipment. We gave them analysers to learn how to use and repair them. And these are not just old, faulty analysers, but fully working equipment on which you can perform tests and learn how to disassemble and reassemble them. We will select the best graduates and invite them to join our service team, which operates throughout Kazakhstan. There are plenty of reserves here, and we intend to work on them. Of course, we will expand our product line with tests that are new to our country (molecular genetic tests, etc.). We will develop the Russian market, etc.
The main thing is to work and move forward!
ULAGATTY MEDITSINA
4 (6) AUGUST-SEPTEMBER 2014
Text: Madina Nurgaliyeva