Report on organization of activities, procedures of guaranteeing qualitative dialysis treatment, collective and personal protective equipment against biological agents, observation of epidemiology standards in HD unit at St. Marina Hospital, Varna Translation from Bulgarian:

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		REPORT

Today, 29 May 2003, a commission appointed by Order # 168 of 26-May-2003, its members being: [5 names: Director of Diagnostic and Treatment Activities, Hospital Epidemiologist, Head of Labor Safety, Hospital Matron, Head of Medical Equipment (Engineer)] has drawn up the following report on:

• organization of activities,
• procedures of guaranteeing qualitative dialysis treatment,
• collective and personal protective equipment against biological agents,
• observation of epidemiology standards.

With regard to the information in Letter incoming # VK/273 of 26-May-2003, after a thorough inspection of the premises of the working, administrative and auxiliary rooms, the documents of the hemodialysis clinic, and conversations with the Head of Clinic, Dr K. Nenov, Ass.-Prof., senior nurse , medical staff on duty during the period 27-29-May-2003: doctors, nurses and orderlies, the following has been ascertained:

1. The given data of 40 % virus carriers are exaggerated and incorrect due to patients’ fluctuation. On 28-May-2003, out of total 95 patients on dialysis, 24 are hepatitis C carriers and 6 carry the surface antigen of HBV, i.e. their relative share is 31.6%.
2. The virus carries' dialyzing is performed on separate HD machines; for the carriers of HBV it is performed in a separate, isolated from the common corridor, room with 2 stations, and for the carriers of HCV 8 stations are devoted in dialysis room # 449. Therefore, the requirements of art. 24 from Regulations # 43 for Prevention and Control of the Virus Hepatitis in R. of Bulgaria, published in State Gazette, issue 103/1995 have been observed. The isolation of HCV carriers in a separate room is still controversial in medical circles and it is not regulated in the statutory standards either of R. of Bulgaria or of the countries from the European Union.
3. During the period 22-26-May-2003, there was no case of dialyzing any Belgian citizen on a machine which had been used by an HBV carrier before. This result has been proved after checking the dialyzed patients' schedules (by names, days and hours), their medical documentation (dialysis sheets, disease files, results from medico-laboratory and serological tests for viruses) and detailed discussion with the responsible persons from the Clinic of Hemodialysis.
4. Never, since the creation of the clinic up to this day, has it been allowed that a patient be connected to an HD machine which is not disinfected, even in cases of urgency. The machines are disinfected according to the instructions of Fresenius, the company manufacturer, as given in the accompanying technical and technological documentation. The disinfectants, which are applied, are received as centralized supply from the Ministry of Health. In order to eliminate any risk of nosocomial infection of patients (regardless Bulgarian of foreign ones) highly effective disinfectants are used with wide spectrum of action (bactericidal, fungicidal, tuberculocidal, virocidal) which are regularly changed in order not to allow any development of resistant microbiological strains. The dosage and time of exposition are programmed automatically. The technicians responsible for the technical maintenance of the machines are qualified and competent.
5. The testing of the patients and the staff for the viruses of hepatitis B and C was performed siste,atically and along all indicators until the end of the first quarter of 2002. After the publication of Regulation # 2 for organization and conduct of preventive examinations of persons from 0 to 18 years and observation of chronically diseased obligatory health insured persons, publ. State Gazette, issue 16 of 18-Feb-2003, the time periods of testing follow the instructions.

Reneta Stoyanova's letter, incoming # VK/273 of 26-May-2003, contains assessments and qualifications which interpret too emotionally and tendentiously long known facts and problems of dialysis treatment. We think that instead of giving recommendations for still higher professionalism in the medical cares, the prestige and the good name of St Marina are lowered.

In conclusion, the commission thinks that the created organization of work, the standards of qualitative dialysis treatment and health care of the patients are on contemporary level and meet the most recent achievements of the medical science. The staff working in the clinic is highly qualified and experienced in the field of hemodialysis. The necessary individual protective means are regularly provided as well as disinfectants, detergents, materials and supply for single use. The disinfection and epidemiologic standards are observed. All who work in the clinic are instructed about the risks resulting from the professional contact with biologically active materials, according to the assessment of risk in the working places and the rules of personal prevention.

Commission members [five signatures]