Unclarified questions after two inspections performed in follow-up of an alert about risk of infection with hepatitis for foreign citizens in the St. Marina Hospital HD Unit, Varna City, Bulgaria Translation from Bulgarian:

Original in Bulgarian

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		From: Reneta Stoyanova [address] 9-Jul-2003
To: Mr Chairman of Parliament Commission of Health Cc: Mr Minister of Health Cc: Mr President of R. of Bulgaria Cc: Mr Premier of R. of Bulgaria

Re: Unclarified questions after two inspections performed in follow-up of an alert about risk of infection with hepatitis for foreign citizens in the St. Marina Hospital HD Unit, Varna City, Bulgaria

Dear Mr Chairman, Mr Minister, Mr President, Mr Premier,

I am addressing you not because I have not addressed the competent bodies in the relevant way but because I have not been satisfied by the measures taken by these bodies. When it concerns human life and health, even the slightest flaw could be fatal, and the bodies who took up the inspections in follow-up of my alert seem to have allowed certain negligence in their work which I shall try to prove herewith.

By the end of May, two inspections were made in the abovementioned HD unit in follow-up of my alert (see Supplement 1. Risk of infection with hepatitis for foreign citizens) whose results were submitted to me (see Supplement 2. Inspections performed: 1^st Inspection Report and 2^nd Inspection Report) by the Minister of Health through a copy of his letter to the Chairman of Parliament Commission of Health (see Supplement 3) with enclosed results from the inspections and a contract concluded for dialyzing of 16 Belgian citizens in the unit in question (see Supplement 4). Minister B. Finkov writes in his letter that "the results from the two inspections unequivocally show that there are no cases of medical malpractice in the treatment and epidemiologic regimes in the clinic of hemodialysis in St. Marina Hospital – Varna and, moreover, that it is one of the leading medical establishments within the network of hemodialysis units in Bulgaria and can successfully participate in the international exchange of patients in the field of dialysis treatment."

Regretfully, I could not share Minister Finkov’s optimism before I have had the answers of the following questions:

1. Is it true that HCV-negative patients are dialyzed on machines supposedly devoted only for HCV-positive patients? (see Supplement 5.)

Yes          No (please, put a tick before the correct answer)

1.1. If no, please, give a well-grounded answer.

2. What is the exact number of the machines devoted to HCV-positive patients at the time of the inspections – seven or eight? (see Supplement 2, 1^st Inspection and 2^nd Inspection)

The number of the devoted machines is seven
The number of the devoted machines is eight

3. What is the percentage of hepatitis virus carriers in the inspected unit (see Supplement 2, 1^st Inspection and 2^nd Inspection)?

Percentage of hepatitis virus carriers in the inspected unit is 31, 6%
Percentage of hepatitis virus carriers in the inspected unit is 26, 32%

4. How is the percentage of a nosocomial infection in an HD unit calculated?

With adding the patients on peritoneal dialysis
Without adding the patients on peritoneal dialysis

5. Where and how is peritoneal dialysis performed?

In an HD unit, upon HD machines
At home, without HD machines

6. The serological tests on the basis of which is calculated the percentage:

Comprise all the patients by name, date and number of the result
Does not comprise all the patients by name, date and number of the result

6.1. In both cases, please present lists

7. Is it true that the patients are not tested regularly?

Yes          No

The inspections: "The testing of the patients and the staff for the viruses of hepatitis B and C was performed systematically 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 16/18-Feb-2003, the time periods of testing follow the instructions."

8. How were tested the patients and the staff during almost a year– from the end of the first quarter of 2002 until publishing of Regulation # 2 in SG, issue 16/18-Feb-2003 – did they have regular tests?

Yes          No

8.1. If yes, please give a well-grounded answer.

9. How were they tested after publishing of Regulation # 2 – did they have regular tests?

Yes          No

10. Does Regulation # 2, in SG, issue 16/18-Feb-2003 regulate the regular serologic testing of patients and staff in the HD unit?

Yes          No

10. 1. If yes, please cite the relevant text from the Regulation.

The inspections: "In view of the high risk of the medical staff’s activities it is necessary that specification and optimization be made of the periodic serologic tests for viruses"

11. What specification and optimization are necessary – specifically?

Please, explain over how long intervals of time the tests for virus carriers should be made and how – for each patient and member of staff in separate with a referral from their GPs or all in a time along a list?

11.1. One of the commissions asserts that “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”.

11.1.1. Where exactly in art. 24 (or else) from Regulation # 43 is it written that patients who are not carriers of the hepatitis C virus can be dialyzed on machines devoted to carriers of hepatitis C virus?

11.1.1.1. In the same Regulation, along with the hepatitis and B and C, it is written about hepatitis D. I have also heard of cytomegalovirus (CMV). Why are there not any test about hepatitis D, which should be done, according to Regulation # 43, let alone about CMV in our HD unit?

11.1.2. Where exactly in Regulation 43/1995 are the time periods indicated over which patients on dialysis should be tested? Information from me: nowhere.

11.1.2.1. Where are such time periods indicated for regular testing of dialysis patients?

12. The alert about risk of infection with hepatitis for foreign citizens (Supplement 1) reports of the lost results from tests for hepatitis and AIDS of several nurses, incl. of nurse Reneta Stoyanova. Is that true?

Yes          No

12.1. If no, please give a well-grounded answer.

13. Information from me: The blood was sent somewhere in February or the beginning of March with referrals from our GPs, and the results had not been found by the end of May. Is that true?

Yes          No

13.1. If no, please give a well-grounded answer.

14. Information from me: On 28 and 29-May-2003 from all the patients and the whole staff blood was taken without any formalities for serologic tests for hepatitis B and C and HIV– along a common list as it was done before the Health Insurance Fund had been intiated. Is that true?

Yes          No

If yes, who ordered this to be done along a common list?

14.1. Who paid for this mass testing of over 100 people all at a time?

Please, explain

14.2. Where was this blood tested and when? What are the results?

Please, explain

Information from me: In the beginning of June, I asked the head nurse of our HD unit about my result (of 29-May-2003) and she informed me orally that the tests are delayed till the end of June because the laboratory expected new, more modern ELISA kits. I do not know anything else because no one called to tell me at least my result.

14.3. The person who ordered the mass testing of all the patients and staff in a mass action in two consecutive day by the end of May why did not get information first whether the laboratory had kits or not?

Please, explain

14.4. Did the laboratory which was awaiting new kits have any old kits?

Yes          No

15. Has the laboratory ever had difficulties in supply with reagent and devices?

It has never had any difficulties
There are still problems
There were some problems but the supply has been improved

15.1. If there were or still are problems in lab supply, please give a well-grounded answer about the measures taken.

16. What are the guarantees that in the future patients and staff will be tested regularly in view of their highly risky epidemiologic settings?

Please, explain

17. Both inspections assert unanimously that "dialyzing of […] HBV carriers […] is done in a separate, isolated from the common corridor, room with two stations." (see Supplement 2, 1^st Inspection and 2^nd Inspection.)

17.1. Where is situated this separate, isolated from the common corridor, room with 2 stations for HBV carriers – at the beginning or at the end of the corridor of the HD unit?

At the beginning of the corridor
At the end of the corridor

17.2. Who order that it should be in the beginning?

Please, explain

17.3. Who order that a partition wall should be erected with a door in it at the beginning of the corridor just opposite the kitchen only a few meters from the entrance of the HD unit?

Please, explain

17.4. What is isolated this way: the yellow room and the kitchen from the remaining part of the HD unit?

Please, explain

17.5. But even in such a strange combination, are the yellow room and the kitchen actually isolated from the remaining part of the HD unit, and, in particular, where do all the patients and staff and external persons go through when they enter the HD unit and set off along the corridor to the patients’ rooms and the HD rooms and the offices in the unit?

Please, explain

18. The inspections claim: "The epidemiologic standards are observed". What are these epidemiologic standards that are observed in the HD unit on inspection?

Please, explain

18.1. Where are the epidemiologic standards documented?

Please, explain

18.2. Has the staff confirmed with their signatures that they have been acquainted with these standards?

Yes          No

18.3. Is it recorded in the epidemiologic standards for viruses of which infectious diseases should the patients and staff in an HD unit be regularly tested?

Yes          No

18.4. What does regular testing of hemodialys patients and staff mean: once a year or every six months or whenever someone has brought a referral from their GPs?

Please, explain

18.5. Do all patients have GPs?

Yes          No

If no, please specify the number of patients on dialysis who have not a GP

18.6. Are the patient on hemodialysis acquainted with the fact that they should be regularly tested and, in particular, at what intervals of time?

Yes          No

18.7. Have the patients signed declarations of informed consent in which they have read that they belong to a group of high risk with regard to infection with hepatitis B, C and with AIDS?

Yes          No

18.8. What information had the patients about the serologic status of the guests arriving from abroad who were going to use their machines?

Please, explain

18.9. How had it been explained to the Bulgarian patients not to worry about any diseases transferred by the patients coming from abroad?

Please, explain

18.10. Do all patients know, and in particular the virus carriers among them how are hepatitis B and C transmitted and what are the chances for them to develop complications or to infect their relatives?

Yes          No

19. How had it been explained to the Bulgarian patients why changes in their usual schedule had to be done?

Information from me: The patients from the three shifts usually coming on Mon/Wed/Fri (about 55 persons) were dialyzed o Sunday, 25-May-2003 instead on Monday, 26-May-2003, and the patients from the two shifts usually coming on Tue/Thur/Sat (about 30 persons) were dialyzed on Monday, 26-May-2003 instead of Tuesday, 27-May-2003. Is that true?

Yes          No

If no, please give a well-grounded answer

20. Information from me: on 27-May-2003, Tuesday, the HD unit was closed for Bulgarians in order to dialyze only foreign citizens. Is that true?

Yes          No

21. Information from me: On Tuesday, 27-May-2003, apart from the two 8-person groups of Belgian patients, another group, of 13 Israeli patients was expected to arrive. Is that true?

Yes          No

22. Information, given to me by a colleague: The Israeli group was dialyzed until 04:00 h on 28-May-2003. Is that true?

Yes          No

If no, when was the Israeli group dialyzed?

23. Not a single Israeli patient was dialyzed on 27^th to 28-May-2003 in the St. Marina Hospital HD unit.

True
False

24. What documents are available in the HD unit after the foreigners have left?

Please, explain

25. Were the foreign patients registered in the medical registers available in the HD unit?

Yes          No

26. Is the auxiliary room at 436 suitable for washing and soaking into disinfectant of supplies for multiple usage? Such as the 19 5-liter buckets and about ten 20-liter buckets all of which daily stained with blood which exposes to risk not only the Bulgarian but also any foreign guest-patients because these buckets are routinely used and were used for the foreign patients at the end of May: in initiating and termination their HD sessions.

Yes          No

26.1. Is it admissible to mix multiple us supplies (i.e. the big and small buckets some of them stained with blood from HCV-negative, others with blood from HCV-positive patient) into the disinfection room?

Yes          No

26.2. How and in what conditions are these buckets disinfected?

Please, explain

26.3. Is it convenient to disinfect t 19 5-liter buckets and about ten 20-liter buckets with lids, daily stained with blood, in a disinfection room appr. 3 m long and 2 m wide (former bathroom)?

Yes          No

26.4. What is the condition of the disinfection room for multiple use supplies (the buckets stained with blood)?

Please, explain

Information from me: The room is too small, dark and covered with mould. Black flakes of plaster fall from the ceiling. The sink is more often blocked than not. The buckets are placed along the two shelves and on the ground without any possibility for them to be thoroughly rinsed and soaked in disinfectants just because of the crowdedness.

26.5. What are the requirements on disinfection rooms for multiple use supplies in HD units?

Please, explain

Information from me: In the same room (the small overcrowded 436: former bathroom) blood stained buckets are washed, dirty water from the buckets for washing the floor is poured down, dirty mops are washed, and patients go in to wash some blood from their hands or sleeves after dialysis, and to drink some water or to blow their nose; at the same time surgical supplies are disinfected there, such are surgical clamps, soaked in two plastic basins at the two sides of the sink. Is that true?

Yes          No

27. Are there auxiliary rooms devoted to HCV-positive patients?

Yes          No

If yes, which are they? Please, specify the room number(s).

28. Is there an auxiliary room at the changing room for the patients?

Yes          No

Information from me: The changing rooms – two extremely small rooms in the foyer before the HD unit – not only have no auxiliary rooms to them but they also have no place for a patient to rest if s/he has to wait or feels unwell. Is that true?

Yes          No

29. Which are the auxiliary rooms for the patients on dialysis?

Please, specify their numbers.

30. Which auxiliary rooms did the foreign patients on dialysis use?

The foreign patients on dialysis did not use any auxiliary rooms in the HD unit.
The foreign patients on dialysis did not use the auxiliary rooms in the HD unit which used the Bulgarian patients.
The foreign patients on dialysis used the same auxiliary rooms in the HD unit which used the Bulgarian patients.

31. In what condition are the auxiliary rooms which use our patients and which the foreign patients had to use as well: is there hot water, toilet paper, soap, and are they disinfected after each usage, especially after usage by a virus carrier?

There is everything: hot water, toilet paper, soap, and they are disinfected after each usage.
There is no toilet paper, soap, the toilet plates are often stained but there is sometimes hot water and the toilets are disinfected once a day at the least.

32. Is it possible in practice to devote mops to wash the floor only around the machines devoted to HCV-positives in the big common room?

Yes          No

32.1. If yes, how are these mops designated?

Please, explain

33. Is it impossible in practice for an HCV-positive patient to suddenly bleed on getting out of his bed and to stain with blood the common room or another bed or the corridor or an auxiliary room in the HD unit?

This in impossible
This in impossible but it does not happen often
This in impossible and even unavoidable because of the very specificity of the work

34. Was the hospital epidemiologist asked for opinion before or during the conclusion of the contract to dialyze the foreign patient in this HD unit?

Yes          No

34.1. If yes, did the epidemiologist approve of dialyzing the foreign patients in this HD unit?

34.1.1. If yes, did she approve of dialyzing the foreign patients in writing or orally?

In writing          Orally

35. Has the epidemiologist, since she has occupied this position, ever noticed anything wrong in the epidemiologic settings of this HD unit?

Yes          No

35.1. If yes, what and where she reported, and what measures were taken?

Please, explain

36. How did the epidemiologist who occupied the position before the present epidemiologist deliver this responsible position: was everything in order in the hospital, and in this HD unit in particular?

Yes          No

37. Does the hospital epidemiologist have at her disposal any data about the percentage of hepatitis infected patients in this HD unit, and about the number of the machine devoted to hepatitis C infected patients in the common room?

Yes          No

37.1. If yes, can she present a table with names, dates of testing, results as well as a suitable way for distribution of the infected patients by machines and by shifts so as HCV-negatives not to use machines devoted to HCV-positives?

Yes          No

38. Does the hospital epidemiologist have at her disposal any data about the percentage of hepatitis infected patients in other HD units in this country?

Yes          No

39. Does the hospital epidemiologist have at her disposal any data about the percentage of hepatitis infected patients in other HD units around the world, for instance in Belgium or Israel?

Yes          No

40. Has the epidemiologist kept a statistic data of virus carriers in this HD unit?

Yes          No

41. Can the epidemiologist (or someone else) present data in dynamics about a period of up to five years backwards: number of patients and staff in each testing, year, how many times were they tested during a year, results, percentage of virus carriers?

Yes          No

42. If the epidemiologist (or someone else) has kept statistics, for how long and who has access to it?

Please, explain

43. What sources does the one who keeps the statistic data draw upon; is her/her access to initial source direct or is there a mediator between the source of data and the person keeping the statistics?

Please, explain

43.1. If there is a mediator, who is s/he and what sources has s/he drawn upon for her/his information about the number of virus carriers in this HD unit over the years?

Please, explain

44. Is it easy to make inspection on the epidemiologic data in this HD unit in dynamics?

Yes          No

44.1 If yes, fro how long backwards?

Please, explain

45. Is it true that there were about 80% hepatitis C infected in this HD unit, as the alert claims?

Yes          No

46. Was a consultant infectionist called to examine the HCV and HBV-positive patients?

Yes          No

47. Was the archive inspected during the inspections? There must be kept the history of disease cases with a recorded consult with infectionist for our infected patients from the time when the percentage had reached about 80%.

The archive has been inspected thoroughly
The archive has not been thoroughly inspected
The archive has not been inspected at all

48. One of the commissions ascertained that “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”, and the other inspection did not mention anything on this issue (see Supplement 2. Inspections Performed, 1^st Inspection and 2^nd Inspection), and Minister Finkov, in his letter to Dr. A. Shterev, first economizes the phrase “during the period 22-26 May, 2003” from the report of the one commission, then does not mention the fact that the other refrained from commenting. The result is the semi-truth: “The report prepared by the commission points that there has not been a case of dialyzing a Belgian patient upon a machine used by a virus carrier of HBV before.” (see Supplement 3)

48.1. Why did Minister Finkov not ask the inspecting commissions the logical question, viz.: Before the period May 22-26, 2003, was there never a machine upon which an HBV-positive patient had been dialyzed in the large HD room?

Please, explain

48.2. Was there never a machine upon which an HBV-positive patient had been dialyzed in the large HD room?

Yes          No

49. Where have our six HBV-positive patients come from?

Please, explain

50. Where had our patient G[…] been dialyzed before he was isolated in the “yellow room” as HBV-positive?

Please, explain

51. Were G.’s test results inspected: first test (date, result), second test (date, result) and so on until his identification as a hepatitis B virus carrier?

Yes          No

52. Are there any machine devoted to new patients who were admitted urgently and because of that had not been tested in advance for hepatitis and AIDS viruses?

Yes          No

53. Are all patients who start dialysis in this HD unit serologically tested in advance?

Yes          No

54. Is there a case of a patient not having been tested more than a month since s/he has started dialysis in this HD unit?

Yes          No

55. Is there a case of a patient not having been tested more than three months since s/he has started dialysis in this HD unit?

Yes          No

56. Is it considered that a machine used by not tested patient is clean?

Yes          No

57. Is it considered that a machine on which a HBV virus carrier was dialyzed for months?

Yes          No

58. On which machine had been patient G. dialyzed before he was moved to the yellow room? G. was identified as hepatitis B virus carrier, and this virus is recognized as much more infectious than that of hepatitis C.

Please, specify the number of the machine

59. The numbers of the machines on which the patients are dialyzed are recorded in which documents? When a patient is identified as virus carriers, is it easy to identify other patients who have shared the same machine with the newly identified virus carrier?

Please, explain

60. Can the numbers stuck on the machines (1, 2, 3 etc.) be unstuck?

Yes          No

61. Can the machines be moved from a place to another or from a room to another?

Yes          No

62. Does anyone watch and record the machine fluctuation: how many new items, what make, used for how many years, bought new from where, documents on the deal?

Yes          No

63. Are there second-hand machines in this HD unit?

Yes          No

64. If yes, were these second-hand machines accompanied with documented warranty that they had not been used by infected patients before?

Yes          No

65. In practice, how can be prevented the mistaken usage of devoted to HCV-positive patients machines by HCV-negative patients in a common room?

Please, explain

66. How are signaled the devoted to HCV-positive patients machines in the common room?

Please, explain

67. What can be done so as a devoted to HCV-positive machine should not be mistakenly used by a HCV-negative patient? (there was a case of such mistaken usage, recorded on 25-Mar-2003 in the physicians’ report available in this HD unit. The head of unit left the reported case unnoticed)

Please, explain

68. Had there never been any problems in this HD unit, problems of whatever character, before the alerting letter of 22-May-2003 was submitted to the highest health authorities?

Please, explain

69. Are there any reports of meetings in this HD unit?

Yes          No

70. What problems agitated the patients in this HD unit?

Please, explain

71. What problems agitated the staff in this HD unit?

Please, explain

72. How was it explained to the nurses in this HD unit that they had to do routine shifts from 18:00 to 24:00 h. (not because of the visiting foreigners but for many months before)?

Please, explain

73. Why were these shifts recorded on the nurses’ schedule not as 18:00 to 24:00 but as 13:00 to 19:00 h?

Please, explain

74. Had nurses ever received any overtime payment before the foreigners arrived?

Yes          No

74.1. If yes, when?

75. Has it happened that a nurse suddenly got sick and the other nurses had to work her shifts too?

Yes          No

76. What problems has the leadership faced?

Please, explain

77. Was there a case when a patient could have been killed through a member of the staff's negligence?

Yes          No

78. What measure were taken after the accident of 24-Jan-2003 a patient nearly died through a member of the staff’s negligence?

Please, explain

79. How many witnesses were there of this accident?

The nurse on duty and the patients in the room of the accident
The nurse, the technician on duty and the patients in the room of the accident
The nurse, the technician, the doctor on duty and the patients in the room of the accident

80. According to the job profile of the HD nurse in this HD unit, is it the nurse alone authorized to connect a patient to his/her HD machine? (see Supplement 8. Job profile of an HD nurse in St. Marina Hospital)

Yes          No

81. Besides a nurse, is there, in practice, a doctor and a technician in the room when dialysis sessions are initiated?

Yes          No

81.1. If no, please explain

82. Are there written explanations on the accident of 24-Jan-2003? (see Supplement 6. Written explanations on the accident of 24-Jan-2003)

Yes          No

83. Was there a meeting of the staff after that accident?

Yes          No

84. Was there a report on that accident to a higher instance?

Yes          No

84.1. If no, please explain.

84.2. If yes, what measures were taken by the higher instance?

Please, explain

85. The inspections have ascertained that the technical staff’s qualification is high. Was the high technical qualification of the staff ever questioned in the alerting letter of 22-May-2003?

Yes          No

86. The technical staff, besides their high technical qualification, do they have high medical qualification as well?

Yes          No

87. Is it true that the technical staff is responsible not only for the disinfection of the machines but also for the distribution of the patients upon the machines?

Yes          No

88. Who controls the disinfection of the machines and the distribution of the patients in practice?

Please, explain

89. Is there an alerting letter to the head of this HD unit about negligent attitude to the disinfection of the machines on the part of a technician? And this done before three witnesses? Is it true that the exposed before witnesses as negligent of his duties was Hikolay Nenov, Eng. (See Supplement 7. Alert to the head of HD unit of 24-Mar-2003)

Yes          No

90. Did the head of HD unit take any measures in follow-up of this alert?

Please, explain

91. Information from me: The alerting letter of 24-Mar-2003 was submitted by me to the executive director, Dr Kr. Ivanov, two months after I had submitted it to the head of HD unit. It was registered by the executive director’s secretary under the number 777/26-May-2003. Did Dr Kr. Ivanov take any measures?

Yes          No

92. Was the head of HD unit alerted about a case of mistakenly connecting an HCV-negative patient to a machine devoted to HCV-positives, the member of staff exposed as guilty being the same Nikolay Nenov, Eng? (see Physician's report of 25-Mar-2003 in the Register of physicians' reports available in the HD unit)

Yes          No

93. Has the head of HD unit taken any measures after he was notified in writing through the physician's report of 25-Mar-2003 about the case?

Yes          No

94. Would the head of HD unit, Dr Kiril Nenov, deny that he knew that not only Nikolay Nenov but all members of the technical staff have systematically violated the requirements of the medical standards that machines devoted to HCV-positive patients should be used by HCV-positive patients only?

Yes          No

95. Are the technicians aware of that they systematically violated the requirements of the medical standards that machines devoted to HCV-positive patients should be used by HCV-positive patients only?

Yes          No

96. Do the HCV-negative (or long time not tested) patients that they have used machines dedicated to HCV-positives?

Yes          No

97. Is it possible to observe the requirements of the medical standards that machines devoted to HCV-positive patients should be used by HCV-positive patients only with the present ration patients: machines and the present distribution of HCV-positives in the shifts? (see Supplement 5.)

Yes          No

98. The commission from the Regional Center of Health ascertained that "the sterilization mode of the machines is automated and does not permit any intervention until the end of the process. A machine cannot be started if the mandatory 45-minute thermochemical disinfection."

98.1 Was there a technically qualified person in this commission?

Yes          No

98.2. What model of HD machines does the commission mean because there are at least three different types of Fresenius machines in the HD unit – newer and older – designated with different letters and numbers, i.e. Fresenius 1008 C, Fresenius 2008 A (I cannot quote the exact letter-and-number designations of the HD machines here because they are not before my eyes and I am not a technically qualified person)?

Please, explain

98.3. Can the abovementioned commission sign under an assertion that a highly qualified technical person will not be able to change the parameter of time for disinfection of an HD machine so that instead of 45 minutes it should be set at, say, 20?

Yes          No

98.4. Did the abovementioned commission read the voluminous manuals for the three models of HD machines available in the UH unit by the time of the inspection?

Yes          No

98.5. Were the manuals translated into Bulgarian?

Yes          No

99. The other inspecting body, among whom there is a technically qualified person – P. Shterev, Eng., assert that “the dosage and time of exposition are programmed automatically”. Can Mr Shterev readily confirm that the time of exposition cannot be changed by a technically qualified person?

Yes          No

99.1. Can Mr Shterev point to the text in a manual where it is specified that the parameter time of exposition has only one value: 45 minutes?

Yes          No

100. The commission from the Regional Center of Health ascertained that “a machine cannot be started if the mandatory 45-minute thermochemical disinfection has not been performed”?

100.1. If a machine has not undergone disinfection, can it not be started either?

If a machine has not undergone disinfection, it cannot be started
Even if a machine has not undergone disinfection, still it can be started

100.2. Can a machine, which is set at disinfection mode, be started before the mandatory time of disinfection has elapsed?

Yes          No

100.3. If no, is it valid for all models of HD machines: both older and newer Fresenius?

For all
Older models can be started while still in disinfection mode (see Supplement 6)

101. Neither one nor the other commission has commented on how new are the newest machines in the HD unit?

Please, explain

102. Has Mr P. Shterev information on how many hours should a dialysis machine be used according to its manual?

Yes          No

103. Is the requirement of the company manufacturer on the number of the hours of exploitation observed in the HD unit?

Yes          No

104. Is the supply with spare parts regular?

Yes          No

105. Has the HD unit (the hospital) any debts to the service of the company manufacturer of the dialysis machines?

Yes          No

106. Does Mr Shterev know which models of Fresenius are the newest on the world market by the time of the inspection – what numbers and letters they bear?

Yes          No

107. Both commissions emphasize on that in the HD unit on inspection the disinfection of the machines between the shifts has always been performed in compliance with all requirements. Was the routine disinfection questioned in the alerting letter?

Yes          No

108. In the alerting letter about risk of infection with hepatitis for foreign patients, it was mentioned that there had been attempts at silencing the voices of subordinates who told unpleasant truths. Did any one ask the staff who were those subordinates and what were those unpleasant truths?

Yes          No

109. Is it possible that the staff has lost memory of what there have been noisy meetings?

Yes          No

110. A question from me: The staff might have lost memory, and no reports from any meetings might not be available. Why, however, no measures were taken neither after the accident of 24-Jan-2003 when a patient’s life was endangered nor after the report of 25-Mar-2003; why even Dr Kr. Ivanov did not reply this alerting letter of mine although it had been registered by his secretary under incoming # 777/26-May-2003. And why, ultimately, on receiving my alerting letter about risk of hepatitis infection fro foreign citizen, Dr. Kr. Ivanov called me to a conversation with threats of dismissal under the pretext that I lower the prestige of my direct boss?

Please, explain

111. A question from me: I cannot prove that Dr. Kr. Ivanov threatened me in advance, therefore I should admit that he did not threaten me but just called me to a conversation in his office. I cannot claim that he threatened me during our conversation, either, because there was not a witness. Therefore, I should admit that the conversation went in a calm atmosphere. I managed as well to tell Dr. Kr. Ivanov that the foreign patients were treated not registered in the two register books of the HD and asked him whether that was alright but, instead of an answer, Dr. Kr. Ivanov handed me my job profile and asked me to submit written explanations on the grounds of art. 193, para. 1, (Art 193. (1) (Alt. - SG, issue 21 of 1990, issue 100 of 1992) The employer is obliged, before imposing any disciplinary punishment, to listen to the worker and to accept his/her written explanations as well as to collect and evaluate the evidence presented), without explaining me in writing what my fault was.

111.1. In my job profile (Supplement 8), there are no instructions on my work conditions, not a word of working with any unhealthy agents and materials: disinfectants, blood, quite a high percentage of virus carriers of hepatitis C and B. Why was the character of my work not specified: whether it is intensive or not, psychotraumatic or not, and so forth?

Please, explain

111.2. Whose obligation it is to write correctly at least the text about my obedience to my direct bosses’s orders as it is put in the Labor Code: to their legal orders?

Please, explain

111.3. How many nurses should care for 95 dialysis patients?

Please, explain

111.4. Should not workers in highly risky settings have shorter working hours?

Please, explain

111.5. Does the staff not have the right to receive free food and working clothes?

Yes          No

111.6. What refreshment do the patients receive?

Information from me: A slice of salami and a slice of bread or something like that. Years ago, they used to receive a lump of cheese or a whole long piece of salami.

116.7. What food do the stationary patients receive?

Information from me: Breakfast: a roll or noodles, lunch: diluted vegetarian soup, dinner: cheap vegetarian stew.

111.8. How are the stationary patients accommodated?

Information from me: In four rooms: four people in each of the two rooms for three persons, and three people in each of the rooms for two persons; people unfamiliar up to the previous day lie on twin-beds, i.e. beds that are joint together; by the official documents, the stationary patients occupy only four beds: two for men and two for women. They have their meal in their overcrowded hospital rooms because the former dining room has been turned into a storeroom which, at the same time, the nurses use for their changing room.

Please, explain

111.9. Is there bed linen for the patients in the stationary and in the HD rooms? Information from me: For the stationary there is some but the HD patients have to bring their own bed sheets from home and to make their beds with them. For the foreigner bed linen was found out: sealed with the stamp of a hotel.

Please, explain

111.10. Are there any nightdresses or pyjamas for the patients?

Information from me: This commodity is very hard to come by.

111.11. Do the HD patients have to bring their own plaster, and other auxiliary supplies, along with the bed sheets?

Information from me: Yes, they have. They have had to bring cotton wool, gauze, even vials of Heparin and solution bottles at hard times. Does such information reach the high governmental levels?

111.12. A number of necessary medicines are still not available in our hospital pharmacy. During April, 2003, for instance, there was no Antistenocardin and Aspirin even for the patients along clinical paths and they had to buy them. Does such information reach the high governmental levels?

111.13. Do the HD patients get kidney transplantation or do they dialyze life-long? Information from me: I have lost lots of friends among our HD patients who died before they were called to Sofia for transplantation, or before they managed to collect enough money for transplantation abroad. Our patients travel to India and Pakistan to get kidney transplantation on the black and to catch diseases unknown in Bulgaria.

111.14. What happened to Marina, 16 years old, who got kidney transplantation in Pakistan this year?

111.15. What will happen to Ani and Boris, sister and brother of healthy parents, she is 23, and he is 17, both on dialysis in our HD unit, if their parents fail to collect the money needed for two transplantations? And then, what if they rejected their kidneys?

111.15.1. Why did Minister Finkov trust an intra-hospital inspection and wrote to Dr. A. Shterev: "the organization of work, the standards of qualitative servicing and the health cares for the patients are on contemporary level and meet the current achievements of the medical science."

111.15.1.1. Which medical science: that in Europe, or in Bulgaria or in Pakistan?

112. On 29-May-2003, I was orally informed by my direct boss that I had been dismissed (this accompanied by shouts but since there is no way for me to prove that too, I should admit that it happened in a calm atmosphere). Immediately I submitted a request on that case to the head of HD unit and to the executive director of the hospital (see Supplement 9. Request to head of HD unit with copy to the executive director) registered under the incoming # 815/29-May-2003. Why have I not had a reply to this request?

Please, explain

113. On 30-May-2003 I submitted a well-grounded request for going on a paid (Supplement 10. A well-grounded request for a paid leave). Immediately, I was allowed one-month-long paid leave until 1-Jul-2003. But why did Dr Kr. Ivanov never pay attention to my arguments?

113.1. The first argument was that after my submitting an alerting letter about certain malpractice in our HD unit, “the atmosphere of tension because of the complicated interpersonal relations in the team strongly distresses me and I can neither perform my working duties nor prepare for my examination”. Why did it not lead him to the thought that I might have been exposed to pressure by my direct boss?

113.2. The second argument was that for four years of distant university studies I had had not a single day off for examinations or intramurals although I had right to study leave had been allowed in writing to use it. Why did it not lead him to the thought that someone might have threatened me so that I should not dare use my due study leave?

Please, explain

114. Why the controlling commissions did not seek my assistance during their inspections? If they had asked me to assist, this letter might have not been written.

Please, explain

115. In the report (see Supplement 2. Inspections performed, 1^st Inspection and 2^nd Inspection) made by one of the commissions, it can be read:

"Reneta Stoyanova's letter, incoming # VK/273/26-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."

115.1. If the facts and problems had been known for a long time, what measures did the hospital leadership take to resolve them?

Please, explain

115.2. If I, with “too emotional and tendentious” interpreting of “long known facts and problems” lower the “the prestige and the good name” of the hospital, why then I was not dismissed on disciplinary grounds?

Please, explain

115. 3. Why did I not receive at least a disciplinary punishment?

Please, explain

116. The contract concluded for dialyzing of the foreign patients (see Supplement 4), poses another round of questions, such as:

116.1. Why there is no indication of the foreign patients’ medical documentation in the contract?

116.2. Why the contract does not provide any procedures for checking the medical status of the arriving foreign patients on admitting them for treatment in a Bulgarian HD unit?

116.3. It is not indicated whether the foreign patients have filled or will fill a declaration of informed consent through which they should be informed about the specific epidemiologic conditions in the HD unit where they are admitted for treatment.

116.4. It is not indicated how the guests will be distributed by HD machines and rooms.

116.5. How can their distribution be indicated when there is no indication of whether there are virus carriers among the arriving guests or not?

116.6. Who are the persons insured on the expense of the Client, namely “one physician, two medical nurses one orderly and one technician” (art. 10 in the contract). Can their names be given?

116.7. What work contracts were concluded between the medical persons, insured on the expense of the Client, and the Client?

116.8. What is the document for accounting and payment of the performed dialysis procedures, in this connection for accounting and payment of the overtime work of the staff, after the guest patients were not registered in the two register books available in the HD unit?

116.9. What is the payment document: what data are written on the invoice, i.e. were all the dialysis procedures performed?

116.10. It is not made clear in the contract how the transaction will be realized, i.e. from what to what date will the guest patient be dialyzed and how the contract is terminated: whether after the six dialysis procedures have been performed or otherwise, because through the contract as it is more procedures could be performed without their being accounted.

116.11. Is/are there an/y additional agreement/s according to art. 15 and/or art. 16?

116.11.1. In the copy of the contract, sent to me in reply to my alerting letter, Supplement 1 is missing which should be, cite “inseparable part of this contract” (art. 6).

116.11.2. Are there any other agreements in writing, also inseparable part of this contract, according to art.17, which were not sent to me?

116.12. Art. 9 and art. 12 in the contract indicate that the Client (Prof. Nenov) shall supply the anticoagulants (art.9), and the Contractor (the hospital) –“the necessary staff, rooms, equipment and supplies which are not delivered from the Ministry of Health along a centralized delivery (electric power, water, dialysis solution, etc.)”

116.12.1. What other supplies apart from “electric power, water, dialysis solution”?

116.12.2. Who provided the blood lines, the solution bottles for filling these blood lines, the latex gloves, gauze, medical alcohol, sticking plaster?

116.12.3. What documents are available which can prove the delivery of the above supplies?

116.13. Art. 13 in the contract indicates that “THE CONTRACTOR shall be obliged while performing the subject of this contract not to use supplies and medicines which have been delivered from the Ministry of Health along a centralized delivery.” However, the two inspections ascertained that supplies which had been delivered from the Ministry of Health along a centralized delivery were used.

116.13.1. One of the commission wrote: “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””

116.13.2. The other commission wrote: “The machines are disinfected according to the instructions of the company manufacturer of disinfectants, Fresenius, and are received along a centralized delivery of Ministry of Health”

116.14. It is not made clear in the contract whether other foreign patients, apart from the 16 Belgians, were on dialysis in the HD unit.

116.15. Did 13 HD patients from Israel come or not?

116.15.1. If they did arrive, is there another contract concluded to arrange the dialyzing of the 13 Israeli HD patients?

116.15.2. If they did not arrive, why did we have to move the three patient shifts from Monday, 26-May-2003, to Sunday, 25-May-2003, and the two patient shifts from Tuesday, 27-May-2003, to Monday, 26-May-2003? I was on duty from 18:00 to 24:00 h. on 25-May-2003, Sunday, in room 436.

I am addressing you with the request to order another, serious inspection, which should answer the questions left unanswered during the two previous inspections, as well as take measures to improve the epidemiologic conditions in the HD unit. I rely on your authority and competence for taking all the necessary measures on reinforcing the prestige of St. Marina Hospital and turning its HD unit into "one of the leading medical establishments within the network of hemodialysis units in Bulgaria and can successfully participate in the international exchange of patients in the field of dialysis treatment", indeed.

I do not seek punishment for the guilty persons but will feel moral satisfaction to learn that the problems having caused me to send my alerting letter will be resolved and will never happen again. The only reason to ask you is the well-being of the patients – regardless ours or foreign. I left my job with a 30-day notification to my employer (see Supplement 11.) and have no intention to return after all humiliation to which I was exposed but there remained diseased people who

• are not tested regularly;
  
• share the machines because there are no separate machines devoted only to hepatitis C virus carriers, and it is impossible to separate some because the human and technical resources of the HD unit in St. Marina Hospital are overloaded;
  
• wait life-long for transplantation or travel to Pakistan "on the black"; have many other unresolved problems (see the whole letter above).

I ask you on behalf of the diseased people to whom I did not even manage to say good-bye, as it behoves after so many years together, and the hemodialysis patients become close friends to us because of the very specificity of the dialysis treatment: three times a week we meet for their procedures for long years on end. I did not manage to say good-bye to my former colleagues, and we spend nearly 16 years in harmonious team-work together. They are a wonderful team of highly qualified cadres who really do their best in serving the patients despite the shortage of information about their working conditions and epidemiologic requirements. I do believe that there will come a day when our HD unit will develop medical tourism on European level.

Perhaps you are this one who will accelerate the advent of this day.


Reneta T. Stoyanova, Personal ID # […], ex nurse with over 25 years of work experience , having worked almost 16 years in the St. Marina Hospital HD unit in Varna: from 1-Oct-1987 to 1-Jul-2003.

Date: 9-Jul-2003          Signature: