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379-

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34.1 ,
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176 .

2009 11
.20.. 379..

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1.1 ,
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1.2 , ,
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1.3
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1.4 .
1.5 ,

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1.6
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1.7 ,
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5.2 , 1, 3, 12
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5.4 ,
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5.6

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5.7 2

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5.8
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5.9 ,
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6.1 ,
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6.2 401, 429, 461-
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6.3 405, 407-
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6.4 429
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6.5
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6.6 , ,
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7.1 ,
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7.2 ,
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4

2009 .11. 20.


379 .


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1.1 :
1.2 : Mycobacterium tuberculosis complex
. ,
2.1 ,
.
2.1.1 :

.
:
x
x
x
x
x
x ,
2.1.2 :
,
.

:
x
x ,
x
x
x
5

x ,
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2.2 , , .
2.3 , .
2.3.1 :

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2.3.2 :

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2.4 :
2.4.1 :14

2.4.2 : ,

2.4.3 :

2.4.4 :
,
2.4.5 : 2


2.4.6 : 5

2.4.7 :
2.5


2.5.1 :

2

2.5.2 :
,


6

2.5.3 : 5

2.5.4 : 2 ,

2.5.5 : ,

2.5.6 :

2.5.7 :

2.6

:
2.6.1
2.6.2 : , , ,
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3.1
3.1.1 , ,
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3.1.2
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3.2


3.2.1 , , .
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3.2.2
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3.2.3
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3.2.4
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0-16 48-72
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3.2.7

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4.1
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11- 5-6
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120-130 (60% ), 7580 (60% ), 400-450 , 3000-3200 , 10
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4.2

5 (4-6)


()
300

(R)

10 (8-12)

600

(Z)

25 (20-30)

1600

(/ )
(H)

11

(E)
(S)

20 (15-25)
15 (15-20)

1200

15 (12-18)

1000

4.3
.
4.3.1 I
x
x

x
: 2HRZE (S) / 4HR
4.3.2 II
x
x
x
: 2HRZES / 1HRZE / 5HRE
4.3.3 III
x ,
x , (I )
: 2HRZE / 4HR
4.3.4
(
, )


30-39
40-54
55-70
I , III

2RHZE (150/75/400/275) / 4RH


(150/75)
3RHZE (150/75/400/275) / 5RHE
(150/75/275)
2S (1 )

II
2

2
750

3
1000

1
500

4.4
10

12

3
-
.
4.4.1

(//)

(H)

10 (10-15)
15 (10-20)
35 (30-40 )
20 (15-25)

(R)
(Z)
(E)
(S)

15 (12-18)

:
250 , 150 , 400 , 250
5-30
.
250 + 150
+ 400 3
, 250 + 150 2
.
4.4.2
5-20 :
(
, )

2RHZ* (60/30/150)
2RH* (60, 60)
4RH* (60/30)
4RH* (60/60)

2RHZ* (60/30/150)
2RH* (60, 60)
2E (100)
4RH* (60/30)


5-7
8-14
15-20
1
1
1
1

2
1
2
1

3
2
3
2

1
1
1
1

2
1
2
2

3
2
3
3
11

13

4RH* (60/60)

20-30 :
( , )


(20-30 )

2RHZ (150/75/400)
2RH* (60, 60)
2Z(400)
4RH (150/75)
4RH* (60, 60)

2RHZE (150/75/400/275)
2RH* (60, 60)
4RH (150/75)
4RH* (60/60)

2
2
2
2
2
2
2
2
2

(
, )
3RHZ* (60/30/150)
3RH* (60, 60)
3E (100)
5RH* (60/30)
5RH* (60, 60)
5E (100)


5-7
8-14
15-20
2 3
1
1
1 2
1
2 3
1
2 3
1
1 2
1
2 3

20-30 :
( , )

(2030 )
3RHZE (150/75/400/275)
2
3RH* (60, 60)
2
5RH (150/75)
2
5RH* (60, 60)
2
5E (400)
1
* .
12

14

:
x
x

x ,

x 30

4.5
4.5.1

. : 2HRZE (S) / 4HR;
2HRZE (S) / 6HE
4.5.2 ,
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7
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4.5.3
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4.5.4

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4.5.5


50 /-
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4.5.6
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13

15


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4.5.7.

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4.5.9
1-2
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4.5.10
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16

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5.5.3 ,

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A15-A19
(Tuberculosis) .
6.1 ,
(-03)-
(-01)- .
16

18

6.2 (-07),
2, 3
(-14), 12-15
(-08),
25-
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6.3 (TB-13)- ,

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6.4
(-10)- 1 15-
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6.6
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6.7 I 25- , II ,
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17

19

2009 .11. .20..


.379.


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1.1 .
x
x
x
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1.1.1 :
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1.1.2 (): ,

1.1.3 (): ,

1.1.4 ():
2-

1.2 :
x
x
1.2.1 :

1.2.2 :
18

20

1.3
1.3.1 : 1

1.3.2 :


1.3.3 : 2


1.3.4 I : I 5

1.3.5 II : II 5 ,

1.3.6 : ,

1.3.7 : ,
,
,

1.4
1.4.1. : 2
;
1.4.2 : 12 30
:
x 5

x 3-4 ,

1.4.3 :
:
x
x 3-4 ,
x ,
1.4.4 :

19

21

1.4.5 : 2
;
1.4.6 : 3 1-
;
1.4.7 : ,

.
2.1
:
2.1.1 I II 3

2.1.2 I II 5

2.1.3 I II
I II

2.1.4 : 1

x ,

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x 2

2.1.5
2.1.6 - ,

2.1.7 -
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20

22

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4.1.1 -
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4.1.5
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4.1.6 25- 7
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18-24 4-7 ,
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21

23

5.1 - ,
(
, )


<33

33-50

51-60

>60 (
)

I : 1
(H)
(100, 300 )

(R)
(150, 300 )
(E)
(100, 400 )
(Z)
(400 )

4-6 // 200-300 /
300 /
8-12 - 600 -
7 3 450-600 - 7 3
7 3

10-20
450-600
600
//
25 // 800-1200
1200-1600
30-40
//

1000-1600

300 /
600 -
7 3

600
1600-2000

1600-2000

2000-2400

500-750

1000

1000

500-750

1000

1000

500-750

1000

1000

500-750

1000

1000

II :
(S)
(1 )
(Km)
(1 )
(Am)
(1 )
(Cm)
(1 )

15-20
//
15-20
//
15-20
//
15-20
//

III :
(Cx)
(250, 500, 750
)
(Ofl) (200,
300, 400 )
(L) (250,
500 )
(Mx)
(400 )
(Gx)
(400 )

20-30
//

1500

1500

1500

800

800

800

800-1000

750

750

750

750-1000

400

400

400

400

400

400

400

400

22

24

IV : 2
(Eth)
(250 )
(Pto) (250
)
(Cs)
(250 )
(Trd)
(300 )

(PAS)
(4 , PASER)

15-20
//
15-20
//
15-20
//
15-20
//
150
//

500

750

750-1000

500

750

750-1000

500

750

750-1000

600

600

900

150

5.2 : -
:

HR-

Z-E-S(Km)*-Ofl-Eth

HRE-

Z-S(Km)*-Ofl-Eth-Cs

HRS-

Z-E-Km-Ofl-Eth(Cs)

HRES-

Z-Km-Ofl-Eth-Cs

,
,
,
.
6
.

4

.

5.3 .

H(S)
HZ

()

R-Z-E(Ofl)

6-9

R-E-Ofl

9-12

,
Ofl .
,

23

25

.
HE

R-Z-Ofl

9-12

H-E-(S)*-Ofl-Z**

12-18

3HRSE/6HRE

RE ( S)

H-Z-Of-S(Km)**

18

RZ ( S)

H-E-Ofl-S(Km)**

18

R-Ofl-Eth-S(Km)**

18

HEZ ( S)

,

.
* ,

. **Z- 2
.
** 2-3
.
** 2-3
.
S- 1
S- Km .
,
6
.

5.4
.
5.5
5.5.1 6
. ,
Eth- .
Z, Cm, Cs, Ofl
.
5.5.2 Z, Eth, Ofl
1-2 ,
, 7 , 2
.
5.5.3 , , ,
Cs- PAS
.
5.5.4 ,
Eth, R, H , Z .
24

26

1-2
.
5.5.5 E, Cm, Eth, Cs
.
5.5.6 ,
.
5.6 0-16
:
x , .
x 15 /- .
5.7 2-


//
///
15-20
1000


,

x
x
x
x
x

x
x
x

15-207,5-10
7,5-10
7,5-10
20-30

800
1500

15-30
15-22,5
15-30

1000
1000
1000

10-20

1000

150

12000

5.8 ,


Cs, H, S, Km, Am, Cm,
Eth/Pto,


200


.
25

27

S, Km, Am, Cm

Cs, H,

Cs, H,
, Eth/Pto

PAS, Eth/Pto
Eth/Pto, PAS, H, E, Z

PAS, Eth/Pto

Z, H, R, Eth/Pto, PAS, E,


.

200




.


,

,

.
.

.
, H

,
1-7

,

26

28



.
S, Km, Am, Cm


.
Cm, Km, Am, S

(

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E


Z,


,
.
Cs, H,
,

.
200
,

.
5.9
,
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5.9.1
5.9.2
5.9.3
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5.9.4
3 , 6 .
,
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27

29

5.9.5
6 5 .
5.9.6 ,
3 , 6
.
.
5.9.7 , , , , ,
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3-6
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5.9.8 ()- ,
.
Eth/Pto 6 .
5.9.9 ,
.
5.9.10
.
5.9.11 .
5.9.12 5
.
5.9.13 -
6, 12, 18, 24 ,
, .

28

30

31

12-18

12-18

18-24

5.10 -


6-8 ,

3
,

,
,
II

,
,

II-III

4-8

29

,

III-IV

14

, 429-
-

.

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.
6.1
- -
- - -
:
x -
x -
x - -
x - -
x
x
x
x ,
x
.
2-3 .
6.2
-
-
:
x
x
x -
x
x
.


-
.

30

32

6.3
6.3.1
x
x
x
x
x
x
x
x
x
x
6.3.2
6.3.3
6.3.4

:
,











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6.4 :
x
x
x
x
x

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( , , , )-

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2-

6.5 -
x 2
x
x ,
x ,
31

33

x
x - 4-6
x - 8

7.1
. . . . . . . . . . . . . . . . . . . . .
//- . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . .
_______/_____/____
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32

34

7.2
Mycobacterium tuberculosis ,
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33

35

7.3
,
. .
1.
x ,
x ,
x 18-24
.
2.
x 4-6
, 18
.
x 15-25 , .
x
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3.
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_________________________________________________________
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20____/____/____

34

36

2009 .11 .20..


379.

, -

- ,
, , ,
. , -
5-10% , -
50% .
.
, /-
.
1.1 - , :
1.1.2
1.1.3
1.1.4
1.1.5
1.1.6


6

6
-

1.2 :
1.2.1 / , 6
1.2.2 / -
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35

37

.
2.1
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2.2
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2.3

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36

38

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3.1

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2

x
x
x
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( , CD4
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x
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37

39

3.2
3.2.1
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CD4 200/-
. CD4
200/-
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38

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4.3.1 D4 200 /3- 3, 4-
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.
4.3.3 :
2
. : 960 (3) + 160
().
100 - .
4.4 , -
42
44

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.
5.1
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5.2 - , /- , - /- ,
- ,
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5.3 ,
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43
45

2009 .11 .20


.379...

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I, II ,
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3.2 ,
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46

, 150- 200 , 20% 60% .


3.3 , , 1.5-1.7 -
, 3 -
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3.4 , 0.5 , 0.3 , ,
0.75 , 0.75 .
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4.1 , , ,
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4.3 , , ,
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4.4 ,
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4.5 , ,
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4.6 ,
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4.7 ,
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6.1

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45
47

6.2


.
6.3
.
6.4 , ,
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6.5

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6.6 , ,
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6.7 ,
.
6.8 , , ,
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6.9 - , ,

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6.10 , ,

.

46
48

2009 .11. .20


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2009 .11 .20


379 . .

HEALTH MINISTERS ORDER


Date: 20 November 2009

Reference # 397

Ulaanbaatar

On approval of the guidelines on tuberculosis care and services


In order to implement the article 34.1 of the Health Law of Mongolia and the National
Stop TB Strategy 2010-2015, it is ordered to:
One. Approve the guidelines on management and organization of tuberculosis (TB) care
and services by Appendix 1, guidelines of drug susceptible TB care and services by Appendix 2, guidelines on drug resistant TB care and services by Appendix 3, guidelines on
TB/HIV coinfection care and services by Appendix 4, guidelines on drug TB management by
Appendix 5, guidelines TB epidemiology and infection control by Appendix 6, guidelines on
monitoring and evaluation by Appendix 7, guidelines on implementation of public-private mix
in TB care and control by Appendix 7, respectively.
Two. Charge organization and operationalization of 1-2 wards with 2-5 beds for drug resistant TB patients according to infection control requirements starting from January 2010
and include related costs into budget starting from 2011 to heads of Darkhan-Uul, Dornogovi, Orkhon, Selenge, Tuv, Khentii and Uvurkhangai aimag health departments and to heads
of above mentioned aimag general hospitals.
Three. Charge expansion of the capacity of the drug resistant TB ward to 60 beds to
the National Center for Communicable Diseases (Mr. D. Nyamkhuu) starting from January
2010.
Four. Expand TB services and care to homeless, vagabonds, and people without permanent residential addresses in Ulaanbaatar, charge sustainable operation of 16 beds in the
TB department at the Enerel Hospital to the Department of Finance and Investment (Mr.
N. Tumendemberel) and City Health Department (Ms. Ts. Gankhuu) starting from January
2011.
Five. Charge the set up of TB drug storage spaces in accordance with Appendix 5 of these
guidelines to the heads of aimag, city health departments, general hospitals and dostrict
health centers.
Six. Charge allocation of cost for receiving TB drugs at the national level to the National
Center for Communicable Diseases (Mr. D. Nyamkhuu), cost for transportation of distributed
drugs to the heads of aimag, city health departments and general hospitals.
Seven. Charge the implementation of the order to the Department of Public Health Policy
Implementation and Coordination (Ms. S. Tugsdelger), the Department of Health Care Policy Coordination (Mr. Sh. Enkhbat), Information, Monitoring and Evaluation Department (Mr.
S. Enkhbold).
Eight. In relation to the approval of the present order, consider the Health Ministers Orders A/190 of 2003 and 176 of 2006 invalid.

MINISTER

S. LAMBAA

90

Appendix 1 of the Health Ministers Order No.


397 of 20 November, 2009
Management and organization of TB care and services
One. National Center of Communicable Diseases
The National Center on Communicable Diseases (NCCD) is responsible for coordination of
implementation of the National Stop TB strategy; the development of standards and general methodology
on TB prevention, diagnosis and treatment; the organization of training and study on TB morbidity,
prevalence, mortality and treatment effects through surveillance as well as laboratory testing methods; the
planning of national prevention measures against drug susceptible and drug resistant TB; the estimation,
procurement, storage, and distribution of TB drugs and reagents; and the provision of technical assistance,
through adoption of the internationally accepted The Patient's charter for TB care.

One. Aimag and city health departments, district health centers


1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9

Depending on the population, TB morbidity and prevalence, provide sustainable human resources
to include 1 TB coordinator, 2-5 specialized doctors, 2-5 nurses, 1-2 laboratory technicians.
Evaluate TB morbidity, diagnosis, treatment and prevention measures within the respective
population every 6 months and on an annual basis, plan further actions, and collaborate with
professional TB organizations.
Allocate financial resources to procure TB drugs, laboratory equipment and reagents in the annual
local budget.
Organize a storage room for anti-TB drugs, according to standards.
In order to ensure accessibility and quality of TB services, the Health department/center shall
monitor TB treatment at the continuation phase provided by family group practice clinics.
In order to make TB services available, strengthen sputum specimen transportation system and
increase coverage of sputum microscopy.
Ensure work station safety and infection control for doctors and health wokers at the TB units,
provide them with necessary equipment.
TB contact investigation, their screening shall be conducted in collaboration with the
epidemiologist responsible for vaccination at the aimag level, with the epidemiologist of the
health center and doctor of the TB dispensary at the city level.
Implement recommendations and instructions from professional inspectorate and quality control
agencies, present local issues to higher decision making authorities and seek solutions from them.
Two. TB dispensary at aimag and district level

2.1
2.2
2.3
2.4

Take a leadership position in presenting local issues and seeking solutions for these issues
TB coordinator is responsible for the activities to fight and prevent TB, and, in collaboration with
local authorities and health decision makers, develop and implement the plan to fight and prevent
TB
Provide technical and methodological support to collaborating local agencies, family group
practices (FGPs), soum doctors and specialists in their effor to fight and prevent TB
Strictly follow and conduct internal monitoring of work station safety and infection control
guidelines at the TB units, departments, and dispensary

91

2.5
2.6

2.7

2.8
2.9
2.10

Take measures on ordering, storing and distributing equipment, drugs and reagents necessary for
TB diagnosis and treatment, monitoring their usage
Doctors and health personel at the TB dispensary provide services and care to suspected, new,
relapsed TB patients, diagnose and treat them under direct observation, identify immediate
contacts of drug susceptible and drug resistant TB patients in collaboration with the
epidemiologist, soum and FGP doctors, and involve the contacts in TB examination
TB doctors at aimag and district level decide which level of the referral system (department,
soum hospital or FGP, daily treatment unit, health volunteer) the patient should be referred,
ensure the patient takes monitoring tests on time during treatment, and coordinate temporary
disability issues
Implement measures related to early detection, treatment and monitoring during antenatal and
post natal period in association with primary health care institutions
Constantly organize information, education and communication activities on early detection and
prevention of TB among the general population and target groups
Deliver on time information and reports on TB to related organizations
Five. Specialized hospitals

3.1

3.2

If the patient is suspected of having pulmonary TB, a sputum sample should be taken and
laboratory tests performed. If it is impossible to do a sputum test, the patient or a sample
should be sent to the respective district TB dispensary for diagnosis. Patients from rural
areas and their samples should be sent to the Reference Laboratory of the NCCD for
diagnosis.
If the smear test is negative or extrapulmonary TB diagnosis needs to be verified, a doctor
should be called from the NCCD for consultation and verification.
Four. Maternity homes

4.1
4.2
4.3

A pediatrician should check whether the newborn has any conditions preventing them from
recieving the BCG vaccine. If there is no preventing conditions, the newborn should receive the
BCG vaccine within 24 hours after the birth.
A specially trained nurse should give the BCG vaccine, record the vaccination or explain the
reason on why the vaccination was not performed in the newborns health book or referral list.
Epidemiologist of the maternity home should teach the method of giving the vaccine, monitor the
storage of the BCG vaccines, and strictly follow instructions on ordering, storage, and distribution
of vaccines.
Five. Primary health care organizations (soum hospitals and FGPs)

5.1
5.2
5.3
5.4
5.5

Study vulnerable populations for TB, organize active and semi-active case finding in association
with related organizations
Evaluate complications and scars of the BCG vaccine in newborns when they are 1, 3, 12 months
old and record it in their health book. If there is no scar, tuberculin skin test should be performed
and, if the result is negative, involve the baby in re-vaccination.
If the newborn did not receive the BCG vaccine after birth, their vaccination should be conducted
in consultation with pediatrician, TB doctor and vaccination specialist of the respective district
health center.
Determine contacts of the TB patients in the area and involve them in preventive examination and
testing
Conduct treatment of TB patients according to guidelines, ensure that patients take monitoring
tests on time, and are informed of the results

92

5.6
5.7
5.8
5.9

If the TB patient under treatment moves to a different area, inform the TB dispensary and, if the
patients treatment is interrupted, clarify the reasons and take necessary measures
If TB is suspected, take a sputum 2 times, conduct a sputum microscopy and if necessary refer the
patient to have a chest x-ray
Provide pregnant mothers and their family members with information related to TB and advise
them to come to hospital, if they have TB symptoms
Constantly organize awareness raising campaigns on TB among the population of the respective
area
Six. Prison units #401, #429, #461 and #407

6.1
6.2
6.3
6.4
6.5
6.6

Create possibilities for TB doctors and health professionals to work full-time and continuously at
the prison units
Health workers of prison units #401, 429 and 461 should conduct regular TB detection screening
among inmates
The TB patients, who need treatment at the prison units 405 and 407, should undergo treatment at
the respective units under supervision of unit doctor. TB doctor should provide technical support
and monitor the treatment.
The drug resistant TB patients should stay and undergo treatment at the hospital of prison unit
429
If inmate with TB has other diseases, the treatment for TB and co-morbidity should be made at
the hospital of 401 prison unit
Reports and data on TB should be sent on time. If the inmate is released pre-term, the statistician
of the Prison unit 429 should inform the TB surveillance and research department. The treatment
should be continued at the place of residence and results should be reported there.
Nine. Enerel hospital

7.1
7.2

Enerel hospital provides TB services and care to homeless, people without permanent residential
address, for 6-8 months under direct observation, undertakes TB detection examination and
among vulnerable groups and constantly organizes prevention activities
TB data and reports should be sent to related organizations

93

Appendix 2 of the Health Ministers Order No 397


of 20 November, 2009
Guidelines on drug susceptible TB services and care
The present guidelines are followed when detecting, diagnosing, treating and monitoring drug
susceptible TB cases.
One. Drug susceptible TB
1.1 Definition: Infectious disease caused by the drug sensitive TB bacteria
1.2 Cause: Drug sensitive Mycobacterium tuberculosis complex
Two. Classification, definition of cases
2.1

The drug susceptible TB is classified by the location of infected organ of which there are two
types: pulmonary and extrapulmonary TB.
2.1.1 Pulmonary TB: Cases with clinical pulmonary symptoms, verified by the bacteriological
and chest x-ray tests belong to this group
Most common clinical forms of pulmonary TB are:
x Tuberculosis of intrathoracic lymph nodes
x Localized TB
x Infiltrated TB
x Lung tubercle
x Disseminated TB
x Cavitation TB, Tuberculous fibrosis of lungs
Extrapulmonary TB: Cases with extrapulmonary clinical symptoms, verified
histilogically and bacteriologically belong to this group.
Most common clinical forms of extrapulmonary TB are:
x TB of peripheral lymph nodes
x Tuberculous meningoencephalitis
x Tuberculous pericarditis
x TB of pleura
x TB of intestine
x TB of genitor-urinary system
x TB of bones and joints
In accordance with severety of clinical symptoms TB is divided into three categories: moderate,
critical and severe.
According to sputum microscopy TB is classified as sputum smear positive and sputum smear
negative
2.3.1
Sputum smear positive, pulmonary TB: cases of pulmonary TB when sputum smear
examination positive for acid-fast bacilli
2.3.2 Sputum smear negative, pulmonary TB: cases with clinical symptoms and plus
radiographic abnormalities consistent with active pulmonary TB, culture-positive for
AFB but sputum smear is negative
2.1.2

2.2
2.3

94

2.4

Definition of the cases:


TB suspect: patient is coughing for more than 14 days
New: A patient who has never received treatment for TB before, or who has taken antiTB drugs for less than 30 days
2.4.3 Relapse: Patient previously treated for TB and declared cured or treatment completed,
who is later diagnosed with bacteriologically positive TB
2.4.4 Transfer out: Referred case from a different aimag or district during the treatment
process
2.4.5 Defaulted: A patient who interrupted treatment for 2 months or more and who
becomes smear positive and starts again the treatment
2.4.6 Failure: Smear positive patient who remained smear positive at five months during
the treatment
2.4.7 Other: cases, which do not belong to any of the above mentioned groups
Treatment outcome:
2.5.1 Cured: Former smear positive patient who was smear negative for 2 or more consecutive
times during treatment follow up
2.5.2 Completed treatment: A patient who has completed treatment but did not complete
treatment follow up bacterialogical tests, or pulmonary sputum smear negative TB
patients and extrapulmonary TB patients who completed treatment
2.5.3 Failure: Smear positive patient who remained smear positive at five months or later
duringtreatment
2.5.4 Defaulted: A patient who interrupted treatment for 2 consecutive months or more
2.5.5 Transferred out: A patient who has been transferred to another aimag, district during the
treatment period
2.5.6 Died: A patient who dies for any reason during the course of treatment
2.5.7 Treatment success: smear positive cases who were cured and completed treatment
Complications:
2.6.1 No complications
2.6.2 Complications: hemorrhage, pneumothorax, athlectasis, failure of vitally important
organs, complications of other associated diseases, etc.

2.4.1
2.4.2

2.5

2.6

Three. Diagnosis
The following methods will be used for the diagnosis of drug susceptible TB:
3.1 Clinical diagnosis
3.1.1 Identification of symptoms, TB contacts, and risk factors for the infection by questionnaire
In children: close contacts, vaccination, history of development and growth, other diseases
3.1.2 Evaluate the current health state of the patient and reveal changes that have occurred in the
organs by physical examination
In children: over sensitivity of tuberculins (inflammation of eye membrane, red indurations),
history of development and growth, scar from BCG vaccine, any additional examinations
Basic tests:
x Pulmonary TB: sputum smear microscopy, culture, chest x-ray

95

Extrapulmonary TB: histological and bacteriological tests, x-ray, immunology, molecular


tests
In children: tuberculin skin test, bacteriological test in stomach waste
Additional tests: blood and urine tests, biochemical test, HIV test
x

3.2 Diagnostic methods


3.2.1

3.2.2

3.2.3

3.2.4
3.2.5

3.2.6
3.2.7

Collection of sputum, storage and transportation


According to standards, sputum should be collected from the patient two times. The first sputum
can be collected at the examination period, and the second time, sputum should be collected next
morning on empty stomach. Sputum should be collected in a wide, disposable container with
opening lid and kept in the refrigerator (+2 - +8).According to guidelines to transport bio
hazardous material, sputum should be transported to laboratory in a short period of time.
Sputum smear microscopy
Sputum smear microscopy is used to diagnose pulmonary and extrapulmonary TB. Smear should
be prepared from the sample and stained by the Ziehl Neelsen method and observed through a
microscope which can enlarge by 1000 times. If there are acid-fast bacterias, the test is
considered positive and, if such bacterias are not present, the test is considered negative.
Culture test
According to doctors prescription, culture is done in order to verify the diagnosis and identify if
the TB is drug resistant.
The sample should be elaborated and cultured for up to 8 weeks in the 2% Ogawa, LevensteinJensen nutritious environment in +37 degrees Celsius. Culture should be checked every week and
results noted and reported.
Chest X-ray test
Posterior, anterior and CT scan are chest x-ray views and through them, it is possible to determine
location, distribution, process and activity of the illness.
Tuberculin skin test
In order to identify whether the patient has TB infection, the tuberculin skin test should be
performed in children and adolescents aged 0-16 and results determined within 48 to 72 hours.
The result is positive, if:
x induration is more than 10 mm
x induration is more than 5 mm for children who are HIV positive, underweight and/or
malnourished
Cases of false positive and false negative results:
x False positive: Incorrect interpretation of the results, infection by nontuberculosis
mycobacterium
x False negative: HIV infection, incorrect storage of tuberculin tests, other viral and bacterial
infections, period within 6 months since viral vaccination, malnourishment, underweight,
treatment which compromises immunity, protein shortage, desseminatedTB.
Histology
Identification of specific inflammation characteristics by analyzing cells taken from organs that
have inflammation changes
Immunology test
This is a rapid test to detect antigens in blood cells. The results are either negative or positive.
Four. Treatment

Directly Observed Treatment Short-course strategy should be used at all levels of health care
services for TB patients.

96

4.1
Nutrition
According to guidelines on nutrition during treatment and care, the diet # 11 should be used 5-6 times per
day*. This diet helps strengthen the immune system to fight against infection. This diet has a 20 percent
increase in the intake of proteins and calories and is rich in carbohydrates, vitamins and minerals.
Daily composition of the diet is proteins 120-130 gr (60% of it is ), dietary fat 75-80 (60% of it is ),
carbohydrates 400-450 gr, calories 3000-3200 kkal, salt 10 gr, respectively. TB patients can eat any type
of food and they should eat more milk and dairy products.
4.5

Dosage of anti-TB drugs


Name of drug
Isoniazid (H)

Drug purpose

To kill bacteria

Rifampicin (R)

10 (8-12)

600

To kill bacteria

Pyrazinamide (Z)

25 (20-30)

1600

To kill bacteria

Children 20 (15-25)
Adults 15 (15-20)

1200

Compromise
development of
bacteria

15 (12-18)

1000

To kill bacteria

Ethambutol (E)
Streptomicine (S)
4.5

Recommended dose
Highest daily dose
Dose (mg/kg )
(mg)
300
5 (4-6)

Treatment categories and regimens

TB treatment consists of intensive and continuation stages.


4.3.1 Category I
x Patients with new sputum smear positive pulmonary TB
x Patients with new, sputum smear negative disseminated TB
x Patients with new, extrapulmonary TB, severe form
Treatment regimen: 2HRZE(S)/4HR
4.3.2

Category II
x Relapse
x Failure
x Defaulted
Treatment regimen: 2HRZES/1HRZE/5HRE
4.3.3

Category III
x Patients with new, sputum smear negative pulmonary TB
x Patients with new, EPTB (except for Category I)
Treatment regimen: 2HRZE/4HR
4.3.4

Combination of TB drugs with fixed dose

97

NameName
of drug
of(abbreviation)
drug (abbreviation)

Dosage
Dosage
according
according
to body
to weight
body weight
30-3930-39
kg kg
40-5440-54
kg kg
55-7055-70
kg kg

2RHZE
2RHZE
(150/75/400/275)
(150/75/400/275)
/
/
4RH (150/75)
4RH (150/75)
3RHZE
3RHZE
(150/75/400/275)
(150/75/400/275)
/
/
5RHE5RHE
(150/75/275)
(150/75/275)
2S (1 2S
g vial)
(1 g vial)

Category
Category
I and III
I and III
2 pills2 pills
3 pills3 pills

4 pills4 pills

Category
Category
II
II
2 pills2 pills
3 pills3 pills

4 pills4 pills

ml1 ml
500 mg
500 mg

ml2 ml
750 mg
750 mg

3 ml3 ml
1000 mg
1000 mg

4.4 Treatment
4.4 Treatment
of TBof
among
TB among
children
children
WHOWHO
recommends
recommends
starting
starting
treatment
treatment
for children
for children
aged more
aged more
than 3than
months
3 months
by dosage
by dosage
according
according
to the to the
childschilds
weight.
weight.
Highest
Highest
daily dose
dailyfor
dose
children
for children
shouldshould
not exceed
not exceed
highest
highest
daily dose
dailyfor
dose
adults.
for adults.
4.4.1 4.4.1 Dosage
Dosage
for pediatric
for pediatric
anti-Banti-B
drugsdrugs
NameName
of drug
of drug

Recommended
Recommended
dose dose
Dose (mg/kg/day)
Dose (mg/kg/day)

Isoniazid
Isoniazid
(H) (H)

10 (10-15)
10 (10-15)

Rifampicin
Rifampicin
(R) (R)

15 (10-20)
15 (10-20)

Pyrazinamide
Pyrazinamide
(Z) (Z) 35 (30-40
35 (30-40
) )
Ethambutol
Ethambutol
(E) (E)

20 (15-25)
20 (15-25)

Streptomycin
Streptomycin
(S) (S) 15 (12-18)
15 (12-18)
Instructions
Instructions
on dosage
on dosage
on drug
oncombination
drug combination
for pediatric
for pediatric
TB TB
Combination
Combination
of Rifampicin
of Rifampicin
250 mg,
250isoniazid
mg, isoniazid
150 mg,
150pyrazinamide
mg, pyrazinamide
150 mg,
150ethambutol
mg, ethambutol
250 mg
250ismg is
suitable
suitable
duringduring
intensive
intensive
phase phase
of TBof
treatment
TB treatment
in children.
in children.
Other Other
combinations
combinations
such such
as 3 as
drugs
3 drugs
combination
combination
of rifampicine
of rifampicine
250 mg
250 +mg
isoniazid
+ isoniazid
150 mg
150 +mg +
pyrazinamide
pyrazinamide
400 mg
400should
mg should
be used
be ifused
regimen
if regimen
without
without
ethambutol
ethambutol
is selected
is selected
at the at
intensive
the intensive
phase phase
of
of
treatment
treatment
and 2 and
drug2combination
drug combination
of rifampicin
of rifampicin
250 mg
250
+ isoniazid
mg + isoniazid
150 mg
150
in mg
the in
continuation
the continuation
phase.phase.
4.4.2 4.4.2 Treatment
Treatment
regimen
regimen
for new
forcases
new cases
of TBof
inTB
children
in children
Treatment
Treatment
for children
for children
weighing
weighing
5-20 kg:
5-20 kg:
NameName
of drug
of drug
(drug(drug
Dosage
Dosage
according
according
to body
to weight
body weight
abbreviation,
abbreviation,
dose) dose)
5-7 kg5-7 kg
8-14 kg
8-14 kg
15-2015-20
kg kg

Without
Without
Ethambutol
Ethambutol
2RHZ*
2RHZ*
(60/30/150)
(60/30/150)
2RH*2RH*
(60, 60)
(60, 60)
4RH*4RH*
(60/30)
(60/30)

1 pill 1 pill
1 pill 1 pill
1 pill 1 pill

2 pills2 pills
1 pill 1 pill
2 pills2 pills

3 pills3 pills
2 pills2 pills
3 pills3 pills

98

4RH* (60/60)
With Ethambutol
2RHZ* (60/30/150)
2RH* (60, 60)
2E (100)
4RH* (60/30)
4RH* (60/60)

1 pill

1 pill

2 pills

1 pill
1 pill
1 pill
1 pill
1 pill

2 pills
1 pill
2 pills
2 pills
1 pill

3 pills
2 pills
3 pills
3 pills
2 pills

Treatment for children weighing 20-30 kg:


Name of drug
(drug Dosage according to
abbreviation, dose)
body weight
Without Ethambutol
2 pills
2RH (150/75)
2 pills
2RH* (60, 60)
2 pills
2Z(400)
2 pills
4RH (150/75)
2 pills
4RH* (60, 60)
With Ethambutol
2RHZE (150/75/400/275)
2 pills
2RH* (60, 60)
2 pills
4RH (150/75)
2 pills
4RH* (60/60)
2 pills
Regimen for relapse pediatric TB cases:
For children weighing 5 20 kg:
Name of drug
(drug Dosage according to body weight
abbreviation, dose)
5-7 kg
8-14 kg
2 pills
1 pill
3RHZ* (60/30/150)
1 pill
1 pill
3RH* (60, 60)
2 pills
1 pill
3E (100)
2 pills
1 pill
5RH* (60/30)
1 pill
1 pill
5RH* (60, 60)
2 pills
1 pill
5E (100)

15-20 kg
3 pills
2 pills
3 pills
3 pills
2 pills
3 pills

For children weighing 20-30 kg:


Name of drug
(drug Dosage according to
abbreviation, dose)
body weight
2 pills
3RHZE (150/75/400/275)
2 pills
3RH* (60, 60)
2 pills
5RH (150/75)
2 pills
5RH* (60, 60)
1 pill
5E (400)
Drugs with * should be selected as first choice.

10

99

Things to pay attention to during the treatment of pediatric TB:


4.4.1 Weight children on a monthly basis during the treatment
4.4.2 If the weight of the child has changed, dosage should be changed according to their weight
4.4.3 Dosage of the drug combination should be checked, in order to avoid overdosage and drug
poisoning.
4.4.4 Children with a body weight above 30 kg should be treated as adults
4.5

Treatment regimens for specific cases


4.5.1

Treatment of pediatric TB Meningitis and disseminated TB


Children with TB meningitis and disseminated TB should be placed in hospital and
treatment should be done there.
Treatment regimen: 2HRZE(S)/4HR; 2HRZE(S)/6HE
4.5.2 Treatment of disseminated and severe form of TB
In the case of TB meningitis, acute disseminated TB, Spinal TB with damaged nerves,
and some severe forms of TB, Isoniazid and Rifampicin can be used for 7 months as
continuation treatment depending on clinical condition.
4.5.3 Surgery
Surgery should be performed, in cases when the drug treatment is not enough, during the
complications of pulmonary TB, tuberculous pericarditis, TB of bones, abdominal TB,
and inflammatory indurations.
4.5.4 Specifics of treatment of pregnant women with TB
If TB treatment is started for pregnant and lactating women, treatment should be
completed. It is possible to breastfeed during anti-TB treatment. It is prohibited to use
streptomycin during the treatment. Pyridoxine should be given to pregnant and lactating
women with TB.
4.5.5 Treatment for women using hormonal contraceptives
Rifampicin compromises the effects of hormonal contraceptives; therefore, it is advised
to use contraceptive with estrogen dose above 50 mg/kg or use other family planning
methods.
4.5.6 Treatment of patients with liver failure
During severe liver disorders, complications of liver disorders, Pyrazinamide should not
be used, liver function should be constantly monitored and treatment should be done
according to 2SHE/10HE regimen. During severe liver inflammation, TB treatment
should be postponed.
Treatment for patients with kidney failure
For patients with severe kidney failure, isoniazid should be used in combination with
pyridoxine, in order to prevent nerve damage. Ethambutol and streptomicine should be
used under doctors observation. Suggested regimen: 2HRZ/6HR
Treatment of diabetic patients
Sugar level should be checked 1-2 times a day, when using pyrazinamide.
Other treatments
Symptomatic treatments such as sustain heart function, vitamins, reduce complications
and side effects, when necessary.

11

100

Five. Treatment follow up


Based on patients health condition, clinical symptoms, social situation, risk of infection the aimag and
district TB doctor decides which level of health care services (TB unit, soum hospital, family health
practitioner, daily treatment unit, health volunteer) holds direct observation of the TB patient.
x Treatment follow up should be done according to the following principles:
x Intake of anti-TB drugs under direct observation
x Monitoring of side effects related to anti-TB drugs
x Bacteriological monitoring of treatment for new pulmonary TB patients should be done at the 2nd
(3rd), 5th, and 6th month of the treatment, and for relapse cases at the 3rd, 5th, and 8th month. Chest
x-ray should be conducted at the end of the treatment.
5.1 Soum hospitals and FGPs will be responsible for treatment and followup of:
5.1.1
5.1.2
5.1.3

Cases with sputum smear negative TB, moderate health condition, without any co-morbidities or
u with stable nderlying condition.
Cases of extrapulmonary TB, moderate health condition, without any co-morbidities or u with
stable nderlying condition
Pediatric pulmonary and extrapulmonary TB cases with moderate health condition, without any
co-morbidities or with stable underlying condition

5.2 Aimag and ditrict TB dispensary is responsible for treatment and follow up of:
5.2.1 Sputum smear positive and negative pulmonary TB cases with moderate or critical health
condition, without any co-morbidities or with stable underlying condition
5.2.2 Extrapulmonary TB cases with moderate or critical health condition, without any co-morbidities
or with stable underlying condition,
5.2.3 Pediatric pulmonary and extrapulmonary TB cases with moderate or critical health condition,
without any co-morbidities or with stable underlying condition,
5.2.4 Smear positive and negative pulmonary TB or extrapulmonary TB cases during pregnancy and
post-partum period with overall satisfactory health condition, without any co-morbidities or with
stable underlying condition
Aimag or district TB doctor decides whether treatment during continuation phase should be
followed up by health volunteers, FGP, soum hospital or TB dispensary
5.3 TB clinical hospital, aimag general hospital and TB department of Enerel Hospital are
responsible for the monitoring and treatment of:
5.3.1
5.3.2
5.3.3
5.3.4
5.3.5
5.3.6

Cases of pulmonary TB with positive or negative smear test, overall health condition is critical or
severe, with associated disease, or associated disease is active
Cases of extrapulmonary TB, overall health condition is critical and severe, with associated disease,
or associated disease is active,
Cases of pulmonary TB combined with extrapulmonary TB, overall health condition is critical and
severe,
Cases of pediatric pulmonary and extrapulmonary TB, overall health condition is critical and severe,
complicated with associated disease or associated disease is active,
Cases of pregnancy and post partum women with pulmonary TB with negative or positive smear
test, or extrapulmonary TB, overall health condition is critical and severe, associated disease is
active,
Cases with strong side effects, contacts of drug resistant TB, interruption of previous
treatment, ineffective treatment, remotely located from DOTS center, impossible to take the

12

101

5.3.7

drugs under direct observation, patients without permanent residential address, poor,
homeless, without legal guardian, drug and alcohol addicts.
The TB doctor of aimag or district will decide whether the continuation of treatment of the above
cases will be done by the health volunteers, FGP, soum hospital or TB dispensary.

5.4 Health volunteers and lunch DOTS


5.4.1 Cases of pulmonary TB with either positive or negative smear test, overall health condition is
satisfactory, without associated disease or associate disease is inactive,
5.4.2 Cases of extrapulmonary TB, overall health condition is satisfactory, without associated disease
or associate disease is inactive.
5.5 Referral of seriously ill patients between hospitals
5.5.1

5.5.2

5.5.3

Cases where TB is suspected, for a patient who undergoes treatment at the clinic or specialized
hospitals, should take all tests to diagnose TB and consultation should be given by a professional
TB doctor. The referral of the patient should be decided based upon bacteriology or histology
results.
If the health condition of the TB patient, diagnosed while in treatment at the clinic or specialized
hospital, is critical and impossible to transport them to another hospital, anti-TB services
and
care should be provided to the patient at the hospital where s/he is staying until his/her condition
stabilized without consideration whether the patient is infectious or not.
When health condition of TB patient with associated disease is critical due to co-morbidity and it
is impossible to transfer the patient to another hospital, anti-TB services and care should be
provided to the patient at the hospital where s/he is staying.
Six. Registration and reporting

The TB should be registered under A15-A19 (Tuberculosis) code, according to the 10th
international classification of diseases.
6.1 The doctor of the TB Dispensary of aimag and district should register the case of drug susceptible TB
in the Registration of TB patient form (-03) and start the Treatment card of TB patient (01).
6.2 The Monthly Report of new and relapsed TB patients (-07), Report on sputum conversion at
the 2nd and 3rd months treatment (-14), Report on treatment outcomes of TB patients registered
12-15 months ago (-08), and TB Laboratory register should be completed by the 25th of every
month, verified by the TB coordinator and statistician, and sent to the TB Surveillance and Research
Department of the NCCD within the first week of the next month or quarter.
6.3 The attending physician should take notes in the Card of hospitalized patients (TB-13) and refer the
patient to health institution, which will provide treatment at the continuation phase on the release of
the patient from the hospital.
6.4 The TB coordinator should complete Annual report of the activities of the TB unit (-10) and
send to TB Surveillance and Research Department by January 15th of the next year.
6.5 The Treatment card of TB patient (-01) should be sent to the TB Surveillance and Research
Department within a month after the completion of treatment.
6.6 If the patient moved to another location during the course of treatment, the Report on patient
referral (-09) should be completed in 3 copies and sent to the patient, to health institution, which
will continue the treatment, and the TB Surveillance and Research Department, respectively. The
receiving health institution should report back and treatment outcomes should be reported at the place
of original registration.

13

6.7 Report on first-line anti-TB drugs should be completed by the 25th of every month and report on
second-line anti-TB drugs, drugs to manage side effects, and reagents should be completed by the 25th
of the last month of each quarter and sent to the TB Surveillance and Research Department of the
NCCD.

102

Appendix 3 of the Health Ministers Order No 397


of 20 November 2009
Guidelines on drug resistant TB services and care
Drug resistant TB is caused by the delayed diagnosis of TB, treatment done without direct
observation, anti-TB drugs used inappropriately, incomplete or incorrect treatment, shortage of anti-TB
drugs during the course of treatment, and using low quality drugs. Lately, drug resistant TB has been
increasing worldwide.
In some cases, people can get infected with drug resistant TB even without using anti-TB drugs.
The present guidelines will be followed in order to prevent against drug resistant TB, its
detection, diagnosis, registration, reporting, treatment and monitoring.
One. Definition and classification
TB cases that are cofirmed by the laboratory tests as caused by drug resistant bacteria are called
drug resistant TB.
1.1 Drug resistant TB is classified as follows:
x Mono-resistance
x Poly-resistance
x Multi-drug resistant TB (MDR-TB)
x Extensively drug resistant TB (XDR-TB)
1.1.1 Mono-resistance:resistant to one of any anti-TB drugs
1.1.2 Polyresistant: resistant to more than one anti-TB drugs, but other than noth isoniazid and
rifampicin
1.1.3 Multi-drug resistance: Resistant to at least isoniazid and rifampicin
1.1.4 Extensively drug resistant: resistant to any fluoroquinolone and at least one of the three
injectable second line drugs
1.2 Classification by the cause
1.2.1 Primary resistance
1.2.2 Secondary resistance
1.2.3 Primary resistance: the form which occurs in patients who never had anti-TB treatment
before or the course of treatment is less than a month;
1.2.4 Secondary resistance: the form which occurs during the course of anti-TB treatment;
1.3 Definition of cases
1.3.1 New: a patient who never had treatment before or the course of treatment is less than
one month;
1.3.2 Relapse: a patient whose most recent reatment outcome was cured or treatment
completed and who is subsequently diagnosed with bacteriologically positive TB by
sputum amerar microscopy or culture;
1.3.3 Treatment after default: a patient who returns to treatment, bacteriaologically positive
by sputum smear microscopy or culture, following interruption of treatment for 2 or
more months;
1.3.4 Treatment after failure of Category I: a patient who received Category I treatment for
TB, with sputum smear positive at 5th months during treatment;
1.3.5 Treatment after failure of Category II: a patient who received Category II treatment
wirg sputum smear at 5th months or later during treatment;
1.3.6 Transfer in: a patient who has been transferred in from another aimag or district in
course of treatment;
1.3.7 Other: sputum smear positive patients with unknown treatment outcome, sputum smear
positive patients who received treatment other than Category I or II, patient who
15
received several unsuccessful treatments, previously treated patients with
extrapulmonary TB.
1.4 Definition of treatment outcomes
1.4.1
1.4.2

Bacteriologically negative: cases of 2 consecutive negative culture;


Cured: in the final 12 months of treatment,
culture is performed every 30 days of which:
103
x Last 5 consecutive negative cultures;
x 3-4 consecutive negative cultures and clinical symptoms disappeared;

Other: sputum smear positive patients with unknown treatment outcome, sputum smear
positive patients who received treatment other than Category I or II, patient who
received several unsuccessful treatments, previously treated patients with
extrapulmonary TB.
1.4 Definition of treatment outcomes
1.3.7

1.4.1
1.4.2
1.4.3

1.4.4
1.4.5
1.4.6
1.4.7

Bacteriologically negative: cases of 2 consecutive negative culture;


Cured: in the final 12 months of treatment, culture is performed every 30 days of which:
x Last 5 consecutive negative cultures;
x 3-4 consecutive negative cultures and clinical symptoms disappeared;
Treatment completed: anti-TB treatment completed fully and culture negative at the end
of treatment in following cases:
x Fewer than 5 cultures were performed in the final 12 months of treatment
x 3-4 consecutive negative culture, but clinical symptoms remain
x Though sputum smear is negative, there is extrapulmonary TB
Died: a patient who dies for any reason during the course of MDR-TB treatment;
Defaulted: a patient whose treatment was interrupted for two or more months;
Failed: of the last 3 consecutive cultures, one or more cultures are positive;
Tranferred out: cases when the patient has moved to another aimag or district during the
course of treatment.
Two. Case finding

2.1

When drug resistant TB is suspected, the drug resistance test (DST) should be performed in the
following cases:
2.1.1 Patients who remain sputum smear positive at 3rd month of receiving Category I and II
treatment
2.1.2 Patients who remain sputum smear positive at 5th month of receiving Category I and II
treatment
2.1.3 Patients who return to treatment, positive by sputum smear microscopy after interruption
of CAT I and CAT II treatment
2.1.4 Relapse of anti-TB first and second line treatment
2.1.5 Other: following cases with treatment course of more than 1 month
x Previous treatment regimen is unclear or sputum smear is negative
x Sputum smear is negative at the beginning of treatment, but turned positive in the
course of treatment
x Sputum smear is negative after interrupting treatment for 2 or more months
2.1.6 Chronic cases with positive sputum smear
2.1.7 Cases of TB among family members and close contacts of drug-resistant TB patient
2.1.8 Cases of TB/HIV co-infection
Three. Laboratory diagnosis

3.1
3.2

The diagnosis of drug-resistant TB should be verified in the following ways:


Isolation
Culture of M.tuberculosis complex will be treated other tests such as niacin, paranitrobezone acid,
and catalyze.
Drug susceptibility testing
In order to determine drug resistance of positive culture tests, first line anti-TB drugs such as
Isoniazid, Rifampicin, Ethambutol, Streptomicine, second line drugs such as Kanamycin,
Ofloxacin, Cycloserine, Ethionamide, or Protionamide, PAS should be tested as per doctors
16
prescription.
Drug resistance will be determined in the Levenstein-Jensen nutritious environment using liquid
drugs in the course of 28 to 42 days.
It is considered drug resistant if the drug concentration exceeds 1%.
In order to determine drug resistance, it is possible to use liquid media as well as molecular
biological methods.
Four. Registration and reporting

104

4.1

The TB doctor at aimag and district level should:

4.1.1

Register the suspected case of drug-resistant TB in the Suspected drug-resistant TB form (MDR

prescription.
Drug resistance will be determined in the Levenstein-Jensen nutritious environment using liquid
drugs
in the course
of 28 toEthionamide,
42 days. or Protionamide, PAS should be tested as per doctors
Ofloxacin,
Cycloserine,
It isprescription.
considered drug resistant if the drug concentration exceeds 1%.
In order
to determine
drug
resistance,
it Levenstein-Jensen
is possible to use
liquid environment
media as well
asliquid
molecular
Drug resistance
will be
determined
in the
nutritious
using
drugs inmethods.
the course of 28 to 42 days.
biological
It is considered drug resistant if the drug concentration exceeds 1%.
In order to determine drug resistance,
it is possibleand
to use
liquid media as well as molecular
Four. Registration
reporting
biological methods.

4.1

The TB doctor at aimag and district level should:

Four. Registration and reporting

4.1.14.1 Register
thedoctor
suspected
caseand
of drug-resistant
TB in the Suspected drug-resistant TB form (MDR
The TB
at aimag
district level should:
TB-15), collect samples, complete the form Request for DST (MDR-TB-06), and send to
Surveillance
Research Department
of the NCCD,
4.1.1laboratory
RegisteroftheTB
suspected
case ofand
drug-resistant
TB in the Suspected
drug-resistant TB form (MDR
TB-15),
collect
samples, complete
Request
(MDR-TB-06),
and send
4.1.2 If the
diagnosis
is confirmed,
discussthe
the form
treatment
issueforat DST
the Doctors
consultation,
and,tobased
laboratory
of
TB
Surveillance
and
Research
Department
of
the
NCCD,
on the Decision of Doctors consultation on the treatment of drug-resistant TB patient (MDR-TB4.1.216) If
the treatment,
diagnosis is confirmed, discuss the treatment issue at the Doctors consultation, and, based
start
on
the
Decision
of Doctors
consultation
onbe
thenoted
treatment
of drug-resistant
TB patient
(MDR-TB4.1.3 Decision on
initiation
of treatment
should
down
on the Registration
Form
of MDR-TB
16)
start
treatment,
patient (MDR-TB-03),
4.1.3 Decision on initiation of treatment should be noted down on the Registration Form of MDR-TB
4.1.4 Startpatient
the Treatment
card of MDR-TB patient (MDR-TB-01), and hand it over to health institution,
(MDR-TB-03),
which
will
be
responsible
forMDR-TB
intensivepatient
treatment,
4.1.4 Start the Treatment card of
(MDR-TB-01), and hand it over to health institution,
4.1.5 If the
patient
to move to
aimag
or district, complete Patient referral form (MDR-TBwhich
will has
be responsible
foranother
intensive
treatment,
3 copies,
andtosend
copy to
the or
patient,
copy
to referral
institution and
4.1.509) Ifinthe
patient has
movefirst
to another
aimag
district,second
complete
Patient
referral health
form (MDR-TBthe 09)
thirdincopy
to theand
TBsend
Surveillance
and
Department
the NCCD,
3 copies,
first copy to
theResearch
patient, second
copy toofreferral
health institution and
third copy of
to the
Surveillance
andshould
Research
Department
of the NCCD,
4.1.6 TB the
coordinator
the TB
aimag
or district
complete
Quarterly
report (MDR-TB-07), Report
4.1.6on treatment
TB coordinator
of for
the the
aimag
or half
district
complete
Quarterly report
(MDR-TB-07),
Report
results
first
of should
the year
(MDR-TB-08),
and Annual
Report of
treatment
th
on treatment
resultsMDR_TB
for the firstpatients
half of the
year (MDR-TB-08),
and25
Annual
Report
of treatment
results
of confirmed
(MDR-TB-10)
as of the
of
the
reporting
month
and
th
results
of
confirmed
MDR_TB
patients
(MDR-TB-10)
as
of
the
25
of
the
reporting
month
and
send them to the TB Surveillance and Research Department of the NCCD within the first week of
send them to the TB Surveillance and Research Department of the NCCD within the first week of
the next quarter.
the next quarter.

Five.
Treatment
Five. Treatment
Treatment
of of
drug-resistant
compriseofofthetheintensive
intensive
stage,
which
last6-8
for 6-8
Treatment
drug-resistantTB
TB should
should comprise
stage,
which
will will
last for
months,
continuationstage,
stage,which
which will
will last
TheThe
timespan
of treatment
lasts for
months,
andand
the the
continuation
last for
for12-18
12-18months.
months.
timespan
of treatment
lasts for
18-24
months
in total
and
a combination of
of 4-7 drugs
18-24
months
in total
and
a combination
drugswill
willbebeused.
used.
Drugs
used
treatmentofofdrug-resistant
drug-resistant TB
5.3 5.3 Drugs
used
forfor
treatment
TB
Drug name (abbreviation and

Drug nameform
(abbreviation
and
of the drug)
form of the drug)

Dose as per body weight


<33 kg

<33 kg

Dose as per body weight

33-50 kg

33-50 kg

Group I: First-line oral drugs

Isoniazid (H)
(pills (H)
of 100 and 300 mg)
Isoniazid

(pills of 100 and 300 mg)

Rifampicin (R)
(pills of 150 and 300 mg)
Rifampicin (R)
Ethambutol (E)
(pills(pills
of 150
and 300 mg)
of 100 and 400 mg)
Pyrazinamid (Z)
(pills of 400 mg)

51-60 kg

51-60 kg

>60 kg
>60 kg
(highest dose)

(highest dose)

Group
I: First-line
drugs300 mg per day or 300 per day or 600
4-6 mg/kg
per day
200-300 oral
mg per
mgmg
3 times
a ormg 3300
times
a week
or 8-12 per
mg 3day day
or 450-600
300
per day
per
day or 600
4-6 mg/kg
200-300
mg per 600
week
times
a
week
mg
3
times
a
600 mg 3 times a
mg 3 times a week
or 8-12 mg 3
day or 450-600
week
times a week
mgweek
3 times a
10-20 mg/kg/per
450-600
mg
600 mg
600 mg
week
day
10-20 mg/kg/per
450-600 mg
600 mg
600 mg
25 mg/kg/per day
800-1200 mg
1200-1600 mg
1600-2000 mg
day

17

30-40 mg/kg/per
day

1000-1600 mg

1600-2000 mg

2000-2400 mg

500-750 mg

1000 mg

1000 mg

500-750 mg

1000 mg

1000 mg

500-750 mg

1000 mg

1000 mg

500-750 mg

1000 mg

1000 mg

1500 mg

1500 mg

1500 mg

800 mg

800 mg

800-1000 mg

17

Group II: Injectables


Streptomicin (S)
(vial of 1 gr)
Kanamycine (Km)
(vial of 1 gr)
Amikacin (Am)
(vial of 1 gr)
Capreomycin (Cm)
(vial of 1 gr)

15-20 mg/kg/per
day
15-20 mg/kg/per
day
15-20
mg/kg/per day
15-20 mg/kg/per
day

Group III: Fluoroquinolones


Ciprofloxacin (Cx)
(pills of 250, 500, 750 mg)
Ofloxacin (Ofl)
(pills of 200, 300, 400 mg)

20-30 mg/kg/per
day
800 mg

105

Kanamycine
(vial of(Am)
1 gr)(Km)
Amikacin
1 gr) (Km)
Kanamycine
(vial(vial
of 1ofgr)
(vial of 1 (Am)
gr)
Amikacin
Capreomycin
(Cm)
Amikacin
(Am)
1 gr)
(vial(vial
of 1ofgr)

15-20
mg/kg/per
day
15-20
day day
15-20 mg/kg/per
mg/kg/per
day
15-20 15-20
mg/kg/per
15-20
mg/kg/per
day day

500-750
500-750mg
mg
500-750 mg
500-750
500-750mg
mg
500-750 mg
mg/kg/per
day
15-20
mg/kg/per
500-750 mg
Group
III: Fluoroquinolones
15-20 mg/kg/per
500-750 mg
day
day
20-30 mg/kg/per
1500 mg
Group III: Fluoroquinolones
day
Group III: Fluoroquinolones
20-30 mg/kg/per
1500 mg
800mg/kg/per
mg
800mg
mg
20-30
1500
day
daymg
800
800 mg
750
750mg
mg
800 mg
mg
800

(vial of 1 gr) (Cm)


Capreomycin
Capreomycin
(vial
of 1 gr) (Cm)
(vial
of 1 gr)
Ciprofloxacin
(Cx)

(pills of 250, 500, 750 mg)


Ciprofloxacin (Cx)
Ofloxacin
(Ofl) (Cx)750 mg)
Ciprofloxacin
(pills
of 250, 500,
(pills
of 200,
300,
400750
mg)
(pills
of 250,
500,
mg)
Ofloxacin
(Ofl)
Levofloxacin
(L)
Ofloxacin
(Ofl)
(pills of 200, 300, 400 mg)
(pills
of 200,
300,
(pills
of 250,
500(L)
mg)400 mg)
Levofloxacin
Levofloxacin
(L)
Moxifloxacin
(Mx)
(pills of 250, 500 mg)
(pills
of 250,
mg)
(pills
of 400
mg)500
Moxifloxacin
(Mx)
Moxifloxacin
(Mx)
Gatifloxacin
(Gx)
(pills of 400
mg)
(pills of 400 mg)
(pills
of 400 mg)(Gx)
Gatifloxacin
Gatifloxacin (Gx)
(pills of 400 mg)
(pills of 400 mg)

1000
mgmg
1000
1000 mg
1000
mgmg
1000
1000 mg
1000 mg
1000 mg

1000
mg mg
1000
1000 mg
1000
mg mg
1000
1000 mg
1000 mg
1000 mg

1500 mg

1500 mg

1500 mg
1500800
mgmg

1500 mg
800-1000
mg
1500
mg

800 mg
800750
mg mg

800-1000 mg
750-1000
800-1000
mg mg

750 mg

750 mg
750
400mg
mg

750 mg
750400
mg mg

750-1000 mg
750-1000400
mgmg

400 mg

400 mg
400
400mg
mg

400 mg
400400
mg mg

400 mg
400 mg
400 mg

750 mg
mg
400
400 mg
mg
400

400 mg
400 mg

400 mg
400 mg

400 mg
400 mg

Group IV: Bacteriostatic second-line oral drugs

400 mg
400 mg

Group
IV: Bacteriostatic
Bacteriostaticsecond-line
second-lineoral
oraldrugs
drugs
Group
15-20 IV:
mg/kg/per
500 mg
750 mr
750-1000 mg
15-20day
mg/kg/per
500mg
mg
750mrmr
750-1000
15-20
mg/kg/per
500
750
750-1000
mgmg
day
15-20 mg/kg/per
500 mg
750 mg
750-1000 mg
day
15-20day
mg/kg/per
500mg
mg
750mg
mg
750-1000
15-20
mg/kg/per
500
750
750-1000
mgmg
day
day
15-20 mg/kg/per
500 mg
750 mg
750-1000 mg
15-20 mg/kg/per
mg/kg/per
500mg
mg
750mg
mg
750-1000
15-20
500
750
750-1000
mgmg
day
day
day
15-20
600 mg
mg
600mgmg
900 mg
15-20mg/kg/per
mg/kg/per
600
600
900
15-20
mg/kg/per
600
mg
600
mg
900
mgmg
day
day
day
150
gr
150
grgr
8 gr8 gr
150
888grgr
8 8gr8
8 gr
mg/kg/per
day
mg/kg/per day
day
mg/kg/per
150
for
adults
150
adults
150
forfor
adults

Ethionamide (Eth)
Ethionamide
(pills
of 250 mg)(Eth)
Ethionamide
(Eth)
(pills
mg)
Protionamide
(Pto)
(pillsofof250
250
mg)
Protionamide
Protionamide
(Pto)
(pills
of 250 mg)(Pto)
(pills
ofof250
mg)
(pills
250
mg)
Cycloserine (Cs)
Cycloserine
(Cs)
Cycloserine
(capsules
of 250(Cs)
mg)
(capsules
of
(capsules (Trd)
of250
250mg)
mg)
Therizadone
Therizadone
Therizadone(Trd)
(Trd)
(pills
of 300 mg)
(pills
(pillsofof300
300mg)
mg)
Paraaminosalicylic
acid
(PAS)
Paraaminosalicylic
acid
(PAS)
Paraaminosalicylic
acid
(PAS)
(powder
of
4
gr,
PASER)
(powder
(powderof
of44gr,
gr,PASER)
PASER)
Thiacetazone
Thiacetazone
Thiacetazone

5.2 Treatment
Treatment
regimen
Treatment
regimen
5.2 5.2
regimen
The
following
treatmentregimen
will
be
chosen
depending
ononthe
of of
drugfollowing
treatment
regimenwill
willbe
be chosen
chosen for
MDR-TB
patients
depending
theform
form
drugTheThe
following
treatment
forMDR-TB
MDR-TBpatients
patients
depending
on
the
form
of drugresistance:
resistance:
resistance:
Drug-resistance form

Drug-resistance
form
Drug-resistance
form
ResistanttotoHR
HR
Resistant

Treatment regimen

Z-S(Km)*-Ofl-Eth-Cs

Resistant to HRS

Z-E-Km-Ofl-Eth(Cs)

Resistant to HRES

Z-Km-Ofl-Eth-Cs

Treatment regimen
R-Z-E(Ofl)

6-9

HZ

R-E-Ofl

9-12

HE

R-Z-Ofl

9-12

H-E-(S)*-Ofl-Z**

12-18

3HRSE/6HRE

H-Z-Of-S(Km)**

18

RE ( S)

and results of treatment, it is possible to change


1818the
injectables and fluoroquinolones. Injectables should
18
be administered for at least 6 months. If culture at
the intensive phase of treatment is negative for 4
consecutive times, continuation phase treatment can
be started.

Treatment regimen for mono-resistant and poly- resistant DR TB


Minimum
course of
treatment
(months)

H(S)

Depending on previous regimen, drug intolerance,

Z-E-S(Km)*-Ofl-Eth

Resistant to HRE

Drug
resistance
form

Depending
drug
intolerance,
Dependingononprevious
previousregimen,
regimen,
drug
intolerance,

Z-E-S(Km)*-Ofl-Eth
Z-E-S(Km)*-Ofl-Eth

Resistant to HR

5.3

Notes
Notes
Notes

Treatmentregimen
regimen
Treatment

Notes
In case of severe forms of TB, Ofl should be used.
If severe form of TB and disseminated TB, the course
of treatment should be prolonged.
In case of severe and disseminated TB, timespan of
treatment should be prolonged.
* If severe form of TB and disseminated TB
injectable should be chosen and used. **Z should be
used for at least 2 months.
**Injectable should be used for at least 2-3 months.

106
** Injectable should be used for at least 2-3 months. If

HE

R-Z-Ofl

9-12

H-E-(S)*-Ofl-Z**

12-18

HE

R-Z-Ofl

H-E-(S)*-Ofl-Z**

Z Z

9-12

12-18

3HRSE/6HRE
3HRSE/6HRE

99

RERE
( S)
( S)

H-Z-Of-S(Km)**
H-Z-Of-S(Km)**

18
18

RZRZ
( S)
( S)

H-E-Ofl-S(Km)**
H-E-Ofl-S(Km)**

18
18

R-Ofl-Eth-S(Km)**
R-Ofl-Eth-S(Km)**

18
18

HEZ
( S)
HEZ
( S)

of treatment
shouldand
be disseminated
prolonged. TB, timespan of
In
case of severe
In case of severe
disseminated TB, timespan of
treatment
shouldand
be prolonged.
*treatment
If severeshould
form be
of prolonged.
TB and disseminated TB
*
If
severe
form
of
TBchosen
and disseminated
TB should be
injectable should be
and used. **Z
injectable
should
be
chosen
and
used.
**Z
should be
used for at least 2 months.
used for at least 2 months.

**Injectable should be used for at least 2-3 months.


**Injectable should be used for at least 2-3 months.

**
Injectableshould
shouldbebeused
usedfor
foratatleast
least
months.
** Injectable
2-32-3
months.
If If
S
is
used
for
one
month
or
the
TB
is
resistant
to
S,
S is used for one month or the TB is resistant to S,
Km
should be
beused.
used.IfIfsevere
severeform
formofof
Km should
TBTB
or or
disseminated
TB,injectable
injectableshould
shouldbebe
used
disseminated TB,
used
forfor
up up
to 6to 6
months.
months.

The
change
thetreatment
treatmentregimen
regimenshould
should be
be decided
decided by
5.45.4 The
change
ininthe
bythe
theDoctors
Doctorsconsultation.
consultation.
5.5
Treatment
regimen
in
specific
cases
5.5
Treatment regimen in specific cases
5.5.1 If If
MDR-TBis isdiagnosed
diagnosedininthe
the first
first 66 months
months of
thethe
5.5.1
MDR-TB
of pregnancy,
pregnancy, ititshould
shouldbebeadvised
advisedto tostop
stop
pregnancy.
Drugs
of
aminoglycoside
group
and
Eth
should
not
be
prescribed
to
pregnant
women.
If
it
pregnancy. Drugs of aminoglycoside group and Eth should not be prescribed to pregnant women. If isit is
required to start treatment in the second half of pregnancy, Z, Cm, Cs, and Ofl should be used under
required to start treatment in the second half of pregnancy, Z, Cm, Cs, and Ofl should be used under
doctors observation.
doctors observation.
5.5.2 When Z, Eth, and Ofl are used for diabetic patients, blood sugar level should be measured 1-2
5.5.2
Z, Eth,
and Ofltoare
for diabetic
patients,should
bloodbesugar
level should
measured
timesWhen
per week.
In addition
this,used
creatinine
and potassium
prescribed
weekly be
during
the first1-2
times
per of
week.
In addition
to the
this,second
creatinine
and
potassium
should
prescribed
month
treatment
and from
month,
their
levels should
be be
monitored
on aweekly
monthlyduring
basis. the first
month
of
treatment
and
from
the
second
month,
their
levels
should
be
monitored
on
a
monthly
basis.
5.5.3 TB patients with acute mental disorders, alcohol and drug addicts should not be prescribed
Cs and
5.5.3
TB
patients
with
acute
mental
disorders,
alcohol
and
drug
addicts
should
not
be
prescribed
Cs and
should use PAS instead
should use PAS instead
5.5.4 When a TB patient has liver disorders or liver disorders in active stage, Eth, R, and H should be
used under doctors observation and avoid using Z. If liver disorder is becoming more active, liver
19
function test should be undertaken 1-2 times per week.
19
5.5.5 For TB patients with kidney failure, E, Cm, Eth, and Cs should be used under doctors
observation.
5.5.6 When necessary, consultation of specialized doctors should be taken and treatment of associated
diseases conducted.

5.6

5.7

Treatment of drug-resistant pediatric (0-16 years old) TB


There are a few factors to keep in mind while undertaking treatment against drug-resistant
pediatric TB. Those include:
x Childrens body mass should be monitored on a monthly basis and the dose of drugs should
be appropriate to the childrens weight.
x Daily dose of Ethambutol should be 15 mg/kg.
Second-line drugs to treat against MDR pediatric TB
Recommended dose
Daily dose
Max. daily dose
(mg/kg)
(mg)
15-20
1000

Drug name
Ethionamide, Prothionamide
Fluoroquinolone group
x Ofloxacin
x Levofloxacin
x Moxifloxacin
x Gathifloxacin
x Ciprofloxacin
Aminoglycoside group
x Kanamycine
x Amikacine
x Capreomycine
Cycloserine or
Therizidone
Paraaminosalicylic acid

107

15-207,5-10
7,5-10
7,5-10
20-30

800
1500

15-30
15-22,5
15-30
10-20

1000
1000
1000
1000

150

12000

Ethionamide, Prothionamide
Fluoroquinolone group
x Ofloxacin
x Levofloxacin
x Moxifloxacin
x Gathifloxacin
x Ciprofloxacin
Aminoglycoside group
x Kanamycine
x Amikacine
x Capreomycine
Cycloserine or
Therizidone
Paraaminosalicylic acid
5.8

15-20

1000

15-207,5-10
7,5-10
7,5-10
20-30

800
1500

15-30
15-22,5
15-30
10-20

1000
1000
1000
1000

150

12000

Adverse effects of anti-TB drugs and their management

Anti-TB drug
Symptoms
Cs, H, S, Km, Am, Cm, Eth/Pto, Damage of nervous system
fluoroquinolone group drugs

S, Km, Am, Cm

Cs, H, fluoroquinolone group


drugs
Cs, H, fluoroquinolone group
drugs, Eth/Pto

PAS, Eth/Pto
Eth/Pto, PAS, H, E, Z

PAS, Eth/Pto

Z, H, R, Eth/Pto, PAS, E,
fluoroquinolone group drugs
S, Km, Am, Cm
Cm, Km, Am, S

E
Z, fluoroquinolone group drugs

Cs, H, fluoroquinolone group

Management
Pyridoxine dose should be increased
up to 200 mg and reduce or remove
dose of the drug, which has adverse
effects. Amithriptiline or nonhormonal anti-inflammation drugs
should be used for treatment.
Hear loss
Hearing test for every patient should
be done before the treatment and in
case of adverse effect, reduce the dose
or remove the drug from treatment.
Seizures
Daily dose of Pyridoxine should be
increased up to 200 mg and treatment
20
against seizures should be prescribed.
Mental changes
Treatment with controlled substances
should be done under psychiatrists
observation and dose of drug with
adverse effect should be reduced or
removed. In the case of psychological
depression, psychiatric treatment
should be done, and dose of the drug
with adverse effect should be reduced
or removed from the treatment.
Hypotheriose
Treat by Thyroxine
Nausea
The adverse effect should be treated
by injection and anti-nausea drugs.
Drugs with adverse effects should be
removed or daily dose reduced.
Stomach inflammation
Antacid, anti-H receptor drugs and
anti-nausea drugs should be used and
drugs with adverse effects should be
given in smaller dose, stopped for 1-7
days or removed from treatment.
Liver inflammation
Stop the treatment, detect other causes
for liver inflammation, and use drugs
to protect the liver.
Kidney failure
Remove the drug with adverse effects
from treatment.
Imbalance of electrolytes Refill needed electrolytes
(reduction of potassium and
magnesium levels in the
blood)
Change in vision
Remove the drug
Joint pain
Non-steroid
drugs
against
inflammation should be used, fitness
108
training should be advised and
remove the drug from treatment.
Paralysis
Fenithoin, valprone acid should be

S, Km, Am, Cm

Kidney failure

Remove the drug with adverse effects


from treatment.
Cm, Km, Am, S
Imbalance of electrolytes Refill needed electrolytes
(reduction of potassium and
magnesium levels in the
blood)
E
Change in vision
Remove the drug
Z, fluoroquinolone group drugs
Joint pain
Non-steroid
drugs
against
inflammation should be used, fitness
training should be advised and
remove the drug from treatment.
Cs, H, fluoroquinolone group Paralysis
Fenithoin, valprone acid should be
drugs
prescribed. Pyrodoxine dose should
be increased up to 200 mg, dose of
influencing drug should be reduced or
removed from treatment.
5.9 Monitoring of treatment
The TB doctor at the aimag and district level decides which level of health institution (TB unit,
soum hospital, family health practitioner, daily treatment unit, health volunteer) directly observes the
treatment of the TB patient, depending on health condition, clinical symptoms, social situation, risk of
infection, etc. of the patient.
The monitoring of the TB treatment should be done according to the following principles:
5.9.1 Intake of anti-TB drugs under direct observation
5.9.2 Monitoring of adverse effects, related to anti-TB drugs
5.9.3 Sputum smear test and culture should be taken on a monthly basis during intensive phase and
once every 2 months during continuation phase of anti-TB treatment
21
5.9.4 Chest x-ray should be done before treatment, once every 3 months during intensive phase and
once every 6 months during continuation phase of anti-TB treatment. If the TB patient is worsening and
there is a need for surgery, chest x-ray should be done regardless of timing.
5.9.5 After completion of MDR-TB treatment culture should be performed every 6 months during 5
years.
5.9.6 Blood and urine tests should be performed before the treatment, once every 3 months during the
intensive phase of treatment and once every 6 months during continuation phase of anti-TB treatment.
Such tests should be performed whenever needed.
5.9.7 Level of potassium, sodium, creatinine, carbamide, bilirubine, and transaminase should be
checked before the treatment, then on a monthly basis during intensive phase and once every 3-6 months
during continuation phase depending on the condition of the patient.
5.9.8 Level of thyroid hormones should be checked before treatment, and further tested whenever
needed. In case Eth/Pto used for treatment, level should be checked every 6 months.
5.9.9 Vision and hearing ability should be checked before treatment and at the end of the intensive
phase of treatment.
5.9.10 Provider initiated HIV testing and counseling should be provided to the patient during the course
of treatment
5.9.11 Body mass of the patient should be checked every month.
5.9.12 After the completion of treatment, chest x-ray and clinical examination should be done at least
once a year for the next 5 years.
5.9.13 The treatment of drug-resistant TB patient should be decided on the 6th, 12th, 18th and 24th month
of treatment at doctors consultation. If the condition of the patient is critical and there are many adverse
effects, treatment issues should be decided whenever necessary.

109

110

Negative

Bacteriological
test
Clinical
condition
Adverse effects

None

None

Underlying
condition

Complications

Minor

Moderate

12-18 months

Timeframe of
treatment

Treatment phase

Family
practice unit,
soum
hospital
Continuation

None

None

Minor

Moderate

Negative

12-18 months

Continuation

Health
volunteer

Minor
intoxication

None, inactive

Minor

Positive,
negative
Moderate

Intensive and
continuation
18-24 months

TB dispensary

5.10 Monitoring of treatment of MDR-TB patient

Significant,
minor
None,
Underlying
condition is
active
Minor
intoxication

Intensive and
continuation
Intensive phase
6-8 months,
Continuationa
phase 3 months
Positive,
negative
Moderate

Daily treatment
unit

Major
intoxication,
hemorrhage,
second-third level
failure of breath
and heart

Underlying
condition is active

Underlying
condition is active
Intoxicated,
hemorrhage, second
level failure of
breath and heart

Significant, minor

Critical

Positive, negative

Significant, minor

Moderate, critical

Positive, negative

4-8 months

Intensive

23

Critical failure of vital


important organs, thirdforth level failure of breath
and heart

Underlying condition is
active

Significant, minor

Severe

Positive, negative

Up to 14 days

Symptomatic

TB clinic and hospital of prison unit 429


MDR-TB department
Intensive

Six. Procedure to decide on the treatment of drug-resistant TB patient


Treatment issues of multidrug-resistant TB patient should be decided at the doctors joint consultation at
the national and aimag levels.
6.1 Composition of doctors consultation at the national level:
Chair Vice Director on Treatment, Service and Care of the NCCD
Secretary Director of TB Surveillance Department
Members:
x Officer on Communicable Diseases of City Health Department
x TB consultation doctor of NCCD
x Epidemiologist of TB Surveillance Department of NCCD
x Director and Attending Physician of MDR-TB Department of NCCD
x Chest x-ray doctor
x Director of TB referral laboratory
x Doctor responsible for drugs monitoring
x TB dispensary doctor of affiliated aimag or district
x Other specialized care doctors will be invited to the consultation when needed.
The consultation with above mentioned composition should be organized 2-3 times a month.
6.2 Composition of consultation at the aimag level:
Chair Head of Aimag General Hospital
Secretary TB Coordinator
Members:
x Quality manager
x TB doctors
x Epidemiologist of the Aimag Health Department
x Chest x-ray doctor
x Other specialized care doctors will be invited to the consultation when needed.
Consultation with above mentioned composition should be organized to decide on treatment of
drug-resistant TB patients and methodological and technical assistance should be obtained from
NCCD when necessary.
6.3 Materials to be prepared for consultation:
6.3.1 Mandatory tests:
x Culture, drug resistance test
x Sputum smear
x Chest x-ray
x Blood test
x Liver function test
x Urine test
x Thyroid hormone test
x Conclusion from ophthalmologist
x Hear ability test
x Pregnancy test for reproductive age women
6.3.2 Brief introduction on history of the illness and results of the tests
6.3.3 Information whether close contacts of the patient were covered in the preventive examination.
6.3.4 Before starting drug-resistant TB treatment, both patient and his/her family member should
give their permission and should have permanent residential address.

24

111

6.4 Drug-resistant TB treatment should not be done in the following cases:


x
x
x
x
x

Changes in lungs are irreversible and of major structural nature because of TB


Major failure of vitally important organs (heart, breathing, liver and kidney)
Acute mental disorders
Patient and/or his/her family members or guardians refused from treatment
Even though second-line anti-TB drugs were used for a prolonged period of time, smear
test shows positive result.

6.5 Cases when the drug-resistant TB patient can be released from hospital:
x Culture test is negative for 2 consecutive times
x Smear test is negative
x Drugs suit well, minor adverse effects
x Overall condition is satisfactory, clinical symptoms improved
x Dynamic improvements in chest x-ray examination
x Stayed in drug-resistant TB department for 4-6 months
x Even though stayed in drug-resistant TB department for 8 months, critical case
when smear test did not show negative results.
Seven. Consent form on acceptance of the treatment of MDR-TB

7.1 Information on the patient


Family name . . . . . . . . . . . . . . . . . . . . .
Surname (parents name) . . . . . . . . . . . . . . . .
Name . . . . . . . . . . . . . . . . . . . . . .
Date of birth _______/_____/____
year / month / day

Registration number FFFFFFFFFF


Home address . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . .
Name of attending physician . . . . . . . . . . . . . . .
Position. . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . .

25

112

7.2 Information on the treatment of MDR-TB


Tuberculosis is caused by Mycobacterium tuberculosis bacteria, spread by air, is a chronic communicable
disease.
When people who have the disease cough, sneeze, spit, talk or sing, the bacteria is spread in the air and
can infect people who are nearby.
TB that becames resistant to anti-TB drugs is called drug-resistant TB. This form of TB is caused by the
irregular intake of anti-TB drugs and incomplete treatment for TB.
Treatment of multiple drug resistant TB is complicated and it usually takes 18-24 months or even longer.
During the first period of at least 6 months, treatment is done at the hospital under direct observation of
the doctor and, when there is no infection, continuation of treatment is done through dispensary for about
18 months. At least 5 different drugs and injectables are used for treatment and the patient has to take
about 15-25 pills daily and receive injections for 6 or more months.
If the patient does not follow the regular pattern of treatment or does not complete the treatment fully,
resistance to drugs used during the treatment may develop, which will lead to further complication of the
disease and cause threat to life.
During the treatment, adverse effects such as nausea, vomiting, joint pain, toning down of muscles, loss
of sleep and appetite, headache, dizziness, loss of hearing and vision, depression and allergies are
observed. In some rare cases, there could be seizures, hallucination, and madness. In such cases, reduction
of drug dosage or removal of it will be prescribed.
Please keep in mind that treatment for multi-drug resistant TB is very expensive, and you are given
only one time opportunity to have this treatment free of charge.
If the patient does not take the drugs regularly, interrupts the treatment, or treatment proves to be
ineffective, it will be stopped by the decision of doctors consultation.
Doctors signature

. . . . . . . . . . . . . . .

Doctors name
(use print letters)

. . . . . . . . . . . . . . .

Position

20____/____/____

. . . . . . . . . . . . . . .

7.3 Declaration of the patient


I have read information on multiple-drug resistant TB and its treatment. I have received sufficient
information and all my questions related to it have been answered.
1. I understood from the doctor that I have multi-drug resistant TB, which is
x Highly infectious,
x Difficult to treat,
x Requires 18-24 months for treatment.
2. In order to cure this disease, I will
x Stay at the hospital for 4-6 months on average under doctors direct observation, and take
anti-TB drugs for at least 18 months through dispensary in the continuation period.
26
x Take 15-25 pills daily and receive injectionsfor la ong period of time.
x Undergo treatment against adverse effects, which may arise during the course of treatment.
3. If I will not complete my treatment fully,
x I will develop resistance to drugs used for 113
the treatment, which will further lead to complications
of the disease and, eventually, cause threat to my life.
x I understand that there is a danger of infecting my family members and friends every time I
sneeze, cough, spit, talk and sing as bacteria are spread in the air.

2. In order to cure this disease, I will


x Stay at the hospital for 4-6 months on average under doctors direct observation, and take
anti-TB drugs for at least 18 months through dispensary in the continuation period.
x Take 15-25 pills daily and receive injectionsfor la ong period of time.
x Undergo treatment against adverse effects, which may arise during the course of treatment.
3. If I will not complete my treatment fully,
x I will develop resistance to drugs used for the treatment, which will further lead to complications
of the disease and, eventually, cause threat to my life.
x I understand that there is a danger of infecting my family members and friends every time I
sneeze, cough, spit, talk and sing as bacteria are spread in the air.
4. If I complete my treatment as per doctors instructions
x I will not spread infection to others and my disease will be cured.
I declare that _________________________________________________________
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________
____________________________________________________________________
Patients will write on their own: I agree to be involved in treatment against multiple-drug resistant TB
and will regularly take all the medications prescribed by the doctor. I will comply with the decision of the
doctors consultation to stop my treatment and waive my other possibilities of treatment, in the case that I
do not take my drugs regularly and interrupt my treatment.
Surname and name of the patient
. . . . . . . . . . . . .
20____/____/____
Signature . . . . . . . . . . . . . .
Surname and name of parents/guardian/family member . .
20____/____/____
Signature
. . . . . . . . . . . . . .

27

114

Appendix 4 of the Health Ministers order No 397


of 20 November, 2009
Guidelines on management of TB/HIV co-infection
The present guidelines will be followed for detection, diagnosis, treatment, monitoring, recording and
reporting of TB/HIV coinfected cases. If a person is infected with Mycobacterium tuberculosis, but not
infected with HIV, his/her chances to develop TB is 5-10%; however, if the person has HIV infection,
his/her chances to develop TB may go up to 50%.
One. Detection
If the patient is registered as having both TB and HIV/AIDS, examination and tests will be performed at
the initiative of the service provider.
1.1
Counselling and testing to detect HIV:
1.1.1 All new cases of TB
1.1.2 At the 6th month of anti-TB treatment
1.1.3 Relapse cases of TB
1.1.4 Every 6 months in drug resistant TB cases
1.1.5 If patient has HIV symptoms during the course of anti-TB treatment
1.2 Tests to detect TB should be performed:
1.2.1 For newly diagnosed cases of HIV/AIDS and every 6 months thereafter
1.2.2 If HIV/AIDS patient has symptoms and signs of TB
Provider- initiated testing and counselling means that doctor and/or health personnel provides the client
with information on HIV testing, then sends the client to have an HIV test, provide the client with
additional counselling after test results are revealed, and provide services and care when necessary.
Two. Definition of the cases
2.1

Pulmonary TB, sputum smear-positive


When HIV infection is confirmed by a laboratory test or the patient has clinical symptoms of
HIV, oneor more initial sputum smear examinations positive for acid-fast bacilli.
2.2

Pulmonary TB, sputum smear-negative

When HIV infection is confirmed by the laboratory test, or the patient has clear clinical
symptoms of HIV, smear test show a negative result for at least 2 consecutive times or smear test result is
negative, but culture test is positive.
2.3

Extrapulmonary TB
x

When HIV infection is verified by a laboratory test, or the patient has clear clinical symptoms of
HIV, sample from organs other than lungs show inflammation by TB bacteria and their presence
is verified by histology and bacteriology.
Three. Diagnosis

3.1

Algorithm to diagnose TB in HIV patient

28

115

Client who coughs for 2 or more weeks


Client who coughs for 2 or more weeks
Sputum smear microscopy and culture
Sputum smear microscopy and culture

Acid- fast bacilli positive

Acid-fast bacilli negative

Acid- fast bacilli positive

x
x
x

Start anti-TB treatment


Start
treatment
by
x preventive
Start anti-TB
treatment
Co-trimoxazole
x Start preventive treatment by
Evaluate
HIV progress (clinical
Co-trimoxazole
classification,
counting
of CD4
x Evaluate
HIV progress
(clinical
cells) classification, counting of CD4

Acid-fast bacilli negative

x
x

Chest x-ray test


clinical
symptoms
xClarify
Chest
x-ray test
x

TB

Clarify clinical symptoms

TB

cells)

TB is not verified

TB is not verified

x
x
x
x

3.2

Monitoring of the HIV/AIDS, STI

xdoctor
Monitoring of the HIV/AIDS, STI
doctor
Differentiate
with other pulmonary
xdiseases
Differentiate
other pulmonary
and treatwith
them
diseases and treat them
Advise to come again if symptoms
x Advise to come again if symptoms
return
return
Re-examination every 6 months
x Re-examination every 6 months

Diagnosis
of pulmonary
TB TB
3.2
Diagnosis
of pulmonary
3.2.1 3.2.1
Clinical
symptoms
Clinical symptoms
x In xthe In
early
periodperiod
of HIV,
general
symptoms
of TB
areare
observed
and
changes
the early
of HIV,
general
symptoms
of TB
observed
and
changesusually
usually
occur in
the in
upper
part of
theoflungs.
occur
the upper
part
the lungs.
x Asx immunodeficiency
deepens,
symptoms
willwill
become
more
likelike
those
As immunodeficiency
deepens,
symptoms
become
more
thoseofofprimary
primaryTB,
TB,
extrapulmonary
TB,
or
disseminated
TB,
the
chest
lymph
gland
and
lower
part
of
lungs
extrapulmonary TB, or disseminated TB, the chest lymph gland and lower part of lungs
be damaged.
will bewill
damaged.
x TB/HIVcoinfected
patients
common
symptoms
such
fever,
weightloss,
loss,and
and
x TB/HIVcoinfected
patients
will will
havehave
common
symptoms
such
as as
fever,
weight
sweating.
In relation
to reduced
immunity
of cells
HIV
patients,coughing
coughingisisnot
not
sweating.
In relation
to reduced
immunity
of cells
in in
HIV
patients,
common
as there
is little
the throat.
common
as there
is little
shockshock
in theinthroat.
3.2.2
x

x
x
x
x
x

Clinical signs

During the early stage of HIV, when changes in the immune system are minor, CD4 cells counts
29
are more than 200/mm, TB patient will have clinical and chest x-ray changes similar to those with
29
no HIV. However, if CD4 cell count is less than 200/mm, uncommon clinical signs of pulmonary
TB will be identified.
Extrapulmonary TB will be commonly observed. TB of lymph nodes, particularly in the neck will
occur.
Percentage of acute, disseminated TB will increase.
In the later stage of HIV, mediastinal lymph nodes will be enlarged and pleural and pericardial
effusion are common. It is uncommon to have emphysema.
TB changes will have abnormal locations. Brain tuberculoma and abscess of thorax can happen.
Fever, weight loss, and sweating will be commonly
observed.
116
3.2.3

Laboratory diagnosis

x
x
x
x
x

no HIV. However, if CD4 cell count is less than 200/mm, uncommon clinical signs of pulmonary
TB will be identified.
Extrapulmonary TB will be commonly observed. TB of lymph nodes, particularly in the neck will
occur.
Percentage of acute, disseminated TB will increase.
In the later stage of HIV, mediastinal lymph nodes will be enlarged and pleural and pericardial
effusion are common. It is uncommon to have emphysema.
TB changes will have abnormal locations. Brain tuberculoma and abscess of thorax can happen.
Fever, weight loss, and sweating will be commonly observed.
3.2.3 Laboratory diagnosis
In order to verify clinical symptoms, basic and additional tests will be performed.

x
x

3.3

Bacteriological test
During HIV/TB coinfection, the sputum smear microscopy commonly shows negative results.
Therefore, culture test should be performed as well. For patients with acute, disseminated TB,
bacteria can grow in blood culture.
Tuberculin skin test
For HIV patient, tuberculin skin test can be negative due to reduced number of immune cells
Chest x-ray test
Chest x-ray should be performed when the patient has HIV, is suspected to have pulmonary TB,
smear test is negative, widely used antibiotics prove to be ineffective. HIV infected patients have
common changes in throat and lungs related to infection of other bacteria; therefore, it is required
to separate TB signs from signs of other diseases.
If the patient has TB, there are specifics such as location in holes and upper side of lungs, scar of
lungs, athlectasis, silicosis but it is difficult to diagnose it only with chest x-ray. The more the
immune system is damaged; the damages in lower parts of lungs and chest lymph glands will
become clearer.
Clinical signs of extrapulmonary TB

In TB/HIV coninfected patients extrapulmonary TB is commonly observed.


3.3.1 Clinical specifics of extrapulmonary TB:
x Aside from clinical symptoms related to changes in the function of the organ, fever, sweating, and
weight loss signs are common.
3.3.2 Diagnosis of extrapulmonary TB
x Diagnosis by clinical symptoms should be verified by the cell and bacteriological tests on the
samples obtained from the patient. Additional tests to determine functional and structural changes
in the organ can be done as well.

30

117

118

Size is 2 cm and more


Asymmetrical/localized
Painless swelling
Firm/fluctuant/fistulated
Mostly located around
neck and all lymph nodes
can enlarge
x Weight loss, night
sweats, fever

x Kaposi sarcoma of skin


and mouth
x Lymphoma, or HIV
lymphadenopathy is
equal on 2 sides
x Fungus and its hard, red,
swollen
x Lymph glands other than
neck

Symptoms of
TB

Non-TB
symptoms

x
x
x
x
x

x HIV test
x Sputum smear, if
coughing
x Needle aspirate for AFB

x Inflammation of 2
sides during
pneumonia and heart
failure
x Kaposi sarcoma
x Other cancer
x Liquid: dirty, with pus,
empyema
x Will not get clots
during heart failure,
but it will not cause
TB

x HIV test
x Chest x-ray
x Sputum smears, if
coughing
x Counting of white
cells and proteins in
the liquid obtained
from aspitate
x Unilateral effusion
x Aspirate of fluid is: clear, has yellowish
color, sticky in the
tube without
anticoagulation
x Weight loss, sweating
and fever
x TB of other organs

Shaking
Heavy breathing
Diarrhea
Traces of blood
in bowel
movement
x Other bacteria
grow in blood
culture
x
x
x
x

x HIV test
x Chest x-ray
x Sputum smear if
coughing
x Blood culture
x Full blood count
x Criptococcal
antigen
x Weight loss,
fever, sweat
x Anemia
x Enlarged liver
and spleen
x Changes such as
spread little
yellow dots at the
x-ray

Diagnosis and immediate management of suspected extrapulmonary TB


TB of lymph nodes
Inflammation of pleura
Disseminated TB

Necessary
tests

3.3.2

x During heart failure,


lung area has shadow,
heart form abnormal
x Hypertension
x ECG shows heart is
enlarged because of
other heart disorders
x Unusual sound
x Shaking in case of
bacteria caused
inflammation of
peridonitis

x No lung changes,
inflammation of
peridonitis in both sides
x Weight loss, fever,
sweats
x TB of other organs

Inflammation of
peridonitis
x HIV test
x Chest x-ray
x Sputum smears if
coughing
x Cardiac ultrasound
x ECG

31

x HIV test
x Chest x-ray
x Sputum smear if
coughing
x Determine protein,
glucose, and AFB
level in brain and
spinal liquid
x Weight loss, fever,
sweat
x Brain and spinal
liquid is clear,
protein level high,
number of glucose
and white cells
reduced
x TB of other organs
x Negative
criptococcal antigen
in spinal liquid
x In bacterial disease,
spinal liquid is
unclear, presence of
neutrofills detected
x Rapid onset
x Spinal liquid has
high pressure
x Positive criptococcal
antigen

TB meningitis

119

Immediate
actions

x Draw off liquid and send


it to cytology and smear
test
x Take biopsy test in all
cases, except for:
- HIV infected patient at
risk to have
disseminated TB
- Clinical symptoms of
TB is clear enough and
there is no time to wait
for biopsy test results

With signs of TB
With signs of TB
x If TB diagnosed, start
x Start TB
treatment
treatment
With no signs of TB
With no signs of
TB
x Count cells and protein
in the liquid and send
x Identify other
for cytological test if
causes
possible.
x When condition
is critical, start
both TB and
antibiotic
treatments
x
x

x
x

With signs of TB
Start TB treatment
Draw off liquid if
breath is very heavy
With no signs of TB
Look for other causes
If sonography verifies
presence of liquid, and
no other diagnosis is
determined for 7 days,
start anti-TB treatment.

32

With no signs of TB
x Positive criptococcal
test, HIV infected,
treatment against
criptococcus if no
other diagnosis is
determined

With sign of TB
x Start TB treatment
x Hospitalization

Four. Treatment
4.1
4.2

The TB treatment for TB/HIV coinfected patient should be the same as with TB patients.
The following principles should be taken into account when doing antiretroviral treatment for
TB/HIVconinfected patient:

D4 cell count
(cells/mm3)
Less than 350
More than 350

Disregard CD4 cell count in case


of extrapulmonary TB
Stage 4 of HIV
Impossible to count CD4 cells
4.3

Recommendation to start
antiretroviral treatment
Recommended to start
antiretroviral treatment
Postpone
antiretroviral
treatment

Timespan for antiretroviral


treatment combination
Within 2-8 weeks

8 weeks later, clinical and


laboratory evaluation should be
done at the end of anti-TB
treatment
start Within 2-8 weeks

Recommended to
antiretroviral treatment
Recommended to start Within 2-8 weeks
antiretroviral treatment
Recommended to start Within 2-8 weeks
antiretroviral treatment

Indications to start preventive cotrimoxazole treatment for TB/HIV coinfected patient


4.4.1 D4 cell count is less than 200 cell/mm3 or stages 3 and 4 of HIV infection, where count
of CD4 cells is disregarded. Preventive cotrimoxazole treatment should last for 2 weeks
before antiretroviral treatment and, if there is no sign of allergy, antiretroviral treatment
should start.
4.4.2

If it is impossible to count CD4 cells, all TB patients should be given preventive


cotrimoxazole treatment

4.4.3

Dosage of preventive cotrimoxazole treatment: Adults and adolescents should take 2 pills
once a day. Daily dosage: 960 mg of Sulphametoxazole (SMZ) + 160 mg Thrimethoprim
(TMP). If patient is allergic to sulphanilamide group, Dapson should be prescribed as 100
mg per day.

4.4

HIV and drug resistant TB coinfection


If HIV patient is infected with drug resistant TB, the diagnosis and treatment should follow
Appendix 3 of the present guidelines.
Five. Treatment monitoring
5.1 Intensive phase of treatment of patients with severe form of TB or drug resistant TB should be done
at hospital and continuation phase should be done under direct observation of TB dispensary doctor.
5.2 Antiretroviral treatment should be done under monitoring of HIV/STI doctor of respective aimag and
district, antiretroviral treatment of drug-resistant TB patient should be done at the drug-resistant TB
department with consultation and monitoring of HIV/STI doctor during intensive phase and with the
STI/HIV/AIDS doctors monitoring at the continuation phase of treatment.
5.3 Sputum smear and culture during monitoring period should follow Appendix 2 and 3 of the present
guidelines.

33
120

Appendix 5 of the Health Ministers order No 397


of 20 November, 2009
Guidelines on management of anti-TB drugs and reagents
The present guidelines should be followed in forecasting, storing, distributing, transporting, using,
monitoring of rational use of anti-TB drugs and reagents.
One. Forecasting of drugs and reagents
Depending on morbidity, number of completed tests, and required stock, forecasting of drugs and
reagents needed nationwide should be completed within the 1st quarter every year and these should include
first and second line TB drugs, drugs for management of adverse effects of drug resistant TB, and
reagents.
Two. Receipt of drugs and reagents
2.1
The working group appointed by the Director of the NCCD shall receive drugs, complete quality
inspection, check packaging, safety, and pollution, and keep accurate records.
2.2
If packaging of the drugs and equipment is damaged, the package does not meet quality
requirements, does not match with initial order, or does not have proper documentation; sign in
temporary waiting list should be placed on the package and kept separately until a further decision is
made.
2.3
Quality of drugs should be validated by the General Department on Quality Assurance and proper
evaluation of the respective officer should be issued.
2.4
The drugs and reagents should be kept at the storage facility of the TB Surveillance Department.
2.5
The expenses related to customs clearance of the anti-TB drugs and reagents will be the
responsibility of the NCCD.
Three. Standard requirements of storage facility
3.1
The doors and windows of the storage facility should be intact and well protected. The inner side
of the walls and ceiling should be light in color, smooth and able to clean using a wet rag. The floor
should not produce dust and be made of material which can stand against light and disinfection cleansers.
The facility should not have any insects and meet hygiene requirements.
3.2
The windows should have protection from direct sun light, the upper pane should open and close
freely, should have proper ventilation, protection from dust and sand, equipped with air ventilation
system, temperature should be kept between 15 to 20 degrees Celsius, relative humidity should be 2060%.
3.3
Thermometer should be placed far from heating equipment, 1.5-1.7 meters up from the floor, not
less than 3 meters away from the door. temperature and humidity should be checked on a daily basis and
accurate records kept.
3.4
Cases of drugs should be placed 0.5 meters away from the walls and ceiling, 0.3 meters away
from the floor and 0.75 meters away from heating equipment. Space between the cases should be 0.75
meters.
Four. Storage and delivery of drugs and reagents
4.1
The drugs, reagents and hospital equipment should be registered by their serial number, placed
according to date of manufacturing and books on income and expenditure should be kept.
4.2
Drugs and reagents, which are big in size and heavy in weight, should be placed on special
shelves, according to the arrow sign on the package. The name and valid date should be visible and, if it is
impossible to place it this way, name and valid date should be written clearly.

34

121

4.3
Liquid drugs and reagents should be placed on the shelves and lower cases of the cupboard, drugs
that are sensitive to light should be stored in dark environment, flammable substances should be kept away
from direct sun light and stored in a cool environment according to handling and storage instructions.
Depending on their physical and chemical qualities, drugs and reagents should be stored in the
temperature, humidity and light, prescribed by the manufacturer.
4.4
According to special guidelines and instructions, controlled substances should be kept separately
in a special drawer.
4.5
Drugs and reagents with expired valid dates and changed appearance should be kept separately
and the working group should document and destroy them according to instructions.
4.6
The anti-TB drugs and drugs to fight side effects should be delivered without damage and
protected from moisture.
4.7
If drugs are damaged or lost during delivery, responsibility should be charged to guilty personnel.
Five. Distribution of drugs and reagents
Depending on annual morbidity, and number of tests completed, the anti-TB drugs and reagents will be
distributed to TB units according to the order of the Health Minister.
Six. Distribution and monitoring of drugs and reagents
6.1
Anti-TB drugs and reagents with extra one quarter stock will be distributed to TB units according
to approved schedule.
6.2
The drug specialist at the TB clinic is responsible for distribution of anti-TB drugs in the from of
patient kit according to prescription of the attending physician.
6.3
Drugs to fight side effects of MDR-TB drugs should be verified according to the prescription and
distributed.
6.4
If the patient transferred out, deceased, or his/her diagnosis was changed, the remaining drugs
should be counted and reported in the stock of respective place.
6.5
If the TB diagnosis was clarified, while undertaking treatment in specialized hospital, the drugs
will be given to patient according to consultation of doctors, based on the prescription given by the
consulting doctor.
6.6
The doctor and pharmacy nurse of the TB Dispensary of the aimag and district should receive the
drugs from the storage facility of the TB Surveillance Department of NCCD according to the instructions
on receiving drugs, and distribute drugs to health volunteers, FGPs, soum hospitals, daily treatment units,
and lunch DOTS units and monitor their further distribution.
6.7
The anti-TB drugs and drugs to fight side effects of MDR-TB drugs should be used only by the
TB patients free of charge.
6.8
The TB Coordinator and department heads of clinics should monitor the usage, storage and
expenditure of anti-TB drugs and reagents at their respective unit.
6.9
The monitoring doctors from the TB Surveillance Department should conduct monitoring of
treatment, storage, security and usage of anti-TB drugs and reagents at the TB Dispensary of aimags and
districts, as well as other hospitals, according to Appendix 7.
6.10
If anti-TB drugs and reagents are sold or used inappropriately, responsibilities should be charged
according to law.

35
122

Appendix 6 of the Health Ministers order No 397


of 20 November, 2009

Guidelines on TB epidemiology and infection control


Chain of TB infection consists of the cause of infection, origin of infection, ways of transmission,
and risk groups.
One. Cause
TB is caused by Mycobacterium tuberculosis complex (M. tuberculosis, M.bovis, M.africanium,
M. Microti) and it is highly adaptable and damages many organs.
The bacteria is very tolerant of environmental changes and it can live in dust for 100 or more
days, in books for 3 months, in soil for 6 months, in water for 150 days, and in a buried corpse for several
months. It remains alive in dried sputum for 10-12 hours. It can live in milk and dairy products for va ery
long time, in particular in butter for 1 year and cheese for 260 days, if stored in a cool place.
It can survive for 50 years in temperatures below -40 and, compared with other bacteria, it is
relative slow in growth dividing once in 20-24 hours.
The outer walls of TB bacteria cells contain fat and oil; therefore it is resistant to physical and
chemical factors, acids and alkalis. It can stay in stomach acid for 6 hours.
It will die in 10 minutes when boiled, in 30 minutes in a wet environment with temperatures of

75 , and in 1 hour under direct sunlight and ultraviolet rays.


Two. Source of infection
A pulmonary TB patient who develops bacteria becomes the source of infection. One infectious
pulmonary TB patient can infect about 15-20 people in a year, if not treated.
The contacts of an infectious TB patient are divided in 4 groups by their risk of infection:
1. People, who live with the patient
2. Close relatives and friends
3. Colleagues
4. Other
Family members of the infectious TB patient are at the highest risk of infecting the disease and the
more distant the connections become, the more the risk reduces.
TB bacteria gets into the body through the respiratory system, but it is called infected by bacteria,
but no disease, when the immune system stops the growth of bacteria and makes it inactive.
People infected with bacteria have:
x No clinical symptoms
x Tuberculin skin test is positive, no changes at other tests
x Not infected others
About 10% of people with TB infection become ill with tuberculosis because of factors related to
the weakened immune system.
Three. Transmission modes
TB is usually transmitted through the air. A TB patient spreads the TB bacteria in the air, when
s/he talks, sneezes, sings and particularly when s/he coughs.
Influencing factors for the spread of infection:
x Coughing frequently in a short period of time
x Developing a lot of sticky sputum
x Late diagnosis, interruption of treatment
x Environment with insufficient oxygen

36
123

Four. Risk groups


Human body has high ability to fight against TB infection and this ability is not always strong for
all people.
4.1
Age specifics
x If infected with TB bacteria in childhood, there is a high probability of developing extensive,
chronic and acute forms of TB.
x From ages 7-13, there is a low probability of morbidity and in case of illness, treatment is
usually successful.
x From ages 14-16, infection can become active and turn into acute TB.
x It is most common to have primary and secondary activation of infection at a young age.
x For elderly people, it is common that chronic, scar TB without clinical symptoms occur.
4.2

Vulnerable groups:
4.3.1 Close contact with TB patient
4.3.2 People with HIV
4.3.3 Drug and alcohol addicts
4.3.4 People with other health risks
4.3.5 People living and working in an environment with high concentration of people
(orphanage, elderly homes, asylums, prisons, detention places, shelter for homeless
people)
4.3.6 Health personnel and health volunteers, who provide services and care to highly
infectious TB patients
4.3.7 Low income people, homeless and dislocated people, who cannot get health services and
care
4.3.8 Infants, children and adolescents living with high risk adults

4.3

Risk factors related to health:


x HIV infection
x Diabetis
x Corticosteroid and immune compromising treatment for a long time (transplantation of
organs)
x Chronic kidney failure
x Some blood desease (leukemia and lymphoma)
x Other cancer (carcinoma of neck and brain)
x Too thin (equal to 10% of body mass)
x Silicosis
x Stomachectomia
x Transplantation of intestines
Five. Point of TB source

The source of TB, risks and transmission ways are called point of TB source.
Soum, family practice unit, aimag and district specialist from place where TB registered should
identify the point of TB source. Special attention should be paid to community houses, dormitory,
orphanage, shelter, monastery, prison and health institution.
Risk of infection depends on:
x Duration of infection developed by the patient
x Duration when contacts get infected
The point of TB source is divided into 3 groups:
x The highest risk of spreading TB infection
x The low risk of spreading TB infection
37
x Probability of spreading TB infection
Six. Investigation of TB contacts
Investigation of contacts aims at identification of TB
source. In order to do investigation of contacts, case
124
index (patient) and contacts should be identified.
6.1
Case index:

x
x

The low risk of spreading TB infection


Probability of spreading TB infection
Six. Investigation of TB contacts

Investigation of contacts aims at identification of TB source. In order to do investigation of contacts, case


index (patient) and contacts should be identified.
6.1
Case index:
x Pulmonary TB, sputum smear positive
x Pediatric TB
x Drug resistant TB patient
6.2
Contact
Family members living with the patient at the time of TB diagnosis are called contacts. If the
contacts were staying in a place with a high concentration of people for a long time, definition of
contact should be broadened.
6.3
Contact investigation
6.3.1
6.3.2
6.4
6.4.1
6.4.2
6.4.3
6.4.4
6.4.5
6.4.6

6.4.7

After the case index (patient) is diagnosed with TB, identification of family members living
together with the patient should be a priority.
After contact investigation, they should be involved in preventive examination and special
attention should be paid to children aged 0-16 and family members with HIV.
Monitoring of contacts of drug susceptible TB patient
After the case index is diagnosed with TB, conatcts should be fully involved in preventive
examination within 14 days after diagnosis. Contact examination should be done free of charge at
the respective soum hospital, FGP, aimag and district TB dispansery and Health Alliance.
Contacts of smear test positive TB patient and pediatric TB should be enrolled in preventive
examination once a year and monitoring should continue for 5 years.
Contacts of drug-resistant TB patient should be enrolled in preventive examination once every 6
months for the first 2 years and once a year thereafter. Total period of monitoring is 5 years.
If contacts of the infectious TB patient are children aged 0-16, they should be given a tuberculin
skin test.
If tuberculin test result is induration of 10 mm or above for children above 5 years old, they
should be given other related tests and, if they do not have active TB, soum or FGP doctor should
monitor them.
If the child did not have BCG vaccine and there is no scar of BCG vaccine as per national
mandatory vaccination schedule, tuberculin skin test should be performed and, if the reaction is
negative, repeat the test after 3-4 weeks, verify the reaction is negative and then decide on the
issue of vaccination.
If a secondary school student or children from kindergarten got ill with any form of TB or
employees of these organizations got ill with smear test positive TB, teachers, kids, employees of
the school or kindergarten should be enrolled in preventive examination.

6.5 Preventive treatment of contacts


6.5.1 If tuberculin skin test reaction is more than 10 mm and there are no signs of TB on clinical
examination and other tests for the under 5 children, who are contacts of drug resistant TB patient,
preventive treatment should be done with Isoniazid administered daily in 10 mg/kg doses
(maximum daily dose is 300 mg) for 6 months. Monitoring should be done by the respective soum
hospital, FGP, aimag and district TB dispansery.
6.5.2 If the close contact of an infectious TB patient is HIV infected but does not have TB, s/he should
be given preventive treatment with Isoniazid. Daily dose should be 300 mg for 6-9 months.
6.6 If contact has TB symptoms or became ill with TB
6.6.1
6.6.2
6.6.3

If there is suspicion of TB, related tests should be performed. If contact became ill with TB, s/he
38
should be registered and treatment should start according to regimen.
If TB was not verified through examination and tests for TB suspect, treatment with widely used
antibiotics should be done.
If symptoms remain after the treatment with widely used antibiotics, detailed test, sputum test and
culture should be repeated and diagnosis should be clarified.

125

6.7 If contact of drug resistant TB became ill


6.7.1 Start treatment against drug resistant TB
6.7.2 Drug resistant test should be performed through culture

6.6.1
6.6.2
6.6.3

If there is suspicion of TB, related tests should be performed. If contact became ill with TB, s/he
should be registered and treatment should start according to regimen.
If TB was not verified through examination and tests for TB suspect, treatment with widely used
antibiotics should be done.
If symptoms remain after the treatment with widely used antibiotics, detailed test, sputum test and
culture should be repeated and diagnosis should be clarified.

6.7 If contact of drug resistant TB became ill


6.7.1 Start treatment against drug resistant TB
6.7.2 Drug resistant test should be performed through culture
6.7.3 Enroll in HIV counselling and testing
Seven. Measures to prevent nosocomial TB infection
Infection control means organizational and precaution system to prevent the spread of infection in
the health facilities.
The system aims to prevent nosocomial infection, early detection of such cases, and implements
urgent measures to liquidate it, in order to provide safe and quality health services and care to the clients.
7.1
Definition
Spread of TB in the hospital means that Mycobacterium tuberculosis was spread from infectious
TB patient to other patients, doctors and health personnel during the course of treatment.
There are 3 levels of prevention measures for hospital induced TB spread.
1. Management and organization
2. Environmental prevention measures
3. Personal protective equipment
7.2
Management and organization
7.2.1 The hospital and health institution evaluate the risk of spreading the TB infection, identify the
departments and units with highest risk and takes measures for their safety.
7.2.2 Develop and implement infection control plan
7.2.3 Doctors and health personnel should be involved in training on TB, its transmission modes,
infection control and preventive measures.
7.2.4 Teach and counsel the patients to cover up their month when coughing and sneezing
7.2.5 Collect sputum in a place with good air ventilation
7.2.6 The patient suspected with TB should undertake examination first in the outpatient clinic.
7.2.7 Laboratory should follow the guidelines on bio safety actions.
7.3
7.3.1
7.3.2
7.3.3

7.3.4

Environmental control measures


Natural and mechanical air ventilation should be in place. Frequently open the windows to change
the air flow.
Constant control should be given to proper function of a mechanical ventilation system.
The air in the rooms should be disinfected using an ultraviolent ray lamp, which develops rays of
200-280 nm of length. The lamp should be placed near to ceiling so that patient and doctors could
not reach it. There should be sufficient air flow in the room. Usage hour of bactericide lamp
should be recorded and, in case the valid hours complete, replaced.
Room air should be disinfected with ultraviolet rays using portable and base disinfection
apparatus.

7.4

Personal protective equipment

7.4.1

Filter masks or respirators no. 95, 100, and 3:


Filter masks no. 95 and 100 can filter air drops of size 0.3m and above with 95-100%. In the
following cases, filter masks no. 95, 100, and 3 must be used:
x Working in the department, hospital and daily treatment unit where sputum smear
positive TB and drug resistant TB patients stay and undergo treatment
39
x Preparing sputum smears and culture in the TB laboratory
x Collecting sputum samples
x Doing bronchoscope
x Doing autopsy
x Measuring lung capacity
x Performing urgent surgery on someone
126who is suspected to have TB

7.4.2

Mask:

x
x
x
x
x
x
x

Working in the department, hospital and daily treatment unit where sputum smear
positive TB and drug resistant TB patients stay and undergo treatment
Preparing sputum smears and culture in the TB laboratory
Collecting sputum samples
Doing bronchoscope
Doing autopsy
Measuring lung capacity
Performing urgent surgery on someone who is suspected to have TB

7.4.2

Mask:
All patients with infectious TB undergoing treatment and services must wear a mask.

7.4.3

Storage of filter masks:


Filter masks (N95, N100, 3) could be used up to 1 month, if stored properly in a clear and dry
environment.
x Major factors that damage filter masks are moist, dust, dirt, and physical pressure. In order not
to press the mask, it should be covered fully with a clean, white cloth.
x Since it can collect moisture, it should be kept in synthetic and polyethylene packages and
attention should be paid to not damage its form, when stored in its case.

7.4.4

Test to check whether filter mask fits ones face


Filter masks have their size choices and all health personnel should have a training to check its fit,
select the right size and use it.
Check by creating positive pressure: Wear the mask and exhale the air slowly to the checks. If
mask fits the cheeks, it will keep its form and there will be no evidence that air goes outside.
Check by creating negative pressure: Wear the mask and inhale, there will be slight tightness on
the cheeks. Hold the breath for 10 seconds and, if the tightness is kept and there is no sign of air
getting in the mask, the mask fits.

7.4.5

Instructions wearing and taking off the filter mask N95, N100, and 3
Follow the instructions on putting filter mask N95, N100, and 3 on and off by the manufacturer.
Filter masks that are past their expiration date, stained with dirt, oil and dust, torn or wet should
be burned.

7.5

Disinfection

TB bacteria are resistant to the environment and most of the disinfection solutions; therefore, the
following disinfection methods should be used.
7.5.1 Disinfection and dismissal of sputum
In the laboratory, the following disinfection solutions should be used in equal to sputum size, in order to
disinfect it.
x 5% phenol solution for 18-24 hours
x 2% Lysol solution for 12 hours
x 3% Virkon solution for 15 minutes
x 1-2% sodium and potassium hypochlorite solution for more than 12 hours.
Disposal of sputum in TB departments and units
x Container with disinfectant will be distributed to patients by the department or unit 3
times a day. Each patient will receive a container with their respective signs.
x For disinfection of sputum one of the above mentioned solutions should be used.
40
x Disposal of sputum should be closely monitored until the release from hospital.
7.5.2 Disinfection of hospital equipment
Equipment
Name of disinfectant,
Working
manufacturer, country
concentration of
solution (%)
Surgery, dental, and
facial equipment
(glass, rubber, metal
and plastic)

Alaminol
(Niopek Russia)
ID 212 (Germany)

Temperature of
working
solution ()

Disinfection
period
(minutes)

3.0

Not less than 18

90

4.0

Not less than 18

60

127

Disposal of sputum should be closely monitored until the release from hospital.

7.5.2 Disinfection of hospital equipment


Equipment
Name of disinfectant,
Working
Temperature of
Disinfection
manufacturer, country
concentration of
working
period
solution (%)
solution ()
(minutes)
x Disposal of sputum should be closely monitored until the release from hospital.
Alaminol
3.0
Not less than 18
Surgery,
dental, and of hospital
7.5.2
Disinfection
equipment
(Niopek
Russia)
facial
equipment
Equipment
Name of disinfectant,
Working
Temperature of
Disinfection
(glass, rubber, metal
ID 212country
(Germany)concentration of 4.0 working
Not less than period
18
manufacturer,
and plastic)
solution (%)
solution ()
(minutes)
Microscope (glass,
Bianol (Russia)
1.5
Not less than 18
rubber, metal and
Steranios 20%
1.0
Not less than 18
Alaminol (Anios France)
3.0
Not less than 18
90
Surgery, dental,
and
plastic)
(Niopek Russia)
facial equipment
Septodor-forte
Not less than 18
(glass, rubber, metal
ID 212 (Germany)
4.0
Not less than 18
60
(Dorvet
Israel)
0.4
and plastic)
Diseffect (USA)
3:128
Not less than 18
Bianol (Russia)
1.5
Not less than 18
30
Microscope (glass,
Corzoline
ID
(Germany)
3.0
Not
less than 18
rubber, metal and
Steranios 20%
1.0
Not less than 18
15
Desoform (Germany)
1.0
Not less than 18
plastic)
(Anios France)
Septodor-forte
Not less than 18
Secusept-forte (Finland) 0.4
5.0
Not less than 1890
(Dorvet Israel)
Helipur X plus
2.5Not less than
Not18less than 1860
Diseffect (USA)
3:128
(Germany)
Corzoline ID (Germany)
3.0
Not less than 18
60
Dulbak solution
-1
Not less than 18
Desoform (Germany)
1.0
Not less than 18
90
(France)
Glutaral (Russia)
Not less than 18
Equipment for facial
Secusept-forte (Finland)
5.0
Not less than 18
30
and computer surgery
Helipur
X
plus
2.5
Not
less
than
18
90
(glass, rubber, metal
Glutaral-H (Russia)
Not less than 18
and plastic) (Germany)
Dulbak solution
-1
Sidex (USA)
- Not less than
Not18less than 1890
(France)
Gigasept
3.0Not less than
Not18less than 1890
Glutaral (Russia)
Equipment for facial
and computer surgery
Lysoformin 3000
0.75
Not less than 18
(glass, rubber, metal
Glutaral-H (Russia)
Not less than 18
90
(Germany)
and plastic)
ColdSpor
10.0Not less than
Not18less than 1890
Sidex (USA)
Gigasept Veltosept (Russia)

60
30
15
90
60
60
90
30
90
90
90
90
90
60
60
10

3.0

- Not less than


Not18less than 1860

30

LysoforminVeltolen
3000 (Russia)
0.75
Glass, rubber, metal
(Germany)Formalin (formaldegid)
and plastic equipment
ColdSpor
10.0
Aldazan 2000 (Germany)
Veltosept (Russia)
Dekonex 50 FF

5.0Not less than


Not18less than 1860
10.0
Not less than 18
Not less than 18
10
3.0
Not less than 18
1.5Not less than
Not18less than 1830

60
60

Glass, rubber, metal


and plastic equipment

60
120

Veltolen (Russia)
Aldesol (Croatia)
Formalin (formaldegid)
Lysetol AF

5.0
10.0

3.0Not less than


Not18less than 1860
Not less than 18
60
2.0
Not less than 18

60

Pliacent
5% glukonat
Aldazan 2000
(Germany)
(Croatia)
Dekonex 50 FF

0.5Not less than


Not18less than 1860
3.0
Water and spirit
1.5
Not less than 18
120

30

Aldesol (Croatia)

3.0

Not less than 18

60

Lysetol AF

2.0

Not less than 18

60

0.5
Water and spirit

Not less than 18

30

No need to dilute

Pliacent 5% glukonat
(Croatia)
1

90

No need to dilute

60

41

41

128

solution
Hydrogen peroxide
Glass, corrosious
Glass,
(Russia) Hydrogen peroxide
metal, plastic
andcorrosious
metal, plastic and
(Russia)
rubber materials
Peroximed
(Russia)
rubber materials

Peroximed (Russia)

Desoxon-1, Desoxon-4
(Russia) Desoxon-1, Desoxon-4
(Russia)
Javelion (France)

Glass, corrosious
Javelion (France)
Glass, corrosious
metal, polymer
Purejavel (France)
metal,
polymer
Purejavel (France)
material
material
Deochlore (France)
Deochlore (France)
Persept (USA)
Persept (USA)
Chloramine
(Russia) (Russia)
Chloramine

3.0 solution Not less than 18

180

3.0

Not less than 18

120

Not less than 18

60

Not less than 18

60

Not less than 18


Not less than 18
Not less than 18
Not less than 18
Not less
than 18
Not less than 18
Not less
Notthan
less18
than 18

60
60
45
240

3.0

0.5
0.2
0.2
0.2
0.28
5.0

3.0
0.5
0.2
0.2
0.2
0.28
5.0

Glass, plastic,
silicone
Anolite Anolite
0.02-0.06
Glass,
plastic, silicone
0.02-0.06
Facial equipment
Grotenat
borerbad
Facial equipment
Grotenat borerbad
(Germany)
(Germany)
ID 220 (Germany)
ID 220 (Germany)
-

Not less than 18

Not less than 18


Not less than 18

Not less than 18

180
120
60
60
60
60
45
240

Not less
Notthan
less18
than 18
Not less
than
Not less18
than 18

30-300
30-300
30 30

Not less
Notthan
less18
than 18

30 30

7.5.3 Other
7.5.3 Other
x
Autoclave
for purification
and disinfection
purposes.
Unclean
containers
x
Autoclave
should beshould
used be
forused
purification
and disinfection
purposes.
Unclean
containers
for for
in 121 for 1 hour, while cleaned container sshould be kept for 30 minutes.
sputum
should
be
purified
sputum should be purified in 121 for 1 hour, while cleaned container sshould be kept for 30 minutes.
In drug TB
resistant
TB department
TB laboratory,
ultraviolet
ray lamp
should
be turned
on for
x
Inxdrug resistant
department
and TB and
laboratory,
ultraviolet
ray lamp
should
be turned
on for
more
than
15
minutes
in
order
to
disinfect
the
air.
more than 15 minutes in order to disinfect the air.
x
Disposable
that are impossible
to disinfect
be burned
x
Disposable
materialsmaterials
that are impossible
to disinfect
shouldshould
be burned
x
Things used by the patient (blanket, mattress, pillow, comforters) should be disinfected in
x
Things used by the patient (blanket, mattress, pillow, comforters) should be disinfected in
descamera or put under direct sun light for at least 8 hours.
descamera or put under direct sun light for at least 8 hours.
7.6

Infection control for drug-resistant TB

7.6.1

TB units and institutions shall follow Health Ministers Order no. 85 on Strengthening infection

7.7

Regimen to follow during the treatment and care of drug resistant TB patient

7.6

Infection control for drug-resistant TB

7.6.1

TB units and
institutions
Ministers
no. 85
on Strengthening
infection the
control
system shall
fromfollow
April Health
15, 2008,
Health Order
Ministers
Order
no. 313 on Changing
control system
from
15, 2008,
Health
no. 313joint
on order
Changing
the on
guidelines
of April
2003, Health
Minister
and Ministers
Minister forOrder
Environment
no 249/201
guidelines
of 2003, the
Health
Ministerof and
Minister
forandEnvironment
order order.
no 249/201 on
Improving
management
waste
of 2002,
provisions ofjoint
the present
7.6.2 Thethe
infection
controlofteam
or committee
of the
health institutions
should
monitor the prevention
Improving
management
waste
of 2002, and
provisions
of the present
order.
of
the
spread
of
nosocomial
drug-resistant
TB.
The infection control team or committee of the health institutions should monitor the prevention
TB units
and institutions
should beTB.
supplied with special ventilations systems, window design to
of7.6.3
the spread
of nosocomial
drug-resistant
change
air
flow
in
the
rooms,
and
ultraviolet
ray lamps
for disinfection
of window
bacteria (11V
TB units and institutions should be supplied with special
ventilations
systems,
design to200280
pt).
change air flow in the rooms, and ultraviolet ray lamps for disinfection of bacteria (11V 2007.6.4
280
pt). In the laboratory where the sputum smear, culture and drug resistance test are performed, a
biosafety cabinet II should be used.
In the laboratory
where the sputum smear, culture and drug resistance test are performed, a
biosafety cabinet II should be used.

7.6.2
7.6.3
7.6.4
7.7

Regimen
to follow
during
treatment
andpatient
care of
drug
patient
7.7.1 The
treatment
of thethe
drug
resistant TB
who
has resistant
a positive TB
sputum
smear and culture should

7.7.1

The treatment of the drug resistant TB patient who has a positive sputum smear and culture should
7.7.2 When providing treatment and care to a drug resistant TB patient whose sputum smear and/or
be done under
the TB doctors monitoring, following all infection control instructions.
culture is positive, filter mask (N95, N100, and 3M) must be used.
When
providing
treatment
and technician
care to a must
drug use
resistant
TB patient
whose3M)
sputum
and/ortests
7.7.3 Doctor and
laboratory
filter mask
(N95, N100,
whensmear
performing
culture is over
positive,
filterofmask
(N95,drug-resistant
N100, and 3M)
a sample
suspected
TB.must be used.
Doctor and laboratory technician must use filter mask (N95, N100, 3M) when performing tests
42
over a sample of suspected drug-resistant TB.

7.7.2
7.7.3

be done under the TB doctors monitoring, following all infection control instructions.

7.7.4

Drug resistant TB patient should use a mask, collect his/her sputum in a special container, which
will be disinfected daily until his/her culture test has negative results for 2 consecutive months. 42

7.8

Infection control in daily treatment unit for


129drug-resistant TB patients

7.8.1

Patients of the daily treatment unit should either have separate rooms for infectious and noninfectious TB or different time schedules can be followed.

7.7.4

Drug resistant TB patient should use a mask, collect his/her sputum in a special container, which
will be disinfected daily until his/her culture test has negative results for 2 consecutive months.

7.8

Infection control in daily treatment unit for drug-resistant TB patients

7.8.1

Patients of the daily treatment unit should either have separate rooms for infectious and noninfectious TB or different time schedules can be followed.
Doctors and health personnel should be involved in the training.
Patients should be given the complete treatment cycle.
Infection control should be the same as above.

7.8.2
7.8.3
7.8.4
7.9
7.9.1

7.9.5

Infection control in radiology department


The department should follow strictly the infection control guidelines as clients with high
probability of TB infection come here for services.
Time schedule to do the chest x-ray should be allocated for in-patients and those suspected of
having TB.
Patients who are coughing must wear a mask over their mouth.
Outpatient clinics should provide services to those suspected of having TB without prior
appointment.
Chest x-ray should be performed in a room with good air flow as a precautionary measure

7.10

Requirement set for maternity department for pregnant women with TB

7.9.2
7.9.3
7.9.4

7.10.1 The maternity department for pregnant women with TB should have a pre-delivery room, delivery
room, post-delivery room for mother and baby, rooms for pre-delivery and post delivery
examination, bathroom for mothers, newborns room, disinfection room and other rooms.
7.10.2 If a pregnant mother has a positive smear test and culture and has drug resistant TB, she should
wear a mask at all times and health personnel working in the department should wear filter masks.
Mother with positive smear and culture tests and drug resistant TB should wear a filter mask
during breastfeeding and at all times while caring for the baby. Air flow in room should be
changed constantly.
7.10.3 To provide services and care to pregnant women, mothers and newborns in the department,
guidelines to prevent against infection should be followed.
7.11
Biosafety in TB laboratory
Laboratory safety
The following orders and guidelines should be followed regarding the safety of the laboratory:
x Health ministers order no. 85 on Strengthening the infection control system of 2008
x Order no. 70 of the Minister for Infrastructure and Tourism on Approving the guidelines of 2006
x Health Ministers order no 403 on Approving the list and guidelines of 2006
x Joint Health and Environmental Ministers order no 249/201 on Improving the management of
wastes of the health institutions of 2002
x Laboratory biosafety manual Third edition of WHO
7.12

Surveillance on TB infection and morbidity among health personnel

7.11.1 All health personnel, such as doctors, nurses, laboratory technicians, assistants, cleaners, health
volunteers and others, enrolled in TB unit or institution for the first time should undertake TB
examination and full tests, take tuberculin skin test, have special health notebook, which should be
updated twice a year after preventive examinations and tests.
7.11.2 All personnel should be trained on TB clinical treatment and infection control.
43
7.11.3 If health personnel contract TB, an epidemiological survey should be conducted and reported to
the TB research and surveillance department.
7.11.4 Report should contain all information related to work station, profession, infection origin,
treatment status, HIV test, etc.
Eight. Prevention measures

130

8.1 Vaccination against TB


BCG vaccine will reliably protect children from disseminated and TB meningitis.

7.11.2 All personnel should be trained on TB clinical treatment and infection control.
7.11.3 If health personnel contract TB, an epidemiological survey should be conducted and reported to
the TB research and surveillance department.
7.11.4 Report should contain all information related to work station, profession, infection origin,
treatment status, HIV test, etc.
Eight. Prevention measures
8.1 Vaccination against TB
BCG vaccine will reliably protect children from disseminated and TB meningitis.
8.1.1
8.1.2

8.1.3

A specially trained nurse should give the newborn the BCG vaccine 24 hours after the birth and
record the vaccination in health books. If vaccine was not given, the reasons should be indicated.
If there are complications after the vaccination, they should be reported and actively managed.
BCG vaccine should not be given, under the following circumstances:
x Pre-term newborn II-IV stage
x Underweight fetus III-IV stage
x Inflammation of fetus
x Inflammation disease
x Newborn hemophilia (moderate-critical, critical form)
x Skin damage
x Acute disease
x TB contact anamnesis of family members
x Brain and spinal disorders and abnormality
Re-vaccination
x The results of the first dose of BCG in newborns should be evaluated in the 1st, 3rd and
12th month of life; records should be kept in the health book. If there is no scar, a
tuberculin skin test should be performed. If it is negative, re-vaccination can be done.
x If the newborn did not receive the BCG vaccine in the maternity home because of health
conditions, a tuberculin skin test should be performed and, if it is negative, the infant
should be re-vaccinated.

8.2 Other measures to control and prevent TB


8.2.1
8.2.2
8.2.3
8.2.4
8.2.5

In order to deliver reliable and correct information on TB to the general population, health
institutions at all levels should constantly organize effect information, education and
communication activities.
New cases of infectious TB should be detected early and treated fully and effectively.
For 0-16 years old children without TB contacts and with positive tuberculin test (more than 17
mm) should be enrolled in TB diagnosis tests and when necessary, preventive treatment should be
given to children below 5 years old.
The homeless and people without residential addresses, as well as low income pregnant women
should be enrolled in TB examination.
Family members of chronic TB patient should have preventive examination annually.

44

131

Appendix 7 of Health Ministers order No 397


of 20 November, 2009
Guidelines on monitoring and evaluation
One. Supportive monitoring
Supportive monitoring is a systematic and continuous process to improve the knowledge, skills
and attitude of health personnel, and increase their efficiency. Supportive monitoring is conducted by
getting acquainted with the activities of TB units and institutions, primary data records, and monitoring
the documents, meeting with health personnel and patients and giving recommendations and
methodological advice accordingly.
Two. Monitoring
Monitoring is a process to follow-up on the implementation of planned activities of the
programme.
Monitoring aims at timely identification of problems and finding proper solutions to them.
Monitoring is conducted through on-site visit of units and/or institution, or review of reports and forms.
Three. Evaluation
Evaluation means review of objectives of the programme cycle and epidemiologic condition.
By conducting monitoring and evaluation,
- Implementation of the programme will improve
- Evaluation of the fulfillment of indicators, and decision makers will be provided with needed
information
- Possibilities will be created for effective and efficient usage of resources
Four. Purpose
Conduct monitoring and evaluation of the implementation and indicators of the sub-programme
on fighting and preventing TB, identify problems and plan further actions to come to better solution.
Five. Basic principles
5.1 Monitoring team at the national level conducts onsite monitoring at the TB dispensary at the aimag
and district level, TB professional institutions, Prison 429, Enerel hospital, and family practice units
according to approved schedule, identify the problems and plan further actions.
5.2 TB coordinator at the aimag and district level conducts monitoring at the family practice units and
soum hospitals on a monthly basis and evaluates whether standards and guidelines have been
followed.
Six. Composition of supportive monitoring team
Composition of the team will include aimag and district monitoring officer, epidemiologist, drug
officer and laboratory technician of TB surveillance and Research Department of the NCCD, aimag and
district officer of MCTH, and officers from Mongolian Family Doctors Association.
6.1 Activities
6.1.1
x
x
x
x

Registration and reporting


Evaluation on the registration of pulmonary TB suspects and their referral to testing
Check whether the data on TB cases at the particular unit matches with data at the NCCD
Monitor whether each TB case was given treatment and a monitoring card and whether the cards
are properly filled in
Check whether monitoring tests are performed according to schedule and the notes on tests match
with laboratory registration

45
132

x
x
x
x
x
x
6.1.2
x
x
x
x
x
6.1.3
x
x
x
x
6.1.4
x
x
x

Clarify whether sputum smear positive patients were registered and monitored and whether data
matches with laboratory registration
Clarify whether all registered patients are undertaking treatment from patient registration,
treatment and records in the monitoring card
Monitor whether treatment regimen and dosage of drugs are correct from the treatment using the
monitoring card
Check storage of drugs, validity date, stock drugs, and monitor whether drugs are packed for all
patients, and check for 10 patients whether the drugs are properly packed, whether the dosage is
correct and match the data with the package card
Follow up on the recommendations from previous monitoring visit
Discussion and interview with health personnel and patients
Laboratory activities
Evaluate whether the laboratory follows work station safety standards
Monitor whether equipment and reagents meet standard requirements, monitor whether adequate
staffing in the laboratory, completeness and accuracy of recording and reporting forms
Check from laboratory record books whether sputum is collected in 2 samples, and whether 1
infection is identified out of 10 suspicious cases
Monitor whether sputum smear microscopy is performed according to standards
Monitor from laboratory record books whether samples are sent to an external quality assurance
on quarterly basis
Measures on epidemiology and TB center
Evaluate the morbidity situation by comparing monthly and quarterly reports of registered
patients, and epidemiology indicators
Check examination of contacts of TB patients according to primary data record books
Monitor whether preventive treatment of contacts is being done according to guidelines and
standards
Evaluate and provide methodological consultation on the infection control measures of TB
outpatient clinic, department and laboratory
The following additional activities should done during facilitative monitoring
Monitoring of terms of reference of the health personnel
Interview with health personnel and patients
Check supply and procurement situation and issue recommendations when needed

6.2 6.2
Indicators
of National
StopStop
TBTB
strategy
Indicators
of National
strategy
Overall
evaluation
of all
andand
institutions
should
bebe
done
Overall
evaluation
of units
all units
institutions
should
doneat atthe
theend
endofofsupportive
supportive monitoring.
monitoring. This
This
should
be
done
according
to
indicators
below.
should be done according to indicators below.
1. Indicators
on TB
1. Indicators
on detection
TB detection
Indicator
Computation
method
Indicator
Computation
method
1. 2 samples
for sputumNumber
Number
of TB
suspects
who
gave
2 samplesofof
1. 2 samples
for sputum
of TB
suspects
who
gave
2 samples
microscopy
sputum
smear
smearsmear
microscopy
(%) (%) sputum
smear
-------------------------------------------- 100
100
-------------------------------------------Total
number
of
TB
suspects
Total number of TB suspects
2. Percentage
of positiveNumber
Number
of new
case
withpositive
positivesmear
smear
2. Percentage
of positive
of new
TBTB
case
with
smear
test
test
result
smear test
test result
------------------------------------------- 100
------------------------------------------- 100
Total
number
of
TB
suspects
Total number of TB suspects
3. Prevalence of positive
Number of registered new TB cases with
3. Prevalence of positive
Number of registered new TB cases with
sputum smear
positive sputum smear result
sputum smear
positive sputum smear result
------------------------------------------ 100
----------------------------------------- 100TB with
Number of projected pulmonary
Number
of
projected
pulmonary
positive sputum smear test results TB with
sputum
smear testnew
results
4. Rate of pulmonary TBpositive
Number
of registered
pulmonary TB cases
4. Rate
of
pulmonary
TB
Number
of
registered
new
pulmonary TB cases
with positive test result
with positive test result 133
with positive
test
result
with----------------------------------------positive test result
per 10000
population
10 000
per 10000 population
----------------------------------------Population number of local area 10 000

Sourceofofinformation
information
Source
Laboratoryregistration
registration
Laboratory
Laboratoryquarterly
quarterly report
report
Laboratory
Laboratoryregistration
registration
Laboratory
Laboratory
quarterly report
report
Laboratory quarterly
TB registration
TB registration
Monthly and quarterly reports
Monthly and quarterly reports
on registered cases
on registered cases
46
TB registration
TB
registration
Monthly
and quarterly reports
Monthly
and quarterly
reports
on registered
cases
onStatistic
registered
cases
number of population

3. Prevalence of positive
sputum smear

4. Rate of pulmonary TB
with positive test result
per 10000 population

-------------------------------------------- 100
Total number of TB suspects
Number of registered new TB cases with
positive sputum smear result
------------------------------------------ 100
Number of projected pulmonary TB with
positive sputum smear test results
Number of registered new pulmonary TB cases
with positive test result
----------------------------------------- 10 000
Population number of local area

2. Indicators on TB treatment and monitoring


Indicator
Computation method
1. Ratio of positive test
Number of all cases with positive test results
result among the
(new+relapse)
pulmonary TB cases
------------------------------------------ 100
Number of all pulmonary TB cases (new
positive test result + new negative test result +
relapse)
2. Percentage of positive
Number of positive test result TB cases who
TB patients who turned
turned negative in the 2nd (3rd) month of
negative in the 2nd (3rd)
treatment
month of treatment
------------------------------------------- 100
Number of positive test result pulmonary TB
cases
3.Treatment effects of all
Successful percentage
Number of successful cases
registered cases /cohort
----------------------------------------- 100
will be different for all
Number of all registered cases
cases/
Percentage who completed treatment
Number of cases with completed treatment
----------------------------------------- 100
Number of all successful cases
Percentage of deceased
Number of deceased cases
----------------------------------------- 100
Number of all registered cases
Percentage of ineffective treatment
Number of cases with ineffective treatment
----------------------------------------- 100
Number of all registered cases
Percentage of interrupted treatment
Number of cases who interrupted treatment
----------------------------------------- 100
Number of all registered cases
Percentage of referred cases
Number of referred cases
----------------------------------------- 100
Number of all registered cases

134

TB registration
Monthly and quarterly reports
on registered cases
TB registration
Monthly and quarterly reports
on registered cases
Statistic number of population

Source of information
TB registration
Monthly and quarterly reports
on registered cases

TB registration
Monthly and quarterly reports
on registered cases

TB registration
Monthly and quarterly reports
on registered cases
Quarterly report on treatment
effects

47

Appendix 8 of Health Ministers order No 397


of 20 November, 2009
Guidelines on public-private mix DOTS in TB care and control
One. Rationale
It is important to involve family group practices (FGPs), private health care providers, non-NTP providers
in TB care and control in order to improve access to primary health care services. Introducing TB services
among FGPs and private providers will help to decrease diagnostic delay and default rates as well as to
increase case detection and cure rates, thus, eventually to contribute to the significant decrease of TB
prevalence and mortality.
These guidelines will be followed in implementation of public-private mix DOTS.
Two. Goal
To improve accessibility and quality of TB services and to contribute to the implementation of the
National Stop TB strategy by introducing and expanding public private partnerships in TB control and
care.
Three. Objectives
3.1 To implement National guidelines on TB care and services by public and private clinics
3.2 To increase TB case detection and cure rates by introducing and implementing DOTS at the public
and private health care organizations not involved in TB control
3.3 To improve access to and quality of DOTS by expanding a partnership among public and private
health care organizations.
Four. Types of public-private partnerships
Non-TB providers working in public and private health sector will be involved in TB control
using the following two types of PPM:
x Public-public
x Public private
4.1 In the framework of publicpublic mix for TB care and control aimag, district health
department/center, branch ambulatories, and tertiary hospitals in the region are expected to refer
suspected TB patients to respective aimag, district TB dispensaries.
4.2 In the framework of public- private mix for TB care and control the role of TB dispensaries, family
group practice clinics and private clinics needs to be distinguished. FGP doctors and nurses are
expected to take sputum specimen from TB suspects, send it to respective TB dispensaries to ensure
diagnosis and if the patient is confirmed to have TB, directly observed treatment (DOT) should be
given at the family clinic. Whereas, private clinics are expected only to refer TB suspects to the
respective aimag, district TB dispensaries.
Five. Leadership, organizational structure and coverage
5.1 The National Coordinating Committee (NCC) responsible for introduction, management and
monitoring of PPM DOTS in TB control will be established under MOH
5.2 District coordinating committees will be also established.

49
135

Six. Implementing mechanism


6.1 Piloting PPM DOTS in TB control. All family clinics, some pulmonary private clinics,

secondary and tertiary level hospitals of selected 2 districts will be involved during pilot
phase. The Ministry of Health (MOH) will sign a Memorandum of Understanding (MOU)
with Mongolian Association of Family Clinics and Mongolian United Association of Private
Health Care Organizations and the parties will be responsible for implementation of duties
mentined in MOU.

6.2 PPM DOTS will be expanded step by step through involvement of other aimags and districts.

Seven. Roles and responsibilities of participating organizations


7.1 National coordinating committee structure
Head: Head of public health policy implementation department, MOH
Deputy head: Deputy director of NCCD, responsible for communicable diseases surveillance and
prevention
Secretary: PPM DOTS focal point at the TB surveillance and research department, NCCD
Members:
x

Officer in charge of HIV/AIDS/STI and TB, MOH

Officer in charge of PPP, MOH

Officer in charge of Public health policy monitoring and evaluation, MOH

Head of TB surveillance and research department, NCCD

Officer in charge communicable diseases, City health department

Head of health department, State Inspectorate Agency

Technical officer in charge of HIV/AIDS/STI and TB, WHO

TB officer of the Global Fund supported projects on HIV/AIDS and TB

Executive director of Mongolian Anti-Tuberculosis Association

Executive director of Mongolian Association of Family Clinics

Executive director of Mongolian United Association of Private Health Care Organizations

Project Coordinator, World Vision Mongolia.

7.2 NCC will perform the following duties including:


7.2.1

Lead and involve participating parties in introducing and expanding PPM DOTS in TB care and
control.

7.2.2

Provide TB drugs, sputum specimen collection containers, IEC materials, recording and reporting
forms to the participating health organizations

7.2.3

Train health providers, who are participating in implementation of PPM DOTS in TB care and control

7.2.4

Monitor and evaluate the implementation of PPM DOTS in TB care and control

50
136

7.2.5

Regular meetings on quarterly basis to provide policy guidance on PPM, to make a decision,
and to manage urgent problems.

7.2.6

Approval of action plan, budget and monitoring of implementation and expenditures for PPM.

7.2.7

Provision of support to promote PPM in TB control.

7.2.8

Monitoring and evaluation of introduction and expansion of PPM in TB control.

7.2.9

Selection and awarding of the selected health organization/health care provider which/who made
significant contribution to case detection rate.

7.3 Aimag, district coordinating committee structure

Head: Ofiicer in charge of health issues at the aimag, district governors office
Deputy head: Aimag, district health department/centers director/deputy director
Secretary: TB coordinator, aimag/district TB dispensary
Members:

7.4
7.4.1

Officer in charge of family clinics, Aimag, district health department/center

Epidemiologist of aimag, district health department/center

Inspector in charge of medical services, Aimag, district state inspectorate agency

Representative of private clinics

Representative of World Visions aimag, district office

Aimag, district coordinator, MATA

Head of aimag, district sub committee, MAFC

Aimag, district coordinating committees responsibilities

Approval of aimag/district action plan, budget on PPM in TB control and monitoring of


implementation and expenditures of this activity.

7.4.2

Regular meeting on quarterly basis in order to manage urgent problems.

7.4.3

Monitoring of introduction and expansion of PPM in TB control in aimag, district and


evaluation of the implementation in collaboration with NCC.

7.4.4

Selection of the selected health organization/health care provider which/who made significant
contribution to case detection rate in aimag, district and introduction to NCC.

7.5 Roles and responsibilities of participating organizations in PPM DOTS for TB care and control

51
137

7.4.4

Selection of the selected health organization/health care provider which/who made significant
contribution to case detection rate in aimag, district and introduction to NCC.

7.5 Roles and responsibilities of participating organizations in PPM DOTS for TB care and control

DOTS components
DOTS components

Public

dispensary
TB

hospital
Public

clinic
Private

clinic
Family

dispensary

hospital

clinic

clinic

1. Political committment

1. Political committment

2. IEC

2. IEC

3. Sputum smear examination

4.

TB

Directly

(DOT)

observed

Directly

observed

treatment

treatment

Family

51

3. Sputum smear examination

4.

Private

(DOT)

5. Effective drug supply and

5. Effective drug supply and

management
management

6. Recording
andand
reporting
6. Recording
reportingsystem
system

7. Referral
center
7. Referral
center
8. DOTS
center
8. DOTS
center

7.6 Roles and responsibilities of the Mongolian Association of Family Clinics (MAFC)
7.6 Roles
and responsibilities of the Mongolian Association of Family Clinics (MAFC)

MAFC will play an important role to introduce and expand PPM in TB control and will have the

MAFC will play an important role to introduce and expand PPM in TB control and will have the
following specific responsibilities:

following specific responsibilities:


7.6.1

7.6.1

To fulfill the roles and responsibilities written in the memorandum of understanding.

To fulfill the roles and responsibilities written in the memorandum of understanding.


7.6.2

To coordinate introduction and expansion of PPM in TB control among family group practice

7.6.3

To organize training and IEC activities of PPM in TB control.

7.6.2clinics.
To coordinate introduction and expansion of PPM in TB control among family group practice
clinics.
7.6.3To coordinate
To organize
training
and IEC
activities activities
of PPM in
control.
7.6.4
sputum
specimen
transportation
andTB
properly
allocate financial resources.
7.6.47.6.5
To coordinate
transportation
andFGPs
properly
allocate financial
resources.
To organizesputum
regularspecimen
monitoring
visits among activities
participating
and introduce
encountered
problems to
7.6.5

NCC for decisive action.

To organize regular monitoring visits among participating FGPs and introduce encountered problems to
NCCToforcollect
decisive
action.
7.6.6
monthly
reports from participating family clinics, combine the report and introduce the PPM
implementation process to NCC on quarterly basis.

7.6.6 To collect monthly reports from participating family clinics, combine the report and introduce the PPM
7.7.1implementation
To fulfill the
rolestoand
responsibilities
written in the memorandum of understanding and
process
NCC
on quarterly basis.
7.7 Roles and
responsibilities
of the Mongolian
Association
of private
Privateproviders.
Health Care
coordinate
introduction
and expansion
of PPMUnited
in TB control
among
Organizations
7.7.2 To organize IEC activities on PPM in TB control. To organize training on PPM in TB
7.7 Roles and responsibilities of the Mongolian United Association of Private Health Care
52
Organizations

control among private providers.

7.7.3

To organize regular monitoring visits among participating private clinics and introduce 52
138action.
encountered problems to NCC for decisive

7.7.4

To report about PPM implementation process to NCC on quarterly basis.

7.7.1
7.7.1
7.7.2
7.7.2
7.7.3
7.7.3
7.7.4
7.7.4

To fulfill the roles and responsibilities written in the memorandum of understanding and
To fulfill the roles and responsibilities written in the memorandum of understanding and
coordinate introduction and expansion of PPM in TB control among private providers.
coordinate introduction and expansion of PPM in TB control among private providers.
To organize IEC activities on PPM in TB control. To organize training on PPM in TB
To organize IEC activities on PPM in TB control. To organize training on PPM in TB
control among private providers.
control among private providers.
To organize regular monitoring visits among participating private clinics and introduce
To organize regular monitoring visits among participating private clinics and introduce
encountered problems to NCC for decisive action.
encountered problems to NCC for decisive action.
To report about PPM implementation process to NCC on quarterly basis.
To report about PPM implementation process to NCC on quarterly basis.

7.8 Roles and responsibilities of FGPs


7.8 Roles and responsibilities of FGPs
7.8.1 To collect sputum specimen from suspected TB patients and send the specimen to aimag,
7.8.1 To collect sputum specimen from suspected TB patients and send the specimen to aimag,

district TB dispensary for diagnosis.


district TB dispensary for diagnosis.
7.8.2 To register suspected TB patients referral and sputum specimen collection on TB
7.8.2 To register suspected TB patients referral and sputum specimen collection on TB
suspect registration form and report it to TB coordinator of aimag, district TB dispensary
suspect registration form and report it to TB coordinator of aimag, district TB dispensary
by Referral slip every time.
by Referral slip every time.
7.8.3 To provide DOT with supervision to confirmed TB patients according to the approved
7.8.3 To provide DOT with supervision to confirmed TB patients according to the approved
National guidelines on TB care and services and to fill out Treatment registration of TB
National guidelines on TB care and services and to fill out Treatment registration of TB
patinets and Treatment card forms.
patinets and Treatment card forms.
7.8.4 To collect TB drugs of the patients from aimag, district TB dispensary on time and to
7.8.4 To collect TB drugs of the patients from aimag, district TB dispensary on time and to
manage drug order, transportation, storage and distribution activities according to the
manage drug order, transportation, storage and distribution activities according to the
approved National guidelines on TB care and control.
approved National guidelines on TB care and control.
7.8.5 To collect and send TB patients specimen on time to TB dispensary for follow up
7.8.5 To collect and send TB patients specimen on time to TB dispensary for follow up
examination.
examination.
7.8.6 To involve TB patients family members for contact examination and fill the Register of
7.8.6 To involve TB patients family members for contact examination and fill the Register of
TB contacts form.
TB contacts form.
7.8.7 To organize IEC activities about TB on regular basis.
7.8.7 To organize IEC activities about TB on regular basis.
7.8.8 To conduct active case finding among the population vulnerable to TB.
7.8.8 To conduct active case finding among the population vulnerable to TB.
7.8.9 To fill out Quarterly report of FGPs on TB services (Annex 9), Specimen
7.8.9 To fill out Quarterly report of FGPs on TB services (Annex 9), Specimen
transportation report of FGPs and report it to aimag, district TB dispensary on monthly
transportation report of FGPs and report it to aimag, district TB dispensary on monthly
and quarterly basis.
and quarterly basis.
7.8.10 To fulfill the roles and responsibilities written in the tri-partite agreement.
7.8.10 To fulfill the roles and responsibilities written in the tri-partite agreement.
7.9 Roles and responsibilities of private providers
7.9 Roles and responsibilities of private providers
7.9.1 To register suspected TB patients on TB suspect registration form and report it to

responsible FGPs or aimag, district TB dispensary where the patient is registered.


7.9.2

53
53
To report referral of suspected TB patient to TB coordinator of aimag, district TB
dispensary by Referral slip.

7.9.3

To organize IEC activities about TB on regular basis.

7.9.4

To fill out Quarterly report of private clinics, branch ambulatories of district health
center, tertiary level hospitals on TB services form and send the report to TB
surveillance and research department of139
NCCD.

7.9.2

To report referral of suspected TB patient to TB coordinator of aimag, district TB


dispensary by Referral slip.

7.9.3

To organize IEC activities about TB on regular basis.

7.9.4

To fill out Quarterly report of private clinics, branch ambulatories of district health
center, tertiary level hospitals on TB services form and send the report to TB
surveillance and research department of NCCD.

7.10

Roles and responsibilities of tertiary level hospitals other than NCCD

7.10.1 To register suspected TB patients on TB suspect registration form.


7.10.2 To collect sputum specimen from suspected TB patients and to perform the test in the

hospital laboratory. If it is not possible to perform sputum smear examination in the


hospital laboratory, the patient or the collected specimen should be sent to respective
aimag, district TB dispensary. If the patient is from rural areas, the patient or the
collected specimen should be sent to national TB reference laboratory of NCCD for
diagnosis.
7.10.3 To report referral of the suspected TB patient to TB coordinator of aimag, district TB

dispensary by Referral slip.


7.10.4 If the patient is diagnosed with smear positive TB, he/she should be sent to the

appropriate health facility for treatment as written in the National Guidelines onTB care
and services.
7.10.5 To fill Quarterly report of private clinics, branch ambulatories of district health center,

tertiary level hospitals on TB services form (Annex 12) and send report to TB
surveillance and research department of NCCD.
7.11

Roles and responsibilities of aimag, district health department/center, aimag hospitals,

and branch ambulatories


7.11.1 To register suspected TB patients referral on TB suspect registration form /Annex 4/,

send the suspected TB patients to aimag, district TB dispensary and report it to TB


coordinator of aimag, district TB dispensary by Referral slip.
7.11.2 To refer sputum smear negative and extrapulmonary TB patients for aimag, district TB

diagnostic consultation committees meeting (Annex 13) to decide about diagnosis and
54
treatment.
7.11.3 To fill Quarterly report of private clinics, branch ambulatories of district health center,

tertiary level hospitals on TB services form (Annex 12) and send the report to TB
surveillance and research department of NCCD.
7.12

Roles and responsibilities of TB dispensaries

7.12.1 To diagnose referred patients from FGPs, private providers, other health providers and

self referred patients.

140

7.12.2 To send diagnosed TB patients to respective FGPs, TB ward of NCCD, or TB

dispensaries according to National guidelines on TB care and services for directly

7.11.3 To fill Quarterly report of private clinics, branch ambulatories of district health center,

tertiary level hospitals on TB services form (Annex 12) and send the report to TB
surveillance and research department of NCCD.
7.12

Roles and responsibilities of TB dispensaries

7.12.1 To diagnose referred patients from FGPs, private providers, other health providers and

self referred patients.


7.12.2 To send diagnosed TB patients to respective FGPs, TB ward of NCCD, or TB

dispensaries according to National guidelines on TB care and services for directly


observed treatment (DOT).
7.12.3 To monitor TB services provided by FGPs and provide technical support.
7.12.4 To provide TB drugs for patients, who are treated under supervision of FGPs and TB

dispensaries and manage drug procurement, transportation, storage, distribution according


to the National guidelines on TB care and control.
7.12.5 To fill out Quarterly report of TB dispensaries on TB services form and to send the

report to TB surveillance and research department of NCCD.


7.12.6 To monitor implementation of PPM in TB control activities in aimag, district levels and

to evaluate its implementation in collaboration with aimag, district coordinating


committees.
7.13

Roles and responsibilities of Mongolian Anti-tuberculosis Association (MATA)

7.13.1 To collaborate closely with TB surveillance and research department of NCCD, aimag,

district TB dispensaries, FGPs and MAFC.


7.13.2 To provide lunch DOTS and home DOTS for TB patients through volunteers.
7.13.3 To involve TB patients for follow up examination on time through volunteers.
7.13.4 To involve TB patients contacts for examination through volunteers.
7.13.5 To conduct IEC activities among TB patients, their family members through volunteers.
Eight. TB diagnostic committee to diagnose sputum smear negative pulmonary and extra
Eight. TB diagnostic committee to diagnose
sputum
pulmonary
TB smear negative pulmonary and extra
pulmonary TB
8.1 Rationale
55
8.1
Rationale
In order to diagnose sputum smear negative pulmonary TB and extra-pulmonary TB the TB diagnostic
In
order to diagnose
sputumofsmear
pulmonary
extra-pulmonary
TBwill
the TB
diagnostic at
committee,
which consists
manynegative
specialists
is needed.TB
TBand
diagnostic
committees
be established
committee,
whichdepartment
consists ofand/or
many specialists
is needed.
willhealth
be established
the aimag health
aimag general
hospitalTB
in diagnostic
aimags andcommittees
at the district
center in at
the
UB.aimag health department and/or aimag general hospital in aimags and at the district health center in
UB.
8.2 TB diagnostic committee structure
8.2
diagnostic
committee
TB TB
diagnostic
committee
will structure
be chaired by deputy director responsible for service delivery at aimag,
district
health
department/center.
members
coulddirector
be the specialists
public and
private
TB diagnostic committee will be The
chaired
by deputy
responsiblefrom
for service
delivery
at clinics.
aimag,
The
names
of department/center.
the members will The
be approved
jointbeorder
of aimag from
healthpublic
departments
andclinics.
aimag
district
health
members by
could
the specialists
and private
general
hospitals
by the
of district
health
centers
director
in UB.
The names
of thedirectors
membersor will
beorder
approved
by joint
order
of aimag
health
departments and aimag
general hospitals directors or by the order of district health centers director in UB.
Chairman - deputy director responsible for service delivery
141
SecretaryTB
coordinator
Chairman -Aimag,
deputydistrict
director
responsible
for service delivery
Members
Aimag, district
district TB
TB coordinator
doctors, internal medicine doctor, surgeon, x-ray doctor, pathologist,
Secretary- Aimag,
pediatrician,
gynecologist
necessary
othermedicine
specialistsdoctor, surgeon, x-ray doctor, pathologist,
Members Aimag,
districtand
TBifdoctors,
internal

8.2 TB diagnostic
committee
structure
8.2 TB diagnostic
committee
structure
TB diagnostic committee will be chaired by deputy director responsible for service delivery at aimag,
TB diagnostic committee will be chaired by deputy director responsible for service delivery at aimag,
district health department/center. The members could be the specialists from public and private clinics.
district health department/center. The members could be the specialists from public and private clinics.
The names of the members will be approved by joint order of aimag health departments and aimag
The names
of the members will be approved by joint order of aimag health departments and aimag
general hospitals directors or by the order of district health centers director in UB.
general hospitals directors or by the order of district health centers director in UB.
Chairman - deputy director responsible for service delivery
Chairman
- deputy
director
responsible
for service delivery
SecretaryAimag,
district
TB coordinator
SecretaryAimag,
district
TB
coordinator
Members Aimag, district TB doctors, internal medicine doctor, surgeon, x-ray doctor, pathologist,
Members
Aimag, district
TB doctors,
internal other
medicine
doctor, surgeon, x-ray doctor, pathologist,
pediatrician,
gynecologist
and if necessary
specialists
pediatrician, gynecologist and if necessary other specialists

8.3.1
8.3.2
8.3.3
8.3.4

8.3 TB diagnostic committees roles and responsibilities


8.3 TB diagnostic committees roles and responsibilities
8.3.1 To make a professional decision about the diagnosis and treatment of sputum negative TB suspect, who is
To makereferred
a professional
the diagnosis and treatment of sputum negative TB suspect, who is
by FGPs decision
and soumabout
hospitals.
referred by FGPs and soum hospitals.
8.3.2 If necessary, the other specialized services should be sought or referred to upper level of health care
services.
If necessary,
the other specialized services should be sought or referred to upper level of health care
services.
8.3.3 The diagnosis of sputum negative pulmonary TB and extra pulmonary TB will be based on bacteriological
and histological
testnegative
results. pulmonary TB and extra pulmonary TB will be based on bacteriological
The diagnosis
of sputum
and histological test results.
8.3.4 TB diagnostic committees meetings shall be held at least once in a month based on the local TB situation.
For urgent
matters TBmeetings
diagnostic
committee
haveonce
unscheduled
meeting.
TB diagnostic
committees
shall
be heldshall
at least
in a month
based on the local TB situation.
For urgent matters TB diagnostic committee shall have unscheduled meeting.
Roles and responsibilities of public and private clinics

DOTS component
1. Political committment
2. Case detection
Clinical evaluation
To
perform
sputum
smear
examination
To take x-ray
3. Case treatment
To monitor DOT
To monitor quality of sputum
specimen
To refer patients according to the
guidelines
To monitor the patient throughout
the treatment course
To involve the treatment interrupted
cases for treatment
4. Uninterrupted drug supply
5. Registration, reporting and
monitoring and evaluation
TB suspect registration form
/Annex 4/
Referral slip /Annex 5/
Treatment registration of TB
patients (Annex 6)
Treatment card (Annex 7)
Register of TB contacts (Annex

TB dispensary
-

Non TB public
hospital
-

Private
clinic
-

Family
clinic
-

8)
Quarterly report of FGPs on TB
services (Annex 9)
Specimen transportation report of
FGPs /Annex 10/
Quarterly report of private clinics,
branch ambulatories of district
health center, tertiary level hospitals

142

56

56

Treatment card (Annex 7)

Register of TB contacts (Annex

8)
Quarterly report of FGPs on TB
services (Annex 9)
Specimen transportation report of
FGPs /Annex 10/
Quarterly report of private clinics,
branch ambulatories of district
health center, tertiary level hospitals
on TB services (Annex 12)
Quarterly report of TB dispensaries
on TB services (Annex 14)
Referral center
DOTS center

Nine. Monitoring
and evaluation
Nine. Monitoring
and evaluation
Nine. Monitoring and evaluation

The monitoring
of implementation
of guidelines
the guidelines
PPM
DOTSininTB
TBcare
careand
and control
control will
The monitoring
of implementation
of the
on on
PPM
DOTS
will
The
monitoring
of
implementation
ofevaluation
the guidelines
on PPM
DOTS
in
TB care
and control will
be
conducted
on
quarterly
basis
and
of
PPM
activities
on
annual
basis.
be conducted
on quarterly basis and evaluation of PPM activities on annual basis.
be conducted on quarterly basis and evaluation of PPM activities on annual basis.
9.1 Process
indicators
9.1 Process
indicators
9.1 Process
indicators
1
2
3
4

1
1
2
2
3
3
4
4

57

Number of doctors who are trained on PPM DOTS

NumberNumber
of doctors
who are
on PPM
DOTS
of doctors
whotrained
are trained
on PPM
DOTS
Number of health health organizations referring suspected TB patients and sputum specimen to

of health health
organizations referring
suspected
TB
patientsand
and sputum specimen to
NumberNumber
of health
organizations
suspected
TBand
patients
DOTS
centerhealth
according
to Nationalreferring
guidelines
on TB care
services sputum specimen to
according
to National
guidelines
on TB
services
DOTS DOTS
center center
according
to National
guidelines
on TB
carecare
andand
services
Number of units implementing PPM in TB control (FGPs, private clinics)

units implementing
in control
TB control
(FGPs,
private
clinics)
NumberNumber
of unitsofimplementing
PPMPPM
in TB
(FGPs,
private
clinics)
Number of PPM units, which are included in joint M&E team
Number of PPM units, which are included in joint M&E team

Number of PPM units, which are included in joint M&E team

9.2 Outcome indicators

9.2 Outcome indicators


1.Case
detection
9.2 Outcome
1.Case
detectionindicators

1.Case detection

1.3

Indicator

1.2
1.2

from PPM
implementers.
branch
ambulatories)
Number
and percentage of smear positive hospital,
(Number
of smear
positive pulmonary TB patients

Number and percentage of smear positive


(Number of smear positive pulmonary TB patients
pulmonary TB patients detected out of all
detected out of all referred patients to DOTS
TB patientssmear
detected
out of all (Number
detected out
of allpositive
referredpulmonary
patients to DOTS
Numberpulmonary
and percentage
positive
smear
TB patients
referred
patients toof
DOTS centers
from PPM centersof
from
PPM units / Number
of patients
referred patients to DOTS centers from PPM centers from PPM units / Number of patients
units.TB patients detected out of all
referred
centers patients
from PPM
pulmonary
detected
outtoofDOTS
all referred
tounits)*100%)
DOTS
units.
referred to DOTS centers from PPM units)*100%)
referred patients to DOTS centers from PPM centers from PPM units / Number of patients
(by unit types: FGPs, private clinic, tertiary level
units.
referred
to DOTS
centers
fromclinic,
PPM tertiary
units)*100%)
(by unit
types: FGPs,
private
level
hospital, branch ambulatories)
hospital, branch ambulatories)
(by(number
unit types:
FGPs,
private
clinic,
tertiary
level
1.3
Percentage of new smear positive cases
of new
smear
positive
cases
detected
1.3
Percentage of new smear positive cases
(number
of
new
smear
positive
cases
detected
hospital,
branch
ambulatories)
detected through referral of PPM
through
referral
of PPM implementers /number of
detected through referral of PPM
through referral of PPM implementers /number of
implementers
new smear positive cases detected throughout the
Percentage
of new smear positive cases
(number
of new
smearcases
positive
cases
detected the
implementers
new smear
positive
detected
throughout
country at a given time period)*100%
country
at a given
time implementers
period)*100% /number of
detected through referral of PPM
through
referral
of PPM
2.Treatment
outcome
implementers
new smear positive cases detected throughout the
2.Treatment outcome

Percentage of TB patients receiving DOT at


Percentage of TB patients receiving DOT at
2.Treatment outcomeFGPs
FGPs

2.2

Calculation method, notes

Number of referred patients to DOTS center By unit types (FGPs, private clinics, tertiary level
Number of referred patients to DOTS center By unit types (FGPs, private clinics, tertiary level
from PPM implementers.
hospital, branch ambulatories)
PPM implementers.
branch
ambulatories)
Numberfrom
of referred
patients to DOTS center By hospital,
unit types
(FGPs,
private clinics, tertiary level

2.1
2.1

2.1

Calculation method, notes


Calculation method, notes

1.1
1.1

1.1

1.2

Indicator
Indicator

2.2
2.2

country at a given time period)*100%

(number of TB patients receiving DOT at FGPs/


(number of TB patients receiving DOT at FGPs/
number of TB patients receiving DOT
number of TB patients receiving DOT
countrywide at a given time)*100%
countrywide at a given time)*100%
Percentage of TB patients receiving DOT at
(number of TB patients receiving DOT at FGPs/
Percentage of new smear positive TB cases
Example: (Number of new smear positive TB
FGPs Percentage of new smear positive TB cases number
of TB
patientsofreceiving
Example:
(Number
new smearDOT
positive TB
cured, completed treatment, failed, defaulted,
143 cases cured, who had treatment at the FGP / Total
at who
a given
cured, completed treatment, failed, defaulted,countrywide
cases cured,
had time)*100%
treatment at the FGP / Total
transferred out, and died, who had treatment number of new smear postive TB cases, who had
transferred out, and died, who had treatment number of new smear postive TB cases, who had
at the FGPs.
treatment at the FGPs)*100%
Percentage
new smear positive TB cases
Example:
(Number
of new smear positive TB
at theofFGPs.
treatment
at the FGPs)*100%

1.3

Percentage of new smear positive cases


detected through referral of PPM
implementers

(number of new smear positive cases detected


through referral of PPM implementers /number of
new smear positive cases detected throughout the
country at a given time period)*100%

2.Treatment outcome
2.1

Percentage of TB patients receiving DOT at


FGPs

(number of TB patients receiving DOT at FGPs/


number of TB patients receiving DOT
countrywide at a given time)*100%

2.2

Percentage of new smear positive TB cases


cured, completed treatment, failed, defaulted,
transferred out, and died, who had treatment
at the FGPs.

Example: (Number of new smear positive TB


cases cured, who had treatment at the FGP / Total
number of new smear postive TB cases, who had
treatment at the FGPs)*100%

58
Ten. Mechanisms to sustain

It is important to use financial and non-financial incentives in order to ensure sustainability of


family and private clinics participation in PPM for TB care and control. One of such incentives
could be inclusion of relevant indicators in tri-partite agreement. This tripartite agreement is
signed between district health center, MAFC and FGP every year. It is advisable to include some
outcome and process indicators related to TB services provided by FGPs in the tri-partite
agreement, evaluate it every year and award the best performing FGP, doctor and nurse from the
aimag, district governor.

144

145

Date

Name

Age,
sex

Home
address

Employment

Date of referral to
test
7

Date of test
9

10

II
Date of referral
11

X-ray test

12

Date of test

Sputum smear test

13

Test result

Tuberculi
n test

Name of the clinic: ..................................................... Doctors name............................................................... Year................

TB suspect registration

14

Date of test

15

16

Diagnosis

60

17

Note

TXT-1

Approved by Health Ministers order No 397


as of 20 November, 2009

Test result

Approved by Health Ministers order No 397


as of 20 November, 2009

TXT-2
Referral slip
Referring to: Name of organization___________________

Patients name ________________________ Age______


ID: _____________________Sex: male female
Home address:
___________________________________________________________________
Phone number: ______________________
Referral date: ______Year____month_____ day
Purpose of referral: ( ) Sputum smear test
( ) Directly observed treatment
( ) Other __________________________
Referring organizations name___________________________
Referring doctors name___________________________

61
146

147

Name

Age,
sex

Home
address

Employmen
t

Diagnosis

First diagnosing health care organization

First time
9

Re-treated
10

11

12

Cured

13

Completed treatment

14

15

Failed

Treatment outcome /Date should be


written /

16

Defaulted

Treatment
coverage

Date of treatment started

Year: ..

17

Transferred out

Family doctor name: . .

18

Died

Family clinic name : ................................

Number

Treatment registration of TB patients

Treatment regime

19

62

TXT-3

Approved by Health Ministers order No 397


as of 20 November, 2009

Note

2 month

3 month

5 month

6 month

Sputum smear microscopy


8 month

Treatment card

TXT-4

Approved by Health Ministers order No 397


as of 20 November, 2009

63

Drug administration notes during intensive phase of treatment:


days
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

month

Smear positivity:

Family clinic name.....................................


Patient name________________________________
Address _______________________________________
Diagnosis:_______________________________________

Signature

Signature

Signature

148

days

10

11

12

13

14

15

16

Drug administration notes during continuation phase of treatment:

Signature

Signature

Signature

Signature

Signature

149

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

64

150

Date

Name

Age,
sex

Home
address

Diagnosi
s
Number of contacts
7

Name of contacts
8

Relation to patient
9

Date of referral for smear


test
10

11

Date of smear test

Sputum smear test result


12

Date of referral for x-ray


13

X-ray

14

Date of x-ray test

Smear test

15

Tuberculin test

16

Date of tuberculin test

Contact prevention

X-ray result

Family doctors name................................................................ Year..................................

Register of TB contacts

17

Date of tuberculin test


checked

Family clinic name

Number

18

65

19

Dia
gno
sis

20

No
te

TXT-5

Approved by Health Ministers order No 397


as of 20 November, 2009

Tuberculin test result

151
TOTAL

Month
Specimen
transportatio
n
Prevention

66

Information, education and


communication

TXT-7

Approved by Health Ministers order No 397


as of 20 November, 2009

Quarterly report of FGPs on TB services


Family clinic name..............................
......... YearMonthDay

Total number of registered


TB patients

Case detection

Aimag/District........................ Khoroo

Number of suspected TB patients


Number of suspected TB patients
referred to sputum smear
examination
Number of suspected TB patients
referred to x-ray
Number of sputum smear
positive pulmonary TB
cases
Number of sputum smear
negative pulmonary TB
cases
Number of extra oulmonary
TB cases

Number of patients receiving DOT at


the family clinic
Frequency of specimen
transportation
Number of transported sputum
specimens
Number of people covered by
prevention services
Number of people covered by
contact preventive services
BCG vaccine scar evaluation
Number of kids covered by BCG
vaccination
Number of trainings conducted
Number of people covered
Number of IEC activities
Number of people covered

152

number

Name of referred patients

Age, sex

Follow up test

Specimen
Date
transported

Test purpose

Date taken

....... year ....... month ....... day

number

Family clinic name ...................................

Specimen transportation report of family group practice clinic

diagnosis

Prepared by........................................(family doctor/nurse)

date

II

Test result

67

TXT-8

Approved by Health Ministers order No 397


as of 20 November, 2009

quality

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