MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 05/2017/TT-BYT
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Hanoi, April 14, 2017
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CIRCULAR
ON MAXIMUM PRICES AND COSTS OF PRICE
DETERMINATION OF UNITS OF QUALIFIED WHOLE BLOOD AND BLOOD PRODUCTS
Pursuant to
the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;
Pursuant to
the Law on Prices No. 11/2012/QH13 dated June 20, 2012;
Pursuant to
the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012 on functions,
tasks, powers and organizational structure of the Ministry of Health;
In
consideration of opinions of the Ministry of Finance as stated in the Official
Dispatch No. 422/BTC-QLG dated January 11, 2017;
At the
request of the Director General of the Department of Planning and Finance;
The
Minister of Health promulgates a Circular on maximum prices and costs of price
determination of units of qualified whole blood and blood products
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1. Scope:
This Circular
deals with maximum prices of certain units of qualified whole blood and blood
products covered by the state budget and health insurance fund and costs of
price determination of a unit of qualified whole blood and blood products.
2. Regulated
entities:
a) Steering
committees of voluntary blood transfusion; organizations and individuals
involving in disseminating and organizing voluntary blood transfusion and blood
donors;
b) Health
facilities responsible for selecting blood donors; receiving blood and blood
components; testing and screening blood; preparing blood products; storing,
preserving, supplying and using blood and blood products as prescribed by the
Ministry of Health.
Article 2. Units of qualified blood and blood products
1. A blood
unit is qualified when it is collected and stored in a plastic bag with
anti-clotting substances and undergone all compulsory screening tests as
stipulated in the Circular No. 26/2013/TT-BYT dated September 16, 2013 by the
Ministry of Health on guidelines for blood transfusion (hereinafter referred to
as "Circular No. 26/2013/TT-BYT").
2. A blood
product is qualified when it is prepared according to statutory standards
specified in the Circular No. 26/2013/TT-BYT .
Article 3. Maximum prices of certain units of whole blood
and blood products
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No.
Whole blood volume
Net volume
(ml) (±10%)
Maximum price (VND)
1
30 ml of whole blood
35
109,000
2
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55
157,000
3
100 ml of whole blood
115
290,000
4
150 ml of whole blood
170
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5
200 ml of whole blood
225
505,000
6
250 ml of whole blood
285
641,000
7
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395
758,000
8
450 ml of whole blood
510
858,000
2. Blood
products prepared from red blood cells (RBCs):
No.
RBC volume
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Maximum price (VND)
1
Packed RBCs separated
from 30 ml of whole blood
20
114,000
2
Packed RBCs separated
from 50 ml of whole blood
30
162,000
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Packed RBCs separated
from 100 ml of whole blood
70
280,000
4
Packed RBCs separated from
150 ml of whole blood
110
402,000
5
Packed RBCs separated
from 200 ml of whole blood
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520,000
6
Packed RBCs separated
from 250 ml of whole blood
180
638,000
7
Packed RBCs separated
from 350 ml of whole blood
230
748,000
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Packed RBCs separated from
450 ml of whole blood
280
838,000
3. Blood
products prepared from fresh frozen plasma (FFP):
No.
FFP volume
Net volume
(ml) (±10%)
Maximum price (VND)
1
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30
64,000
2
50 ml of FFP
50
92,000
3
100 ml of FFP
100
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4
150 ml of FFP
150
177,000
5
200 ml of FFP
200
280,000
6
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250
343,000
4. Blood
products prepared from frozen plasma:
No.
Frozen plasma volume
Net volume
(ml) (±10%)
Maximum price (VND)
1
30 ml of frozen plasma
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54,000
2
50 ml of frozen plasma
50
77,000
3
100 ml of frozen plasma
100
120,000
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150 ml of frozen plasma
150
167,000
5
200 ml of frozen plasma
200
220,000
6
250 ml of frozen plasma
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262,000
5. Blood
products prepared from platelet-rich plasma (PRP)
No.
PRP volume
Net volume
(ml) (±10%)
Maximum price (VND)
1
100 ml of platelet-rich
plasma separated from 250 ml of whole blood
100
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2
150 ml of platelet-rich
plasma separated from 350 ml of whole blood
150
228,000
3
200 ml of platelet-rich
plasma separated from 450 ml of whole blood
200
248,000
6. Blood
products prepared from platelet concentrates
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Platelet concentrate volume
Net volume
(ml) (±10%)
Maximum price (VND)
1
1-unit platelet
concentrate (separated from 250 ml of whole blood)
40
140,000
2
2-unit platelet
concentrate (separated from 500 ml of whole blood)
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290,000
3
3-unit platelet
concentrate (separated from 750 ml of whole blood)
120
445,000
4
4-unit platelet
concentrate (separated from 1,000 ml of whole blood)
150
558,000
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No.
Cryoprecipitate volume
Net volume
(ml) (±10%)
Maximum price (VND)
1
10 ml of
cryoprecipitate volume (separated from 250 ml of whole blood)
10
78,000
2
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50
359,000
3
100 ml of
cryoprecipitate volume (separated from 2,000 ml of whole blood)
100
638,000
8. Blood
products prepared from white blood cell (WBC) concentrates:
No.
WBC concentrate volume
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Maximum price (VND)
1
Pooled granulocyte
concentrate (5x109 BC)
125
339,000
2
Granulocyte pool (10x109
BC)
250
678,000
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No.
Blood product volume
Net volume
(ml) (±10%)
Maximum price (VND)
1
8-unit platelet
concentrate (separated from 2,000 ml of whole blood) (excluding a pooled bag
and leukoreduction filter)
250
1,068,000
2
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50
713,000
3
Cost of preparing
apheresis WBC concentrate (excluding an apheresis kit)
250
924,000
4
Cost of preparing
apheresis platelet concentrate (excluding an apheresis kit)
250
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5
Cost of preparing
apheresis platelet concentrate (excluding an apheresis kit)
120
514,000
10. Maximum
prices specified in Clauses 1, 2, 3, 4, 5, 6, 7, 8 and 9 this Article shall not
include:
a) Cost of
transporting blood from blood banks to health facilities. In the cases
where a blood bank transports blood to a health facility, price of a unit of
blood or blood product shall be added as cost of transport with the maximum of
VND 17,000/blood unit (blood product unit);
b) Cost of
testing abnormal antibodies according to provisions of Point a Clause 1 and
Point c Clause 4 Article 14 of the Circular No. 26/2013/TT-BYT. If a blood
transfusion facility perform a test on abnormal antibodies, price of a unit of
whole blood or packed red blood cell volume of over and equal to 250 ml and
blood product such as apheresis platelet concentrate, apheresis WBC concentrate
or platelet concentrate shall be added up to VND 17,000/unit;
c) Cost of
nucleic acid testing (NAT) is specified in Point b Clause 1 and Point
g Clause 4 Article 14 of the Circular No. 26/2013/TT-BYT. Where a blood bank
perform a NAT, price of a unit of whole blood or packed red blood cell volume
of over and equal to 250 ml and blood product such as
apheresis platelet concentrate, apheresis WBC concentrate
or platelet concentrate shall be added up to VND 210,000/unit;
d) Cost of compulsory conditional
testing is prescribed in Points a, b and c Clause 2 and Points c, i and k
Clause 4 Article 14 of the Circular No. 26/2013/TT-BYT. Blood banks are
permitted to perform the aforementioned tests only after they meet applicable
regulations on blood transfusion and get opinions from attending doctors;
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11. Health
facilities performing tests stated in Points d and dd Clause 10 this Article
are eligible to collect costs from patients or receive payment from the health
insurance fund according to prices approved by competent authorities as
prescribed in applicable regulations.
Article 4. Costs of price determination of units of
qualified whole blood and blood products
Unit prices of
qualified whole blood and blood products shall be determined based on the
process of receiving, screening blood and blood components and preparing blood
products according to:
1. Funding for
organizations and facilities responsible for disseminating and organizing
voluntary blood transfusion events: The maximum is VND 50,000/blood donor.
Contents,
amount of funding and use thereof are specified in provisions of Clause 2
Article 3 of the Circular No. 182/2009/TT-BTC dated September 14, 2009 by the
Ministry of Finance on guidelines for contents and funding for dissemination of
voluntary blood transfusion.
2. Payment for
on-site food and drink for donors of blood including whole blood and blood
components (both voluntary and professional blood donors): The maximum is: VND
30,000/donor/blood transfusion. Blood banks shall organize the blood transfusion
carefully and publicly to provide blood donors with food and drink before and
after they donor blood.
3. Direct
payment to professional blood donors:
a) For whole
blood donors:
- 250 ml of
blood volume: VND 195,000;
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- 450 ml of
blood volume: VND 430,000;
b) For donors
of separate blood components:
- A blood
product volume from 250 ml to 400 ml: VND 400,000;
- A blood
product volume from 400 ml to 500 ml: VND 600,000;
- A blood
product volume from 500 ml to 650 ml: VND 700,000.
4. Payment to
voluntary blood donors:
a) Payment for
gifts given to voluntary whole blood donors:
- 250 ml of
blood volume: VND 100,000;
- 350 ml of
blood volume: VND 150,000;
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b) Payments
for gifts given to donors of separate blood components (platelet concentrates,
granulocyte concentrates or peripheral blood stem cells, etc.):
- A blood
product volume from 250 ml to 400 ml: VND 150,000;
- A blood
product volume from 400 ml to 500 ml: VND 200,000;
- A blood
product volume from 500 ml to 650 ml: VND 250,000;
c) Payment for
travel costs of voluntary blood donors: Average payment does not exceed VND
50,000/donor/blood transfusion.
5. Cost of
kits for collecting blood, plastic blood bags, materials, stationary,
electricity, water serving tasks related to collecting blood, testing and
screening blood and blood products.
6. Salary paid
in accordance with each grade, position, allowance and contribution as
regulated in state policies; Exclusive allowances as stipulated in the Decision
No. 73/2011/QD-TTg dated December 28, 2011 by the Prime Minister on guidelines
for certain exclusive allowances for officials and employees working public
health facilities and allowances for epidemic fighting.
7. Cost of renting
vehicles and using fuel while collecting blood at mobile blood collection areas
as stated in actual invoices or contracts.
8. Cost of
clinical examination, cost of purchasing materials, chemicals and testing
biological products to perform compulsory tests as prescribed in the Circular
No. 26/2013/TT-BYT.
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10. Cost of
removing unqualified blood units.
11. Payment
for providing consulting services for voluntary blood donors at public health
facilities that are responsible for receiving and screening blood.
12. Other
reasonable and legal costs related to receiving, screening, preparing, storing
and distributing blood and blood products.
Article 5. Implementation
1. Depending
on provisions herein and actual situations of organizations, heads of
organizations shall develop and set particular price of each unit of qualified
whole blood and blood product, price of transporting blood from blood banks to
health facilities and the tests as specified in Points b and c Clause 10
Article 3 herein provided that:
a) Prices do
not exceeding maximum prices stated in Article 3 herein applied to cases in
which the payment is made from the state budget, revenue from medical
examination and treatment as regulated by public health facilities and the
health insurance fund;
b) Prices
ensure covering actual costs reasonably, effectively and in accordance with
market conditions for cases of the payment that are not stated in Point a of
this Clause.
2. In
the cases where a blood bank transports blood to a health facility and tests as
specified in Points b and c Clause 10 Article 3 this Clause shall have price of
transporting blood and price of testing added to each unit price of blood or
blood product to pay the price to a health insurance authority or collect the
price from a patient as regulated and ensure provisions in Clause 1 this
Article.
In an
emergency where a health facility self-collects blood and blood products for
prompt blood transfusion, a social security authority shall cover cost of
transporting blood and blood products with the maximum price of VND
17,000/blood unit (blood product unit). The difference between the cost of
transporting blood collected by the health facility and the payment made by the
social security authority (if any), the health facility shall use its permanent
budgets for covering cost and making financial statements.
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4. Estimate
and financial statements on funding shall be made according to regulations of
the Law on State Budget and Law on Accounting and relevant written guidance.
Article 6. Reference clause
In the cases
where referenced documents stated herein are amended, amended ones shall
prevail.
Article 7. Implementation clauses
1. This Circular
comes into force from June 01, 2017.
2. The
Circular No. 33/2014/TT-BYT dated October 27, 2014 by the Ministry of Health on
maximum prices and costs of price determination of units of qualified whole
blood and blood products shall invalidate from the effective date of this
Circular.
Any issues
arising in the course of implementation shall be reported promptly to the
Ministry of Health.
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