MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No. 05/2017/TT-BYT | Hanoi, April 14, 2017 |
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
Article 1. Scope and regulated entities
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
1. Whole blood units:
No. | Whole blood volume | Net volume | Maximum price (VND) |
1 | 30 ml of whole blood | 35 | 109,000 |
2 | 50 ml of whole blood | 55 | 157,000 |
3 | 100 ml of whole blood | 115 | 290,000 |
4 | 150 ml of whole blood | 170 | 417,000 |
5 | 200 ml of whole blood | 225 | 505,000 |
6 | 250 ml of whole blood | 285 | 641,000 |
7 | 350 ml of whole blood | 395 | 758,000 |
8 | 450 ml of whole blood | 510 | 858,000 |
2. Blood products prepared from red blood cells (RBCs):
No. | RBC volume | Net volume | 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 |
3 | 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 | 145 | 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 |
8 | 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 | Maximum price (VND) |
1 | 30 ml of FFP | 30 | 64,000 |
2 | 50 ml of FFP | 50 | 92,000 |
3 | 100 ml of FFP | 100 | 155,000 |
4 | 150 ml of FFP | 150 | 177,000 |
5 | 200 ml of FFP | 200 | 280,000 |
6 | 250 ml of FFP | 250 | 343,000 |
4. Blood products prepared from frozen plasma:
No. | Frozen plasma volume | Net volume | Maximum price (VND) |
1 | 30 ml of frozen plasma | 30 | 54,000 |
2 | 50 ml of frozen plasma | 50 | 77,000 |
3 | 100 ml of frozen plasma | 100 | 120,000 |
4 | 150 ml of frozen plasma | 150 | 167,000 |
5 | 200 ml of frozen plasma | 200 | 220,000 |
6 | 250 ml of frozen plasma | 250 | 262,000 |
5. Blood products prepared from platelet-rich plasma (PRP)
No. | PRP volume | Net volume | Maximum price (VND) |
1 | 100 ml of platelet-rich plasma separated from 250 ml of whole blood | 100 | 209,000 |
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
No. | Platelet concentrate volume | Net volume | 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) | 80 | 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 |
7. Blood products prepared from cryoprecipitate:
No. | Cryoprecipitate volume | Net volume | Maximum price (VND) |
1 | 10 ml of cryoprecipitate volume (separated from 250 ml of whole blood) | 10 | 78,000 |
2 | 50 ml of cryoprecipitate volume (separated from 1,000 ml of whole blood) | 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 | Net volume | Maximum price (VND) |
1 | Pooled granulocyte concentrate (5x109 BC) | 125 | 339,000 |
2 | Granulocyte pool (10x109 BC) | 250 | 678,000 |
9. Blood products using additional kits and materials:
No. | Blood product volume | Net volume | 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 | Cryoprecipitated antihaemophilic factor inactivating viruses (excluding a virus inactivated kit) | 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 | 924,000 |
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;
dd) Costs of performing blood group test, immunocompetence test, abnormal antibody determination and identification, bed side blood group test and kits for blood units and blood product units to patients.
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;
- 350 ml of blood volume: VND 320,000;
- 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;
- 450 ml of blood volume: VND 180,000;
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.
9. Cost of permanent maintenance of assets and facilities related to receiving, screening and storing blood and blood products.
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.
3. Health facilities shall record the receipt and use of funding for receiving, screening, preparing, storing, transporting and using blood and blood products; declare and post prices as regulated by law.
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.
| PP. MINISTER |
---------------
This document is handled by Vinas Doc. Document reference purposes only. Any comments, please send to email: inf[email protected]