Establishment & Utility of Blood Storage Facility: A Secondary Care Center Experience

Global Journal of Pathology & Laboratory Medicine
Volume 1, Issue 6, July, Pages: 5-14

Received: June 08, 2022, Reviewed: June 15, 2022, Accepted: June 30, 2022, Published: August 3, 2022

Unified Citation Journals, Pathology 2022, 1(6) 5-14; https://doi.org/10.52402/Pathology214
ISSN 2754-0952

Author: Dr. Pooja Jain¹, Dr. Shalini Trivedi¹, Dr. Rohit Kumar², Dr. Udita Singhal¹, Dr. Uma Kumar³

¹ Department of Pathology, E.S.I Hospital & dental college, Rohini, Delhi.
² Department of Biochemistry, Safdarjung Hospital, New Delhi.
^3. Department of Pathology, Janakpuri Superspeciality Hospital, New Delhi.

ABSTRACT
National Blood Policy 2002, GOI states the objective to provide a safe, adequate quantity of blood, and blood components. Blood transfusion services may be broadly categorized as, either Hospital based/Stand-alone blood banks or Blood storage centres. Secondary care, 300 bedded hospital had no facility of Blood transfusion Services Till 2009. On persuasion, the decision of starting a Blood Storage facility was taken as the hospital was consuming less than 2000 units of blood & its components annually. The nearest tertiary care hospital of the same organisation was decided as mother Blood Bank, hence in charge of the tertiary care hospital Blood Bank was contacted to be our Mother Blood Bank, MoU was signed between the two. As per,” Guidelines for Setting up Blood Storage Centres “by NACO, all the Space, Human resource, material resources criteria were fulfilled, application for license was submitted to State Food Drug Controller Office. This study aims to provide essential background knowledge regarding establishment, day to day functioning & utility of Blood Storage Facility at secondary care centre in India.

KEYWORDS: Blood Storage Facility, First Referral Unit, NACO Guidelines, National Blood Policy, Schedule K of Drugs & Cosmetics Act, State Licensing Authority.

INTRODUCTION
Blood Transfusion Service is a vital part of the Health System and there is no substitute for Human Blood and its components. (1) The provision of safe and adequate blood and blood products at the national level is the responsibility of each country’s government/national health authority. (2)
There has been a significant improvement in the health status of the Indian population, however, maternal mortality due to causes related to pregnancy and childbirth continues to be high. According to the estimates of the Registrar General of India, the Maternal mortality Ratio in 1998 was 407 per 100,000 population. The National Population Policy 2000, has charged us with the responsibility of bringing it down to 100 by the year 2010.7 Blood safety is essential to ensure that a patient who comes for treatment will not become sick from another illness.  Blood products should be safe, clinically effective, and of appropriate quality. Also, increasing advancement in the field of Transfusion Technology has necessitated enforcing stricter control over the quality of Blood and its products. (7)
“Blood Storage Center” refers to a division of a hospital laboratory where the storage of blood products occurs and where proper testing is performed to reduce the risk of transfusion-related events. The blood storage unit is part of FRU and is the backbone of Obstetric care in the country. The blood bag must be handled with care and treated thoroughly as it is related to someone’s life. The development of a Web-based Blood Bank Management System (BBMS) is proposed to provide the country with management functions of the blood bank & blood storage center to handle the blood bag.
To establish the Blood Storage Centres, it is essential to train the medical officers and technicians working in these FRUs in the various methods of handling blood including storage, blood grouping, cross-matching, transfusion, and adverse reactions. (7)
The Department of Family Welfare is now initiating the setting up of a Blood Storage Centres at the First Referral Units (FRUs) to make blood readily available, especially at the time of emergency. This service would be available to the women during and after childbirth and is expected to bring down Maternal mortality.
It is estimated that about one-third of all maternal deaths are due to hemorrhage, both antepartum and postpartum (SRS-1998). The National Family Health Survey 1998- 99 has brought out that almost half of the pregnant women are moderate to severely anemic. The presence of anemia in a pregnant woman who develops a hemorrhage increases the chances of her dying, manifold. Timely transfusion of blood is thus an important intervention that can save the lives of many such women if an adequate supply of blood is available at the first referral unit level. If it is used appropriately, many women who would otherwise die can be saved.
Non-availability of blood storage/transfusion facilities at the first referral units has been a major constraint in the provision of emergency obstetric care services. The Drug and Cosmetics Act has recently been amended to set up blood storage facilities at the FRUs / CHCs / PHCs. The main aim of this notification is to make abundant availability of whole human blood or its components to the said hospitals without taking license. However, this exemption applies to those centers, which are transfusing blood and/or its components less than 2000 units per annum.
The benefits attached to blood transfusion should be weighed against the risks involved with the transfusion of blood. Since blood cannot be sterilized, there is the possibility of transmitting any agent present in red cells or plasma which has not been detected by routine screening tests for transfusion-transmissible infections, including HIV, Hepatitis B, C, and other Hepatitis viruses, Syphilis, and Malaria, etc.
However, there is no substitute as yet developed which has all the properties of blood. Though, replacement fluids, plasma protein solutions, and hemoglobin substitutes are being used in place of blood components in special conditions.

REVIEW OF LITERATURE
Functionally, blood transfusion services may be broadly categorized as,

• Hospital-based blood bank
• Stand-alone blood bank
• Blood storage centers. (4)

The blood safety program in India aims to make available safe and quality blood within one hour of requirement in a health facility. (5) In India, access to safe blood is mandated by law and it is the primary responsibility of the government (WHO, 2002). (4,5) The availability and accessibility of safe blood and blood products are vital for the prevention of HIV infection and to the achievement of the health-related Millennium Development Goals to reduce child mortality, improve maternal health, and combat HIV and other infections. (6) However, access to safe and effective blood products is a major challenge in low and middle-income countries like India due to various reasons such as lack of basic facilities and systems, quality, and safety standards that need to be established, executed & strengthened, and insufficient supply.
The development of a Web-based Blood Bank Management System (BBMS) is proposed to provide management functions to the blood bank & blood storage center to handle the blood bag. Blood Bank Management System (BBMS) is a web-based system that provides information on blood bags and their transfusion services in the country. With this system, the information regarding the result of the blood test that has been conducted on each of the blood bags and whether the blood bag can be delivered to the patient or not can be maintained.
The process of managing the blood bag that is received from the mother’s blood bank blood needs proper and systematic management. The blood bag must be handled with care and treated thoroughly as it is related to someone’s life.

NATIONAL BLOOD POLICY
The government of India published in the year 2002 the National Blood Policy. The objective of the policy is to provide a safe, adequate quantity of blood, blood components, and products. The policy also addresses various issues about technical personnel, research, and development and eliminates profiteering by the blood banks by selling blood. (1)

BLOOD STORAGE CENTERS (BSC)
Ministry of Health & Family Welfare (Department of Health) vide Notification No. GSR 909(E) dated 20th December 2001 exempted blood storage Centres run by FRU, Community Health Centre, PHC, or any hospital from the purview of obtaining a license for operation. This notification has been inserted under Schedule K of Drugs & Cosmetics Rules, 1945 under serial no. 5B. The main aim of this notification is to make abundant availability of However, this exemption applies to those Centres which are transfusing blood and/or its components less than 2000 units per annum. To ensure the safety and quality of blood and/or its components to be stored in such blood storage centers, the notification lays down some conditions which have to be met before getting exemption from the purview of taking a license from the respective State Drugs Controllers. The details of the notification and guidelines issued in this regard by the Ministry of Health and Family Welfare are in Annexure I. (7)
According to the FRU guidelines, the blood-storage facility is one of the three critical determinants as First Referral Units (FRUs) have been identified to deliver Emergency services. (8)
An inspection of the proposed Blood Storage Centre should be carried out by the respective State Drug Control Department to satisfy the conditions and facilities. The State Licensing Authority should forward the approved Blood Storage Centres to the concerned Zonal Officer.
The Blood Bank should label the blood units/components as per the Drugs & Cosmetics Rules, 1945. The Blood banks that intend to supply the blood units/components should perform the mandatory tests before supplying them to Blood Storage Centres. The label of the tested blood unit should contain the test particulars with the date of testing before supplying to Blood Storage Centres.
A Standard Operating Procedure Manual (SOPM) should be developed as a part of the guidelines to facilitate the training of medical officers and technicians from identified FRUs, which would act as Blood Storage Centres (BSCs).
A formal training program of 3 days duration is envisaged for one medical officer and one laboratory technician from each of the identified FRUs where blood storage centers are to be set up. It is however considered essential, that the medical officers and also the clinicians who handle obstetric emergencies are sensitized to the important issues related to various aspects of transfusion of blood and blood products.
Two systems have been selected as the benchmark for the development of the Blood Storage center in ESIC Hospital, Rohini. They are the Blood Bank at ESIC Basaidarapur Hospital and a BBMS standalone version. whole human blood or its components to the said hospitals without taking a license.

AIMS & OBJECTIVE
This project aims to provide essential background knowledge regarding the utility and day-to-day functioning of a Blood Storage facility at a secondary care center in New Delhi, India.

RESEARCH METHODOLOGY
Establishment of Blood Storage Facility: A Secondary care center experience

• A 300 bedded secondary care hospital with a super specialty referral facility.
• Hospital had a fully functional obstetric Unit, Operation theatres, Nursery and ICU
• Lacunae recognised by administration for not having Blood transfusion services in a hospital
• Hospital requirement is less than 2000 blood units per annum
• Decision for establishment of BSC for Blood transfusion services taken by administration (MS), under guidance of Headquarters.
• The Blood Storage facility was started under the department of Pathology with specialists initiating & overseeing the work.
• MoU was signed between tertiary care Hospital Blood Bank and Medical Superintendent, Secondary care Hospital.,
• A tertiary care Hospital Blood Bank designated as Mother Blood Bank for our blood storage facility.
• NACO 2007, MoHFW, Government of India, New Delhi, guidelines is followed to fulfill all the space, Human resource, and material resources criteria.
• As per Annexure 1, an application for approval of the BSC was applied to State Drug Controller Authority, along with a Site plan, List of staff with necessary certificates relating to education, experience, and training in Blood Banking.
• After submission of the application, the State Drug Controller inspectors inspected the proposed site and facilities for all the requirements.
• Few non-conformities were pointed out by the Drug Controller team, within two months, corrections were made and a repeat application was submitted.
• On repeat inspection by the Drug Controller team, the approval was sent to Zonal Officer vide the format and directly the approval was received by post in our hospital.

DATA ANALYSIS AND INTERPRETATION
The blood bank storage center was equipped for the issue of Whole blood, packed red cell concentrate & performing Blood Grouping, DCT & ICT. The equipment was installed within warranty, or AMC and CMC as mentioned in Guidelines for establishing Blood Storage Centers, NACO, MOHFW, 2007. The below table-1 shows the utility of the Blood Storage facility in a Secondary care centre, Rohini, New Delhi from 2017 to 2021

TABLE-1: STATISTIC OF BLOOD STORAGE FACILITY FROM 2017 TO 2021

DISCUSSION
The Hospital/Organization under which the Blood Storage Centre is functioning will be legally identifiable. The Blood Storage Center (BSC) had valid approval from the State/ Union territory licensing authority under Drug and Cosmetic Rules 1945 (Schedule- K) with further amendments.
The blood bank with which the BSC is attached should have a valid license from Central Drugs Standard Control Organization (CDSCO) and approved by Drug Controller General (India), Central Licensing approving authority under Drug and Cosmetic Rules 1945 with further amendments.
Licensing/Approval of blood storage and transfusion facilities
To procure licensing/ approval, an application should be made as per the guidelines enclosed in Annexure I. The First Referral Unit, Community Health Centre, Primary Health Centre, and/or any Hospital should be approved by the State / Union Territory Licensing Authority after satisfying the conditions and facilities through inspection.
The applicant has to furnish an undertaking to the licensing authority that the captive consumption of Whole Human Blood or Components shall not be more than 2000 units annually. (Extract from notification No x11014/3/2001 DMS&PFA). (7)
The applicant should furnish the name of the medical officer responsible for conducting the operation of the blood storage center with attested certified copies of MBBS or MD qualification, name, certified copies of qualification, and experience of the blood bank technician. (7,9) The applicant should enclose a list of equipment needed for storage viz blood bank refrigerator etc and also a site plan. (7)
The applicant has to furnish the source of procurement of Whole Human Blood / Blood Components namely the name and address of the Blood Banks. These should be licensed blood banks run by Government Hospitals/Indian Red Cross/Regional Blood Transfusion Centres only. (7,9)
Even in the case of FRUs/ CHCs/ PHCs before applying for the approval, the storage center has to identify and obtain consent vide MOU (Memorandum of Understanding) from the blood bank, from which they will get the supply of blood/blood components. MOU of Blood Storage center, with parent blood bank, should clearly define the responsibility of mother blood bank and BSC.
The approval should be valid for two years from the date of issue unless sooner suspended or canceled, and First Referral Unit, Community Health Centre, Primary Health Centre, or the Hospital should all apply for renewal to the State Licensing Authority three months before the date of expiry of the approval. (7,9)
In case the license of the parent blood bank/center is canceled, the license of the storage center is also automatically canceled.  The storage centers, can, however, get affiliated with more than one blood bank/center to ensure uninterrupted supplies, but a separate approval is required in each case, it can be up to three blood banks.

CONCLUSION
The Blood Storage facility (BSC) is a management system that is developed to manage the supply of blood during Routine & emergency services in secondary care hospitals. The blood storage facility had been developed in the secondary care center with user requirements. This is to make sure that the management of the bloodstock became effective, systematic, and meets user requirements. The functional services provided in the current version are profile management, bloodstock management, and blood analysis management. According to Facility Survey 2007-08, though 52% of Community Health Centres (CHC) were designated as FRUs, only 9.1% had blood storage facilities (IIPS, 2010). (4,13)
As per the Concurrent Evaluation of the National Rural Health Mission (NRHM) in 2009, only 14% of the CHCs were having blood storage facilities, and 74.1% of the District Hospitals have Blood Bank/ Blood storage units (GOI, 2013). (4,14) which indicated the huge gap in making blood accessible to the rural population.
The NACP phase III aimed to establish blood storage centers in 3222 CHCs with the equipment grant by RCH-II & annual recurrent grant by DAC and make available refrigerated vans in 500 districts for networking with blood storage centers (NACO, 2007g). (4,15)
But, there are only 745 blood storage centers functioning across the country (NACO, 2013). (4,16) Though the creation of blood storage centers in sub-district level and first referral units has resulted in better access to blood than previously, these are still not available to all due to licensing and regulations as these blood storage centers are not authorized to supply blood to other facilities. (4) It is estimated that if FRUs were equipped with the proper blood supply, they could reduce maternal mortality by 30%. (4,17)

REFERENCES:
[1] Regulatory Requirements of Blood and/ or its components including Blood Products. 2. Study of Blood transfusion services in Maharashtra, Gujarat States in India. K.V. Ramani, Dileep V. Mavalankar, and Dipti Govil. Journal for Health Population Nutrition 2009 Apr;27(02),259-270.
[2] Study of Blood transfusion services in Maharashtra, Gujarat States in India. K.V. Ramani, Dileep V. Mavalankar, and Dipti Govil. Journal for Health Population Nutrition 2009 Apr;27(02),259-270.
[3] Hemogenomics. Blood safety. 2007 Apr;17(01) Rapid Situation Assessment of Blood Transfusion Services in India,2014
[4] NACO, Ministry of Health & Family Welfare of India in collaboration with U.S Centres for Disease Control and Prevention (HHS/CDC/CGH) Division of Global HIV/AIDS, India and Christian Medical Association of India (CMAI), 10, 22,27. 5. WHO. (2002). Blood Safety, Aid Memoire for National Blood program. Geneva: World Health Organization.
[5] WHO. Universal Access to Safe Blood Transfusion WHO Global Strategic Plan 2008,15. Geneva: World Health Organization.2008
[6] Guidelines for Setting up Blood Storage Centres “by NACO, Ministry of Health and Family Welfare Government of India, New Delhi, 2007. 6-22.
[7] GOI. Guidelines for operationalizing first referral units. New Delhi: Maternal Health Division, Department of Family Welfare, Ministry of Health and Family Welfare, Government of India. 2004
[8] Design guidelines for Blood Centres, WHO, Western Pacific Region,2010. 5,9
[9] Trivedi S, Kumar R, Yadav S, Suri M. Establishment of the blood storage facility at secondary care hospital: Esic Experience and Review of literature. Int J Med Lab Res 2018, 3(3):29-36
[10] Report of Expert Working Group Set up under Chairpersonship of Special Director General Health Services, Review & Recommendations; Manpower Norms for Blood Banks. 6,7.
[11] GOI. Report of the Working Group on National Rural Health Mission (NRHM) for the Twelfth Five Year Plan (2012-2017). New Delhi: Planning Commission, Government of India. 2011
[12] IIPS. District Level Household and Facility Survey 2007-08. Mumbai: International Institute for Population Sciences and Ministry of Health and Family Welfare, Government of India. 2010
[13] GOI. Health and Family Welfare Statistics in India-2013. New Delhi: Statistics Division, Ministry of Health and Family Welfare, Government of India.
[14] NACO. (2007g). Project Implementation Plan for National AIDS Control Programme, Phase-III (2007-12). New Delhi: Department of AIDS Control, Ministry of Health and Family Welfare, Government of India.2013
[15] NACO. Annual Report 2012-13 New Delhi: Department of AIDS Control, Ministry of Health & Family Welfare, Government of India.2013
[16] HINDU, T. (2007). Blood storage centers to reduce maternal mortality. 2007

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To citation of this article: Dr. Pooja Jain¹, Dr. Shalini Trivedi¹, Dr. Rohit Kumar², Dr. Udita Singhal¹, Dr. Uma Kumar³

¹ Department of Pathology, E.S.I Hospital & dental college, Rohini, Delhi.
² Department of Biochemistry, Safdarjung Hospital, New Delhi.
^3. Department of Pathology, Janakpuri Superspeciality Hospital, New Delhi.

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