MEMORANDUM OF AGREEMENT

THIS IS A TECHNICAL AGREEMENT FOR THE PROVISION OF BLOOD COMPONENTS TO

BILASA BLOOD BANK AND PRANAAM ENT AND EYE CARE

This agreement made at Raipur Dt-8-05-2019

Between

Pranaam Ent And Eye Care

B-10, New Rajendra Nagar Main Road, Raipur (C.G.)

And

BILASA BLOOD BANK

Near Arogya Hospital,Shankar nagar,Raipur (C.G.)
 AGREEMENT FOR PROVSION OF BLOOD COMPONENTS BY BILASA BLOOD BANK
TO PRANAAM ENT AND EYE CARE

1. Duration

From 8-05-2019 until terminated by either party (agreement to be reviewed annually)

2. Service objectives

The objective of this Agreement is to secure for Blood Bank the provision of Blood Components and
related services to a level satisfies the requirements of the blood safety and Quality Regulations 2005.

3. Service to be coverd

The main elements of the service to be covered by this agreement are

 Provision of blood components for emergency stock.

 Provision of compatible red cells for named patients.
 Provision of blood components for storage as required

The supplying blood bank will supply blood and blood components ( and related services) in compliance
with the Blood Safety and Quality Regulation 2005 No.50 (SI 2005/50) as amended (the Regulation . It is
recognized that the requirements of the Regulations are to be met by the supplying and receiving
facilities and me be subject to inspection by the MHRA to assess compliance with the Regulations. For
Reference the man applicable section are .

Section 9 Blood Bank requirements ;

Section 10 Requirements for Blood Bank’s to provide information to the secretary of State.
Section 11 Service of notices relating to hospital Blood Banks.
Section 12 Objections to suspensions, revocations etc.
Section 14 Disclosure of information by Blood establishments and hospital Blood Banks inspections,
etc.

4. Location

The Blood Banking services are provided from the Pranaam Ent And Eye Care
site, Through the directorate of Laboratory Medicine at Raipur. The blood bank operates in compliance
with the Blod safety and Quality Regulations 2005.

5. Quality Management Specification

the Supplier undertakes to ensure that all blood components supplied will be accompanied by
appropriate documentation and will be transported in a validated manner which ensure that the supplied
components remain with in specification throughout the transport period and until they are transferred
to controlled temperature storage.
The supplying and receiving hospitals will adhere to the quality system for Blood Banks as required by the
blood safety and quality regulations 2005. Where relevant, the following particulars will apply ;
  There are standard operating procedures for the storage, distribution and transport of blood and
blood components with in the supplying and receiving hospitals.

 Blood components will be issued and transported in accordance with the Regional/National transfer
Policy.

 A fully documented procedure exits covering responsibilities and actions to be taken by each single
hospital in the event of a recall of blood components.

 ‘Cold chain” procedures, supported by documentary evidence, ensure specify temperature and
storage condition are satisfactorily maintained at all times. Unused blood will only be accepted on
return to be supplier if there is documented evidence that the cold chain procedure and the
Regional/National Transfer Policy have been strictly adhered to.

 There are standard operating procedures for the reporting of serious adverse events and reaction
relating to the transfusion of blood components within the supplying and receiving Hospitals.

 Staff receive appropriate and regularly updated training in all of the above activities and appropriate
records of this training are kept.

6. Traceability

It is essential that there is complete traceability for all units transferred.

Full records will be maintained of the distribution of all components from the supplier to the
receiving hospital and there will be a documented process in place to confirm the member of staff who
received the supplied components and when they were received.
The originating BILASA blood bank will be responsible for full final traceability of units transferred to
PRANAAM ENT AND EYE CARE . At the time of transfer the originating hospital will records that the units
have been transferred. For blood components that have been transfused, For, PRANAAM ENT AND EYE
CARE will be responsible for recording the final fate of the units in the patient’s notes and transferring
the information back to the originating BILASA BLOOD BANK for final documentation within the
transfusion laboratory computer system. For blood components that have not been transfused,
PRANAAM ENT AND EYE CARE will be responsible for recording the final fate of the components,
including the reason they were not used and transferring the information back to the originating Bilasa
Blood Bank for final documentation with in the transfusion laboratory computer system and notification
of the blood service. Irrespective of whether the blood was transfused or discarded, the receiving
hospital must return the traceability Documents/label to the originating hospital.

If the transferred units bypass the receiving laboratory, e.g. in an emergency situation, then both
hospital should work together to ascertain the final fate of the units.
7. Transport

BILASA BLOOD BANK will be responsible for providing transport required for all products and will be
responsible for all units in transit until their arrival at the receiving hospital has been documented

Commission directive 2005/61/EC regarding traceability requirements and notification of serious adverse reaction
and events has a dead line transposition in to national legislation of 31 August 2006. It introduces requirements for
traceability and the reporting of serious adverse events and reaction by “ Reporting establishments “ . Reporting
establishments are defined in the directive as: blood establishments and hospital blood banks and “ facilities “ such
as hospitals , clinics, manufacturers and biomedical research institutions to which blood or blood components may
be delivered. There fore, it will be necessary for both parties to an agreement such as this to review their
arrangements for compliance when the amended regulation come in to force.

8. Mandatory Haemovigilance Reporting

There are standard operating procedures for the notification of serious adverse events and reaction that
satisfy the requirements of the blood safety and quality regulations 2005 at both supplying and receiving
hospitals and this are supported by appropriate training records all Serious Adverse Reaction and Serious
Adverse Events as detailed by the MHRA in there guidance on reporting to SABRE will be notified by the
recipient hospital to the blood bank Manager ( Or Nominated deputy) at the supplying hospital
immediately. These will be investigated by both parties and the necessary reports made to SABRE by the
blood bank Manager of the supplying hospital ( or nominated deputy) on behalf of both parties.

Adverse reactions / events which could have been due to faulty components must also be reposted to
SNBTS as soon as possible.

9. Charging

There are charging arrangements these can be appended to this document.

10. Compliance

The supplying Blood Bank will wish to assure themselves that the procedure and practices within the
receiving hospital satisfy the requirements of this agreement.

11. Remedies for non-performance

In the event of either party not performing according to the agreed terms of this technical Agreement,the
following procedures will apply:-

 Where one party considers that the other party has failed to meet its obligations, that party will
instigate a meeting with the other within four weeks.
 Following the meeting, the party which has not performs adequately will be given four weeks to
resolve issue, to the satisfaction of the other party. There will be joint discussion between both
parties to reach a mutually acceptable out come.
 Where non-performance has not been rectified with in the agreed timescale, the non-performance
can be taken through identified performance management arrangements .
The local hospital transfusion committee will be informed and the chair of that committee will ensure
the issue is resolved in an acceptable timescale. Where this is not achieved the HTC chair will notify
the clinical governance committee and escalate the matter as appropriate.

Appendices

Charges if applicable
Regional/National Blood component transfer policy
SOP for recall of components

For, Pranaam Ent And Eye Care For, BILASA BLOOD BANK

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PROPRIETOR Authorised Signatory