SOP for Assam Plasma Bank:
MoHFW, GOI clinical guideline on 27th June'20, approved convalescent Plasma therapy under investigational therapy.
- Convalescent plasma (Off Label) may be considered in patients with moderate disease who are not improving (oxygen requirement is progressively increasing) despite use of steroids.
The Government of Assam has released clinical management protocol on 2nd July'20, considering Convalescent plasma therapy as one of the therapy options, with reference from MoHFW guideline.
The Plasma transfusion from the Plasma bank shall be done only in the Medical Colleges of Assam and other government Covid Hospitals with prior approval considering the available facility and sentiment of donors supporting the treatment of general populace of the state of Assam.
Operations of Plasma Bank – All the norms and regulations of transfusion medicine will be followed for operationalization of the Plasma Bank.
- A plasma bank to treat complicated cases of COVID-19 functioning at Medical Colleges of Assam.
- The HOD of Blood Bank of the respective Medical College shall be responsible for the management of Plasma extraction, measurement of titres, storing the plasma in the required temperature as per protocol.
- The Convalescent plasma should bear special labelling as an investigational product for the treatment of COVID-19.
- The Institutional Medical Board for COVID-19 management in the Medical College,which includes HOD General Medicine/Pulmonary Medicine, ICU in-charge and other faculties involved in COVID-19 management,shall be responsible for decision on providing Convalescent Plasma Therapy (CPT) for a particular patient.
- The Medical board shall be responsible for obtaining and maintaining relevant documentation/ ethics committee approval etc, as this is an investigational therapy.
- The Adverse Drug Reaction (ADR) Monitoring Board of the respective medical college to oversee the drug reactions as per Pharmacovigilance guidelines.
- Donor Selection
- All laboratory confirmed(RAT/RT PCR) COVID-19 patients can donate their plasma 28 days after complete resolution of the symptoms, provided:-
- Informed consent is available.
- The patient should be more than 18 years of age.
- Only males & nulliparous female donors of weight >55Kg will be included.
- Once the donor comes to the blood bank for plasma donation, one RAT will be done and if negative and RT PCR sample will be collected and sent for testing. The plasma will be collected without waiting for the RTPCR results. However, such plasma collected will be labelled and kept separately and depending up on the RTPCR result only, shall be accepted. In case of positive RTPCR, the collected plasma will be discarded immediately following disposal protocols.
- Other criteria for blood donation to be ensured as per the clinical Management SOP from Govt. of Assam released on 2nd July'2020.