Jalandhar : Three HIV positive blood units were issued from the blood bank functioning from the premises of the Civil Hospital here. The state Department of Drugs Control observed that the “poor quality” blood of the bank was “unsafe for transfusion” and put patients’ lives at risk. The observations were made in an inspection report on the basis of which a formal show- cause notice was issued to the blood bank on August 24.
The blood bank was directed to immediately stop its operations till the deficiencies were removed. The facility was also directed to transfer the entire stock of tested and stored blood/blood components to other licensed blood banks. After receiving a notice, the blood bank stopped operations from August 26 onwards.
What notice states
- Total 17 discrepancies have been listed at the blood bank.
- The blood bank issued HIV +ve blood units bearing No. 2120, 2207 and 2204
- The bank has no policy for discard of blood units which fall under grey zone in TTI testing
- Various expired reagent/kits were kept in serology lab
- Various reagents i.e. Anti A , Anti B and Anti-D monoclonal anti-bodies were kept in uncontrolled storage condition
- The bank did not produce QC test report of whole human blood IP, packed red blood cells IP, platelet concentrate USP, fresh frozen plasma BP and cryoprecipitate USP.
- The bank did not produce the QC test report of reagent/kits.
- Donor medical form was not in-line with the Drugs and Cosmetics Act 1940.
- Forms of some donors were not filled properly by Blood Transfusion Officer
- Teflon tape and whitener was used at certain places in donor registers
- Register was not completely filled by technician/Blood Transfusion Officer and was not in line with NACO guidelines
- It was found that there was no permanent Blood Transfusion Officer at the bank
The notice served by Amit Duggal, Assistant Commissioner, Food and Drugs Administration, Punjab, stated, “Your blood bank is indulging in collection and supply of poor quality blood which is dangerous and unsafe for transfusion to patients/recipients and puts their life at risk. As such, it is against the patient’s safety compliance.”
Discrepancies came to the fore when the blood bank was inspected by Arvind Singh Panwar, Drug Inspector, Central Drug Standard Control Organisation, Baddi, and Ravi Gupta, Drugs Control Officer, Kapurthala, on August 1 for the renewal of its licence.
The notice stated why should the blood bank’s licence No. 1708-B not be suspended/cancelled on account of violations of the Drugs and Cosmetics Rules 1945?
Abhinav Trikha, Commissioner, Food and Drugs Administration, Punjab, said, “We are the regulating and not the implementing authority for blood banks. Any further action would be initiated by the Director, Health.”
Dr Adarsh Pal Kaur, Director, Health and Family Welfare, said, “Blood banks are under the Punjab State AIDS Control Society. So, they might be in a better position to tell. However, we will conduct an inquiry into the issue. As far as FIR is concerned, that can only be filed if the inquiry finds that the blood bank staff is erring.”
Bobby Gulati, Assistant Director, Punjab State AIDS Control Society, said, “The blood was found HIV non-reactive on being tested. The patients, who were given blood, have been found HIV negative. So, action can only be taken if they turn HIV positive.”
Gulati said, “Notably, HIV symptoms appear two to six weeks after exposure. In some patients, it may take months to years for symptoms to appear.”
Vinit Puri, general secretary, Hindustan Welfare Blood Donors Club, who runs an NGO, donated 1,157 units of blood to the bank from 2022 to 2023. He said, “The glaring discrepancies raise concern on all blood units in use at the bank. Requisite action should be taken against culprits who issued HIV +ve blood units. The patients who received such units should be traced. The authorities should conduct an inquiry into the matter.”
Notably, the Phagwara blood bank has not been new to controversy. The blood bank was closed in 2020 after HCV positive blood was issued to a 85-year-old woman and mismatched blood was given to a 19-year-old recipient.
A copy of the show-cause certificate issued by the Drug Department has also been marked to the Principal Secretary, Health and Family Welfare; Commissioner Food and Drugs Administration, Punjab, Drugs Controller General (India); Director, Health and Family Welfare, Punjab; Deputy Drugs Controller (India); Additional Project Director, Punjab State AIDS Control Society; Civil Surgeon, Kapurthala; Zonal Licensing Authority (Drugs), Jalandhar, and Drugs Control Officer, Kapurthala.
