The more than a decade-long wait of the metro blood bank at Aundh District Hospital (ADH) just got longer. Reason being the inspection team has once again found certain lacunae in the blood bank, addressing which is compulsory for the bank to get an operational license. According to the ADH blood bank authorities however, they have completed all compliances this time and will write to the Food and Drug Administration (FDA) next week for permission to start the facility.
All the work of the ADH blood bank involving medical equipment, laboratory and infrastructure has been completed. However, a joint inspection of the blood bank carried out by the FDA, Central Drugs Standard Control Organisation (CDSCO) and blood transfusion officer (BTO) of Sassoon Hospital on February 28, 2023 found 12 lacunae in it due to which permission to start the facility was denied in March this year. The joint inspection found that the blood bank had only one nurse who was also working at the ADH. The inspection also found that the records of medicines and registers were unavailable; refrigeration was sans calibration; the log book for equipment and instruments was lacking; there were no standard operating procedures (SOPs) for blood component preparation; storage cabinets were not connected to the compliance management system; there were leakages in the false ceiling/testing area/rooms; and the air-conditioners were not functioning.
S V Pratapwar, joint commissioner of FDA (drug), said that the ADH blood bank had been asked to complete all compliances after which it would get permission, subject to another inspection. “The main flaw we found was the staff crunch. We are waiting for the ADH blood bank’s response and only after receiving it can we conduct the inspection. All compliances are mandatory without which permission cannot be granted,” Pratapwar said.
{{/usCountry}}S V Pratapwar, joint commissioner of FDA (drug), said that the ADH blood bank had been asked to complete all compliances after which it would get permission, subject to another inspection. “The main flaw we found was the staff crunch. We are waiting for the ADH blood bank’s response and only after receiving it can we conduct the inspection. All compliances are mandatory without which permission cannot be granted,” Pratapwar said.
{{/usCountry}}Whereas Dr Nisha Teli, BTO at the ADH blood bank, said, that they had immediately started working on the shortcomings as soon as they received the FDA report. “The permission has been pending since a while but that’s due to the delay in construction, repairs and procurement of medical equipment and machinery from other government departments. Now, everything has been completed and only minor work on the leakage in the false ceiling is pending which will be completed in a couple of days,” Dr Teli said.
Dr Nagnath Yempalay, civil surgeon of Pune district and head of the ADH, informed that they have submitted a letter to the public works department (PWD) for repairs on Tuesday and hopefully, the work will be completed in a couple of days. “The National Health Mission (NHM) team will provide the staff required at the ADH blood bank. Already, we have the required technicians and technical staff. Almost all the compliances have been completed and we will definitely get approval in a couple of weeks,” Dr Yempalay said.
In January 2012, the state government had decided to start 10 metro blood banks in Maharashtra. Accordingly, the State Blood Transfusion Council (SBTC) had completed the modalities of setting up the metro blood banks in 10 districts including Pune, Thane, Ahmednagar, Nashik, Amravati, Nagpur, Parbhani, Satara, Chandrapur and Jalgaon. While the metro blood banks in seven districts had got the necessary approvals, those in Pune and two other districts were still to get approvals. Once the ADH blood bank gets approval, it will be able to provide concentrated human red blood corpuscles, platelets, single donor platelets, fresh frozen plasma and Cryoprecipitated Antihemophilic factors for patients across the district.