Private blood bank at Cooper Hospital among 3 suspended by FDA till Nov 7 over safety lapses | Mumbai News


Private blood bank at Cooper Hospital among 3 suspended by FDA till Nov 7 over safety lapses

Mumbai: Three blood banks will remain suspended till Nov 7, after inspections by the Food and Drug Administration (FDA) found discrepancies and violations such as unauthorised supply of blood, improper storage, lack of disinfection measures and improper documentation. This also includes a public-private partnership (PPP) blood bank at Cooper Hospital which was suspended for five days initially and a three-day reduction was provided after an appeal.Cooper Hospital blood bank is run by Samarprit Bahuddeshiya Sevabhavi Vikas Sanstha and the services were suspended throughout Thursday and will remain suspended on Friday with permission to resume on Sunday. Hospital authorities said for the next three days, they will be relying on the blood bank at Trauma Hospital in Jogeshwari.FDA officials said the notice was served on them 90 days prior. The contraventions at the PPP blood bank were largely document-related: “…multiple forms were incomplete, as the complete residential and communication addresses of the donors were not recorded.”However, more serious violations were found in private blood banks at Ghatkopar (East): Deepak Foundation’s Anviksha Blood Centre and Samarpan Blood Centre. The inspections at all the three blood banks were held in August, with prior intimation of suspension dates. Both of these blood banks were suspended for 11 days from Oct 28 to Nov 3.A review of internal documents shows that at Samarpan Blood Bank, “blood was supplied to Surya Hospital’s blood storage centre without an agreement or licensing authority approval.”Additionally, fresh frozen plasma units were found partly thawed in the deep freezers and only one to two platelet bags out of 500-600 a month were sterility tested, against the required 1%. The document also noted that the single-donor plateletpheresis (SDP) consent form did not explain the risks of apheresis, and donors were not screened for anticoagulant or antiplatelet drugs other than aspirin.Apheresis is a medical procedure where a machine draws blood and separates out a specific part it needs (like platelets or plasma) and pumps the rest back into the body.At Anviksha Blood Centre, opened blood bag foil packs were not resealed and the opening date was not marked. “Sterility testing of empty blood bags used a 5-day incubation instead of the required 14 days,” the document noted.Moreover, positive blood bags were not disinfected with hypochlorite. Both the blood banks are in close proximity to BMC-run Rajawadi Hospital. Hospital officials told TOI that it is possible that in the event of a shortage at their own blood bank, patients may have taken blood from these two but clarified that no adverse event has been recorded so far.



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