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Bhilai, Jul 24: The Blood Bank of Jawahar Lal Nehru Hospital and Research Centre, Sector 9 is yet to ensure compliance of provisions of Drugs and Cosmetics Act, 1940 and the rules made there under as well as other guidelines issued by CDSCO and Health Secretary of CG Govt. This revelation was made in the report submitted by CDSCO at High Court of Chhattisgarh after conducting investigation on July 11. The hospital and BSP authorities failed to submit their reply before the court on the day of hearing. The court has given them some more time and instructed them to submit their reply by August 03, 2018. On the other hand, the victim father has alleged that the CDSCO probe was incomplete as the inspection was carried out only at the Blood Bank. The victim father has demanded elaborate investigations over the matter.
The Central Drugs Standard Control Organisation (West Zone), Mumbai has submitted the report before High Court of Chhattisgarh regarding joint inspection carried out at the Blood Bank of Jawahar Lal Nehru Hospital and Research Centre, Bhilai to check the compliance of Drugs and Cosmetics Act 1940 and the rules made there under. The joint inspection was conducted by Brijraj Singh, Mrs Gayatri (Drug Inspectors of Food and Drugs Administration, Durg – Bhilai); Baljeet Singh (Drug Inspector of CDSCO) and subject expert Dr Sankalp Sharma on July 11, 2018. The team inspected whether the provisions of Drugs and Cosmetics Act, 1940 and the rules made there under and other relevant rules are being followed by JLNH in compliance with the orders issued by CDSCO on March 19, 2017 and orders of Appellate Authority (Secretary, Health, CG Govt) issued on May 23, 2018.
The inspection team found that there was need to modify the Standard Operating Procedures (SOPs) according to changes made in routine testing, documents and records control. The team found that the JLNH Blood Bank was having record of ELISA testing of the collected blood bags / units but the bag number was not mentioned in the ELISA test report and TTI Test Register.
The team further found that the blood bank was not having the day-wise record (viz manufacturer, lot no, mfg, date of expiry, etc) of empty blood bags used for collection of while blood. On directions of the authorities, the blood bank had started maintaining the foresaid record but on the day of inspection the probe team found that some opened bags were lying on the registration counter while some others were placed in the examination room, whole blood areas, components area and store room as well. There were no records of purchase, use and stock of needles and syringes which is contravention of schedule.
In the previous investigations, it was found that the donor consent form for certain bags (3463, 3568, 3736 and 3907) were not approved by the medical officer of the blood bank for purpose of declaring donor fit for donation of blood. This violation was admitted by the blood bank. The investigation held on July 11, 2018 found that all donor consent form are being prepared in accordance to NACO Guidelines however the Form needs to be modified. Name and signature of medical officer and counselor as well as donor screening questionnaire should be included in the Form.
The blood bank had earlier admitted that the Donor Consent Form No 2538 was incompletely filled and Form Number 0631 was not verified by the medical officer. Investigating this fact, the investigation team found that the Donor Consent Form has been revised as per NACO Guidelines but still needs modification. The Point âfâ on page number 06 needs to be modified to bring uniformity between English and Hindi versions and it should also be signed by Medical Officer and Counselor. The team further found that the voluntary and replacement donor information has not been provided in Donor Screening Questionnaire. The team found that the JLNH Blood Bank is still taking replacement donor however efforts are taken to encourage voluntary donation.
The investigation team found that the Standard Operating Procedure (SOP) for the pooled cell for Blood Grouping and Cross Matching need to be revised. During earlier investigations, it was found that the preparation of pooled cell suspension for grouping was specified as One Minute & 1000 rpm but the technician was following 20-30 seconds & 3000 rpm. The investigation team asserted that the SOP should be followed strictly.
The team found that there was need to comply for Platelet Labeling. The blood bank is using label for blood bags as per the guidelines however the label for platelets needs to be modified for RBC contamination, swirling and turbidity in platelets under heading of physical examination.
The investigation found that the blood bank component preparation room was still occupied with wooden chairs, blood bag corrugated boxes, card boards and other goods. Further the entry to general store room was through component preparation area. The team found that this non-compliance of rules exists yet.
The team further stated in its report that the sterility testing as per IP and anti-hemophiliac factor activity testing is required to be carried out. The aliquots for pediatric patients prepared for blood components shall be performed by sterility connecting device. The equipment has been procured but it is yet to be used. The team suggested that the whole blood shall be issued in small aliquots to pediatric patients.
The team further observed that the blood bank needs to comply with the guidelines regarding training for Counselor on SOP for all aspects of donor counseling. The BSP management has given approval in principle and the process is on for procurement of NAT.
