Re: Response to the Health Canada Inspection of Edmonton Centre, July 2011

Transcription

1 Canadian Blood Services Societe canadienne du sang 1800 Alta Vista Ottawa, ON K1 G 4J5 T F CBS Control #: CBS5357 HPFB File # C REF: H-1112-EDM Mr. Dennis Shelley, Operational Manager Western Operational Centre Health Products and Food Branch Inspectorate # Canada Way, 4th Floor BURNABY, British Columbia V5G 1J9 Dear Mr. Shelley: Re: Response to the Health Canada Inspection of Edmonton Centre, July 2011 The following are the actions undertaken by Head Office and Edmonton Centre in response to the observations contained in the Health Canada Exit Notice. Manufacturing control I Contrale de la fabrication - C Review of component production records identified the following: a) The End Labelling Records from for a clinic dated indicated that the time the platelets were out of storage for end labelling was 11:11 to 13:35, which exceeds the 30 minute time limit outlined in SOP Furthermore the end labelling record was checked as "Time limit acceptable" and had been reviewed and signed by the supervisor. NDAS temperature records for the end labelling area were retrieved and indicate that the temperature during that time in the end labelling area was within the normal platelet storage temperature of 20 to 24 degrees. a) Non-conformance was initiated on Our investigation in PROGESA confirmed that all of the pooled platelets end labeled on , were completed between 11:13 and 11:33. There was only one end labeling session. There was no impact on product quality as the storage temperature for platelets was maintained at 20 to 24 degrees. b) The Bacterial Detection Testing records for clinic dated indicated the sample transfer time of a plateletpheresis unit (C ) was 11 :34 which was less than the required 24 hour time from stop bleed time to sample time and was out of line with the other plateletpheresis units in the same inoculation batch. BacT Alert loading records indicate the implicated sample was actually loaded within the same Share your vitali,iy P'artagez vo~r~ vit~lite

2 Canadian Blood Services time frame (14:29-14:39) as other samples in the batch which were sampled after 24 hours as required by SOP b) Non-conformance was initiated on The staff member who performed the inoculation confirmed that the samples were inoculated in order of the batch as documented on the Bacterial Detection Testing records; thus, it is likely that the time was incorrectly documented as 11:34. Based on our investigation, it was determined that there was no impact on product quality. a & b) Feedback was given to the staff members involved in the incidents. Also, an was sent on to all Production staff, outlining the observations and stressing the importance of ensuring documentation is complete and correct, time limits are met and attention to detail while performing and documenting for procedures and when performing Supervisory Review. These issues will also be reviewed at the next staff meeting. In addition, a note was added to the records referencing the NCRs. Manufacturing control I Controle de la fabrication - C Review of completed shipment acceptance documents for critical supplies found that the Goods Receipt Slips with the required QAlQC sign off had not been retained by Logistics; rather an unsigned copy was retained thus providing no evidence of completion of step 1.14 of SOP Acceptance of Critical Supplies. The verification of the batch number performed by QC as indicated in step 1.14 of SOP , Acceptance of Critical Supplies, and documented on the Goods Receipt slip, is also the same task performed by Logistics as per SOP , Receiving Inventory - CBS Sites, step 1.6.2, which states "... obtain a second verification of the batch number on the Goods Receipt Slip by a second person, if applicable... ". Logistics will perform all batch verification moving forward. The batch verification requirement for QNQC in SOP will be removed at the next revision. The target date for implementation of the revised SOP is In addition, staff were instructed by the department trainer to retain the signed Goods Receipt slips, and a Read and Sign memo dated , was issued reminding them of this requirement. Equipment I Equipement - C Review of equipment preventive maintenance records found the following: a) SOP Inspection and Preventive Maintenance ofthe NDAS, step requires the method of testing for the temperature highllow alarm thresholds to be recorded in section C of the NDAS Maintenance Inspection form (# ), however this information was not recorded on these forms. a) The alarms were challenged as required, and the results were documented on the NDAS Maintenance Inspection form; however, the method was not documented as required. This issue was discussed with local staff members during the inspection and they were reminded of the requirement to document the method used for challenging the alarm limits in Section C of the NDAS

3 Canadian Blood Services Maintenance Inspection form. This issue was also discussed nationally, during a teleconference for NDAS on , and followed up in an to Integrated Equipment Services staff, including the NDAS technical specialists, on b) The Vital Signs Monitor Biomedical Inspection PM record for Carescape PMS-0208 dated did not include the required information on the thermometer simulator used during the PM. It was however determined that Edmonton centre has only one temperature simulator (TST -0075) and this simulator was within calibration when used for this particular PM. b) The Employee who completed the record is no longer with Canadian Blood Services; therefore, no further actions or feedback is required. A notation was documented on the form referencing the observation. Records I Dossiers - C Review of clinic records found the following: a} Record of Donation C collected had a yes response to question 6(a} - In the last 12 months have you travelled outside Canada or the US and stayed less than 6 months, and the RN notes state "6a Jamaica non-endemic", however the locations travelled to in Jamaica were not documented as required by SOP , attachment 6. Note that within Jamaica it is only Kingston that is considered a malaria risk and this was a B2 collection. a) Non-conformance was initiated on There was no recipient risk, as an assessment was made which determined that the area visited was non-endemic. A Read and Sign memo was circulated on Individual feedback was given to applicable staff on Group feedback will be given at the Red Deer Staff Meeting on and the Edmonton Staff Meeting on b) The Lot N umber of Supplies (Plateletpheresis) record dated and the Lot Number of Supplies (Whole Blood) record dated both listed the expiry date for the sterile small gloves as and management review of these forms had been completed. It was determined that the expiry date of this specific lot number ( EU) of small sterile gloves was and the manufactured date of the gloves was b) Non-conformance and were initiated on and , respectively. There was no risk associated with this documentation discrepancy as the small sterile gloves in use at the time were in date. The documentation was corrected according to Good Documentation Practices. A Read and Sign memo was circulated on Individual feedback was given to applicable staff on Group feedback will be given at the Red Deer Staff Meeting on and the Edmonton Staff Meeting on

4 Canadian Blood Services Manufacturing control/ Contrale de la fabrication - C During review of the May warehouse requisition forms and the corresponding transfer orders it was found that for centre whole blood and apheresis clinics, there were numerous requisition forms where the quantity of items ordered and filled were different from those of the respective transfer orders. There was no risk to SQulPP associated with this observation. All Inventory supply quantities are reconciled monthly through an inventory count process, and critical supplies are traceable through Clinic Services forms, and not through the Warehouse Requisition forms. A Read and Sign memo dated was issued to Logistics warehousing personnel, reminding them of the requirement to correctly document quantities of supplies issued on the Warehouse Requisition forms. Records / Dossiers - C Review of records found the following: a) The Sebra Shaker Calibration and Maintenance Log daily records for shaker BCS-0176 for the month of March 2011 had not been reviewed by the department supervisor/designate. a) The Sebra Shaker Calibration and Maintenance Log records, for shaker BCS- 0176, for the month of March 2011 were filed prior to review. These records were reviewed by the department supervisor/designate upon discovery on The review confirmed that the shaker maintenance and calibration requirements were met during the month of March. A Read and Sign memo was circulated on Group feedback will be given at the Red Deer Staff Meeting on and the Edmonton Staff Meeting on b) The PocH-1 Maintenance and QC Log dated had not been signed off by the supervisor/designate. b) The PocH-i Maintenance and QC Log, dated , was reviewed and signed by the supervisor/designate on All results were found to be within range. A Read and Sign memo was circulated on Group feedback will be given at the Red Deer Staff Meeting on and the Edmonton Staff Meeting on c) Documentation of the time the temperature system stabilization was reached for Buffy Coat Van EHC 516 was missing for the Weekly Vehicle Inspection report dated which is contrary to step 1.7 of SOP Vehicle and Auxiliary Equipment Inspection Record and Vehicle Log. In addition, the inspection report of week for the same Buffy Coat Van had one of the dates on the report incorrectly documented. c) Our investigation revealed that the pod temperatures were properly and thoroughly documented on associated Clinic Shipping Record - TCV forms (F060007) which accompanied blood units from mobile clinic There was no risk to SQulPP associated with this observation. A Read and Sign memo

5 Canadian Blood Services dated was issued to Logistics drivers reminding them of the requirement to correctly complete the Weekly Vehicle Inspection Record, including the time of Buffy pod stabilization, if applicable, and correct documentation of dates. In addition, the annual Quality module training delivered to Logistics department for 2011 was on Good Documentation Practices. This training was completed by , after this documentation error occurred. d) For Donor and Clinic Services Support department, the transfer list for document archive box REC was missing the documentation of the date the person packed the box and for Records Content List dated the box 10 number was missing. d) Our investigation identified that the clerk was using the new forms for the first time, as this was a new process for Records Management and Off Site Storage. As well, formatting of the form was not consistent for signatures and dates. Feedback was given to the Head Office process owner on and the form will be revised with the post-implementation changes, by There was no risk associated with these documentation discrepancies as traceability of the boxes was not affected. The box number was added to the Records Content List dated , according to Good Documentation Practices. Feedback was given to the clerk regarding the missing information on the records. e) The Buffy Coat Transportation System - Calibration record dated did not indicate the air conditioner air filter was either inspected, cleaned or replaced but the overall inspection of the air conditioner air filter was initialled as completed. e) Our investigation identified that there was no risk associated with this observation, as the air temperature was being maintained in the system, and was documented on the Temperature Controlled Vehicle Ranger / Kerr Maintenance Inspection form ( ) during the inspection and subsequent inspections. An inspection of the filters was completed on , which identified that the air filters were present and clean. An Equipment Service Report was completed to document the service activity for the Buffy Coat transportation system (equipment /0 TVE-F7) on In addition, feedback was provided on , to the individual involved in the scheduled maintenance performed on Sincerely, Dr. Christian Choquet Vice-President Quality & Regulatory Affairs