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AUDIT DU BPBR

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Responses to the observations of the Health Canada inspection of the Montréal facility January 19–30, 2004 OBSERVATIONS AND RESPONSES WHOLE BLOOD – Staff – C.02.006 1. The following omissions or shortcomings were observed in staff training programs: The files of two employees working in the IT department did not specify which versions of the SOPs for which training and annual recertification have to be completed. Annual recertification has not been carried out during the past year in the following cases: • One employee of the Material Resources department has not been recertified since 2001. • One employee working in the IT department has not received recertification since April 2002. • Two employees working in Production Information Systems have not been recertified since June 2002; however, a request to begin the recertification process was made on January 21, 2004. Response: In reference to IT department employees: In January 2004, an information system quality control specialist joined the IT division team. This person ensures that IT staff receive the appropriate regulatory training and is also responsible for the updating of training files. As a result of Health Canada’s observation, the employee training files have now been corrected and the SOP versions are duly noted. The information system quality control specialist will also ensure that the employee in question is recertified before the end of March 2004. A new position ...
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Responses to the observations of the Health Canada inspection of the Montréal facility January 19–30, 2004 OBSERVATIONS AND RESPONSES WHOLEBLOODStaff – C.02.006 1. Thefollowing omissions or shortcomings were observed in staff training programs:
The files of two employees working in the IT department did not specify which versions of the SOPs for which training and annual recertification have to be completed.
Annual recertification has not been carried out during the past year in the following cases:
One employee of the Material Resources department has not been recertified since 2001.
One employee working in the IT department has not received recertification since April 2002.
Two employees working in Production Information Systems have not been recertified since June 2002; however, a request to begin the recertification process was made on January 21, 2004.
Response: Inreference to IT department employees: In January 2004, an information system quality control specialist joined the IT division team. This person ensures that IT staff receive the appropriate regulatory training and is also responsible for the updating of training files. As a result of Health Canada’s observation, the employee training files have now been corrected and the SOP versions are duly noted. The information system quality control specialist will also ensure that the employee in question is recertified before the end of March 2004. A new position of computerized production systems quality control specialist was created in February 2004 in the Production Information Systems division. The incumbent will ensure that the appropriate regulatory training will be provided and that the two employees in question will be recertified before the end of March 2004. In reference to the Material Resources department:
Responses to the observations of the Health Canada inspection of the Montréal facility January 19–30, 2004
Recertification for 2004 was completed on February 15, 2004. Certain members of the staff have been designated as being responsible for ensuring appropriate follow-up for regulatory training.
Compliance:March 31, 2004 WHOLEBLOOD– Equipment - C.02.005 2. Asobserved during the last inspection, blood collection equipment scheduled for periodic calibration has not been returned systematically to the Biomedical Equipment department. In those instances where equipment was not returned, no follow-up of the departments concerned was carried out.
Response:The SOP regulating calibration and maintenance is under review.
Compliance:June 30, 2004 However, as of the beginning of March, a monthly reminder will be sent to those departments that have failed to return all the equipment required for calibration. WHOLEBLOOD– Facilities – C.02.004 3. Inreference to the Milli RX 75 water purification system:
The TEC-ENR-013 form, which is used to log maintenance procedures, was not always thoroughly filled out. Therefore, it was not possible to verify if maintenance tasks were carried out according to the specified frequency.
There was no procedure in place to ensure that maintenance tasks that had been requested on work order forms and then postponed were actually carried out within an acceptable time frame.
Response:Corrected during the inspection.
Compliance:N/A
Responses to the observations of the Health Canada inspection of the Montréal facility January 19–30, 2004 WHOLEBLOOD– Equipment – C.02.005 4. Thefollowing omissions were noted in the maintenance file of the Cobe 2991 red blood cell washers:
The 2003 daily (CON-ENR-033), weekly (CON-ENR-034) and monthly (CON-ENR-035) maintenance forms of one red cell washer had not been signed by the supervisor.
The ID number of the washer concerned (#1 or #2) was not recorded on the CON-ENR-035 form.
Daily maintenance tasks had not been documented on 4 occasions in April and May 2003.
Response:The 2003 daily (CON-ENR-033), weekly (CON-ENR-034) and monthly (CON-ENR-035) maintenance forms will be reviewed and signed by the head of the department by February 27, 2004. The washer ID number will be specified through the addition of a space on the form where the EC number of each unit may be recorded. A form modification request will be forwarded to the Compliance and Licensing Direction at the beginning of March. Daily maintenance was not carried out on April 17 because the unit was not in use. This practice was in compliance with procedure CON-INS-008, page 6. The lack of maintenance work for May 14, 19 and 22 was recorded in a declaration of non-compliance (CON-M-04-011). Staff will receive a reminder and training follow-up before mid-March. Compliance:March 15, 2004
Responses to the observations of the Health Canada inspection of the Montréal facility January 19–30, 2004 WHOLEBLOOD– Raw Materials Analysis – C.02.009 5. Duringa thrombapheresis donor selection interview, the attending nurse confirmed the donor’s irregular pulse rate (originally indicated by the IVAC vital signs monitor) by again using the IVAC monitor, instead of proceeding manually, as required by SOP 01 200.
Response:The nurse in question was briefed on this observation.  Theentire nursing staff will participate in an evaluation based on role-playing situations in order to determine any lack of compliance with SOP 01 200. Following an analysis of the results of this evaluation, if there has been a failure to comply with regulations, it will be discussed on an individual basis with the nurses implicated. Compliance:April 30, 2004WHOLEBLOOD– Equipment – C.02.005 6. Duringpreventive maintenance work carried out on November 12, 2003 on the Cell Dyn 314 84 unit, the calibration certificate of the manometer used was unavailable.
Response:In reference to preventive maintenance work carried out on November 12, 2003 on the Cell Dyn analyser, the unit’s supplier is unable to provide a copy of the manometer calibration certificate. However, the supplier has guaranteed in writing that any abnormal pressure/vacuum setting of the Cell Dyn 314 84 unit would be caused by faulty control settings. In this case the unit cannot be used.
A formal request has been sent to the supplier, asking that, in the future, calibration certificates be provided prior to preventive maintenance work. The supplier will also repeat the maintenance work carried out on November 12, 2003.
Compliance:March 15, 2004
Responses to the observations of the Health Canada inspection of the Montréal facility January 19–30, 2004 WHOLEBLOOD– Equipment – C.02.005 7. Thecertificate of the RD Service technician carrying out preventive maintenance work on the EC02678 laminaire flow hood in May 2003 was not available.
Response:Corrected during the inspection.
Compliance:N/O