Re Responses to the Health Canada Audit of Sudbury by giv23807

VIEWS: 7 PAGES: 4

									                                                              2004-06-11
                                                              CBS Control #2908
                                                              Ref #AUD04-214
                                                              HC File # C1892-100390


Mr. Jean-Marc Charron
Operational Manager
Ontario Operational Centre
Health Products and Food Branch Inspectorate
2301 Midland Avenue
Toronto, Ontario M1P 4R7


Dear Mr. Charron:

               Re: Responses to the Health Canada Audit of Sudbury Centre
                                     10-14 May 2004

       The following are the actions undertaken by the Sudbury Centre and Head Office in
response to the observations contained in the Health Canada Exit Notice.

Raw material testing / Analyse des matières premières – C.02.009

1.     During the review of records of donation (RD) for the January 29, 2004 Centre
       Clinic, RD with donation number 0550 2 200826 for a male donor had question 18
       (Male Donors: have you had sex with a man even one time since 1977?) marked as
       N/A and there was no evidence of follow up.

       A QIR was initiated on 2004-05-13 and the unit has been recalled. An Error/Accident
       Report was submitted to Head Office on 2004-05-14. Training will be provided to all
       screening nurses by 2004-06-30.

Raw material testing / Analyse des matières premières – C.02.009

2.     During the review of records of donation (RD) for the January 6, 2004 Walden
       Mobile Clinic, RD with donation number 0550 0 712736 had a recorded pulse of 101
       and the donor was accepted. The Donor Selection Criteria Manual version 7
       indicated that a donor requires a pulse rate greater than or equal to 50 and less than
       or equal to 100 beats/minute.

       A QIR was initiated on 2004-05-13. Training will be provided to all screening nurses by
       2004-06-30.
                                                                                               2


Manufacturing control / Contrôle de la fabrication – C.02.011

3.     The investigation regarding suspected duplicate donors #4586784 and #4063328 was
       inadequate in that there was no follow-up or action taken even though the birth
       dates of both profiles were identical. Further, no follow-up was performed to
       confirm that one of these donors is allegedly deceased. During the inspection a
       HEAT ticket (Call ID: 00267515) and change of information form was generated
       and the donor records were updated.

       Resolved during inspection.

Records / Dossiers – C.02.021

4.     During the review of Post Donation Information (PDI) 03-256 dealing with skin
       lesions not being documented on the record of donation (RD), it was noted that the
       Consignee Notification of Blood Component Product Withdrawal form listed the
       reasons for withdrawal as question 9b not being addressed and skin lesions not
       documented on the RD, however, question 9b was addressed on the RD.

       A QIR was initiated on 2004-05-14. A memo was issued to staff identifying correct
       documentation for PDI withdrawals on 2004-05-27.

Equipment / Equipement – C.02.005

5.     The following were noted regarding the equipment records on file for service
       performed on the COBE Spectra plateletpheresis machine, S/N ISO2298, on April
       16, 2004 for a plasma pump failure defect:
       a)      The “Management Action” section of Defective Equipment and Supplies form,
               CTR003-1, indicated that the work had been performed on 2004-04-16, however, the
               service report (#4560) provided by the service provider indicated that the service
               was performed and completed on 2004-04-19. QIR #04-05-27 was initiated during
               the inspection and the form was corrected. (Resolved during inspection).

       b)      This service was not recorded on the Defective Equipment/Service record form
               N765-1. QIR #04-05-26 was initiated during the inspection and the form was
               corrected. (Resolved during inspection).

       c)      The Test Equipment Verification form, CTR-030-1, was not completed as required
               by COP CTR 030, Review of External Service Providers/PM/
               Calibration/Verification, version 3. QIR #04-05-28 was initiated during the
               inspection.

               Training to CTR 030 and the associated form will be provided to all apheresis
               nurses by 2004-06-30. In addition CTR 030 -1 was completed for the repair
               made on 2004-04-19.

       d)      There was no evidence that the service report provided by the external service
               provider was reviewed for completeness, the test results were within the acceptable
               parameters or that the report was accepted by CBS as required by COP CTR 030,
               Review of External Service Providers/PM/ Calibration/Verification, version 3.
                                                                                               3


               Training to CTR 030 and the associated form will be provided to all apheresis
               nurses by 2004-06-30.

       e)      The employee responsible for reviewing service reports for the equipment was not
               trained in COP CTR 030, Review of External Service Providers/PM/
               Calibration/Verification, version 3.

               A QIR was initiated on 2004-05-10. Training to CTR 030 and the associated
               form will be provided to all apheresis nurses by 2004-06-30.

Manufacturing control / Contrôle de la fabrication – C.02.011

6.     During the review of QIR QS Log #04-04-85 dealing with a barcode scanner
       misread, the Bar Code Label Incident Report (form F110120) was not completed as
       required by SOP 07 197, Non-Conformance of Bar Code Label Entries, version 3.
       Further, this SOP did not clearly indicate the circumstances under which CBS Head
       Office should be notified.

       SOP 07 107 Non-Conformance of Bar Code Label Entries was originally written and
       implemented with BCIS (Blood Component Issuing System). BCIS system was developed
       in-house and did not undergo robust input verification functionality. This was due to
       technology limitations of its original programming language which was CA Clipper. Bar
       code scanners are electromechanical devices with an inherent rate of read errors. Read
       errors are detected as part of the input verification routines in commercial off the self
       computer applications such as MAK PROGESA. Therefore read errors will occur but are
       highly detectable as the computer application will not accept the invalid entry. Due to
       the low frequency and randomness of the errors a route cause cannot be determined. An
       internal change request has been generated (CR 03264) requesting this SOP be
       rescinded from Centre operations.

Manufacturing control / Contrôle de la fabrication – C.02.011

7.     There were no service level agreements in place with the external service provider of
       the establishment’s security system and the monitoring station used for the
       laboratory refrigerators, freezers and incubators.

       A Service Agreement will be developed between CBS and the external service provider.

Premises/Locaux – C.02.004

8.     There was no evidence to indicate that all automated monitoring and alarming
       equipment at the off site storage was inspected annually by a certified firm contrary
       to Schedule “E” of the Lease Agreement between the landlord and Canadian Blood
       Services.

       The landlord has been contacted and an inspection will be completed by 2004-06-30.
       Sudbury Centre will schedule future annual inspections.
                                                                                                    4



Equipment / Equipement – C.02.005

9.        The following were noted regarding the equipment records on file for the COBE
          Spectra plateletpheresis machine, S/N ISO2298:

          a)        The Daily Maintenance and Cleaning form N754-7 for May 2004 did not have the
                    complete equipment serial number indicated on the form and was not completed in
                    a consistent manner. QIR #04-05-25 was initiated during the inspection and the
                    form was corrected. (Resolved during inspection).
          b)        Maintenance records were not organized in that the equipment binder contained
                    documentation and entries for plateletpheresis machine S/N ISO2232.

          Equipment documentation was organized by 2004-05-21. Orientation will be provided to
          all apheresis nurses regarding the organization of equipment documentation by
          2004-06-30.

        If you require any clarification, please do not hesitate to contact the undersigned. Please refer to
the above control number in any correspondence.

                                                                   Sincerely,




                                                                   Lois Atherton
                                                                   Director, Audits




ljh/audits/HealthCanada/2004-2005/Sudbury/ResponsesSudbury

								
To top