Canadian Blood Services Societe canadienne du sang CBS Control #: CBS5590 HPFB Fi le #: C1? REF: H-1213-BRP

Transcription

1 Canadian Blood Services Societe canadienne du sang CBS Control #: CBS5590 HPFB Fi le #: C1? REF: H-1213-BRP 1800 Alta Vista Ottawa, ON K1 G 4J5 T F Mr. Richard Kirchner Supervisor, BTOX / GCP Un it Inspectorate Program, Ontario Region Health Canada 180 Queen Street W est, 10th Floo r Toronto, ON M5V 3L7 Dear Mr. Kirchn er: Re: Responses to Health Canada Inspection of Brampton Production and Distribution Centre to The following are th e acti ons undertaken by th e Ca nad ian Blood Services in response to the observations co nta ined in the Health Canada Exit Notice. Manufacturing control I Centrale de la fabrication - C Immediate actions were not carried out for a recall required under Non-Conformance Report (NCR) The date discovered for the issue was and the action noted under "Section 2: Immediate Actions" was "015 recall LB# ". However, the associated Component Retrieval Record (CRR) was not completed until This is contrary to step of SOP , Non-Conformance - Immediate Actions, Revision 2. Th e Product and Hospital Service staff member received refresher training to SOP , Non Conformance - Immediate Actions on Non-Conform ance was initiated on capturing th e details of this event. Manufacturing control I Centrale de la fabrication - C The following deficiencies were noted for documents re lated to NCR : a) The "Donated in Hema-Quebec" section was noted as "N/A" in the related Post Donation Deferral Form (PDDF). However, according to the related Record of Donation (Donation No. C ), the "Donor's Clinic of last attendance" was "HO" under the Registration Information Section.

2 Canadian Blood Services Non-Conformance was initiated on The importance of accurate documentation was reviewed with the involved staff member. In addition, refresher training to , Assessment of Hema-Quebec Donation History and SOP , Managing Recalls with PROGESA was completed on A corrected PDDF was attached to the original PDDF. The risk was assessed as minimal as the appropriate actions were carried out at the time. b) There was information missing on the corresponding PDDF form related to the donor's address, telephone#, and Clinic Attended. This is contrary to step 1.2 of the SOP , Information Received Post Donation, Revision 10. Non-Conformance was initiated on Feedback was provided to the involved staff member stressing the importance of Good Documentation Practices. In addition, refresher training to SOP , Information Received Post Donation, version 10, was completed on A corrected PDDF was attached to th e original PDDF. c) The "Reason for Recali/Withdrawal" in the related "Notification of Component RecalllWithdrawal" document was documented as "Other". However, it was confirmed that it should have been noted as "Incomplete Documentation on the Record of Donation." Non-Conformance was initiated on This documentation discrepancy was discussed with staff on Manufacturing control / Contrale de la fabrication - C The following deficiencies were noted for documents related to NCR : a) The Collection/Pooling Date for DNLlPNL No. C S under "Section 8: Product listing for Reportable Events" for this NCR was noted as However, the related "Notification of Component RecalllWithdrawal" record noted the Collection Date as " ". This is contrary to step of SOP , Managing Recalls with Progesa, Revision 8. Non-Conformance was initiated on Please note that the collection date of does not appear in our re cords. According to the Notification of Component Recall! Withdrawal record referred to in this observation, th e collection date of was documented on the Notification of Component RecalllWithdrawal record, rather th an the pooling date of , as required. The documentation discrepancy and the in structions in SOP , Managing Recalls with PROGESA, Step was reviewed with the employee involved on Furthermore, Medical Laboratory Technologists, Senior Technologists and Charge Technologists were asked to review with staff SOP 08772, Step , by to ensure that it is understood th at "collection date" for pooled platelets reflects th e pooling date when completing the Notification of Component RecalllWithdrawals form. b) There was information missing on the corresponding PDDF form related to the donor's address, telephone#, Clinic Attended, and Clinic Date. This is contrary to step 1.2 of the SOP , Information Received Post Donation, Revision 10.

3 Canadian Blood Services Non-Conformance was initiated on Feedback was provided to the involved staff member stressing the importance of Good Documentation Practices, In addition, refresher training to SOP , Information Received Post Donation, version 10 was completed on A corrected PDDF has been attached to original PDDF. Manufacturing control I Contro Ie de la fabrication - C Several NCRs were not completed in a consistent manner. For example: There were inconsistencies between the "Date discovered" and "Date occurred" categories under "Section 1: Non-Conformance Details" for NCR's , , and Canadian Blood Services agrees that there are some issues with the consistency in which non-conformance report forms are being completed. This issue with non-conformance records will be added to the items to be discussed in face-to-face meetings with Quality Assurance staff and members of management at all locations in Southern and Central Ontario by the Executive Director, Quality System Support as part of the implementation activities for the Standardized Deviation Management Process Ph ase 2 (SDMP-P2) initiative. These discussions will be completed prior to Brampton implementation of SDMP-P2, currently scheduled for In addition, a particular focus will be placed on assessing the quality of the non-conformance records as part of the SDMP-P2 post implementation monitoring and assessment work, currently scheduled to be completed by , in order to determine if additional actions are needed to improve on the quality of these records. Manufacturing control I Controle de la fabrication - C During Lot acceptance of RadSure labels received on November 29/2012, initials were not recorded on the corresponding Irradiation Indicator Shipment Acceptance form. This is contrary to step of SOP , Lot Acceptance of Irradiation Indicators, Revision 5. Our investigation confirmed that the Irradiation Indicator Shipment Acceptance form was implemented on The correct version ofthe Irradiator Indicator Shipment Acceptance form (IISA)was used at the time of receipt ofthe RadSure labels on and SOP , Lot Acceptance of Irradiation Indicators, version 4 was followed. The revised version ofthe lisa form was implemented with SOP , version 5, on Manufacturing control I Controle de la fabrication - C NCR was initiated for the receipt of Rad-Sure labels with Lot number U15. The non-conformance was reported as"... the Distribution department did not include a "Logistics Shipment Acceptance Stamp" on the packing slip... " However, it could not be determined whether this stamp was actually required. The work instructions in section 3 and 4 of SOP , Receiving Inventory-CBS Sites, Revision 4, were not clear in describing the steps required to receive labels, which are transferred to the user department, undergo lot acceptance, and are then approved for release by QA. Furthermore, Irradiation Indicator Labels were not included in Supplement v.01, approved on

4 Canadian Blood Services Our in vestigation confirmed that the current procedure (SOP , Receiving Inventory-CBS Sites, version 4, Step 1.6.2) was followed. RadSure labels are a non-inventory item and the use of the Shipment Assessment Stamp is not required until after the delivery is made to the department. There is currently a working group reviewing SOP This information will be provided for consideration as part of their review. Manufacturing control! Contr61e de la fabrication - C Step of SOP 12203, Receiving Inventory - CBS Sites, Revision 4, states "Obtain Proof of delivery, if applicable". During the inspection, it was confirmed that this step is not optional and that proof of delivery should be obtained for the delivery of all noninventory supplies. This was not done for the delivery of RadSure labels with lot number U15. The requirement was discussed with warehouse staff on to ensure that proof of delivery is obtained for the delivery of all non-inventory supplies including RadSure labels, in accordance with Step of SOP , Receiving Inventory - CBS Sites, version 4. Manufacturing control! Contr61e de la fabrication - C Despite retraining between and , procedures were not followed for SOPs associated with receiving supplies, including SOP Receiving Inventory - CBS Sites, Revision 4; SOP , Shipment Acceptance of Blood Packs, Revision 3.0, SOP , Acceptance of Critical Supplies, Revision 3.0. Examples of supplies not received as required by these SOPs include: Fenwal Optipure blood packs with lot no. 12G12L01; Vacutainer Tubes with lot no ; and Vacutainer Tubes with lot no A new Center Operating Procedure, COP v. 01 was developed and implemented on to facilitate which SOPs to follow pertaining to material received. The documentation that was reviewed preempted the implementation of this COP. We will verify documentation since implementation of COP v.01 to assess if refresher training is required. Manufacturing control! Contr61e de la fabrication - C In the response letter to Health Canada dated , CBS Control # CBS5502, the foliowing statement was made: "Assessment and improvements to SOP 12203, Receiving Inventory - CBS Sites (Observation 7 and 19). This will take six to nine months. In the interim, a Directive will be implemented by clarifying current practices." However, a Directive was not implemented.

5 Canadian Blood Services Following our initial response on , it was determined that the instructions in SOP Section 2 actually indicate clearly how to record the temperature monitoring device information upon receipt of Plasma Protein Products. It was decided that training could address the observations appropriately and that a Directive dealing with issues raised in Observation 7 and 19f was not necessary. The intent of Directive , Update Documentation Requirements for Receipt of Goods was written and implemented on in response to previous Health Canada audit observations (i. e. observation #3 from Ottawa - Concourse Gate, and observations 19b, 19d and 24 from Brampton. Manufacturing control I Contr61e de la fabrication - C There was no definition for "Date Discovered" in the Non-Conformance Report Job Aid, V Canadian Blood Services agrees that there is no formal definition for "Date Discovered" in the Non-Conformance Report Job Aid , nor is this term defined or specific guidance given in any other non-conformance process related documentation. While the absence of a definition for this term and the potential that this may contribute to variation amongst staff in the date they record on the non-conformance report form for 'Date Discovered' is recognized, variation in the date recorded does not have any impact on product quality or necessary actions taken at the time of the non-conformance. It is recognized, however, that variation in the 'Date Discovered' recorded on the non-conformance report form can cause confusion in the assessment of the history of actions taken in response to the identification of a nonconformance based on the non-conformance record. In particular, variation in the 'Date Discovered' can make it difficult to ascertain from the non-conformance record that all required actions, including quarantine/recall of suspect product and reporting to regulatory authorities where required, were completed in a timely manner upon discovery of the non-conformance. This deficiency in process documentation will be addressed only after the completion of the Standardized Deviation Management Process Phase 2 (SDMP-P2) initiative roll-out to all Canadian Blood Services locations currently in progress (Brampton implementation scheduled for ). This issue will be added to the SDMP-P2 post implementation monitoring and assessment work already underway, and will be prioritized for addressing with all other issues identified based on risk. Personnel I Personnel - C Several "Validation of Skills Records" (VSR) were not being completed as required by the "Training Practices Guide, Part 4 - Validation Skills", Some examples are as follows: a) The "Observer Signature", "Date", and "Manager Notified" sections were not completed for the following training records: CA and Phlebotomist, training completed on ; RN, training completed on ; RN, training completed on Non-Conformance was initiated on Our investigation revealed that some of the trainers did not have a clear understanding of instructions for completing Validation of Skills Record. Feedback was provided to staff involved and refresher training to the Training Practices Guide, Part 4, Validation Skills was completed by

6 Canadian Blood Services b) Although the VSR for an RN, training completed on , indicated an "Unsatisfactory" Assessment for SOP , Perform Health Interview, the "M anager Review - Action on Recommendations, "Manager Signature" and "Date" sections were not completed. Non-Conformance was initiated on During the validation of skills assessment held on , the trainer's assessment for SOP , Perform Health Interview determined the staff member's skill level to be satisfactory. However, the written test which was marked on indicated an unsatisfactory result. The trainer met with responsible staff on to review the Validation of Skills Record. At that time, the trainer noted acceptable demonstration of knowledge. The staff member was assessed as satisfactory. The Validation of Skills Record was then completed and signed off by the Manager. Refresher training to the Training Practices Guide, Part 4, Validation of Skills was completed by the Manager on Personnel I Personnel - C The "Regional Manager Field" and the "Manager Supply Services" were trained to SOP , Receiving Inventory - CBS Sites, Revision 4 on March 4, However, this revision of the SOP was not approved until April 11, This was determined to be a documentation discrepancy. Our investigation confirmed that the Regional Field Manager and the Manager of Supply Services were trained to SOP , version 4 on and not on as re corded. ( please refer to observation 2 1). Personnel I Personnel - C The Assistant Quality Assurance Manager position was not listed on the Quality Assurance Brampton Site Training Matrix. During the inspection, it was confirmed that this is a separate position that may have unique training requirements. The Assistant Manager, Quality Assurance position is considered a designate for the Quality Assurance Manager. Although this position title was not identified on the local Quality Assurance training matrix, the Assistant Manager was trained to all required procedures. A review of the Brampton Quality Assurance training matrix identified that the Assistant Manager, Document Control was also missing on the local matrix. Both Assistant Manager positions were added to the local matrix and the matrix was approved on In addition, the Head Office standardized Quality Assurance training matrix was revised on to include the training requirements for both the Assistant Manager, Quality Assurance and Assistant Manager, Document Control positions. Th e Brampton Quality Assurance training matrix now aligns with the Head Office standardized Quality Assurance training matrix. Personnel I Personnel - C SOP 12203, was identified as required training for Brampton Quality Assurance Staff. The Assistant Quality Manager had not yet completed training to this SOP.

7 Canadian Blood Services Non-conformance was initiated on Training ofthe Assistant Manager, Quality Assurance and the Quality Assurance Manager was completed on and respectively. As per Directive , version 2, a review ofthe required QA training and supporting documentation was completed by It was confirmed that all other staff who performed the release of critical supplies were trained to SOP Receiving Inventory, on No other gaps were identified. Personnel / Personnel - C SOP , Inspection/Preventive Maintenance of Sorvall Centrifuges was not listed on the Brampton Laboratory Training Matrix. However, it was confirmed that Laboratory personnel are responsible for performing Steps 1.5 and 1.6 of this SOP. Non-Conformance was initiated on Steps 1.5 and 1.6 were added to the Production Training Matrix on In addition, all Medical Laboratory Technologists, Senior Technologists and the Charge Technologist have completed th e review of SOP Steps 1.5 and 1.6. Personnel / Personnel - C For several observations noted during the inspection conducted between and , the corrective actions undertaken were listed as staff meetings, staff huddles, minutes sent to staff and s sent to staff. However, it could not be determined which staff attended the meetings or reviewed the notifications as attendance/staff review was not documented. For example: An informal staff meeting held to review SOP by Biomed in response to observations 12b and 14b; Production Huddle minutes for in response to observation 12; to Distribution Staff sent on in response to observation 40; and Production Huddle minutes for in response to observation 39. Starting , an attendance record will be used to capture staff attendance at meeting and huddles, and a subsequent "read and sign" will occur for those staff not in attendance. Equipment / Equipement - C The following deficiencies were noted on NDAS records: a) The NDAS Alarm History Review Log for November 2012 (Component Production) was not filled out according to SOP , NDAS Site Operation, Revision 5. Although, BRM 1076 went out of range on Nov 19, 2012, there was no alarm noted or SQuiPP assessment conducted for this excursion on the corresponding Alarm History Review Log. Despite re-training as part of the corrective actions to similar observations made during the May 2012 inspection, the related procedure was not followed.

8 Canadian Blood Services Non-Conformance was initiated on Assignment of NDAS Alarm History Log completion was added to the posted task list for Production in late October SOP requirements for the NDAS Alarm History Review was reinforced at the Medical Laboratory Technologist/Senior Medical Laboratory Technologist meeting on In addition, effective , a check box for completion of NDAS Alarm History Review Log will be placed on the daily Shift Update tool. Staff will document that the Alarm History Review Log was completed on their shift. b) BRM 1092 went out of range several times in November However, there were no notations on the corresponding trend log and SQuiPP assessments were not conducted for these excursions. This was contrary to SOP , NDAS Site Operation, Revision 5. The frequency with which the temperature will briefly go out of range is due to the opening of the freezer door during loading of conditioned ice packs. Ice packs are conditioned prior to loading them into BRM 1092 storage freezer. The freezer alarm is triggered due to the sensitivity and set points of the alarm. Feedback was provided to Distribution staff on to remind them of the required SQulPP assessment including notations associated with temperature excursions. Equipment I Equipement - C The November 2012 (Distribution) NDAS Alarm History Review Log were not available for review, contrary to SOP 13009, NDAS Site Operation, Revision 5. Despite retraining as part of the corrective actions to similar observations made during the May 2012 inspection, the related procedure was not followed. Non-Conformance was initiated on Daily reviews did not occur for the time period to , and the NDAS Alarm History Review Logs were not completed as per SOP for to When these omissions were noted on during supervisory review, a retroactive review was completed for the NDAS points. It was assessed th at the excursions had no impact on SQuIPP. Following our review of NDAS Site Operation with staff, to clarify responsibility of completing the daily NDAS Alarm History Review Log was assigned to the day shift. Equipment I Equipement - C The NDAS trend log reports were not consistently run in November 2012 for BRM 1066, 1065, and 1064, related to equipment shared between Component Production and Distribution. For example: The NDAS trend log for BRM 1066 was not completed between Nov 20-27,2012. Additionally, the NDAS Point-Production record for Nov 27, 2012 noted these three probes as "N/A". NDAS Site Change Request was submitted on to assign ownership of probes BRM 1064, BRM 1065 and BRM 1066 to Product Distribution staff to clarify the responsibility for running trend logs and to ensure that this activity is conducted consistently.

9 Canadian Blood Services Equipment I Equipement - C NDAS points BRM 1022 and 1031 were noted as being "out of service" on the NDAS Trend Logs run between Nov 10 and Nov 20,2012 for BRM 1021 and 1030, respectively. The same NDAS points were also noted as being "out of service" on the NDAS Points - Production record for Nov 27, However, it was confirmed that these probes were never implemented. The original specifications for th e number of NDA S points included points 1022 and as secondary points in two separate small areas. Prior to moving into the Brampton Site, th e User Department determined th at th ese secondary points were not required. Primary NDA S probes have been in use since the Brampton Site go-live. A NDA S Site Change Request was initiated to remove points 1022 and This is targeted for completion by Records I Dossiers - C The Supply Services Confirmation of Employee Training form for training on SOP , Receiving Inventory - CBS Sites, Revision 4, listed the document number as COP and the. version as 5. Our investigation confirmed that th e staff were trained to SOP , version 4, in May however the Confirmation of Employee Training (CET) record contained incorrect information. A corrected CET was initiated and all affected staff were retrained to SOP , version 4, in August If you require clarification or further information, please do not hesitate to contact the undersigned. Please refer to the above control number in all correspondence. Sincerely, (. C LLo ti..eu.-g etr~ f- Or. Christian Choquet Vice-President Quality & Regulatory Affairs Fax Number: