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Re: Responses to the BBR Audit of Newfoundland & Labrador Centre 28 May - 01 June 2001


Re: Responses to the BBR Audit of Newfoundland & Labrador Centre 28 May - 01 June 2001

The following are the actions undertaken by the Newfoundland & Labrador Centre and Head Office in response to the observations contained in the Bureau of Biologics and Radiopharmaceuticals Exit Notice.

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

REPEAT OBSERVATION – Although a cooling trend was apparent, product received at the Centre from Grand Falls and some mobile clinics remained at temperatures greater than 10 degrees Celsius, more than 12-14 hours after collection.

As indicated in our response to the Halifax audit of 2001-04-02 to 2001-04-06, it has been determined that the issue of transportation of units shipped over extended periods of time will require a comprehensive assessment of Canadian Blood Services' current practices. A working group will be created to complete this assessment. Recommendations will then be brought forth to the Executive Management Team, by 2001-09-30, for resolution and a plan will be forwarded to the Bureau.

Personnel / Personnel - C.02.006

During the absence of the Medical Director his duties were performed by physicians who were not employed by Canadian Blood Services. The Centre did not have any contract with these physicians to define their duties, responsibilities and authority. In addition there was no evidence that they had received training in CBS procedures.

During the noted absence of the Centre Medical Director, a designated CBS Medical Director was the main coverage for all medical issues with the exception of the plateletpheresis program.

The local physicians used for apheresis issues had been notified of the expected coverage by way of memorandum, were very experienced with apheresis procedures and had been issued appropriate CBS procedures for review.

At the time of the audit and currently, CBS is in the process of negotiating a contract with local physicians for plateletpheresis coverage when the Centre Medical Director is unavailable for consultation.

Quality control department / Service du contrôle de la qualité - C.02.014

There was no independent review of the LDMS Composite Report prior to release of product.

Resolved during audit.

Manufacturing control / Contrôle de la fabrication - C.02.011

There were no written instructions provided to the Centre regarding the dual population of tested blood components following implementation of HIV NAT. A draft copy of Directive D2001-019, Withdrawal and Destruction of HIV NAT Untested Frozen Components was submitted to Health Canada on April 6, 2001 but the final version was not issued to Centres prior to implementation of HIV NAT.

Directive D2001-019, Withdrawal and Destruction of HIV NAT Untested Frozen Components was distributed to CBS Centres on 2001-06-15. The effective date in the Directive is "As soon as operationally feasible but to be completed by 2001-09-24". Thank you for pointing out the delay in the distribution of this directive.

Manuafacturing control / Contrôle de la fabrication - C.02.012

Centre Operating Procedure (COP) QS. NF.021, Procedure for Management of Consumable Product Quarantine and Recall was not followed during the recalls of Leukofix (November 2000), and test kit for HTLV- I/II (November 2000) and HIV-1p24 (January 2001)

Centre Operating Procedure QS.NF.021 "Procedure for Management of Consumable Product Quarantine and Recall" will be reissued for staff review by 2001-07-20. Furthermore, beginning 2001-10-01, Quality Systems will provide training for centre staff to ensure appropriate recall procedures are completed in the event of consumable product recalls.

Equipment / Equipement - C.02.005

The validation protocol for the Sebra 1040 Digital Shakers did not challenge the following specifications, variance of oscillation (cpm), tilt angle (degrees) and accuracy of the timer (flow). Eight shakers were not tested at mobile clinic sites. The digital weight readings from the shakers and the scale weights were not recorded for those shakers, which were tested at mobile clinic sites.

The Sebra 1040 Digital Shakers were purchased and implemented prior to March 2000. Therefore they fall under the guidance provided by the BBR (letter of 2000-07-14). The guidance indicated that there was no need to revalidate equipment already in existence at CBS. In addition, the shakers were implemented after two pilot trials that were pre-approved and reported to the BBR. Our policy is that existing equipment will be revalidated only after significant repairs. Their state of validation is maintained through the preventive maintenance and calibration programs.

Quality control department / Service du contrôle de la qualité - C.02.015

Reagents for use with transmissible disease tests kits that were received separately from the kits were not subject to quality control testing prior to use.

Effective 2001-06-18, all reagents that are received separately from the transmissible disease test kits will be subject to quality control testing prior to use.

A directive has been developed to address quality control testing of reagents for use with transmissible disease test kits received separately from the kits. The directive will be effective 2001-07-15

Manufacturing control / Contrôle de la fabrication - C.02.011

There was no consistency in the records kept for Directed Donations and Emergency Release of Product.

To ensure consistency in the records kept for Directed Donations and Emergency Release, a centre checklist will be developed for each type of file to ensure all required documents are available prior to closing the files. This checklist will be effective 2001-08-06.

Also effective 2001-08-06, CS 90-214 "Directed Donation Program: Registration and Health Assessment", as well as CS 90-04 130 "Emergency Issue" will be revised to reflect this change in the process for management of these records.

Manufacturing control / Contrôle de la fabrication - C.02.011

A defective pack (leak at spike entry port) was not labelled with a Special Information Tag (SI Tag) as required by SOP 01 081 and subsequently the unit was partially processed. A non-conformance report was not completed after the error was discovered to allow for appropriate follow up of the incident.

Since this occurrence on 2001-02-01 all centre collections staff have completed recertification in SOP 01 081 "Special Information Tag". Recertification was completed 2001-05-31. In addition to this, centre non-conformance #QS2001-668 has been initiated to ensure appropriate follow up of the incident is completed.

Manufacturing control / Contrôle de la fabrication - C.02.012

There was no standard practice for the notification of recalls of consumable products to the Centre from CBS Head Office.

An SOP to address notification of recalls of consumable products to the Centres from CBS Head Office ( SOP 08 139 Notification of Recall - Head Office) was submitted to the Bureau on 2000-11-07 as part of the Recall Standard Operating Procedures package (CBS#1308, BBR Control Number 068994). An Acceptable Screening letter (Document #228225) dated 2000-12-05, assigning the submission Category III status, is the last correspondence received from the Bureau concerning this submission,

Quality control department / Service du contrôle de la qualité - C.02.015

The antisera used for phenotyping red cell units was not subject to quality control testing prior to use.

Effective 2001-09-28 COP QC.NF.013 "Procedure for ABO and Rh Antisera Lot Shipment Receipt and Acceptance Testing" will be revised to include that all antisera used for phenotyping red cells will be subject to quality control testing prior to use.

A change request will be submitted to the Change Control Unit to implement on a National basis a lot acceptance program for incoming reagents (to include phenotyping antisera). An impact assessment across all Centres will be performed to determine purchasing patterns, product stability, potential problems, staff/operational impact and propose implementation plan. The BBR will be notified of this CCU review outcome.

Personnel / Personnel - C.02.006

There was no programme in place at the Centre to assess staff, at appropriate frequencies for the manual procedures that are used for transmissible disease testing.

A COP will be developed to put in place a programme to assess staff at appropriate frequencies for the manual procedures that are used in Transmissible Disease Testing. Effective date: 2001-09-28.

Further, national training policies and procedures are being developed. These will include a requirement for routine competency in selected critical processes and procedures. These policies and procedures will be in place by 2001-12-31.

Manufacturing control / Contrôle de la fabrication - C.02.011

There were no records to indicate the date that the tapes used for daily back-up of the LDMS system were put into service, as required by Standard Operating Procedure 07 112, Managing Magnetic Media Room.

Effective 2001-07-03, new tapes will be used to provide for daily back up of the LDMS system and labelled as required. Also, as required by Standard Operating Procedure 07 112, records will indicate the date the tapes were placed into service.

Personnel / Personnel - C.02.006

There was no Job Description for the position of Coordinator Centre Systems at the time of staffing of the position.

Resolved during audit.

Manufacturing control / Contrôle de la fabrication - C.02.011

There was no copy of Directive D 2001-003, Use of Temperature Indicators in Centre Shipments of Plas®SD Plasma (Human), Solvent/Detergent Treated, Frozen, in the work area where the product would be packed for shipping.

Resolved during audit.