Héma-Québec passes annual inspection at his Montreal Centre

MONTREAL, QUEBEC, April 19, 1999 - HÉMA-QUÉBEC has successfully completed another phase in its young history.

Following the annual inspection of procedures which took place from March 23 to 26, inspectors from the Bureau of Biologics and Radiopharmaceuticals (BBR), Health Canada maintained HÉMA-QUÉBEC's license as Québec's blood supplier.

The maintaining of the license signifies that the Québec organization is complying in all respects with the safety measures imposed by Health Canada and reassures the public and hospital patients that they can have confidence in their blood supplier.

Once a year, Health Canada inspects all transfusion centres in Canada to ensure that safety procedures are followed and consequently that our blood banks are as safe as possible.

Throughout their inspection, BBR inspectors noted that safety with respect to blood units and the various blood products was a priority for HÉMA-QUÉBEC's staff.

The inspectors made only few minor observations concerning product safety, and measures have already been, or soon will be, taken to remedy the situation. Their comments were directed either at the way certain procedures were carried out or they pertained to the way in which files are completed.

"The results obtained are a reflection on our excellent staff and I would like to take this opportunity to thank them for their hard work since HÉMA-QUÉBEC began operating," said André Roch, Senior Director of Operations.

HÉMA-QUÉBEC must organize about 1,858 blood donor clinics throughout the province in order to supply the 450,000 blood components needed by the hospitals.To fulfill its mission, the Québec company counts on blood donors and on the cooperation of some 25,000 volunteers to organize the clinics.

As part of its mandate, Héma-Québec's mission is to provide the Québec population with safe, top-quality and sufficient blood components, products and substitutes to meet the needs of hospitals and offer recognized expertise and specialized immunohematology services.

OBSERVATIONS AND RESPONSES
WHOLE BLOOD - Manufacturing Control - C.02.011 1.
On one occasion, directive D96-043 "use of sterile gloves for venipuncture" was not followed with respect to the palpating of the prepared puncture site. It is acceptable to palpate only above the area where the needle is to be inserted.
Response: To correct the situation, the person concerned was immediately informed that she had not complied with directive D96-043. She was evaluated and received more training regarding that directive on April 15, 1999. This measure will be recorded in the training file.

WHOLE BLOOD - Manufacturing Control - C.02.011 2.
On several occasions, some of the centrifuges for platelet production indicated temperatures of less than 20oC. The acceptable temperature range is from 20o to 24oC.
Response : Further to comments received during the inspection, a preliminary study was conducted of this equipment on March 24, 1999. It seems to confirm that the buckets and the products remain within the norms even if the displayed temperature drops below 20oC. All our centrifuges of this type will undergo thorough validation by July 31, 1999.

WHOLE BLOOD - Premises - C.02.004 3.
The quarantine area used to store blood components was also used to store released test kits.
Response: Blood components in quarantine and released test kits will be stored in separate refrigerators upon the delivery of new refrigerators, scheduled for July 31, 1999.

WHOLE BLOOD - Manufacturing Control - C.02.011 4.
Procedure SL 211 called "Blood component preparation CP2D platelets, leukocytes reduced using PL leukotrap system" 1) was not followed with respect to the labelling of the platelet satellite packs, and, 2) shows that plasma satellite packs (which are empty) are labelled at this stage. The practice was to label platelet packs during the rest period and plasma packs immediately before freezing.
Response : Procedure SL 211 will be replaced with SOP 02 064 - Preparation of AS-3 red blood cell leukocytes reduced by filtration and SOP 02 080 - Preparation of CP2D platelets, leukocytes reduced by filtration once leukoreduction by filtration process is implemented. Both these SOPs correct the situation brought to light in the observation.

WHOLE BLOOD - Quality Control Department - C.02.015 5.
Error and Accident Reports 60-98-056 and 60-98-057 were incomplete: 1) additional investigations were required for Error and Accident Report 60-98-056, and 2) two people were involved in Error and Accident Report 60-98-057, but a follow-up was conducted with only one of them.
Response : 1) Error and Accident Report 60-98-056 concerns the process of identifying blood product consignees. The additional investigations resulted in modifications to the LGP-INS-002 procedure - Handling and shipping of blood products to ensure clearer instructions on the use of shipping labels. Employees involved will receive training in the modified procudure after its approval by BBR. 2) The follow-up will be conducted and completed with the other person involved in Error and Accident Report 60-98-057 by April 30, 1999.

WHOLE BLOOD - Manufacturing Control - C.02.012 6.
Error and Accident Reports 60-98-021 and 60-98-068 were incomplete because a copy of the relevant record of donation was not included.
Response : A copy of the record of donation is now included in Error and Accident Reports 60-98-021 and 60-98-068. As of April 19, 1999, a copy of the record of donation will be attached to the Error and Accident Reports, when necessary.

WHOLE BLOOD - Manufacturing Control - C.02.011 7.
In the blood component lab, rejected ABO labels were not defaced according to directive D96-030.
Response : On March 26, the person in question was informed of the requirements of directive D96-030. This information was recorded in the training file.

WHOLE BLOOD - Production Control -C.02.011 8.
The Bio-Tek L312 reader was verified twice, after changing a lamp, which is contrary to procedure. Response : A non-conformance report will be completed and a memo sent to employees in the department in question by May 15, 1999. Reading of this memo will be documented. WHOLE BLOOD - Records - C.02.020 9. The Olympus PK 7200 files "Preventive Maintenance Check List" and "Field Service Report" were not legible.
Response : The carbon copies will be retrieved from accounting and from now on the original Olympus records will be copied. This process will go into effect starting with Olympus representative's next visit.

WHOLE BLOOD - Quality Control Department - C.02.015 10.
The results of the review of the preventive maintenance record pertaining to the Hamilton AT pipettor were not documented.
Response : This practice will change and the name of the company and the reviewer will be documented. A memo listing the critical points to be reviewed during record verification will be issued on May 15, 1999. Reading of this memo will be documented.

WHOLE BLOOD - Files - C.02.020 11.
Reports of equipment breakage for the Hamilton AT pipettor and the Olympus PK 7200 analyzer were not always initialed or reviewed by the supervisor.
Response : A memo listing the critical points for review of the maintenance and verification documents will be issued and filed. Also, to reflect these changes, form ASQ-ENR-064 equipment breakage report will be modified by May 15, 1999.

WHOLE BLOOD - Quality Control Department - C.02.015 12. There was no description of the steps to follow for counting the leucocytes in the deglycerized red blood cell units.
Response : Since this step was unnecessary, it will be eliminated beginning in May 1999.

WHOLE BLOOD - Manufacturing Control - C.02.011 13.
Step 7.12.1 of the VIR-INS-008M procedure was not followed: "place them (the serum tubes) in the RC-29A refrigerator and put the orange covers back on". Several tubes were not covered.
Response : A memo with a reminder about the process will be issued by May 15, 1999. Reading of this memo will be documented.

WHOLE BLOOD - Records- C.02.020 14. Post-it notes were found in the non-conformance files and the maintenance schedule for the virology equipment.
Response : A memo will be sent to the staff concerned forbidding the use of post-it notes by May 15, 1999. Reading of this memo will be documented.

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