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Berd inspection at Héma-Québec from december 6-14, 2001

Berd inspection at Héma-Québec from december 6-14, 2001

OBSERVATIONS AND RESPONSES
WHOLE BLOOD - Quality Control Department - C.02.015
1. NAT samples were stored at room temperature prior to being packaged for the external laboratory, putting in question the maximum time permitted at room temperature (8 hours ) between sampling and screening tests.

Response:
Personnel assigned to preparing NAT samples will be encountered and made aware of the importance of not leaving samples at room temperature for unjustified periods of time. A memo will be issued.

Moreover, we will evaluate the need for an additional refrigeration unit near the workstation.
In conformity: 30-01-2002

WHOLE BLOOD - Manufacturing control - C.02.011
2. A unit of blood, labeled conforming but expired since September 13, 2001, was sealed in a container labelled "Donor rejected" and stored in the RC-37A. At least two procedures were not followed:
1) The investigation further to the application of a DAR was incomplete, resulting in the disposal of only the plasma;
2) The procedure governing printing of a pre-expiration list of products showed that there was a unit of blood in inventory, that it had not been destroyed.

Response:
2.1 and 2.2 :
As specified in the SOP, a list of expired products is issued daily and shows all products that will expire at midnight on that day. All products appearing on this list are withdrawn from available inventory and placed in a sealed container.

To ensure that all expired products have in fact been destroyed, we will compare the expired products list every day against the list of expire
In conformity: 30-01-2002

WHOLE BLOOD - Manufacturing control - C.02.011
3. Ice packs, which are stored between -8 and -14oC, were taken out of their storage area well before they were used to package blood products, without validation of the time delay.

Response:
A systematic evaluation of the time that ice packs are kept at room temperature will be performed in January. This will enable us to establish maximum exposure conditions and times during the packaging process.
In conformity: 28-02-2002

WHOLE BLOOD - Manufacturing control - C.02.011
4. SOP LGP-SPE-010 entitled "Packing methods for blood products" was not respected regarding the step "Add paper as necessary to fill the empty space".

Response:
Documented training on SOP LGP-SPE-010 "Packing methods for blood products" will be provided to all personnel assigned to shipping operations. We will specifically underline the importance of strictly following the instructions in this SOP as this methodology was validated to ensure the quality, integrity and safety of our products during transportation to hospitals.
In conformity: 30-01-2002

WHOLE BLOOD - Quality Control Department - C.02.015
5. Regarding "Recovery yields after RCPL and WB filtration of leukocyte?reduced donations":
1) Yields for June 2001 were done on 3 bags instead of 10
2) Yields for August 2001 were done on 8 bags instead of 10
3) Yields for September 2001 were not done.

Response:
The employees in question will receive training by February 28, 2002 to ensure that this task will no longer be overlooked. An employee will be appointed to issue reports on the monthly recovery yields after RCPL and WB filtration of leukocyte-reduced donations. A follow-up, one week prior to the end of each month, will be performed by the personnel responsible for quality control to ensure that the report is duly completed before the end of the current month.
In conformity: 28-02-2002

WHOLE BLOOD - Records - C.02.020
6. Transcription errors were found in the following reports:
1) On the worksheet "Anti-erythrocytes antibody screening" (BDS-ENR-003) dated September 14, 2001, a different plate number was entered by two people for the same plate.
2) In a designated donor record, the date of donation 936727-1 noted in the donor record and recipient record were not the same.

Response:
6.1 The responsible person will be encountered and instructed to pay careful attention when transcribing information. Moreover, a sample of BDS-ENR-023 "Anti-erythrocyte antibody screening" will be verified to determine whether these undetected transcription errors are isolated incidents. The blood bank SOPs are currently undergoing a major review; forms will be reviewed, among other things, to decrease the quantity of required manual transcriptions.
In conformity: Sample of BDS-ENR-023 on 25-01-2002
Review of blood bank SOPs on 01-03-2003

6.2 The record was corrected. The quality improvement report SCP-M-01-108 was completed.
In conformity: 08-01-2002

WHOLE BLOOD - Records - C.02.020
7. A review of PROGESA anomaly records showed that:
1) In certain circumstances, a non-conformance should have been documented (INF-117 and INF-093);
2) The documentation supporting the anomaly was unavailable (INF-121 and INF-124);
3) The anomaly was closed in the record on August 23, 2001 but not in the database printed October 9, 2001 (INF-152) and vice versa (INF-129).

Response:
7.1 Two ASQ-ENR-011 non-conformances (PRO-M-02-001 and PRO-M-02-002) were completed 03-01-2002 for anomaly records INF-117 and INF-093.
In conformity: 03-01-2002

7.2 The personnel assigned to anomalies will be asked to document their responses and corrective actions in more detail in the future. This request will be sent by February 28, 2002.
In conformity: 28-02-2002

7.3 The database printed October 9, 2001 will be corrected to indicate the closing date of August 23, 2001 for anomaly INF-152, and the status "in progress" will be indicated for anomaly INF-129. This correction will be made by January 30, 2002.
In conformity: 30-01-2002

WHOLE BLOOD - Records - C.02.020
8. A review of the documentation showed that:
1) Equipment maintenance forms and "Updating laptop computer" sheets had not been adequately completed.
2) Several sections had not been completed on Quality improvement reports (ASQ-ENR-050.11 and ASQ-ENR-011) .
3) Numerous inspection sheets for refrigeration devices and quality control reports had been verified several months later.
4) Follow-up forms for the receipt of donation number labels from distributor for September to November 2001 and the collection pack registers from October 2001 had not been verified.
5) In one case, the platelet pheresis control sheet from September 2001 had not been verified.

Responses:
8.1 A reminder concerning the GMPs will be done by January 30, 2002 for personnel who complete "Updating laptop computer" sheets so that they will adequately document when a laptop computer is unavailable or not updated.
In conformity: 30-01-2002

8.2 Quality Assurance, which is the last department to receive these records, must ensure they are completed adequately.
In conformity: 08-01-2002

8.3 It was agreed upon with the Biomedical Equipment Department (BED) that all forms will be verified within a maximum of 14 days following their completion. A memo will be issued.
In conformity: 30-01-2002

8.4 A systematic verification of all documents "Follow-up forms for the receipt of donation number labels from distributor" and "Collection pack registers" for 2001 will be completed.
The personnel who verify these documents will follow up on these forms regularly.
In conformity: 01-03-2002

8.5 The platelet pheresis quality sheet for September 2001, which had not been verified or signed, was verified and signed on December 10, 2001.
In conformity: 10-12-2001

WHOLE BLOOD - Manufacturing control - C.02.0119. Several donation number labels were found on the floor in the "walking" refrigerator RC-26A.

Response:
The problem of detaching labels was raised last year. The problem was rectified by the latest label version that we are currently using. As few labels had fallen off, and in order to take appropriate corrective action, we will proceed as follows:
- Regularly verify for the presence of detached labels.
- If other labels are found on the floor, the situation will be evaluated so as to take the necessary corrective measures.
In conformity: 31-03-2002

WHOLE BLOOD - Manufacturing control - C.02.01110. In a designated donor record, authorization by the medical director, Medical Affairs for a first donation was not documented in form SCP-ENR-030.

Response:
The personnel in question will receive additional training on SOP SCP-INS-012 "Designated donations program", referred to in form SCP-ENR-030 "Request to designate donations program".
In conformity: 01-02-2002

WHOLE BLOOD - Manufacturing control - C.02.012
11. The deadlines stipulated in procedure ASQ-INS-028 for a response from the auditee were not always respected. For example:
1) For the audit AUD-01-008, the response to the auditor's last follow-up (August 17, 2001) was received in December
2) For the audit AUD-01-009, the response to the auditor's last follow-up (July 20, 2001) was not received, whereas it had been requested for August 13, 2001.

Response:
The deadlines stipulated for responding to audits are now determined at the end of the audit with the manager of the department being audited. The auditors and the auditees discuss corrective actions before the final response is sent. This eliminates the need to request a review of responses, by enabling identification of appropriate corrective actions and limiting subsequent communications, which cause delays.
In conformity: 15-01-2002

WHOLE BLOOD - Premises - C.02.004
12. Plasma from a rejected donor was stored in a sealed container in an area for products released for distribution (in inventory).

Response:
It was agreed upon with the personnel in question that any product having been placed in quarantine for various reasons will be transferred to the quarantine areas. A memo will be distributed and a documented follow-up performed with the personnel involved.
In conformity: 30-01-2002

WHOLE BLOOD - Equipment - C.02.005
13. During calibration of a shaker, the standard weight was placed directly on the table.

Response:
Operating the Sebra shaker does not require such a high level of precision in terms of the handling of the standard weights. It is therefore not necessary to place the standard weight back in its original case after each calibration. Instead, it can be placed on a clean surface during the calibration.
All SOPs in question will be modified accordingly.
In conformity: 01-06-2002

WHOLE BLOOD - Manufacturing control - C.02.011
14. A job-aid describing the steps for calibrating the Sebra shaker was not controlled.

Response:
All cases standard weights for shakers will be verified. All job aids will be withdrawn. Employees will use the controlled documents already distributed for this purpose.
In conformity: End of February 2002

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