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Re: Responses to the BBR Audit of Regina Centre 4-8 June 2001


Re: Responses to the BBR Audit of Regina Centre 4-8 June 2001

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

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

1. Review of the Record of Donations (RD) for mobile clinic, Moose Jaw, on 2001 Jan 03 showed:

  1. Incorrect clinic date (year as 00 and not 01) on 4 RDs.
  2. A or D on RD for Hemocue results was not circled as required in WI 7.1 of SOP 01 050 Determine Hgb/Hct (Whole Blood/Autologous) on 2 RDs (Resolved During Inspection – Discussed with staff 2001-04-10).
  3. On one RD the screening nurse entered a comment to clarify question 8(b) but it was marked as 8(a).

  1. The Records of Donation from 2001-01-01 to 2001-01-15 were reviewed to ensure the correct year was entered. A Non Conformance report was initiated 2001-06-15 for the incorrect date entry.
  2. Resolved during inspection. – Discussed with staff 2001-04-10.
  3. A Non Conformance Report was initiated 2001-06-14 for the documentation error. The process to ensuring correct documentation was reinforced with Nursing department staff at the 2001-06-15 department meeting.

Manufacturing control / Contrôle de la fabrication – C.02.011

2. Supervisory review was not performed for the months of April and May 2001 for Cobe Spectra- QC Maintenance record (Form RNP009).

Resolved during the inspection.

Manufacturing control / Contrôle de la fabrication – C.02.011

3. Uncontrolled documentation (memo) available in Component Production which provides instructions for the manufacturer of platelets.

Resolved during the inspection.

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

4. The scope of the audit for Regina General Hospital must be expanded to include the process of doing blood counts since they are routinely done to resolve MD-16 sample flags for plateletpheresis donors.

The scope of the audit of the Regina General Hospital will be expanded to include the process of doing blood counts. The Internal Audit Schedule has been changed to reflect an audit of the Regina Hospital Laboratory by September 30, 2001.

Manufacturing control / Contrôle de la fabrication – C.02.011

5. REPEAT OBSERVATION

There was no monitoring of the humidity for the Olympus PK7200. The manufacturer’s recommendations is that relative humidity should fall between 40-80%. The letter from Olympus dated September 17, 1999, states that humidity “less than 40% may potentially cause erratic level detection, static interference…” The further indicated that “your experience over the past several years…would be the best indicator….in your lab”. Since the Olympus PK7200 has just been installed at this Centre, that information is not available.

A study to measure and evaluate relative humidity in Canadian Blood Services laboratories that use the PK instruments has been developed. Pending the delivery of the monitoring equipment, it is anticipated that the study will commence on 2001-09-30.

Records / Dossiers – C.02.024

6. Some supplies listed on Temperature Sensitive Products Listing (RNQ031) were stored in a storage area not monitored for temperature.

Resolved during the inspection.

Equipment / Equipement – C.02.005

7. The calibration due date label was out of date for the Thermograph (CHR-0001) in the Component Production area, although the calibration had been performed.

Resolved during the inspection.

Manufacturing control / Contrôle de la fabrication – C.02.012

8. The audit schedule was not up to date.

Resolved during the inspection.

Manufacturing control / Contrôle de la fabrication – C.02.011

9. Some forms did not indicate the acceptable ranges for example:

  1. Form F020331 Copper Sulphate Quality Control Record
  2. Centre Form Clocks, Elapsed-Time.

  1. A Change Request will be submitted to CCU by 2001-07-24 to revise the form as requested.
  2. The form,’Clocks Elapsed – Time’, was revised to indicate the acceptable ranges 2001-06-08.

Records / Dossiers – C.02.020

10. Some records were incomplete, not reviewed, or had inaccurate information recorded:

  1. Form Hamilton AT Pipetter/Diluter (Summit) User Maintenance Log (2001 Feb)
  2. Form F040353 Olympus PK7200 Weekly Maintenance Log (2001 Jan)
  3. Centre version of F030949 Monthly Report of Whole Blood Components (Resolved During Inspection)
  4. Equipment Service Request for preventative maintenance of the Fiche Reader (FIC-0001, dated 2001-01-13)
  5. Clocks, Elapsed-Time (2001-01-10 and 2001-01-11).

  1. The documentation error was corrected and a Non Conformance Report was initiated on 2001-06-06. The laboratory manager reviewed the intent of the review process with the technologists at the Technologist Meeting on 2001-06-06.
  2. The documentation error on Form F040353 Olympus PK7200 Weekly Maintenance Log was corrected and a Non Conformance Report was initiated on 2001-06-06. The Laboratory Manager reviewed the intent of the review process with the technologists at the Technologist Meeting on 2001-06-06.
  3. Resolved during inspection.
  4. The supervisory review of the Equipment Service Request form was performed 2001-06-07. A Non Conformance Report was initiated 2001-06-14. The Clocks, Elapsed – Time form for (2001-01-10 and 2001-01-11) was completed 2001-06-14. A Non Conformance Report was initiated 2001-06-14.