AABB Audit January 16 to January 18, 2001

Nonconformance Reference # 1
Section 2.0 Resources:
2.1 Current job descriptions shall be maintained and shall define appropriate qualifications for each job position.
Objective Evidence:
4 job descriptions reviewed - 2 for QA, 2 for collections - there was no evidence of qualifications required for the positions.

Answer: 1
Job description will be reviewed to include qualifications required for the position, i.e. education, training, experience or a combination of all the above.
In compliance: September 2001

Nonconformance Reference # 2
Section 3.0 Equipment :
3.3.1 The calibration process shall includeÖ unique identification, action to be taken for unsatisfactory results.
Objective Evidence :
1- Beckman centrifuge taken out of service, repaired by Beckman representative and lacks documentation of review of repair by metrology and acceptance by supervisor.

Answer: 2-1
A job aid will be written to provide the appropriate review of the documentation by a person in charge after every maintenance service from an external firm.
In compliance: March 31, 2001

Objective Evidence :
2- Washer # 14 in TD Lab does not have a "unique identifier". There is evidence that this washer has been replaced multiple times and # 14 is applied to each new washer.

Answer: 2-2
Number 14 identifies a workstation within the laboratory. Our traceability system enables us to know at anytime the unique equipment (by recording the serial number) used at the workstation # 14. The form will be corrected to assure this traceability. The regular change of this equipment within a workstation is covered by our contract with the supplier.
In compliance: March 2001

Nonconformance Reference # 3
Section 3.0 Process Control :
5.1.2 The blood bank Ö shall participate in a proficiency testing program. Results shall be reviewed and corrective action taken, where appropriate when expected results are not achieved.
Objective Evidence :
1- There is no evidence of a process or procedure addressing review and management of proficiency test results.

Answer: 3-1
A SOP will be implemented that will address review and management of proficiency test results.
In compliance: June 2001

Objective Evidence :
2- ABO & Rh proficiency is not performed on the Olympus PK 7200. CAP samples are tested by manual methods.

Answer: 3-2
The quality controls received by the College of American Pathologists (CAP) cannot be used on the Olympus PK7200 (sample volume too small for the automated equipment). Samples identified on the Olympus will be tested along with the CAP samples by the manual method which is used to resolve ABO/Rh discrepancies on donor samples.
In compliance: March 2001

Nonconformance Reference # 4
Section 3.0 Process Control :
5.1.3 Quality Control : A program of quality control that is sufficiently comprehensive to ensure that reagents equipment and methods functions as expectedÖ
Objective Evidence :
1- CMV Test Kit 0280745 - qualification testing not performed adequately - test results were repeated inconsistent with standard practice.

Answer: 4-1
SOPs concerning quality control lots will be revised to specify the procedure in case of failures.
In compliance: March 2001

2-. Temperature record for SS 29-A (15 - 25 oC) indicates several instances of the temperature being out of range with no explanation (November 2000). Record was reviewed by supervisor.

Answer: 4-2
There is no blood product stored in the SS-29A. This space is only kept for the UPS (Uninterrupted power supply) batteries following a recommendation from the UPS supplier to prolong the shelf-life. We document the temperature only for our records. The SS-29A has not been taken out of our controlled areas.
In compliance: February 2001

Nonconformance Reference # 5
Section 3.0 Process Control :
5.7.2 If a sterile connection device is usedÖ the weld shall be inspected for completeness
Objective Evidence :
1- There is no evidence of documentation of inspection of the weld.

Answer: 5
The inspection of the weld is done but not documented. The actual form on which sterile connections are documented will be revised to include the confirmation of this inspection.
In compliance: April 2001

Nonconformance Reference # 6
Section Documents & Records:
6.1.4 Annual review of each policy, process and procedure by an authorized individual
Objective Evidence :
1- There is no evidence that an annual review of policies, processes and procedures is performed.

Answer: 6
The annual review of policies, processes, and procedures is covered by a SOP. We will initiate this annual review starting April 1, 2001.
In compliance: starting April 1, 2001

Nonconformance Reference # 7
Section Facilities & Safety:
10.0 The blood bankÖ shall have policies, processes and procedures to ensure the provision of safe ... conditions in the workplace.
Objective Evidence:
1- The blood bank is not enforcing the use of safety and protective equipment:

7-1 Ear protection while using dry ice machine;
7-2 Splash shields in the TD Lab;
7-3 Availability of latex and non-latex gloves not evident.

Answer: 7-1
Our CSST (Workers Compensation Board) is presently studying the decibels level to identify the appropriate hearing protection needed. The recommendation is expected at the end of February 2001. The recommendation will take place immediately.
In compliance: March 2001

Answer: 7-2
Our CSST (Workers Compensation Board) is currently identifying the appropriate splash shields. These will then be installed.
In compliance: March 2001

Answer: 7-3
We have non-latex and latex gloves available. They will be identified appropriately.
In compliance: March 2001