QBC STAR™ System User’s Manual
5–6
L–000867(A)
External liquid controls
QBC Controls are available for additional performance monitoring of the QBC STAR system. You
must
run liquid controls
and document the results before you begin testing with a new lot or newly received shipment of QBC STAR tubes. You
must
run liquid controls and document the results with each instance of instrument relocation or repair. Consult the
package insert accompanying the controls for preparation instructions and expected results. You
must
also follow any
quality control requirements from your regulatory or accreditation agencies.
Profi ciency Tests
Profi ciency testing is an external evaluation of the quality of a laboratory’s performance. Laboratories enrolled in a profi ciency
testing program for the QBC STAR System will receive fi ve unknown specimens, three times each year. These specimens are run
in the same way that patient specimens are tested. Results are submitted to the profi ciency testing program for comparison
to results obtained by other laboratories using the QBC STAR System.
A partial list of organizations that may offer profi ciency testing for the QBC STAR System is shown below:
American Profi ciency Institute (API)
American College of Phycisians (ACPS)
1159 Business Park Drive
2011 Pennsylvania Ave., NW
Traverse City, MI 49686
Suite 800
800-333-0958
Washington, D.C. 20006
800-338-2746
American Academy of Family Physicians
College of American Pathologists (CAP)
PT Program Coordinator
Surveys Department
11400 Tomahawk Creek Parkway
325 Waukegan Road
Leawood, KS 66211
Northfi eld, Illinois 60093
800-274-7911
800-323-4040
American Association of Bioanalysts (AAB)
205 West Levee
Brownsville, Texas 78520
800-234-5315
Level 1
Level 2
Level 3
Min
Target
Max
Min
Target
Max
Min
Target
Max
36.9
37.9
38.9
44.9
45.9
46.9
65.1
66.1
67.1
12.3
12.9
13.5
14.8
15.6
16.4
20.6
21.7
22.8
31.6
34.0
36.6
31.6
34.0
36.5
30.7
32.8
35.0
90
100
110
342
360
378
615
647
679
4.6
5.7
6.8
9.5
10.6
11.7
48.5
53.5
58.5
2.2
2.7
3.2
6.0
6.5
7.0
28.3
31.3
34.3
38
47
57
56
61
67
54
59
63
2.4
3.0
3.6
3.5
4.1
4.7
20.2
22.2
24.2
43
53
62
33
39
44
37
41
46
HCT (%)
HGB (g/dL)
MCHC (g/dL)
PLT (x 109/L)
WBC (x 109/L)
GRAN (x 109/L)
%GRANL
L/M (x 109/L)
%L/M