PROFICIENCY TESTING
PERFORMANCE EVALUATION
2024 Immunology / Immunohematology - 3rd Event
1159 Business Park Drive, Traverse City, MI 49686
800-333-0958 (toll free) / +1 231-941-5887 (international)
www.api-pt.com
Please check the reports carefully. Errors made by API will be corrected if
reported within 60 days of the final report date.
Customer Information
Maireth Gomez
Clinica Zayma #2
Calle 28 7 11
Monteria,
Colombia
82770
API Customer Number:
CLIA Number:
CLIA ID indicates results available to CMS.
Results also available to:
,
The American Proficiency Institute evaluation reports consist of four parts : Report Cover, Performance Summary, Comparative Evaluation, and Participant Data
Summary. The Performance Summary and Comparative Evaluation are enclosed, and the Participant Data Summary is available on our website. Click on 'Participant
Data Summaries' on the left side of the screen, choose a Test Event, and select an analyte and peer group to view the statistics.
Laboratories should review the Performance Summary and Comparative Evaluation thoroughly for failures or 'not graded' analytes. Laboratories are responsible for
documenting and performing corrective action for failures and must perform a self-evaluation using statistics presented in the Participant Data Summary for samples
that have not been graded.
PERFORMANCE REVIEW AND CORRECTIVE ACTION
After reviewing the evaluation reports, complete the information below and retain this form along with the enclosed reports for your records.
Reviewed by (Lab Director or designee):
Date:
Corrective action taken (if indicated):
API Program Coordinator:
Anita Hoeksema: [email protected]
Final Report - 12/17/2024
Authorized by: Leigh Akerley
Technical Director
Part 1 of 4, Page 1 of 1
Customer No:
82770
CLIA No:
Address:
Not on file
Maireth Gomez
Clinica Zayma #2
Calle 28 7 11
Monteria,
Colombia
1159 Business Park Drive, Traverse City, MI 49686
Performance Summary
2024 Immunology / Immunohematology - 3rd Event
This is a summary of your proficiency testing performance for the last three test events. It is divided into sections according to specialty/sub-specialty. Unsuccessful long-term
performance, where indicated, is based on unsatisfactory scores for two of three test events.
The scores for individual analytes are defined as the ratio of acceptable responses to the number of samples tested, expressed as a percentage. Unsatisfactory performance
(denoted by ü) is indicated for any analyte with less than 80% (100% for ABO Group, D (Rh) Typing, and Compatibility Testing). Analytes that are scored for CMS are designated
by (**).
DIAGNOSTIC IMMUNOLOGY
General Immunology
Anti-HAV, IgM
Anti-HCV
Anti-HIV **
Anti-HIV-1/2, HIV-1 p24Ag (VM)
C-Reactive Protein (quan)
HBsAg **
HBsAg (confirmatory)
A-82770
2024 1st
2024 2nd
2024 3rd
100%
100%
100%
100%
100%
80%
100%
100%
100%
100%
100%
100%
80%
80%
80%
100%
100%
100%
ü 50%
80%
100%
Part 2 of 4, Page 1 of 1
Long Term
Notes (2024 3rd)
Testing Suspended
Testing Suspended
12/17/2024
1159 Business Park Drive, Traverse City, MI 49686
Comparative Evaluation
2024 Immunology / Immunohematology - 3rd Event
Customer No:
82770
CLIA No:
Address:
Not on file
Maireth Gomez
Clinica Zayma #2
Calle 28 7 11
Monteria,
Colombia
Kit No: 1
ISO/IEC 17043 - Proficiency Testing Provider
This report shows the result you reported, expected result, mean, SD (Standard Deviation), SDI (Standard Deviation Interval), and your grade for each sample tested. The SDI
compares your laboratory's result to the comparison group's mean and is defined as follows:
SDI =
Reported Result - Comparison Group Mean
Comparison Group Standard Deviation
Analytes that are scored for CMS are designated by (**). Analytes designated by (^) are not included in API's scope of ISO/IEC 17043 accreditation.
C-REACTIVE PROTEIN
Analyte / Method
C-Reactive Protein (quan) (mg/dL)
Randox RX Imola / Randox RXSeries Full
Range CRP
Sample
CRP-05
CRP-06
Reported Result
2.43
1.38
Expected Result
2.58 - 3.52
1.29 - 1.90
Mean
3.049
1.599
SD
0.232
0.113
SDI Performance
-2.7 Unacceptable
-1.9 Acceptable
VIRAL MARKERS
Analyte / Method
Anti-HAV, IgM
Other reagent-please review
Anti-HCV
Other method- wrong program
Anti-HIV-1/2 (VM) (screen) **
Other method-please review
HBsAg **
Other method-please review
Sample
VM-11
Reported Result
Non-reactive / Negative
Expected Result
Performance
Non-reactive / Negative
Acceptable
VM-12
Non-reactive / Negative
Reactive / Positive
Unacceptable
VM-13
Non-reactive / Negative
Non-reactive / Negative
Acceptable
VM-14
Non-reactive / Negative
Non-reactive / Negative
Acceptable
VM-15
Non-reactive / Negative
Non-reactive / Negative
Acceptable
VM-11
Reactive / Positive
See Data Summary
Not Graded 11
VM-12
Reactive / Positive
See Data Summary
Not Graded 11
VM-13
Non-reactive / Negative
See Data Summary
Not Graded 11
VM-14
Non-reactive / Negative
See Data Summary
Not Graded 11
VM-15
Non-reactive / Negative
See Data Summary
Not Graded 11
VM-11
Non-reactive / Negative
Non-reactive / Negative
Acceptable
VM-12
Non-reactive / Negative
See Data Summary
Not Graded 2
VM-13
Reactive / Positive
Reactive / Positive
Acceptable
VM-14
Non-reactive / Negative
Non-reactive / Negative
Acceptable
VM-15
Reactive / Positive
Reactive / Positive
Acceptable
VM-11
Non-reactive / Negative
Reactive / Positive
Unacceptable
VM-12
Non-reactive / Negative
Non-reactive / Negative
Acceptable
VM-13
Reactive / Positive
Reactive / Positive
Acceptable
VM-14
Non-reactive / Negative
Non-reactive / Negative
Acceptable
VM-15
Non-reactive / Negative
Non-reactive / Negative
Acceptable
2 - No Consensus
11 - No Appropriate Peer Grp
A-82770
Part 3 of 4, Page 1 of 1