Program: {{mc.record.selSubscription.programName}}
Program Code: {{mc.record.selSubscription.vCode}}
Report Issued Date: {{mc.record.selSubLot.resDate}}
Round No: {{mc.record.selSubLot.name}}
Cycle No: {{mc.record.selSubscription.cycleName}}
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Organized by: FUGEN BIOMED FUGEN BIOMED PVT. LTD.
Program Co-coordinator: Ms. Hinal K. Mistry
Report Authorized by: Dr. Pranav Naik
Contact Details: 11, Dharmabhakti Complex, Khushalwadi, Jamalpore, Navsari – 396445, Gujarat, India 104, Dharmabhakti Complex, Khushalwadi, Jamalpore, Navsari – 396445, Gujarat, India
E-mail: pmt@fugenbiomed.com
Contact No.: 7096119992
Lot No.: {{mc.record.selSubLot.programLotNo}}
Result Deadline Date: {{mc.record.selSubLot.subDate}}
Test Sample: Ready to use control sample contain human erythrocytes, mammalian leukocytes and mammalian platelets suspended in plasma like fluid with preservative. It has chemical-physical characteristics similar to patient samples.
Subcontract Activities: Procurement of samples
Homogeneity and Stability: Samples are procured from ISO 9001:2015/ISO 13485:2015 certified suppliers, who have successful track records of providing samples for the EQA programs, of global recognition. Homogeneity and stability study of the test samples are carried out by supplier using their internal procedures in accordance with the ISO 13528:2015 standard.
Confidentiality: EQAsure is committed to maintain confidentiality for each participant. To protect the privacy of each participant assigned an Unique Participant Number (UPN), which known to EQAsure and participant only. The result contained in report is for the use of the laboratory only.
Statistical Evaluation:
At the end of each exercise, laboratory specific report in PDF format is issued. This report provides detailed analysis of performance of all reported analytes for particular exercise.
Evaluation of result is based on the comparison between the result reported by the participant and assigned value calculated based on result submitted by homogenous participants. The result is presented in statistical as well as in graphical presentation.
The assigned value coincides with the average of the result submitted by the participant (Average of the homogenous group). The mean and standard deviation of the homogeneous group are calculated using Algorithm A described in Annex C of ISO 13528:2015 standard.
Standard uncertainty of assigned value is determined as per below given formula.
U (xpt) = 1.25 x σ/√p
Laboratory performance is evaluated as a Z-score and calculated as per below formula given in ISO 13528:2015 standard:
Z = (Xi-Xpt) / σpt
Acceptance criteria:
- -2 ≤ Z-score ≤ 2 – “Acceptable”
- -3 < Z-score < -2 or 2 < Z-score < 3 – “Questionable”
- < -3 Z > 3 – < -3 Z-score > 3 – “Unacceptable”
Organized by: FUGEN BIOMED PVT. LTD.
PT Coordinator: Dr. Pranav Naik
Report Authorized by: Dr. Pranav Naik
Contact Details: 104, Dharmabhakti Complex, Khushalwadi, Jamalpore, Navsari – 396445, Gujarat, India
E-mail: pmt@fugenbiomed.com
Contact No.: 7096119992
Lot No.: {{mc.record.selSubLot.programLotNo}}
Type Of Scheme: Simultaneous Scheme
Result Deadline Date: {{mc.record.selSubLot.subDate}}
PT Item Description: Ready to use PT item contains human whole blood.
Subcontracted Activities Homogeneity and Stability Testing of PT item.
Homogeneity and Stability: Homogeneity and Stability testing of PT item were done as per ISO 13528 standard. The PT item should be considered adequately homogeneous if Ss ≤ 0.3σpt or 0.1δE. The PT item should be considered adequately stable if |X - Y| ≤ 0.3σpt or 0.1δE.
Confidentiality: EQAsure is committed to maintain confidentiality for each participant. To protect the privacy of each participant assigned an Unique Participant Number (UPN), which is known to EQAsure and participant only. The result contained in report is for the use of the laboratory only. EQAsure will not disclose participant details to any third party, unless required by regulatory authority and/or accreditation bodies, without the prior permission of the participant.
Statistical Evaluation: At the end of each round, participant specific report in PDF format is issued in participant login. This report provides detailed analysis of performance of all reported analytes for particular round. This report provides performance evaluation all reported results of analytes by participant for particular round.
Evaluation of performance is based on the comparison between the result reported by the participant and assigned value (robust mean) is calculated based on result submitted by homogenous participants. The statistical evaluation is presented in tabulated form as well as in graphical presentation.
Assigned value (robust mean) and standard deviation of the homogeneous group are calculated using Algorithm A described in Annex C of ISO 13528 standard. As consensus value from participant results is used to establish assigned value (robust mean) hence metrological traceability of results is not appropriate.
Standard uncertainty of assigned value is determined as per below given formula.
U (xpt) = 1.25 x σ/√p
Participant performance is evaluated as a Z score and calculated as per below formula given in ISO 13528 standard:
Z = (Xi-Xpt) / σpt
Acceptance criteria for Z Score:
Criteria | Description |
---|
|Z| ≤ 2.0 | If your Z score lies between ±2.0 Z score - considered to be Acceptable |
2.0 < |Z| < 3.0 | If your Z score lies between ± 2.0 to 2.99 - considered to be Questionable (warning signal) |
|Z| ≥ 3.0 | If your Z score is ± 3.0 Z score or more then it - considered to be Unacceptable (action signal). |
Note: All necessary details regarding design and implementation of PT, are provided in “Instructions for Participants” as well as on web portal.