SMILE Johns Hopkins University Baltimore, MD USA Guidelines for Manual Evaluation of CAP Urinalysis Results Author : Heidi Hanes, BS, MT (ASCP) SH Document Number: Pro22-23 Effective (or Post) Date: 10 Dec 08 Date of last review: 5 Aug 2010 Reviewed by: Heidi Hanes SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE. Purpose: These instructions are for performing a manual evaluation of CAP Urinalysis survey results. They can be adapted for performing manual evaluations for results from other EQA providers. Manual evaluations are performed when official grading is not done by your EQA provider. This can be because the survey was not resulted by the due date or when an additional instrument is tested. Materials: You will need the following documents: • A list of the instruments and methods that your laboratory uses for each analyte tested. • CAP Kit Instructions – These will be used to find your instrument/method codes. You will need this information to decide on a peer group. • CAP Participant Summary Report (PSR) – This lists the peer group means and standard deviations. • Urinalysis Manual Evaluation Template (Appendix A) – You complete this spreadsheet to determine if your results are acceptable according to the CAP/CLIA criteria used by SMILE. Procedure: How to complete and interpret the manual evaluation: 1. Open the CAP Urinalysis Manual Evaluation Template excel file. Save the file according to your naming convention – it should be specific for the instrument used and the survey module (e.g. Seimen Diag Clinitech 500 CAP2008 Urinalysis CM--A Manual Evaluation). 2. Each analyte has its own section on the template (Appendix A). Depending on whether the results are quantitative or qualitative there are two table formats. Refer to Appendix B for an example of where to find necessary information in the CAP Participant Summary Book and for how to enter information in the correct area of the template. Pro22‐23_Guide_Man_Eval_Urinal_Rslt .doc Page 1 of 4
Transcript
SMILE Johns Hopkins University
Baltimore, MD USA
Guidelines for Manual Evaluation of CAP Urinalysis Results
Author: Heidi Hanes, BS, MT (ASCP) SH
Document Number: Pro22-23
Effective (or Post) Date:
10 Dec 08
Date of last review: 5 Aug 2010 Reviewed by: Heidi Hanes
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE.
Purpose: These instructions are for performing a manual evaluation of CAP Urinalysis survey results. They can be adapted for performing manual evaluations for results from other EQA providers. Manual evaluations are performed when official grading is not done by your EQA provider. This can be because the survey was not resulted by the due date or when an additional instrument is tested. Materials: You will need the following documents:
• A list of the instruments and methods that your laboratory uses for each analyte tested.
• CAP Kit Instructions – These will be used to find your instrument/method codes. You will need this information to decide on a peer group.
• CAP Participant Summary Report (PSR) – This lists the peer group means and standard deviations.
• Urinalysis Manual Evaluation Template (Appendix A) – You complete this spreadsheet to determine if your results are acceptable according to the CAP/CLIA criteria used by SMILE.
Procedure: How to complete and interpret the manual evaluation: 1. Open the CAP Urinalysis Manual Evaluation Template excel file. Save the file
according to your naming convention – it should be specific for the instrument used and the survey module (e.g. Seimen Diag Clinitech 500 CAP2008 Urinalysis CM--A Manual Evaluation).
2. Each analyte has its own section on the template (Appendix A). Depending on whether the results are quantitative or qualitative there are two table formats. Refer to Appendix B for an example of where to find necessary information in the CAP Participant Summary Book and for how to enter information in the correct area of the template.
Pro22‐23_Guide_Man_Eval_Urinal_Rslt .doc Page 1 of 4
SMILE Johns Hopkins University
Baltimore, MD USA
Quantitative Analyte Procedure:
Qualitative Analytes
Specific Gravity
Acceptable Criteria = ± 2 SD or 0.010, whichever is greater
a. Analyte Name: Found in the top box. b. Acceptability Criteria: The acceptability criteria are listed below the
analyte name. SMILE uses acceptability criteria that have been established by CAP and/or CLIA regulations.
i. For most analytes, you will see only one type of acceptability criteria (e.g. + 20%).
ii. For other analytes, two sets of acceptability criteria are listed (e.g. + 20% or + 1.0, whichever is greater). In this case, you can evaluate the results using both criteria and choose the one that gives the wider acceptability range.
c. Peer Group: Use this information to determine your peer group. Sometimes, CAP does not have a peer group for your specific instrument and method combination. In this case, you can contact SMILE, and your primary or back-up representative can help you determine the correct peer group to use.
d. Your Result: Enter your results for each specimen. These results should be entered in columns B or J on the template.
e. Mean: Use the CAP Participant Summary Report (PSR) to find the peer group mean. The peer group mean should be entered in column C or K on the template.
f. SD: Use the CAP PSR to find the peer group standard deviation for each specimen. The peer group standard deviations are entered in columns D or L on the template.
g. Lower and Upper: The template has been arranged so that your acceptable range is automatically calculated when you enter your result, the peer mean, and the peer standard deviation.
i. Lower: Columns E and M list the lower limit of the acceptable range.
ii. Upper: Columns F and N list the upper limits of the acceptable range.
h. SDI: The SDI is automatically calculated when you enter your result, peer mean, and peer SD. Use the SDI listed in column G or O to determine if there is a positive or negative bias present.
i. Any SDI greater than + 2.0 indicates a bias for that specimen. ii. If two or more specimens demonstrate a bias in the same (positive
or negative) direction, then there is a bias for that analyte.
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SMILE Johns Hopkins University
Baltimore, MD USA
i. Your Grade: If your results fall within the acceptability limits, column H or P should indicate “Acceptable” for your grade. If your results are outside of the acceptable limits, your grade will be “Unacceptable.” (Note that if the result is on the upper or lower limits of the acceptable range the spreadsheet may read “unacceptable” when the result is really acceptable. Under these circumstances, the acceptability column should be corrected). NOTE: The quantitative analytes are Gastric pH, Osmolality and Specific Gravity.
Qualitative Analytes Procedure:
Qualitative Analytes
Protein, Urine
Your result Good/Acceptable Responses Your Grade CM-14 Negative Negative Good CM-15 300 - 600 mg/dL (2+) 300-600, or ≥ 1000 mg/dL Good CM-16 300 - 600 mg/dL (2+) 100-150 or 300-600 mg/dL Good
a. Analyte Name: Found in the top box. b. Acceptability Criteria: For qualitative procedures in urinalysis, evaluation is
based on participant consensus by method and instrument. For each analyte, a minimum of two, but not more than four, responses will be given a passing score. Analyte results graded “Good” performance must have 80% participant consensus. Eighty percent participant consensus can be determined by grouping the mode with the next one or two most frequent responses. This group will be given “Good “performance. “Acceptable” performance will be given to additional responses until a minimum of 90% of participant results are given a passing score. In the case of a negative specimen, negative responses must constitute 90% participant consensus. Specimens with results for one of more methods distributed over both negative and positive responses (non consensus) will not be evaluated. Specimens for which there is greater than 90% of participant responses distributed over more than four responses will be graded as “Non- Consensus”
c. Peer Group: Use this information to determine your peer group. For the Qualitative analytes there will be several results. The category with the most entries is the “Good” result. Results on either side of the “Good” result are Acceptable results. Occasionally, CAP will allow up to 3 results to be included in the acceptable range. Read the PSR Evaluation Criteria for detail grading information or contact your SMILE representative for assistance.
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SMILE Johns Hopkins University
Baltimore, MD USA
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If CAP does not have a peer group for your specific instrument and method combination, you can contact SMILE, and your primary or back-up representative can help you determine the correct peer group to use.
d. Your Result: Enter your results for each specimen. These results should be entered in columns B-D or J-L on the template.
e. Good/Acceptable Response: Enter the Good and Acceptable response in columns E-G or M-O on the template.
f. Your Grade: For the qualitative analytes you must type in Acceptable or Unacceptable manually.
3. Evaluate your results. Conduct investigations for any analytes demonstrating unacceptable results or a positive/negative bias.
Appendices:
A. Urinalysis Manual Evaluation Template B. Urinalysis Manual Evaluation Example
ater
(Enter Your Lab Name, Survey Provider, Year and Event ) (Example - JHU CAP 2008 Clinical Microscopy CM-B)
Specific GravityAcceptable Criteria = ± 2 SD or 0.010, whichever is gre
Osmolality Accetable Criteria +3SD
Your result Mean SD Lower Upper SDI Your Grade Your result Mean SD Lower Upper SDI Your GradeCM-01 0.000 0.000 #DIV/0! Unacceptable CM-01 0 0 #DIV/0! UnacceptableCM-02 0.000 0.000 #DIV/0! Unacceptable CM-02 0 0 #DIV/0! UnacceptableCM-03 0.000 0.000 #DIV/0! Unacceptable CM-03 0 0 #DIV/0! Unacceptable
pH, Urine Urine hCGYour result Good/Acceptable R Youesponses r Grade Your result Your GradeIntended Response
CM-01 CM-01CM-02 CM-02CM-03 CM-03
Protein, Urine - Qualitative Glucose, UrineY ltYour result G d/A t bl Y GRGood/Acceptable Responses dYour Grade GY ltYour result Y G dd/A t bl R Your GradeGood/Acceptable Responses
CM-1 CM-01CM-2 CM-02CM-3 CM-03
Ketones, Urine Bilirubin, UrineYour result Good/Acceptable R Youesponses r Grade Your result Your GradeGood/Acceptable Responses
CM-01 CM-01CM-02 CM-02CM-03 CM-03
Blood/Hgb, Urine Leukocyte Esterase, UrineYour result Good/Acceptable R Youesponses r Grade GoYour result Your Gradeod/Acceptable Responses
CM-01 CM-01CM-02 CM-02CM-03 CM-03
Nitrite, Urine Urobilinogen, UrineYour result Good/Acceptable R Youesponses r Grade Your result Your GradeGood/Acceptable Responses
CM-01 CM-01CM-02 CM-02CM-03 CM-03
Urine Sediment Identification CSF & Body FluidYour result Intended/Peer R Youesponse r Grade InYour result Your Gradetended/Peer Response
Your result Intended/Peer R Youesponse r Grade Your result Mean SD Lower Upper SDI Your GradeCM- CM-01 0 0 #DIV/0! UnacceptableCM- CM-02 0 0 #DIV/0! UnacceptableCM- CM-03 0 0 #DIV/0! UnacceptableCM-CM-CMCM-CM-
1
2008 CM-A PARTICIPANT SUMMARY
Evaluation Criteria
QUALITATIVE
For qualitative procedures in urinalysis, evaluation is based on participant consensus by method and instrument. For each analyte, a minimum of two, but not more than four, responses will be given a passing score. Analyte results graded “Good” performance must have 80% participant consensus. Eighty percent participant consensus can be determined by grouping the mode with the next one or two most frequent responses. This group will be given “Good” performance. “Acceptable” performance will be given to additional responses until a minimum of 90% of participant results are given a passing score. In the case of a negative specimen, negative responses must constitute 90% participant consensus. Specimens with results for one of more methods distributed over both negative and positive responses (non consensus) will not be evaluated. Specimens for which there is greater than 90% of participant responses distributed over more than four responses will be graded as “Non-consensus”.
Specific Gravity Peer Group Mean ± 2 SD or 0.010, whichever is greater
Low and high values shown in the Participant Summary indicate the range of values reported.
Low and high limits of acceptability are shown on the evaluation report.
Data are not included for methods used by fewer than 10 laboratories.
PHOTOMICROGRAPHS/PHOTOGRAPHS
Photomicrographs/Photographs are evaluated for CAP purposes according to 80% or greater consensus of either referees or participant laboratories. "Good" performance is given for the intended response. Additionally, the Hematology and Clinical Microscopy Resource Committee may, at its discretion, grant either "good" or "acceptable" performance for other equivalent response.
To provide a timely evaluation of your results, statistics presented in this Participant Summary reflect a minimum of 80% of participant enrollment. In the event a result is not graded, a numeric code will appear next to your result. A definition of the code will appear on the first page of the evaluation. Please see “Actions Laboratories Should Take when a PT Result is Not Graded” on page 56.
MHANES2
Callout
Acceptability Criteria
3
Urine hCG
Evaluation is based on sensitivity of the kit and participant consensus by method. The hCG level was intended to be positive.
YD Diagnostics UriScan PT/PRO - - - - - - 1 6 - - - - * Roche pH Instrumentation Users: Results should be reported in whole numbers from 5.0 to 9.0, with the exception of 6.5.
** Roche pH Visual Users: Results should be reported in whole numbers, 0.5 increments are not allowed.
