Instructions for Using the Newborn Screening Quality Assurance Program

Proficiency Testing Data-Reporting Web Site

Version 5 – April 1, 2009

Centers for Disease Control and Prevention Atlanta, GA

Newborn Screening Quality Assurance Program

Instructions for Using the Proficiency Testing Data-Reporting Web Site Version 5 – April 1, 2009

NOTE: The Newborn Screening Internet application operates in Microsoft Internet Explorer. If you have difficulty accessing the Web site, try again at a later time. CONTENTS:

I. Setting the Page Caching Option in Your Browser II. Setting the JavaScript Execution Option in Your Browser III. Setting the Display Resolution on Your Monitor IV. Login Procedure V. Know the Details VI. Q & A (Questions and Answers)

Important note: The following instructions contain screen shots that were made using specific versions of the browsers and operating systems. While we have tried to present several options, we have by no means exhausted every possibility. For example, most of these screen shots were taken from machines running Windows XP Professional 5.1 and Internet Explorer 6.0. If you are using a different version, the dialogs you see on your machine may differ from those here. In most cases, you can find the correct options and information based on the information given here. If, however, you cannot follow these instructions in your case, please contact us (see the contact information at the end of this document).

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I. Setting the Page Caching Option in Your Browser

For the Newborn Screening Internet application, it is very important to set the page caching option in your browser to refresh each page every time it is displayed. Without this option set, changes to lab and year/quarter selections will not persist through use of the Back button. To set this option in Microsoft Internet Explorer: 1. Click Tools on the menu bar, then Internet Options. 2. With the General tab selected, click the Settings button under "Browsing History.”

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3. In the “Check for newer versions of stored pages” option group, click the circle beside

“Every visit to the page.”

4. Click OK. 5. Click OK. By selecting the option “Every visit to the page,” the browser will always retrieve the page from the Internet rather than from your hard drive. This ensures that your pages always show and use the correct year and quarter.

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II. Setting the JavaScript Execution Option in Your Browser The Newborn Screening application uses JavaScript. You must allow JavaScript execution in your browser. Without this option set, you will receive error messages on some pages, and some pages may not display properly. To set this option in Microsoft Internet Explorer: 1. Click Tools on the menu bar, then Internet Options. 2. Click on the Security tab. 3. Click on the Internet icon (the globe which is highlighted by default). 4. Click the Custom Level button.

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5. Scroll down to the “Scripting” section to Active scripting and make sure that the Enable

button has been selected.

6. Click OK. 7. Click OK. 8. From the File menu, click Close. 9. Re-launch your browser to ensure that changes to the core function settings are complete.

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III. Setting the Display Resolution on Your MonitorThis site is best viewed at 800 X 600 resolution or higher. To adjust the resolution for the Microsoft Windows XP Professional 5.1 operating system (other operating systems will use a similar process):

1. Double click the icon My Computer.

2. Double click the icon Control Panel. Note: Your “My Computer” dialog box may not look exactly like this. It may contain different icons, and it may be in a different format. In any case, it will contain a Control Panel icon. It may be more convenient for you to access the Control Panel by clicking the Start menu, then Settings, then Control Panel.

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3. Double click the icon Display.

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4. Click the tab Settings.

5. Go to the Desktop area box and move the arrow to 800 X 600 pixels or higher. If you set your

resolution at 1024 X 768 pixels, most pages can be viewed without scrolling. (Your computer may not be capable of 1024 X 768 resolution). Your monitor resolution is now set for maximum performance for the Newborn Screening Web site.

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IV. Login Procedure To open Internet Explorer:

1. Double click browser icon.

2. Enter the following URL:

http://wwwn.cdc.gov/nsqap/public/default.aspx To complete self registration (First Login):

Note: Request Login Registration from Carol Bell at CBell@cdc.gov and provide first name, last name, and e-mail address. You will receive a self registration invitation by e-mail containing an encrypted link. To complete registration:

1. Open self registration invitation, click on link labeled “Click here to register.”

2. Enter First Name.

3. Enter Last Name.

4. Enter Lab Code.

5. Enter E-mail Address.

6. Create a User ID.

7. Create a Security Question.

8. Create an Answer to your security question.

9. Click Submit.

10. Create New Password (follow password requirements, which are available in English and

Spanish).

11. Confirm New Password.

12. Click Submit (now you are back on the login screen).

13. Enter User ID you created.

14. Enter Password you created.

15. Click Login. To login after self registration is completed:

1. Click User Login.

2. Enter User ID (created by user).

3. Enter Password (created by user).

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4. Enter Year (e.g., 2009).

5. Select Quarter (e.g., 3).

6. Click Log In. To change your password on Change Password Screen:

1. Enter Old Password

2. Create New Password (follow password requirements, which are available in English and Spanish).

3. Confirm New Password.

4. Click Submit. Message says, “Your password has been changed. Login using your new

password.”

5. On Login Screen: Enter your User ID and the new password you created. If you forget your password:

1. Click User Login.

2. Enter your User ID.

3. Click Forgot password?

4. Answer your security question (the user created a security question and answer during registration). Answer is case-sensitive.

5. Confirm E-mail address.

6. Click Submit.

7. Create New Password (follow password requirements, which are available in English and

Spanish).

8. Confirm New Password.

9. Click Submit. Message says, “Your password has been changed. Login using your new password.”

10. On Login Screen: Enter your User ID and the new password you created.

To update contact information (Contact is the person that receives packages and reports):

1. On Data Entry Main Menu screen, click Update Contact Information.

2. Enter/Update Information. (Lab name, Contact name, Address 1, City, Country, Phone, and E-mail are required.)

3. Click Submit.

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V. Know the Details Because there are now over 431 laboratories worldwide participating in the Newborn Screening Quality Assurance Program, a Standard Operating Procedure had to be established. Data from all participants regardless of laboratory category (state, contract, manufacturer, international) will undergo the same process.

1. Method code is required for all analytes.

2. For Results, inequalities (< or >) cannot be entered. Enter absolute values only. If you cannot enter an absolute value, leave the field empty. Because of this constraint in the database, the quantitative-data fields are not designated as required fields.

3. Equations for converting "units" are provided for T4, TSH, 17-OHP, and the amino acids.

4. Clinical assessments are required for all five specimens per analyte. If you routinely

report T4 and TSH, clinical assessments are required for both. When clinical assessments are reported for both T4 and TSH, the evaluations will be done on the TSH clinical assessments.

5. Cutoffs are not required but should be reported. Reporting a cutoff could give you a second

chance. When a non-match occurs between the expected and reported clinical assessments, an evaluation algorithm is used to determine if the non-match is related to the reported cutoff or to a mistake in measuring the quantitative results. You are at risk if a laboratory-specific cutoff is not reported because the algorithm cannot be used. You will be evaluated using the CDC cutoff (see table of CDC cutoffs on Web site).

6. Absolute values must be used for cutoff values. Inequalities (< or >) or percentages (e.g.,

lower 10%) cannot be reported for cutoffs, e.g., if cutoff is <5, report cutoff as 5.

7. If "Required Fields” are not completed, data will not Submit. To Enter Data: SUGGESTIONS: To make the data entry process easier, Tab through all fields, one after the other. Use the number key pad (must turn-on Num Lock) on the right side of the keyboard to enter data.

1. On Data Entry Main Menu screen, click Data Entry.

2. On the Analyte Menu screen, select the analyte that you want to report Results for by clicking on the analyte name.

3. On Data Entry screen, verify Year and Quarter before entering data. If they are incorrect,

go back to the Data Entry Main Menu screen and select the appropriate Year and Quarter.

4. Enter Method code (required). Select the method code from the drop down menu. Note: Typing the method code number does not bring up the correct code.

5. Enter Results in the units requested. If conversion of units is necessary, convert results

before entering data. Conversion factors are available on the Data Entry Main Menu.

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6. Enter appropriate Clinical Assessment (required). Note: Use the Tab key to move to the clinical assessment field. Press the number 1 key or the number 2 key to select your choice. An alternative method would be to click and scroll with the mouse.

7. Enter Cutoff in the units requested. If conversion of units is necessary, convert cutoff

before entering value.

8. After completing all entries, click Submit.

9. The Data Entry Confirm screen will be displayed. Review the accuracy of the data.

10. If data are incorrect, click Back to return to the Data Entry screen. Tab or use the mouse to locate the Result field that needs to be edited. After editing, click Submit.

11. If data are correct, click Confirm to save and transmit your data to the CDC database.

12. A confirmation message will be sent to the e-mail address listed in Update Contact

Information. You will be returned to the Analyte Menu screen so you can continue entering data for additional analytes.

To View and Print Results:

1. On the Analyte Menu screen, click View Laboratory Summary Report to view a final report for accuracy.

2. To Print a Data Record to Keep: Go to the menu bar, click File, and then click Print for a

copy of the Laboratory Summary Report.

3. Click Back on the menu bar to return to the Analyte Menu screen. To Edit Data AFTER confirmation: Note: Data can be edited until the data-reporting deadline. After this date, the database will be locked and no changes can be made.

1. To Edit AFTER Confirmation, click Data Entry, then click the desired analyte on the Analyte Menu screen.

2. To Edit the method code or cutoff value, Tab or use the mouse to move to the appropriate

field; then correct the error.

3. To Edit Results, Tab or use the mouse to move to the appropriate field. Correct the error, click Submit, review data, and click Confirm to transmit the edited data to the CDC database. You will be returned to the Analyte Menu screen.

Note: The edited data will over-write the previous data. The Editing procedure is available until the database is locked.

4. Remember to print a revised Laboratory Summary Report after data have been edited.

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To Delete Data from the CDC database AFTER confirmation: Note: Erroneously entered data can be deleted until the data-reporting deadline. After this date, the database will be locked and no changes can be made.

1. To Delete data AFTER confirmation, click Data Entry, then select analyte on the Analyte Menu screen. All previously entered data for the selected analyte will appear.

2. Click Delete All Data for this Analyte. All data for the analyte, including method code and

cutoff, will be deleted from the CDC database. If data need to be re-entered, follow the Data Entry procedure above. If no data are needed for the analyte, click Delete All Data for this Analyte to return to the Analyte Menu screen.

If you have questions about the Web site, first check the Questions and Answers section of this document to see if the answer to your question is there. If you cannot find the answer, contact Carol Bell at 770-488-4023 or CBell@cdc.gov.

The Q & A section begins on the next page.

Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services or the Association of Public Health Laboratories.

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VI. Q & A: Questions and Answers This list of questions and answers was developed based on the comments submitted by the twenty participants of the Worldwide Pilot Study Team. There are two sections: (1) computer and technical questions and (2) data handling and procedural questions. Look for the answer to your question before contacting CDC. Computer and Technical Questions Q1: I saw the official report pages on the screen with no problem; but when I tried to print them,

everything on the pages, except the CDC letterhead, was shifted to the right so a column was cut off. What can I do?

A1: It can be easily fixed by changing the Internet Explorer margin settings while the NSQAP

Web site is open. On the Internet Explorer menu bar, Click File, Click Page Setup, then make the margin changes. Try setting your margins to: Left 0.25 inches, Right 0.25, Top 0.5, Bottom 0.5.

Q2: My standard screen setting is 1024 by 768 pixels. I prefer my setting rather than the 800 by

600 pixels that you suggest for best viewing of the Web site. Does it matter? A2: No. 800 by 600 pixels is the minimum resolution for best viewing. Use the resolution that you

find most comfortable. The resolution setting is controlled in your computer, not the Web site. See the instructions for how to set the resolution.

Q3: I could reach the Web site, but I could not login. When I entered my User ID and password, I

got the following message: “User ID and/or Password are invalid.” Am I doing something wrong?

A3: You are using the wrong User ID and/or the wrong password. Be sure to enter the User ID

that is specifically for gaining access to the Internet data-reporting Web site, then click “Forgot password” (See section IV. Login Procedure) and follow the procedure.

Q4: I can't remember my password. A4: To reset your password after entering User ID, Click Forgot Password. Answer your security

question, enter your e-mail address, then create a new password. If all else fails, contact Carol Bell at 770-488-4023 or by e-mail at CBell@cdc.gov.

Q5: I could reach the Web site, but I could not login. When I entered my User name and User ID,

access was denied. Any suggestions? A5: There is not a field for User name. The first field is User ID. Enter the User ID that is

specifically for gaining access to the Internet data-reporting Web site. The second field is Password. Enter your password. If you can’t remember your password, see Q&A 4. If all else fails, contact Carol Bell at 770-488-4023 or by e-mail at CBell@cdc.gov.

Q6: Can I add or delete a User ID from my list when it becomes necessary? A6: Yes. If you want to make User ID changes, contact Carol Bell at 770-488-4023 or by e-mail

at CBell@cdc,gov.

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Q7: I got "kicked off" the Web site because I took too long to enter my data. What is the time-out

setting and can you increase it? A7: The time-out setting was 6 minutes, it has been increased to 20 minutes. Q8: I printed the pages of the quarterly report from Public Reports on the first screen but did not

see the "mean reported concentrations" report showing the individual method means. Where can I find it?

A8: The Mean Reported Concentrations report is not available in View Public Reports. You must

login to access the report. After login, click Report on the Data Entry Main Menu, then click Mean Reported Concentrations by Method.

Q9: Since there are only two choices (1-within normal limits or 2-outside normal limits) for clinical

assessments for most analytes, can both choices be listed together so as to eliminate the need for a dropdown box?

A9: Tab to the clinical assessment box, then press the number 1 key or the number 2 key to

choose your response. This will eliminate a click on the drop down box. Please note the following suggestion, which is listed in the instructions: To make the data entry process easier, Tab through all fields, one after the other. Use the number key pad (must turn-on Num Lock) on the right side of the keyboard to enter data.

Q10: I entered data for several analytes but waited to click Submit until after I entered data for

my last analyte, Citrulline. When I looked at my laboratory summary report, it indicated that only Citrulline data were entered. I had to enter my data again. What happened to the other data?

A10: To send data to the database, you must click Submit on the first screen then click Confirm

on the second screen for each analyte you report, not just the last analyte. Q11: Why is there not a Back button or a Print button on the Laboratory Summary Report? A11: For the most recent version of the Web site, we have chosen to use the Back and Print

functions on the browser menu bar. Q12: How do I exit an official report page? A12: Click Back on the menu bar. The application returns to the Quarterly Reports menu. Q13: How do I print the official report pages shown on the screen? A13: Click File on the menu bar and select Print. Click Print or OK on the print dialog box and a

copy of the report will print. Click Back on the menu bar. The application returns to the Quarterly Reports menu.

Data Handling and Procedural Questions Q14: There is not a data-reporting screen for hemoglobins. Will you add that in the future? A14: Hemoglobin data are different from other analyte data. For hemoglobins, multiple methods

per specimen may be reported, and phenotypes are reported instead of quantitative values. As a starting place, we chose to design the Web site using analytes that are reported in the same type of data: one method code, one quantitative value, one cutoff value, one clinical assessment. Future enhancements may include hemoglobins.

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Q15: I deliberately reported a mismatch between the quantitative value and the clinical

assessment. I expected a warning that a mismatch occurred. A15: This is neither an automatic evaluation system nor a system to prompt you when a

mismatch between quantitative value and clinical assessment occur. If that were true, then everyone could correct errors before submitting data and always be 100% proficient. Participants must be free to enter whatever data they have and to make mistakes; otherwise, it would mask a laboratory’s true performance and skew the overall performance of program participants.

Q16: For my test results, I substituted 4.9 for <5. My method is semi-quantitative and does not

reach such a precision. Any comments on how to report values that are not absolute? A16: Inequalities (< or >), ranges (4-6, 6-10), and percentages (%) cannot be entered. If you

cannot enter an absolute value, leave the field empty. Because of this constraint in the database, Results fields are not designated as required fields. If you enter a value that is not the true assayed value for the specimen, the statistics will be skewed. The procedure for calculating the statistical summary analyses has not changed between reporting systems of paper form and Internet. In the SAS database, data were not included for values reported as inequalities, values reported as ranges, and values reported in wrong units. Performance is evaluated on the clinical assessment, not on the quantitative data. A dialog box pops up to remind you not to enter inequalities or ranges.

Q17: I have results that are below or above the standard curve. It doesn't seem appropriate to

enter the lowest or highest standard value because of the possible differences in linearity between methods. How do I handle this?

A17: Leave the Results field empty. Results fields are not designated as required fields. We

gather quantitative data so we can produce statistics on each specimen for informational purposes. If you enter a value that is not the true assayed value for the specimen, the statistics will be skewed. Performance is evaluated on the clinical assessment, not on the quantitative data.

Q18. My cutoff for Phe has a demographic influence (age in hours) that the Web site does not let

us enter. Any comments on this? A18: In the instructions that are included with the proficiency testing specimens, there is a

statement that says, "every enclosed specimen represents a full-term (>2500 g) baby 24 hours of age who is on no medication, has not had a transfusion, and has had sufficient intake of a protein and lactose-based diet for detection of any metabolic disorder." Only analyte cutoffs appropriate for this scenario should be reported.

Q19: I should report a cutoff for TSH, Phe, Gal, and 17-OHP. This presents a problem for

laboratories that use floating cutoffs. What can we do? A19: If you use floating cutoffs, report the cutoff value used on the day of the proficiency testing

specimen run, i.e., report the absolute value of the particular percentile used for that specific day and run.

Q20: We use the lowest 10th percentile and a two standard deviation cutoff for T4 results. It is

only possible to enter an absolute cutoff value for thyroxine, which is not applicable to our program. What should I do?

A20: A cutoff is not required for T4, leave the field empty.

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Q21: After all my data have been entered including clinical assessments for both T4 and TSH, I

noticed that clinical assessments for T4 are not displayed on the laboratory summary report. Is this normal?

A21: Yes. In the past, that is how the data were handled in the SAS computer program, and it

will remain the same for the Internet system. There are two analytes (T4 and TSH) that lead to one clinical assessment for one disorder, hypothyroidism. If we accepted clinical assessments for both T4 and TSH, the N for hypothyroidism would double and that is misleading. We chose to require clinical assessments for all analytes, including T4, just to be consistent across the Web site.

Q22: In the Web site, we are required to report clinical assessment codes for both T4 and TSH.

In the past, one clinical assessment code was reported by participants performing both T4 and TSH testing, not two. Using a separate clinical assessment code for T4 and for TSH could cause conflicting interpretations. How is this handled?

A22: In the past, some laboratories reported both T4 and TSH clinical assessments. If that

occurred, our procedure was not to enter the clinical assessment code for T4 into the database; therefore, there were not conflicting interpretations. We entered the quantitative values for T4 so statistics could be calculated. For both the SAS program and the new Internet program, when clinical assessments are reported for both T4 and TSH, the evaluations will be done on the TSH clinical assessments. No changes have been made in the evaluation procedure. We chose to require clinical assessments for all analytes, including T4, just to be consistent across the Web site.

Q23: Where do I enter my quantitative results for Biotinidase? A23: There are no fields for Biotinidase quantitative results because many laboratories either do

not report quantitative data or report data in many different units. We cannot run statistics on the data, so we chose to not collect the data until they become standardized.

Q24: My staff likes to use paper forms to organize and record results before they give the data to

me for data entry into the Web site. Since you no longer provide forms, what can we do? A24: Go to Data Entry Main Menu and print Worksheets for 27 Analytes (PDF). The worksheets

provide a place to write method code, results, clinical assessments, and cutoff. Method codes and clinical assessment codes are listed in the PT instructions that arrive with the panel. The Web site is ready for data entry on the shipping day. Click Schedules to find shipping dates.

Q25: I cannot access the Web site at http://wwwn.cdc.gov/nsqap/public/default. What should I

do? A25: Add aspx to the end of the Web site URL (http://wwwn.cdc.gov/nsqap/public/default) or

Click on the Web site hyperlink that has been included in several e-mail messages sent by Carol Bell to the NSQAP contact person for your laboratory.

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