Att. C1 Annual submission instructions

NASS Annual Submission Guide for Reporting Year 2007

TABLE OF CONTENTS
Introductory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
•

Reporting Deadline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

•

Required Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

•

Beginning the Annual Submission Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

•

A Note to Importers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Section 1:

Step 1 - Review Current Clinic Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Section 2:

Step 2 - Resolve Open Cycles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Section 3:

Step 3 - Review Inconsistent and Unlikely Cycle Data . . . . . . . . . . . . . . . . . . . 11

Section 4:

Step 4 - Generate Annual Submission Clinic Table . . . . . . . . . . . . . . . . . . . . . 13

Section 5:

Step 5 - Submit Final Annual Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Appendices
•

Appendix 1 - NASS Screen Shot of the Submit Annual Data Web Page . . . . 17

•

Appendix 2 - Minimum Clinic Data Required to Complete Step 1 . . . . . . . . . . 18

•

Appendix 3 - Example of Annual Current Clinic Profile Report . . . . . . . . . . . . 19

•

Appendix 4 - Example of Annual Open Cycle Report . . . . . . . . . . . . . . . . . . . 21

•

Appendix 5 - Sample Page From the Comprehensive Edit Report . . . . . . . . . 22

•

Appendix 6 - Sample Template of Annual Submission Clinic Table . . . . . . . . 23

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INTRODUCTORY INFORMATION

This guide provides step by step instructions for submitting annual data required by the
Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992 through the National Assisted
Reproductive Technology (ART) Surveillance System (NASS) at www.artreporting.org. Federal
Register notices are posted on the NASS website that describe who is required to report to CDC
and the process for reporting. Section 2.8 of the NASS User’s Manual describes how to access
the Federal Register Notices.
Reporting Deadline - The deadline for reporting 2007 data is December 15, 2008. An
ART program will not be considered to be in compliance with the federal reporting requirements
of FCSRCA if the ART program was in operation in the full year that is being reported, i.e., the
clinic was in operation after January 1 of the reporting year, and fails to submit a dataset to Westat
in the required data reporting system (NASS) by the reporting deadline.

ART programs

considered to not be compliant with the federal reporting requirements of FCSRCA will be listed
as non-reporters in the 2007 Assisted Reproductive Technology Success Rates report.
Required Documents - As part of the annual reporting process, your clinic will need to
submit the hardcopy documents listed in the table on the following page to:
NASS Processing Center
Westat
1450 Research Boulevard, Room TC1021F
Rockville, MD 20850-3195
Phone (if required by overnight couriers): 1-888-650-0822
Beginning the Annual Submission Process: The annual reporting year submission
process in NASS includes five steps that are explained in the remainder of this guide. The NASS
Submit Annual Data screen walks you through this process step by step, and includes links to the
documents and reports that you are required to review and/or submit to Westat. (The table on the
next page summarizes the complete list of documents that must be sent to Westat.)

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Required Documents for
Annual Submission

Comprehensive Edit Report

Annual Submission Clinic Table
Certificate proof of embryo
laboratory accreditation

Additional
Information/Directions
Available

Clinic Signature Required?

Submit
Copy or
Original

Yes
Data Manager or Medical
Director

Original

Section 3, NASS Annual
Submission Guide

Yes
Medical Director

Original

Section 4, NASS Annual
Submission Guide

No

Copy

Section 4.2, NASS User’s
Manual

Original

Please contact the NASS
Help Desk for further
information
1-888-650-0822

Letter documenting clinic
reorganization (if applicable)

To access the Submit Annual Data screen and begin the submission process, you must
log into NASS and select the reporting year for which you are submitting clinic and patient cycle
data (see Section 3.2 of the NASS User’s Manual).

This will take you to the Select/Add Patient

Screen shown below.

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Once you are in the Select/Add Patient screen, go to the menu on the left hand side of
NASS and click on the Clinic Profile & Data menu item to view the sub-menus (see below).

Click here to display the sub-menu.

Click here to go to the Submit Annual Data screen.

Select Submit Annual Data from the sub-menu by clicking on it. This will take you to the
Submit Annual Data screen shown in Appendix 1 at the end of this guide. Follow the instructions
and steps on the Submit Annual Data screen. Please keep in mind the following procedures when
completing this step by step process:
•

The reports shown as links in the Run Report column of the screen can be selected
and run in any order for you to review. However, the reports may not be complete
or final depending on the status of patient cycle and clinic data entry at your clinic.

•

You must indicate that each step is complete by checking the corresponding Step
Completed box before moving on to indicate that the next step is complete. For
example, after completing Step 1, you must enter and save a check mark in the
corresponding Step Completed box prior to being able to save a check mark for
completing Step 2. If you do not complete the steps in the order shown, you will
see the following message when trying to save work in progress.

•

If you wish to save your check marks, and have not completed all steps of the
submission process, you can click the Save Completed Steps button at the bottom
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of the Submit Annual Data screen (see next page). This way, the next time that you pull up this
screen, check marks you have entered for completed steps will show.
•

A check mark must be entered and saved in all four Step Completed boxes (for
Steps 1 through 4) before being able to submit your data to Westat by pressing the
Submit Final Annual Data button at the bottom of the screen. If you have not

checked through all the steps, you will see a message similar to the one below indicating which
steps you have not completed and saved.

In addition to on-screen instructions, additional information about each step is provided
below in Sections 1 through 5 of this guide. If you have further questions, please contact the
NASS Help Desk for assistance at 1-888-650-0822.
A Note to Importers - The annual submission process includes the same steps described
in this guide for all clinics whether they have chosen to use a vendor or other medical record
system to import their data into NASS. Please note that clinics who have chosen to submit
their data to SART must also comply with these instructions. Clinics using alternative medical
record systems to enter and manage their data for import into NASS are responsible for ensuring
that their data can be accurately extracted and imported into NASS by the reporting deadline.

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The annual submission process assumes that import files have passed quality and content
checks, and have been accepted and loaded into NASS. Numerous edits and logics have been
programmed into NASS to help reduce error in data entry and consistency. Once imported data
have been loaded into NASS for all cycles at a clinic, replacement import files will not be accepted
to correct erroneous data, or to add additional data. After importing, the following types of
cleanup actions must be performed in NASS:
•

Changing data (e.g., correcting a data point, adding missing data or cycles);

•

Marking any incomplete cycles as “Completed”; and

•

Updating data (e.g., current clinic address).

Please refer to the NASS Import User’s Guide for additional instructions about submitting
your cycle data to NASS through the import process, and for information on data quality checks
on imported data. This manual can be downloaded from within the NASS web site.

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Section 1.

Step 1 - Review Current Clinic Information

The first step in the annual submission process is to ensure that the current clinic
information entered in NASS is accurate. The following information will be shown at the bottom
of the Clinic Table and included in the CDC annual report appendix exactly as the text has been
entered in NASS:
•

Clinic name, address, and telephone and fax numbers;

•

Name and degrees of Medical Director verifying the data;

•

Laboratory name and accreditation details;

•

Reorganization status if applicable; and

•

Services offered and clinic profile (e.g., donor embryo program, SART member).

The Annual Current Clinic Profile report that can be generated in Step 1 is designed to
provide this information on a printout for your review. The information shown on the printout is
dependent on how your clinic has answered the Current Clinic Status question in NASS (See
Section 4.2.2 of the NASS User’s Manual for details). The Annual Current Clinic Profile report will
produce a printout with different clinic information depending on whether you have indicated in
NASS that your clinic has reorganized, changed its name, or maintained the same reporting year
status.
Click on the report link in the Step 1 row to print this report and review the current clinic
information that will be published in the CDC annual report.

7

Click here to run the Annual
Current Clinic Profile Report.

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Any changes that need to be made to your clinic information must be done in NASS. To
do so, click on the Clinic Profile & Data menu item shown on the left-hand side of the NASS
screen (note: this menu item appears once you have selected a reporting year in NASS). Select
Enter Clinic Profile from the sub-menu by clicking on it. This will take you to the first of four clinic
profile reporting screens. See Section 4.2 of the NASS User’s Manual for further information
about entering or updating your clinic profile information.
You may rerun the Annual Current Clinic Profile report until the data are accurate and final.
When the clinic information is finalized in NASS as you want it to appear in the CDC annual
report, click the Step Completed box for Step 1. You will see an on-screen edit message like the
one shown below if you have not entered the minimally required clinic data in NASS. The system
will not allow you to check off that Step 1 is complete until data have been entered in all the NASS
A message like this will pop up if
required clinic data have not been
entered in NASS.

fields listed in Appendix 2.

Click here to check off when this
step has been completed.

Section 4.2 of the NASS User’s Manual provides further definitions and explanations for
each of the clinic fields listed in Appendix 2. Please note that the Medical Director name and
degrees listed on the report will be the same as printed in the CDC annual clinic table as having
verified the data at the clinic. An example of an Annual Current Clinic Profile report for a clinic
that has not reorganized or changed its name since the reporting year is included as Appendix 3.

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Section 2.

Step 2 - Resolve Open Cycles

Step 2 is designed to ensure that all cycles entered for the reporting year have been
marked “Completed” in NASS before moving on to Step 3 in the submission process. To check
if you have any open cycles in the reporting year, click on the report link in the Step 2 row to print
the Annual Open Cycle Report.

Click here to run the Annual
Open Cycles Report.

Cycles that have not been marked as complete will be listed in the printout along with other
information to help you identify which cycles need to be resolved in NASS before proceeding. See
Section 6.8.4 of the NASS User’s Manual for information on how to indicate that open cycles are
complete. An example of the Annual Open Cycles Report is shown in Appendix 4.
The Annual Open Cycles Report should be rerun until it indicates that there are no more
open cycles for this reporting year. You can then click on the Step Completed box for this step.
If you try to put a check mark in this box without having indicated that all cycles for this reporting
year are complete (that is – your clinic still has open cycles for this reporting year), you will get the
edit message show on the next page.

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Section 3: Step 3 - Review Inconsistent and Unlikely Cycle Data

Once you have completed Step 2, you must ensure that the cycles entered in NASS do
not have any inconsistent data, i.e., data that do not make sense based on the information
entered for that cycle. You should also review all unlikely data entered in NASS, i.e., data that are
unlikely to occur, but occasionally could be seen, to ensure they are valid. See Section 1.15 of
the NASS User’s Manual for more information about inconsistent and unlikely data. While a
number of logics are built into NASS so that the user can catch inconsistent data as they are being
entered, this comprehensive QC checking program needs to be run by the clinic before data can
be submitted for the annual report.
To review inconsistent and unlikely data for the reporting year that you are submitting, click
on the report link in the Step 3 row to print the Comprehensive Edit Report. Please note that only
cycles that have been marked “Completed” will be shown on this report. While you can run
this report at any time during the year to check on your data, it is essential to make sure that no
cycles are open for the reporting year when you are running and reviewing this report as part of
the annual submission process. If you were able to check the Step Completed box for Step 2 (the
step to review open cycles), then you should not have any open cycle left for this reporting year,
and the Comprehensive Edit Report should represent all your entered cycles.
Click here to run the
Comprehensive Edit Report

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A sample page from a Comprehensive Edit Report is shown in Appendix 5. The report
must be rerun until all inconsistent data have been corrected in NASS, and unlikely data have
been reconciled or confirmed as accurate. Handwritten corrections to data on the hardcopy of
this report will not be accepted for the annual submission. However, you may write notes or
comments about unlikely data that have been confirmed by your clinic on the final hardcopy such
as for values that are higher than usually reported or are outside of an expected range.
When the final report has been run with no more inconsistent data, and with assurance
that unlikely data are accurate, you can then click on the Step Completed box for Step 3.
Please note that it is not functionally practical for NASS to perform a realtime scan to
determine whether there are remaining inconsistent data issues before allowing you to mark the
Step Completed box.

Therefore, your clinic is ultimately responsible for ensuring that all

inconsistent data have been resolved before you check the Step Completed box for this step.
The clinic Data Manager, or the Medical Director, must sign off on the final hardcopy of the
Comprehensive Edit Report, and forward this document to Westat with the other annual
submission materials listed in the introduction of this guide.

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Section 4: Step 4 - Generate Annual Submission Clinic Table

After Steps 1 through 3 have been completed, you are ready to run and review the Annual
Submission Clinic Table. This is the table that will appear in the CDC annual success rate report
for your clinic. Click on the report link in the Step 4 row to print the table.
Click here to run the Annual
Submission Clinic Table

The generated table will have all the required fields presented in a format similar to that
on the CDC annual report. See Appendix 6 for a sample template of what the clinic table will look
like generated in NASS. The clinic report pages that are ultimately published by CDC will be
formally formatted (e.g., colors, shading, text fonts) for presentation to the public.
The information on current clinic profile and services, reporting year name and city/state,
and the Medical Director verifying the data should be the same as you reviewed on the Annual
Current Clinic Profile report from Step 1. All cycles that have been marked completed in NASS
that are eligible to be included in the report should be represented in the data on this table. If you
think that the cycle count is not accurate – either too low or too high – begin by ensuring that:
•

There are no open cycles for this reporting year that should have been marked
Completed in NASS. See instructions for Step 2 to resolve open cycles.

•

Patient cycles have been entered in the correct reporting year in NASS (e.g., a
cycle with a start date during 2007 erroneously entered in the 2008 reporting year
section of NASS). See Chapter 3 of the NASS User’s Manual for assistance with
selecting the correct reporting year.

•

Your clinic has entered all cycles for all patients. See Chapter 5 of the NASS
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User’s Manual if you need step-by-step instructions on adding a patient or cycle
that should have been entered for this reporting year, or to find an existing patient’s
cycle(s) that should be in NASS.
•

Cycles that should be included in the annual submission report have not been
marked “Deleted”. See Section 5.7 of the NASS User’s Manual for information on
how a cycle may have been deleted. Note that your clinic cannot un-delete or
retrieve a cycle once it has been deleted from your NASS database. Any
erroneously deleted cycles would have to be re-entered before proceeding with the
annual submission process.

In addition to the reports available in Steps 1 and 2 of the Submit Annual Data screen,
there are the following NASS reports that can be generated and reviewed to check data reported
in the annual submission:
•

Report-001 lists all cycles that are complete or open for a particular reporting year.
Completed cycles are included in the annual table; open cycles are not.

•

Report-002 generates the cycle data entered for a specific patient.

•

Report-004 allows clinics to review specific data points for all cycles included in the
annual clinic success rate table.

See Chapter 8 of the NASS User’s Manual for information on generating reports in NASS.
Certain types of cycles will be automatically excluded from the annual submission (e.g.,
evaluation of new treatment procedures). Contact the NASS Help Desk (1-888-650-0822 or
NASS@Westat.com) if you want to find out why one or more of your cycles may have been
excluded from the clinic table.
The clinic table statistics may be rerun as often as necessary until the data are ready for
submission. Handwritten corrections to data on the hardcopy of this report will not be accepted
for the annual submission. All corrections must be made within NASS prior to re-running and
signing the final report. When you have generated your clinic’s final Annual Submission Clinic
Table, you can then click on the Step Completed box for this step.
The Medical Director must sign off on the final hardcopy of the Annual Submission Clinic
Table and forward this document to Westat with other annual submission materials listed in the
introduction of this guide.
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Section 5: Step 5 - Submit Final Annual Data

You are ready to submit your final reporting year data for publication after Steps 1 through
4 have been performed, the Completed Steps boxes have been checked and saved, and the
Annual Submission Clinic Table is final. Please note that once you have submitted your final
data, you will no longer be able to make any changes, additions or deletions to these data
in NASS. However, your clinic may continue to view these data in NASS for this reporting year
(i.e., in “read-only” mode).
To submit your data, click on the Submit Final Annual Data button at the bottom of the
Submit Annual Data Screen.

Click here to submit your final annual data

After clicking on this button, you will see a pop-up box on the screen asking if you are sure
that you want to submit the data (see next page).

Click OK if you want to continue with the

submission.

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If you have not completed all four previous steps and checked off all the Step Completed
boxes, you will see a pop up message like the one below telling you which step has not been

marked as completed.

Once you have successfully submitted your annual data, the Step Completed check boxes
on the screen will become read-only as well as the cycle data that you submitted for this reporting
year.

If you discover an error after your final data submission, please contact the NASS Help

desk for assistance at 1-888-650-0822 or NASS@Westat.com.

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Appendix 1 - NASS Screen Shot of the Submit Annual Data Web Page

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Appendix 2
Minimum Clinic Data Required in NASS to Complete Step 1
Required
Fields for
Reorganized
and Closed
Clinics

NASS Screen

Screen Section

Clinic Data Variable

Notes

Name&Address

Reporting Year
Clinic Name

•
•
•

Name 1
City
State

Name 2
should be
included if
applicable

/

Name&Address

Current Clinic
Information

•
•
•
•
•
•
•
•

Status
Name 1
Address 1
City
State
Zip code
Phone
Fax

Name 2 and
Address 2
should be
included if
applicable

/

•
Key Staff

Medical
Director

•
•

First Name of Medical
Director
Last Name of Medical Director
Degree(s) of Medical Director

•
•
•
•
•
•

SART Member
Gestational carriers services
Single women services
Donor egg program
Donor embryo program
Embryo freezing offered

•
•

Name 1
CAP accredited
(yes/no/pending)
JCAHO accredited
(yes/no/pending)
NYSTB accredited
(yes/no/pending)

Services&Profile

Lab&Certificatio
n

Services and
Profile

Current
Embryo Lab
Information

•
•

18

/

These data
variables must
be complete
for all embryo
labs used by a
clinic

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Appendix 3
Example of Annual Current Clinic Profile Report

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Appendix 4
Example of Annual Open Cycle Report

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Appendix 5
Sample Page From the Comprehensive Edit Report

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Appendix 6
Sample Template of Annual Clinic Submission Table

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