Download:
pdf |
pdfRevisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
Changes to the Application
Reasons for the Change
Instructions Section
Instruction
Page
5&6
Section Number: NA
Section Title: Statement Concerning
Information Collection Requirements And
Uses
We have moved the instructions from before the CMS- •
576 form to after the CMS-576 form (pages 5-6)
•
Existing Data Field Text 1: NA
Instruction
page
4
Location: Instructions page
Section Number: NA
Section Title: Statement Concerning
Information Collection Requirements And
Uses
Existing Data Field Text:
“According to the Paperwork Reduction Act of
1995, no persons are required to respond to a
collection of information unless it displays a valid
OMB control number. The valid OMB control
1
1. The PRA Disclosure Statement was relocated to
page 4 at the end of the revised CMS-576 form.
2. A title was added above the PRA Disclosure
statement text to identify it and draw attention to
this statement,
3. The text font of the PRA disclosure statement was
increased to make is more noticeable and easier to
read.
This is the text contained in the data field (a/k/a “data item”) in question in the existing version of the CMS-576 form.
We have moved the instructions from before
the CMS-576 form to after the CMS-576 form
(pages 5-6)
We made this change because we believe that
the form should be displayed first and any
other information provided on the pages after
the form.
We made these changes to the PRA Disclosure
Statement because:
1. The PRA Disclosure Statement was with the
instruction page. Since we relocated the
instruction page to after the CMS-576 form, the
PRA Disclosure statement also had to be
relocated.
2. The PRA Disclosure Statement in the existing
version of the CMS-576 form is printed in tiny
font, is untitled, and is located at the very
Page 1 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
number for this information collection is 09380512. The time required to complete this
information collection is estimated to average 2
hours per response, including the time to review
instructions, search existing data resources,
gather the data needed, and complete and review
the information collection. If you have any
comments concerning the accuracy of the time
estimate(s) or suggestions for improving this
form, please write to CMS, Attn: PRA Reports
Clearance Officer, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.”
Location: Instruction page (bottom of page)
I
Changes to the Application
4. The PRA disclosure statement text was updated to
the most current version required by OSORA:
“PRA Disclosure Statement
According to the Paperwork Reduction Act of
1995, no persons are required to respond to a
collection of information unless it displays a
valid OMB control number. The valid OMB
control number for this information collection
is 0938-0512 (Expires XX/XX/20XX). This is
a required information collection. The time
required to complete this information
collection is estimated to average of 24 hours
per response, including the time to review
instructions, search existing data resources,
gather the data needed, and complete and
review the information collection. If you have
comments concerning the accuracy of the time
estimate(s) or suggestions for improving this
form, please write to: CMS, 7500 Security
Boulevard, Attn: PRA Reports Clearance Officer,
Mail Stop C4-26-05, Baltimore, Maryland
21244-1850.”
“****CMS Disclosure****
Please do not send applications, claims,
payments, medical records or any documents
containing sensitive information to the PRA
I
Reasons for the Change
bottom of the instruction page, where it is not
very noticeable. Readers would tend to skip
such text.
I
3. The text of the PRA Disclosure Statement on
the existing version of the CMS-576 form is out
of date and missing required text. It needed to
be updated.
To fix these issues, we did the following:
1. Relocated the PRA Disclosure Statement to
right after the signature block of the
revised CMS-576 form.
2. Used the most recent version of the PRA
Disclosure language required by OSORA
and
3. Added a title to identify the purpose of this
text. Also, we placed this text in size 14
font so that it clearly visible.
Page 2 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
I
Changes to the Application
Reports Clearance Office. Please note that any
correspondence not pertaining to the
information collection burden approved under
the associated OMB control number listed on
this form will not be reviewed, forwarded, or
retained. If you have questions or concerns
regarding where to submit your documents,
please contact [email protected].”
I
I
Reasons for the Change
•
This change was made because the CMS
Regional Offices were renamed as “CMS
Locations.” Therefore, the reference to “For
CMS Regional Office Use Only” is no longer
valid.
CMS Regional Office Use Only Section
1
1
Section Number: NA
Section Title: CMS Regional Office Use Only
Existing Data Field Text: “CMS Regional
Office Use Only”
Location: Row 1
In the title row of this section, the text:
“CMS Regional Office Use Only”
was changed to:
“To Be Completed by CMS Staff Only”
•
•
Some people still refer to the CMS regions as
Regional Offices and some refer to them as the
current name of CMS Locations. To avoid
confusion, we have revised the text as follows:
“To Be Completed By CMS Staff Only”
We believe this revised text requests the same
information without creating confusion.
Page 3 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
1
1
Current Section Number, Section Title,
Data Field Text and Location
Section Number: N/A
Section Title: CMS Regional Office Use Only
Existing Data Field Text: Medicare Number
Location: Row 2, column 1
1
1
Section Number: N/A
Section Title: CMS Regional Office Use Only
Existing Data Field Text: Medicare Hospital
Number
Location: Row 2, column2
I
Changes to the Application
We have changed the text of this data field from:
“Medicare Number”
in the existing CMS-576 form
to
“OPO’s CMS Certification Number (CCN)
in the revised CMS-576 form
We have changed the text of this item from:
I
1. The term “Medicare Number” is confusing and
non-specific. There are several “numbers”
associated with Medicare providers including
NPI, PTAN, Tax ID and CCN numbers.
“Medicare Number” does not specify which
type of Medicare number is being requested.
“Hospital CCN Number”
in the revised CMS-576 form
I
2. Also, “Medicare Number” does not indicate
which party’s Medicare number is being
sought.
3. To correct this issue, we have re-titled this
section to “OPO’s CMS Certification Number
(CCN).” We believe this title is much more
specific in nature and will help avoid
confusion.
•
“Medicare Hospital Number”
in the existing CMS-576 form
to
Reasons for the Change
•
We have retitled this data field because
“Medicare Hospital Number” is confusing and
does not make any sense. There is no such
thing as a “Medicare Hospital.” This appears
to be an error in which the words “Medicare”
and “Hospital” were reversed.
To correct this error, we have re-titled this
field as “Hospital CCN Number” which is a
more accurate description of the information
being sought and will elicit the information
being sought.
Page 4 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
1
1
Current Section Number, Section Title,
Data Field Text and Location
Section Number: N/A
Section Title: CMS Regional Office Use Only
Existing Data Field Text: DHHS Regional
Office
Location: Row 2, column 3
I
Changes to the Application
1. We have changed the text of this item from:
“DHHS Regional Office”
in the existing CMS-576 form
to
“CMS Location”
In the revised CMS-576 form
2. We have also relocated this revised text to the 3rd
row, in the 1st column of the revised CMS-576 form,
in the section titled “To Be Completed by CMS
Staff Only”
1
1
Section Number: N/A
Section Title: CMS Regional Office Use Only
Existing Data Field Text: Date of SA Receipt
Location: Row 3, column 1
1. We have retitled:
“Date of SA Receipt”
In the existing CMS-576 form
to
“Date of CMS Receipt”
In the revised CMS-576 form
2. We have also relocated this data field from the row
3, column 1 to Row 2, column 1
I
Reasons for the Change
•
This change was made because the CMS
Regional Offices were renamed to “CMS
Locations.”
•
Also, the Regional Offices , (now titled “CMS
Locations” )have never had DHHS in their title
either before or after being renamed.
Therefore, the reference to “DHHS Regional
Office” is no longer valid.
I
To correct this issue, we have renamed this data
item to “To Be Completed by CMS Staff Only.” We
believe this revised title reflects the intended
meaning that the data items in this section should
be completed by the CMS Location staff.
•
•
We have retitled this data items from “Date of
SA Receipt” to “Date of CMS Receipt” because
it would be the CMS Locations that would
receive the completed CMS-576 form and not
the State Survey Agencies.
We have relocated this data filed because we
have revised this section by deleting or
relocating some of the unnecessary data items.
Therefore, the remaining data items required
relocation.
Page 5 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
1
1
Current Section Number, Section Title,
Data Field Text and Location
Section Number: N/A
Section Title: CMS Regional Office Use Only
I
Changes to the Application
This item has been deleted.
I
•
Existing Data Field Text: Date of RO Receipt
Location: Row 3, column 2
1
1
Section Number: N/A
Section Title: CMS Regional Office Use Only
Existing Data Field Text: State/Reg.
Location: Row 3, column 3
•
This “State/Reg.” data field has been deleted
Reasons for the Change
We have deleted this data field because it is
not necessary to document when the SA
received the CMS -576 form. The SA can
document the date they receive the completed
CMS-576 form in their internal computer
system.
I
We made this change because it is only
necessary to document the date the CMS
Locations (formerly titled “CMS Regional
Offices”) receive the completed CMS-576 form
because the CMs Location staff would be the
personnel that would process and use the
information contained in the CMS-576 form.
We have deleted this data field for the following
reasons:
1. It is no longer necessary to collect this
information;
2. This information is not helpful; to CMS; and
3. The state in which the OPO is provided with
the OPO address.
Page 6 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
1
1`
Current Section Number, Section Title,
Data Field Text and Location
Section Number: N/A
Section Title: CMS Regional Office Use Only
I
Changes to the Application
The “State/County Code “ data field has been deleted
Location: Row 3, column 4
1
Section Number: N/A
Section Title: None
Existing Data Field Text: NA
Location: Row 4, column 1
We have deleted this data field for the following
reasons:
I
1. It is no longer necessary to collect this
information;
Existing Data Field Text: State/County Code
1
I
Reasons for the Change
2. This information is not helpful; to CMS; and
3. This is a duplicate of the same data field
located in the section to be completed by the
OPO staff, row 1, column 2. There is no need to
collect the same information twice.
We have added a new shaded title row as row #4 on
the revised CMS-576 form which contains the
following text:
“To Be Completed by the OPO Provider Staff”
The rows below rows 1-3 are to be completed by
the OPO staff since they are outside the grey area
designated as “For CMS Regional Office Use
Only.” However, this is not specified in the
current version of the CMS-576 form.
Also, the 4th row is not contained in the gray
section and also above the section below titled ““I.
Identifying Information.”
We believe that the position of the 4th row could
be confusing and raise questions as to whether it
should be completed by the CMS or OPO staff.
Page 7 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
1
New Page
#
1
Current Section Number, Section Title,
Data Field Text and Location
Section Number: NA
Section Title: None
Existing Data Field Text:
Location: Row 4, columns 1-5
I
Changes to the Application
I
Reasons for the Change
To prevent such confusion and to clearly delineate
where the section to be completed by the CMS
Location staff ends and the section to be
completed by the OPO staff begins, we have added
a new title row as row #4 (not counting the
document heading row) which states the
following: “To Be Completed by the OPO Provider
Staff.”
I
We have deleted row #4 of the previous version of the Below are explanations for the changes made to
CMS-576 form and moved the data fields from this row each section listed below.
to other positions or deleted them as follows:
Column 1 – Related Provider Number:
1. This data field was moved to Row 2, column 3 in
the “To Be Completed by CMS Staff Only” section
of the revised CMS-576 form.
Column 1 – Related Provider Number:
These changes were made to reduce redundancies
in the data fields, and to make the title of the data
fields more accurate,
Column 2 – State/County Code:
This item has been deleted
Column 2 – State/County Code:
This item has been deleted because this
information is no longer relevant.
2. This data field was also retitled as “Related CCN
Number (e.g. for CHOWS / Mergers/
Consolidations)”
3. This data field was also retitled as “Related CCN
Number (e.g. for CHOWS / Mergers/
Consolidations)”
Page 8 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
I
Changes to the Application
Column 3 – State/Region Code:
This item has been deleted
Column 4 – FY Ending Date:
This item has been relocated to line 3, column 3 in the
revised CMS-576 form in the “To Be Completed by
CMS Staff Only” section. This data field was also
retitled as “Current Fiscal Year End Date.”
Column 5 – Medicare Provider Number:
This item was moved to Row 5, column 3 in the
revised CMS-576 form in the “To Be Completed by the
OPO Provider Staff” section. This data field was also
retitled as “CMS Certification Number (CCN)”
I
I
Reasons for the Change
Column 3 – State/Region Code:
This item has been deleted because this
information is no longer relevant.
Column 4 – FY Ending Date:
We made these changes because we believe that it
would be better for the CMS staff to complete this
data field. Many non-government persons are not
familiar with the fiscal year concept and would get
confusing with determining the end date for the
fiscal year.
We retitled this item to “Current Fiscal Year End
Date” to make it clear what dates should be added.
Column 5 – Medicare Provider Number:
We made this change because this same item
appears twice on the current version of the CMS576 form in both the “CMS Regional Office Use Only”
and also in the ““To Be Completed by CMS Staff
Only” section. There is no need to collect the same
information twice and it doesn’t matter whether
this information is supplier by the OPO provider
or the CMS Location.
Therefore, we have elected to move this field to
the “To Be Completed by CMS Staff Only” section
and ha 6ve the OPO staff fill in their Medicare CCN.
Page 9 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
Changes to the Application
Reasons for the Change
Section I - Identifying Information
1
1
Section Number: 1.
Section Title: Identifying Information
Existing Data Field Text: Name of Facility
Location: Row 5, column 1
1
1
Section Number: 1
Section Title: Identifying Information
Existing Data Field Text: Street Address
Location: Row 5 , column 2
1. The title of this data field has been changes from:
“Name of Facility”
in the existing CMS-576 form
to
“Name of OPO”
In the revised CMS-576 form
1. We changed the name of this data field because
we believe that the title “Name of Facility “ is
too vague and could refer to any type of health
care provider. We believe the title “Name of
OPO” is more specific and better reflects the
information to be collected.
2. This data field was relocated to row 1, column
2. This data field has been relocated to row 1 , column
1 of section 1 because the items in the row
1 of section titled “Identifying Information”
above in the current version of the CMS-576
form have either been deleted or relocated.
The data field for the street address of the OPO has
been relocated from
Page 1, row 5, column 2, in the existing version
of the CMS-576 form
to
Page 1, row 5, column 1 in the revised version
of the CMS-576 form.
1. This change has been made because some of
the data fields in the section to be completed
by the OPO staff have been deleted, requiring
that the remaining data fields be rearranged. .
2. Also, we have rearranged the remaining data
fields because we believe that the logical order
of the data fields containing identifying
information about the OPO would be:
1. Name of OPO
2. CCN Number of OPO
3. Street Address
4. City & County
Page 10 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
1
New Page
#
1
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 1
Section Title: Identifying Information
Existing Data Field Text: City, County and
State
Location: Row 6, column 1
I
Changes to the Application
The following changes were made to this data field:
1. We separated this data field into the following 2
separate data fields:
•
•
City/County
State
2. The City/County data field was relocated from
page 1, row 6, column 1
to
page 1, row 6, column 2.
3. The State data field was relocated from
page 1, row 6, column 1
To
Page 1, row 7, column 1
I
I
Reasons for the Change
5.
6.
7.
8.
State
Zip Code
Telephone Number of OPO
Name of OPO or CEO or Director
These changes have been made because some of
the data fields in the section to be completed by
the OPO staff have been deleted, requiring that the
remaining data fields be rearranged.
Also, we have rearranged the remaining data
fields because we believe that the logical order of
the data fields containing identifying information
about the OPO would be:
1.
2.
3.
4.
5.
6.
7.
8.
Name of OPO
CCN Number of OPO
Street Address
City & County
State
Zip Code
Telephone Number of OPO
Name of OPO or CEO or Director
We believe that it would be better to separate the
City, County & State data fields to prevent having
too much separate information being included
into one single data field. It is customary in most
Page 11 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
1
New Page
#
1
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 1
Section Title: Identifying Information
Existing Data Field Text: Zip Code
1
1
Location: Row 6, column 2
Section Number: 1
Section Title: Identifying Information
Existing Data Field Text: Telephone No.
(include area code)
Location: Row 6, column 3
I
Changes to the Application
I
Reasons for the Change
forms to collect this information separately in
separate data fields.
The Zip Code data field was relocated from:
Page 1, row 6, column 2
to
Page 1, row 7, column 2
The Zip Code data field was relocated from:
Page 1, row 6, column 3
to
Page 1, row 7, column 3
I
Also, these data fields should be placed on
separate data fields to allow for exportation of the
from the Excel files. If the City, county and state
are all included in the same data field it would not
be possible to search and filter the exported data
by any of the separate fields separately if they are
combined into one data field on the CMS-576
form.
These changes have been made because some of
the data fields in the section to be completed by
the OPO staff have been deleted, requiring that the
remaining data fields be rearranged.
These changes have been made because some of
the data fields in the section to be completed by
the OPO staff have been deleted, requiring that the
remaining data fields be rearranged.
Page 12 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
1
1
Current Section Number, Section Title,
Data Field Text and Location
Section Title: Identifying Information
Section Number: 1
Existing Data Field Text: Name of Chief
Executive
Location: Row 7, column 1
1
1
Section Number: 1
Section Title: Identifying Information
Existing Data Field Text: Service Areas
(Attach separate sheet if necessary (TITLE
ROW)
Location: Row 8
I
Changes to the Application
The following changes has been made to the “Name of
Chief Executive” data field:
1. We have changed the text of this data field from:
“Name of Chief Executive”
to
“Name of OPO CEO or Director”
I
Reasons for the Change
1. This data field was relocated to row 8 because
some of the data fields in this section have
been deleted, requiring that the remaining
data fields be rearranged.
I
2. The name of this data field was changed to
“Name of OPO CEO or Director” in the revised
CMS-576 form because we believe that “Name
of Chief Executive” is vague and does not
2. The ”Name of OPO CEO or Director” data field was
identify which Chief Executive’s identity was
relocated from:
being sought. For example, was the name of
the OPO’s CEO or an associated hospital’s CEO
Page 1, row 7, column 1
being sought?
to
Page 1, row 8 column 1
The title in this header row has been changed from:
“SERVICE AREA (Attach Separate Sheet if
necessary)” in the existing CMS-576 form
to
Area Served By This OPO Provider”
in the revised CMS-576 form
We changed the text of this header row because
we believe that the text in the current version of
the CMS-576 form is vague and non-specific. We
believe that the revised text better describes the
information that is being requested.
Page 13 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
1
1
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 1
Section Title: Identifying Information
Existing Data Field Text: A. List Counties
Served (or State if the service includes the
entire State)
Location: Row 9
1
1
Section Number: 1
Section Title: Identifying Information
I
Changes to the Application
1. The “A. List Counties Served (or State if the
service includes the entire State)” data field was
relocated from:
Page 1, row 9
to
Page 1, row 10
2. The lettering identifying each item (i.e.- a., b., c., d.)
has been removed.
1
1
Section Number: 1
Section Title: Identifying Information
Existing Data Field Text: C. Total
Population
Location: Row 11
1. This change has occurred because 2 of the data
fields in this section have been deleted and the
remaining data fields been rearranged.
I
2. The lettering for the data items was removed
because after the deletion of 2 of the 4 data
items, there are only 2 items left. We do not
believe there is a need to use lettering to
identify only 2 data items.
This data field had been deleted
This data field has been deleted in the revised
CMS-576 form because CMS no longer needs to
collect this information.
This data field had been deleted
This data field has been deleted in the revised
CMS-576 form because CMS no longer needs to
collect this information.
Existing Data Field Text: B. Geographic
Boundaries
Location: Row 10
I
Reasons for the Change
Page 14 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
1
1
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 1
Section Title: Identifying Information
Existing Data Field Text: D. List All Acute
Care Hospitals With An Operating Room And
The Equipment And Personnel To Retrieve
Organ
Location: Row 12
I
Changes to the Application
1. The “D. List All Acute Care Hospitals With An
Operating Room And The Equipment And
Personnel To Retrieve Organ” data field was
relocated from:
Page 1, row 12
To
Page 1, row 11
2. The lettering identification for the data fields in
this section has been deleted.
I
Reasons for the Change
1. This change to the location of this data item
was caused by the deletion of several data
items in the section above. Also, the remaining
data fields were re-arranged.
I
2. The lettering of the items in this section has
been removed because we deleted 2 out of 4 of
the data fields in this section, leaving on 2
remaining data fields on this section in the
revised CMS-576 form. We do not believe it is
necessary to use lettering to identify the
remaining 2 items. Also, lettering
identification is not used anywhere else in the
CMS-576 form.
Page 15 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
Changes to the Application
Reasons for the Change
Section 3 - Administration & Staffing
1
1
Section Number: 3
Section Title: Administration & Staffing
Existing Data Field Text: (TITLE ROW)
Board Of Directors And Advisory Board (Give
names and title of members who represent
the following)
Location: Row 14
1
1
Section Number: 3
Section Title: Administration & Staffing
Existing Data Field Text: 1. Hospital
Administrator
Location: Row 15, Column 2
The header row for this section has been split from 1
column into 2 columns and the text changed from:
“BOARD OF DIRECTORS AND ADVISORY BOARD
(Give names and titles of persons who represent
the following)” in the existing CMs-576 form
to
1. We changed the text in this header row
because we believe that the text in the current
version of the CMS-576 form is vague and nonspecific. We believe that the revised text
better describes the information that is being
requested.
I
2. Also, we separated the name and title of the
OPO Administrative staff into to 2 separate
“Name of OPO Administrative Staff” (Column #1)
data fields to allow for their separate
“Title of OPO Administrative Staff” (Column #2)
exportation of the from the Excel files.
in the revised CMS-576 form
1. This item was changed from
“Hospital Administrator”
In the existing CMS-576 form
to
“Name of OPO Administrator”
In the revised CMS-576 form
2. A new data field was added to the right for
“Title of OPO Administrator”
1. The intent of this item is to collect the name of
the OPO’s Administrator. However, in the
current CMS-576 form, this item asks for the
name of the hospital administrator. We
believe this is confusing because in many cases
the OPO is not a hospital. We have changed the
text of this item to “Name of OPO’s
Administrator” to be more specific and prevent
confusion.
2. In the current version of the CMS-576 form,
the name and title of the hospital
administrator is collected on the same data
Page 16 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
1
New Page
#
1
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 3
Section Title: Administration & Staffing
I
Changes to the Application
1
1
Section Number: 3
Section Title: Administration & Staffing
Existing Data Field Text: 3. Director
Location: Row 17 Column 3
field. However, if this data is exported, it
would not be possible to export separately or
search and filter the name and title of the
hospital (to be changed to OPO) administrator
separately in the exported data.
This data field has been deleted because CMS has
determined that it is no longer necessary to collect
this information.
1. The text of this data field has been changed from
1. The intent of this item is to collect the name of
the OPO’s Medical Director. However, in the
current version of the CMS-576 form, this item
asks for the name of “Director”. We believe
this is vague and could be confusing. To
correct this issue, we have changed the text of
this data item to “Name of OPO’s Medical
Director.”
“Director”
in the existing CMS-576 form
to
“Name of OPO’s Medical Director”
In the revised CMS-576 form
2. We placed this revised text into a separate row
I
To correct this issue, we have added a new
column to the right in which to add the tile of
the OPO Administrator.
This data field has been deleted
Existing Data Field Text: 2. Intensive Care or
Emergency Room Personnel
Location: Row 16, Column 2
I
Reasons for the Change
Page 17 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
1
New Page
#
1
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 3
Section Title: Administration & Staffing
Existing Data Field Text: NA
Location: NA
I
Changes to the Application
1. A new data field for “Name of OPO’s Program
Manager" was added at section 3, row 16, column
2 of the revised CMS-576 form.
2. A new data field for “Title of OPO’s Program
Manager” was added at section 3, row 16, column
3 of the revised CMS-576 form.
I
Reasons for the Change
2. In the current version of the CMS-576 form,
the name and title of the director is collected in
the same data field. However, if this data is
exported from the fillable CMS-576 form, it
would not be possible to export the name and
title as separate pieces of information so that
they could be searched and filtered separately
in the exported data.
I
To correct this issue, we have added a new
column to the right in which to add the tile of
the OPO Administrator.
These 2 new data fields were added because we
believe that it is important to collect the name and
title of the OPO’s program manager. This is
because the program manager plays an important
part in managing the day to day activities and
projects of the OPO.
Page 18 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
1
1
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 3
Section Title: Administration & Staffing
Existing Data Field Text: 4. Donation
Coordinator
Location: Row 18, Column 3
1
1
Section Number: 3
Section Title: Administration & Staffing
I
Changes to the Application
1. The text of this data field has been changed from
“Donation Coordinator”
in the existing CMS-576 form
to
“Name of OPO’s Donation Coordinator”
in the revised CMS-576 form
2. A new data field was added in a new column to the
right for “Title of OPO’s Donation Coordinator”
1
1
Section Number: 3
Section Title: Administration & Staffing
Existing Data Field Text: 6. Organ
Procurement Specialist
Location: Row 16, Column 3
1. We changed the name of this items to make it
more specific.
This data field has been deleted because CMS has
determined that the information is no longer
needed.
1. The text of this data field has been changed from
1. We believe that the existing text of “Organ
Procurement Specialist” is vague because it
does not state for whom the Organ
Procurement Specialist is employed. For
example, is the Organ Procurement Specialist
one that is employed at a hospital that is
donating organs from one of its deceased
patients or seeking organs for a patient on the
“Organ Procurement Specialist”
in the existing CMS-576 form
to
“Name of OPO’s Organ Procurement Specialist”
in the revised CMS-576 form
I
2. We added a new, separate column in which the
title for the OPO’s donation coordinator can be
added for the reasons started above.
This data field has been deleted
Existing Data Field Text: 5. Tissue Banks
Location: Row 15, Column 3
I
Reasons for the Change
Page 19 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
I
Changes to the Application
2. A new data field was added in a new column to the
right for
“Title of OPO’s Organ Procurement Specialist”
1
2
Section Number: 3
Section Title: Administration & Staffing
Existing Data Field Text: Voluntary Health
Associations
Location: Page 1, Row 17 & 18, Column 3
This data field has been deleted.
I
Reasons for the Change
recipient’s list? Or, is the Organ Procurement
Specialist employed by the OPO?
I
We have revised the text of this data item to
“Name of OPO’s Organ Procurement
Specialist” because we believe this text
provides the required level of specificity.
2. In the current version of the CMS-576 form,
the name and title of the Organ Procurement
Specialist is collected in the same data field.
However, if this data is exported from the
fillable CMS-576 form, it would not be possible
to export the name and title as separate pieces
of information so that they could be searched
and filtered separately in the exported data.
To correct this issue, we have added a new
column to the right in which to add the tile of
the OPO’s Organ Procurement Specialist.
We have deleted this data field because we have
determined that it is no longer necessary to collect
this information.
Page 20 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
2
NA
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 3
Section Title: Administration & Staffing
I
Changes to the Application
This data field has been deleted
Existing Data Field Text: 8. Physician With
Knowledge, Experience, Or Skill In The Field
Of Human Histocompatibility Or An
Individual With A Doctorate Degree In
Biological Science Or Who Has Knowledge,
Experience, Or Skills In The Field Of Human
Histocompatibility
Location: Page 2, Row 1, Column 2
Section Number: 3
Section Title: Administration & Staffing
Section Number: 3
Section Title: Administration & Staffing
We have deleted this data field because CMS has
determined that it is no longer necessary to collect
this information.
This data field has been deleted
We have deleted this data field because we have
determined that it is no longer necessary to collect
this information.
This data field has been deleted
We have deleted this data field because we have
determined that it is no longer necessary to collect
this information.
Existing Data Field Text: 9. Transplant
Surgeons (from each transplant hospital with
an agreement in the service area)
Location: Page 2, Row 2, Column 2
I
Reasons for the Change
I
Page 21 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
Existing Data Field Text:-10. Members Who
Represent The Public Residing In The Area
Location: Page 2, Row 3, Column 2
Section Number: 3
Section Title: Administration & Staffing
I
Changes to the Application
This data field has been deleted
Existing Data Field Text: “11. Neurosurgeon
Or Another Physician With Knowledge Or
Skills In The Field Of Neurology”
Location: Page 2, Row 4, Column 2
2
2
Section Number: 4
Section Title: Narrative
Existing Data Field Text: “Answer The
Following Questions And Attach Supporting
Documentation”
Location: Page 2, Row 5, Column 2
I
I
Reasons for the Change
We have deleted this data field because we have
determined that it is no longer necessary to collect
this information.
Section 4 - Narrative
We have changed the instructions for this section
from:
“Answer The Following Questions And Attach
Supporting Documentation” in the existing
CMS-576 form
to
“Provide narrative responses to the following
questions regarding your OPO (in a separate
1. We have changed the text of the instructions
for providing narrative responses to the
questions because we do not believe they are
specific enough for several reasons, including:
a. the person completing the CMS-576 form is
required to provide narrative responses to
these questions, however this is not
specifically stated in these instructions;
Page 22 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
I
Changes to the Application
document) and provide all documentation
required to support your responses” in the
revised CMS-576 form.
I
Reasons for the Change
b. The responses to the questions are to be
provided in a separate document which is
to be attached to the CMS-576 form, but
this is not stated in the instructions; and
I
c. The person completing the CMS-576 form
should attach all documentation that
supports all responses to all questions. We
do not believe that this is properly
emphasized in the instructions.
We believe that the modified instructions to
section 4 on the revised CMS-576 form are
more specific and provide more information to
the person completing the CMS-576 form
about how to complete their narrative
responses to the questions. For example, these
revised instructions advises the person
completing the CMS-576 form that the
responses provided to the questions in section
4 must be provided in a separate document,
must be in a narrative format and that all
documentation supporting all responses to all
questions must be provided.
2. In the current version of the CMS-576 form,
the instructions for completion of the
responses to the questions in section 4 are
Page 23 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
I
Changes to the Application
I
Reasons for the Change
contained in the same row and column as the
questions themselves. We believe this format
make the completion instructions less visible
to the reader.
I
To fix this issue, we have placed the revised
completion instructions in a separate row
which is located above the rows containing the
questions. (We have also placed each question
in a separate row as discussed below).
We believe that the modified instructions in
the revised CMS-576 form are more specific
and provide more specific information to the
person completing the CMS-576 form about
how to complete their narrative responses to
the questions. For example, these revised
instructions advises the person completing the
CMS-576 form that the responses provided to
the questions in section 4 must be provided in
a separate document, must be in a narrative
format and that all documentation supporting
all responses to all questions must be
provided.
Page 24 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
2
2
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 4
Section Title: Narrative
Existing Data Field Text: “1. Attach
documentation of working relationship that
exists with facilities of the service area for
harvesting organs. Specify percentage of
hospitals in the service area that you have a
working relationship with and specify bed
capacity of associated hospitals.”
Location: Page 2, Row 5, Column 2
I
Changes to the Application
1. Question #1 has been changed from:
“Attach documentation of working
relationship that exists with facilities of the
service area for harvesting organs. Specify
percentage of hospitals in the service area
that you have a working relationship with
and specify bed capacity of associated
hospitals” in the existing CMS-576 form:
to
“Submit a plan to show evidence of transition
planning to ensure continuity of organ
procurement services if a CHOW takes place”
in the revised CMS-576 form.
2. Question #1 in the existing CMS-576 form has not
been used in the revised CMS-576 form.
I
Reasons for the Change
The CMS-576 form is completed by OPOs seeking
new CMS designation or OPOs that are undergoing
a change of ownership (CHOW). CMS has placed a
moratorium on designation of new OPOs, This
moratorium is expected to last for the foreseeable
future. Therefore, we expect that CMS-576 forms
will be submitted by OPOs undergoing CHOWs
only until said moratorium has been lifted
I
We made this change because the only OPOs
expected to submit CMS-576 form for the
foreseeable future are those undergoing a change
of ownership (CHOW). Therefore, the questions in
section 4 should be geared towards situations in
which an OPO is contemplating to or undergoing a
CHOW.
Also, we have changed question #1 because the
revised question asks the OPO to provide a
transition plan to ensure continuity of operations
after a CHOW takes place. We believe that this
information is necessary to CMS to collect.
Also, we will be collecting information about the
hospitals in the OPO’s service area with which the
OPO has agreements with the revised question #2
in the revised CMS-576 form. Therefore, we will
still be collecting some of the information sought
by question #1 in the existing version of the CMS576 form.
Page 25 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
2
New Page
#
2
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 4
Section Title: Narrative
Existing Data Field Text: “2. Specify
allocation plan for donated organs among
transplant patients.”
Location: Page 2 Row 6, Column 2
I
Changes to the Application
1. Question #2 has been changed from:
“Specify allocation plan for donated organs
among transplant patients” in the existing
CMS-576 form.
to
“Specify the number of hospitals in your
OPO’s service area with which you have
agreements and provide plan for how these
hospitals will notified if a CHOW is to take
place” in the revised CMS-576 form.
I
I
Reasons for the Change
We have decided not to use the text of question #1
on the existing version of the CMS-576 form on the
revised version of the CMS-576 form for several
reasons. First, this information is already being
collected by some of the other questions. Also, the
existing and all previous version of the CMS-576
form have contained 12 questions that require a
narrative response and supporting
documentation. Preparing a response to these
questions and gathering the documents to support
the responses is burdensome to the OPO provider.
We do not want to increase burden to the OPO
provider but adding additional question,
Question #2 in the revised CMS-576 form has the
following purposes:
1. To identify the hospitals in the OPO’s service
area with which the OPO has an agreement;
and
2. To require the OPO to provide a plan for how it
will notify the hospitals with which it has an
agreement in the event that a CHOW does take
place.
Page 26 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 4
Section Title: Narrative
Existing Data Field Text: “3. Discuss
arrangements for tissue typing donated
organs.”
Location: Page 5, Row 5, Column 2
I
Changes to the Application
2. Question 2 in the existing CMS-576 form was
added with revisions to the revised CMS-576 as
question #4.
1. Question #3 has been changed from:
“Discuss arrangements for tissue typing
donated organs” in the existing CMS-576 form
to
“Describe the role of the OPO in training
hospital designated requestor(s) in
establishing and implementing protocols for
making routine inquiries about organ
donations by potential donors” in the revised
CMS-576 form.
I
Reasons for the Change
This information is important because CMS needs
to know the number and names of the hospitals in
an OPO’s services are with which that OPO has an
agreement.
I
Also, CMS needs to be able to review the OPO’s
written plans for notification of the hospitals in
the OPO’s services area with which they have an
agreement that a CHOW is going to take place to
ensure that the notification will be adequate,
timely and contain the required information.
1. It is important to note that the text of question
#3 in the revised CMS-576 form is not one of
the questions contained in the existing CMS576 form.
This question was added to collect information
about the role of OPO training in establishing
and implementing protocols for making
routine inquiries about organ donations by
potential donors. This is information that CMS
believes is necessary to track at this time.
2. In the existing CMS-576 form, there are 12
questions to which a narrative response and
supporting documents must be provided.
These questions cover various topics.
Page 27 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 4
Section Title: Narrative
Existing Data Field Text: “4. Discuss and
document your accounting procedures and
give name and address of accounting firm.”
Location: Page 5, Row 5, Column 2
I
Changes to the Application
2. The text of question #3 in the current CMS-576
form was made question #7 (with revisions) in the
revised CMS-576 form.
1. Question # 4 has been changed from:
“Discuss and document your accounting
procedures and give name and address of
accounting firm” in the existing CMS-576 form.
to
“Provide your organization’s plan for the
allocation of donated organs among
potential transplant recipients” in the revised
CMS-576 form
I
Reasons for the Change
In the existing CMS-576 form, the questions do
not seem to be placed in any particular order.
Likewise, the questions containing similar
topics are not grouped together.
We believe that it would aid the person
completing the CMS-576 form if the questions
are placed in a more logical order such as if the
questions of like topics are placed together.
Therefore, we have revised the order of the
questions to do this.
I
It is important to note that the text of question #4
in the revised CMS-576 form is question #12 in
the existing CMS-576 form.
We made this change to place the set of narrative
questions in a more logical order and to group
question of like type and topic together.
2. The text of question #4 in the existing version of
the CMS-576 form has been made question #9
(with revisions) in the revised CMS-576 form.
Page 28 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 4
Section Title: Narrative
Existing Data Field Text: “5. Submit
quantifiable data showing service area,
population and number of potential donors
per year.”
Location: Page 2, Row 5, Column 2
Section Number: 4
Section Title: Narrative
Existing Data Field Text: “6. Document your
affiliation with tissue banks for the retrieval,
processing, preservation, storage and
distribution of tissues to assure that all usable
tissues from potential donors are obtained.”
Location: Page 2, Row 5, Column 2
I
Changes to the Application
1. Question #5 has been changed from:
“Submit quantifiable data showing service
area, population and number of potential
donors per year” in the existing CMS-576 form
to
“Describe procedures for complying with
OPTN allocation policies” in the revised CMS576 form.
2. The text of question #5 in the existing version of
the CMS-576 form has not been used on the revised
version of the CMS-576 form.
1. Question #6, has been changed from:
“Document your affiliation with tissue banks
for the retrieval, processing, preservation,
storage and distribution of tissues to assure
that all usable tissues from potential donors
are obtained” in the existing CMS-576 form.
to
“Provide documentation of your coordination
activities with transplant programs in the
service area” in the revised CMS-576 form.
I
Reasons for the Change
Due to changes in the OPO regulations, we are
required to collect information about the OPO’s
compliance with OPTN allocation policies.
Therefore, we needed to add a question regarding
this issue,
I
As we have already addressed the OPO’s service
area in revised question #2, we believe that
question #5 is the most appropriate question to
delete and replace with a question about OPTN
compliance.
1. Due to changes in the OPO regulations, we are
required to collect information about the
OPO’s coordination activities with transplant
programs in their service areas. Therefore, we
needed to add a question regarding this issue,
As we have already addressed the OPO’s
service area in revised question #2, we believe
that question #5 would be the most
appropriate one to delete and replace with a
question about OPTN compliance.
Page 29 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
I
Changes to the Application
2. The text of question #6 in the existing CMS-576
form has been added as question #8 (without
revisions) in the revised CMS-576 form.
Section Number: 4
Section Title: Narrative
Existing Data Field Text: “7. Discuss and
document your procedures for testing for HIV
reactivity to prevent the acquisition of organs
infected with the etiologic agent for acquired
immune deficiency syndrome.”
Location: Page 2, Row 5, Column 2
1. Question #7 been changed from:
“Discuss and document your procedures for
testing for HIV reactivity to prevent the
acquisition of organs infected with the
etiologic agent for acquired immune
deficiency syndrome” in the existing CMS-576
form
to
“Discuss your organization's arrangements
for tissue typing of donated organs” in the
revised CMS-576 form.
I
Reasons for the Change
2. We also made this change to place these
questions in a more logical order and to group
question of like type and topic together.
I
It is important to note that text of question #7 in
the revised CMS-576 form is the text (with
revisions) from question #3 in the existing CMS576 form.
We have added question #7 from the current CMS576 form as question #10 on the revised CMS-576
form because we wanted to place the questions in
a more logical order and group question of like
type and topic together.
2. The text of question #7 in the existing CMS-576 has
been added as question #10 (with revisions) to the
revised CMS-576 form.
Page 30 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 4
Section Title: Narrative
Existing Data Field Text: “8. Document your
arrangements to coordinate activities with
transplant centers in your service area.”
Location: Page 2, Row 5, Column 2
Section Number: 4
Section Title: Narrative
Existing Data Field Text: “9. Discuss and
document your procedures for ensuring the
confidentiality of patient records.”
Location: Page 2, Row 5, Column 2
I
Changes to the Application
1. Question #8, has been changed from:
“Document your arrangements to coordinate
activities with transplant centers in your
service area” on the existing CMS-576 form
to
“Document your affiliation with tissue banks
for the retrieval, processing, preservation,
storage and distribution of issues to assure
that all usable tissues from potential donors
are obtained.” on the revised CMS-576 form.
2. This text of question #8 in the existing CMS-576
form has been added as question #6 (with
revisions) in the revised CMS-576 form.
1. Question #9, has been changed from:
“Discuss and document your procedures for
ensuring the confidentiality of patient
records” on the existing CMS-576 form
to
“Discuss and document your accounting
procedures and provide an audit letter on
letterhead with the name and address of your
accounting firm” on the revised CMS-576 form.
I
Reasons for the Change
1. It is important to note that the text of the new
question #8 on the revised version of the CMS576 form is question #6 on the existing version
of the CMS-576 form.
I
2. We moved this question from #8 to be
question #8 because we wanted to place these
questions in a more logical order and to group
question of like type and topic together.
It is important to note that the revised text for
question # 9 on the revised CMS-576 form is the
text from question #4 (less revisions made) on the
existing CMS-576 form.
We revised the text and order of the questions in
this section because we wanted to place these
questions in a more logical order and to group
question of like type and topic together.
Page 31 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 4
Section Title: Narrative
Existing Data Field Text: “10. Discuss and
document your activities relating to
professional education concerning organ
procurement.”
Location: Page 2, Row 5, Column 2
Section Number: 4
Section Title: Narrative
Existing Data Field Text:
11. Document your assistance with hospitals
in establishing and implementing protocols
I
Changes to the Application
2. Question #9 on the existing CMS-576 form has
been added as question #11 (with revisions) on the
revised CMS-576 form.
1. Question #10 has been changed from:
“Discuss and document your activities
relating to professional education
concerning organ procurement” in the
existing CMS-576 form
to
“Provide your written procedures for
screening and testing for HIV and other
infectious diseases” in the revised CMS-576
form.
2. Question #10 on the existing CMS-576 form has
been made question 12 on the revised CMS-576
form.
1. Question #11 has been changed from:
“Document your assistance with hospitals in
establishing and implementing protocols for
making routine inquiries about organ
I
I
Reasons for the Change
1. It is important to note that question #10 in the
revised CMS-576 form corresponds to question
#7 (with revisions) on the existing CMS-576
form.
2. We moved this question from #7 on the
existing CMS-576 form to question #10 on the
revised CMS-576 form because we wanted to
place these questions in a more logical order
and to group question of like type and topic
together.
1. It is important to note that the text of question
#11 on the revised CMS-576 form corresponds
to question #8 on the existing CMS-576 form.
Page 32 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
for making routine inquiries about organ
donations by potential donors.
Location: Page 2, Row 5, Column 2
Section Number: 4
Section Title: Narrative
Existing Data Field Text: “12. Discuss and
document your procedures for allocating
organs equitably among transplant patients
consistent with OPTN criteria as approved by
the Secretary.”
Location: Page 2, Row 5, Column 2
I
Changes to the Application
donations by potential donor” in the existing
CMS-576 form
to
“Provide your procedures for ensuring the
confidentiality of patient records” on the
revised CMS-576 form.
2. Question #11 on the existing CMS-576 form has
been made question #3 (with revisions) on the
revised CMS-576 form.
1. Question #12 has been changed from:
“Discuss and document your procedures for
allocating organs equitably among
transplant patients consistent with OPTN
criteria as approved by the Secretary” on the
existing CMS-576 form
to
“Discuss and document your activities
relating to professional education
concerning organ procurement” on the
revised CMS-576 form.
I
Reasons for the Change
2. We revised the text and order of the questions
in this section because we wanted to place
these questions in a more logical order and to
group question of like type and topic together.
I
1. 1t is important to note that question #12 in the
revised CMS-576 form corresponds to question
#10 on the existing CMS-576 form.
2. We revised the text and order of the questions
in this section because we want to place them
in a more logical order and to group question
of like type and topic together.
Page 33 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
I
Changes to the Application
2. Question #12 on the existing CMS-576 form has
been added as questions #4 and #5 (with
revisions) on the revised CMS-576 form.
I
I
Reasons for the Change
Section 5 - Performance
Section Number: 5
Section Title: Performance
Existing Data Field Text: Number Of Actual
Donors
Location: Page 2, Row 8, Column 2
Section Number: 5
Section Title: Performance
Existing Data Field Text: Number of Kidneys
Transplanted
Location: Page 2, Row 9, Column 2
This data field has been deleted.
CMS is no longer required to collect this data.
•
•
More specifically, section 5 has been deleted in its
entirety
•
This data field has been deleted.
More specifically, section 5 has been deleted in its
entirety.
Deletion of this data field will decrease the
burden associated with completion of the CMS576 form.
•
CMS is no longer required to collect this data.
Deletion of this data field will decrease the
burden associated with completion of the CMS576 form.
Page 34 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 5
Section Title: Performance
I
•
•
Existing Data Field Text: Number of Kidneys
Recovered
Location: Page 2, Row 10, Column 2
Section Number: 5
Section Title: Performance
•
•
Existing Data Field Text: Number of
Extrarenal Organs Recovered
Location: Page 2, Row 11, Column 2
Section Number: 5
Section Title: Performance
Existing Data Field Text: Number of
Extrarenal Organs Transplanted
Location: Page 2, Row 12, Column 2
•
•
Changes to the Application
This data field has been deleted.
I
•
More specifically, section 5 has been deleted in its
entirety.
•
This data field has been deleted.
•
More specifically, section 5 has been deleted in its
entirety.
•
This data field has been deleted.
•
More specifically, section 5 has been deleted in its
entirety.
•
Reasons for the Change
CMS is no longer required to collect this data.
I
Deletion of this data field will decrease the
burden associated with completion of the CMS576 form.
CMS is no longer required to collect this data.
Deletion of this data field will decrease the
burden associated with completion of the CMS576 form.
CMS is no longer required to collect this data.
Deletion of this data field will decrease the
burden associated with completion of the CMS576 form.
Page 35 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
I I I
Existing
Page #
New Page
#
2
33
Current Section Number, Section Title,
Data Field Text and Location
Section Number: 5
Section Title: Performance
Existing Data Field Text: Average Number of
Organs Procured Per Donor
I
•
•
Changes to the Application
This data field has been deleted.
More specifically, section 5 has been deleted in its
entirety.2
I
•
•
Location: Page 2, Row 13, Column 2
Reasons for the Change
CMS is no longer required to collect this data.
I
Deletion of this data field will decrease the
burden associated with completion of the CMS576 form.
Attestation Statement
2
3
Section Number: NA
Section Title: Attestation Statement
Existing Data Field Text:
“Whoever knowingly or willfully makes or causes
to be made a false statement or representation on
this statement, may be prosecuted under
applicable federal or state laws. In addition,
knowingly and willfully failing to fully and
accurately disclose the information requested
may result in denial of a request to participate, or
where the entity already participates, a
termination of its agreement or contract with the
state agency or the secretary, as appropriate.”
1. We have increased the font of this text.
2. We have also added the title “Attestation
Statement” above this text.
•
•
•
The text of the attestation statement was
written in very small font making it very hard
to read. This would make the reader tend to
skip over reading this important statement.
Also, this text was not identified with a title.
As the person signing the CMS-576 form must
attest that they are not knowingly or willfully
making or causing to be made a false
statement(a) representation, it is important
that they read and understand the attestation
statement.
To correct these issues, we have done the
following:
Page 36 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
Changes to the Application
•
Location: Page 2, Row 14, Column NA
•
Signature Lines
2
3
Section Number: NA
Section Title: Signature line
Reasons for the Change
We have divided the signature line into 2 rows, with 2
columns and added the following new fields with the
following titles and properties:
Existing Data Field Text:
Row 1, Column 1:
SIGNATURE OF AUTHORIZED OFFICIAL (Sign Printed Name of Authorized OPO Representative
In Ink)
Row 1, Column 2:
Location: Page 2, Row 15, Column 1
Title of Authorized OPO Representative
Row 2 Column 1:
Signature of Authorized OPO Representative
Note: We have formatted this data field for an
electronic signature
Row 2, Column 2:
Date
To identify the attestation statement we have
titled it as “Attestation Statement”; and
Printed the text of this statement in size 14
font so that it is clearly visible and stands out
to the reader and signer of the CMS-576 form.
We believe that more than just a signature should
be obtained from the person signing a form such
as the CMS-576 form. We say this because many
person’s signatures are difficult to read, Therefore,
it is important to get the person’s printed name in
addition to their signature.
We also believe it is important to get the signer’s
official job title . This will allow CMS to ensure
that they have the requisite authority to sign the
CMS-576 on behalf of the OPO.
In addition, we formatted the signature block for
electronic signature. This will allow the OPOs to
electronically sign the document and transmit
them via email to CMS.
Finally we have formatted the date signed field as
a .pdf fillable field so that the signer can fill in the
data electronically.
Page 37 of 38
Revisions to Form CMS-576
Organ Procurement Organization (OPO) Request For Designation As An OPO
Under § 1138 Of The Social Security Act
Existing
Page #
New Page
#
Current Section Number, Section Title,
Data Field Text and Location
Section Number: NA
Section Title: Date signed
Existing Data Field Text: “Date”
Location: Page 2, Row 15, Column 2
Changes to the Application
Note: We have formatted this data field as a .pdf
fillable date field so that it can electronically be filled
completed .
See the row above for a description of the changes
made to the date field
Reasons for the Change
We have made the date field in the revised CMS576 form fillable so that this form can be
completed electronically. This makes it easier to
complete this form and also prevents inability to
read the date due to illegibility of the handwriting,
Page 38 of 38
| File Type | application/pdf |
| File Title | Revisions to Form CMS-576 |
| Author | CAROLINE GALLAHER |
| File Modified | 2023-03-23 |
| File Created | 2023-03-21 |