Amd_0001_Att_D_Collection_of_Progress_Reports_NCBI_.xlsx

XLSX spreadsheet 77 KB Posted Aug 9, 2019

Attached to: National Cord Blood Inventory (NCBI)
Solicitation number: 19-250-SOL-00062
Issued by: Department of Health and Human Services Health Resources and Services Administration Headquarters

About this file

Written by GovTribe AI · Dec 28, 2023

This notice provides information regarding a planned solicitation for National Cord Blood Inventory (NCBI) services. The Health Resources and Services Administration (HRSA), Healthcare Systems Bureau, Division of Transplantation intends to issue a solicitation to contract with one or more qualified cord blood banks to collect and maintain at least 150,000 new cord blood units for hematopoietic stem cell transplantation through the C.W. Bill Young Cell Transplantation Program donor registry. The contractor must operate an established cord blood bank with an approved Biologics License Application and accredited donor collection and processing standards. Services include adding licensed cord blood units from a diverse donor pool to the public inventory, making units available through the transplantation program and for peer-reviewed research, and maintaining a self-sufficiency plan. The proposed period of performance is five years with an option to extend an additional ten years. The solicitation is expected to be issued in early July 2019 on a full and open basis in accordance with FAR Part 15.

From the source

Att D NCBI Collection of Progress Reports Amd 0001

View the file

Other files

File	Type	Posted
SF30_19-250-SOL-00062_Amendment_0001.pdf	PDF	Aug 9, 2019
Amd_0001_NCBI_-_Consolidated_Questions_-_Answers.pdf	PDF	Aug 9, 2019
Solicitation_A_thru_M_NCBI_20190808_Amd_0001.pdf	PDF	Aug 9, 2019
Att_C_QASP_NCBI_07222019.pdf	PDF	Jul 22, 2019
Att_F_Billing_Instructions_NCBI_07222019.pdf	PDF	Jul 22, 2019
SF33_19-250-SOL-00062_07222019.pdf	PDF	Jul 22, 2019
Att_K_Past_Performance_Questionnaire_Letter_NCBI_07222019.pdf	PDF	Jul 22, 2019
Att_H_Disclosure_of_Lobbying_Activities_NCBI_07222019.pdf	PDF	Jul 22, 2019
Att_L_Pricing_Proposal_Table_NCBI_07222019.xlsx	XLSX spreadsheet	Jul 22, 2019
Att_J_CWBYCTP_Contractor_CBU_Eligibility_Requirements_for_Public_Registry_NCBI_07222019.pdf	PDF	Jul 22, 2019
Att_E_CPARS_Information_Sheet_NCBI_07222019.pdf	PDF	Jul 22, 2019
Att_I_Summary_Tables_NCBI_07222019.xlsx	XLSX spreadsheet	Jul 22, 2019
Att_D_Collection_of_Progress_Reports_NCBI_07222019.xlsx	XLSX spreadsheet	Jul 22, 2019
Att_G_HHS_Subcontracting_Plan_Template_NCBI_07222019.pdf	PDF	Jul 22, 2019
Solicitation_A_thru_M_NCBI_07222019.pdf	PDF	Jul 22, 2019
Att_B_Non-Disclosure_Agreement_NCBI_07222019.pdf	PDF	Jul 22, 2019
Att_A_PWS_NCBI_07222019.pdf	PDF	Jul 22, 2019

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Attachment D Gen Info

Attachment D, Collection of Progress Reports Template:

These are guidance templates for the content required for the progress reports. Please refer to progress report tasks for requirements.

At the post-award, in-person, site visit, CORs will explain the content and reporting requirements in detail.

The reports may be provided in a different format as agreed to by the COR. The content of the reports may be changed by the Government.

CBU CLIN Reference number (#) is the number assigned to each CBU delivered for the respective CLIN. Reference numbers shall be in chronological order. The first CBU delivered to that CLIN is 1, the second CBU is 2, and so forth, through the CLIN target. If in the first month, two units are delivered to a CLIN, then the second's month report on that same CLIN will start with Reference# 3. Each CLIN shall have a separate report sheet. All sub CLINs shall be reported on the same CLIN report sheet. For example, report for "primary" CLIN 0001 shall include report for 0001a/b/c. If target for CLIN 0001 is 100, CLIN Reference #s for CLIN 0001 would be 1-100.

First Month: Reference # "1"&"2"			Second Month: Reference # is "3"&"4"
"CBU CLIN Reference #"	Contract Line Item Number (CLIN)	CBB CBU ID#	"CBU CLIN Reference #"	Contract Line Item Number (CLIN)	CBB CBU ID#
"1"	0001b		"3"	0001a
"2"	0001a		"4"	0001c

1 Contract Key Item Updates Progress Report# 1: Contract Key Item Updates

Contract #: HHSH

Contractor: As listed on HRSA Contract

Deliverable #

Report Period:

Fiscal Year (FY):

Report Date:

Describe new information/change and any affect on NCBI contract or delivered CBU, corrective action or resolution with timeline (if applicable), and any other pertinent information. Reports on contract activity should be reported to the COR using progress reports except for information that the Contractor deems urgent and should not be delayed by monthly reporting or as specified by task and schedule of deliverables.
Key Personnel
Key Personnel Title	Name			Designation Date	Award or Mod #
Project Director
Coordinator
Current FY notifications to COR about Key Personnel
Date	Description
XX/XX/20XX
FDA
FDA, HPC BLA	Date
Approval
Current FY notifications to COR about FDA changes affecting the contract
Date	Description
XX/XX/20XX
Cord Blood Bank Accreditation
Accrediting Organization(s)		Inspection Dates	Accreditation Dates

Current FY notifications to COR about accreditation(s) changes affecting the contract
Date	Description
XX/XX/20XX

2 CBU Collection Schedule Progress Report #2: CBU Collection Schedule

Contract #: HHSH

Contractor: As listed on HRSA Contract

Deliverable #

Report Period:

Fiscal Year:

Report Date:

Collection Site Details (List all sites for NCBI collections since entry date of contract):						Collection Site Agreements
Hospital Name	City	State	Collection Model(s)	Number of Births	Collection Hrs/Mo	Start Date	Expiration date	Open Date	Close Date
Collection Site 1
Collection Site 2
Collection Site 3
Collection Site 4
Collection Site 5
			Total

CBU Collection Schedule

Contract Year 1/CLIN 0001 for FY 2020 Deliveries

Jul

Aug

Sep

Oct

Nov

Dec

2020 Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

P=Planned; A= Actual

CBU Total Planned

CBU Total Actual to date

CBU Total Delta to date

B/AA

Asian

White, Non-Hispanic

White, Hispanic

Multi-race, NH/PI, AI/AN

CBU Totals

Collection Site 1 name

Collection Site 2

Collection Site 3

Collection Site 4

Collection Site 5

CBU Totals

Number of Collection Sites

3 CBU Delivery Schedule Progress Report #3: CBU Delivery Schedule

Contract #: HHSH

Contractor: As listed on HRSA Contract

Deliverable #

Report Period:

Fiscal Year (FY):

Report Date:

CBU Delivery Schedule

Contract Year 1/CLIN 0001

Jul

Aug

Sep

Oct

Nov

Dec

2020 Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Correlates with Monthly Deliveries on SF 1034 P=Planned; A= Actual

CBU Total Planned

CBU Total Actual to date

CBU Total Delta to date

B/AA

Asian

White, Non-Hispanic

White, Hispanic

Multi-race, NH/PI, AI/AN

CBU Totals

Collection Site 1

Collection Site 2

Collection Site 3

Collection Site 4

Collection Site 5

CBU Totals

CBU (Planned)Delivery Schedule by Site for Year 1 (a table for each year in B.2 Price)

Cord Blood Unit Race and Ethnicity

Site 1

Site 2

Site 3

Site 4

Site 5

TOTAL

B/AA

Asian

White, Non-Hispanic

White, Hispanic

Multi-race, NH/PI, AI/AN

CBU Totals

4 NCBI CBU Delivery

Progress Report #4: NCBI CBU Delivery

Submit a separate report for each Contract Line Item Number (CLIN) from contract).

Submit each month an invoice is submitted for the CLIN.

Contract #: HHSH

Contractor: As listed on HRSA Contract

Deliverable #

Report Period (Delivery Service Period):

Fiscal Year (FY):

Report Date:

CLIN: 0001 (includes all subsets of 0001 such as 0001a, 0001b, etc.)

Contract Year:

Date CLIN funds added to the contract: XX/XX/XX

Earliest CBU Collection Date for CLIN: As specified by contract.

Final CBU Collection Date for CLIN: As specified by contract

Each CBU reported on this table as a delivery shall receive a permanent reference number in chronological order. The reference numbers by primary CLIN shall begin at 1 through the final quantity of CBU per CLIN. For example, the first CBU shall be assigned the number "1" and if the total CLIN quantity is 20, the final reference number shall be assigned 20. If a CLIN has several subsets, for example, CLIN 0001 is comprised of 0001a, 0001b, and so forth, the total quantity of 0001 (sum of all subsets) shall be used as the quantity for progress reporting. Each CLIN (and subsets) shall be reported on separated CLIN CBU Delivery Reports; mixture of CLINs and contract years on a single report shall be rejected.

PDF version submitted with invoices as supporting documentation.

Excel and PDF versions submitted as monthly progress reports.

								NCBI CBU Minimum Acceptable Values by R/E per Del. #22
								TNC
								CD34
								Viability
CBU CLIN Delivery Reference #	Contract Line Item Number (CLIN)/FY awarded	CBB CBU ID#	Registry CBU ID#	Collection Date	SPA-CC Registration Date	CBU Specs TNC	CBU Specs CD34	CBU Specs Viability	AI/AN	B/AA	Asian	NH/PI	White (non Hispanic)	White His-panic	Multi-race
1	0001a
2	0001a
3	0001b
4
5
6
7
8
9
10
11
12																Total
							Report Period (Monthly) Total		0	0	0	0	0	0	0
							CLIN Total

5 B1 Inv Summary & Cum Reports Progress Report #5: B-1 Invoicing Summary and Cumulative Reports

Contract #: HHSH
Contractor: As listed on HRSA Contract
Deliverable #
Delivery Service Period (invoice month):
Fiscal Year (FY):
Report Date:
Submit PDF version with invoices as supporting documentation.
Submit Excel as monthly progress report to COR.
					*Delivered includes units on the current invoice
B-1 Monthly Invoice					B-1 Cumulative Summary							Delivery Performance Achievements
CLIN 0001 Year 1	CLIN	Price/CBU	Number of CBU Invoiced	Amount Current Invoice	Target	Delivered*	Remain	$Target	$Paid	$ Remain	% Paid	Percent Delivered	Performance Standard Date*	Met Performance Standard Date
B/AA	0001a		4	$0.00	100	10	90					50%
Asian	0001a		2	$0.00	50	10	40					75%
White, non-Hispanic	0001b		1	$0.00	50	25	25					100%
White, Hispanic	0001a		0	$0.00	100	20	80
Multi-race, NH/PI, AI/AN	0001a		4	$0.00	50	10	40
Total CLIN 0001			11	$0.00	350	75	275

B-1 Monthly Invoice

B-1 Cumulative Summary

Delivery Performance Achievements

CLIN 0002 Year 2

CLIN

Price/CBU

Number of CBU Invoiced

Amount Current Invoice

Target

Paid

Remain

$Target

$Paid

$ Remain

% Paid

Percent Delivered

Performance Standard Date

Met Performance Standard Date

B/AA

50%

Asian

75%

White, non-Hispanic

100%

White, Hispanic

Multi-race, NH/PI, AI/AN

Total CLIN 0002

B-1 Monthly Invoice					B-1 Cumulative Summary
Invoice Total all CLINs	FY $ obligated	CLIN	Number of CBU Invoiced	Amount Invoiced to Date	Target	Paid	Remain	$Target	$Paid	$ Remain	% Paid
Total Contract Year 1	2019	0001			350	75	275	$0.00	$0.00	$0.00	0.0%
Total Contract Year 2	2020	0002			400	0	0	$0.00	$0.00	$0.00	0.0%
Total Contract Year 3	2021	0003
Total Contract Year 4	2022	0004
Total Contract Year 5	2023	0005
Contract Total					750	75	275	$0.00	$0.00	$0.00	10.0%

CBU Contract Total by Race and Ethnicity	TARGETS all CLINs	Remain All CLINs	Invoiced All CLINs	CBU Race and Ethnicity	Established Minimum TNC Count by Race/Ethnicity for non-contracted CBUs (As submitted per Deliverable #22)	Established Minimum TNC Count by Race/Ethnicity for contracted CBUs (As submitted per Deliverable #22)
B/AA				B/AA
Asian				Asian
White, non-Hispanic				White, non-Hispanic
White, Hispanic				White, Hispanic
Multi-race, NH/PI, AI/AN				Multi-race
TOTAL as of Report Period				NH/PI
				AI/AN

6CBU for Peer Reviewed Research Progress Report #6: CBU for Peer-Reviewed Research

Contract #: HHSH

Contractor: As listed on HRSA Contract

Deliverable #

Report Period:

Fiscal Year (FY):

Report Date:

Peer Reviewed Research

CBU Quantity

Study Title or Investigator

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

CBU Total

Total Fees Charged

Report Period Total

Total Year 1, FY 2020

Total Year 2, FY 2021

Total Year 3, FY 2022

Total Year 4, FY 2023

Total Year 5, FY 2024

CONTRACT TOTAL

7 CBU Availability Stat Summary Progress Report #7: CBU Availability Status Summary

Contract #: HHSH

Contractor: As listed on HRSA Contract

Deliverable #

Report Period:

Fiscal Year (FY):

Report Date:

CBU Contract Total by Race and Ethnicity (Monthly Reporting)	CBU TARGETS all ClINs	CBU Remain All CLINs	CBU Delivered All CLINs	TOTAL CBU Available, Distributed, Not Available, and CBU not yet replaced	NCBI CBU Available through CW Program	NCBI CBU Distributed for therapy to a designated patient through FDA BLA or IND	NCBI CBU Not Available for < 12 consecutive months	NCBI CBU Removed not yet replaced (<30 days from removal date)	NCBI CBU Replaced	NCBI Removed
B/AA
Asian
White, Non-Hispanic
White, Hispanic
Multi-race, NH/PI, AI/AN
Report Period Total
*Total Year 1, FY 2020
*Total Year 2, FY 2021
*Total Year 3, FY 2022
*Total Year 4, FY 2023
*Total Year 5, FY 2024

*FY totals entered only at the end of each FY.

After the report period for the FY ends, on Sep 30, the FY total is the "final" totals for CBU activity that occurred during that FY (Oct 1-Sep 30)

8 NCBI CBU Shipped

Progress Report # 8: NCBI CBU Shipped

Submit a separate report for each CLIN (CLIN: Contract Line Item Number from HRSA Contract).

Contract #: HHSH

Contractor: As listed on HRSA Contract

Deliverable #

Report Period:

Fiscal Year:

Report Date:

Enter "1" for HRSA R/E Category and for CBU shipped

CBU Distribution Information

SCTOD

Contract Line Item Number (CLIN)

CBU CLIN (Delivery) Reference #

CBB CBU ID#

Other CBU ID#

Shipment Date

Collect Date

AI AN

B/AA

Asian

NH PI

White non-Hispanic

White His-panic

Multi-race

Recipient Race

Method (Direct, CWBYCTP, Other)

IND

BLA

SCTOD received CBU pre-transplant data

0001

Report Period Total

Total Year 1, FY 2020

Total Year 2, FY 2021

Total Year 3, FY 2022

Total Year 4, FY 2023

Total Year 5, FY 2024

CONTRACT TOTAL

9 CBU Shipped Summary

Progress Report #9: CBU Shipped Summary

Identify NCBI CBU shipped as pursuant to this contract and previous NCBI contracts: Transplant, Unrelated Donor

Contract #: HHSH

Contractor: As listed on HRSA Contract

Deliverable #

Report Period:

Fiscal Year (FY) :

Report Date:

		Cumulative CBU Shipped				CBU Shipped
Cumulative CBU SHIPPED (all contract years)	Cumulative # of recipients by R/E	Total Number of CBU shipped	CBU NCBI - current contract	NCBI -previous contracts	Non-NCBI	Total for FY 2020	FY 2021	FY 2022	FY 2023	FY 2024
AI/AN	1000	1000	500	400	100	500	500
B/AA
Asian
NH/PI
White Hispanic
White Non-Hispanic
Multi-race
Cumulative Total

FY 20XX - CBU SHIPPED (NCBI, previous NCBI contracts, Non-NCBI)

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Current FY TOTAL

AI/AN

B/AA

Asian

NH/PI

White Hispanic

White Non-Hispanic

Multi-race

Report Period Total

Total Year 1, FY 2020

Total Year 2, FY 2021

Total Year 3, FY 2022

Total Year 4, FY 2023

Total Year 5, FY 2024

CONTRACT TOTAL

10 CBU Removed Replaced by CLIN

Progress Report #10: CBU Removed/Replaced by CLIN

For monthly reporting, a new sheet shall be started for EACH CLIN. Once an entry is made, the entry remains on the sheet and new entries are entered below it. The September report for each year should have all entries for that FY.

Contract #: HHSH

Contractor: As listed on HRSA Contract

Deliverable #

Report Period:

Fiscal Year (FY):

Report Date:

Removed CBU Information

Replacement CBU Information

Enter "1" for R/E Category of removed CBU

Contract Line Item Number (CLIN)

CBU CLIN (Delivery) Reference #

CBB CBU ID#

Other CBU ID#

Collection Date

Removal Date

Replacement Date

CBU CLIN Reference #

CBB CBU ID#

Other CBU ID#

Collection Date

SPA-CC Registration Date

AI AN

B/AA

Asian

NH PI

White

White His-panic

Multi-race

*If AI/AN or NH/PI replaced by another R/E, provide R/E of replacement CBU.

Reason for CBU removal

0001

R0001-1

R0001-2

TOTAL

*Per contract requirements

11 CBU Removed Summary Progress Report # 11: CBU Removed Summary

Contract #: HHSH

Contractor: As listed on HRSA Contract

Deliverable #

Report Period

Fiscal Year (FY):

Report Date:

CLIN, CBU Removed

Oct

Nov

Dec

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

TOTAL

0001a/b/c

0002

0003

0004

0005

Report Period Total

Total Year 1, FY 2020

Total Year 2, FY 2021

Total Year 3, FY 2022

Total Year 4, FY 2023

Total Year 5, FY 2024

CONTRACT TOTAL

12NCBI CBU Transfer or Receipt Progress Report #12: NCBI CBU Transfer or Receipt

Contract #: HHSH

Contractor: As listed on HRSA Contract

Deliverable #

Report Period:

Report Date:

Transfer Date:

Receipt Date:

CLIN: 0001 (includes all subsets of 0001 such as 0001a, 0001b, etc.)

Contract Year: Year 1

Contractor Receiving NCBI CBU:

Contractor Transferring NCBI CBU:

CBU Transfer (units transferred to and from the contract): Each CBU reported on this table shall receive a permanent transfer number in chronological order. The transfer number shall begin at 1 through the final quantity of CBU transferred. For example, the first CBU shall be assigned the number "1" through the total numbered transferred.

CBU Transfer # or Receipt # (as applicable)

CBU CLIN (Delivery) Reference # (reported to HRSA for initial delivery to NCBI)

Contract Line Item Number (CLIN)/FY awarded

CBB CBU ID#

Registry CBU ID#

Collection Date

AI AN

B/AA

Asian

NH PI

White

White His-panic

Multi-race

0001a

Total

Report Period Total

Total Year 1, FY 2020

Total Year 2, FY 2021

Total Year 3, FY 2022

Total Year 4, FY 2023

Total Year 5, FY 2024

CONTRACT TOTAL

13 Self Sufficiency Progress Report #13: Self-Sufficiency

Contract #: HHSH

Contractor: As listed on HRSA Contract

Deliverable #

Report Period:

Fiscal Year (FY):

Report Date:

Self-Sufficiency Report

Year 1 (EDOC 2019 - Sep 2020)

Year 2 (Oct 2020-Sep 2021)

Year 3 (Oct 2021-Sep 2022)

Year 4 (Oct 2022-Sep 2023)

Year 5 (Oct 2023-Sep 2024)

Cunulative Contract Total FY to Date)

Annual Self-Sufficiency

Plan

Actual

Plan

Actual

Plan

Actual

Plan

Actual

Plan

Actual

Plan

Actual

Number of cord blood units collected

Number of CBU (NCBI and non-NCBI) added to the public inventory

Number of cord NCBI blood units reimbursed

Number of Collection Sites

Total Expenses

Revenue from CBU shipments

Revenues from other than CBU shipments

NCBI Reimbursement Amount

HRSA funding through CW Program contractors

Total Revenues

Difference = Exp - Rev

Self-Sufficiency Report

Year 1 (EDOC 2019 - Sep 2020)

Year 2 (Oct 2020-Sep 2021)

Year 3 (Oct 2021-Sep 2022)

Year 4 (Oct 2022-Sep 2023)

Year 5 (Oct 2023-Sep 2024)

Cumulative Contract Total FY to Date)

Number of CBU (NCBI and non-NCBI) added to the public inventory by race and ethnicity

Plan

Actual

Plan

Actual

Plan

Actual

Plan

Actual

Plan

Actual

Plan

Actual

AI/AN

B/AA

Asian

NH/PI

White Hispanic

White Non-Hispanic

Multi-race

Total

File details come from the government source that posted it. Updated Dec 28, 2023.