N01PC65003-74_Amendment_8_SF_30_53017_FINAL.pdf

AMENDMENT TO SOLICITATION

REQUEST FOR PROPOSAL: N01PC65003‐74

AMENDMENT No. 08

Date of Issuance: May 31, 2017

1. Regarding the DQI measures referred to in Task Order A, I searched for definitions of these on the

SEER web site but the only reference I found was a screen shot from chapter 1 of the SEER*DMS manual. Could we please obtain definitions (i.e., what is in the numerator, what is in the denominator)? Some examples a) Percent non‐specific histology: which histologies are counted in the numerator; is the denominator all reportable non‐DCO cases (i.e., all behaviors) or limited to invasive cases? b) Percent unknown laterality: is the denominator limited to cases with cancers of paired organ sites? Would it be possible to obtain better documentation?

RESPONSE: See the attached document at the end of this Amendment for the definitions of the current DQP measures.

2. Task Area 8 (VTR) – Business Proposal: The current VTR project is separately funded as an RRSS, similar to the annual Patterns of Care Study; however, in the current RFP it is unclear whether the budget would be separate, or a portion of the Core budget. Will future VTR projects be funded separately, as the Patterns of Care Studies are? If not, for budgeting purposes, parties will need to know the planned frequency of studies (annual or otherwise), number of cases to be ascertained, and specific requirements for tissue/slide handling and preparation, whether professional pathologist services will be required, and other special requirements. Please provide further clarification.

RESPONSE: The Base Statement of Work includes all potential work that may be included under this IDIQ contract, including a Task Area for Virtual Tissue Repository. All potential projects will be issued under Separate Task Order Requests for Proposal (TORFP) when a bona‐fide need is identified or as part of negotiations with Offerors in the Competitive Range. The Additional

Business Proposal (Attachment 21) clearly states that budgets are only to be submitted for Task

Orders A, B, and C.

3. Is there a contact name and phone number for questions regarding the Spreadsheet of Proposed

Estimated Costs? We are having difficulty completing it and I’m not sure how to add three years to the seven‐year spreadsheet.

RESPONSE: All questions should be directed to the following point of contact:

Lee J. Oliver, Contract Specialist NCISEER_2018@mail.nih.gov

This information can also be found in the RFP in item #11 on the facepage. Please note that the

Excel spreadsheet (Attachment #17) provided in Amendment #04 is a fully editable Excel

Spreadsheet.

4. Are our responses to Sections 3, 4, and 5 in this solicitation meant to be standalone documents?

RESPONSE: All responses should be standalone sections located in the Technical and Business

Proposals. Only one Technical Proposal should be submitted divided into Sections. Please refer to

Attachment #14 and #21.

5. SEER requires certain fields/data items that are not required by ACOS/COC programs. An example of this is the reportability of analytic vs. non‐analytic cases. Another example of this are SEER EOD

2018 fields. Are we allowed to budget funds for Registry staff to collect these data fields/items?

RESPONSE: American College of Surgeons/Commission on Cancer (ACoS/CoC) programs are generally required by their state laws to report to their central state registry with the central state registry, not the ACoS/CoC program setting the requirements on the data to be collected and submitted. It is the responsibility of the central registry to ensure that their laws allow for this. An

Offeror that lacks these laws would have to determine how these data items/fields are to be collected. If costs for this are proposed, documentation and narrative budget justification would need to be provided.

6. In Attachment 21, page 15, it states: “For year 1, Offerors should budget $50,000 in the government‐share and an additional $50,000 in the cost‐share budgets for costs associated with establishing local level NIST Moderate level controls. These costs may include but are not limited to the services of a consultant, laptop/desktop encryption software and staff training. Subsequent years should budget $50,000 in the government‐share budget.” Could you please provide further clarification regarding this cost? Where in the budget should this cost be placed, for example as one line item in the Other Direct Costs budget? Is there a reason 50% of this cost is to be charged against the cost‐share budget in year 1, when in general only 20% cost share is required? Are we able to count this expense as part of the overall 20% cost share, or is it a separate cost share item?

RESPONSE: Cost‐Share is required for Sample Task Order A. The 20% Cost‐share requirement is based on a total budget, Contractor Cost‐share of 20% to Government share of 80%, not by Cost

Category or line item. It is the Offeror’s decision as to which costs should be included in

Government vs. Cost‐Share.

It was the Government’s decision to have these base year NIST costs split 50/50 between

Government and Cost Share. These expenses will count toward the required 20% cost‐share. If the

Offeror decides to include all the costs associated with NIST moderate level controls in the Cost‐ share, that is acceptable. However, Contractors must note that the Government will not provide costs in excess of $50,000 in the Government share for the base year.

7. On page 7 of 10 of Attachment 3, Base Statement of Work, Task Area 4 – SEER*Educate, it appears this statement of work relates to the development, enhancement, and maintenance of

SEER*Educate. We anticipate our Registry will not perform this function, but rather will be a user of the system. Are we required to respond to this Task Area, other than to state we anticipate being a user of the system?

RESPONSE: As indicated in the Additional Technical Proposal Instructions (Attachment #14)

Offerors must address all Task Areas in the Base Statement of Work in their proposals.

8. On page 7 of 10 of Attachment 3, Base Statement of Work, Task Area 5 – SEER*DMS Migration

Activities, our Registry has already migrated to SEER*DMS. Do you need a detailed description of the activities that occurred as a result of this migration, or are we able to simply state we have already migrated to SEER*DMS?

RESPONSE: As indicated in the Additional Technical Proposal Instructions (Attachment #14)

Offerors must address all Task Areas in their proposals. If an Offeror has already completed a migration to SEER*DMS it is the Offeror’s decision as to how to address this Task Area in their

Technical Proposal.

9. Task Area 1, a Programmatic Meeting, is requested in Attachment 3, Base Statement of Work;

Attachment 4, Task Order A – Core Infrastructure; Attachment 5, Task Order B – Virtual Pooled

Registry; and Attachment 6, Task Order C Programmatic Meeting. While Task Order C does not require a technical proposal, should Task Area 1, Programmatic Meeting, be addressed in the

Technical Proposals for the Base Statement of Work, Task Order A, and Task Order B?

RESPONSE: Yes, as this meeting is included in the Sample Task Order A & B Statements of Work.

Also, Offerors are required to address all Task Areas in the Base Statement of Work. Offeror’s should follow the guidance provided in the Additional Technical Proposal Instructions

(Attachment #14) and Additional Business Proposal Instructions (Attachment #21).

10. We see where you have stated the North American Industry Classification System (NAICS) Code for this solicitation is [541712 (2012) or 541715 (2017)]. Is this the same NAICS code we should use for prior SEER‐related awards? If not, how can we find out the NAICS code for these awards?

RESPONSE: The NAICS code for any previous NCI SEER award has no bearing on the NAICS code selected for Solicitations N01PC65003‐74. Solicitation N01PC65003‐74 is independent of any previous NCI SEER award and should be treated as so. All Offerors should update their SAM.gov record to reflect capability to perform the NAICS code included in the RFP.

11. Regarding the “Technical Proposal Cost Information/Summary of Labor and Direct Costs” sheet

(Attachment 11): should this be limited to direct costs that are being requested from the government as part of the application or should it also include direct costs that are part of the required cost‐share?

RESPONSE: This is a Request for Proposals (RFP), not a Request for Applications. This should be limited to the Government share only.

12. Regarding Attachment 21 item vi. on page 15 of 17, please confirm that the requested $50,000 in cost share shall be factored in to the overall requirement of 20%.

RESPONSE: Yes, the $50,000 should be factored into the 20% requirement of the Cost‐Share.

13. Regarding Attachment 21 item vi. on page 15 of 17, please clarify what is expected for "establishing local level NIST Moderate level controls," and clarify what associated costs should be factored in to accomplish this?

RESPONSE: This is discussed in Section H.18.B. It is the Offeror’s decision to determine what will be required and at what proposed cost. Offerors are reminded that the NCI will be responsible for the SEER*DMS hosting IT‐SP. Offerors are also reminded that any unit costs over $500 per unit must include a quote supporting the proposed cost/price.

14. It is not clear from Attachment 14 where in the Technical Proposal a Schedule of Deliverables should be included (p. 85, 1.4). Should three separate schedules, one for each of the sections 3‐5 of the

Technical Proposal be provided? Many of the items listed for inclusion on the schedule (s)? on page

18 (Article F2) pertain to Task Areas 1 and 2 of the Base SOW. However, Sections 3‐5 described in

Attachment 14 do not cover these first two Task Areas. It is thus additionally unclear where to include the schedule of the specific deliverables related to these Task Areas 1 and 2, e.g. Deliverable

# 1 or Deliverable #25 (page 18‐20).

RESPONSE: Please see the response provided in question #11 in Amendment #7. Deliverables and their schedule will be provided during negotiations.

Data Quality Profile (DQP)

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The Data Quality Profile (DQP) is distributed at the SEER Managers’ meeting each November. This document describes the calculations used for this report. It was updated in 2012 to reflect changes in the calculation method for the one‐year reporting delay (cervix in situ are no longer excluded).

This document was prepared by Linda Coyle at IMS (coyle@imsweb.com). There are 16 scored markers and one non‐scored marker.

Input Data File: The DQP is based on each registry’s final SEER submission file after it has been processed by IMS staff. NCI‐approved modifications and additions may be made to the file during that processing (approved corrections, addition of variables such as the IHS flag, etc).

This is the same file that is used to create the SEER*Stat research database.

The following records are excluded from calculations.

In situ cervix: cases coded as C530‐C539 with behavior=2 are excluded.

Invalid site: cases with invalid site are excluded. Valid site codes are C000‐C809. A blank or null value is not valid.

Invalid histology: cases with invalid histology are excluded. Valid histology codes are 8000‐9999. A blank or null value is not valid.

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Marker Numerator Denominator

1. Death Certificate Only

Goal: < 1.5% and > 0.0%

Calculated by SEER*Edits

1. Year Dx: current reporting year.

2. Type of reporting source = 7

Year Dx: current reporting year.

2. Cause of death missing for patients known to be dead

Goal: < 2.5%

Calculated by SEER*Edits

1. Years DX from 1995 (or first available year dx after 1995) through the current reporting year.

2. Sex = 1 or 2

3. Sequence = 0 or 1

4. Vital status = 4

5. Year of death less than or equal to the reporting year.

6. Cause of death = 7777 or 7797

Criteria 1‐5 for the numerator.

3. Unknown or Ill‐defined primary site

1. Year Dx: current reporting year.

2. Type of reporting source does not equal 7 (Death

Certificate).

3. Primary Site code is C760‐C765, C767, C768, C809.

Criteria 1‐2 defined for the numerator.

4. Non‐specific histology

Goal: < 2.5%

Calculated by SEER*Edits

1. Year Dx: current reporting year.

2. Type of reporting source does not equal 7 (Death

Certificate)

3. Diagnostic confirmation < 5

4. Histology ICD‐O‐3 is 8000 or 8001.

Criteria 1‐2 defined for the numerator.

5. Unknown laterality

Goal: < 6.0%

1. Year Dx: current reporting year.

2. Type of reporting source does not equal 7 (Death

Certificate)

3. Laterality = 3 or 9. (3=only one side, not specified;

9=Paired, No Information)

1. Criteria 1‐2 defined for the numerator.

2. And Laterality does not equal 0 (0=Not paired)

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6. Unknown SEER historic stage

Goal: < 10.0%

2. Excluding pleura, brain, lymphoma, KS, misc, benign/bordlerine,.

3. Excluding DCOs.

4. Historic stage = 99

Criteria 1‐3 defined for the numerator.

7. Invalid or missing census tract

Goal: < 2.0%

2. Census Tract 2010 is 999999 or null; or the census tract fails the edit that verifies tract and county (IF441)

Year Dx: current reporting year

8. SEER estimated completeness excluding prostate

Goal: >= 98.0%

2. Behavior is 2 or 3

3. Sex is 1 or 2

4. Site is not Prostate (Site= C619 histology < 9590)

An estimate based on a linear regression (ordinary least squares) of counts for prior years. 10 years of data are used for the regression, if the data are available in the file (this may include data prior to the registry’s SEER start year).

Note: If R‐squared < 0.5, the average of the last two years is used.

9. Percent complete as of February excluding prostate

Goal: >= 95.0%

This is the same value as #8, but this value is based on the February submission (three months later). It is the February completeness estimate for (reporting year + 1).

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10. 1 year reporting delay

Number of cases with year dx = (reporting year – 1) that submitted in current November submission but not submitted in the previous November submission.

Number of cases for (reporting year – 1) in the current submission.

11. Follow-up age < 20 (Invasive Cases)

Goal:

>= 90% ‐ Contractual Standard >=80% ‐ Minimum Acceptable

1. SEER reportable cases that also meet these criteria:

a. Sequence is 00 or 01.

b. Site/Beh :

i. Malignant (behavior = 3)

ii. or uncertain benign/malig (behavior = 1) and year of diagnosis <= 2000

iii. or Bladder (C670‐C679)

2. Sex is 1 or 2

3. Years DX: 1995 to (reporting year minus 1) for some registries; 2000 to (reporting year minus 1) for other registries.

4. Age: 0‐19

5. Date of Last Contact >= Reporting Year or patient is deceased (vital status = 4).

Criteria 1‐4 defined for the numerator.

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12. Follow-up age 20-64

>=80% ‐ Minimum Acceptable

Calculated by SEER*Edits

Same as the numerator for 11 except that age = 20‐64 Same as the denominator for 11 except that age = 20‐64

13. Follow-up age 65+

>= 95% ‐ Contractual Standard >=90% ‐ Minimum Acceptable

Same as the numerator for 11 except that age >= 65 Same as the denominator for 11 except that age >= 65

14. Follow-up all in situs

>=80% ‐ Minimum Acceptable

1. SEER reportable cases that also meet these criteria:

a. Sequence is 00 or 01.

b. Behavior is 2 (in situ) but the site is:

i. Not cervix (C530‐C539) with histology = 8000‐9589

ii. And not bladder (C670‐C679)

2. Sex is 1 or 2

3. Years DX: 1995 to (reporting year minus 1) for some registries; 2000 to (reporting year minus 1) for other registries.

4. Date of Last Contact >= Reporting Year or patient is deceased (vital status = 4).

Criteria 1‐3 defined for the numerator.