Amendment_0001,_2017-N-66809,_MRA.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION

NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO.

IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

NSN 7540-01-152-8070

Previous edition unusable

This amendment is issued to make the following changes to Request for Proposal number 2017-N-66809:

(See page 2)

Centers for Disease Control and Prevention Office of Acquisition Services 2920 Brandywine Road Atlanta, GA 30341

See Block 6

HCVJC5X2-2017-14405

2017-N-66809

08/21/2017

07/28/2017

1 10

SUMMARY OF CHANGES

This amendment is issued to make the following changes to solicitation number 2017-N-66809 and answer questions submitted.

A. Correct Section G paragraph G.6 and change the Wage Determination number from WD 05-2133 (Rev. 15) to WD 15-4471 (Rev.-6) was first posted on www.wdol.gov on 08/01/2017.

B. Add to Section H, the following paragraph:

H.8. All data produced as a result of this contract belong to CDC. The Contractor shall provide electronic and paper copies of all source code, programs and documentation of programs used for MMP data runs or to create MMP data bases. MMP data sets developed for transfer shall not remain with the Contractor and must be destroyed once documentation of a successful transfer is received. The Contractor shall not retain any copies of data generated under the contract. During or after the life of the contract, no MMP data may be released except after CDC approval. All requests which the Contractor receives from third parties for access to the data must be referred to the Contracting Officer. At the end the of the Contract, a signed document shall be provided validating that MMP data has not been retained by the Contractor.

C. Revise the Deliverable Table as follows:

Task Number Deliverable Delivery Date Deliver To

Task 1.0 Transition Plan 1 week after contract award

COR

Task 2.0 Kick‐Off Meeting Notes 3 weeks after contract award

COR

Task 3.0 Report of findings 4 weeks after request submitted

COR

Task 3.1 Report and demonstration of modifications

12 weeks after request submitted

COR

Task 3.2 Data Dictionary June 15 of each year COR

Task 4.0 Written verification of complete SA&A process as specified by CDC Security

Officer

November 15, 2017 with recertification as indicated

COR

Task 5.0 E‐mail confirmation of beginning of testing phase

October 15 of base year and April 15 of each year after

COR

Task 5.1 Test plan October 1 of base year and February 1 of each year after

Task 5.2 Testing report Report due with each updated version of

Discovere® or the comparable web‐based application

COR

Task 6.0 MMP Discovere® or comparable web‐based application deployment verification

November 15 of base year and June 15 of each year after

COR

Task 6.1 MMP Discovere® or comparable web‐based application Operating manual

November 15 of base year and June 15 of each year after

COR

Task 7.0 Completion of 4‐hour web training session

November 30 of base year and June 30 of each year after

COR

Task 7.1 Distance learning web training

6 web trainings completed by

September 30 of each year

COR

Task 7.2 Annual CDC web training Web training completed by

September 30 of each year

COR

Task 7.3 Monthly webinar support Recording of webinar due monthly, 10 days after webinar

COR

Task 8.0 Technical support Ongoing, addressed 48 hours after request submitted

COR

Task 9.0 Data Management plan submitted and approved

May 1 of each year COR

Task 9.1 Demographics table Monthly DCC and COR

Task 9.2 Data structure file Monthly DCC and COR

Task 9.3 Full processed national dataset and 23 project areas subsets

Quarterly DCC and COR

Task 9.4 Full national raw dataset April 30 of each year DCC and COR

Task 9.5 Final full national raw dataset

July 15 of each year DCC and COR

Task 9.6 National reabstraction report and 23 project area subsets

Quarterly DCC and COR

Task 9.7 National reabstraction dataset and 23 project areas subsets

Quarterly DCC and COR

Task 9.8 Final fully processed national dataset and 23 project area subsets

July 15 of each year DCC and COR

Task 10.0 List of automated programming quality assurance checks

November 1 of base year and May 1 of each year after and updated on an ongoing basis

COR

Task 10.1 National quality assurance reports and project area specific reports

Monthly DCC and COR

Task 11.0 Status calls notes Biweekly COR

Final Data Disposition

Certification letter (See

Special Considerations‐‐

Data Disposition)

One week prior to the end of the performance period

D. Questions and Answers

In section C.1.5. on page 5, it states that 400 individuals are interviewed from each area, and that the behavioral information is captured as part of MMP; and that MRA is used for capturing clinical care, treatment, and outcomes of HIV patients who are in care. This suggests the interviews are captured for each participant separately from the medical record data.

Question 1a. How is the interview data captured as part of MMP? Is there a separate system for data collection?

Answer 1a: Yes

Question 1b. Do the same clinicians conducting interviews also support MRA submissions?

Answer 1b. Typically those conducting interviews or MRAs are not clinicians. Data collection staff and strategy varies by project area.

Question 2. Are patient interviews linked to and combined with the medical record information?

Answer 2. Yes

Question 2a. How is this data combined and at what level (individual, clinic-level, area/jurisdiction) is the data related for MMP analysis?

Answer 2a. This is done at the end of each data collection year. It is combined at an individual level.

Question 2b. What data elements are used to link this information?

Answer 2b. Participant IDs are used.

Question 2c. If at the patient-level (using participant IDs) then is this integration of data part of the requirements for monthly, quarterly, and annual dataset that abstracts (for requirement C.4.9 Data Management)?

Answer 2c. No

In section C.1.6, on page 5, it states that since 2012 Discovere has produced timely and accurate information that allowed for analysis to meet the objectives of MMP.

Question 3a. If this is the case, then what are the driving factors for modifications and adding capabilities into the system such as search? As a web-based data collection portal is all data entered manually?

Answer 3a. Yes

Question 3b. Does the system provide automation for any part of the data capture?

Answer 3b. Yes

Question 3c. Are there issues with form design and usability?

Answer 3c. CDC is interested in considering proposals from those with expertise in electronic medical record applications about how to improve data collection.

Question 4. What is the response from the participating areas/jurisdictions in terms of usability and desired improvements?

Answer 4. CDC is interested in considering proposals from those with expertise in electronic medical record applications about how to improve data collection.

Question 5. What capabilities would make an alternative system to Discovere® more attractive to the CDC MMP program?

Answer 5. CDC is interested in considering proposals from those with expertise in electronic medical record applications about how to improve data collection.

In section C.2.0, it states that Discovere® or a comparable web-based medical record abstraction application must provide uninterrupted data collection through May 31st of each year. And in section C.3.3, it states that the application must be deployed by June 15 each year after testing of the modifications or new application is complete.

Question 6. Is data collection ongoing on a monthly basis via Discovere web-based portal? Or is the data collected less frequently, given HIV/AIDS testing is usually quarterly for HIV-positive individuals?

Answer 6. Data collection is ongoing from June 15 – May 31 each year.

Question 7. If data collection is ongoing on a monthly, quarterly, and annual basis, will CDC maintain Discovere as-is until the modified or new web-based application is deployed on June 15, 2018?

Answer 7. As stated in the SOW, the new application needs to be deployed for data collection by November 15, 2017.

Question 8. Given the data is currently hosted and collected by Cerner in its Discovere system, will CDC require Cerner to provide access to their hosted databases with SFTP or other secure data transfer protocols for preparing data reports (per requirement C.4.9 “Data Management” and requirement C.4.10 “Automated Programming”)?

Answer 8. No. Anything related to Data Management is solely the responsibility of the new contractor.

Question 9. Will CDC consider the cost of maintaining Discovere in its current state as part of the total costs if a new web-based application is proposed for transition?

Answer 9. All proposals will be considered.

Question 9a. If not, then this would make transitioning to a new web-based application much more cost-competitive.

Answer 9a. All proposals will be considered.

Question 9b. If so, would CDC consider an earlier release date for a comparable system before June 15 to reduce the cost of maintaining two systems? Followed by a second release on June 15th for desired modifications and enhancements?

Answer 9b. As stated in the SOW, a web-based application is required to be deployed for data collection by November 15, 2017. Subsequent deployment will be on June 15 of each year.

In section C.4.3.1, the types of modifications or new functionality is identified as changes to data elements and the incorporation of a searchable database. Adjustments to lists and data elements are usually straightforward, but depending on the frequency and volume of those changes, as well as approvals, these adjustments can scale quickly to require more resources and/or schedule based on the change process. Given that the RFP requires Firm-Fixed Price:

Question 10. Is there a list of desired changes (i.e. backlog) of changes expected for the first year?

Answer 10. No

Question 11. Will CDC agree to work with the Offeror to identify a technically feasible list given resource and schedule constraints, given the proposed staffing mix and internal CDC testing and approval processes for changes?

Answer 11. Yes

Question 12. Is a searchable database intended to support jurisdictions submitting data into the MRA web-portal or for the purposes of ad-hoc queries by CDC end users of the data?

Answer 12. Yes for data entry.

In section F.4, Deliverable(s)/Reporting Schedule, there is a deployment date listed for Task 6.0 of November 15th and June 15th; and there is a security requirement listed for task 4.0, “Written verification of complete SA&A processes as specified by CDC Security Officer.” Given that CDC IT policy requires 60 days notice for deployments on externally hosted servers for performing the C&A process and gaining ATO (as sated on page

23, section H.3.3), this would make it impossible to provide a new application that is deployed for external use in time to meet the deliverable schedule. Given those constraints and requirements:

Question 13. For a comparable web-based data collection application to Discovere, will CDC allow for SA&A to be completed prior to the annual production release on June 15th, in accordance with CDC Security requirements, as stated in Task C.4.6.1 Task 6.0?

Answer 13. SA&A must be completed by November 15, 2017 with deployment of the application also on November 15, 2017.

Question 14. For a comparable web-based data collection application to Discovere, will CDC allow for the November 15th deployment to be internally available for evaluation and not a production deployment?

Answer 14. No

Question 14a. Can this intermediate deployment requirement be postponed based on feasibility analysis of the new application?

Answer 14a. No. This requirement is feasible without a delay in the MMP data collection cycles. For example, a commercially available product currently in use in the Department of Health and Human Services, could already have met most SA&A requirements. Candidates with expertise in the SA&A process should propose methods to meet both the security requirements and the MMP schedules. If candidates propose a cost saving solution that also improves efficiency in the system, a minor delay (less than 60 days) in schedules would be considered.

Question 14b. Can the requirement for November 15th be waived given that C.4.6.1 Task 6.0 requires only an annual deployment of the updated system?

Answer 14b. Annual deployment is required for each data collection year. Deployment on November 15, 2017 is for the 2017 cycle year. Deployment on June 15, 2018 is for the 2018 data collection year. The Deliverable schedule in the SOW has been updated to clarify this requirement for two deployments within the base year of the contract.

Question 15. For related Task 6.1, can the Operating Manual be in a draft form as the proposed new system for proposals offering alternatives to Discovere for the November 15th deliverable?

Answer 15. No

Question 15a. Can this intermediate deployment requirement be postponed based on feasibility analysis of the new application?

Answer 15a. No. See answer for 14a and 14b.

Question 15b. Can the requirement for November 15th be waived given that C.4.6.1 Task 6.0 requires only an annual deployment of the updated system?

Answer 15b. No. See answer for 14b.

Question 16. For related Task 7.0, can the 4-hour web-based training be used to review the proposed new system for requirements and design feedback on November 30th, given it is within two months of the beginning of the period of performance?

Answer 16. This depends on specifics of the proposal.

Question 17. For related Task 7.3, can monthly webinars be at first used for the purposes of gathering and verifying requirements with data collectors to ensure a responsive and better data collection instrument for the MMP program?

Answer 17. This depends on the specifics of the proposal.

Question 18. For related Task 7.1, can these six webinars for the base year of performance be held in the second half of the year, in order to allow time for putting a new system in-place (at least in the base year)?

Answer 18. This depends on the specifics of the proposal.

In section M.3.3, Previous Experience, it states the Offeror shall have at least 5 years of successful experience developing medical record abstraction applications for HIV related projects. Medical record abstraction is common practice for reporting and management systems for healthcare, but for the experience to be specifically for HIV-related projects and HIV medical and diagnostic elements significantly reduces the number of contractors that can potentially qualify for this proposal.

Question 19. Does CDC expect additional contract experience in the Technical Approach showing 5 years of “Previous Experience” outside of the limit on the past 3 years of current “Past Performance” as stated in section L.10.2.3?

Answer 19. No, CDC hereby updates the Previous Experience requirement from five (5) years to three (3) years.

Question 20. Will medical record abstraction and management for diseases and disabilities, such as disability claims that could relate to HIV or not, be considered relevant experience to qualify Offerors?

Answer 20. All proposals and experience will be reviewed and considered for relevance.

Question 21. What type of access controls currently implemented for Discovere, and what kind of access controls would be required for a comparable web-based application for user management, roles, and access?

Answer 21. The contractor shall maintain all access controls based on a list of users and access requirements.

Question 22. Would CDC consider a custom-built or customized COTS application if the application was comparable in terms of lifecycle costs for all 5 years (base year plus option years) as being competitive?

Answer 22. CDC will not support the development or build of a new web-based application. As stated in the SOW, this action is to procure a customizable, web-based application.

Question 23. Can the proposal for years two through five also include a separate time and materials CLIN to adjust future modifications, given that the uncertainty in what future modifications will be needed to meet CDC needs?

Answer 23. All proposals will be considered.

Question 24. Would CDC consider COTS from Electronic Data Capture (EDCs) for Clinical Data Management to be acceptable, and, if so, what certifications and standards must those COTS meet (e.g. 21 CFR Part 11)?

Answer 24. All proposals will be considered.

Question 25. Does CDC have now with Discovere® or expect in modifications the web-based application to integrate with EHR systems or allow for standard data uploads, which could automate, speed up and improve the quality of data collection efforts?

Answer 25. All proposals will be considered.

Question 26. What data standards are currently used by Discovere? Do these meet the MRA MPP requirements and standard definitions?

Answer 26. Data standards currently used by Discovere meet MMP MRA requirements.

Question 27. Does CDC expect to improve validation with use of other enterprise systems that provide standard vocabularies for data entry, such as PHIN VADS? Or will an International standards such as ICD-10 be used?

Answer 27. Use of standard vocabularies for data collected would be encouraged for purposes of validation and improving consistency in data collection.

Question 28. Reference Solicitation # 2017-N-66809; Section L.10 states that “Four (4) volumes are required”, but the table contained in Section L.10 only details requirements for Volumes I, II and III. Respectfully request that the Government please provide clarification specific to the correct number of Volumes required and any additional instructions specific to a fourth volume, should there be a requirement for one.

Answer 28. Paragraph L.10 is corrected to read: Three (3) volumes are required.

Question 29. Reference Solicitation # 2017-N-66809; Section L.1 - Respectfully request that the Government please remove FAR 52.222-46 from the requirements, as it was not included in the current CDC contract. We will provide all assurances that our professional staff are compensated fairly, but our company does not furnish this information.

Answer 29. In accordance with FAR instructions for using FAR clause 52.222-46, this clause is proper for this acquisition. See excerpt below.

22.1103 -- Policy, Procedures, and Solicitation Provision.

All professional employees shall be compensated fairly and properly. Accordingly, the contracting officer shall insert the provision at 52.222-46, Evaluation of Compensation for Professional Employees, in solicitations for negotiated contracts when the contract amount is expected to exceed $700,000 and the services are to be provided which will require meaningful numbers of professional employees. This provision requires that offerors submit for evaluation a total compensation plan setting forth proposed salaries and fringe benefits for professional employees working on the contract. Supporting information will include data, such as recognized national and regional compensation surveys and studies of professional, public and private organizations, used in establishing the total compensation structure. Plans indicating unrealistically low professional employee compensation may be assessed adversely as one of the factors considered in making an award.

Question 30. Reference Solicitation # 2017-N-66809; Sections K.7 and I.6 - Respectfully request that the Government please remove FAR 52.227-15 and 52.227-16 from the requirements, as these were not included in the current CDC contract.

Answer 30. The referenced FAR clauses are intended clauses. Additionally, FAR clause 52.227-14 is hereby added. If an alternate is applicable to your proposal, please specify one (1) of the five (5) alternates specified.

Question 31. Reference Solicitation # 2017-N-66809; Form SF-33, Block 9 states that “…original and one copy…” are due and should be delivered to the place specified in Block 8 of the same form, should it differ from Block 7. Block 8 is blank and Block 7 lists a physical address, while Sections L.2.(d) and L.12 both state that proposals are to be emailed to Pat Billins at pbillins@cdc.gov. Respectfully request that the Government please provide clarification specific to the method of delivery and the address (physical or electronic) to which proposals are to be sent.

Answer 31. Form SF-33, Block 9 is hereby corrected to read “0”. Only one (1) electronic copy is required.

Offerors shall follow Section L instructions.

Question 32. Reference Solicitation # 2017-N-66809; Form SF-33, Block 9 states that proposals are due on August 25, 2017 at 2:00pm while Section L.12 states that proposals are due on August 28, 2017 at 2:00pm. Respectfully request that the Government please provide clarification specific to the correct due date.

Answer 32. SF-33, Block 9 is hereby corrected to read 8/28/2017.

Question 33. Reference Solicitation # 2017-N-66809; RFP Section L.9.(d) Cost and Pricing Data states that “Certified cost and pricing data are required with initial to establish the reasonableness of the proposed amounts in the absence of competition.” Respectfully request that the Government waive the requirement for Certified Cost and Pricing Data as defined in section 2.101 of the FAR and required under FAR subsection 15.403-4. We submit FAR subsection 15.403-1(c)(3)(i) as a basis for this request, which discusses standards and exemptions from certified cost or pricing requirements on “Any acquisition of an item that the contracting officer determines meets the commercial item definition in 2.101, or any modification, as defined in paragraph (3)(i) of that definition, that does not change the item from a commercial item to a noncommercial item, is exempt from the requirement for certified cost or pricing data.” We fully intend to supply and deliver commercial items under the resulting contract. Our understanding of the FAR is that a waiver should be granted, based upon the fact that our offerings will be fully commercial in type.

Answer 33. Competition is expected for this award; however, should only one (1) proposal be received, certified cost and pricing data will be required from the sole Offeror. That said, it will not be necessary unless requested after proposals are received.

E. All other terms and provisions remain unchanged.