Questions and Answers - 27FEB2020 Final.pdf

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Attached to
Clinical Reference Laboratory Testing Services Federal contract opportunity
Solicitation number
W81K04-20-R-0017-0001
Issued by
Department of the Army Medical Command

About this file

This document contains questions and answers regarding a solicitation for Clinical Reference Laboratory Testing Services. The solicitation seeks laboratory testing services to support various Department of Defense medical treatment facilities. Services include specimen pick-up and transportation, reference and routine testing, interface with electronic health record systems including CHCS and MHS Genesis, and transition assistance for the new contract award. The transition period is scheduled from October 2020 through March 2021, with full performance period running from April 2021 through September 2025. Pricing is required for all tests listed in Exhibit C of the solicitation. The contract value is estimated between $55.6 million for one year under the previous contract, and a maximum of $412 million as specified in the current solicitation. Proposals are due in July 2020 and award is scheduled for announcement also in July 2020.

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Other files for this federal contract opportunity

Other files attached to Clinical Reference Laboratory Testing Services, newest first.
File Type Posted
Exhibit J DHA B2B Gateway Questionnaire -- 26 Feb 2020.docx DOCX document
W81K04-20-R-0017-0001 Reference Lab Amendment.pdf PDF
Exhibit C_Schedule of Required Tests -- 26 Feb 2020.xlsx XLSX spreadsheet
Attachment 11 Workload by MTF FY2018 -- 26 Feb 2020.xlsx XLSX spreadsheet
Exhibit B_Summary by Facility Name -- 26 Feb 2020.xlsx XLSX spreadsheet

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PAGE AND PARAGRAPH OFFEROR’S QUESTIONS GOVERNMENT’S RESPONSE

N/A When does the USG expect to announce an award?

The Government expects to announce the award in July 2020. However, this date is subject to change.

N/A We noted the transition period has been pushed back from April 1, 2020 to October 1, 2020. Please explain the reason(s) for changing the timeline?

The projected start date of 1 Oct 2020 is established to provide adequate time for completion of the competitive source selection process following receipt of proposals.

N/A What is the difference between a Submitting Activity (SA) and a Medical Treatment Facility (MTF)?

Both terms are used throughout the

PWS.

The terms are synonymous within the context of the Government’s requirement.

We've compared (1) a rough estimate of DoD's anticipated spend based on the utilization data provided with the solicitation, (2) the $412M maximum value specified in the solicitation, and (3) the 12-month contract value of $55.646M stated as part of an October 2018 J&A for an extension with LCA. However, we are unable to reconcile the numbers and determine a reasonable spend estimate. Can the USG provide additional insights regarding the expected spend associated with this RFP opportunity?

No. The requirement should be viewed and responded to within the context of the current solicitation.

N/A Is there a cost to the contractor associated with interfacing with the CHCS sites?

The Government assumes there would be development, maintenance and sustainment costs associated with establishing interfaces/connections from the offeror’s Laboratory Information System (LIS) to the Government’s EHR (i.e., CHCS and MHS Genesis). The offeror’s costs associated with supporting these requirements would be the responsibility of the contractor.

DFARS 252.204-7012, page

Section 252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting, section 2.(i) and (ii) states the contractor systems must comply with NIST

DFARS 252.204-7012 is updated per Amendment 0001 to the solicitation.

The correct link is:

https://www.nist.gov/publications/protectin https://www.nist.gov/publications/protecting-controlled-unclassified-information-nonfederal-systems-and-organizations-1

SP800-171. Can an offeror request variance(s) from the full control set described in NIST SP800-171 and still be eligible for award? If there are requests to vary from the full control set described in NIST SP800-171, should those requests be submitted with the bid or after award?

g-controlled-unclassified-information-nonfederal-systems-and-organizations-1 or direct download at https://nvlpubs.nist.gov/nistpubs/SpecialPu blications/NIST.SP.800-171r2.pdf.

Yes. In addition to the clause at DFARS 252.204-7012 we draw your attention to the solicitation provision at DFARS 252.204- 7008, which further describes the representations made by submission of an offeror as well as the procedures for proposed variances

DFARS 252.204-7012, page

Verification is requested on the Framework for the ATO because of references to multiple sets of control documents - is compliance with all of the documents referenced below required, or is NIST SP800-171 the overall framework for certification?

• Section 252.204-7012 Safeguarding covered defense informant and Cyber Incident Reporting, section 2.(i) and (ii)states the contractor systems must comply with NIST

SP800-171

• In Section

PERFORMANCE WORK

STATEMENT CLINICAL

REFERENCE

LABORATORY TESTING

SERVICES, requirement

1.7.15 indicates adhering to DoDI 8510.01 for RMF And 1.10.8 DoDI 8500.01,

1.10.9.2 DoD System

Security Requirements

IAW

• 4.2.1.12 requirements AR25-1 Information Management Army Information Technology, AR25-2 Army Cyber

Compliance with all documents referenced is required. In addition to the NIST SP 800-171 rev. 2, DoDI 8510.01, AR 25-1, and additional guidance, the Government also utilizes the NIST SP 800-53 rev. 4 as security control baseline selection for DoD IT.

https://www.nist.gov/publications/protecting-controlled-unclassified-information-nonfederal-systems-and-organizations-1 https://www.nist.gov/publications/protecting-controlled-unclassified-information-nonfederal-systems-and-organizations-1 https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-171r2.pdf https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-171r2.pdf

Security and DoD 6025.18- R DoD Health Information Privacy Regulations

DFARS PWS 1.4.3, page 53 Will the ATO-C be issued by the contractor, or will the contractor be expected to have a third party issue the ATO-C?

Any ATO-C will be issued by a Designated Approval Authority (DAA), who is a government official.

PWS para. 1.8.3.3, page 56 What impact will the rollout of MHS Genesis have on laboratory support?

Refer to:

PWS para. 1.8.6. Computer / IT Support Personnel. The Contractor shall provide computer support personnel to address CHCS Lab Test file/table build and MHS Genesis Test File support. Computer support personnel will assist sites with the modification and /or build of Lab Test files (LTF) to support the vendor’s electronic interfacing capabilities to both CHCS and MHS Genesis.

PWS para. 1.8.6.3 When a test is requested that is not already interfaced, Computer Support Personnel will build the LTF or work with MHS Genesis Test File support team to ensure test is interfaced within 5 working days.

PWS para. 8.16.2.2. The CHCS LTFs must be created and validated, using MTF specific processes and procedures, before full performance.

PWS para. 8.16.2.3. Submitting activities that are under MHS Genesis a designated government POC, at the MTF, will work with the Contractor to set up and request “work-orders” to the MHS Genesis team. The POC and Contractor IT POC will verify the test files for accuracy and completeness.

PWS para. 1.8.3.3, page 56 Can the government provide a timeline/schedule for the rollout of MHS Genesis?

The Government is not able to provide a definitive final deployment schedule as it is an evolving document based upon results of the phased roll-outs.

Completion is currently expected on or about the end of FY24.

See attached PDF for current wave deployment schedule dated May 2019.

Wave Deployment Schedule MAY 2019.p

PWS para. 1.8.3.3, page 56 Will CHCS and MHS Genesis run concurrently, and when will CHCS be phased out?

Yes. Sites will remain on CHCS until they are live with MHS Genesis. Once a site is live with MHS Genesis, CHCS will only be used for historical purposes.

See previous wave deployment schedule for tentative implementation dates of MHS Genesis.

PWS para. 1.8.5, page 57 Please provide additional details regarding specimen pickups and transportation - which facilities will require a daily specimen pickup (days needed and number of pick-ups per day would be helpful) and which facilities may utilize an alternative shipping option?

Workload Data by MTF provides baseline requirements for specimen pickup and transportation, and is incorporated as Attachment 11 to the solicitation (ref. Solicitation Amendment 0001). PWS para. 1.8.5.2 States: “The Contractor shall provide routine local courier pick-up services at each SA on a daily basis (Monday – Friday, excluding federal holidays) at a time mutually agreed upon by the SA COR and the Contractor.”

All facilities may utilize alternative shipping options as agreed upon between the SA COR and the Contractor.

PWS para. 2.4, #8, page 65 Reference laboratories are covered entities under HIPAA and do not become a business associate (as that term is defined in the HIPAA Privacy Rule) of another covered health care provider, such as a hospital or physician, by providing laboratory services to that covered health care provider. The Privacy Rule, at 45 CFR § 164.506, makes it clear that any covered entity, including a reference laboratory as well as referring physicians or

HIPAA language is incorporated within the solicitation as it is mandatory. Please see also DoDM 6025.18, Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in DOD Health Care Programs, March 13, 2019, available at https://www.esd.whs.mil/Portals/54/Docu ments/DD/issuances/dodm/602518m.pdf?

ver=2019-03-13-123513-717, which further explains the relationship between associates and DoD covered entities.

https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/602518m.pdf?ver=2019-03-13-123513-717 hospitals, is permitted to make disclosures of protected health information to another health care provider for treatment purposes, to health plans for payment purposes, and to other covered entities for either party’s health care operations purposes. Considering the foregoing, please clarify the intent of the HIPAA Business Associate Provisions included in the solicitation.

PWS para. 2.4, #9, page 68 It appears that paragraph 9 is not applicable ("inoperative," according to the solicitation). Please confirm or clarify.

HIPAA Paragraph 9 is applicable because the TOM is not incorporated by reference. The bracketed language that appears below paragraph 9, starting with “This paragraph 9 is inoperative” and ending with “See paragraph 8.1.4 above.”

has been deleted. This is corrected in Amendment 0001 of the solicitation.

PWS para. 4, page 72 It is our understanding that the health and immunization requirements set forth in this section (and in PWS 1.9.5) apply only to contractor-provided specimen processing/data entry technicians working on-site in MTFs under the contract. Please confirm or clarify.

Correct. The Contractor shall ensure that all CSPs/technicians performing services in MTF(s) under this contract shall comply with the Health and Immunization requirements.

PWS para. 8.2.4, page 81 Can the USG provide additional information about your "large batch" testing needs? What tests will be ordered and at what volumes?

No specific requirements outside of the already provided workload data at this time. Offeror needs to have a mechanism in place to potentially support new Government testing requirements (e.g., Pain Management and PFAS testing).

PWS para. 8.7.1.3, page 82 Will the USG provide assistance support for administrative coordination to achieve the ATO-C approval?

Yes. A USG Sponsor is required, and will be provided, for administrative support for RMF ATO-C as well as the connection to the Government via the DHA B2B Program Management Office.

PWS para. 8.16.2.1, page 85 Will the USG provide training in CHCS LTF? If not, where can the training be accessed?

Online training will be provided only as found on JKO website. Access granted once contractor has CAC Card.

PWS para. 8.16.2.2, page 85 This requirement states that the LTFs must be created and validated using MTF-specific processes and procedures. Please clarify if this means there will be no standard

There is not one standard procedure across the services. Contractors who have remote access will coordinate with respective MTFs and be trained by supporting MTF LIS personnel.

process.

PWS para. 8.16.3.2, page 85 How will delays caused by circumstances completely out of the contractor's control be accounted for in the six-month timeline for the

ATO-C?

According to PWS 8.16.3.1. The Contractor must attend a monthly teleconference, at a minimum, to discuss and provide a progress report on/around the 5th of each month, between the MEDCOM COR, RMF Team, and the Contractor. The report and discussion will include progress and issues on the efforts to achieve the required electronic interface. Depending on the circumstance, the Government will determine if a modification to the contract to extend the transition timeline is warranted.

PWS para. 9.7, page 86 This item states that the CAP interim checklist and inspection reports should be submitted within 10 days after receiving the report;

this conflicts with PWS 1.6.1.6 which states that such documentation is required upon request. Please clarify.

PWS 9.7 is changed to state “upon request” to be consistent with requirement in 1.6.1.6. (ref. Solicitation Amendment 0001)

PWS para. 9.8, page 86 This item relates to training for employee and subcontractor staff.

Please clarify, is this requirement only for contractor staff with access to the DoD facilities, networks, and systems?

Correct. This requirement is for contractor personnel that require access to DoD facilities and/or network systems.

Addendum to 52.212-1, Paragraph 1.b, page 128

Offerors are required to submit electronic files in formats compatible with Microsoft Office 2007. Are .xlsx and .docx files acceptable?

Yes. Both are acceptable. Addendum to 52.212-1, Para. 1.b. is revised to address the use of .xlsx and .docx files (Ref.

Solicitation Amendment 0001).

Addendum to 52.212-1, Paragraph 1.b, page 128

Offerors are required to submit electronic files in formats compatible with Microsoft Office 2007. May offerors return their Small Business Subcontracting Plans as PDFs?

Yes. Small Business Subcontracting Plans may be submitted in Adobe pdf format. Addendum to 52.212-1, Para. 1.b.

is revised to address the use of Adobe pdf files (Ref. Solicitation Amendment 0001).

Addendum to 52.212-1, Proposal Table of Contents, One of the items required in Vol I, Business Proposal is the SF 1449.

Are offerors required to complete the SF1449 continuation sheets and submit those with this volume?

(We are submitting this inquiry because completing and submitting

Yes. Offerors shall submit a complete copy of the solicitation in their Volume I, Business Proposal. This will require completion of the SF1449 continuation pages as well as all other sections (e.g.

FAR 52.219-28, FAR 52.209-2, etc.) that require a response from the offeror.

the SF1449 continuation sheets with the SF1449 will mean including pricing information in the Business Proposal volume.)

Addendum to 52.212-1, Proposal Table of Contents, is amended to address this change. (Ref. Solicitation Amendment 0001).

Addendum to 52.212-1, Proposal Table of Contents, One of the items required in Vol I, Business Proposal is the SF 1449.

Should offerors also submit a copy of the full solicitation? (We are submitting this inquiry because that does not seem to be the requirement, however there are several sections, such as 52.219-28 on p. 15-16 and ,52.209-2 on p.

140, that need a response from the offeror.)

No. A complete copy of the solicitation is not required. Offerors shall provide a completed copy of page 1 of the SF1449 and shall provide all other sections that require a response from the offeror (e.g.

FAR 52.219-28, FAR 52.209-2, etc.)

Addendum to 52.212-1, Paragraph (1), page 133

The subfactor content detailed here states that the offeror should provide the proposed locations and distribution of specimen processing/data entry technicians in support of PWS paragraph 1.8.2, however PWS 1.8.2 refers to the Contractor Representative. Please clarify this requirement.

PWS paragraph 1 is corrected to reference 1.8.3. Specimen Processing / Data Entry Technician(s). (ref.

Solicitation Amendment 0001).

Addendum to 52.212-1, Paragraph (5), page 133

The subfactor content detailed here states that the offeror should detail the systems/processes supporting changes to the Government's LIS in support of PWS paragraph 8.1.6, however the solicitation does not include a PWS 8.1.6. Please clarify this requirement.

PWS paragraph 5 is corrected to reference 1.8.6. (ref. Solicitation Amendment 0001).

Addendum to 52.212-1, Paragraph (2), page 134

Please clarify if the DHA B2B Phase 2 Gateway Questionnaire is included in the 100-page limit for Vol II, Technical Quality Proposal.

Offerors shall submit the DHA B2B Phase 2 Gateway questionnaires as an appendix to the Technical Proposal. This document is excluded from the 100 page limitation. The DHA B2B Gateway Questionnaire is added as Exhibit J to the Solicitation (ref. Solicitation Amendment 0001)

Volume V, page 137 Which small business subcontractors are required to be disclosed as part of an offeror's Vol V, Small Business Participation Proposals - only the "major" subcontractors (defined on page

All small business subcontractors you intend to do business with shall be disclosed in the Offeror’s Volume V, Small Business Participation Proposal (ref. “Small Business Participation Proposal (Format Example)”), included

135 as a subcontractor performing more than 25% of the contract effort)?

in the solicitation.

Factor 4, item (a), page 151 The evaluation criteria for the Small Business Participation Proposal indicates that the standard is met when the offeror has submitted "an acceptable" small business participation proposal.

What is the USG's definition of an acceptable proposal?

In the addendum to FAR 52.212-2, Small Business Participation Proposal (b), it states that Acceptable is when the Small Business Participation proposal clearly meets the minimum requirements of the solicitation. The Small Business Participation proposal will be evaluated to determine the offerors commitment to small business and the Small Business Subcontracting Plan will be evaluated to determine if the plan is compliant with the requirements of FAR 52.219-9 and the small business subcontracting goals set forth in the solicitation.

Exhibit C Does the provided utilization represent the entirety of the reference testing opportunity, or is there additional utilization referred to other vendors that is not listed on Exhibit C (i.e. the RFP published utilization file)?

Exhibit C represents historical utilization of reference testing support required by the Government under the current DoD Reference Lab contract.

While this requirement encompasses the majority of the Government’s reference testing support, MTF’s have had the ability to contract separately for testing not specifically covered under the current contracted fee schedule. In this case those separately contract testing requirements would not be covered within Exhibit C.

Exhibit C What specific time period do the provided six-month (base period) and 12-month (full-year periods) represent?

The current projected period of performance for the Transition Period will be 1 Oct 2020 through 31 March 2021. Full performance would be 1 Apr 2021 through 30 Sep 2025. The period of performance for each CLIN is specified in the CLIN description and is included in the “Delivery Information” section of the solicitation. Period of performance dates are adjusted in Solicitation Amendment 0001

Exhibit C We believe there may be a typo in Cell L:2 (“Estimated Quantity 6 MONTHS”) on tabs Year 2, Year 3, Year 4, and Year 5 - although labeled as 6-month quantities, the listed volumes are twice what is

Exhibit C, Cell L:2, Years 2 through 5 are corrected. A revised copy of Exhibit C is included with Solicitation Amendment 0001.

listed on the Base Period tab, which we understand to be the only six-month ordering period.

Exhibit C In tabs “Year 4” and “Year 5,” there is a line item for test code “998074” “STAT” with a volume listed as 962 units; this line item is not found on the tabs for “Base Period, “Year 2,” or “Year 3”. All of the tabs in the utilization file (Base Period – Year 5) include a separate row at the bottom of the worksheet detailing “STAT” volume with 2,000 units in base year (understood to be a 6-month period) and 4,000 units in each full year period (Years 2 – 5). Is the additional line item for “STAT” found on the tabs for “Year 4” and “Year 5” incremental to the separately listed “Stat” volumes at the bottom of those sheets, or is the volume for that line item already included in the volumes at the bottom of those sheets? And if so, can the volume from this line item on the Year 4 and Year 5 tabs be disregarded?

Exhibit Years 4 and 5 tabs are corrected to remove the additional STAT item. A revised copy of Exhibit C is included with Solicitation Amendment 0001.

Exhibit C Is it possible to obtain utilization data at the MTF-level (as opposed to the aggregated data provided in Exhibit C) so offerors may better understand the volume differences among each of the DoD facilities?

We think this data is critical to enabling a strong understanding of the logistics requirements.

Workload by MTF data is incorporated as Attachment 11 to the solicitation (ref.

Solicitation Amendment 0001).

Exhibit C The RFP stipulates that offerors must provide a price for all services listed in Exhibit C, however there are some listed services where the provided source data does not enable respondents to effectively identify an applicable cross-map and provide a price. One example is “999985” “Miscellaneous Testing” with a base period utilization of 3,943 and subsequent full-year utilization counts of 7,866.

A full list of these services is attached for the USG to review and address. The file has three tabs:

Need More Information (NMI), N/A, and Included in Testing.

• For each NMI, the same comment applies for all -the test could not be found on the incumbent vendor website and we are requesting specific tests/descriptions in order to make a correct “match.”

Can the USG provide additional information for each of these line items?

• N/A line items are not actually tests. How should such line items be handled?

• “Included in testing” is used to flag line items that are not stand-alone tests but part of a base code. Such line items could include specimen processing, interpretation codes, reporting codes, etc.

Specific examples are on the “Included in testing” tab of the attachment (please note, these examples are not all inclusive but representative of the most common scenarios). How should an offeror handle line items that it does not bill separately for and that are being captured in the base (parent) code?

No additional information is available for tests identified as Needing More Information (NMI). Offeror’s shall utilize the information provided for each item in Exhibit C (e.g. CPT Code, Method, etc.) to make the most suitable match.

Line items identified as “Not a Test” are removed from Exhibit C. (ref.

Solicitation Amendment 0001)

For any item listed on Exhibit C that the offeror determines is not separately priced, the offeror shall enter $0.00 for that item.

Exhibit C What is your expectation for circumstances where, regardless or despite the information provided, a vendor can absolutely not identify

Offeror shall insert $0.00 for any item listed on Exhibit C that the offeror determines is not separately priced. (ref.

Solicitation Amendment 0001) or correctly map to a service on this RFP? We note that the requirement says there must be a price for all services (Vol IV, item (5), page 136), but there's a likelihood that this may not be possible. Please comment.

Exhibit D and Exhibit J When will the Medical Device Cybersecurity Assessment (Questionnaire) and DHA B2b gateway questionnaire be provided?

Offerors shall submit the Medical Device Cybersecurity Assessment (Questionnaire) and DHA B2B Phase 2 Gateway questionnaires as appendices to the Technical Proposal. Both documents are excluded from the 100 page limitation for offeror's technical proposal.

B2B Gateway Questionnaire is added as Exhibit J to the Solicitation (ref.

Solicitation Amendment 0001)

Exhibit D #1.2 (page 101)

What is the process for obtaining access to the DISA Stigs documents?

Obtaining access to STIGs, DHA scan policies, and benchmarks are made available to all users who are granted a government CAC. They are allowed to go to the DHA site and download that content.

Exhibit D #1.3.11 (page 102)

When and who determines if a full Independent Verification and Validation (IV&V) is required, or is this the Assessment and Authorization process?

A full IV&V will be required. It is part of the Assessment and Authorization (A&A) process.

Exhibit D #1.3.12 (page 102)

The government defines the third party to use for the A&A/IV&V – how is the contract handled with the Vendor? And is the vendor expected to pay for the assessment?

Under current procedures the A&A/IV&V functions are completed by DHA J6. The direct costs associated with conducting the A&A/IV&V are covered by the Government and should NOT be included within the offeror’s proposal.

Exhibit D #4.1.1.1-4.2.1.4 (page 105)

Please clarify if all Vendor Cybersecurity staff are required to have the reference certifications, or if this applies just to a subset of the organization.

Only a subset. For the ATO process, the ISSM requires IAM Level II or III Certification. Background checks will be conducted on any contractor requiring a CAC Card.

Page 128 of 167, Para. 1.b Referencing the page size limitation, will the government allow 11"x17" pages, used sparingly, to allow figures, graphics, or charts to be presented in a way to ensure their readability (viewing comfort)? It would be

Yes. The Addendum to 52.212-1, Para.

1.a. is revised to address the use of 11x17 pages. Each 11x17 page will count as two pages (Ref. Solicitation Amendment 0001).

expected that each printed side of an 11x17 page would count as two pages against any stated page limitation?

Page 128 of 167, Para. 1.a Referencing requirement that all electronic files be Microsoft Office 2007 compatible, will the government allow offerors to submit the electronic version of the "sanitized" Volume II - Technical Quality Proposal to be submitted as a redacted .pdf file? Allowing this format ensures the integrity of the redacted information.

Yes. The Addendum to 52.212-1, Para.

1.b. is revised to address the use Adobe pdf files for sanitized Volume II - Technical Quality Proposals (Ref.

Solicitation Amendment 0001).

Page 130 of 167, Para. 1.d.(5) Referencing the "Proposal Table of Contents", specifically for Volume II - Technical Quality Proposal, please confirm the government's instruction is for offerors to submit three "SANITIZED" CD-R copies of this volume and a single (1) paper copy of the "SANITIZED" version of this document.

Correct. Per the "Proposal Table of Contents", the requirement for Volume II

- Technical Quality Proposal is four CD- Rs and one Paper Copy. One CD-R must be unsanitized. Three of the four CD-Rs and paper copy must be sanitized.

Page 130 of 167, Para. 1.d.(5) Please confirm that the proposal deliverables for Volume II are:

- Unsanitized: One (1) CD-R and One (1) paper copy

- Sanitized: Three (3) CD-R and One (1) paper copy

Correct. Per the "Proposal Table of Contents", the requirement for Volume II

- Technical Quality Proposal is four CD- Rs and one Paper Copy. One CD-R must be unsanitized. Three of the four CD-Rs and paper copy must be sanitized.

Pages 114-115 of 167, Attachment 2, Proposal File Naming Convention

Referencing all versions of Volume II - Technical Quality Proposal, Attachment 2 indicates that each CD-R must have individual electronic files (with specified filenames). However, under section "a) Submission of Technical Quality Proposals (Volume II)", on page 132 of 167, the government states "Technical Quality Proposal shall be submitted as one complete document. For example do not submit five separate documents for the Table of Contents, Sub- factors and the Glossary. " Please advise if CD-R contents (electronic files) for Volume II should be submitted in accordance with Attachment 2 or Section L instructions.

Submit all versions of Volume II - Technical Quality Proposal, on each CD- R as individual electronic files with specified filenames. The references to "one complete document" are removed from the solicitation (Ref. Solicitation Amendment 0001).

Pages 114-116 of 167, Attachment 2, Proposal File Naming Convention

Will the government allow offerors to submit all electronic files, with exception of the offeror-completed Exhibit C (a .xlsx file) to be submitted in .pdf format?

Yes. Addendum to 52.212-1, Para. 1.b. is revised to address the use Adobe pdf files (Ref. Solicitation Amendment 0001).

Page 135 of 167, SUBCONTRACTOR/TEAMI

NG PARTNER CONSENT

LETTERS

Please confirm that Consent Letters are only required for those major subcontractors (defined as those subcontractors performing more than 25% of the contracted effort) and/or Teaming Partners who are included in any of the three required Performance Assessment Submissions.

Yes, a completed consent form should be submitted as part of your Performance Risk (Past and Present Performance) Volume for each Subcontractor/Teaming Partner identified in your Volume III (ref.

Addendum to 52.212-1, Volume III).

Page 135 of 167, SUBCONTRACTOR/TEAMI

NG PARTNER TABLE

Please confirm that Attachment 4 is only required to be completed for those offerors who are submitting as part of a Joint Venture or other Teaming Agreement; or when major subcontractors (defined as subcontractors performing more than 25% of the contracted effort) are being offered.

Confirmed, however, attachment 4 is required for all business arrangements in which the offeror intends to participate during the performance of any resulting contract/TO (ref. Addendum to 52.212-1, Volume III). Not just major subcontractors.

Page 135 of 167, PERFORMANCE

ASSESSMENT

SUBMISSION

Please confirm that the two (2)-page limitation only pertains to the summary section of each PAS, and that the "Statement of Relevancy" and "Reference Customer Information Sheet" (Attachment 5) are excluded from this two (2)-page limitation.

Correct. The two page limitation applies only to the summary section of each PAS.

Page 114 of 167, Attachment 2 Please advise in which electronic file, for each volume, should the "Volume Cover Page" be located?

A volume cover letter may be submitted as a separate electronic file for each volume.

Page 134 of 167, "SUBFACTOR 1B -

TRANSITION PLAN AND

LABORATORY

INFORMATION SYSTEMS

(LIS) AND INTERFACE:",

Sub-paragraph (2)

The required DHA B2B Phase 2 Gateway Questionnaire and the NESSUS scan of the system can encompass hundreds of pages. Will the government confirm that these two document requirements be removed from any page count limitations for Volume II? If exempted from page limitations, then please confirm these two documents may be provide as appendices to the Technical Quality Volume. If not exempted, then please advise what minimal

Offerors may submit NESSUS or ACAS scans (or commercial equivalent) and B2B Phase 2 Gateway questionnaires as appendices. These documents are excluded from the 100 page limitation for offeror's technical proposal.

information is required to satisfy government's request in this proposal.

Page 134 of 167, "SUBFACTOR 1B -

TRANSITION PLAN AND

LABORATORY

INFORMATION SYSTEMS

(LIS) AND INTERFACE:",

Sub-paragraph (2)

Please confirm that government will accept the results of an ACAS system vulnerability scan in lieu of a NESSUS scan, which is acceptable to the Defense Health Agency (DHA) organization that oversees RMF implementation.

Yes. An ACAS System vulnerability scan is acceptable.

Pages 114-116 of 167, Attachment 2; and Pages 129- 130 of 160, "PROPOSAL

TABLE OF CONTENTS"

The required filenames in the "Document Titles" column of Attachment 2 - Proposal File Naming Convention do not align/match with the contents requirements identified in the "Document Title" column in the

"PROPOSAL TABLE OF

CONTENTS" table in Section L.

Will the government please amend one or both of these tables to ensure alignment between the requirements of Attachment 2 and the Instructions to Offerors?

The two tables are not meant to align/match because one addresses the Proposal Table of Contents and the other addresses the Proposal File Naming Convention. Attachment 2, Proposal File Naming Convention, shall be utilized for naming all electronic documents.

Exhibit C Referencing the RFP's Exhibit C, electronic filename: W81K04-20- R-0017 Exhibit C_Schedule of Required Tests 30 Jan 2020.xlsx, can the government please confirm that the text in Cell L2 of the "Year 2", "Year 3", "Year 4", and "Year 5" tabs/worksheets read "Estimated Quantity 12 MONTHS" and not "Estimated Quantity 6 MONTHS"?

Exhibit C, Cell L:2, Years 2 through 5 are corrected. A revised copy of Exhibit C is included with Solicitation Amendment 0001.

Exhibit C Can the government provide further detail regarding how they summarized Exhibit C's utilization data and how the Unites States Coast Guard is specifically included within this RFP utilization data?

The government relied on the FY2018 Utilization Report. This utilization data included multiple instances of similar tests which were combined to reflect the Government's total requirement in order to simplify the offeror's proposal response.

Ex:

001974 Thyroxine (T4) Free, Direct, S

QTY=2414 INCLUDES:

001974 Thyroxine (T4) Free, Direct, S =2200 019745 T4,Free(Direct) = 71 001975 T4F = 134 001976 Thyroxine (T4) Free, Direct, S = 7

001977 Thyroxine (T4) Free, Direct, S = 2

While the USCG is referenced in the PWS, utilization data for the USCG is not included in the estimated quantities for Exhibit C. Should the USCG require services under any resultant contract, utilization data will be provided at that time.

Page 132 of 167, "TECHNICAL QUALITY

PROPOSAL

INSTRUCTIONS"

The RFP provides that offerors’ Volume II Technical Quality Proposal “shall not contain . . . past performance or incumbency information.” RFP at 132.

However, some past performance and incumbency information may be required for an offeror to fully respond to the RFP. For instance, the RFP requires offerors to describe their transition plans and LIS implementation (RFP at 132), as well as provide information on contracting personnel’s roles, responsibilities, and experience (RFP at 134). It would be very difficult, if not impossible, for an incumbent contractor to respond to these RFP requirements without some reference to its past performance and incumbency.

Please delete “past performance or incumbency information” from the RFP, or confirm that this provision does not prohibit an offeror from discussing its past performance and incumbency information to the extent the offeror deems it necessary to respond to the information requested for the Technical Quality Proposal.

Past performance and incumbency language is removed from the Addendum to 52.212-1 (ref. Solicitation Amendment 0001).

DoD Summary by Facility Name

In comparing the facilities listed in PWS Exhibit B, it appears five facilities supported on the current contract/program are not included in Exhibit B (Dunham Army Medical Center/Carlisle Barracks in Carlisle, PA, Madigan Army - Sierra Army Depot in Herlong, CA, Exhibit B, Summary by Facility Name, is updated to include the 5 sites listed, and included with Solicitation Amendment 0001.

McDonald Army Health Center in Ft. Eustis, VA , Navy BHC Portsmouth ME in Kittery, ME, & Occupational Health Clinic in West Point, NY). Can you please either amend Exhibit B to include these five sites or confirm they are not to be serviced under the new contract?

File details come from the government source that posted it. Updated .