Amendment SF 30.pdf

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.

15A. Name and Title of Signer (Type or Print) 16A. Name and title of Contracting Officer (Type or Print)

15B. Contractor/Offeror 15C. Date Signed 16B. United States of America

(Signature of Contracting Officer)

16C. Date Signed

(Signature of person authorized to sign)

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITIONS UNUSABLE Prescribed by GSA FAR (48 CFR) 53.243

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. Contract ID Code Page of Pages 1 1

2. Amendment/Modification No. 3. Effective Date 4. Requisition/Purchase Req. No. 5. Project No. (if applicable)

0001 02/12/2021 NMAN8200-21-00380

6. Issued By Code AJ930073 7. Administered By (If other than Item 6) Code NOAA/Eastern Acquisition Division 200 Granby Street, Suite 405 Norfolk, VA 23510

See Block 6

8. Name and Address of Contractor (No., Street, County, and Zip Code) (X) 9A. Amendment of Solicitation No.

X

1305M221QNMAN0042

9B. Date (See Item 11) February 18, 2021 10A. Modification of Contract/Order No.

10B. Date (See Item 13)

Code Facility Code

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X

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

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 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDG- MENT 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 you 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.

12. Accounting and Appropriation Data (if required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACT/ORDERS.

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

(x) 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 fourth 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)

E. IMPORTANT: Contractor is not, X is required to sign this document and return 1 copies to the issuing office.

14. Description of Amendment/Modification (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Amend Solicitation 1305M221QNMAN0042 as follows:

a. Provide Exibit 1 – Solicitation Questions and Responses attachment to solicitation, containing all questions submitted by the indicated deadline and corresponding OMAO responses.

b. Revise Attachment I – Statement of Work and Attachment II – Pricing Schedule; both documents are hereby replaced by the

“Amendment 0001” versions.

c. Except for the changes made herein, all other terms, conditions, and provisions remain unchanged.

Exhibit #1

Question

No. Question Response

Could you please tell me if the Combined Synopsis/Solicitation posted as solicitation number 1305M221FNMAN0042 will be a follow-on requirement to any work performed currently or in the past, or will this be a new requirement?

If possible, can you please provide the most recent contract or task order number?

This requirement is an evolved re-compete for the current Indefinite Delivery Indefinite Quantity (IDIQ) Multiple Award contracts awarded to BioIQ, Inc. under 1305M220DNMAN0070 and Lab24, Inc. (dba Florida Family Laboratory, Inc.)

under 1305M220DNMAN0071.

Several Task Orders have been issued under both base contracts.

RFQ P3, Section A - Instructions and Pricing Schedule.

A firm-fixed price (FFP) multiple-award (up to three (3) awardees) Indefinite-Delivery Indefinite-Quantity (IDIQ) is anticipated in response to this RFQ.

Will NOAA consider awarding a single contract to an offeror with the capacity and demonstrated performance to fulfill the entire contract?

Upon evaluation of all timely submitted responses, the Government will only award to respondents with an overall “Acceptable” response or better based on the non-price factors identified within the Solicitation.

In the event that only one (1) response is rated overall as “Acceptable” or better, the Government may consider an award to a single respondent.

RFQ P30, Section E - Solicitation Provisions A) Instructions to Offerors "Volume III - Completed Provisions herein" (and) "The response shall be subdivided by the factors listed above and shall collectively be no more than 20 pages."

Please confirm Volume III Completed Provisions is outside the 20 page allowable page limit.

Volume III – Completed Provisions is not included in the overall response page limit of 20 pages.

RFQ P30, Section E - Solicitation Provisions A) Instructions to Offerors Volume III - Completed Provisions herein

Please confirm Completed Provisions only requires submittal of FAR 52.213-3 Offeror Representations and Certifications.

Volume III – Completed Provisions requires the respondent’s completed provisions within FAR 52.213-3 Offeror Representations and Certifications.

Firms may provide the completed Representations and Certifications documentation from beta.SAM.gov as Volume III – Completed Provisions, if desired.

Both forms of Volume III will be acceptable and considered equal.

RFQ P42, Section E - Solicitation Provisions D) FAR 52.214-20 Bid Samples (b) Bidders must furnish bid samples as part of the bid.

Please clarify what bid samples are being requested with the bid and when and to whom they need to be submitted.

In order to satisfy the submission of required Bid Samples, defined in FAR 52.214-20, respondents shall provide one (1) sample testing kit of each of the proposed COVID-19 Testing types offered within their response.

These samples must be provided to:

NOAA/OMAO

Office of Health Services Attn: Captain Christian Rathke 8403 Colesville Road, Suite 500 Silver Spring, MD 20910

All samples must be received at the above location by the solicitation closing date and time.

To further ensure all submitted samples are received by OMAO as a required portion of each firm’s response, it is recommended that all respondents provide tracking information via email along with all other response documentation.

SOW P2 2, Scope Telehealth monitoring of self-administered tests must be approved in advance by Marine Operations, and must be made available by the vendor.

Will NOAA allow for Insurance/Medical billing to go along with our telehealth services?

This requirement does not allow for Insurance/Medical billing through this contract vehicle.

SOW P3 3, D. Volume. A total of 5,500 rapid antigen cards/cassettes will be needed per year.

Please clarify if pricing should assume a volume of 5,500 rapid antigen cards/cassettes per year or 3,000 per year.

Pricing should assume a volume of 3,000 rapid antigen cards per year.

Additionally, Attachment I – Statement of Work (SOW) – Revision I is hereby incorporated to reflect this corrected information contained within.

This revised documentation replaces the originally referenced Attachment I – Statement of Work throughout this Solicitation.

Atch II, Pricing Schedule, **In order to determine the total evaluated cost, the government will utilize an estimated quantity of 3,000 for each of the various five (5) testing types, multiplied by the quoted unit cost per testing type, to develop the period’s total evaluated cost and total evaluated value overall.

Should contractors assume 15,000 or 45,000 test kits as the anticipated total annual test kit volume?

Respondents should assume an estimated quantity of 15,000 testing kits as the anticipated total annual volume of various testing kits. However, this is an estimated quantity and is intended for an equal means of developing each respondent’s total overall evaluated price.

Atch II Pricing Schedule. Contractor's Clinician-administered COVID-19 test.

Please confirm that in support of contractor-provided testing NOAA will provide on-site facilities, tables, chairs, signage, internet access, waste disposal.

AOC - In the event of a clinician administered testing event, tents, tables, chairs, Internet, and signage can be provided by the Government.

However, medical waste disposal should be covered by the vendor.

MOC - Testing Events related to NOAA vessel crew testing will not have access to these materials at testing sites. Clinicians should bring all necessary materials, or contractor must provide/deliver beforehand. The Government will arrange the testing site availability only (e.g.

parking lot or hotel conference room). Mobile testing unit or similarly self-contained clinician set-up is needed for clinician-supported Marine Ops events. In addition, medical waste disposal should be covered by the vendor.

Atch II, Pricing Schedule, Contractor's Clinician-administered COVID-19 test.

Labor is a substantial cost variable based on the quantity and locations of contractor's clinician-administered tests. Please provide additional detail on the quantities of contractor's clinician-administered tests to include a breakdown of the

Vendors should factor clinician costs into the “per unit” cost of the clinician administered test within the Attachment II - Pricing Schedule.

Task Orders issued against the awarded vehicle will specify the total number of tests needed per location and testing event. For example, a testing number of tests and the number of testing days of by location to support accurate pricing.

event in any of the Attachment I - Statement of Work potential locations could require a clinician to administer 5-150 at a single day testing event.

Additionally, please consider adding a separate CLIN for contractor clinician labor supported by an estimate of the number of contractor's clinician-administered testing days and hours by location.

Attachment II - Pricing Schedule has been revised to include CLINs for a clinician event (at any of the potential locations stated with the Attachment I - Statement of Work) based on testing event lengths, CONUS or OCONUS locations, and corresponding administered testing ranges.

Regarding the following requirement:

"The Contractor shall diligently count and examine all goods tendered for shipment, receipt for them, and make appropriate written exception for any goods not in apparent good order."

a) Is this requirement applicable to the products being sought? It is not advisable to open cartons of this kind of product. Any discrepancy in the shipment quantity is human error which will be rectified as outlined in the solicitation document.

b) What is the proof you require for the product having been counted? The invoice and packing slip would indicate the quantity being sent. These are generated only after products have been counted and set aside/allocated for the order.

c) If the product is drop shipped by the manufacturer, will you accept the required proof by the manufacturer?

a) This language is included in order to ensure that any discrepancy in the shipment, human error, lost shipments, etc. are to be replaced by the contractor at no additional cost to the Government within a timely manner following discovery of such circumstance.

b) & c) Respondents may develop method(s) for tracking products and proof of item quantities as they see fit in order to adhere to this requirement.

Details regarding the firm’s methods to meeting this requirement shall be included within the Volume I – Non-Price, Section A. Technical Capability portion of their submitted response.

Are clinician administered tests defined as samples collected by a clinician?

Clinician administered tests and/or samples collected by a clinician are interchangeable terms meaning the same.

14 Are the clinicians administering tests at locations that are CLIA certified as Moderately Complex or Highly complex?

If CLIA certifications are required for testing locations, vendors are responsible for such documentation.

15 Do any of the locations have labs? None of the locations where testing events will be necessary have labs on site.

16 Are there any carrier restrictions at any locations?

Vendors are to familiarize carrier restrictions for COVID testing samples from any of the potential locations listed in the Attachment I - Statement of Work.

17 If the tests come only in individual shipping labels, is that ok?

Individual kits with individual shipping labels is required for individually packaged testing kit identified within the Attachment II - Pricing Schedule. However, when conducting clinician administered testing events, individual shipping labels is not a feasible method for shipment of samples at a bulk testing event. Shipping in the most efficient method is required for testing events of bulk samples.

18 How many samples are required? One for each type or a box? In order to meet the requirements of FAR 52.214- 20, Bid Samples, respondents shall provide one (1) sample testing kit of each of the proposed COVID- 19 Testing types offered within their response.

The detailed information for where to submit these samples and to whom are provided herein in response to Question # 5.

19 Is “Buy American” included in this solicitation?

Yes, FAR 52.225-1, Buy American-Supplies (May 2014) is included within this solicitation and the resulting award.

Past performance- Is this general business performance or is this in reference to test kits/lab products/lab services performance? This is pertinent for businesses that have retooled to offer medical products recently or businesses/individuals with medical experience started divisions/businesses that offer test kits recently.

As stated on Page 31 of the Solicitation RFQ Package, “The quoter is required to identify past or current contracts (including Federal, State, and local Government and/or commercial) for efforts similar to the requirement herein. The Government may consider this information, as well as information obtained from any other sources, when evaluating the quoter’s past performance. Quoters lacking relevant past performance history, or for whom past performance information is either not available or has not been submitted to the Government, will receive a neutral rating for past performance.”

Past Performance Questionnaire- Can you modify the due date to be after “Intent to Award” within a specific time period? It would be less of an imposition on clients to request documents at that stage.

No changes will be made to the Past Performance Questionnaire or the due date for this information.

Travel is not included in Attachment II – Pricing Schedule.

How should we account for travel costs if the Government requires the Contractor’s clinicians to travel to and administer tests in the various locations throughout the US, its territories, Caribbean Islands, or international locations?

Attachment II - Pricing Schedule has been revised to include CLINs for a clinician event (at any of the potential locations stated with the Attachment I - Statement of Work) based on testing event lengths, CONUS or OCONUS locations, and corresponding administered testing ranges.

Is Volume II – Price included in the page count since it is a separate Excel file?

Volume II – Price page count limit excludes the respondent’s submitted Attachment II – Pricing Schedule.

Is Volume III – Completed Provisions included in the page count since the FAR provisions in Volume III are lengthy and outside the control of the Offerors.

Volume III – Completed Provisions are excluded from the total page count limit.

Are the Past Performance Questionnaires (that the Offeror's Client will send to NOAA) excluded from the page count?

A firm’s completed Past Performance Questionnaires received from Past Performance references are excluded from the total page count limit.

Should our price include "cost for delivery FOB" or the NTE $5,000 or BOTH?

Cost for delivery and return shipping shall be included in the individual testing kit unit cost for all testing kit types indicated in Attachment II - Pricing Schedule other than the Rapid Antigen Testing Cards and clinician administered testing event bulk testing.

Delivery costs and return shipping shall be included in the individual test unit cost to account for bulk delivery of kits and return shipping for bulk samples to laboratory.

Can the Government clarify how many tests and at what frequency it anticipates shipping test kits?

The operational needs of MOC will drive the number of testing events and testing kits needed. At a minimum, AOC requires approximately 600 various tests/month and have been ordering the tests in bulk each month for centralized shipping from AOC out to individuals deployed in various mission locations.

The frequency and number of testing kits stated within the solicitation and herein are estimates and definitive quantities and locations will be designated at the Task Order level.

Please confirm that the Government is requiring physical samples of each proposed COVID test to be mailed / delivered to the Contracting Officer and received by the RFQ due date.

In order to meet the requirements of FAR 52.214- 20, Bid Samples, respondents shall provide one (1) sample testing kit of each of the proposed COVID- 19 Testing types offered within their response.

The detailed information for where to submit these samples and to whom are provided herein in response to Question # 5.

Can the government please confirm that the past performance information forms (Attachment III) are not included in the 20 page limit for the Technical Capability section?

The respondent’s completed Past Performance Information Forms (Attachment III) are to be submitted as part of Volume I – Non-Price Factors, Section B) Past Performance and are included as part of the overall total page count limit.

Is Volume II – Price included in the page count since it is a separate Excel file?

Volume II – Price page count limit excludes the respondent’s submitted Attachment II – Pricing Schedule.

Is Volume III – Completed Provisions included in the page count since the FAR provisions in Volume III are lengthy and outside the control of the Offerors.

Volume III – Completed Provisions are excluded from the total page count limit.

It appears NOAA is looking for PCR and rapid Antigen testing that can be administered by our onsite medical teams or self-administered home kits. Will NOAA consider responses that do not offer home test kits, but do offer contractor administered onsite PCR and rapid Antigen testing services at all locations?

PCR Self Administer Tests are required herein;

therefore, all responses shall include this product and service within their submitted response.

There are two types of Rapid Antigen Tests (At- Home, and Clinician administered); Either option satisfying the need for rapid antigen tests herein will be acceptable.

When performing onsite testing services, will NOAA provide indoor space or facilities to administer the testing services or will the contractor need to provide a mobile lab and all necessary infrastructure, including tenting, for either walk-up or drive through operations?

See response provided to Question #9 herein.

Will NOAA consider responses that include nextgen testing options using FDA/EUA approved onsite rapid PCR/Molecular tests which can deliver results in 30-45 minutes yet still meet NOAA’s sensitivity and specificity requirements?

Yes, nextgen testing options are acceptable as long as the tests can meet the sensitivity and specificity requirements; however, this could become a lengthy method of testing people without several molecular analyzers.

NOAA lists operational locations and pricing that include international ports. Will NOAA consider responses that are unable to provide testing at international locations?

Vendors that are unable to provide any of the required services within the Attachment I - Statement of Work will not be determined acceptable for award.

36 Is this going to be a firm fixed price type of contract or time and material?

As stated on Page 3 of the Solicitation RFQ Package, “A firm-fixed price (FFP) multiple-award (up to three (3) awardees) Indefinite-Delivery Indefinite-Quantity (IDIQ) is anticipated in response to this RFQ.”

On the SOW there are land based locations and ships where the testing is to occur. In Part 3 of the /Requirements of the SOW Section D it states that “The expectation is to be able to handle up to 100 tests in one day per location.”

Is there a “minimum number of tests for the locations?

Task Orders issued against the awarded vehicle will specify the total number of tests needed per location and testing event. For example, a testing event in any of the Attachment I - Statement of Work potential locations could require a clinician to administer 5-150 at a single day testing event.

38 What’s the anticipated total contract minimum number of test for each type of test?

Each testing event is driven by OMAO’s operational needs. Task Orders issued against the awarded vehicle will specify the total number of tests needed per location and testing event.

39 For the international locations, Would the contracting officer consider cost plus type of agreement for those tests?

All services required are Firm-Fixed Price (FFP); a Cost Plus Type contract will not be utilized.

In section E it states “The contractor shall comply with the standard in which results are returned within 48 hours of receipt at the analyzing facility. Are there penalties if this doesn’t occur?

Yes, the contractors inability to meet this urgent timeframe will result in negatively documented Contractor Performance Assessment Reporting System (CPARS) records. If persistent and impactful to NOAA’s mission, additional actions may be required.

Will NOAA provide space and the needed infrastructure (utilities, port a johns and space for job trailers) to support pop up sites if NOAA building space isn’t available.

See response to Question # 9 herein.

42 Will security clearances be needed for individuals? No, security clearances will not be required for individuals performing services under this vehicle.

43 Are any of the locations operating 24/7?

The testing events are typically scheduled to occur between 9am to 5pm, any day during the week;

however, the need for testing events could occur at any time.

Does NOAA anticipate screening individuals arriving in shifts?

Such as a maintenance facility that may be operating 24/7, 3 work shifts per day?

No, screening individuals will not be necessary.

45 Will some form of health/test authentication need to be provided? Sticker or test passport?

This verification and vetting should be completed by the vendor for that clinician providing us the services.

46 Are any biometrics readings needed, temperature, heart rate, respiration for each person?

No, testing only is needed at organized testing events.

Will there be a need for case management of individuals who test positive?

No, there will not be a need for case management of individuals that test positive; this will be conducted by the Government.