A.09.01_Pre-Solicitation_Amendment_W81K00-17-T-0268-00001_final.pdf

W40M USA HLTH CONTRACTING ACT

SOUTHERN REG CONTR OFC

POC: GERALDINE I. HERNANDEZ

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

0011020553

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to address the follow ing:

1. The follow ing document is hereby added to the Solicitation as Attachment 1 - Questions presented to the Government w ith Replies.

2. No further questions w ill be accepted and the Solicitation closing date remains unchanged.

3. A revised Statement of Objectives has been incorporated to reflect the clarif ication of questions asked in related subject paragraph/section w hen possible.

4. All other terms and conditions remain unchanged.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 51

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

16C. DATE SIGNED

BY 14-Sep-2017

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81K00-17-T-0268

X 9B. DATED (SEE ITEM 11)

18-Aug-2017

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

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 Offer is extended, X is not extended.

Offer 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 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 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 CONTRACTS/ORDERS.

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

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)

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

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

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

14-Sep-2017

CODE

W40M USA HLTH CONTRACTING ACT

SOUTHERN REG CONTR OFC

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K00-17-T-0268

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN description has changed from HEMATOLOGY COAGULATION ANALYZER -CPT to

HEMATOLOGY COAGULATION ANALYZER - CPR.

The CLIN extended description has changed from:

HEMATOLOGY COAGULATION ANALYZER - Cost-Per-Test (CPT) Agreement The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Objectives to support the San Antonio Military Medical Center (SAMMC), Joint

Base San Antonio, TX.a. three (3) Hematology Coagulation Analyzer’s: Two (2) high volume (300 or more Samples per day) floor models and one (1) medium volume (150 - 299 Samples per day) table top analyzer.b. all other computer hardware/software required for the use of theanalyzersSupport: The contractor shall provide preventive maintenance as per the Statement of Objectives. Training: Training will also be provided in accordance with the

Statement of Objectives. If the associated equipment/hardware/software become obsolete during the course of this contract, the contractor shall replace the existing equipment with new equipment at no additional cost to the

Government, unless approved otherwise by the Contracting Officer. Note: Quantities are estimated. The

Government will order supplies as needed, and only pay for those supplies that are ordered, received, and accepted.Period of Performance: 01 October 2017 - 30 September 2018The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the

Government.Treasury Account Symbol: 97 0130

To:

HEMATOLOGY COAGULATION ANALYZER - Cost-Per-Reportable (CPRR) Agreement The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Objectives to support the San Antonio Military Medical Center

(SAMMC), Joint Base San Antonio, TX.a. three (3) Hematology Coagulation Analyzer’s: Two (2) high volume

(300 or more Samples per day) floor models and one (1) medium volume (150 - 299 Samples per day) table top analyzer.b. all other computer hardware/software required for the use of theanalyzersSupport: The contractor shall provide preventive maintenance as per the Statement of Objectives. Training: Training will also be provided in accordance with the Statement of Objectives. If the associated equipment/hardware/software become obsolete during the course of this contract, the contractor shall replace the existing equipment with new equipment at no additional cost to the Government, unless approved otherwise by the Contracting Officer. Note: Quantities are estimated. The Government will order supplies as needed, and only pay for those supplies that are ordered, received, and accepted.Period of Performance: 01 October 2017 - 30 September 2018The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the

Government.Treasury Account Symbol: 97 0130.

SUBCLIN 0001AA

The CLIN description has changed from Manadatory Test to Mandatory Test/Specialty Reagents.

Manadatory Test - See the Price List below. The list contains anticipated reagents and associated quantities for the

Hematology Coagulation Analyzer’s. Specialty reagents are ordered on an as-needed basis. Payment will only be made for those items that are ordered, received and accepted by the Government.Treasury Account Symbol: 97-

0130.

Mandatory Test/Specialty Reagents - See the Price List below. The list contains anticipated reagents and associated quantities for the Hematology Coagulation Analyzer’s. Specialty reagents are ordered on an as-needed basis.

Payment will only be made for those items that are ordered, received and accepted by the Government.Treasury

Account Symbol: 97-0130..

CLIN 1001

HEMATOLOGY COAGULATION ANALYZER -CPRR.

furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Objectives to support the San Antonio Military Medical Center (SAMMC), Joint

Base San Antonio, TX.a. three (3) Hematology Coagulation Analyzer’s: Two (2) high volume (300 or more Samples per day) floor models and one (1) medium volume (150 - 299 Samples per day) table top analyzer.b. all other computer hardware/software required for the use of theanalyzersSupport: The contractor shall provide preventive maintenance as per the Statement of Objectives. Training: Training will also be provided in accordance with the

Statement of Objectives. If the associated equipment/hardware/software become obsolete during the course of this contract, the contractor shall replace the existing equipment with new equipment at no additional cost to the

Government, unless approved otherwise by the Contracting Officer. Note: Quantities are estimated. The

Government will order supplies as needed, and only pay for those supplies that are ordered, received, and accepted.The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government.Period of Performance: 01 October 2018 - 30 September

2019Treasury Account Symbol: 97 0130 offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Objectives to support the San Antonio Military Medical Center

(SAMMC), Joint Base San Antonio, TX.a. three (3) Hematology Coagulation Analyzer’s: Two (2) high volume

(300 or more Samples per day) floor models and one (1) medium volume (150 - 299 Samples per day) table top analyzer.b. all other computer hardware/software required for the use of theanalyzersSupport: The contractor shall provide preventive maintenance as per the Statement of Objectives. Training: Training will also be provided in accordance with the Statement of Objectives. If the associated equipment/hardware/software become obsolete during the course of this contract, the contractor shall replace the existing equipment with new equipment at no additional cost to the Government, unless approved otherwise by the Contracting Officer. Note: Quantities are estimated. The Government will order supplies as needed, and only pay for those supplies that are ordered, received, and accepted.The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government.Period of Performance: 01 October 2018 - 30 September

2019Treasury Account Symbol: 97 0130.

SUBCLIN 1001AA

The CLIN description has changed from Mandatory Test to Mandatory Test/Specialty Reagents.

Manadatory Test - See the Price List below. The list contains anticipated reagents and associated quantities for the

Hematology Coagulation Analyzer’s. Specialty reagents are ordered on an as-needed basis. Payment will only be made for those items that are ordered, received and accepted by the Government.Treasury Account Symbol: 97-

Mandatory Test/Specialty Reagents - See the Price List below. The list contains anticipated reagents and associated quantities for the Hematology Coagulation Analyzer’s. Specialty reagents are ordered on an as-needed basis. Payment will only be made for those items that are ordered, received and accepted by the

Government.Treasury Account Symbol: 97-0130..

CLIN 2001

furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Objectives to support the San Antonio Military Medical Center (SAMMC), Joint

Base San Antonio, TX.a. three (3) Hematology Coagulation Analyzer’s: Two (2) high volume (300 or more Samples per day) floor models and one (1) medium volume (150 - 299 Samples per day)table top analyzer.b. all other computer hardware/software required for the use of theanalyzersSupport: The contractor shall provide preventive maintenance as per the Statement of Objectives. Training: Training will also be provided in accordance with the

Statement of Work. If the associated equipment/hardware/software become obsolete during the course of this contract, the contractor shall replace the existing equipment with new equipment at no additional cost to the

Government, unless approved otherwise by the Contracting Officer. Note: Quantities are estimated. The

Government will order supplies as needed, and only pay for those supplies that are ordered, received, and accepted.The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government.Period of Performance: 01 October 2019 - 30 September

2020Treasury Account Symbol: 97 0130 offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Objectives to support the San Antonio Military Medical Center

(SAMMC), Joint Base San Antonio, TX.a. three (3) Hematology Coagulation Analyzer’s: Two (2) high volume

(300 or more Samples per day) floor models and one (1) medium volume (150 - 299 Samples per day)table top analyzer.b. all other computer hardware/software required for the use of theanalyzersSupport: The contractor shall provide preventive maintenance as per the Statement of Objectives. Training: Training will also be provided in accordance with the Statement of Work. If the associated equipment/hardware/software become obsolete during the course of this contract, the contractor shall replace the existing equipment with new equipment at no additional cost to the Government, unless approved otherwise by the Contracting Officer. Note: Quantities are estimated. The

Government will order supplies as needed, and only pay for those supplies that are ordered, received, and accepted.The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government.Period of Performance: 01 October 2019 - 30 September

2020Treasury Account Symbol: 97 0130.

SUBCLIN 2001AA

The CLIN description has changed from Mandatory Tests to Mandatory Test/Specialty Reagents.

Manadatory Test - See the Price List below. The list contains anticipated reagents and associated quantities for the

Hematology Coagulation Analyzer’s. Specialty reagents are ordered on an as-needed basis. Payment will only be made for those items that are ordered, received and accepted by the Government.Treasury Account Symbol: 97-

Mandatory Test/Specialty Reagents - See the Price List below. The list contains anticipated reagents and associated quantities for the Hematology Coagulation Analyzer’s. Specialty reagents are ordered on an as-needed basis.

Payment will only be made for those items that are ordered, received and accepted by the Government.Treasury

CLIN 3001

furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Objectives to support the San Antonio Military Medical Center (SAMMC), Joint

Base San Antonio, TX.a. three (3) Hematology Coagulation Analyzer’s: Two (2) high volume (300 or more Samples per day) floor models and one (1) medium volume (150 - 299 Samples per day) table top analyzer.b. all other computer hardware/software required for the use of theanalyzersSupport: The contractor shall provide preventive maintenance as per the Statement of Objectives. Training: Training will also be provided in accordance with the

Statement of Objectives. If the associated equipment/hardware/software become obsolete during the course of this contract, the contractor shall replace the existing equipment with new equipment at no additional cost to the

Government, unless approved otherwise by the Contracting Officer. Note: Quantities are estimated. The

Government will order supplies as needed, and only pay for those supplies that are ordered, received, and accepted.The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government.Period of Performance: 01 October 2020 - 30 September

2021Treasury Account Symbol: 97 0130 offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Objectives to support the San Antonio Military Medical Center

(SAMMC), Joint Base San Antonio, TX.a. three (3) Hematology Coagulation Analyzer’s: Two (2) high volume

(300 or more Samples per day) floor models and one (1) medium volume (150 - 299 Samples per day) table top analyzer.b. all other computer hardware/software required for the use of theanalyzersSupport: The contractor shall provide preventive maintenance as per the Statement of Objectives. Training: Training will also be provided in accordance with the Statement of Objectives. If the associated equipment/hardware/software become obsolete during the course of this contract, the contractor shall replace the existing equipment with new equipment at no additional cost to the Government, unless approved otherwise by the Contracting Officer. Note: Quantities are estimated. The Government will order supplies as needed, and only pay for those supplies that are ordered, received, and accepted.The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government.Period of Performance: 01 October 2020 - 30 September

2021Treasury Account Symbol: 97 0130.

SUBCLIN 3001AA

Manadatory Test - See the Price List below. The list contains anticipated reagents and associated quantities for the

Hematology Coagulation Analyzer’s. Specialty reagents are ordered on an as-needed basis. Payment will only be made for those items that are ordered, received and accepted by the Government.Treasury Account Symbol: 97-

Mandatory Test/Specialty Reagents - See the Price List below. The list contains anticipated reagents and associated quantities for the Hematology Coagulation Analyzer’s. Specialty reagents are ordered on an as-needed basis. Payment will only be made for those items that are ordered, received and accepted by the

Government.Treasury Account Symbol: 97-0130..

CLIN 4001

The CLIN description has changed from HEMATOLOGY COAGULATION ANALYZER - CPT to

HEMATOLOGY COAGULATION ANALYZER - CPRR.

furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Objectives to support the San Antonio Military Medical Center (SAMMC), Joint

Base San Antonio, TX.a. three (3) Hematology Coagulation Analyzer’s: Two (2) high volume (300 or more Samples per day) floor models and one (1) medium volume volume (150 - 299 Samples per day) table top analyzer.b. all other computer hardware/software required for the use of theanalyzers.Support: The contractor shall provide preventive maintenance as per the Statement of Objectives. Training: Training will also be provided in accordance with the Statement of Objectives. If the associated equipment/hardware/software become obsolete during the course of this contract, the contractor shall replace the existing equipment with new equipment at no additional cost to the

Government, unless approved otherwise by the Contracting Officer. Note: Quantities are estimated. The

Government will order supplies as needed, and only pay for those supplies that are ordered, received, and accepted.The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government.Period of Performance: 01 October 2021 - 30 September

2022Treasury Account Symbol: 97 0130 offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Objectives to support the San Antonio Military Medical Center

(SAMMC), Joint Base San Antonio, TX.a. three (3) Hematology Coagulation Analyzer’s: Two (2) high volume

(300 or more Samples per day) floor models and one (1) medium volume volume (150 - 299 Samples per day) table top analyzer.b. all other computer hardware/software required for the use of theanalyzers.Support: The contractor shall provide preventive maintenance as per the Statement of Objectives. Training: Training will also be provided in accordance with the Statement of Objectives. If the associated equipment/hardware/software become obsolete during the course of this contract, the contractor shall replace the existing equipment with new equipment at no additional cost to the Government, unless approved otherwise by the Contracting Officer. Note: Quantities are estimated. The Government will order supplies as needed, and only pay for those supplies that are ordered, received, and accepted.The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government.Period of Performance: 01 October 2021 - 30 September

2022Treasury Account Symbol: 97 0130.

SUBCLIN 4001AA

Manadatory Test - See the Price List below. The list contains anticipated reagents and associated quantities for the

Hematology Coagulation Analyzer’s. Specialty reagents are ordered on an as-needed basis. Payment will only be made for those items that are ordered, received and accepted by the Government.Treasury Account Symbol: 97-

Mandatory Test/Specialty Reagents - See the Price List below. The list contains anticipated reagents and associated quantities for the Hematology Coagulation Analyzer’s. Specialty reagents are ordered on an as-needed basis.

Payment will only be made for those items that are ordered, received and accepted by the Government.Treasury

The following have been added by full text:

ATTACHMENT 1

W81K00-17-T-0268

HEMATOLOGY COAGULATION ANALYZER

Questions & Answers presented to the Goverment

Attachment 1

Q1. Page 52, section 7. Program Management. Does the Project Manager need to be named in the RFP response or later upon award?

A1. No, later upon award. See SOO 7.2.1.

Q2. Per 7.2.5., are the Project Manager and IT Project Manager required to be onsite for only the installation/validation portion or onsite for a set period of time post installation?

A2. The Project Manager and IT Project Manager must remain onsite until the installation/validation is complete and it is determined they are not needed on site.

Q3. Per 7.3, is the workflow to be performed after the award of the contract? Please clarify.

A3. Yes, after award.

Q4. Will the new analyzers be placed in the current configuration, noted on page 54? Are any changes to the layout anticipated?

A4. See SOO 5.1.9. The Contractor shall provide relocation of instruments up to two (2) times after initial installation between testing locations where needed to meet evolving mission requirements.

Q5. Page 45, section 5.2. Required Equipment - Do all three analyzer need to be interfaced to the automated line?

The RFQ states “The systems must have the ability to interface”. Based on the onsite visit it was understood Total

Laboratory Automation is not required for coagulation. Please confirm.

A5. See SOO 5.2.1.10. The systems must have the ability to interface with third party pre-analytical automation systems, to include automated track systems/centrifuges.

Q6. For special coagulation testing, the following questions will need to be answered to accurately determine volumes: Will all tests be run around the clock?

A6. Most special coagulation tests are batched weekly. Most special coagulation tests are batched weekly. These are performed during day shift, 7:30 thru 4:30, Monday thru Friday. They are not run around the clock. ATIII are run 24/7 if requested.

Q7. Is there a set schedule for performing special coagulation testing? Will each test be batched? If so, when will each test be performed? Once/week, twice/week, daily 5 days per week, daily 7 days per week, on demand, etc.

A7. Most special coagulation tests are batched once each week, Monday thru Friday. Factor VIII is sometimes performed on demand. Other factors are also performed on demand, but rarely. ATIII is also sometimes performed on demand, but majority of ship-ins are batched once per week. Depending on volume, some tests such as Lupus could be run twice in a week.

Most special coagulation tests are batched once each week, Monday thru Friday, 7:30 thru 4:30, Factor VIII is sometimes performed on demand. Usually performed during day shift, 7:30 thru 4:30, Monday thru Friday.

Other factors are also performed on demand, but rarely. ATIII is also sometimes performed on demand, can be run on any shift, 1 st , 2 nd or 3 rd , but majority of ship-ins are batched once per week, Monday thru Friday, 730 to 430.

Depending on volume, some tests such as Lupus could be run twice in a week, first shift, Monday thru Friday.

Q7. What is the frequency for running controls?

A7. QC is run every 8 hours at the beginning of each shift for routine testing which includes, PT, PTT, Fib, D-

Dimer and Heparin. There are 3 shifts. Routine testing is performed 24/7.

Q8. Which inhibitor is being tested? Factor VIII, IX, etc.? If there are more than one factor, what is the volume for each one?

A8. Usually Factor VIII Inhibitor at approx. 2 per month. Rarely Factor IX, Factor V usually once per year.

Q9. Please clarify, if possible, required workflow requirements for special coagulation testing.

A9. There is no workflow requirements for special coag testing. Instrument has to be the same instrument used for

Routine Coag testing.

Q10. Page 51, section 5.5. Training. Per 5.5.1, who in the Laboratory will be the point of contact to coordinate this training?

A10. The COR must coordinate training schedules with the Contractor.

Q11. Will the personnel be allowed to attend classes without having bench responsibilities?

A11. Yes

Q12. Please clarify the procedure for the contractor to follow in terms of making the plans for basic and advanced onsite workshops and training.

A12. The contractor will coordinate with the COR to determine what timeframes are needed for the basic and advanced workshops and training.

Q13. Is there an estimate on the cost to provide additional dedicated lines and LIS interfaces? Please confirm an estimate on these cost as well as where these costs are to be notated.

A13. Any additional dedicated lines and LIS interfaces that are needed for successful system operations will be identified by the Contractor in their proposal. In addition, the contractor shall provided detailed pricing to the

Government in the event the Government IT personnel are unable to provide. The Contractor should add this to his/her pricing volume as an additional line item.

Q14. Page 45, section 5.1. Specific Tasks/Description. Per 5.1.9., initially, will all three analyzers be installed in the main lab?

A14. Initially yes, however, there are plans in progress to move the bench top analyzer to the ED lab once the ED operations has been moved to their new location in the building. Timeline for this is TBD.

Q15. What is the plan for the bench top analyzer within the first 12 months? If moved, will the personnel trained on the analyzer move with the system? Will additional onsite training be required in the new location?

A15. The plan for the bench top analyzer is for it to be moved to the ED lab, no time frame as of yet. Additional training should not be required.

Q16. Pages 3, 5, 7, 9, and 11. The first line indicates CPT. The third line indicates Cost-Per-Test (CPT).

A16. All references to CPT (Cost-Per-Test) have been revised to read Cost Per Reportable (CPRR)

Q17. Per CPRR instructions on page 43 (5.1.1.), these items should be noted as CPRR (cost per reportable result) for PT, PTT, D-Dimer, Fib, and Anti-Xa assays.

A17. Page 43 Para 5.1.1 reads, "All costs for Prothrombin Time (PT), Activated Partial Prothrombin Time (aPTT), D-Dimer,Fibrinogen (FIB) and Anti-Xa assays will be calculated on a cost per patient reportable or patient billable basis based on the number of patients listed for each mandatory test listed in Table 1." They are identified as CPRR

Assays.

Q18. Please specify PT, PTT, D-Dimer, Fib, and Anti-Xa assays for this section.

A18. The government does not understand the questions as it identifies the assays as CPRR’s.

Q19. Please change CPT and Cost-Per-Test references to instead note CPRR and cost per reportable result.

A19. The reference to CPT (Cost-Per-Test) have been revised to read Cost Per Reportable (CPRR).

Q20. Please remove the two following paragraphs:

a. Note: Quantities are estimated. The Government will order supplies as needed, and only pay for those supplies that are ordered, received, and accepted.

b. The Government will order items on as needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government.

A20. The paragraphs will not be removed.

Q21. The two above paragraphs contradict each other. Quantities are determined in advance to determine pricing.

Quantities are paid based on reportable results performed, not on tests ordered, received, and accepted.

A21. The paragraphs will not be changed.

Q22. Question 8. Pages 4, 6, 8, 10, and 12. Please replace the word Mandatory with Specialty, if possible.

Mandatory is used on the tables on pages 15-20. It is also used on Table 1. However, these tables include both routine CPRR tests and special coag testing. It is confusing for these pages to know what is expected. Specialty, correct?

A22. Table 1 will be changed to read “Mandatory/Specialty Test”. In addition, a separate table does not add any additional information/value. All tests are (test per reportable) and the analyzers must be able to run all testing listed as per the Statement of Objectives.

Q23. Pages 12 and 13. For the CLIN items, are only the Maximum Amounts supposed to be completed?

A23. Page 12 – 13 “CONTRACT MINIMUM/MAXIMUM QUANTITY AND CONTRACT VALUE” has been removed and replaced with Minimum and Maximum Text.

Q24. Pages 15 to 20. Please separate these into two sets of tables per page 43, section 5.1.1.

i. Routine – CPRR – PT, PTT, D-Dimer, Fib, and Anti-Xa

ii. Special coag – All other tests

A24. A separate table does not add any additional information. All tests are test per reportable and the analyzers must be able to run all testing listed as per the Statement of Objectives. DFARS Provision 252.204-7011

Alternative Line Item Structure has been added to the solicitation. This provides Contractors with the flexibility to deviate from the Schedule B format provided the provision instruction are followed.

Q25. Routine – CPRR. Only CPRR price and extended price can be completed for CPRR calculations.

A25. This is a correct sentence. Fill in only what is applicable.

Q26. Special coag. Section 5.1.1 indicates these will be cost per kit. The only columns would be Kit price and catalog number. There needs to be flexibility to add additional lines for additional products needed such as controls and calibrator products in order to run the tests.

A26. DFARS Provision 252.204-7011 Alternative Line Item Structure has been added to the solicitation. This provides Contractors with the flexibility to deviate from the Schedule B format provided the provision instruction are followed.

Q27. Page 73, proposal items. Please clarify items to include in each email. Are these correct? Should subfactors each be delivered in a separate email? Pricing and Past Performance was listed, but a Past Performance section was not found.

i. Volume I Administrative

ii. Volume II Technical Capability including Subfactors 1a, 1b, 1c, and 1d.

iii. Volume III Price

iv. Volume VI Subcontractors

A27. RFP Page 72 - Emails, regardless of size, need to be received by the government server, by the stated date and time as indicated in Block 8 of the DD Form 1449. Files larger than twenty (20) MB need to be transmitted into separate emails. If your proposal is more than 20 (MB) with attachements, it will need to be broken down into separate emails with fewer attachments per email. iv. Volume VI Subcontractors should be the Subcontracting

Plan per the RFQ Addendum.

Q28. Pricing and Past Performance was listed, but a Past Performance section was not found.

A28. The paragraph you are referencing states: “Offerors shall submit proposals in accordance with the following format. Each Factor addressed below (i.e.,Technical Capability, SubFactors, Pricing and Past Performance) shall be its own electronic file”. The reference to Past Performance was given as an example only and is not being evaluated as part of this solicitation.

(End Questions/Answers)

MINIMUMS AND MAXIMUMS

MINIMUMS AND MAXIMUMS.

1. The Government agrees to a guaranteed minimum amount of $10,000.00 for the base period only.

There is no guaranteed minimum for the option periods.

2. The maximum amount the Government may order under the contract - provided all option periods are exercised, delivery orders are issued for each period of performance, and those delivery orders are subsequently funded - is

$3,182,920.00

DELIVERY ORDER PROCEDURES.

1. The final unit prices established in any contract resulting from this solicitation will be applicable to any delivery orders issued under the contract. The Government will only pay for actual quantities ordered and accepted, regardless of the quantities established on the contract and any delivery order issued thereunder. Therefore, the offeror is hereby informed that the final unit prices are not subject to adjustment on the basis of a difference between estimated and actual quantities.

2. Performance under a delivery order shall commence only upon receipt of a fully executed delivery order issued via electronic mail (e-mail), regular mail, facsimile, or by verbal direction of the Contracting Officer. If a verbal order is given, a written delivery order will be established within five days that verifies the verbal order.

3. Federal Acquisition Regulation (FAR) 52.216-19, Order Limitations, lists the minimums and maximums associated with each delivery order.

252.204-7011 ALTERNATIVE LINE-ITEM STRUCTURE (SEP 2011)

(a) Line items are the basic structural elements in a solicitation or contract that provide for the organization of contract requirements to facilitate pricing, delivery, inspection, acceptance and payment. Line items are organized into contract line items, subline items, and exhibit line items. Separate line items should be established to account for separate pricing, identification (see section 211.274 of the Defense Federal

Acquisition Regulation Supplement), deliveries, or funding. The Government recognizes that the line item structure in this solicitation may not conform to every offeror's practices. Failure to correct these issues can result in difficulties in accounting for deliveries and processing payments. Therefore, offerors are invited to propose an alternative line item structure for items on which bids, proposals, or quotes are requested in this solicitation to ensure that the resulting contract structure is economically and administratively advantageous to the Government and the Contractor.

(b) If an alternative line item structure is proposed, the structure must be consistent with subpart 204.71 of the

Defense Federal Acquisition Regulation Supplement and PGI 204.71. A sample solicitation line-item structure and a corresponding offer of a proposed alternative line-item structure follow.

Solicitation:

Item No. Supplies/Service Quantity Unit Unit price Amount

0001............................ Computer, Desktop with 20 EA

CPU, Monitor, Keyboard and Mouse.

Alternative line-item structure offer where monitors are shipped separately:

Item No. Supplies/Service Quantity Unit Unit Price Amount

0001............................ Computer, Desktop with 20 EA

CPU, Keyboard and Mouse.

0002............................ Monitor................. 20 EA

(End of provision)

The following have been modified:

52.212-1 ADDENDUM

ADDENDUM TO 52.212-1

(m) Offerors shall submit signed and dated proposals to arrive no later than the date and time specified in

Block 8, SF 1449 (Tuesday, 19 September 2017, 10:00 am, CST). Offerors shall submit electronic copies of their proposal via email to Gerri Hernandez (geraldine.i.hernandez.civ@mail.mil) AND Robyn A Villafranco robyn.a.villafranco.civ@mail.mil. Hard copies of the proposal are not required. Offerors submitted after the date and time specified are untimely and will not be considered for award.

- Emails, regardless of size, need to be received by the government server, by the stated date and time as indicated in Block 8 of the DD Form 1449. Files larger than twenty (20) MB need to be transmitted into separate emails.

- Documents submitted once the Request for Proposal has closed will not be evaluated.

MINIMUMS AND MAXIMUMS.

1. The Government agrees to a guaranteed minimum amount of $10,000.00 for the base period only. The minimum guarantee will be met with the issue of Task Order 01. There is no guaranteed minimum for the option periods.

2. The maximum amount the Government may order under the contract - provided all option periods are exercised, task orders are issued for each period of performance, and those task orders are subsequently mailto:geraldine.i.hernandez.civ@mail.mil mailto:robyn.a.villafranco.civ@mail.mil funded - is $3,182,920.41.

****** SITE VISIT INFORMATION - 29 August 2017, 10:00 AM, Central Standard Time. **********

a. A Site Visit for this effort will be held at the following location:

San Antonio Military Medical Center (SAMMC), 4299 George Bush

Joint Base San Antonio – Fort Sam Houston, Texas

b. A site visit for prospective offerors will be conducted on 29 August 2017, 10:00 AM, Central Standard Time.

Offerors are encouraged to attend to view general and local conditions that may affect your pricing strategies. Not attending the site visit will not relieve offeror from the responsibility of properly estimating the cost of successfully performing the work. In no event shall not attending the site visit constitute grounds for a claim after contract award.

Attendance is limited to two (2) individuals per Contractor. All questions that arise during or after the site visits must be submitted in writing to the undersigned not later than 05 September 2017. All questions must be submitted in writing to geraldine.i.hernandez.civ@mail.mil and robyn.a.villafranco.civ@mail.mil. No questions will be addressed after that date.

c. Each person attending the site visit will need to submit the following information to to geraldine.i.hernandez.civ@mail.mil NLT 23 August 2017. If this information is not submitted by the required time and date indicated above, your company will not be able to attend the site visits due to security concerns. There will be NO EXCEPTIONS:

Name and title of individual, including First and Last name

Date of Birth (DD/MM/YY)

Driver’s License number

Company Name

Daytime Phone Number of personnel attending site visit(s)

Additionally, for access to the installations with a privately-owned or company-owned vehicle, you will be responsible for showing current driver’s license, current registration, and current insurance. If the vehicle is a rental vehicle, then rental agreement paperwork and current driver’s license shall suffice. If your company fails to submit this information by the requested time and date, your company will not be allowed to attend the site visit due to strict security concerns. If your personnel fail to bring the proper credentials for admittance to the base and the specified sites, attendance of the site visit will not be possible due to security protocols. Only those individuals submitted in advance will be allowed to attend the site visits.

PROPOSALS WILL CONSISTS OF THE FOLLOWING:

Volume I. Administrative

1. Provide the following items:

• Completed SF 1449: Blocks 12, 17 (to include CAGE code and DUNS number), 30A - C

• Completed SF 30: Blocks 8 and 15A - C, should any amendments be issued.

• Point of Contact Information (Name, Telephone Number, Fax Number, and Email)

• Statement that the offeror will hold its quote firm for at least 90 days from the due date for receipt of quotes, subject to any changes that may occur as a result of discussions if applicable.

• Potential contractors must be registered in the System for Award Management (SAM) to be eligible for award.The SAM website is http://www.sam.gov.

mailto:robyn.a.villafranco.civ@mail.mil mailto:geraldine.i.hernandez.civ@mail.mil

• Offerors shall submit proposals in accordance with the following format. Each Factor addressed below (i.e., Technical Capability, SubFactors, Pricing and Past Performance) shall be its own electronic file.

Volume II. Technical Capability.

Factor 1.

Technical Capability.

Offerors shall explain in detail/demonstrate how their proposed items will meet the Statement of Objectives as specified here in the solicitation via the submission of a written capability statement, product literature, or other materials, to include proof where applicable (e.g., Food and Drug Administration approval of equipment and assays). Offerors shall separately address each paragraph AND subparagraph within the Statement of Objectives.

Failure to separately address each paragraph will be construed to mean the offeror is unable to meet that the requirements of that particular paragraph and would thus not be eligible for award.

This is an "all or none" solicitation, in that the offerer must provide a quote for all CLINs listed. Failure to provide a quote for any CLIN, unless it is specifically identified as "not separately priced" within the quote, will be construed to mean the offeror is not quoting that CLIN and thus, not eligible for award.

Offerors must provide the following:

- Subfactor 1A. Instruments/Equipment and Reagents/Consumables.

- The following are the required features of the equipment:

A fully automated coagulation analyzer systems (inclusive of instruments, ancillary equipment, maintenance, services, repairs, support, parts) as required in order to maintain the systems in optimal operating condition, and any installation and removal, at no extra cost to the Government. Potential contractors must also provide any and all maintenance, spare parts, on-site labor for emergency repairs, travel and trained service technicians as part of the

Cost-per-test requirement.

a. Describe how their product meets each of the twenty-eight (28) specifications outlined under the

Performance Requirements. Table 1 of the Statment of Objectives.

b. These instruments, to include any connections between the instruments/equipment, shall be approved the

US Food and Drug Administration (FDA).

c. Each analyzer will come equipped to perform continuous, random statistical analysis; capable of internal, real-time statistical Quality Control (QC). Each analyzer must include comprehensive, full integrated QC program that uses common statistical control rules (e.g., Westgard Rules). In addition, the QC program must be able to present data in a graphical format useful to detect shifts and/or trends in the QC system

(e.g., Levy-Jennings charts). The system must be able to participate in additional QC assessments using peer-group comparisons available on at least a monthly basis, with statistical comparisons including the mean, standard deviation and % coefficient of variation by QC lot number at a minimum.

d. The analyzer must provide results for PT, aPTT, Fibrinogen, D-Dimer and Anti-Xa within 15 minutes of sample introduction to the system.

e. The system must provide a minimum test throughput of at least 150 tests per hour for PT and aPTT respectively.

f. Each system must have a maximum sample size less than 200 µL in all modes with a maximum dead volume of 250 µL.

g. The analyzers will have an interface that is compatible to the government system (CHCS) and will be able to recognize CHCS generated bar-code labels (code 39 or 128) on primary sample tubes.

h. The systems must provide the capability to perform reflex testing without the need to retrieve/replace specimens on the analyzer.

i. The system must provide basic clot-detection capability.

j. Analyzer routine manual maintenance will be minimized; no manual maintenance is preferred.

k. The analyzer must have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in Table 1.

l. The PTT reagent must be appropriately sensitive and responsive to Heparin.

m. The system must continually monitor volumes and expiration for all on-board reagents, providing a warning and testing lockout for reagents that are expired.

n. Each analyzer must be capable of performing to produce results that are accurate and precise throughout the manufacturer’s stated linearity/analytical measurement range.

o. All analyzer/data management system displays and supporting literature shall be in the English language.

p. Analyzer initial startup from the shutdown state must not exceed 30 minutes.

q. Lab Layout. The offeror shall provide a diagram or other graphical representation demonstrating how its proposed equipment fits within the dimensions below with its quote. NOTE: A floor drain or dedicated water system is available.

- Subfactor 1B. Service and Maintenance.

a. The Contractor shall provide direct customer service and support, 24 hours/7 days a week, to include hotline telephone service (provided in English) and on-call emergency repair, to assist operators in correcting equipment problems.

b. The Contractor will maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the Government. This includes emergency repairs as well as

Preventive Maintenance Services (PMS), safety tests, calibrations/calibration verifications, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

c. The Contractor must provide a full unscheduled and PMS throughout the contract. PMS must be at no additional cost to the Government, inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor’s instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzers, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

d. Scheduled routine PMS must be performed between 0730-1630 Monday-Friday, excluding Federal

Holidays.

e. The Contractor must provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level must be performed by Contractor service personnel in accordance with requirements as specified in the Contractor’s instrument maintenance manual. Completion of installation of the analyzers will establish time-zero for determining the time frame for performance of periodic services.

f. Upon notification of equipment failure, the Contractor’s qualified service technician must establish telephonic contact within 60 minutes of the Government’s notification to the Contractors Customer

Service “Hotline.”

g. For equipment supporting the Core Laboratory, the service technician must be on-site to provide unlimited service within twelve (12) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial on-site response by the Contractor. Should all coagulation analyzers become inoperable, the Contractor’s service technician must be on-site within four (4) hours of initial notification. The repair of at least one (1) analyzer must be completed within eight (8) hours of initial notification. If deemed necessary, after consultation with the COR, if at least one analyzer cannot be repaired within eight (8) hours of the initial notification, the Contractor shall, where requested, arrange the pickup and delivery of critical specimens to a College of American Pathologists accredited clinical laboratory, with priority testing service provided for STAT/ASAP specimens. The Contractor shall pay all costs associated with the provision of this alternative testing, including those for delivery of hardcopy patient results by express courier, directly to the laboratory, for as long as all analyzers remain inoperable.

The Contractor shall provide replacement parts used, as necessary, claimed from local operator-level maintenance kits.

- Subfactor 1C. Training.

a. The Contractor shall provide the following for all testing locations at BAMC:

b. The Contractor shall provide initial operator training (on or off-site) to all technicians assigned to the

Government site normally assigned to perform the associated testing prior to implementation of the analyzer for patient testing. In addition, the Contractor shall provide training for two (2) primary (key) operators, per analyzer prior to or no later than one week following implementation of the analyzer.

c. All training shall include basic analyzer operation, troubleshooting procedures, performance of operator level periodic preventive maintenance procedures, and use any data management/quality control software.

d. Upon renewal of the 3rd option year and in the case of any significant software or assay procedural updates, the Contractor shall provide one (1) primary (key) operator training slot per major analyzer. This training can be on or off-site at the Contractor’s full expense.

e. Each analyzer must come equipped with an un-interruptible power supply (UPS) capable of providing all necessary electrical power to each analyzer system, to include the data management system, for 15 to 20 minutes after loss of power.