W81K0019Q0198 0002.pdf

0011360720

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

A pre-aw ard protest w as received w hich has since been resolved. As a result, this Amendment 0002 is now being issued requesting receipt of proposals by the date and time of "10:00 AM 30 Dec 2019" as show n on Block 8. "OFFER DUE DATE/LOCAL TIME:" of the SF1449 to all interested offerors (unrestricted full and open competition). If you have previously submitted a proposal you must resubmit all required documents. All interested parties must return the solicitation and all amendments in order to be considered for this requirement. Solicitation instructions are included.

1. CONTRACT ID CODE PAGE OF PAGES

1 12

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

16C. DATE SIGNED

BY 26-Nov-2019

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 W81K0019Q0198

X 9B. DATED (SEE ITEM 11)

24-Jul-2019

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 X is extended, 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

26-Nov-2019

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

FT SAM HOUSTON TX 78234-0000

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

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81K0019Q0198

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

SOLICITATION INSTRUCTIONS

Solicitation Instructions W81K0019Q0198 U0002 Attached is a solicitation for BLOOD DONOR TESTING for Carl R. Darnall Army Medical Center, Fort Hood, Texas, 76544 in support of the Robertson Blood Center, Ft Hood, Texas, and the Ft Leonard Wood, Blood Donor Center, Ft Leonard Wood, Missouri.

In order to be considered for the proposed contract the appropriate person must:

1. Fill out pricing as appropriate for each of the items listed in CLIN 0001AA Here you would put the total cost of the requested item CLIN 0001AB Here you would put the total cost of the requested item CLIN 0001AC Here you would put the total cost of the requested item CLIN 0001AD Here you would put the total cost of the requested item CLIN 1001AA Here you would put the total cost of the requested item CLIN 1001AB Here you would put the total cost of the requested item CLIN 1001AC Here you would put the total cost of the requested item CLIN 1001AD Here you would put the total cost of the requested item CLIN 2001AA Here you would put the total cost of the requested item CLIN 2001AB Here you would put the total cost of the requested item CLIN 2001AC Here you would put the total cost of the requested item CLIN 2001AD Here you would put the total cost of the requested item CLIN 3001AA Here you would put the total cost of the requested item CLIN 3001AB Here you would put the total cost of the requested item CLIN 3001AC Here you would put the total cost of the requested item CLIN 3001AD Here you would put the total cost of the requested item CLIN 4001AA Here you would put the total cost of the requested item CLIN 4001AB Here you would put the total cost of the requested item CLIN 4001AC Here you would put the total cost of the requested item CLIN 4001AD Here you would put the total cost of the requested item

2. Proposed vendor MUST fill out block 17a with the company CAGE Code, company name and company address.

3. Proposed vendor MUST SIGN and DATE in blocks 30 a, b, and c. Please return the completed solicitation via email to karan.e.quiles.civ@mail.mil NLT 10:00 a.m. Monday, 30 December 2019, Central Standard Time as noted in Block 8 of the solicitation. Proposed vendor must also return Amendment 0001 and Amendment 0002.

If you have any questions please contact via email ONLY (no phone inquiries or answers) at karan.e.quiles.civ@mail.mil. All questions must be submitted via email by 10:00 a.m. Thursday, 5 December 2019, Central Standard Time. They will be addressed via email NLT, 3:00 p.m. Tuesday, 17 December 2019, Central Standard Time. NO other questions shall be addressed after the question submittal time of 10:00 a.m. Thursday, 5 December 2019, Central Standard Time. NOTE: several questions have previously been answered at Amendment 0001.

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 26-Aug-2019 10:00 AM to 30-Dec-2019 10:00 AM.

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

Blood donor testing non-personal services in accordance with the Performance Work Statement to support the Robertson Blood Center, Fort Hood, Texas and the Blood Donor Center, Fort Leonard Wood, Missouri. Period of Performance is 1 October 2019 to 30 September 2020. The Government will only pay for actual tests completed.

Subject to availability of FY20 funds.

To:

Blood donor testing non-personal services in accordance with the Performance Work Statement to support the Robertson Blood Center, Fort Hood, Texas and the Blood Donor Center, Fort Leonard Wood, Missouri. Period of Performance is 1 March 2020 to 30 September 2020. The Government will only pay for actual tests completed.

Subject to availability of FY20 funds.

DELIVERIES AND PERFORMANCE

The following Delivery Schedule Item has been deleted from SUBCLIN 0001AA:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 01-OCT-2019 TO

30-SEP-2020

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

FOB: Destination

W45XTR

The following Delivery Schedule item has been added to SUBCLIN 0001AA:

CAGE

POP 01-MAR-2020 TO

30-SEP-2020

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule Item has been deleted from SUBCLIN 0001AB:

CAGE

POP 01-OCT-2019 TO

30-SEP-2020

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule item has been added to SUBCLIN 0001AB:

CAGE

POP 01-MAR-2020 TO

30-SEP-2020

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule Item has been deleted from SUBCLIN 0001AC:

CAGE

POP 01-OCT-2019 TO

30-SEP-2020

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule item has been added to SUBCLIN 0001AC:

CAGE

POP 01-MAR-2020 TO

30-SEP-2020

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule Item has been deleted from SUBCLIN 0001AD:

CAGE

POP 01-OCT-2019 TO

30-SEP-2020

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following Delivery Schedule item has been added to SUBCLIN 0001AD:

CAGE

POP 01-MAR-2020 TO

30-SEP-2020

N/A W2M5 CARL R DARNALL ARMY MED C

POP SEE LINE ITEM(S)

MEDICAL SUPPLY OFFICER DACH

BLDG 36065 SANTE FE AVE

FORT HOOD TX 76544-5063

The following have been modified:

52.212-1 ADDENDUM

Offeror shall submit signed and dated proposals to Fort Hood Health Contracting Branch, Regional Health Contracting Office (RHCO), Central Army Health Contracting Activity, MEDCOM office no later than the date and time specified in Block 8, of the Standard Form 1449, Solicitation/Contract/Order for Commercial Items. The proposal shall have a title page identifying the offeror, the full address, phone and facsimile numbers, points of contact (POCs) of the offeror, the solicitation number and its contents.

Note: Facsimile offer and electronic (e-mail) offer is also acceptable, provided they meet the requirements listed above. Electronic (e-mail) is the preferred method. Quote can be faxed to 254-553-3906 ATTN: Karan E. Quiles

Quotes must be submitted NLT the offer due date/local time CST by e-mailing to: karan.e.quiles.civ@mail.mil, or faxing to (254) 553-8440 Attn: Karan E. Quiles. No telephonic questions or offers will be accepted. A technical proposal must be included with the offers. Offers without a technical proposal will not be considered.

Offer shall clearly identify each part of their quote, as described below. Please Note "Quotes must be received by Monday, 30 December 2019 at 10:00 a.m. Central Standard Time (CST). Untimely received quotes will NOT be considered for award." Please note the time and date also noted in BLOCK 8 of the solicitation.

Administrative

a. Request for Quote. The offeror shall include a copy of the completed SF 1449, with the signature and include the name of the offeror, address, phone and fax numbers in Block 17a.

b. The offeror shall submit a completed copy of FAR 52.212-3, Representations and Certifications – Commercial Items. If the offeror has completed the Online Representations and Certifications Application (ORCA) at https://www.sam.gov/ the offeror shall indicate such on the FAR clause. Offeror Representations and Certifications

– Commercial Items. All offerors must be registered in the System for Award Management (SAM) prior to award, and lack of registration shall make an offer ineligible for award.

c. The offeror shall submit completed provisions FAR 52.209-2, FAR 52.209-7, FAR 52.209-11, FAR 52.222-22 and FAR 52.222-25 as part of the RFQ. The provisions are located on pages 48-51 of the solicitation (approximately).

Pricing

a. Pricing for Requirements. The offeror shall submit proposed pricing for all Contract Line Item Numbers (CLINs) and subContract Line Item Numbers (subCLINs) (if applicable) as identified in the Request for Quote, unless otherwise noted. Include the unit price and the total extended price for each CLIN.

Technical

a. The technical proposal shall be addressed in sufficient written detail for the Government to determine if the offeror’s service(s) adequately perform the specific requirements as stated in 52.212-2. The proposed offeror shall be in compliance with the Performance Work Statement for the duration of the contract. In order to meet and maintain the high quality standards of Carl R. Darnall Army Medical Center, Robertson Blood Center, Fort Hood, Texas 76544 and Fort Leonard Wood, Blood Donor Center, General Leonard Wood, Missouri, 65473 a list of the necessary requirements for this action have been compiled and are within the entirety of the Performance Work Statement.

Note that the entire PWS is relevant however please take special note of the following:

Reference PWS 1.1: The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for HBsAg, Anti-HBc, Anti- HCV, Anti-HTLV I/II, Anti-HIV 1/2, STS (syphilis), ABO/Rh, ABSC, NAT pooled testing for HIV/HCV/HBV, individual donor testing for West Nile Virus, Chagas (T. cruzi), and individual donor testing for Zika Virus for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri. Samples drawn from platelet donors will require the above testing and, in addition, CMV testing. Any confirmatory/supplemental tests required will be free of charge and included in the cost of whole blood panel testing. The Contractor will provide for third party shipping or transport of specimens on behalf of the government, to be reimbursed at cost by the contract.

Reference PWS 1.1.1. SCOPE: All tests shall be executed at the contractor's premises, OR within the Contractor's network of laboratories (affiliate or qualified subcontractor). Contractor's referrals to such affiliate's or qualified subcontractor's laboratories shall be kept to a minimum for control and uniformity purposes.

Reference PWS 1.1.2.: All testing shall be performed in accordance with the Food and Drug Administration regulations. The contractor will also provide any additional testing that is deemed by the FDA as required for the safety of the national blood supply as required by Robertson Blood Center, FT Hood, Texas, and FT Leonard Wood Blood Donor Center, FT Leonard Wood, Missouri (herein referred to as blood donor centers), will be performed IAW Code of Federal Regulation, Title 21(CFR) and applicable industrial standards.

Reference PWS 1.2.4. The contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations.

Reference PWS 1.3.1.4. The Contractor shall operate a quality control program as required by CLIA and FDA. Current CLIA requirements are located at the Health Care Financing Administration's website: http://www.phppo.cdc.gov/CLIA. Upon request of the COR and the Contractor shall provide documentation of quality assurance policies, quality control results for assays, on-going calculations of quality control performance (coefficient of variation, mean and standard deviation), monthly Levy- Jennings graphs, documentation of appropriate analyzer maintenance. Upon request, the Contractor shall provide verification results for assays of non-regulated analytes, and analytes for which proficiency testing does not currently exist.

Reference PWS 1.3.1.5. All test methods, test kits and reagents, used for blood donor testing, shall be FDA approved. Any non-FDA approved method being performed shall have a documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

Reference PWS 1.4.1. Maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

Reference PWS 4.1.1. COMMERCIAL CATALOG OF LABORATORY SERVICES. The Contractor shall provide a copy of its commercial catalog of laboratory services. Information shall also be provided by the Contractor to the COR. The Contractor shall provide a hard copy or electronic copy during the start-up period to each COR. Examples of the information to be provided include the following:

o Test specific specimen collection and preservation requirements for each test or analyte.

o Test specific method and interpretation for each test or analyte.

o Test specific method reference ranges, when required.

o Test specific method sensitivity, specificity, and interferences, when required.

o Test specific schedule of performance and average turnaround time for each.

o Result Code

Reference PWS 4.1.1.1. Updated information on test methodology changes, (i.e. changes in normal ranges, methods, and reporting units, etc). In the event of any methodology change, written information/instruction shall be provided to the contracting officer and COR within 15 calendar days prior to the Contractor implementing said change. This will allow time for changes in testing algorithms. Changes to procedures with less than 15 calendar days notice shall be made only with concurrence by the COR. The COR will notify the contracting officer in the event of noncompliance with this requirement.

Reference PWS 4.1.2. PRODUCT INFORMATION. The Contractor shall provide product information on new test(s) offered by the Contractor. Updated information shall be provided to the contracting officer and COR once test procedure validation is complete.

Reference PWS 5.1. TESTING. The Contractor shall maintain and be FDA licensed for blood donor testing and provide the full range of blood donor testing currently required by the FDA. Contractor will inform of any delay in test results within the 12 hour period via telephone, e-mail or secure fax. The Contractor will provide additional FDA licensed confirmatory testing if available for donor specimens that are initially reactive as required by regulatory and service agencies. The additional confirmatory testing results shall be available within 7 calendar days to the blood donor centers. Any additional testing required by the FDA will be provided by the Contractor during the term of the contract. All blood donor laboratory testing shall be executed in accordance with standard industry practices. Contractor must have a sample surge capacity of at least 1000 samples per day to accommodate any unforeseen mission requirements or contingency missions that would require an upsurge in blood and blood product requirement, plus other new tests added during the term of the contract. Contractor will have a plan in case of a national emergency (example 9/11), that will ensure no delay or stoppage of service.

Special Delivery Mail

a. Offeror is cautioned that the United States Postal Service (USPS) does not deliver directly to the Fort Hood Health Contracting Branch, Regional Health Contracting Office (RHCO), Central Army Health Contracting Activity, MEDCOM. All USPS mail is delivered to a central location at Carl R. Darnall Army Medical Center.

Offer should be sent in sufficient time to ensure arrival at the contracting office by the specified date and time.

Offeror should consider the additional time needed for mail distribution when preparing their offers.

b. Offeror may drop-off their proposal at the Fort Hood Health Contracting Branch, Regional Health Contracting Office (RHCO), Central Army Health Contracting Activity, MEDCOM, prior to the specified due date and time. For directions to the contracting office, contact Karan E. Quiles, karan.e.quiles.civ@mail.mil

The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found.

(End of Provision)

52.212-2 ADDENDUM

Award will be made using the lowest price technically acceptable (LPTA) source selection process. Award will be made to the responsible offeror on the basis of the lowest evaluated price of proposals meeting or exceeding the acceptability standards for non-cost factors. Award may be made without discussions with offerors (except communications conducted for the purpose of minor clarification). Therefore, each initial offer should contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the contracting officer to be necessary.

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer, conforming to the solicitation is Lowest Price, Technically Acceptable (LPTA). Award will be made on all or nothing basis. The following evaluation factors shall be used to evaluate offers: Technically Acceptability and Price.

EVALUATION PROCESS:

Award will be made using the lowest-price, technically-acceptable source selection process. The Government will initially list proposals from lowest to highest price. The Government will evaluate the lowest priced proposal first. If that proposal is determined technically unacceptable, the Government will evaluate the next lowest priced proposal and continue in that manner until a proposal is rated Technically Acceptable. If a proposal is rated Technically Unacceptable, the Government will not evaluate any other factor. USING THIS PROCEDURE, THE

GOVERNMENT MIGHT NOT EVALUATE ALL PROPOSALS.

The following evaluation factors shall be used to evaluate offers:

Technical Proposal: Offeror must meet the salient physical, functional, or performances characteristic specified in this solicitation and clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification.

The factors of the technical proposal shall be addressed in sufficient written detail for the government to determine if the offeror possesses sufficient technical capability to adequately provide the requested supplies. This factor will be rated as either “acceptable” or “unacceptable”. This solicitation is Lowest Price, Technically Acceptable

(LPTA).

a) The offeror shall submit completed provisions FAR 52.209-2, FAR 52.209-7, FAR 52.209-11, FAR 52.222-22 and FAR 52.222-25 as part of the RFQ. The provisions are located on pages 48-51 of the solicitation (approximately), offers submitted without completed provisions shall not be considered for award.

b) Offeror must clearly state how they propose to meet all of the requirements as listed within the

Performance Work Statement.

Offeror must take particular note of the following that are incorporated within the Performance Work Statement:

Reference PWS 1.1: The Contractor shall provide all required facilities, personnel, services, transportation, materials, equipment, and supplies required to provide testing for HBsAg, Anti-HBc, Anti- HCV, Anti-HTLV I/II, Anti-HIV 1/2, STS (syphilis), ABO/Rh, ABSC, NAT pooled testing for HIV/HCV/HBV, individual donor testing for West Nile Virus, Chagas (T. cruzi), and individual donor testing for Zika Virus for specimens submitted by Robertson Blood Center, Ft Hood, Texas, and Ft Leonard Wood, Blood Donor Center, FT Leonard Wood, Missouri. Samples drawn from platelet donors will require the above testing and, in addition, CMV testing. Any confirmatory/supplemental tests required will be free of charge and included in the cost of whole blood panel testing. The Contractor will provide for third party shipping or transport of specimens on behalf of the government, to be reimbursed at cost by the contract.

Reference PWS 1.1.1. SCOPE: All tests shall be executed at the contractor's premises, OR within the Contractor's network of laboratories (affiliate or qualified subcontractor). Contractor's referrals to such affiliate's or qualified subcontractor's laboratories shall be kept to a minimum for control and uniformity purposes.

Reference PWS 1.1.2.: All testing shall be performed in accordance with the Food and Drug Administration regulations. The contractor will also provide any additional testing that is deemed by the FDA as required for the safety of the national blood supply as required by Robertson Blood Center, FT Hood, Texas, and FT Leonard Wood Blood Donor Center, FT Leonard Wood, Missouri (herein referred to as blood donor centers), will be performed IAW Code of Federal Regulation, Title 21(CFR) and applicable industrial standards.

Reference PWS 1.2.4. The contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations.

Reference PWS 1.3.1.4. The Contractor shall operate a quality control program as required by CLIA and FDA. Current CLIA requirements are located at the Health Care Financing Administration's website: http://www.phppo.cdc.gov/CLIA. Upon request of the COR and the Contractor shall provide documentation of quality assurance policies, quality control results for assays, on-going calculations of quality control performance (coefficient of variation, mean and standard deviation), monthly Levy- Jennings graphs, documentation of appropriate analyzer maintenance. Upon request, the Contractor shall provide verification results for assays of non-regulated analytes, and analytes for which proficiency testing does not currently exist.

Reference PWS 1.3.1.5. All test methods, test kits and reagents, used for blood donor testing, shall be FDA approved. Any non-FDA approved method being performed shall have a documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

Reference PWS 1.4.1. Maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

Reference PWS 4.1.1. COMMERCIAL CATALOG OF LABORATORY SERVICES. The Contractor shall provide a copy of its commercial catalog of laboratory services. Information shall also be provided by the Contractor to the COR. The Contractor shall provide a hard copy or electronic copy during the start-up period to each COR. Examples of the information to be provided include the following:

o Test specific specimen collection and preservation requirements for each test or analyte.

o Test specific method and interpretation for each test or analyte.

o Test specific method reference ranges, when required.

o Test specific method sensitivity, specificity, and interferences, when required.

o Test specific schedule of performance and average turnaround time for each.

o Result Code

Reference PWS 4.1.1.1. Updated information on test methodology changes, (i.e. changes in normal ranges, methods, and reporting units, etc). In the event of any methodology change, written information/instruction shall be provided to the contracting officer and COR within 15 calendar days prior to the Contractor implementing said change. This will allow time for changes in testing algorithms. Changes to procedures with less than 15 calendar days notice shall be made only with concurrence by the COR. The COR will notify the contracting officer in the event of noncompliance with this requirement.

Reference PWS 4.1.2. PRODUCT INFORMATION. The Contractor shall provide product information on new test(s) offered by the Contractor. Updated information shall be provided to the contracting officer and COR once test procedure validation is complete.

Reference PWS 5.1. TESTING. The Contractor shall maintain and be FDA licensed for blood donor testing and provide the full range of blood donor testing currently required by the FDA. Contractor will inform of any delay in test results within the 12 hour period via telephone, e-mail or secure fax. The Contractor will provide additional FDA licensed confirmatory testing if available for donor specimens that are initially reactive as required by regulatory and service agencies. The additional confirmatory testing results shall be available within 7 calendar days to the blood donor centers. Any additional testing required by the FDA will be provided by the Contractor during the term of the contract. All blood donor laboratory testing shall be executed in accordance with standard industry practices. Contractor must have a sample surge capacity of at least 1000 samples per day to accommodate any unforeseen mission requirements or contingency missions that would require an upsurge in blood and blood product requirement, plus other new tests added during the term of the contract. Contractor will have a plan in case of a national emergency (example 9/11), that will ensure no delay or stoppage of service.

1. Technical Acceptability: Offer will be found technically acceptable if the offer meets the performance requirements and criteria as listed within the Performance Work Statement.

Each proposed vendor must be able to conform to all of the requirements and perform all of the requirements that are listed within the Performance Work Statement in a comprehensive and complete manner in order to be considered for award.

Acceptable: Documentation provided clearly meets the minimum requirements of the solicitation.

Unacceptable: Documentation provided does not meet the minimum requirements of the solicitation.

Any technical factor rated technically unacceptable makes the offeror ineligible for award.

Technical Acceptability: Each of the above factors must be found technically acceptable in order to be eligible for award.

2. Price:

(a.) Price will be evaluated using various price analysis techniques and procedures IAW FAR 15.404-1(b) including, but not limited to, comparison of proposed price received in response to the solicitation with a comparison to the government estimate. Evaluation of price will include a determination that the price is fair and reasonable.

(b) Quotes must be submitted NLT the offer due date/local time CST by e-mailing to: karan.e.quiles.civ@mail.mil, or faxing to (254) 553-3906 Attn: Karan E. Quiles. No telephonic questions or quotes will be accepted. A signed SF form 1449 with completed pricing data must be submitted. E-mail is the preferred method.

(c) Evaluation Process: All offers will be evaluated IAW FAR 15.101-2 first: Award will be made using the lowest-price, technically-acceptable source selection process. The Government will initially list proposals from lowest to highest price. If a proposal is rated Technically Unacceptable, the Government will not evaluate any other factor.

USING THIS PROCEDURE, THE GOVERNMENT MIGHT NOT EVALUATE ALL PROPOSALS. Proposals receiving a rating of “less than adequate” or “not acceptable” will not be eligible for award.

(d) Questions: If you have any questions please contact via email ONLY (no phone inquiries or answers) at karan.e.quiles.civ@mail.mil. All questions must be submitted via email by 10:00 a.m. Thursday, 5 December 2019, Central Standard Time. They will be addressed via email NLT, 3:00 p.m. Tuesday, 17 December 2019, Central Standard Time. NO other questions shall be addressed after the question submittal time of 10:00 a.m. Thursday, 5 December 2019, Central Standard Time. NOTE: several questions have previously been answered at Amendment 0001.

(d). A written notice of award or acceptance of an offer, will be furnished via e-mail to the successful offeror within the time for acceptance specified in the offer and shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: See Addendum 52.212-2

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

(End of Summary of Changes)