W9114F21Q0121 0001 Amendment.pdf

0011626242

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 do the follow ing:

a. Provide responses to questions asked by industry. See Questions and Answ ers.

b. Change the Subfactor 4 Reagents and Supply requirements to a minimum reagent on-board shelf-life of 48 hours.

c. Change the Salient Characteristics, Data Management System requirements to manage at least 1,000 patient results.

d. Correct numbering in the Addendum to 52.212-1 and in 52.212-2.

e. Change the closure date and time to 1 October 2021 at 16:00 Central European Summer Time (CEST). See 'Summary of Changes' for details.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 12

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

16C. DATE SIGNED

BY 16-Sep-2021

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 W9114F21Q0121

X 9B. DATED (SEE ITEM 11)

17-Aug-2021

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

16-Sep-2021

CODE

W40M RHCO USAHCA EUROPE

REGIONAL HEALTH CONTR OFC EUROPE

CMR 402

APO AE 09180

W9114F 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W9114F21Q0121

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 17-Sep-2021 12:00 AM to 01-Oct-2021 04:00 PM.

The following have been added by full text:

QUESTIONS AND ANSWERS

1. We have the following question in regards to Subfactor 4: Reagents and Supplies, “Quoter shall provide statement to confirm to provide c. The shelf-life for onboard reagent to be a minimum of 220 hours for PT and APTT; 72 hours for Fibrinogen and D-Dimer.”

Question: Would it be a criterion for exclusion of this tender award if we can´t meet the onboard shelf-life with 3 of the reagents?

Response: All technical evaluation criteria need to be met in order to be technically acceptable. The minimum reagent on-board shelf-life was changed to 48 hours.

2. We have the following question in regards to the Salient Characteristics, Data Management Systems, “d. Shall manage and store at least 20,000 patient results and quality control data.”

Question: Does 20,000 patient results mean actual saved results or 20,000 patient data?

Response: Only 1,000 saved results are sufficient and therefore the amount of patient results required was changed to 1,000.

3. Question: Is it possible to extend the quote due date to 1 October 2021?

Response: The RFQ closure date and time was change to 1 October 2021 at 16:00 Central European Summer Time (CEST)

(End of Questions and Answers)

The following have been modified:

CLAUSE(S) 52.212-1 - ADDENDUM TO 52.212-1

Paragraph 52.212-1 (a) is hereby replaced with the following:

Does not apply to this Request for Quote.

Paragraph 52.212-1(b)(4) is hereby replaced with the following:

If a Quoter believes that the requirements in these instructions contain an error, omission, or are otherwise unsound, the Quoter shall immediately notify the Contracting Officer (KO) in writing with supporting rationale.

Factor 1 - Technical: The quoter must demonstrate compliance with the requirements in the solicitation by submitting a written quote which addresses compliance with each of the following technical factors:

Subfactor 1: Installation, Validation, and Regulatory Compliance

a. The Quoter shall provide a capability statement to provide the installation and initial validation in accordance with the CLIA/NCCLS guidelines to include

i. normal range verification

ii. linearity and limits of quantitation (reportable range)

iii. correlation with current methods/instruments

iv. validation of analytical measurement range (AMR)

v. validation of precision and accuracy

vi. establishment of initial control ranges

b. The Quoter shall provide a statement to confirm to provide all reagents, controls, calibrators, and linearity materials for initial validation. Initial validation studies shall be performed on-site by the Contractor or appropriate Subcontractor.

Subfactor 2: Training

The Quoter shall provide a statement to confirm to provide

a. At least two paper and two digital copies of the Operator’s Manual, Maintenance Instructions, and

Warranty.

b. On-site training to four (4) primary operators at time of installation and complete on-site training with all technicians using the instrument within 12 months of installation.

c. Train two primary operators per analyzer per contract year at the contractors training site at no additional cost to the Government. Training shall include costs of lodging, travel, food, teaching staff and training handouts. Travel costs shall not exceed the current JTR/JFTR. Travel benefits shall be provided in-kind (rather than in cash). All training shall be provided in English.

d. All training manuals/guides, instructional literature, and any other related written/electronic material in English. Training shall include basic operation of the analyzers, troubleshooting procedures, performance of operator-level periodic preventive maintenance procedures, and use of the data management/quality control software.

Subfactor 3: Maintenance, Repair, Service, and Support

a. The Quoter shall provide a statement to confirm to perform preventive maintenance services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

b. The Quoter shall provide a statement to confirm that the provided quote is inclusive of all costs for the performance of scheduled periodic maintenance (as required by the instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

c. The Quoter shall provide a statement to confirm to provide the following

i. Upon analyzer failure between 0800-1600 Central European Time (CET) Monday-

Friday, the Contractor’s qualified service technician to be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement) within 24 hours.

ii. The equipment shall be repaired and operational within 48 hours of the initial response by the Contractor.

d. The Quoter shall provide a statement to confirm to provide

i. Should both analyzers become inoperable, the Contractor’s qualified service technician shall be on-site within four hours of initial notification and the repair of at least one instrument completed within one working day.

ii. While both analyzers are inoperable, the Contractor shall arrange transport of critical specimens to a College of American Pathologists (CAP) accredited clinical laboratory of their choice within Germany along with the retrieval of hardcopy patient results by express courier.

iii. The selected laboratory shall provide patient reports in English that include reference ranges for the test performed. The Contractor is responsible for costs associated with this service. If both analyzers remain inoperable for three days, a replacement analyzer shall be provided, validated, and installed at the Contractor/Vendor’s expense.

e. The Quoter shall provide statement to confirm to provide

i. Same day customer service and support for emergency service requirements.

ii. A service hotline with English menu options and English-speaking technical support staff available to assist operators in correcting equipment operation problems.

iii. A service hotline available Monday through Friday, 0800-1600 Central European Time

(CET).

Subfactor 4: Reagents and Supplies

Quoter shall provide statement to confirm to provide

a. All reagents and assays to be FDA approved.

b. All reagents to be maintained on-board once opened (removing and refrigeration between runs shall not be required for stated shelf-life).

c. The shelf-life for onboard reagent to be a minimum of 48 hours for PT, APTT, Fibrinogen and D-

Dimer.

d. Reagent packs to be changeable without requiring additional calibration or QC.

e. Reagent and QC material to be supplied for at least one year without lot changes.

f. Reagents to have a minimum shelf-life of three (3) months upon receipt by the Government.

g. Reagent and QC supply amount to account for QC frequency per CAP requirements (usually three times daily, 365 days per year, despite sample load).

Subfactor 5: Salient Characteristics

Quoter shall provide statement of conformance that the quoted equipment meets all salient characteristics.

SALIENT CHARACTERISTICS

1. Instrument Capability

a. All instruments, methods, controls and reagents supporting the following assays shall be FDA approved

i. D-Dimer

1. The D-dimer test shall be FDA approved for the exclusion of Deep Vein

Thrombosis (DVT) and Pulmonary Embolism (PE).

ii. Prothrombin Time (PT) with International Normalized Ratio (INR)

iii. Activated Partial Prothrombin Time (APTT)

iv. Fibrinogen

b. The fibrinogen method shall have at least 50 laboratories in the College of American Pathology (CAP) Proficiency Testing program; the D-Dimer, PT, INR, and APTT assays shall have at least 500.

c. All sample, calibrator, and QC dilution shall be performed automatically.

d. Minimum throughput shall be 50 samples per hour.

e. Shall have a STAT interrupt capability, i.e. in-situ prioritization of STAT samples.

f. Shall allow for continuous loading of samples and reagents while running.

g. Shall be capable of handling all specimen tubes sizes, including pediatric and micro containers.

h. Shall be capable of producing results within 10 minutes of sample loading for the PT, APTT, Fibrinogen, or D-Dimer assays.

i. Shall be capable of automated handling of closed tubes (e.g. cap-piercing).

j. Shall be equipped with an uninterruptible power supply capable of powering the analyzer and data management system for >20 minutes.

k. The electrical requirement shall be compatible with German electrical infrastructure: 220VAC at

50Hz.

l. Onboard storage shall have capacity for at least 20 refrigerated reagents

m. On-board reagents and QC material shall be temperature controlled sufficient to meet stability requirements

n. Instrument dimensions including all accessories shall fit within a 1.5 square foot area.

2. Data Management Systems

a. Shall include a bidirectional interface compatible with DoD medical informatics systems including the Composite Health Care System (CHCS).

b. All system displays and support literature shall be in English

c. Shall include an integrated (i.e. internal) bar code reader for samples, reagents, and QC material.

d. Shall manage and store at least 1,000 patient results and quality control data.

e. Shall include a printer and produce hard copy patient reports.

f. Shall provide Levey-Jennings graphs and be capable of applying Westgard quality control result decision rules in real-time. The user shall have the ability to quickly and simply select the rules to be applied.

g. Shall monitor reagent and QC material on-board shelf life and prompt user when items expire.

(End of Salient Characteristics)

Failure to receive an Acceptable rating of any of the above salient characteristics / evaluation criteria will result in an Unacceptable technical rating unless the error(s), deficiency (ies) or omission (s) can be corrected.

FACTOR II: PRICE. Quoters shall submit prices on all line items of this RFQ. Prices will be evaluated for reasonableness based on anticipated adequate price competition. Price analysis will be performed through the use of comparative price quotation analysis for technically acceptable quotations. Prices will not be rated.

Paragraph 52.212-1(b)(6) is hereby added:

Price. A unit price and extended amount (i.e., quantity multiplied by unit price) shall be submitted for each Contract Line Item Number (CLIN).

Paragraph 52.212-1 (c) is hereby replaced with the following:

The quoter agrees to hold the prices in its quote firm for 60 calendar days from the date specified for receipt of quotes, unless another time period is specified in an addendum to the Request for Quote.

Paragraph 52.212-1 (d) is hereby replaced with the following:

Does not apply to this Request for Quote.

Paragraph 52.212-1 (i) is hereby replaced with the following:

Does not apply to this Request for Quote.

The following Paragraphs are hereby added:

Paragraph 52.212-1 (h) (ii) Only one Purchase Order will be issued as a result of this RFQ. The Purchase order will be issued on an “All OR NONE” basis. Quotes for less than all of the solicited line items will be rejected as nonconforming and unacceptable to the RFQ.

Paragraph 52.212-1 (m) Quotes shall describe how your product meets the above salient characteristics and are equal to the items listed in the schedule.

Paragraph 52.212-1 (n) ELECTRONIC Quote. Quoters may submit electronic Quote in response to this Request for Quote. The Quote must be received by the Quote due date/local Germany time as specified in block 8 of the SF

1449 cover page to the inbox of the following email address: henningfalk.mayer-goldstein.ln@mail.mil Vendors may call Mr. Henning Mayer-Goldstein at 011-49-6371-9464-6789 to verify receipt of the quote. If the vendor chooses to email the quote, the Government will not be responsible for any failure of transmission or receipt of the quote, or any failure of the vendor to verify receipt of the emailed quote.

The technical quote shall not exceed 20 pages, font size 12. Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the quote. Your technical quote shall be structured as a written narrative to address what the Government is asking for in the afore-mentioned technical factors and subfactors. Copies of certifications, accreditations etc. and pages for price quotation do not count against the 20-page limitation.

Paragraph 52.212-1 (o) QUESTIONS. Prospective quoters are strongly encouraged to submit any questions regarding this Request for Quote no later than five business days prior to the request for quote due date specified in block 8 of the SF 1449 cover page. Questions can be emailed to henningfalk.mayer-goldstein.ln@mail.mil, or fax +49-6371-86-8070. All questions received will be answered officially through an amendment to the Request for Quote for distribution to all prospective quoters. Questions received after the local Germany cut-off date/time will not be accepted by the Government.

Paragraph 52.212-1 (p) The non-FAR Part 12 discretionary FAR, DFARS, AFARS, and LOCAL provisions included herein are incorporated into this Request for Quote 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.

Paragraph 52.212-1 (r) If a Quoter believes that the requirements in these instructions contain an error, omission, or are otherwise unsound, the Quoter shall immediately notify the Contracting Officer (KO) in writing with supporting rationale.

ACQUISITION PROCEDURE: This is a commercial item under FAR Part 12 and the acquisition procedures to be used for this purchase will be in accordance with FAR Part 13.5 Simplified Procedures for Certain Commercial Items.

SPECIAL NOTE: All vendors must be registered in the System for Award Management (SAM) prior to issuance of a Purchase Order. Vendors may obtain information on registration and annual confirmation requirements by calling 1-866-606-8220 or via Internet at https://www.sam.gov.

(End of Addendum)

EXTENDED CLIN DESCRIPTION

Installation, Validation, and Regulatory Compliance

b. The Contractor shall provide the installation and initial validation in accordance with the CLIA/NCCLS guidelines to include

i. normal range verification

ii. linearity and limits of quantitation (reportable range)

iii. correlation with current methods/instruments

iv. validation of analytical measurement range (AMR)

v. validation of precision and accuracy

vi. establishment of initial control ranges

c. The Contractor shall provide all reagents, controls, calibrators, and linearity materials for initial validation. Initial validation studies shall be performed on-site by the Contractor or appropriate Subcontractor.

Training

The Contractor shall provide

a. At least two paper and two digital copies of the Operator’s Manual, Maintenance Instructions, and Warranty.

b. On-site training to four (4) primary operators at time of installation and complete on-site training with all technicians using the instrument within 12 months of installation.

c. Train two primary operators per analyzer per contract year at the contractors training site at no additional cost to the Government. Training shall include costs of lodging, travel, food, teaching staff and training handouts. Travel costs shall not exceed the current JTR/JFTR. Travel benefits shall be provided in-kind (rather than in cash). All training shall be provided in English.

d. All training manuals/guides, instructional literature, and any other related written/electronic material in English. Training shall include basic operation of the analyzers, troubleshooting

Maintenance, Repair, Service, and Support

a. The Contractor shall perform preventive maintenance services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

b. The contract is inclusive of all costs for the performance of scheduled periodic maintenance (as required by the instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

c. The Contractor shall provide the following

i. Upon analyzer failure between 0800-1600 Central European Time (CET) Monday-

Friday, the Contractor’s qualified service technician to be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement) within 24 hours.

ii. The Contractor shall repair the equipment to be operational within 48 hours of the initial response by the Contractor.

d. The Contractor shall provide

iv. Should both analyzers become inoperable, the Contractor’s qualified service technician shall be on-site within four hours of initial notification and the repair of at least one instrument completed within one working day.

v. While both analyzers are inoperable, the Contractor shall arrange transport of critical specimens to a College of American Pathologists (CAP) accredited clinical laboratory of their choice within Germany along with the retrieval of hardcopy patient results by express courier.

vi. The selected laboratory shall provide patient reports in English that include reference ranges for the test performed. The Contractor is responsible for costs associated with this service. If both analyzers remain inoperable for three days, a replacement analyzer shall be provided, validated, and installed at the Contractor/Vendor’s expense.

e. The Contractor shall provide

iv. Same day customer service and support for emergency service requirements.

v. A service hotline with English menu options and English-speaking technical support staff available to assist operators in correcting equipment operation problems.

vi. A service hotline available Monday through Friday, 0800-1600 Central European Time

Reagents and Supplies

Contractor shall provide

b. All reagents to be maintained on-board once opened (removing and refrigeration between runs shall not be required for stated shelf-life).

c. The shelf-life for onboard reagent to be a minimum of 48 hours for PT, APTT, Fibrinogen and D- Dimer.

d. Reagent packs to be changeable without requiring additional calibration or QC.

e. Reagent and QC material to be supplied for at least one year without lot changes.

f. Reagents to have a minimum shelf-life of three (3) months upon receipt by the Government.

Salient Characteristics

Contractor provided equipment shall meet all salient characteristics.

(End of Extended CLIN Description)

a. All instruments, methods, controls and reagents supporting the following assays shall be FDA approved

i. D-Dimer

1. The D-dimer test shall be FDA approved for the exclusion of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

ii. Prothrombin Time (PT) with International Normalized Ratio (INR)

iii. Activated Partial Prothrombin Time (APTT)

iv. Fibrinogen

b. The fibrinogen method shall have at least 50 laboratories in the College of American Pathology (CAP) Proficiency Testing program; the D-Dimer, PT, INR, and APTT assays shall have at least 500.

c. All sample, calibrator, and QC dilution shall be performed automatically.

d. Minimum throughput shall be 50 samples per hour.

e. Shall have a STAT interrupt capability, i.e. in-situ prioritization of STAT samples.

f. Shall allow for continuous loading of samples and reagents while running.

g. Shall be capable of handling all specimen tubes sizes, including pediatric and micro containers.

h. Shall be capable of producing results within 10 minutes of sample loading for the PT, APTT, Fibrinogen, or D-Dimer assays.

i. Shall be capable of automated handling of closed tubes (e.g. cap-piercing).

j. Shall be equipped with an uninterruptible power supply capable of powering the analyzer and data management system for >20 minutes.

k. The electrical requirement shall be compatible with German electrical infrastructure: 220VAC at

50Hz.

l. Onboard storage shall have capacity for at least 20 refrigerated reagents

m. On-board reagents and QC material shall be temperature controlled sufficient to meet stability requirements

n. Instrument dimensions including all accessories shall fit within a 1.5 square foot area.

2. Data Management Systems

a. Shall include a bidirectional interface compatible with DoD medical informatics systems including the Composite Health Care System (CHCS).

b. All system displays and support literature shall be in English

c. Shall include an integrated (i.e. internal) bar code reader for samples, reagents, and QC material.

d. Shall manage and store at least 1,000 patient results and quality control data.

e. Shall include a printer and produce hard copy patient reports.

f. Shall provide Levey-Jennings graphs and be capable of applying Westgard quality control result decision rules in real-time. The user shall have the ability to quickly and simply select the rules to

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

(a) The Government will issue a purchase resulting from this request for quote (RFQ) to the responsible quoter whose quote conforming to the RFQ is the best value to the Government, price and other factors considered.

Issuance of purchase order will be made using the lowest price technically acceptable (LPTA) source selection process. The following factors shall be used to evaluate quotes:

Factor 1 - Technical: The quoter shall submit a written quote which explains how to comply with the requirements in the RFQ:

Subfactor 1: Installation, Validation, and Regulatory Compliance

a. The Quoter shall provide a capability statement to provide the installation and initial validation in accordance with the CLIA/NCCLS guidelines to include

iii. normal range verification

iv. linearity and limits of quantitation (reportable range)

v. correlation with current methods/instruments

vi. validation of analytical measurement range (AMR)

vii. validation of precision and accuracy

viii. establishment of initial control ranges

b. The Quoter shall provide a statement to confirm to provide all reagents, controls, calibrators, and linearity materials for initial validation. Initial validation studies shall be performed on-site by the Contractor or appropriate Subcontractor.

Subfactor 2: Training

The Quoter shall provide a statement to confirm to provide

a. At least two paper and two digital copies of the Operator’s Manual, Maintenance Instructions, and

Warranty.

b. On-site training to four (4) primary operators at time of installation and complete on-site training with all technicians using the instrument within 12 months of installation.

c. Train two primary operators per analyzer per contract year at the contractors training site at no additional cost to the Government. Training shall include costs of lodging, travel, food, teaching staff and training handouts. Travel costs shall not exceed the current JTR/JFTR. Travel benefits shall be provided in-kind (rather than in cash). All training shall be provided in English.

d. All training manuals/guides, instructional literature, and any other related written/electronic material in English. Training shall include basic operation of the analyzers, troubleshooting

Subfactor 3: Maintenance, Repair, Service, and Support

a. The Quoter shall provide a statement to confirm to perform preventive maintenance services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

b. The Quoter shall provide a statement to confirm that the provided quote is inclusive of all costs for the performance of scheduled periodic maintenance (as required by the instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

c. The Quoter shall provide a statement to confirm to provide the following

i. Upon analyzer failure between 0800-1600 Central European Time (CET) Monday-

Friday, the Contractor’s qualified service technician to be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement) within 24 hours.

ii. The equipment shall be repaired and operational within 48 hours of the initial response by the Contractor.

d. The Quoter shall provide a statement to confirm to provide

vii. Should both analyzers become inoperable, the Contractor’s qualified service technician shall be on-site within four hours of initial notification and the repair of at least one instrument completed within one working day.

viii. While both analyzers are inoperable, the Contractor shall arrange transport of critical specimens to a College of American Pathologists (CAP) accredited clinical laboratory of their choice within Germany along with the retrieval of hardcopy patient results by express courier.

ix. The selected laboratory shall provide patient reports in English that include reference ranges for the test performed. The Contractor is responsible for costs associated with this service. If both analyzers remain inoperable for three days, a replacement analyzer shall be provided, validated, and installed at the Contractor/Vendor’s expense.

e. The Quoter shall provide statement to confirm to provide

vii. Same day customer service and support for emergency service requirements.

viii. A service hotline with English menu options and English-speaking technical support staff available to assist operators in correcting equipment operation problems.

ix. A service hotline available Monday through Friday, 0800-1600 Central European Time

Subfactor 4: Reagents and Supplies

Quoter shall provide statement to confirm to provide

b. All reagents to be maintained on-board once opened (removing and refrigeration between runs shall not be required for stated shelf-life).

c. The shelf-life for onboard reagent to be a minimum of 48 hours for PT, APTT, Fibrinogen and D-

Dimer.

d. Reagent packs to be changeable without requiring additional calibration or QC.

e. Reagent and QC material to be supplied for at least one year without lot changes.

f. Reagents to have a minimum shelf-life of three (3) months upon receipt by the Government.

Subfactor 5: Salient Characteristics

Quoter shall provide statement of conformance that the quoted equipment meets all salient characteristics.

a. All instruments, methods, controls and reagents supporting the following assays shall be FDA approved

i. D-Dimer

1. The D-dimer test shall be FDA approved for the exclusion of Deep Vein

Thrombosis (DVT) and Pulmonary Embolism (PE).

ii. Prothrombin Time (PT) with International Normalized Ratio (INR)

iii. Activated Partial Prothrombin Time (APTT)

iv. Fibrinogen

b. The fibrinogen method shall have at least 50 laboratories in the College of American Pathology (CAP) Proficiency Testing program; the D-Dimer, PT, INR, and APTT assays shall have at least 500.

c. All sample, calibrator, and QC dilution shall be performed automatically.

d. Minimum throughput shall be 50 samples per hour.

e. Shall have a STAT interrupt capability, i.e. in-situ prioritization of STAT samples.

f. Shall allow for continuous loading of samples and reagents while running.

g. Shall be capable of handling all specimen tubes sizes, including pediatric and micro containers.

h. Shall be capable of producing results within 10 minutes of sample loading for the PT, APTT, Fibrinogen, or D-Dimer assays.

i. Shall be capable of automated handling of closed tubes (e.g. cap-piercing).

j. Shall be equipped with an uninterruptible power supply capable of powering the analyzer and data management system for >20 minutes.

k. The electrical requirement shall be compatible with German electrical infrastructure: 220VAC at

50Hz.

l. Onboard storage shall have capacity for at least 20 refrigerated reagents

m. On-board reagents and QC material shall be temperature controlled sufficient to meet stability requirements

n. Instrument dimensions including all accessories shall fit within a 1.5 square foot area.

2. Data Management Systems

a. Shall include a bidirectional interface compatible with DoD medical informatics systems including the Composite Health Care System (CHCS).

b. All system displays and support literature shall be in English

c. Shall include an integrated (i.e. internal) bar code reader for samples, reagents, and QC material.

d. Shall manage and store at least 1,000 patient results and quality control data.

e. Shall include a printer and produce hard copy patient reports.

f. Shall provide Levey-Jennings graphs and be capable of applying Westgard quality control result decision rules in real-time. The user shall have the ability to quickly and simply select the rules to

EVALUATION STANDARDS. The quoter’s technical quote will be evaluated using the following standards for a final rating:

ACCEPTABLE: A quote that meets the Government’s technical requirements identified in the Request for Quotation.

UNACCEPTABLE: A quote that fails to meet the Government’s technical requirements identified in the Request for Quotation.

Factor 2 - Price: The Government will issue a Purchase Order to the vendor who submits a quote that has lowest evaluated price, which is technically acceptable. All Contract Line Item Numbers (CLINS) must be priced by the quoter. If the quoter failed to price all CLINs, the quote will not be considered for issuance of a Purchase Order.

Paragraph (b) is hereby replaced with the following:

(b) Options. The Government will evaluate quotes for issuance of purchase order 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.

Paragraph (c) is hereby replaced with the following:

(c) A quote is not an offer and, consequently, cannot be accepted by the Government to form a binding contract.

Therefore, issuance by the Government of an order in response to a supplier’s quote does not establish a contract. The order is an offer by the Government to the supplier to buy certain supplies or services upon specified terms and conditions. A contract is established when the supplier accepts the offer.

Paragraph (d) is hereby added:

(d) The word "quoter" shall be substituted for the word "offeror" wherever it appears in FAR 52.212-3, Alternate I and DFARS 252.212-7000.

(End of provision)

(End of Summary of Changes)