W91YTZ24Q0093-0001.pdf

W40M MRCO EAST

MEDICAL READINESS CONTR OFFICE EAST

POC: FRANK A. WHORTON

6000 MACARTHUR BLVD

BETHESDA MD 20816

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 correct the ordering period to a 4-year period from 1 October 2024 through 30 September 2028.

1. CONTRACT ID CODE PAGE OF PAGES

1 7

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

16C. DATE SIGNED

BY 04-Sep-2024

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 W91YTZ24Q0093

X 9B. DATED (SEE ITEM 11)

30-Aug-2024

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

04-Sep-2024

CODE

W40M MRCO EAST

MEDICAL READINESS CONTR OFFICE EAST

9275 DOERR ROAD BLDG 1221

FORT BELVOIR VA 22060-5580

W91YTZ 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W91YTZ

FACILITY CODECODE

EMAIL:TEL:

W91YTZ24Q0093

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

BLANKET PURCHASE AGREEMENT

BPA Master Dollar Limit: TBD BPA Call Limit: TBD Period of Performance: 01-Oct-2024 to 30-Sep-2028 (Adjusted according to award date) PSC Codes: 6550

BLANKET PURCHASE AGREEMENT

Between

And

United States Department of Defense Medical Readiness Contracting Office – East

BLANKET PURCHASE AGREEMENT (BPA)

TERMS AND CONDITIONS

ORDERS WILL BE MADE BY PLACING CALLS FOR ITEMS REQUIRED. PAYMENT WILL BEMADE FOR

ITEMS RECEIVED. PAYMENT WILL BE MADE VIA WIDE AREA WORK FLOW (WAWF).

1. BLANKET PURCHASE AGREEMENT (BPA)

This agreement is established in accordance with Federal Acquisition Regulation (FAR) Part 13, Subpart 13.303, Blanket Purchase Agreements (BPAs). This Blanket Purchase Agreement (BPA) is entered into on the date in Block 3 of the form 1155 and shall be effective 01-Oct-2024 to 30-Sep-2028 (date to be adjusted according to award date) unless sooner cancelled in writing by either party. This Blanket Purchase Agreement has a five year ordering period.

The BPA will be reviewed by the Contracting Officer at least once annually before the anniversary of the effective date, and revised to conform to all requirements of Statutes, Executive Orders, and the FAR as these changes occur.

Any revision shall be evidenced by a modification to this BPA.

Pricing will be reviewed by the contractor and the customer prior to the end of each 12 month term of the agreement, in order to assess potential price adjustments based on actual volumes achieved during the year.

There are no funds available for this BPA. Funds will be made available and the Government will only be obligated for payment upon issuance of valid orders placed against this BPA. The Government is only obligated to the extent of authorized orders made against the BPA.

2. DESCRIPTION OF AGREEMENT

Contractor shall provide Coagulation Testing System in accordance with the attached Statement Of Work (SOW).

3. PRICING

Part Number

Description Unit of Measure Estimated Annual

Quantity

Price

Glucose Testing Strips (1,800 test strips per case)

Case 50

Glucometer Control Solution 1, (1 bottle per package)

Each 600

Control Solution 3, StatStrip (1 bottle per package)

Each 600

Extended Meter Warranty Each 40

Any changes to established pricing in this BPA will be submitted in writing to the Contracting Administrator, Frank Whorton frank.a.whorton.civ@health.mil and cc Rebecca Ruff @ rebecca-lynn.m.ruff.civ@health.mil . Activity will be charged established pricing until a modification is done to adjust pricing on the BPA.

4. DELIVERY TICKETS:

All shipments under this BPA shall be accompanied by a delivery ticket that contains the following information:

Name of supplier BPA Number and CALL Number Date of request Request Number Itemized list of services performed Quantity, unit price, and extension of each item, less applicable discounts (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided that the invoice is itemized to show this information).

Date of Performed Services

5. INVOICES/PAYMENTS:

The contractor shall create a separate invoice for each call. Invoices shall include, at minimum, the information stated under “Delivery Tickets”, above.

Invoice payments will be made via Wide Area Work Flow (WAWF). The contractor shall submit invoices for calls placed by authorized callers to the attention of the ordering individual who will verify material and services receipt and process payments.

5.1 QUARTERLY REPORTS:

Authorized ordering individuals shall submit monthly call reports no later than the 5th business day of each month to:

Medical Readiness Contracting Office - East E-mail: frank.a.whorton.civ@health.mil and cc rebecca-lynn.m.ruff.civ.@mail.mil

6. INDIVIDUALS AUTHORIZED TO PLACE CALLS/CALL LIMITATION:

Individuals authorized to place purchases/calls under this agreement are identified by the Medical Readiness Contracting Office - East (MRCO-E) and is identified by name, organization component and dollar limitation per call for each individual authorized to place purchases/calls as follows:

NAME ACTIVITY SINGLE PURCHASE LIMIT

TO BE DETERMINED PRIOR TO AWARD

Calls placed by individuals not on the list are “not” authorized and shall not be honored by the contractor. Supplies provided by the contractor in violation of this authorization will be treated as an unauthorized commitment and may result in termination of this agreement by the Government. Changes in the authorized ordering individual list shall require the signature of the Administering Contracting Cell: MRCO-E Payment for calls placed against subject Blanket Purchase Agreement will be made through (WAWF).

7. PLACEMENT OF ORDERS (CALLS):

Orders shall be placed by authorized personnel as calls against this BPA via FAX, mailed order, telephonically (with written follow-up).

NAME ACTIVITY SINGLE PURCHASE LIMIT

TO BE DETERMINED PRIOR TO AWARD

8. NUMBERING OF PURCHASES/CALLS PLACED UNDER THIS AGREEMENT

Each order under this agreement, paid by WAWF shall be assigned a call number with a prefix. The prefix X will be used for all calls placed under this BPA. Numbers will consist of three numeric characters, i.e., 001, 002, 003, etc., therefore call numbers will read, for example, X001, X002, X003 etc.

9. TERMS AND CONDITIONS:

9.1. CONTRACTOR RESPONSIBILITIES

9.1.1. Contractor shall provide Blood Glucose Analyzer Supplies and Incidental Service for 40 Glucose Analyzer meters in accordance with the attached Statement Of Need (SON).

COMBINED SYNOPSIS

The Medical Readiness Contracting Office – East, intends to solicit, negotiate, and award a Single-Award Blanket Purchase Agreement (BPA) for Blood Glucose Analyzer Supplies and Incidental Service for 40 Glucose Analyzer meters at Eisenhower Army Medical Center, Fort Eisenhower, GA as listed in the BPA Agreement Statement of Need. Proposals shall conform to the requirements of Addendum to 52.212-1 and FAR 52.212-1 Instructions to Offerors. Award will be made in accordance with Addendum to FAR 52.212-2 and FAR 52.212-2 Evaluation – Commercial Items.

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This requirement is being solicited as unrestricted. This solicitation is a request for quote (RFQ).

The ordering period for the BPA will be a 4-year ordering period. The NAICS Code is 325413.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-06 (as of 29 Aug 24). Interested persons may identify their interest and capability to respond to the requirement and submit proposals. All proposals received after the date of publication of this synopsis will be considered by the Government.

Questions concerning this acquisition may be addressed frank.a.whorton.civ@health.mil and cc rebecca-lynn.m.ruff.civ@health.mil no later than 03 Sep 2024, 11:00 AM Eastern. Submit proposals via email ONLY to frank.a.whorton.civ@health.mil and cc rebecca-lynn.m.ruff.civ@health.mil no later than 09 Sep 2024 @ 11:00 AM Eastern. No telephonic requests will be honored.

Clauses and provisions throughout this solicitation can be viewed by accessing website www.acquisition.gov. All offerors are cautioned that if selected for award, they must be registered with the System for Award Management (SAM) program. The SAM can be accessed via the internet at https://www.sam.gov/portal/public/SAM/.

Confirmation of SAM registration will be validated prior to awarding a contract.

Vendors shall include a completed copy of FAR provision 52.212-3 Alt 1, Offeror Representations and Certifications with their offer. Offerors shall include a confirmation of receipt of any amendments to this solicitation. Failure to submit a confirmation could result in the offer being determined non- responsive. Clause 2-4 Contract Terms and Conditions—Commercial items, applies to this acquisition to include any applicable addenda.

STATEMENT OF NEED

Statement of Need Glucometer Supplies and Incidental Services

1. Introduction:

The Point of Care Testing (POCT) section located within the Department of Pathology at Dwight D.

Eisenhower Army Medical Center (DDEAMC) is seeking a Blanket Purchase Agreement for glucometer supplies and an instrumentation warranty necessary to conduct patient care testing throughout the agency.

Glucometer supplies include reagents, quality control and/ or calibration material, glucometer strips and consumables.

2. Background:

On September 30, 2024, the current POCT supply and instrument warranty contract will expire. DDEAMC currently has over twenty (20) POCT sites established throughout the organizational footprint. POCT capabilities enable healthcare providers and staff to conduct immediate, qualitative assessments of patient glucose levels. Such capabilities enable healthcare providers and staff to implement expedited treatment options toward critically ill patient populations. POCT instrumentation, reagents, and consumables shall be FDA approved for POCT of critically ill patient populations. Requested supplies and consumables shall be delivered in the amounts specified within a week of ordering to sustain POCT workload/ healthcare service demands.

Shipped reagents and consumables shall have expiration dates no less than six (6) months from the delivery date. The reagents shall function properly, passing all lot-to-lot tests. Calibration material and quality controls shall function properly and test within the ranges established by the manufacturer.

3. Minimum Requirements / Specifications / Salient Characteristics:

The vendor shall provide the needed reagents to perform correlation, precision, carry-over and validation studies throughout the period of performance of this agreement and for all newly added tests on manufacturer-supplied and/ or third-party assays. All reagents, consumables and studies shall meet guidelines recommended by the FDA, Clinical Laboratory Standards Institute (CLSI), College of American Pathologists (CAP), and Clinical Laboratory Improvement Amendments (CLIA). All supplied reagents, consumables, glucose strips and quality control material shall be compatible for clinical use with forty (40) Government-owned NovaBiomedical StarStrip Glucose meters.

4. Delivery Terms:

Deliveries shall be at 300 East Hospital Road, Fort Eisenhower, GA 30905. Deliveries shall be made during normal hours of operation, Monday through Friday, 0800 – 1600hrs, except for weekends and/ or during scheduled, recognized federal holidays.

Recognized Federal Holidays:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

5. Training: N/A

6. Documentation:

The contractor shall provide two (2) up-to-date copies of the operating manual and two up-to-date or current (2) copies of the service manual

7. Installation: N/A

8. Inspection and Acceptance:

Inspection and acceptance of deliverables shall be performed by the Government personnel at the Government Facilities.

9. Commercial Extended Warranty / Maintenance Service:

1. The contractor shall provide a service warranty for all Government-owned glucometers (40) and accessories which include glucometer docking stations and carrying cases. The vendor shall provide available customer service resources that are available 24/7/365. This warranty shall include a full scope of instrumentation repairs and instrument replacements. Instrument replacements shall be made available to the agency within 48 hours of submitted request from end users. The vendor shall be responsible for all instrument repairs on-site within 24 hours of submitted request when applicable. When applicable, on-site repairs will be performed during normal agency hours of operation, Monday through Friday, 0800-1700hrs, except on weekends or recognized federal holidays.

2. Government owned glucometers shall maintain ability to alert users for values outside the normal range and/ or critical range, maintain pass-code capabilities, maintain ability to lockout unauthorized users, allow patient identification to be entered manually or through the use of a barcode scanner, be readily capable of performing testing on different sample types without operator intervention selecting venous, capillary, neonatal, or arterial sample types, capable of compensating for hematocrit or temperature, be capable of performing barcodes scans on quality control reagents/ consumables, test strips, and patient identification using alpha/ numeric data entry with an overall testing time of less than ten (10) seconds, be capable of testing specimens and providing plasma-like values, provide consistent and accurate results with correlations to laboratory devices with an r value >/= 0.90: linear regression with a positive slope at or near 1.00; bias of 95% of individual results from POCT devices should agree within +/-15% of lab devise. The minimum acceptance criteria for accuracy as stated by ISO 15197; 95% of the individual glucose results shall fall within 15mg/dl of the manufacturer’s measurement procedure at glucose concentrations less than 75 mg/dl and within 20% of glucose concentration greater than or equal to 75mg/dl. Instruments shall maintain a reportable range of 10-600mg/dl, not be affected by maltose, xylose, oxygen or hematocrit interferences or limitations. Instruments shall be capable of correlating with plasma-like reference samples.

Glucometers shall maintain capability to utilize data management software to identify and lockout any unauthorized user who has been identified by the Pathology department, determine date of user competency and lockout users that have exceeded the prescribed time period, lockout users attempting to utilize the glucometer without acceptable current liquid/ external quality control material, lockout users attempting to use reagents/ quality control material with lot numbers not approved for use, be customizable for site specific testing, provide patient and quality control data for electronic review purposes, support other manual test result entry (as applicable) through the use of the meter itself as an entry interface into the Military Health System – Genesis (MHS-G).

Estimated Annual Usage

Part Number Description Unit of Measure Quantity

Glucose Testing Strips (1,800 test strips per case)

Case 50

Glucometer Control Solution 1, (1 bottle per package)

Each 600

Control Solution 3, StatStrip (1 bottle per package)

Each 600

Extended Meter Warranty Each 40

(End of Summary of Changes)