36C26023Q0862.docx
DOCX document 194 KB Posted
- Attached to
- 6640--CPRR TESTS FOR A1C HEMOGLOBIN INSTRUMENTS AND REAGENTS Amendment to extend Federal contract opportunity
- Solicitation number
- 36C26023Q0862
About this file
This is a solicitation from the Department of Veterans Affairs for cost per reportable test (CPRR) services for hemoglobin A1c testing instruments and reagents at the VA Portland Health Care System. Key details include:
-
The contractor shall provide all equipment, reagents, supplies, and services required to perform hemoglobin A1c testing via contractor-owned analyzers. The contract is a base year plus four option years.
-
The contractor must meet technical requirements for the analyzer including throughput, quality control, and interfacing capabilities. Reagents must be provided with expiration dates of at least three months.
-
The contractor is responsible for maintenance, repairs, upgrades, training, waste characterization, and completing a transition period for the services. Pricing is on a per test basis for reported results.
-
The solicitation response date is September 7, 2023. The contract award will be made to the responsible offeror whose proposal is most advantageous based on price and technical evaluation factors.
View the file
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| 36C26023Q0862_1.docx | DOCX document |
On GovTribe
Work with this file on GovTribe
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
36C26023Q0862
PAGE 1 OF
1. REQUISITION NO.
2. CONTRACT NO.
3. AWARD/EFFECTIVE DATE
4. ORDER NO.
5. SOLICITATION NUMBER
6. SOLICITATION ISSUE DATE
a. NAME
b. TELEPHONE NO. (No Collect Calls)
8. OFFER DUE DATE/LOCAL
TIME
9. ISSUED BY
CODE
10. THIS ACQUISITION IS
UNRESTRICTED OR
SET ASIDE:
% FOR:
SMALL BUSINESS
HUBZONE SMALL
BUSINESS
SERVICE-DISABLED
VETERAN-OWNED
SMALL BUSINESS
WOMEN-OWNED SMALL BUSINESS
(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED
SMALL BUSINESS PROGRAM
EDWOSB
8(A)
NAICS:
SIZE STANDARD:
11. DELIVERY FOR FOB DESTINA-
TION UNLESS BLOCK IS
MARKED
SEE SCHEDULE
12. DISCOUNT TERMS
13a. THIS CONTRACT IS A
RATED ORDER UNDER
DPAS (15 CFR 700)
13b. RATING
14. METHOD OF SOLICITATION
RFQ
IFB
RFP
15. DELIVER TO
CODE
16. ADMINISTERED BY
CODE
17a. CONTRACTOR/OFFEROR
CODE
FACILITY CODE
18a. PAYMENT WILL BE MADE BY
CODE
TELEPHONE NO.
UEI:
EFT:
PHONE:
FAX:
17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED
SEE ADDENDUM
19.
20.
21.
22.
23.
24.
ITEM NO.
SCHEDULE OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA
26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA
ARE
ARE NOT ATTACHED.
27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA
ARE
ARE NOT ATTACHED
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________
29. AWARD OF CONTRACT: REF. ___________________________________ OFFER
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND
DATED ________________________________. YOUR OFFER ON SOLICITATION
DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY
(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE
ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED
SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:
30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED
AUTHORIZED FOR LOCAL REPRODUCTION
(REV. NOV 2021)
PREVIOUS EDITION IS NOT USABLE
Prescribed by GSA - FAR (48 CFR) 53.212
7. FOR SOLICITATION
INFORMATION CALL:
STANDARD FORM 1449
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
648-23-4-1360-0071
08-30-2023 Tyrone Whalen 360-553-7671 09-07-2023 11:00
PDT
36C260 Network Contracting Office 20
ATTN: V4CONT
1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661
X
325413 1250 Employees
N/A
Department of Veterans Affairs Portland VA Medical Center 3710 NW US Veterans Hospital Road
Portland OR 97239 36C260 Network Contracting Office 20
ATTN: V4CONT
1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661
Dept of Veterans Affairs
FMS-VA-2(101)
Financial Services Center
PO BOX 149971
Austin TX 78714-9971
See CONTINUATION Page
a. Location: Portland VA Medical Center.
b. Supplies Being Solicited: CPRR Tests for A1C Hemoglobin Instruments and Reagents.
c. This is a Base Plus Four Option Years Purchase Order.
Base Year: 09/27/2023 - 09/26/2024 Option Year One (1): 09/27/2024 - 09/26/2025 Option Year Two (2): 09/27/2025 - 09/26/2026 Option Year Three (3): 09/27/2026 - 09/26/2027 Option Year Four (4): 09/27/2027 - 09/26/2028
d. Please see the Continuation Pages below for details regarding the submission of quotes, E.1 52.212-1.
e. For further information, please contact Tyrone Whalen at Tyrone.Whalen@va.gov.
See CONTINUATION Page x
Jose Ronstadt
Table of Contents
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 3 |
| B.1 CONTRACT ADMINISTRATION DATA | 3 |
| B.2 PRICE/COST SCHEDULE | 4 |
| ITEM INFORMATION | 4 |
| B.3 DELIVERY SCHEDULE | 5 |
| SECTION C - CONTRACT CLAUSES | 14 |
| C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022) | 14 |
| C.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989) | 20 |
| C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) | 20 |
| C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) | 20 |
| C.5 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) | 20 |
| C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) | 21 |
| C.7 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018) | 22 |
| C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 22 |
| C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JUN 2023) | 23 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 32 |
| SECTION E - SOLICITATION PROVISIONS | 33 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAR 2023) | 33 |
| E.2 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) | 37 |
| E.3 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022) | 38 |
SECTION B - CONTINUATION OF SF 1449 BLOCKS
B.1 CONTRACT ADMINISTRATION DATA
1. Contract Administration: All contract administration matters will be handled by the following individuals:
a. CONTRACTOR:
b. GOVERNMENT: Contracting Officer 36C260 Network Contracting Office 20
ATTN: V4CONT
1601 E. Fourth Plain Blvd Bldg.17, Suite B428 Vancouver WA 98661
2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:
| [X] |
| 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or |
| [] |
| 52.232-36, Payment by Third Party |
3. INVOICES: Invoices shall be submitted in arrears:
| a. Quarterly | [] |
| b. Semi-Annually | [] |
| c. Other | [x] MONTHLY |
4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.
ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
| AMENDMENT NO |
| DATE |
B.2 PRICE/COST SCHEDULE
ITEM INFORMATION
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/ |
SERVICES
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 45,600.00 |
| EA |
| __________________ |
| __________________ |
COST PER REPORTABLE TESTS D-100 CPR Billing.
Contract Period: Base POP Begin: 09-27-2023 POP End: 09-26-2024
| 45,600.00 |
| EA |
| __________________ |
| __________________ |
COST PER REPORTABLE TESTS D-100 CPR Billing.
Contract Period: Option 1 POP Begin: 09-27-2024 POP End: 09-26-2025
| 45,600.00 |
| EA |
| __________________ |
| __________________ |
COST PER REPORTABLE TESTS D-100 CPR Billing.
Contract Period: Option 2 POP Begin: 09-27-2025 POP End: 09-26-2026
| 45,600.00 |
| EA |
| __________________ |
| __________________ |
COST PER REPORTABLE TESTS D-100 CPR Billing.
Contract Period: Option 3 POP Begin: 09-27-2026 POP End: 09-26-2027
| 45,600.00 |
| EA |
| __________________ |
| __________________ |
COST PER REPORTABLE TESTS D-100 CPR Billing.
Contract Period: Option 4 POP Begin: 09-27-2027 POP End: 09-26-2028
| GRAND TOTAL |
| __________________ |
B.3 DELIVERY SCHEDULE
| ITEM NUMBER |
| QUANTITY |
| DELIVERY DATE |
| 0001 |
| SHIP TO: |
| Department of Veterans Affairs |
VA Portland Health Care System 3710 SW US Veterans Hospital Road Portland, OR 97239
USA
45,600.00
45,600.00
45,600.00
45,600.00
45,600.00
STATEMENT OF WORK FOR COST PER TEST RESULT A1C
1) SCOPE:
Contractor shall provide all equipment, reagents, standards, supplies, consumable/disposable items, parts, accessories, and any other item required for the proper operation of the contractor owned analyzers and peripherals for the generation of hemoglobin A1c testing cost per test/reportable result (CPRR) services on behalf of VA Portland Hospital Care System Pathology and Laboratory Medicine. The VA Portland Health Care System currently leases a Bio-Rad D-100 for the testing of whole blood for Glycohemoglobin(A1c). The lease is based on cost per tests and includes all reagents, calibrators, supplies, and instrument service required to run this assay.
2) DEFINITIONS:
Cost Per Test (CPT): Contractors shall provide a price for each patient, QC and survey sample test that can be performed on its equipment. The per test price shall include costs covering (a) equipment use, (b) all reagents, calibrators, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of a patient test result, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs), (d) training for Government personnel, and (e) cost of shipping and handling of all reagents, calibrators, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of test results. Contractors shall provide delivery, installation and removal of equipment at no additional charge.
3) GENERAL REQUIREMENTS:
Clinical laboratory analyzer for Glycohemoglobin (Hemoglobin A1C) testing instrument shall be capable of producing accurate and reproducible assays on EDTA whole blood specimens by established in vitro diagnostic methods. The A1c result shall provide accurate test assay result for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.
a) Time for analyses must be less than 50 seconds per sample.
b) Offered equipment shall be new equipment. Remanufactured and discontinued models will not be accepted.
d) The awarded contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. These enhancements shall be delivered and installed at the medical facility within 60 days of issuance to the commercial market.
e) An operator’s manual shall be furnished with each instrument supplied to VA and updates to manual shall be provided in a timely manner.
f) Editable electronic copy in CLSI (Clinical and Laboratory Standards Institute) format of operating procedures and related training and maintenance documents shall be furnished with each instrument supplied to the VA.
g) System must be certified by the National Glycohemoglobin Standardization Program (NGSP).
h) All proposed equipment must fit the existing tabletop space at the facility, without the need for renovation work. Small scale re-arrangement of furniture is acceptable. Fitting existing space shall include conforming to the current structural parameters of each lab, in each facility, in terms of delivery, installation and lab space. (i.e. equipment size, weight, packaged size for delivery, electrical/voltage).
i) Clinical Laboratory assays currently performed at the facility shall include, but may not be limited to the following assays.
i. Glycohemoglobin (Hemoglobin A1C).
j) Pricing: The (CPT) Per Test shall include all costs for:
i. Equipment use, reagents, calibrators, microvials, consumable/disposable items, parts, accessories and any other items required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of a patient test result.
ii. All necessary maintenance to keep equipment in manufacturer’s operating conditions, both preventive maintenance, and emergency repairs.
iii. Training for facility personnel operating equipment.
k) The awarded contractor shall provide delivery, installation, set-up, validation and method comparison, including all supplies provided by the vendor, and decontamination, packaging and removal of equipment at completion of this agreement at no additional charge to the Government.
4) SYSTEM REQUIREMENTS
The instrument testing for Glycohemoglobin (Hemoglobin A1C) shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below
a) Meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA), the Clinical and Laboratory Standards Institute (CLSI), and the National Glycohemoglobin Standardization Program (NGSP).
b) System shall have a Coefficient Variation (CV) of less than 2.5%
c) A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.
d) Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric.
e) Smart consumables - RFID technology used on all consumables: cartridge, prefilter, buffers and washes. Chip contains lot #, expiration date, open vial stability information, used & remaining tests, set values, etc.
f) STAT area available.
g) Automated specimen handling/loading system.
h) No requirements for sample pre-treatment unless sample dilution required for acceptable total peak area count result.
i) Minimal reagent preparation
j) Minimal Maintenance
k) Ability to store and transmit records (at least 24 hours of instrument throughput) in case of interface outage.
l) On board reagent stability sufficient to accommodate both high and medium volume use. Contractor to provide expiration dates of at least three (3) months for reagents.
m) Capability to store at least two years or 100,000 patient results in database for immediate recall.
n) Instrument must be approved by the Food and Drug Administration (FDA) and shall have the following:
i. Ability to monitor instrument performance.
ii. On Board reagent inventory system.
iii. Minimal carryover.
iv. High volume cartridge for 10,000 tests requires only 1 calibration. Calibrators reconstituted automatically by the system.
v. Redundant buffers & wash on-board. Buffers and wash can be changed while the system is running.
vi. Result review automation/auto-verification functionality with on-board Advisor software:
a. review chromatography
b. flag normal vs abnormal results
c. allow for batch result releasing
d. eliminate the need for printing results individually
e. standardize result review across operators
vii. Automatic sample repeat without operator intervention when rule triggered.
viii. System must use ion-exchange high performance liquid chromatography (HPLC) method.
ix. Complete separation of the labile and stabile hemoglobin A1C.
x. Methodology that provides no interference from common hemoglobin (Hb) variants, including Hb AS, AC, AD and AE
xi. Able to detect and report HbA1c in the presence of Hemoglobin F, up to 30% HbF.
xii.Able to detect and report HbA1c in the presence of Hemoglobin A2.
o) A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.
p) Software allows run to stop if calibration or QC fails - avoids loss of an entire run.
q) Direct primary tube sampling from blood collection tubes. Must be cap piercing and require no pretreatment. Must read the barcode of each sample. Can perform off line dilution if required (i.e. short draws or pediatric tubes)
r) Analyzer needs to detect low reagent volumes and alert end-user through software.
s) Probe detects bottom of patient sample tube in order to optimize whole blood sampling.
t) QC requirements – 2 levels of QC every 24 hours
u) Calibration must be easily performed and must maintain stability on the analyzer between calibrations. Calibrators must be traceable to a recognized national standards organization as stated by the Clinical and Laboratory Standards Institute (CLSI) and/or College of Clinical Pathology (CAP).
v) Capability to detect out of range quality control.
w) Remote support capability with secure software is available with VA approval.
x) On- board QC data management system with a minimum storage capacity of 4 QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data
y) Time for analyses must be less than 45 seconds per sample 80 samples per hour.
5) INTERFACE REQUIREMENTS
The C&A requirements do not apply, and a Security Accreditation Package is not required. The system should have the capability to interface with lab information system. There is no plan to interface the instrument at this time.
6) CONSUMABLE/REAGENT REQUIREMENTS
a) All consumable supplies (reagents, standards, disposables, parts, accessories, etc.) required for the proper operation of the contractor's equipment and necessary to perform tests on the equipment shall be included.
b) In the event that the consumables are found to be defective and unsuitable for use with the contractor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the respective Lab Facility, Pathology and Laboratory Medicine Department, in the most expeditious manner possible, without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the contractor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory may result in default.
c) The contractor shall maintain on Government provided space a continuously stocked inventory of calibrators, reagents, supplies, disposables, parts, accessories, and any other material required to properly perform tests on the offered equipment. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO).
d) Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. Do we provide all startup material? The Contractor shall perform, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all 6 of the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format.
7) MAINTENANCE, REPAIR AND UPGRADE REQUIREMENTS
a) With the exception of the specific maintenance and repair requirements stated herein, which shall have precedence; preventive maintenance, emergency repair, maintenance credit for equipment malfunction, and replacement laboratory equipment shall be performed and provided in accordance with the terms, conditions, and provisions of contractor's existing Federal Supply Service Contract.
i) 14. PM every 30,000 tests done by contractor.
b) Equipment repair response time shall be no more than 24 hours Monday-Friday.
c) Emergency repairs shall be performed after initial telephone notification that the equipment fails any parameters. The contractor shall provide the Government with a designated point of contact and telephone number and shall make arrangements to enable his maintenance representative to receive such notification. The contractor shall be on-site at the facility to perform emergency repair service within twenty-four (24) hours after receipt of initial telephone notification of a malfunction.
d) Contractor shall provide technical support service to assist in troubleshooting and provide maintenance coverage Monday through Friday excluding holidays, 8:00am – 5:00pm MT.
e) In addition to above the contractor shall furnish a malfunction incident report to the installation upon completion of each repair call. The report shall include, as a minimum, the following:
i. date and time notified;
ii. date and time of arrival;
iii. serial number, type and model number(s) of equipment;
iv. time spent for repair;
v. description of malfunction and repair; and
vi. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance and any other testing as needed.
f) During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 5% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the using facility to replace the initial laboratory equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance manufacturer’s instruction, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 95% in each month of the term of the agreement.
g) The contractor shall not leave a service call open pending verification that repairs are completed by the contractor’s maintenance personnel. For each instrument provided the contractor shall treat each notification for an emergency/repair service call from the Government as a separate and new service call.
h) The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement applies to “system upgrades” that enhance the models of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade due to significant changes in the hardware operational capability, upgrade offered to commercial customers at no additional charge, upgrade to replace models of equipment no longer Contractor supported.
8) TRAINING REQUIREMENTS
a) On-site training and key operator training shall be provided.
b) The Contractor shall provide an ongoing on-site instrument training program that is coordinated with and timely to the equipment installation to cover operation of the system, data manipulation, and basic trouble shooting and repair.
c) A training program that involves off-site travel shall be paid for by the contractor and shall include the cost of airfare, transportation, room and board for 1 government participant.
9) CHARACTERIZATION OF WASTES
a) Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results.
b) Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.
c) The determination and description shall address the following:
i. Waste Toxicity
ii. Waste Ignitability
iii. Waste Corrosivity
iv. Waste Reactivity
v. Hazardous waste from non-specific sources (F-listed)
vi. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed)
vii. Solid Waste
viii. Exclusions
d) The contractor shall provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.
e) Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review.
f) At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response: Please include TOTALS for each i) – xv).
i. Barium
ii. Cadmium
iii. Chromium
iv. Copper
v. Lead
vi. Mercury
vii. Nickel
viii. Silver
ix. Zinc
x. Arsenic
xi. Selenium
xii. Tin
xiii. pH
xiv. Flash point (to higher than 200F)
xv. BOD; biochemical oxygen demand
g) The documentation the contractor provides shall be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system
10) TRANSITION PERIOD:
a) Upon award of the contract, the transition period for the awarded contractor to have all A1C Hemoglobin equipment and peripherals installed at the effected facility shall be 60 calendar days after award. During this same period all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed.
b) No later than 90 calendar days after award, the contractor shall have completed full transition of all services under this agreement to include all correlation studies, validations, etc., and shall have full and sole responsibility for equipment, supplies and services under the awarded contract.
c) Billing by Contractor starts on the first day of patient testing after all installation, training, and method validations have been completed and accepted in writing by the Contract Specialist (no later than 90 calendar days from time of award). At this time, the awarded contractor shall have completed full transition of all equipment, supplies and services under this agreement and shall have full and sole responsibility for equipment, supplies and services under the awarded contract.
11) TERMS AND CONDITIONS:
a) Contractor shall provide all equipment, supplies and services in accordance with the terms and conditions stated herein for the participating medical facility.
b) If, for any reason, a contractor ceases testing of any A1C Hemoglobin assays, the contractor must notify the VA contracting officer or equivalent 60 days prior to the assays being discontinued. Until a new solicitation can be issued or the problem resolved, the contractor shall be held liable for all costs if performance is ceased, as the lab facility may have to resort to outsourcing the tests in order to continue patient care.
| DESCRIPTION |
| ITEM NUMBER |
| QTY |
| IFCAP |
| COST |
| Calibrator Pack |
| 290-1006 |
56378
| Prefilter (5 per package) |
| 290-1007 |
56372
| Elution buffer A |
| 290-1010 |
56373
| Elution buffer B |
| 290-1011 |
56374
| Wash Solution |
| 290-1012 |
56375
| Sample Diluent |
| 290-1009 |
56376
| Microvials (100 per package) |
| 1200-0243 |
56377
| Analytical Cartridge/Calibrator Pack |
| 290-1004 |
56371
| Cleaning Tube |
| 290-1008 |
56379
| Sample Probe |
| 12000182 |
Estimated Quantities to run tests
45,600
Page 1 of Page 1 of
SECTION C - CONTRACT CLAUSES
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)
(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—
(1) Within a reasonable time after the defect was discovered or should have been discovered; and
(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.
(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.
(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.
(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.
(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.
(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.
(g) Invoice.
(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—
(i) Name and address of the Contractor;
(ii) Invoice date and number;
(iii) Contract number, line item number and, if applicable, the order number;
(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;
(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;
(vi) Terms of any discount for prompt payment offered;
(vii) Name and address of official to whom payment is to be sent;
(viii) Name, title, and phone number of person to notify in event of defective invoice; and
(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.
(x) Electronic funds transfer (EFT) banking information.
(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.
(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.
(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.
(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.
(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.
(i) Payment.—
(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.
(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.
(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.
(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.
(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—
(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—
(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);
(B) Affected contract number and delivery order number, if applicable;
(C) Affected line item or subline item, if applicable; and
(D) Contractor point of contact.
(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.
(6) Interest.
(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.
(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.
(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—
(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;
(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or
(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).
(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.
(v) Amounts shall be due at the earliest of the following dates:
(A) The date fixed under this contract.
(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.
(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—
(A) The date on which the designated office receives payment from the Contractor;
(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or
(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.
(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.
(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:
(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or
(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.
(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.
(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.
(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.
(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.
(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.
(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.
(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.
(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 4701 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.
(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:
(1) The schedule of supplies/services.
(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;
(3) The clause at 52.212-5.
(4) Addenda to this solicitation or contract, including any license agreements for computer software.
(5) Solicitation provisions if this is a solicitation.
(6) Other paragraphs of this clause.
(7) The Standard Form 1449.
(8) Other documents, exhibits, and attachments
(9) The specification.
(t) [Reserved]
(u) Unauthorized Obligations.
(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:
(i) Any such clause is unenforceable against the Government.
(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.
(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.
(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.
(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.
(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
The following clauses are incorporated into 52.212-4 as an addendum to this contract:
C.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)
The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within . Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.
(End of Clause)
C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)
The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within .
(End of Clause)
C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)
(a) The Government may extend the term of this contract by written notice to the Contractor within ; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least days before the contract expires. The preliminary notice does not commit the Government to an extension.
(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.
(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.
(End of Clause)
C.5 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)
(a) Definitions. As used in this clause—
(1) Contract financing payment has the meaning given in FAR 32.001;
(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;
(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;
(4) Invoice payment has the meaning given in FAR 32.001; and
(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.
(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.
(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:
(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.
(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).
(d) Invoice requirements. Invoices shall comply with FAR 32.905.
(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for—
(1) Awards made to foreign vendors for work performed outside the United States;
(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;
(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;
(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or
(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.
(End of Clause)
C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)
The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.
(End of Clause)
C.7 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)
Shipment of deliverable items, other than reports, shall be to:
Department of Veterans Affairs Portland VA Medical Center 3710 NW US Veterans Hospital Road
Portland OR 97239 (End of Clause)
C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):
https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/
(End of Clause)
| FAR Number |
| Title |
| Date |
| 52.203-17 |
| CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS |
| JUN 2020 |
| 52.204-7 |
| SYSTEM FOR AWARD MANAGEMENT |
| OCT 2018 |
| 852.239-75 |
| INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE |
| FEB 2023 |
| 52.204-16 |
| COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING |
| AUG 2020 |
PLEASE NOTE: The correct mailing information for filing…
This is the start of the file's text. The full file is on GovTribe.
File details come from the government source that posted it. Updated .