SOL Terms - Conditions - COBAS Pure c303 - e402 - ISE Classic Service.pdf

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

SANTA FE INDIAN HEALTH CENTER

SECTION 1: GENERAL:

1.1 SERVICES

1.1.1 The Indian Health Service (IHS), Albuquerque Area Office (AAO), Santa Fe Indian Health Center has a need for a COBAS Pure c303/e402/ISE, Classic Service, Calibrators, Consumables, Controls, Reagents for Laboratory Department, Santa Fe, NM.

1.1.2 The Government contemplates to award single award resulting from this solicitation.

1.2 PRICE OR COST

1.2.1 This solicitation will result in a Firm-Fixed-Price (FFP) contract acquisition with a Base and Four Option Year renewals.

1.3 GENERAL CONTRACT INFORMATION:

1.3.1 This is a non-personal service contract, as defined in Federal Acquisition Regulation (FAR) 37.101, a contract under which the personnel rendering the services are not subject, the contract’s terms or the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

1.3.2 As an independent Contractor; billing and collecting for the federal, state and other local city/county taxes is the burden of the Contractor, this includes the New Mexico Gross Receipt Taxes (NMGRT) for services provided in any county of the State of New Mexico.

1.3.3 The Contractor's price/cost for services under this contract should include all applicable taxes for Internal Revenue Service (IRS), State of New Mexico Taxation and Revenue agency and/or other revenue agencies. The Indian Health Service will not withhold taxes nor will it issue a W-2 to the contractor.

1.4 CONTRACT PRICE

1.4.1 This solicitation will result in an FFP contract. The price for this contract is $ (TBD)

1.4.2 Upon delivery and acceptance of the item(s) specified in the DELIVERY Article in SECTION F of this contract, the Government shall pay to the Contractor resulting from the awarded contract price.

1.4.3 Upon delivery and acceptance the services described in the Performance Work Statement (PWS) and identified in the schedule of charges below, the Government shall pay to the Contractor the total prices set forth below and will be paid from the following Contract Line Item Numbers (CLINs) accordingly:

SCHEDULE OF CHARGES FOR THE BASE PERIOD:

Item # Start End Total Amount

CLIN 1 BASE YEAR

TBD, 2023 – TBD, 2024

COBAS Pure c303/e402/ISE, Classic Service, Calibrators, Consumables, Controls, Reagents.

TOTAL FOR BASE YEAR: $

1.4.4 The Contractor shall be paid upon submission of an invoice and completion and acceptance (if deliverable) or verification (if service) by the Contracting Officer's Representative (COR), of the deliverables and/or services indicated below. Submit invoices in accordance with the instructions contained in FAR clause 52.232-25, Prompt Payment, and Section G.10 of this contract.

1.5 OPTION PRICES

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

1.5.1 Unless the Government exercises its option, pursuant to the option clause referenced in the Contract Clauses section, this contract consists only of the Base Period specified in this contract.

1.5.2 Pursuant to either the FAR Clause 52.217-8, Option to Extend Services or the FAR Clause 52.217-9, Option to Extend the Term of the Contract, set forth in Section I, Contract Clauses, of this contract, the Government may, a unilateral contract modification, require the Contractor to perform the Option Period(s) as defined in the PWS of this contract. A notice that the Government intends to exercise any of the options will happen prior to the contract’s expiration date. Specific information regarding the timeframe for this notice is set forth in the OPTION PROVISION of this order. When exercising an option period, the fixed price rate of this contract is set forth below.

1.5.3 Upon the delivery and acceptance of the Option Services described in the PWS of the contract and identified in the schedule of charges below, the Government shall pay the Contractor the unit price(s) set forth below and will be paid from the following Contract Line Item Numbers (CLINs) accordingly;

1.5.4 If the Government exercises its option pursuant to the OPTION PROVISION of this contract, the Government's total estimated contract amount, represented by the sum of the price of base plus option periods and the period of performance will be as follows:

SCHEDULE OF OPTION PERIODS:

Item # Start End Total Amount

CLIN 2 OPTION YEAR ONE:

TBD, 2024 – TBD, 2025

COBAS Pure c303/e402/ISE, Classic

TOTAL FOR OPTON YEAR ONE: $

Item # Start End Total Amount

CLIN 3 OPTION YEAR TWO:

TBD, 2025 – TBD, 2026

COBAS Pure c303/e402/ISE, Classic

TOTAL FOR OPTION YEAR TWO: $

CLIN 4 OPTION YEAR THREE

TBD, 2026 – TBD, 2027

COBAS Pure c303/e402/ISE, Classic

TOTAL FOR OPTION YEAR THREE: $

CLIN 5 OPTION YEAR FOUR

TBD, 2027 – TBD, 2028

COBAS Pure c303/e402/ISE, Classic

TOTAL FOR OPTION YEAR FOUR: $

1.5.5 Note: Unit price shall be an all-inclusive rate of all other fees including, state, federal, local taxes and miscellaneous cost associated with the above services.

1.5.6 PRICING

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

Offers provide COBAS Pure c303/e402/ISE, Classic Service, Calibrators, Consumables, Controls, Reagents for the specified Albuquerque Area Indian Health Service, Santa Fe Indian Health Center in the following format:

Discount Information

Description Value of Discount Over Term

Santa Fe IHS Svc Hosp cobas pure <c 303 | e 402> $0.00 cobas pure <c 303 | e 402> - CLASSIC $0.00

Equipment Freight $0.00

Monthly Standing Order Freight Up to $0.00

Value Adds

Description Value

# of

Units Value Over Term

Training Travel $0.00 2 $0.00 cobas pure c 303 | e 402 - Allowance for Ancillary Items Up to $0.00 1 Up to $0.00

Water System and Service Allowance Up to $0.00 1 Up to $0.00

Training $0.00 2 $0.00

Product Pricing

Reagents Material

Number Annual

Reportables Price per

Kit Tests per Kit Annual

Kits Annual Total

Clinical Chemistry

A1CX3, 200T, cobas c pack green 08445699190 539 $ 200 11 $

ALB2, 750T, cobas c pack green 08056692190 3,788 $ 750 7 $

ALBT2, 500T, cobas c pack green 08056722190 415 $ 500 3 $

ALP2, 1100T, cobas c pack green 08056757190 3,447 $ 1,100 6 $

ALTP , 450T, cobas c pack green 08056773190 3,469 $ 450 11 $

AMYL2, 750T, cobas c pack green 08056811190 28 $ 750 2 $

ASTP, 500T, cobas c pack green 08056838190 3,468 $ 500 9 $

BILT3, 1050T, cobas c pack green 08056960190 3,463 $ 1,050 8 $

CA2, 1500T, cobas c pack green 08057427190 3,913 $ 1,500 4 $

Cartridge CL 03246353001 3,949 $ 9,000 7 $

Cartridge K 10825441001 3,945 $ 9,000 7 $

Cartridge NA 10825468001 3,999 $ 9,000 7 $

CHOL2, 2600T, cobas c pack green 08057443190 5,023 $ 2,600 3 $

CK, 500T, cobas c pack green 08057460190 22 $ 500 7 $

CO2-L, 250T, cobas c pack green 08057494190 3,911 $ 250 22 $

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

Reagents Material

Number Annual

Reportables Price per

Kit Tests per Kit Annual

Kits Annual Total

CREAJ2, 2500T, cobas c pack green 08057532190 5,513 $ 2,500 3 $

CRP4, 500T, cobas c pack green 08057591190 116 $ 500 5 $

D BILI, 350T, cobas c pack green 08764760190 39 $ 350 26 $

ETOH2, 150T, cobas c pack green 08445672190 2 $ 150 1 $

GGT-2, 400T, cobas c pack green 08057796190 78 $ 400 5 $

GLUC3, 3300T, cobas c pack green 08057800190 4,135 $ 3,300 2 $

HDLC4, 350T, cobas c, Integra 07528566190 792 $ 350 6 $

LDL-C Gen.3, 200Tests, cobas c,Int 07005717190 892 $ 200 11 $

LIPC, 200T, cobas c pack green 08057982190 64 $ 200 13 $

MG2, 690T, cobas c pack green 08058016190 182 $ 690 2 $

NH3L2, 300T cobas c pack green 08058024190 14 $ 300 3 $

PHOS2, 750T, cobas c pack green 08058610190 3,693 $ 750 7 $

RF-II, 400T, cobas c pack green 08058628190 20 $ 400 2 $

TP2, 1050T, cobas c pack green 08058652190 109 $ 1,050 2 $

TRIGL, 1000T, cobas c pack green 08058687190 623 $ 1,000 2 $

UA2, 1300T, cobas c pack green 08058750190 60 $ 1,300 2 $

UREAL, 600T, cobas c pack green 08058806190 2,647 $ 600 7 $

Clinical Chemistry Total: $

Immunoassay

Ferritin Elecsys E2G 300 07027273190 92 $ 300 3 $

FT3 G3 Elecsys E2G 300 V2 09005811190 35 $ 300 4 $

FT4 G2 Elecsys cobas e 200 06437281160 94 $ 200 13 $ hCG STAT Elecsys E2G 100 V2 08890595190 13 $ 100 3 $ proBNP G2 Elecsys E2G 300 V2.1 09315284190 17 $ 300 3 $

PTH Elecsys E2G 300 07251068190 50 $ 300 3 $

T4 Elecsys E2G 300 V2 09007784190 8 $ 300 4 $

Total PSA Elecsys cobas e 100 V3 08791686160 11 $ 100 13 $

Troponin T Gen5 Elecsys E2G 300 V2 08469890160 8 $ 300 3 $

TSH Elecsys E2G 300 V2 08443432190 1,171 $ 300 8 $

Vitamin B12 G2 Elecsys E2G 300 07028121190 227 $ 300 3 $

Vitamin D total G3 Elecsys E2G 300 09038086190 376 $ 300 4 $

Immunoassay Total: $

Annual Estimated Total: $

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

Additional Committed Products

Materials Material Number Price per Kit Annual

Kits Annual Total

Total PSA Elecsys E2G 300 V2 08791732190 $ 1 $

Annual Estimated Total: $

Committed Product Pricing

Annual Committed Total: $

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

SECTION 2: DEFINITIONS:

2.1 Acceptance: Constitutes acknowledgement that the supplies or services conform to the applicable contract quality and quantity requirements, except as provided in FAR subpart 46.5 and subject to other terms and conditions of the contract.

2.2 Approval: Acknowledgment by the designated Government official that submittals, deliverables, or administrative documents (e.g., insurance certificates, installation schedules, planned utility interruptions, etc.) conform to the contractual requirements. Government approval does not relieve the Contractor from responsibility for compliance with contract requirements.

2.3 Area: A defined geographical region for Indian Health Service administrative purposes. Each Area Office may administer several Service Units.

2.4 Contracting Officer (CO): A Government employee with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.5 Contracting Officer's Representative (COR): A federal employee who assists the ordering/issuing activity-contracting officer in the administration of task orders issued under this contract. The COR is primarily responsible for the technical assistance and day-to-day program management of the ordering activity's task orders. Ordering activities may have different designators for this employee.

2.6 Contractor: The individual award a legal binding contract to provide supplies and services.

2.7 Customer: Staff of the IHS service unit and health center.

2.8 Customer Evaluation/Input: Written comments made to the COR regarding the Contractors performance. This is one of the criteria used to evaluate the Contractor's performance.

2.9 Dependability: Qualities of being trusted and being able to repeat the same task to yield the same result.

2.10 Federal Acquisition Regulation (FAR): The FAR is the primary regulation for use by all Federal Executive agencies in their acquisition of supplies and services with appropriated funds.

2.11 Indian Health Service Housing Units: A facility physically separated from a hospital, consisting of forty housing units with sheds/garages.

2.12 Non-Personal Services Contract: Contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.13 Ordering Activity: An authorized user of IHS that may issue a task order to obtain required services under this contract.

2.14 Outcome: End result.

2.15 Past Performance Information: Relevant information regarding a contractor's actions under previously awarded contracts.

2.16 Quality Assurance Surveillance Plan (QASP): A written document prepared and used by the government for Quality Assurance surveillance of the contractor's performance.

2.17 Service Contract: Is a contract that directly engages the time and effort of a contractor whose primary purpose is to perform an identifiable task rather than to furnish an end item of supply. A service contract may be either a non-personal or a personal contract. It can also cover services performed by either professional or nonprofessional personnel whether on an individual or organizational basis.

2.18 Service Unit: The local administrative unit of IHS.

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

SECTION 3 – GOVERNMENT-FURNISHED PROPERTY AND SERVICES:

3.1 The Government will provide the following item(s) of Government property to the Contractor for use in the performance of this contract. This property used and maintained by the Contractor in accordance with provisions of FAR Clause 52.245-1, Government Property.

No Government furnished property will be provided except for a parking location for the Mobile Mammography Unit during visits.

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

SECTION 4: CONTRACTOR-FURNISHED ITEMS:

4.1 The Contractor will provide Chemistry Testing: COBAS Pure c303/e402/ISE, Classic Service, Calibrators, Consumables, Controls, Reagents for Laboratory Department

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

SECTION 5 – REQUIREMENTS:

5.1 The contractor will provide a COBAS Pure c303/e402/ISE, Classic Service, Calibrators, Consumables, Controls, Reagents as follows:

5.1.1 Provide Santa Fe Indian Health Center clinical laboratory a main analyzer and a backup equipment to run all assays for Chemistry testing.

5.1.2 Provide adequate consumables, test reagents and other supplies to perform testing on equipment being provided.

5.1.3 Provide on a monthly basis and on an as-needed basis, reagents and consumables - frozen items will be shipped overnight, all other items will be shipped within a week from placement of order.

Delivery of items must adhere to manufacturer’s storage requirements from receipt of product to the supplier until receipt from consumer.

5.1.4 Provide on-site Validation and Calibration Verification (as required by CLIA if only two-point Calibration) for each analyte being performed on site for the initial install and every six months.

5.1.5 Reagents lots must have reasonable expiration dates, with availability of sequestered lots.

5.1.6 Provide technical support at no additional charge – this includes onsite support and any costs associated with replacement parts. Technical service must be provided within 24 hours, no more than 48 hours, after notification to Vendor technical support from an AAIHS facility with onsite support deployed no later than 48 hours after determination is made for need of onsite support.

5.1.7 Comply with all federal regulatory requirements as applicable and have an established quality assurance program to ensure the quality, storage, and handling of reagents.

5.1.8 Provide training as needed for new, on-going, or replacement operators. Training can be provided through onsite training, or through virtual platforms.

5.1.9 Service Requirements

5.1.9.1 Preventative Maintenance: The contractor will be responsible for ensuring preventative maintenance services and scheduling are in accordance with CLIA requirements.

5.1.9.2. Unscheduled Maintenance: The contractor will provide support services and be available for technical support calls at minimal between the hours of 7am – 7pm, M-F. The contractor will provide response to service calls no more than 24 hours after initial call is generated. The contractor will provide on-site support as needed, within 24 hours of call placement, at no additional cost to the government.

5.1.9.3 Service Reports: The contractor will provide service reports for all services performed to the Laboratory Supervisor, or Laboratory COR.

5.1.10 Data Management and Interfacing Requirements: The contractor will need to have a Business Partner Interconnection Security Agreement (BPISA) with Albuquerque Area Indian Health Service in place prior to award of contract. The contractor will provide the following information for any components included in the system setup, as applicable:

(1) MAC address

(2) IP address

(3) Windows Operation System

(4) Security software

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

5.1.11 Business Reporting Requirements: Provide annual business reports for Santa Fe Indian Health Center Facility to include information on total costs, annual volumes for use of reagents and consumable, total number of maintenance or services calls, summary report for scheduled/unscheduled service calls; this to include a high level summary of all labs. Reports should be made available to the Santa Fe Indian Health Center no later than February of the proceeding reporting year

5.1.12 Provide a Quality Management program for reporting of all Quality Controls Methods run on each analyzer.

5.1.13 Quality Control: Contractor should provide means of documentation to ensure proper installation of equipment and training of testing personnel in accordance with Federal requirements.

Contractor in accordance with Public Law 100-578, Section 353(c)(2), should perform studies and/or services on all equipment to be used in clinical settings. This includes but not limited to validation studies, correlation studies, preventative maintenance services, etc.

5.1.14 Records/Data: All testing and service records will be considered government property and will be retain in accordance with Federal, State, and Local regulations.

5.1.15 Deliverables and Reports: In addition to the applicable requirements, the contractor shall provide the following deliverables and reports:

• Service and Maintenance

• Training (initial, yearly thereafter)

• Quarterly Business Reports

5.1.16 Delivery Instructions: All deliverables shall be delivered to the client unless otherwise agreed upon.

5.2 Delivery Schedule: Will be between the hours of 8:00 am to 4:30 pm. There will be no scheduled work on weekends or Federal holidays. If there should be any change in normal working hours, this will be coordinate with the COR.

5.3 The Contractor must perform standards as listed in the Federal Code of Conduct.

5.4 Conditions of Contract Services:

5.4.1 Subpoenas/Testimonies:

Contractors are mandated to cooperate with the appropriate IHS managers when the contractors' employees are subpoenaed or requested by Tribal, State or Federal Parties to provide testimony.

As stated in Section 5-27.3(8)(9) of the Indian Health Manual.

5.5 Challenges to Conflicts - For any inconsistency between COR and Contractor's employee, this PWS follows this order of precedence:

a) First Priority: Contractor's Agency

b) Second Priority: COR

c) Third Priority: CO

5.6 When the Contractor demonstrates impaired judgement, they cannot continue working on the contract.

The Government reserves the right to remove from the facility any Contractor employee who in the judgment of a licensed healthcare practitioner is impaired.

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

SECTION 6 – QUALITY ASSURANCE SURVEILLANCE PLAN

Performance-Based Task Indicator Standard Quality Assurance Incentives

The contractor shall provide all requirements based on CLIA and accreditation guidelines for performance of Quality Laboratory Testing and as stated on the SOW.

Technical Factors/approached for Quality Testing performance.

Outstanding – 100% of Technical Work and Quality test perform and deficiency listings have been completed

Acceptable – 80 to 99% Satisfactory – of Technical Work and Quality test perform and deficiency listings have been completed

65 to 80% of Technical Work and Quality test perform and deficiency listings have been completed

Will be monitored on a periodic basis when services are being performed. Final determination will happen when jobs have been completed.

Outstanding - payment will not be held up.

Acceptable - payment could be held up depending the level of quality testing.

Satisfactory – payment will be held up until areas have been corrected.

Timeliness and scheduling of deliverable

Outstanding – 100% of reagent supplies/consumables, Validations studies and PM services are scheduled, delivered on a timely basis.

Acceptable – 80 to 99% of reagent supplies/consumables, Validations studies and PM services are scheduled, delivered on a timely basis.

Satisfactory – 65 to 80% of reagent supplies/consumables, Validations studies and PM services are scheduled, delivered on a timely basis.

Will be monitored based on ordering of supplies, scheduling of any PM requirements. Final determination will happen when all deliverables are completed.

Outstanding - payment will not be held up.

Acceptable - payment could be held up depending the level of acceptance

Satisfactory – payment will be held up until all deliverables are accepted without additional delays.

Cost

1. Fair and

Reasonable

2. Cost is accurate

3. Invoicing is timely and states only of what is delivered.

Outstanding – 100% of fair and reasonable and accurate

Acceptable – 80 to 99% of fair and reasonable and accurate

Satisfactory – 65 to 80% fair and reasonable and accurate

Will be monitored on a periodic basis when services are being performed. Final determination will be reviewed on invoice accuracy.

Outstanding - payment will not be held up.

Acceptable - payment could be held up depending on accuracy of invoice received.

Satisfactory – payment will be held up until areas have been

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE depending on accuracy of invoice received with any discrepancy noted as corrected.

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

SECTION 7 - PACKAGING AND MARKING

7.1 PACKAGING

All deliverables shall be preserved, packaged, and packed in accordance with normal commercial practices to meet the packing requirements of the carrier including which is necessary to prevent deterioration and damages due to the hazards of shipping, handling, and storing.

7.2 MARKING

Each package/container delivered to the address shown in Section G.10 entitled "Contracting Officers' Representative Appointment and Authority" and shall be clearly marked as follows:

• Name of Contractor

• Contract Number

• Description of Items Contained Therein

• Consignee's Name and Address

7.3 DELIVERY

All deliverables delivered to the following addresses:

Santa Fe Indian Health Center (SFIHC) Celeste Denipah, Acting Laboratory Supervisor Laboratory Department 1700 Cerrillos Road Santa Fe, NM87505

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

SECTION 8 - INSPECTION AND ACCEPTANCE

8.1 INSPECTION AND ACCEPTANCE: All work under this contract is subject to inspection and final acceptance by the Contracting Officer or the duly authorized representative of the government. The COR, as a duly authorized representative of the Contracting Officer, shall assume the responsibilities for monitoring the Contractor's performance, evaluating the quality of services provided by the Contractor and performing final inspection and acceptance of all deliverables and services called for by the contract.

8.2 FEDERAL ACQUISITION REGULATION {48 CFR CHAPTER 1) CLAUSES

FAR Clause No. Title Date 52.246-4 Inspection of Services – Fixed Priced (Aug 1996)

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

SECTION 9 - DELIVERIES OR PERFORMANCE

9.1 PERIOD OF PERFORMANCE: The period of performance is a Base Period of 12 months with four – 12-month Option Periods, unless extended by modification to this contract. The Government may exercise options to extend the period of performance in accordance with FAR Clause 52.217-9 - Option to Extend the Term of the Contract (Oct 2014); upon written notification by the Contracting Officer within 30 days of contract expiration.

The Federal Acquisition Regulation defines an unauthorized commitment as an agreement that is not binding solely because the government representative who made it lacked the authority to enter into that agreement on behalf of the government. Only contracting officers have the authority to make purchases or award contracts. Upon receipt and/or execution of any order placed for goods or services, the vendor shall verify that the Government Agent issuing the order has necessary authority to entire into the purchase order/contract. If it is determined that the vendor failed to do so, they may be held liable for future Unauthorized Commitments.

The following individuals will be the Government's points of contact during the performance of this Contract.

9.1.1 Services under this contract shall commence NLT 10 days after all clearances occur.

Base: TBD, 2023 to TBD, 2024 Option Year 1: TBD, 2024 to TBD, 2025 Option Year 2: TBD 2025 to TBD, 2026 Option Year 3: TBD, 2026 to TBD, 2027 Option Year 4: TBD, 2027 to TBD, 2028

9.1.2 Performance must be for the period of TBA, 2023 to TBA, 2024 unless the period changed by written modification to the purchase order in accordance with FAR 52.217-9, Option to Extend the Term of the Contract.

9.1.3 Total contract award must not exceed five years. Based option year renewals on satisfactory services provided availability of funds for the appropriate fiscal year, and existing requirements.

9.2 PLACE OF PERFORMANCE: The contractor must provide a COBAS Pure c303/e402/ISE, Classic Service, Calibrators, Consumables, Controls, Reagents to the following Albuquerque Area Indian Health Service Facility:

9.2.1 Santa Fe Indian Health Center

Attn: Celeste Denipah Laboratory Department 1700 Cerrillos Road Santa Fe, NM 98505

9.3 GOVERNMENT HOLIDAYS: (https://www.federalpay.org/holidays)*

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

*Any other day specifically declared by the President of the United States to be a national holiday (see www.opm.gov/fedhol).

http://www.opm.gov/fedhol

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

SECTION 10 - CONTRACT ADMINISTRATION

10.1 AUTHORITIES OF GOVERNMENT PERSONNEL: Notwithstanding the Contractor's responsibility for total management during the performance of this Contract, the administration of the Contract will require maximum coordination between the Government and the Contractor. The following individuals will be the Government's points of contact during the performance of this Contract.

10.2 CONTRACTING OFFICER

10.2.1 The IHS Contracting Officer (CO) is the only individual authorized to modify this Contract. The CO responsible for administrative and contractual issues concerning this Contract is:

Eric Wright, (CO) Indian Health Service/Division of Contracts & Grants Management (DCGM) 4101 Indian School Road NE, Suite 225 Albuquerque, NM 87110 Phone: 505-256-6752 Email: eric.wright@ihs.gov

Sent all communications pertaining to contractual and/or administrative matters to the address above and to the Contract Specialist administering this Contract.

10.3 CONTRACT ADMINISTRATOR

All Contract administration performed by:

Patricia Trujillo, Contract Specialist (CS) Indian Health Service/Division of Contracts & Grants Management (DCGM) 4101 Indian School Road NE, Suite 225 Albuquerque, NM 87110 Phone: 505-256-6754

Email: patricia.trujillo@ihs.gov

10.3 CONTRACTING OFFICER'S REPRESENTATIVE (COR)

10.4.1 Celeste Denipah, is hereby designated as COR for this service. The COR responsibilities will be to coordinate with the contractor the technical aspects of this service and the review of performance hereunder. The COR does not have the authority to change or alter the order amount, terms and conditions.

10.4.2 Keith Adcock, is hereby designated as the Alternate COR for this service. The Alternate COR responsibilities will be to help coordinate with the contractor the technical aspects of this service and the review of performance hereunder. The Alternate COR does not have the authority to change or alter the order amount, terms and conditions.

10.4.3 The COR and Alternate’s responsibilities will include ensuring contractor accountability. Monitoring the Contractor’s technical progress including the surveillance and assessment of performance and recommending to the CO changes in requirements. Interpreting the PWS. Performing technical evaluations as required. Perform technical inspection and acceptance as required. Assisting the Contractor in the resolution of technical problems encountered during performance. Perform receiving and processing invoices for payment.

10.4 TECHNICAL MONITORING

(a) Performance of work under this contract must be subject to the technical direction of the COR identified above, or an Alternate COR designated in writing. The term "technical direction" includes, without limitation, direction to the Contractor that directs or redirects the labor effort. Shifts the work between mailto:patricia.trujillo@ihs.gov

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE work areas or locations, fills in details and otherwise serves to ensure that task areas outlined in the PWS accomplished satisfactorily.

(b) Technical direction must be within the scope of the specification(s)/work statement. The COR does not have authority to issue technical direction that

(1) Constitutes a change of assignment or additional work outside the specification(s)/ statement of work;

(2) Constitutes a change as defined in the clause entitled "Changes";

(3) In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

(4) Changes any of the terms, conditions, or specification(s)/work statement of the contract;

(5) Interferes with the Contractor's right to perform under the terms and conditions of the contract; or

(6) Directs, supervises or otherwise controls the actions of the Contractor's employees.

(c) Technical direction may be oral or in writing. The COR shall confirm oral direction in writing within five work days, with a copy to the Contracting Officer.

(d) The Contractor shall proceed promptly with performance resulting from the technical direction issued by the COR. If, in the opinion of the Contractor, any direction of the COR, or his designee, falls within the limitations in (b), above, the Contractor shall immediately notify the CO no later than the beginning of the next Government work day.

(e) Failure of the Contractor and the CO to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled "Disputes."

10.5 INVOICE SUBMISSION

10.5.1 The Contractor shall submit invoice per order. Advance payments will not be issued by Finance unless stated herein. Upload complete invoice with all required documentation to: https://www.ipp.gov

*Please do not sent any copies to the CS or Finance Office for any invoices related documents such as deliverables, reports or balance statements). Failure to upload required documents directly to the website listed above will delay prompt payment of your invoice.

10.5.2 Additionally, the Contractor is required to include the Unique Entity Identifier (UEI) on each invoice.

For additional information about the UEI (hhtps://www.sam.gov).

10.5.3 Submit invoices in accordance with the contract terms, i.e. payment schedule, progress payments, partial payments, deliverables, etc.

10.5.4 All information set forth in FAR 32.905(b), Content of Invoices, must be included in all invoices for it to constitute a proper invoice.

FAR 32.905(b):

(b) Content of invoices.

(1) A proper invoice must include the following items (except for interim payments on cost reimbursement contracts for services):

(i) Name and address of the contractor.

(ii) Invoice date and invoice number. (Contractors should date invoices as close as possible to the date of mailing or transmission.)

(iii) Contract number or other authorization for supplies delivered or services performed (including order number and line item number).

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(iv) Description, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed.

(v) Shipping and payment terms (e.g., shipment number and date of shipment, discount for prompt payment terms). Bill of lading number and weight of shipment will be shown for shipments on Government bills of lading.

(vi) Name and address of contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment).

(vii) Name (where practicable), title, phone number, and mailing address of person to notify in the event of a defective invoice.

(viii) Taxpayer Identification Number (TIN). The contractor must include its TIN on the invoice only if required by agency procedures. (See 4.9 TIN requirements.)

(ix) Electronic funds transfer (EFT) banking information.

(A) The contractor must include EFT banking information on the invoice only if required by agency procedures.

(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 must have submitted correct EFT banking information in accordance with the applicable solicitation provision (e.g., 52.232-38, Submission of Electronic Funds Transfer Information with Offer), 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.

(x) Any other information or documentation required by the contract (e.g., evidence of shipment).

(2) An interim payment request under a cost-reimbursement contract for services constitutes a proper invoice for purposes of this subsection if it includes all of the information required by the contract.

(3) If the invoice does not comply with these requirements, the designated billing office must return it within 7 days after receipt (3 days on contracts for meat, meat food products, or fish; 5 days on contracts for perishable agricultural commodities, dairy products, edible fats or oils, and food products prepared from edible fats or oils), with the reasons why it is not a proper invoice. If such notice is not timely, then the designated billing office must adjust the due date for the purpose of determining an interest penalty, if any.

(4) Per the Accounts Payable office, failure to submit invoices to the Department of Accounting Services can result in delayed payment of your invoice.

In accordance with OMB Memorandum, M-11-32, Agencies shall make payments to small businesses as soon as practicable, with the goal of making payments within 15 days of receipt of a proper invoice. If a small business contractor is not paid within this (15 day) accelerated period, the contractor will not be given a late-payment interest penalty. Interest penalties, as prescribed by the Prompt Payment Act, remain unchanged by means of this memorandum. All small businesses shall label all invoices as "Small Business."

Additionally, in accordance with OMB Memorandum, M-12-16, fill prime contractors are encouraged to disburse funds received from the Federal Government to their small business subcontractors in a prompt manner. To assist prime contractors in expediting contractor payments to small business https://www.acquisition.gov/far/part-4#FAR_Subpart_4_9 https://www.acquisition.gov/far/part-52#FAR_52_232_38 https://www.acquisition.gov/far/part-52#FAR_52_232_33 https://www.acquisition.gov/far/part-52#FAR_52_232_34

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE subcontractors, Agencies shall, to the full extent permitted by law, temporarily establish an earlier, accelerated date for making agency payments to all prime contractors. Consistent with OMS Memorandum M-11-32 above, Agencies shall have a goal of paying all prime contractors within 15 days of receiving proper documentation. In an effort to support small business growth, drive economic activity and job creation, the Contractor is encouraged to accelerate payments to their small business subcontractors.

In accordance with the requirements of the Debt Collection Improvement Act of 1996, all payments under this contract will be made by electronic funds transfer (EFT). The Contractor shall provide financial institution information to the Finance Office designated above in accordance with FAR 52.232-33 Payment by Electronic Funds Transfer.

Failure to submit directly to the offices listed above will delay prompt payment of your invoice.

352.232-71 ELECTRONIC SUBMISSION OF INVOICE REQUESTS (FEB 2022)

(a) Definitions. As used in this clause- Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system.

Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. Unless otherwise agreed to by the contracting officer per HHSAR 352.232.71(c), the use of IPP shall take precedence over previously established invoicing procedures."

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

http://www.ipp.gov/

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

SECTION 11 - SPECIAL CONTRACT REQUIREMENTS

11.1 CONTRACTOR PERFORMANCE EVALUATION REPORT

11.1.1 During the life of this contract, the contractor's performance will be evaluated on an interim and final basis pursuant to FAR Subpart 42.15. Evaluation will become part of the contract file and will be used as past performance information in evaluating the Contractor's, and any significant subcontractors or affiliates, past performance on future contracts.

11.1.2 Contractor Performance Assessment Report System (CPARS) is an on-line reporting system https://www.cpars.gov/. The Contractor Performance Report is completed by the COR electronically and sent to the Contractor for review and approval at the end of each performance period as an interim report and at the end of the contract performance as a final report. After review by the Contracting Officer, the report becomes a permanent record of the Contractor's past performance.

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SECTION 12 - FEDERAL ACQUISITION REGULATIONS (FAR) 48 CFR CHAPTER CLAUSES

12.1 CLAUSES INCORPORATED BY REFERENCE - FAR 52.252-2 (FEB 1998)

This Contract incorporates FAR provisions/clauses referenced, 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 website address: FAR -https://www.acguisition.gov/far/index.html.

FAR Clause Title Date

52.204-7 System for Award Management (Oct 2018)

52.229-3 Federal, State, and Local Taxes (Feb 2013)

52.246-4 Inspection of Services – Fixed Price (Aug 1996)

Following Clauses in Full Text:

12.2 52.209-5 - CERTIFICATION REGARDING RESPONSIBILITY MATTERS (OCT 2015)

(a) (1) The Offeror certifies, to the best of its knowledge and belief, that—

(i) The Offeror and/or any of its Principals—

(A) Are □ are not □ presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency;

(B) Have □ have not □, within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State, or local) contract or subcontract; violation of Federal or State antitrust statutes relating to the submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating Federal criminal tax laws, or receiving stolen property (if offeror checks “have”, the offeror shall also see 52.209-7, if included in this solicitation);

(C) Are □ are not □ presently indicted for, or otherwise criminally or civilly charged by a governmental entity with, commission of any of the offenses enumerated in paragraph (a)(1)(i)(B) of this provision;

(D) Have □, have not □, within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds $3,500 for which the liability remains unsatisfied.

(1) Federal taxes are considered delinquent if both of the following criteria apply:

(i) The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if there is a pending administrative or judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted.

(ii) The taxpayer is delinquent in making payment. A taxpayer is delinquent if the taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is not delinquent in cases where enforced collection action is precluded.

(2) Examples.

(i) The taxpayer has received a statutory notice of deficiency, under I.R.C. § 6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(ii) The IRS has filed a notice of Federal tax lien with respect to an assessed tax liability, and the taxpayer has been issued a notice under I.R.C. § 6320 entitling the taxpayer to https://www.acguisition.gov/far/index.html

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE request a hearing with the IRS Office of Appeals contesting the lien filing, and to further appeal to the Tax Court if the IRS determines to sustain the lien filing. In the course of the hearing, the taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior opportunity to contest the liability. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek tax court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(iii) The taxpayer has entered into an installment agreement pursuant to I.R.C. § 6159. The taxpayer is making timely payments and is in full compliance with the agreement terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full payment.

(iv) The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under 11 U.S.C. 362 (the Bankruptcy Code).

(ii) The Offeror has o has not o , within a three-year period preceding this offer, had one or more contracts terminated for default by any Federal agency.

(2) “Principal,” for the purposes of this certification, means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

This Certification Concerns a Matter Within the Jurisdiction of an Agency of the United States and the Making of a False, Fictitious, or Fraudulent Certification May Render the Maker Subject to Prosecution Under Section 1001, Title 18; United States Code.

(b) The Offeror shall provide immediate written notice to the Contracting Officer if, at any time prior to contract award, the Offeror learns that its certification was erroneous when submitted or has become erroneous by reason of changed circumstances.

(c) A certification that any of the items in paragraph (a) of this provision exists will not necessarily result in withholding of an award under this solicitation. However, the certification will be considered in connection with a determination of the Offeror’s responsibility. Failure of the Offeror to furnish a certification or provide such additional information as requested by the Contracting Officer may render the Offeror non-responsible.

(d) Nothing contained in the foregoing shall be construed to require establishment of a system of records in order to render, in good faith, the certification required by paragraph (a) of this provision.

The knowledge and information of an Offeror is not required to exceed that which is normally possessed by a prudent person in the ordinary course of business dealings.

(e) The certification in paragraph (a) of this provision is a material representation of fact upon which reliance was placed when making award. If it is later determined that the Offeror knowingly rendered an erroneous certification, in addition to other remedies available to the Government, the Contracting Officer may terminate the contract resulting from this solicitation for default.

12.3 52.212-4 - CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL ITEMS

(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

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE 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.

http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_233_1 https://www.acquisition.gov/far/part-52#FAR_52_202_1

SOLICITATION #: 75H70723Q00090 COBAS PURE c303 / e402 / ISE

(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…