03. SOW-SPECS GPA IHS ABG_2025_dj.pdf

STATEMENT OF WORK (SOW)

RapidPoint 500e®Arterial Blood Gas (ABG) Analyzers

1. Scope of Work

Contractor shall provide to the Great Plains Area Indian Health Service, hereafter referred to as the GPA IHS, with the services/items described in this statement of work, and the referenced quotes/terms & conditions provided by the contractor for the period, and at the location(s), specified.

This Cost Per Reportable Result Firm Fixed Price contract aims to provide GPA IHS with RapidPoint 500e blood gas analyzers, along with necessary reagents, consumables, and service support, to be delivered to the five GPA IHS hospitals listed in the table below:

Facility Address

Cheyenne River Health Center 24276 166th Street, Airport Rd. Eagle Butte, SD. 57625 Phone 605-964-7724

Pine Ridge Hospital

P.O. Box 1201, East Highway 18, Pine Ridge, SD 57770 Phone 605-867-5131

Rosebud Comprehensive Health Care Hospital

P.O. Box 400, 400 Soldier Creek Dr. Rosebud, SD 57570 Phone: 605-747-2231

Standing Rock Service Unit

10 Standing Rock Avenue, P.O. Box J, Fort Yates, ND 58538 Phone: 701-854-3831

Turtle Mountain Service Unit Quentin N. Burdick Memorial Health Care Facility

Moonlight Drive Highway 5, Belcourt, ND 58316 Phone (701) 477-6111

2. Background

Three GPA IHS hospitals use the RapidPoint 500e as their blood gas analyzer. The GPA IHS plans to standardize the blood gas analyzers across all five GPA IHS hospitals in the region to take advantage of volume discounts, facilitate reagent sharing, and simplify training processes. Maintaining laboratory operations relies on support from personnel service contracts, and many contractors move between facilities within the GPA IHS system depending on the start and end dates of these contracts.

Using standardized equipment reduces the time required for training, allows contractors to integrate more effectively into laboratory teams, and enhances laboratory quality due to increased familiarity with the equipment. Additionally, standardization enables the area to benefit from volume discount pricing, which helps lower operating costs, especially during periods of budget scrutiny. Smaller hospitals benefit as well, as they can take advantage of the higher testing volumes of larger hospitals rather than facing higher prices for conducting tests at lower volumes. By performing tests on the same model, healthcare providers can compare patient results from another GPA IHS hospital and know that the results are equivalent.

The RapidPoint 500e performs automatic quality control every eight hours, freeing laboratorians from manually conducting quality control checks at each shift.

3. Requirements/Services to Be Provided:

a. General Requirement:

i. Placement, replacement, service and maintenance of specific Siemens Blood Gas Analyzers, associated hardware items, and delivery of specified reagents, controls and other consumables to the GPA IHS facilities listed above.

ii. The contractor shall be able to have the five (5) RapidPoint® 500e Blood Gas Systems delivered to the GPA IHS facilities (Attachment B) within 30 days from the date of contract award in order to facilitate systems testing prior to beginning work.

SUBJECT: SOW – RapidPoint 500e®Arterial Blood Gas (ABG) Analyzers

iii. A listing of the estimated yearly quantity is provided under this agreement located in Attachment A (Test Volume). Quantities listed in the attachment are estimates based upon prior history of actual volumes and are intended to provide the potential contractor a basis for calculating their pricing. They are not a guaranteed minimum.

iv. The pricing shall be based on new equipment. Remanufactured or used models will not be accepted. The contractors’ offered blood gas analyzer/system(s) must conform to the facility’s existing space.

v. The analyzers must meet the test volume in Attachment A and match or improve the turnaround time requirements. The system should streamline all aspects of testing, thereby improving efficiency and productivity of the using facility.

vi. The contractor shall provide the facility with Food and Drug Administration (FDA) approved analyzers, reagents, controls, calibrators, linearity material, disposables, any consumable part necessary for analyzing/testing on the analyzer. Contractor shall list the consumable parts provided. Contractor shall state any parameter/function that is pending FDA approval at the time of the submission.

4. Orders:

All products ordered under this BPA are issued by Task Orders/Delivery Order and placed by the individual service unit. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the Task Order/Delivery Orders issued by authorized individuals.

a. The minimum guarantee in the amount of $1,000.00 is to be awarded as the first Task Order/Delivery Order concurrent with contract award. Upon issuance of a Task Order/Delivery Order, the minimum guarantee of $1,000 will be de-obligated and cannot be invoiced as the minimum guarantee was met with award of a Task Order/Delivery Order. In the event a Task Order/Delivery Order is not awarded on this contract, the contractor is entitled to invoice for the minimum guarantee of $1,000.

b. Specifications: See Attachment C

5. System Requirements:

a. The desired blood gas instrumentation must have the capability of performing and/or reporting the following parameters on arterial, venous, or mixed venous whole blood specimens:

1. pH 2. pO2 3. pCO2 4. Base Excess

5. Bicarbonate 6. TCO2 7. Oxygen Saturation 8. Co-Oximetry

b. In addition, the analyses must take place on a single instrument and a single specimen. The instrument shall be able to perform the complete profile described above discretely by either direct or indirect (calculated) measurement and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the National Committee for Clinical Laboratory Standards (NCCLS).

c. The contractor shall provide the facility, for the duration of the contract, with all reagents, controls (both blood gas and co-oximetry), calibrators, disposables, any consumable part (inclusive of replacement parts per manufacturers maintenance guidelines, aspiration devices, etc.), necessary for analyzing/testing to produce a patient result. All linearity material and any commercial system correlation samples needed may be provided to meet TJC requirements.

d. Contractor must provide a printer and all thermal paper for generating paper copy of results, and provide a replacement printer as needed.

e. Contractor shall specify calibration frequency of one point, two point, and system calibrations in accordance with regulatory requirements. The system must alert the operator of a calibration drift.

f. Contractor must provide on-board commercial quality control for every twenty-four hours of operation to include: three levels for blood gases and three levels for co-oximetry to be analyzed on each analyzer at the facility.

g. The system must have a sampling system that can aspirate directly from a syringe or an evacuated blood collection tube and can accommodate any sample type without any additional adapter devices. The sampling system must have the capability of walk away processing that negates the need for additional instrument prompting. The contractor must also state the sample size required for patient testing.

h. The sampling system must immediately alert the operator that a sample is not positioned properly, there is insufficient sample quantity, and have early clot detection that alerts the operator to the suspected existence of a fibrin clot in the specimen. The contractor must define the methodology for clot detection.

i. The system must have ready to use reagents that have on board stability greater than or equal to 25 days. Contractor shall list all reagents needed for blood gas/chemistry/co-oximetry analysis, the format/size of the reagents, and if the supplies are stored at room temperature or refrigerated.

Contractor may state if reagents and controls are color-coded. Packaging should be maximized to accommodate the specimen volume at the facility and not require a frequent exchange of inventory on the equipment.

j. The system may provide reagent inventory, in real time that can be printed at selected time intervals for reagent documentation.

k. The system must be programmed to perform and execute auto quality control without operator intervention. Perform automatic corrective action on the system if the results of the quality control testing are not acceptable and have the ability to lock out/suppress a test if there are QC failures.

l. The contractor is to define the actual hands-on maintenance time required for daily, weekly, monthly, and as needed maintenance. The contractor is to include the analyzer time required to perform each maintenance task. Contractor must list which tasks are user level and which tasks are service level. Systems that use electrodes must have minimal maintenance, electrode replacement must be accomplished easily, and the new electrode must be operational within two hours of replacement. The analyzer may have on-board integrated maintenance and trouble-shooting procedures.

m. The contractor must provide a comprehensive QC program, provide QC for all tests listed in Attachment A and must provide the following options:

i. QC files may be edited or corrected for errors manually with/without password protection.

ii. Have on-board quality control data storage (for at least 90 days) and reporting capabilities.

iii. Ability to view/print daily, monthly QC results and Levy-Jennings graphs.

iv. Ability to visually alert the operator of QC (Westgard/user defined rules) failures.

v. Electronic transfer of QC Data to contractor without the need for manual entry.

vi. Automatic enrollment in a Quality Assurance program, (if available), that has peer participation of at least 50 participants. Reports of peer data will be current and available within 2-4 weeks of the data submission for hard copy review.

n. The contractor must supply equipment that performs satisfactorily at any laboratory relative humidity between 5 – 85% and any laboratory temperature between 15 – 30 degrees Celsius.

6. Instrumentation and Software:

a. The equipment shall include 120-volt UPS that has a 2–3-hour back-up capability for all analyzers. The contractor will be responsible for replacing the UPS should it become dysfunctional and provide battery replacement as needed.

b. The system will support multiple barcode formats including but not limited to Code 39, Code 128 and Codabar that may be enabled concurrently.

c. The system must accept at a minimum, a 10-character specimen identifier that is alphanumeric (letters and numbers).

d. The system must be able to store and retransmit records (24 hours of maximum instrument throughput) in case of interface downtime. The system may have the ability to edit sample/patient identifier after interface downtime and then be able to resend the sample/patient information to the host for verification.

e. The contractor must provide all upgrades to the equipment hardware, software, and operating systems without additional charge to the GPA IHS (e.g., upgrades that correct either a mechanical or software deficiency of the system). These enhancements to the contractor’s equipment shall be delivered and installed at the site within two months of their issuance or date of first commercial availability. The contractor will always maintain compatibility of systems with whatever host LIS is in place, especially when contractor software is upgraded.

f. The contractor must remove all equipment within 90 days of the expiration of the terms of this BPA but not until the completion of the new contractor’s equipment installation inclusive of completed cross over studies. The facility, per their protocol, will be responsible for the removal/erasing of the hard drive at analyzer removal/upgrade.

7. Installation:

a. The contractor shall list analyzer/utility requirements (electrical, water, plumbing, reagent and bio-hazardous disposal, temperature, humidity, etc.). The contractor shall provide weight and dimensions of proposed analyzers.

b. The contractor must indicate any routine and /or special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: paper, printer cartridges, drainage systems, surge suppressors, etc. Any items excluded by the contractor shall be delineated in their proposal. The cost of the excluded items must be incorporated in the price proposal.

c. The contractor shall provide the facility with all reagents, calibrators, control, and any cross-over supplies needed at installation and during training of staff. The contractor must pay all shipping costs for the analyzers and all supplies needed for the installation, correlation studies and training of staff. Test counts for billing will begin after all required studies, performed at installation of new equipment, are reviewed and approved.

d. At installation/set-up the contractor/technical support specialist shall perform all validation studies including installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy TJC standards), reference range studies, staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. The service must be available during regular office hours on a 5 days/week basis.

e. The contractor must provide equipment installation and possible reinstallation costs if the equipment is required to be moved due to construction or laboratory redesign.

f. The contractor will work with the facility to adjust reagent supply to match workload changes and to provide the option annually for the facility to adjust the shipment table. The contractor shall state what their policy is in regard to adjusting a standing order or ordering an additional shipment of supplies.

8. Training/Procedures:

a. The contractor shall provide all necessary procedure manuals, troubleshooting manuals, operator manuals, technical manuals for computer interfacing, SDSs, etc. (also available on computer disc).

Procedures must be in the Clinical and Laboratory Standards Institute (CLSI) format.

b. The contractor must provide on-site primary user training and provide competency training material for all users on all shifts.

9. Support Services:

a. The contractor must follow the manufacturers preventative maintenance schedule for the duration of the contract.

b. The contractor shall replace any analyzer that is provided during the terms of this BPA that has not been repaired to the workable satisfaction of the facility. Should the repair record of any individual analyzer/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 using facility to replace the initial laboratory analyzer/equipment with new analyzer. Each analyzer provided by the contractor shall maintain an uptime of 95% in each month during the terms of the agreement.

c. The contractor shall provide instrument support service sufficient to aid with troubleshooting and repair of the analyzers. The contractor must list their service options available. For any site that may encounter the rare occasion when primary and backup analyzers, if installed, are inoperable (service has now escalated to emergency status), service shall immediately dispatch a field service engineer for repair. Contractor is to explain their policy in relation to service if the occasion should occur when all analyzers are inoperable. The support service must follow-up all down calls within 1 hour. The FSR will always keep the facility informed of the timeline for when repairs are to be completed. All repairs on instrument must be completed (at no cost to the facility/clinic) within 24 hours from the time the field service engineer arrives.

d. The contractor will provide twenty-four hour/seven-day service hotline with technical support. All calls will be answered within one hour via telephone.

e. Service is to include all travel, parts for repair or replacement, and labor.

f. The contractor will pay all routine shipping fees for supplies, consumables, and equipment to perform testing at initial installation and with routine supply delivery.

g. If 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 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the contractor will deliver to the facility, in the most expeditious manner possible, without additional costs to the facility, the necessary consumable in sufficient quantity until the arrival of the standing order/routine supplies delivery.

h. The contractor must provide replacement parts and any components necessary for the operation of the instrument(s) to produce patient results.

10. Value Added Characteristics:

a. The contractor will provide replacement parts and any components necessary for the operation of the instrument(s) to produce patient results.

b. The system may have the ability for the electronic transfer of the manufacturer’s QC ranges to the instrument without the need for manual entry.

c. The system may have the ability to have on-board documentation for out-of-range quality control and instrumentation problems.

d. The analyzer may have onboard maintenance records that can be modified for additional user defined maintenance records and printed at selected time intervals for maintenance documentation.

e. The system may have a touch-screen interface in addition to the keyboard and mouse.

f. The contractor may provide on-site refresher training in renewal option years of the contract if so exercised. User also has the option of sending one additional staff member per analyzer for primary off-site training in renewal option years. Renewal option year training is to include all costs of off-site training, i.e., transportation (air and ground), room and board, etc.

g. The system may list additional parameters such as lactic acid, creatinine, blood urea nitrogen, etc.

that can be analyzed on a patient sample.

h. The system may have FDA approval for pH of other body fluids.

i. The system may have the ability to have on-board parallel QC lot capability, allowing for old and new lot QC to be run consecutively for validation for effective time management and accreditation compliance.

11. Other Terms and Conditions:

a. This shall be based on the Period of Performance:

i. Base Year: 1/1/2026 – 12/31/2026

ii. Option Year 1: 1/1/2027 – 12/31/2027

iii. Option Year 2: 1/1/2028 – 12/31/2028

iv. Option Year 3: 1/1/2029 – 12/31/2029

v. Option Year 4: 1/1/2030 – 12/31/2030

12. Salient Characteristics:

1. The blood gas system can analyze Whole Blood sample types: arterial, venous, mixed venous, and capillary.

2. The preferred analyzer has automatic quality control, can run three levels of control every 8 hours, or can be scheduled based on QC protocol.

3. The preferred system is a cartridge-based analyzer.

4. The preferred system has a reagent onboard stability greater than or equal to 25 days.

5. The preferred blood gas analyzer has an integrated 1D/2D bar-code scanner.

6. The preferred system has clot and air bubble detection.

7. The preferred system does not need adapters for proficiency testing.

8. The preferred system has a self-cleaning sample probe and is safely contained within the measurement cartridge to minimize operator exposure to biohazards.

9. The preferred system has a universal sampling port that requires only one sampling procedure, regardless of the syringe or capillary type and manufacturer.

10. The vendor should provide unlimited online user training.

11. A 24-hour online customer resource center and technical assistance center provided.

12. The analyzer shall have small footprint to allow installation on counter and prevent unnecessary construction.

ATTACHMENT A: Annual Volumes

Analyte Cheyenne River Pine Ridge Rosebud Standing Rock Turtle

Mountain

ABG 374 1685 1450 57 530

Co- Oximetry 19

ATTACHMENT B: Address and Core Business Hours

Facility Hours of Operation Cheyenne River Health Center 24276 166th Street, Airport Rd. Eagle Butte, SD. 57625 Phone 605-964-7724

24/7

Pine Ridge Hospital P.O. Box 1201, East Highway 18, Pine Ridge, South Dakota 57770 Phone 605-867-5131

24/7

Rosebud Comprehensive Health Care Hospital P.O. Box 400, 400 Soldier Creek Dr. Rosebud, South Dakota 57570 Phone: 605-747-2231

24/7

Standing Rock Service Unit 10 Standing Rock Avenue, P.O. Box J, Fort Yates, North Dakota 58538 Phone: 701-854-3831

Monday – Friday: 0800 a.m. .to 4:30 p.m.

On-Call: Monday – Friday: 4:30 p.m. to 8:00 a.m.

Saturday & Sunday: On-Call

Turtle Mountain Service Unit Quentin N. Burdick Memorial Health Care Facility Moonlight Drive Highway 5, Belcourt, North Dakota 58316 Phone (701) 477-6111

24/7

Attachment C

Equipment Information - Blood Gas Part # Onsite Quantity RP500e BLOOD GAS ANALYZER USA 11416751 N 4 RP500e BLOOD GAS ANALYZER USA 11416751 Y 1

UPS STANDARD 120V 10324789 N 4

UPS STANDARD 120V 10324789 N 1

Service Service Level Quantity Start Year # Of Years Comments

Warranty Service RAPIDPOINT 500e PLUS 4 1 2 Year(s) Included Warranty Service RAPIDPOINT 500e PLUS 1 1 8 Month(s) Included Extended Service RAPIDPOINT 500e PLUS AGREEMENT 1 13 36 Month(s) Included Extended Service RAPIDPOINT 500e PLUS AGREEMENT 4 3 3 Year(s) Included Extended Service RAPIDPOINT 500e PLUS 1 9 12 Month(s) Included

Products: Reagents Pricing - Blood Gas

Reagent Part # Total Tests / Yr. Total Kits / Yr.

MCART LAC 250 Test 1049144 19,500.00 78.00

Products: Supplies - Blood Gas Part # Annual # of Kits Total Annual

AQC CTL 10310323 78.00 Included CVM CTL 10316535 12.00 Included Hi Flow Air Filter - RP500 - CONS 10322638 6.00 Included Luer Capillary 10309073 18.00 Included Paper Printer Thermal 10315772 72.00 Included RapidQC 1 CTL 10309925 1.00 Included RapidQC 2 CTL 10309926 1.00 Included RapidQC 3 CTL 10309927 1.00 Included Wash/Waste Cart 4pk 10329097 60.00 Included