FULL AND OPEN - OCAO IHS CHEMISTRY ANALYZER COST PER TEST REQUIREMENT

Questions & Answers / Clarifications

This document provides responses to vendor questions regarding the solicitation, clarifying various aspects of the opportunity.

• Calcium Testing: Haskell location does perform calcium testing.
• Lab Layouts & Analyzer Fit: Specific lab dimensions are provided for smaller footprint labs (83.5" W x 33.5" D x 64.5" H) and larger footprint labs (110" W x 34.9" D x 68" H). The requirement for specific analyzer dimensions was deemed unduly restrictive, and the government will accept vendor assertion that analyzers will fit existing space, noting current sites house Siemens EXL analyzers.
• COVID Testing Methodology: The government confirms COVID testing is still desired on chemistry analyzers, though volumes may have decreased. They are interested in options for performing this testing on the platform.
• Pricing Model: The government confirms they are charging "Cost Per Test," which includes charging for patient testing, calibration, and QC testing.
• El Reno Volumes: Acknowledged mistake in SOW regarding El Reno volumes; updated counts were submitted.
• Thyroxine (T4) Volumes: T4 is no longer run by the system; the listed volumes were incorrect.
• Additional Assays: The government is interested in including Drugs of Abuse, Syphilis, Procalcitonin, Vitamin B12, and Vitamin D at the Lawton location.
• Immunoassay Tests: Vendors requested Immunoassay tests be preferred vs. required due to low site volumes. The government will keep TSH and FT4 in-house but is open to discussion.
• Wewoka Building: Lab specs reflect the current lab space, not the new building under construction.
• Training: Training will be "Offsite or onsite" for 2 operators (1 primary, 1 secondary).
• Water System: The requirement for in-line plumbing for a water system was deemed unduly restrictive, as only one vendor could meet it. The government acknowledges current analyzers have higher water utilization without issue.

These clarifications address vendor concerns about restrictive requirements and provide necessary details on lab space, testing capabilities, and pricing. Bidders should review these responses to ensure their proposals accurately reflect the clarified requirements.

Statement of Work (SOW) / Performance Work Statement (PWS)

To provide a clinical Cost-Per-Test chemistry analyzer agreement, including equipment, lease, preventative maintenance, technical support, and reagent/supplies services for the Oklahoma City Area Office (OCAO), Indian Health Services (IHS).

• Provide chemistry analyzers with specific assay availability (General Chemistry, Drugs of Abuse, Therapeutic Drug Monitoring, Cardiac, Diabetic, Communicable Disease).

• Analyzers must support workflow priority designation (Routine, STAT, ASAP), require minimal reagent preparation, and have a minimum of 3-point calibrations for most analytes.

• Capability for dry system analysis and in-line plumbing to a water source is required.

• Analyzers must support current throughput needs (>350 tests/hour) and accommodate different site requirements (smaller footprint for <100,000 tests/year, redundant systems for >100,000 tests/year).

• Include all necessary operational equipment (computer, printer, UPS, water system, etc.) and LIS interface capabilities.

• Provide onsite installation, setup, correlations, calibrations, precision studies, linearity studies, and AMR studies.

• Perform onsite preventative maintenance according to manufacturer guidelines.

• Offer 24/7 technical assistance via phone, with onsite support available within 24 hours if remote resolution is not possible.

• Provide onsite training for operators during installation and offer offsite training for new users annually.

• Supply all reagents and supplies for routine operation, calibrations, quality control, and proficiency testing, covering a comprehensive list of analytes.

• Analyzers must meet specified technical criteria and throughput requirements.

• Onsite support must be available within 24 hours for unresolved issues.

• Reagents and supplies must be provided to meet estimated test volumes for various sites.

• Correct items to be provided within 7 days of order.

• Base year: 12 months from date of award.

• Four (4) option years.

• Performance is for the Oklahoma City Area Office laboratories.

• Compliance with HSPD-12 for identification and access.

• Facility is a tobacco/smoke-free environment.

• Contractor personnel must adhere to security regulations, including escort by officials, presenting identification, and following safety procedures.

• Contractor must not disclose any information concerning OCAO operations.

• Service representatives must be manufacturer-trained and certified.

• A termination amortization schedule will be included in the contract.

Questions & Answers / Clarifications

This document provides responses to vendor questions regarding the solicitation, clarifying various aspects of the opportunity.

• Calcium Testing: Haskell location does perform calcium testing.
• Lab Layouts & Analyzer Fit: Specific dimensions are provided for analyzer installation: smaller labs can accommodate an analyzer 83.5" W x 33.5" D x 64.5" H, while larger labs can fit one 110" W x 34.9" D x 68" H. These dimensions are per analyzer, not total space.
• COVID Testing Methodology: Confirmation is sought on whether COVID testing is performed on chemistry analyzers, specifically if it's antigen-based. Vendors may offer a more cost-effective alternative if the methodology is confirmed.
• Pricing Model: Clarification is requested on whether the Proposal Request Pricing is 'Cost Per Test' (includes calibration and QC) or 'Cost Per Reportable' (patient testing only).
• El Reno Volumes: An error in the SOW regarding El Reno chemistry/IA volumes has been corrected and updated test counts submitted.
• Thyroxine (T4) Volumes: The "Thyroxine" (T4) test is no longer run by the system, despite a listed volume in the "total" column.
• Lawton Site Analyzers: The requirement for 2 analyzers at sites with >100,000 tests (Lawton) refers to the space currently occupied by one analyzer per site.
• Additional Assays for Lawton: The system is considering adding Drugs of Abuse, Syphilis, Procalcitonin, Vitamin B12, and Vitamin D assays to the menu capabilities at the Lawton location.

These clarifications may impact vendor understanding of equipment requirements, testing capabilities, pricing structures, and potential future assay additions. Bidders should review these answers carefully to ensure their proposals accurately reflect the clarified requirements.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial products or services, issued as a Request for Quotation (RFQ) under solicitation number 246-26-P-0010. The U.S. Indian Health Service (IHS) Oklahoma Area is seeking a "Chemistry Analyzer Cost Per Test Leasing Agreement." The acquisition will be procured using Full and Open competition.

• Product/Service: Chemistry Analyzer Cost Per Test Leasing Agreement.

• Vendor Requirements: Detailed requirements are specified in the attached Statement of Work (SOW).

• Technical Qualifications: Offerors must demonstrate capability in supplying equipment, services, maintenance, warranty, and supplies. This includes technical aspects like chemistry assays, workflow prioritization, reagent preparation, hardware/software capabilities, RPMS connectivity, bloodborne pathogen technology, installation, maintenance, technical assistance, training, and supplies.

• Past Performance: Offerors must provide at least two references for similar contracts performed within the last two years, including detailed contract information and any problems encountered and their resolutions.

• Contract Type: Firm-fixed-priced IDIQ contract.

• Period of Performance: Base period from 07/01/2026 – 06/30/2027, with four one-year option periods.

• Locations: Services are required at multiple IHS facilities in Oklahoma, Kansas, and potentially other locations.

• Submission Deadline: Quotes must be submitted no later than the date specified in the solicitation to Edson Yellowfish via email (Edson.Yellowfish@ihs.gov).

• Submission Requirements: Vendors must submit a completed Price Schedule (including option periods), and additional documents to demonstrate technical qualifications. All contractors must be registered in SAM.gov.

• Evaluation Criteria: Offers will be evaluated based on Technical Qualifications, Past Performance, and Pricing. Technical Qualifications and Past Performance are considered significantly more important than Pricing.

  • Technical Qualifications will be rated on a scale of 1 (Unacceptable) to 5 (Excellent).
  • Past Performance will be rated on a scale of 1 (Unacceptable) to 5 (Excellent).
  • Pricing will be evaluated through a price/cost analysis.

• Competition: Full and Open.

• Small Business: Various FAR clauses related to small business utilization, subcontracting plans, and post-award rerepresentations apply (e.g., FAR 52.219-4, 52.219-8, 52.219-9, 52.219-16, 52.219-28).

• Indian Preference: HHSAR 352.226-1 and HHSAR 352.226-2 apply.

• This solicitation incorporates provisions and clauses by reference; full text is available at www.acquisition.gov.

• No fax quotations will be accepted; electronic submissions via email are the only acceptable method.

• Offerors must be registered in the System for Award Management (SAM.gov).

Statement of Work (SOW)

To provide a clinical Cost-Per-Test chemistry analyzer agreement, including equipment, lease, preventative maintenance, technical support, and reagent/supplies services for the Oklahoma City Area Office (OCAO) of the Indian Health Services (IHS).

• Equipment: Provide chemistry analyzers capable of performing General Chemistry, Drugs of Abuse, Therapeutic Drug Monitoring, Cardiac Assays, Diabetic Assays, and Communicable Disease testing. Analyzers must support workflow priority designation (Routine, STAT, ASAP), require minimal reagent preparation, offer 3-point calibrations for most analytes, and have dry system analysis capability. Both smaller footprint analyzers (<100,000 tests/year) and larger footprint systems with redundant capabilities (>100,000 tests/year) are required, with specific size constraints provided for each.
• Supplies & Reagents: Furnish all necessary reagents and supplies for routine operation, patient sample testing, calibrations, quality control, and proficiency testing. A comprehensive list of specific assays and estimated annual quantities per site is included.
• Services: Include installation, setup, on-site correlations, calibrations, precision studies, linearity studies, and AMR studies. Provide preventative and corrective maintenance according to manufacturer guidelines. Offer 24/7 technical assistance via phone, with on-site support available within 24 hours if remote resolution is not possible.
• Training: Provide on-site training for all operators during installation and offer off-site technical training for new users annually.
• Ancillary Equipment: Include all equipment for analyzer operation, such as computers, printers, UPS power supplies, and water systems. Ensure proper interface and bidirectional connection with the LIS system, with the vendor responsible for building and maintaining the interface.

Base year of 12 months from date of award, with four (4) one-year option years.

• HSPD-12 Compliance: All contractor personnel requiring physical or logical access must obtain an HSPD-12-compliant access card following a favorable background investigation.

• Environment: The OCAO is a tobacco/smoke-free environment. No tobacco/smoking use is permitted during service.

• Security: Contractor personnel must contact the designated government POC upon arrival. The contractor is responsible for information security and must adhere to all on-premises regulations, including escort requirements, identification, and safety procedures.

• Confidentiality: Contractor shall not disclose any information concerning OCAO operations.

• Personnel Qualifications: Service representatives must be trained and certified by instrument manufacturers.

• Termination: A termination amortization schedule will be included; failure to exercise options will be treated as a termination for convenience.

• Appropriately selected chemistry analyzer provided.

• Installation & setup with required studies.

• Technical support and corrective maintenance.

• Proper interface with the RPMS system.

• Correct items provided within 7 days of order.

Form / Attachment / Pricing Sheet

This document is a pricing sheet intended for bidders to provide cost information for various laboratory tests and supplies. It serves as a template for itemizing costs associated with the opportunity.

• Test / Supply Item: A comprehensive list of specific laboratory tests and medical supplies for which pricing is required.
• Price Base Year: Field to enter the cost for each item during the base year of a potential contract.
• Price OY 1 - OY 4: Fields to enter the costs for each item for Option Years 1 through 4.

Bidders are expected to fill in the unit price for each listed item for the base year and each subsequent option year. This information will likely be a critical component of the proposal evaluation.