26R00003 SF30 0001 QnA SOW.pdf

(x)

75H70626R00003 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

Aberdeen SD 57401 115 Fourth Ave, SE Federal Building Aberdeen Area Indian Health Servic

11/03/20250001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

11/03/2025

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Firm-Fixed-Price, Non-personal service, Multiple Contractor, Indefinite Delivery/Indefinite

Quantity (IDIQ) contract to provide Cost Per Reportable Result (CPRR) for Automated

Chemistry and Immunochemistry Instrumentation. Period of performance to be a base year with four (4), one (1) year options.

The "Unit Price" is an all-inclusive cost. All "inclusive cost" is defined as including travel, lodging, per diem, fringe benefits, i.e., life insurance, social security, federal, state, and local taxes, plus all other costs pertinent to the performance of this purchase.

LIST OF CHANGES:

Bids due date: 02-DEC-25 changed to 15-DEC-25

Bids due time: 12:00 PM changed to 14:00 PM

Continued ...

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

VALERIE K. HEART BROKER

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

Working Copy

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 12

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75H70626R00003/0001

Period of Performance: 01/01/2026 to 12/31/2026

The Contractor must provide only new equipment and new parts for the required products described herein; no used, refurbished, or remanufactured equipment or parts shall be provided under any circumstances. Absolutely no Gray Market Goods or

Counterfeit Electronic Parts shall be provided.

Gray Market Goods are defined as genuine branded goods intentionally or unintentionally sold outside of an authorized sales-territory or by non-authorized dealers in an authorized territory. All equipment shall be accompanied by the Original Equipment Manufacturers (OEMs) warranty. Counterfeit Electronic Parts are defined as unlawful or unauthorized reproduction, substitution, or alteration that has been knowingly mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified electronic part from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitution includes used electronic parts represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

Invoice Processing Platform (IPP)

The Indian Health Service (IHS) is in the process of implementing an electronic invoicing system.

In compliance with the Office of Management and

Budget (OMB) M-15-19 memorandum, Improving

Government Efficiency and Saving Taxpayer Dollars

Through Electronic Invoicing, directing Federal agencies to adopt electronic invoicing as the primary means to disburse payment to vendors.

Invoices submitted under any award resulting from this solicitation will be required to utilize the

Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and

Processing of Payment Requests.

IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the

Treasury's Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St.

Louis (FRSTL). Respondents to this solicitation are encouraged to register an account with IPP if

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 12

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75H70626R00003/0001 they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register, however, we encourage you make sure your organization and designated IPP user accounts are valid and up to date.

The IPP website address is: https://www.ipp.gov

If you require assistance registering or IPP account access, please contact the IPP Helpdesk at (866) 973-3131 (M-F 8AM to 6PM ET), or

IPPCustomerSupport@fiscal.treasury.gov

Should the contractor feel that use of the IPP would be unduly burdensome, their response to this solicitation should include an explanation of this position for a determination by the contracting officer.

The Government reserves the right to accept or reject services, if the level of performance is unacceptable.

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

Questions received during Solicitation with Responses from the Program

Received questions 1-5: 11/19/2025 Responses received: 11/20/2025 Responses sent to contractor: 11/20/2025

1. How many instances of RPMS are shared across the 11 sites? Are there 11 individual instances? 1 instance of 2 sites sharing 1 RPMS and 1 instance of 3 sites sharing 1 RPMS

2. If there are any shared instances, please provide the names of the sites for each instance and who is sharing that specific instance of RPMS? Fort Yates and Mclaughlin share RPMS, and Pine Ridge shares RPMS with Kyle and Wanblee

3. How many instances of Data Innovations (DI) are shared across the 11 sites? Are there 11 individual instances? 1 instance of 2 sites sharing 1 DI and 1 instance of 3 sites sharing 1 DI

4. If there are any shared instances, please provide the names of the sites for each instance and who is sharing that specific instance of Data Innovations (DI)? Fort Yates and Mclaughlin share 1 DI, and Pine Ridge shares DI with Kyle and Wanblee

5. Would GPAIHS be interested in housing autoverification rules in a centralized location/site? No, our current EMR/LIS (RPMS) is not capable of auto verification

Received questions 1-14: 11/14/2025 Responses received: 11/14/2025 Responses sent to contractor: 11/14/2025

Extension of submission due date

1. All questions are currently due on Friday, November 14th at 12pm CST.

Question: Please extend the submission due date to at least 10 business days (excluding the Thanksgiving holiday weekend) after answers are provided for all vendor questions to allow adequate time for response to the answers and changes to the solicitation. Thank you!!

Mona, you can extend but NOT past Thanksgiving.

Combined Synopsis document

2. The solicitation states that “E. The quoted unit pricing must be all inclusive (to include but not be limited to travel, lodging, per diem, fringe benefits, federal, state and local taxes) plus all other costs pertinent to the performance of this contract. Utilize your most competitive and reasonable rates.

Question: Based on the requirements of the Statement of Work, please confirm pricing is based on per site testing menu versus aggregate across all sites. If not, please clarify explicitly how the pricing should be structured and presented.

Pricing is by site with aggregate discounts.

3. The solicitation states that “Unit price” is defined as (in the Combined Synopsis) and in the Solicitation Package Block 20 as travel, lodging, per diem, fringe benefits, [i.e., life insurance, social security,] federal, state and local taxes) plus all other costs pertinent to the performance of this contract.

Question: Please provide additional clarification of what is the unit price? The total site price for each period of performance or is the unit the CPT pricing by assay?

FSC Group 66, Part III, requires the cost per reportable test (CPRT), also known as cost per patient reportable result (CPRR) or cost per test (CPT), to be an all-inclusive price that covers equipment use, reagents, supplies, maintenance, and training for a single reportable patient result. The specific cost is not a fixed government-mandated number but is defined by the contractor and the specific equipment and tests offered.

Question: Should this definition of “unit price” actually include, for each site, instrument(s), service/maintenance, reagents, controls, standards/calibrators, and consumables? If so, please update the documents to indicate this.

FSC Group 66, Part III, requires the cost per reportable test (CPRT), also known as cost per patient reportable result (CPRR) or cost per test (CPT), to be an all-inclusive price that covers equipment use, reagents, supplies, maintenance, and training for a single reportable patient result. The specific cost is not a fixed government-mandated number but is defined by the contractor and the specific equipment and tests offered.

Solicitation Package document

4. The solicitation states in Block 20, “The contract is defined as Firm-Fixed-Price, Non-personal service, Multiple Contractor, Indefinite Delivery/Indefinite Quantity (IDIQ) contract to provide Cost Per Reportable Result (CPRR) for Automated Chemistry and Immunochemistry Instrumentation. Period of performance to be a base year with four (4), one (1) year options.”

Question: Does GPAIHS intend for the “unit price” to include, for each site, instrument(s), service/maintenance, reagents, controls, standards/calibrators, and consumables?

• Yes Question: How is the vendor to structure responses for each site for Quantity, Unit, Unit Price, and Amount?

Should the vendor assume Quantity is to be 12, Unit is to be month, Unit Price is the estimated price based on the annual test volumes provided, and Amount is the annual cost based on the annual test volumes provided?

Normally, for a CPRR contract, vendors provide a CPRR rate for each individual assay listed in the annual test volumes, and these are summed up to provide a total estimated cost.

Provide CPRR pricing for each individual site for a full year based the test volumes provided.

SOW document

5. The solicitation states on Page 1, “1. INTENT: The Government will issue a Multiple Vendor Cost Per Reportable Result (CPRR) IDIQ contract for Automated Chemistry and Immunochemistry Instrumentation for technically acceptable vendors with the lowest bid.“ Question: Is this to be an individual or group decision? Does GPAIHS work as a hub-and-spoke model? Is one site a “mother” or “big sister” to another site?

Group decision deciding which vendors are technical acceptable, but individual sites will select the vendor the technically acceptable list.

6. The solicitation states on Page 1, “4. PRICES AND TERMS: GPAIHS will provide an estimated volume by test as reflected in Attachment C for each individual IHS hospital and clinic laboratory. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in Attachment C, but does not guarantee volumes as listed; they are estimates ONLY.

For volume growth, estimate 20% increase per year over the length of the contract.

Question: To clarify, does GPAIHS anticipate 20% growth at each location for each year of the contract? Yes, possibility does exist for growth depending on economy.

Does GPAIHS need this information for budgeting purposes, or does the group expect to double their volumes over the next 5 years? We need this for budgeting purposes

7. The solicitation states on page 2, “2.1.ii. Equipment must maintain, or preferably reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory.”

Question: Please indicate the current number of workstations in use at each location specifically dedicated for chemistry resulting. None, are specifically dedicated to chemistry. The vendor has the option to conduct a site visit and look over the layout.

8. The solicitation states on page 4, “3.3.i.5. The ability to process both spun and unspun specimens simultaneously. (Inlet or similar device) Question: Does GPAIHS require automation at any of the eleven (11) locations, such as a track system to move samples from one analyzer or module to another? No, due to space limitations listed in the SOW

9. The solicitation states on page 7, “3.3.iii.23.Single lot of reagents for each test/analyte per monthly shipment with a minimum dating of 90 days.

Question: Please revise this requirement to state 30 days as 90 days is limiting.

No, 90 days due to remoteness of facilities and unforeseen weather conditions and situations.

10. The solicitation states on page 8, “c.1 A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. All monitors/screens will clearly display information in all light conditions.“ Question: Please provide CADs or chemistry area dimensions and/or pictures of the available chemistry space so vendors can understand the available area for the equipment installation.

• The dimensions provided would include any pre-analytic module

Total Max Footprint Cheyenne River 120” W x 48” D Pine Ridge 120” W x 48” D Rosebud 88” W x 48z’ D Standing Rock 63” W x 48” D Turtle Mountain 110” W x 48” D FT. Thompson 60” W x 54” D Kyle 60” W x 54” D McLaughlin 72” W x 33” D WWKMHCC 120” W x 48” D Wanblee 51” W x 45” D x 31”

H Wagner 60” W x 54” D

Vendor has the opportunity to conduct site visits to determine conditions.

Additional questions

11. Question: For each site, please provide the current instrumentation, model, vendor, and quantities, including any automation, if applicable.

Cheyenne River Siemens EXL & XPand

Pine Ridge Ortho 5600

Rosebud Siemens EXL & XPand

Standing Rock Ortho 3500 & Abbott Architect

Turtle Mountain Ortho 7600

FT. Thompson Ortho 350

Kyle Siemens Xpand

McLaughlin Ortho 350

WWKMHCC Ortho 5600

Wanblee Siemens Xpand

Wagner Siemens XPand

No Automatation at any sites.

12. Question: Would GPAIHS sites be open to sending out very low-volume assays found on pages 25-28?

• No

13. Question: For each site, please provide answers to the follow quality control questions. Sites use either MAS or BioRad depending on which control has a significant peer group or is provided by the instrument vendor.

1. Please identify which control vendor you currently use.

2. Are you using QC peer review software? If so, is the vendor to include the cost of the software license for this? Yes, whichever software is provided by the QC manufacturer

3. Please share the annual quantity and list numbers for your current controls that you acquire today. Generally speaking, hospitals, run two level per day 365/year.

Sisseton and Wagner run two level of control 365/year and the remaining four clinics run two levels of control 5 days/week (excluding holidays)

4. Would you be willing to utilize a different QC vendor? As long as the peer group is statistically significantly in size.

5. If the respondent could offer a direct connection between the analyzers and the peer QC software (without additional costs of going through middleware), would that be of interest? Yes, that is a preferred method

14. Question: For each site, please provide answers to the following middleware questions.

1. Where would servers be located? All sites have virtual/terminal servers that are off-site

2. Would each site have a physical server, or would be virtual servers be utilized? See response to question #1 above.

3. Do any of the sites autoverify results today? If so, please specify which ones. If not, please indicate which ones are interested in autoverification with this contract. No, not able with current LIS.

4. Are validation rules or autoverifcation rules standardized throughout GPAIHS today? N/A

5. Does GPAIHS intend to standardize validation rules or autoverifcation rules throughout GPAIHS with this new contract? N/A

Received questions 1-7: 11/14/2025

Responses sent to contractor: 11/14/2025

1. Item 4 states for volume growth, estimate 20% per year over the length of the contract. A 20% growth year on year would more than double the patient volumes in 5 years. Is 20% growth expected at the end of 5 years for an annual growth of 3.7%?

a. This is an estimate and we would like to keep it at 20% growth annual.

2. Please clarify expectation of Contractor Middleware System identified in item 2.2.iii.. Are you seeking automation?

a. We are not seeking automation

b. Need an instrument that is capable of bi-directional communication that is supplied by IHS (i.e. Data Innovations)

3. Item 3.2, last sentences reads “Specific tests that require back-up performance are listed in Attachment A.” Are there specific tests requiring back-up or just the specific sites?

a. Sending new SOW with and (*) listing testing that requires back performance.

4. Item 3.3.iii.21 states “For those sites requiring back up analyzers, it is essential for the backup analyzer to be a mirror image as the primary analyzer.” However at the bottom of attachment A, the back-up requirements for Cheyenne River, Rosebud and Turtle Mountain is only for Chemistry Chemistry and not Immunochemistry. For Cheyenne River, Rosebud and Turtle Mountain is a mirror backup required? If not required will backup instrument be required to use same reagent and consumables ie. adding no additional part numbers to run instrument and perform testing.

a. For Cheyenne River, Rosebud and Turtle Mountain is a mirror backup required?

No, back immunochemistry is required.

b. The backup instrument is to use the same reagents and consumables.

5. Item 3.3.b.2. requires “Patient status display for technologist review and workflow management for all integrated (linked) testing instruments” Are you looking for a central display?

a. Not required, analyzers will not be linked.

6. Item 3.3.d.4. last sentence “Intra-VISN facility variations should be kept at an absolute minimum.” Is this referring to Intra-Area?

a. Delete this sentence from the solicitation. It was copied over from an old SOW.

7. Item 3.3.e. 25.

1. B-type Natriuretic Peptide (BNP) and N-terminal Pro-B-type Natriuretic Peptide (NT ProBNP) are both specified. Are both tests required or can one of the two be offered?

i. For this matter are considered the same test, those numbers can be combined.

2. Are the tests listed which have no volume commitments required or desired? E.g.

Carcinoembryonic antigen (CEA), Digoxin, MDMA, and Valproic Acid

i. Desired - if the facilities want to add on in the future.

Received questions 1-3: 11/13/2025

Responses sent to contractor: 11/14/2025

1. Could a CAD or .dwg of those sites requesting The ability to process both spun and unspun specimens simultaneously “Inlet or similar device” please be made available? (#3. Operational and Technical Features, i. Specimen Processing , #6.) No dimensions were included for the allowable space for sites that we would be proposing an inlet.

• The dimensions provided would include any pre-analytic module

Total Max Footprint Cheyenne River 120” W x 48” D Pine Ridge 120” W x 48” D Rosebud 88” W x 48z’ D Standing Rock 63” W x 48” D Turtle Mountain 110” W x 48” D FT. Thompson 60” W x 54” D Kyle 60” W x 54” D McLaughlin 72” W x 33” D WWKMHCC 120” W x 48” D Wanblee 51” W x 45” D x 31” H Wagner 60” W x 54” D

• We can try to find engineer drawing of the facilities that would benefit from a pre-analytic module.

2. Alternatively, would vendors be allowed to visit those sites to perform measurements?

• Site visits have been encouraged throughout the this solicitation process, as long as this doesn't delay the solicitation process.

3. Would it be allowable to have vendors present system-wide solutions in a virtual presentation?

• Yes, as long as this doesn't delay the solicitation process.

STATEMENT OF WORK

Clinical Laboratory Chemistry and Immunochemistry Instrumentation

Great Plains Area Indian Health Service

IDIQ LANGUAGE

1. INTENT: The Government will issue a Multiple Vendor Cost Per Reportable Result (CPRR) IDIQ contract for Automated Chemistry and Immunochemistry Instrumentation for technically acceptable vendors with the lowest bid. Contractor agrees to the following terms of the IDIQ exclusively with the Great Plains Area

Indian Health Service (GPA IHS) facilities listed by Attachment/herein and awarded in the final IDIQ.

However, as requirements change, facilities within GPA IHS may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the IDIQ as new technology becomes available on the market and added to the base FSS contract.

2. 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.

3. ORDERS: All products ordered under this IDIQ are issued by Task Orders/Delivery Order by the placed by the individual service unit. This IDIQ 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.

4. PRICES AND TERMS: GPA IHS will provide an estimated volume by test as reflected in Attachment C for each individual IHS hospital and clinic laboratory. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in

Attachment C, but does not guarantee volumes as listed; they are estimates ONLY. For volume growth, estimate 20% increase per year over the length of the contract.

5. TERM OF AGREEMENT: This will be a multiple award, CPRR IDIQ with one base year and four, one-year options and shall be effective for the term of the contract. If the Contractor fails to perform in a manner satisfactory to the CO, this IDIQ may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the

CO. This IDIQ shall be reviewed annually. GPA IHS intends to establish the base year of the agreement for the period of 1/1/2026 through 12/31/2030.

6. IDENTIFICATION: Delivery Orders issued shall be identified by their applicable IDIQ

Contract Number and TO/DO Number.

7. ORDERING METHOD: The participating facilities may order products via Electronic Data

Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

1. SCOPE OF PROCUREMENT:

i. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability

(if discrete testing is required) and be able to simultaneously perform the complete profile as described below meeting the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards

Institute (CLSI).

ii. Equipment must maintain, or preferably reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory.

iii. If Contractor offers a family of analyzers, the technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

iv. Equipment shall be acquired for each of the clinical laboratories located at the GPA IHS facilities listed in Attachment B.

v. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

vi. Special handling for emergency orders of supplies: In the event that the supplies 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 is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site 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 laboratory of the monthly standing order/routine supplies delivery.

2. DEFINITIONS:

i. Cost per Patient Reportable Result (CPRR)‐ as defined in the Federal Supply Schedule FSC

Group 66, Part III, Cost‐Per‐Test Clinical Laboratory Analyzers ‐ Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) 5-year equipment use, (2) all reagents, standards, quality 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 of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards

Institute (CLSI). (3) all necessary maintenance to keep the equipment in good operating condition

(This element includes both preventive maintenance and emergency repairs) and (4) training for

Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge.

ii. Business Associate Agreement (BAA)‐ A business associate is an entity, including an individual, company, or organization that, on behalf of IHS, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). IHS is a covered entity under the HIPAA Privacy

Rule (Privacy Rule). HIPAA regulations require IHS to execute HIPAA‐compliant BAAs with certain entities that receives, uses, or discloses IHS PHI in order to perform some activity for IHS.

These BAAs obligate IHS business associates to provide the same protections and safeguards to PHI that is required of IHS under the Privacy Rule.

iii. Contractor Middleware System ‐ Generally a separate component/ computer that electronically links the testing instrumentation to manage data, results and workflow. (Not to be confused with Data Innovations)

iv. Throughput – The speed that the equipment processes and/or operates reported in units per hour.

3. Test Menu: Refer to Attachments A and C for desired test menu and estimated annual volumes by laboratory.

3. GENERAL REQUIREMENTS:

1. Primary analyzer(s) – Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer may serve as a back‐up analyzer

(see definition below) and shall replace the requirement for offering that category of equipment.

2. Back‐up Analyzer; equipment required in support of operations for the GPA IHS laboratories in the event the primary analyzer(s) becomes non‐operational/non‐functional. This category of equipment shall only be operated during periods of time when the primary instrumentation is not available for use. As such, the requirements for consumable supplies, i.e., reagents, quality control material, calibrators, etc., shall be minimal and corollary to the successful operation of the primary instrumentation. Specific tests that require back‐up performance are listed in Attachment A. Additional primary analyzers required for the performance of daily workload are not considered back‐ups for the purposes of consumables, reagents, etc.

3. Operational and Technical Features‐ The instrumentation offered shall be approved by the Food and Drug Administration (FDA) and Contractor’s FSS Contract at the time of proposal submission and have the following:

i. Specimen Processing. Offering for Clinical Laboratory Chemistry and Immunochemistry

Instrumentation in accordance with the requirements of each respective laboratory, as listed in

Attachment A, shall have the following:

1. Sufficient capacity and throughput to meet the volume and service demands as defined in

Attachments A and C.

2. The ability to prioritize STAT specimens. (Specimen Management System)

3. Minimal operator intervention to introduce STAT specimens or to change a routine

4. specimen to a STAT specimen. (Specimen Management System)

5. The ability to detect processing errors and provide error notification. (Specimen

Management System)

6. The ability to process both spun and unspun specimens simultaneously. (Inlet or similar device)

7. The ability to sample through a variety of types and sizes of blood collection tubes.

8. The system must contain computer interface compatible with the current IHS laboratory information system and existing universal interface. The fully operational interface (both hardware and software) shall be immediately available for implementation to the IHS computerized hospital information system.

ii. Barcoding:

1. The accuracy of the barcode reading must have less than 1.0% failure rate.

2. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

3.Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha, numeric, and/or alphanumeric concurrently.

iii. Testing Instrumentation: The testing instrumentation must be approved by the Food and Drug

Administration (FDA) and on Contractors’ FSS Contract at the time of proposal submission and shall have the following:

1.The capability of performing analysis on 100% of the tests listed in Attachment A.

2.Sufficient capacity and throughput to meet the volume and service demands as defined in

Attachments A and C.

3. An instrument management system (internal to testing instrumentation) that provides/ maintains the following:

1. Ability to monitor instrument performance.

2. Continuous monitoring of vital functions with immediate operator notification of failure(s) and on‐board storage of these records.

3. Capability to detect and alert operator of out-of-range quality control results via flagged results on QC printout and visual alerts on display monitor.

4. Ability to store and retransmit patient records to the IHS Laboratory Information system for a minimum 72 hours in case of interface outage.

5. Capability to record, store and print the following information:

i. Required quality control and instrument maintenance information.

ii. Patient demographic information and specimen results.

6. On board reagent inventory system.

7. A bi‐directional, bar‐coded computer interface compatible with the current IHS laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the IHS computerized hospital information system.

i. The accuracy of the barcode reading must have less than a 1.0 % failure rate.

ii. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

iii. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha and/or numeric depending on site that may be enabled concurrently.

4. Bar coding of reagents and the ability to track reagent containers throughout the testing process through the use of bar code technology. Ability to prioritize STAT testing without compromising existing programmed testing.

5. Minimal operator intervention to introduce STAT specimens or to change a routine specimen to a STAT specimen, as well as introduce STAT specimens during a test run without aborting a run.

6. On board reagent stability sufficient to accommodate both high and low volume use.

7. The ability to detect and alert operator of low liquid levels and the potential of depletion.

8. The ability to unload/remove empty reagent containers from the equipment during operation (on the fly) without interrupting testing in progress.

9. The ability to support multiple reagent lots of the same reagent on the equipment at the same time with active, valid calibrations.

10. The ability to calibrate more than one lot of a reagent at a time.

11. The capability to calibrate assays during test run without aborting the run.

12. The capability to store, print, and retrieve calibration data.

1. For routine (general) chemistry tests, when more than one lot of a given reagent that has a valid calibration and quality control material is programmed to run as a control (in the control mode):

i. Quality control material will automatically be run on all lots of those reagents when the respective test is requested .

ii. Quality control results will be easily distinguishable i.e., identified by reagent lot number or similar mechanism, on instrument printout or display monitor.

iii. Operator may select to run a test on only a specified lot of reagents even though more than one lot has a valid calibration

13. The ability to continuously load patient specimens.

14. The ability to detect short samples.

15. Clot detection with alert notification.

16. Primary tube sampling from various manufacturers and sizes of evacuated tubes.

17. The instrumentation shall be capable of handling all routine sample collection tubes plus other various sized sample containers i.e., sample cups (0.5, 1.0, and 2.0 ml), carrier tubes and tube inserts.

18. The capability to auto dilute a test when defined limits are exceeded. (Contractor shall list all analytes that can be set to auto dilute on each instrument model offered.)

19. The capability to program a test as a repeat with interfacing of results to overlay initial result.

20. Safety features to avoid unnecessary exposure to biohazardous and chemical material.

The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

21. For those sites requiring back up analyzers, it is essential for the backup analyzer to be a mirror image as the primary analyzer.

22. Ability to store and retransmit records (72 hours of maximal instrument throughput) in case of interface outage.

23. Single lot of reagents for each test/analyte per monthly shipment with a minimum dating of 90 days.

24. IDMS traceable Creatinine reagent.

25. No requirements for sample pre‐treatment.

26. Minimal carryover.

27. Long calibration stability.

28. The capability of incorporating other manufacturer’s reagents

29. The capability of incorporating new technologies via automated line expansion.

30. Minimal daily, weekly and monthly maintenance.

b. Data/Instrument Management System

1. Sufficient memory to store patient information and test records with downloading capability to an external medium for long term storage of patient records and other information.

2. Patient status display for technologist review and workflow management for all integrated (linked) testing instrumentation.

3. Ability to retransmit patient records to universal interface system in case of interface outage.

4. Technology to automatically repeat testing based on customer configurable testing criteria (repeat testing)

5. Technology to automatically direct additional specimen testing based on customer‐ configurable testing criteria (reflex technology).

6. Technology for remote connectivity to troubleshoot maintenance issues.

7. Technology to send QC to vendor for peer-to-peer comparison.

8. Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity.

9. Contractor shall assist customer with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow.

10. When requested, the contractor shall help sites implement an autoverification script in

RPMS from the middleware rules package.

11. The supplied software packages must be able to automatically link a critical result to an ordering provider’s contact information. The software must be able to either robotically call critical values; automatically send an email to the ordering provider notifying that there is a critical value; automatically fax a critical value result to the provider’s fax number.

c. Hardware Features‐ The instrumentation shall have the following:

1. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. All monitors/screens will clearly display information in all light conditions.

2. A printer(s) that has the capability of printing a patient report with patient demographic information that includes the patient’s name, medical record number (SSN) and accession or unique identifier number (UID).

3. The vendor must repair or replace the printer if malfunctioning within 24 hours for the duration of the contract.

4. An uninterruptible power supply (UPS) with line conditioner for each instrument provided.

Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records.

d. Method Performance/Validation Requirements

1. Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, The Joint Commission (TJC) standards and Federal regulations. All studies performed will be appropriate for the test menu of the respective laboratory to include serum, plasma, urine and body fluids as applicable.

2. Correlation studies for each analyte. A minimum of 40 samples spanning the reportable range, shall be run by the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed.

Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y‐ intercept, correlation coefficient, ROC analysis, and meet current standards defined by

CLSI.

3. Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5‐point linearity analysis that adheres to the Beer‐Lambert Law and spans the entire range shall be performed as a minimum.

4. Precision study using normal and abnormal control material. This shall include, at a minimum, within run precision study of 10 normal and 10 abnormal controls.

5. Sensitivity. Sensitivity may be validated concurrently with correlation studies.

6. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.

7. Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge.

e. Required Analytes‐ The instrumentation must be capable of analyzing the following at a minimum:

B = Blood, C = CSF, U = Urine, * = Backup test required; ^ = Pine Ridge IHS

1. Acetaminophen * 2. Alanine Aminotransferase (ALT) * 3. Albumin (B, U) *

4. Alcohol (ETOH) * 5. Alkaline Phosphatase (ALP) * 6. Ammonia *

7. Amylase (B, U) * 8. Aspartate Transferase (AST) * 9. Bilirubin, Conjugated

10. Blood Urea Nitrogen (BUN) * 11. B-type Natriuretic Peptide (BNP) 12. Calcium *

13. Carbon Dioxide (CO2) * 14. Carcinoembryonic antigen (CEA) 15. Chloride (B, U) *

16. Cholesterol 17. C-Reactive Protein (CRP) 18. Creatine Kinase (CK)

19. Creatinine (B, U) * 20. Digoxin 21. Dilantin

22. Direct Bilirubin (DBILI) 23. Ferritin 24. Folate

25. Follicle Stimulating Hormone (FSH) 26. Free Thyroxine (FT4) 27. Gamma-glutamyl transferase (GGT)

28. Glucose (B, U) * 29. HBsAG 30. HCV

31. Hemoglobin A1C (HgbA1C) 32. High-Density Lipoprotein (HDL) 33. HIV

34. Iron 35. Lactate Dehydrogenase 36. Lactic Acid

37. Lipase * 38. Low-Density Lipoprotein (LDL) 39. Luteinizing Hormone

40. Magnesium * 41. Microalbumin 42. Phosphorus

43. Potassium * 44. Procalcitonin 45. Prolactin

46. Prostate Specific Antigen (PSA) total 47. Protein, (C, U) * 48. Quant BHCG *

49. Rheumatoid Factor 50. Salicylate 51. Sodium *

52. Syphilis Antibodies 53. Thyroid-Stimulating Hormone (TSH) 54. Total Bilirubin (TBIL) *

55. Total Iron Binding Concentration

(TIBC)

56. Total Protein (B, C, U) 57. Transferrin

58. Triglycerides 59. Troponin, (cTn or hs-cTn) ^ 60. TSH

61. Uric Acid 62. Valproic Acid 63. Vancomycin

64. Vitamin D 25 total 65. 66.

f. Reference Range‐ A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used:

i. A verification of the manufacturer’s suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 individual references shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification. If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

ii. If a laboratory is currently using the proposed instrument/reagent system, the “in‐use” reference range can be transferred to the “new” system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed.

g. Reports‐ The Contractor shall provide to the Contracting Officer Representative (COR) and other individuals

(designated post‐award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter’s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. At the end of each Period of Performance (POP) year (base and each option), an annual report of sales by participating facility as well as a GPA IHS total will be provided. In addition, a total TO/DO sales/savings report will be provided at the end of each Period of Performance (POP) year (base and each option), to include any extensions. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per IDIQ contract) shall not be accepted. There will be no additional charges for any reports required as part of the IDIQ. These reports will be in an Excel spreadsheet, multiply tabs may be used, to include a GPA IHS summary tab. Attachment C may be used as a template to provide these quarterly reports.

h. Support Features‐

i. Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

ii. 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. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this IDIQ contract. The Contractor shall perform/assist, 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 of the statistical analysis as stated in the Method Performance/Validation section above and provide electronic and hard‐copy data in an organized, clearly comprehensible format.

iii. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services and minimally equivalent to the terms and conditions for training defined in the Contractor’s Federal

Supply Schedule FSC Group 66, Part III, Cost‐Per‐Test/Cost Per Reportable Result Clinical

Laboratory Analyzers contract. This key operator training for 2…