26R00003 SF30 0002 add CRSU and updated 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

11/03/20250002

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.)

** ADDING CHEYENNE RIVER SERVICE UNIT**

** Change to Statement of Work **

DO NOT NEED back-up requirement for Quant BHCG in the table listed on page 22.

Please update proposals as necessary - due date and time have been adjusted to provide appropriate opportunity for corrections.

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.

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 .

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 4

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

75H70626R00003/0002

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.

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

51 Cheyenne River Base year (138 121) Clinical

Chemistry Immunochemistry Instrumentation

52 Cheyenne River OY1 (138 121) Clinical Chemistry

Immunochemistry Instrumentation

(Option Line Item)

12/01/2026

Period of Performance: 01/01/2027 to 12/31/2027

53 Cheyenne River OY2 (138 121) Clinical Chemistry

Immunochemistry Instrumentation

(Option Line Item)

12/01/2027

Period of Performance: 01/01/2028 to 12/31/2028

54 Cheyenne River OY3 (138 121) Clinical Chemistry

Immunochemistry Instrumentation

(Option Line Item)

12/01/2028

Period of Performance: 01/01/2029 to 12/31/2029

55 Cheyenne River OY4 (138 121) Clinical Chemistry

Immunochemistry Instrumentation

(Option Line Item)

12/01/2029

Period of Performance: 01/01/2030 to 12/31/2030

The Contractor must provide only new equipment

Continued ...

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

Sponsored by GSA

FAR (48 CFR) 53.110

3 4

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

75H70626R00003/0002 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 they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register, however, Continued ...

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

4 4

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

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

75H70626R00003/0002 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)

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 operators, shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the

Contractor shall provide training for minimally two operators per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the IHS and the Contractor. A training program that involves off‐site travel shall include the cost of airfare, room and board for each participant.

1. In addition, basic operator training shall be provided by Contractor on‐site for all operators on all shifts, as applicable.

iv. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back‐up instrumentation, and any incremental support/ancillary equipment, e.g., water system, offered according to the following terms:

1. Service Requirements

1. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour.

2. Equipment repair service shall be provided 24/7 for medical center-based laboratories and 5 days per week during core business hours for outpatient clinic laboratories. See Attachment B defining core business hours of each facility included in this solicitation.

2. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and IHS laboratory personnel. Equipment repair response time shall be no more than 8 hours.

1. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

2. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

i. date and time notified

ii. date and time of arrival

iii. serial number, type and model number of equipment

iv. time spent for repair, and

v. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

3. Each notification for an emergency repair service call shall be treated as a separate and new service call.

v. Upgrades ‐

1. The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state‐of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the IDIQ; however, it does refer to significant changes in the hardware operational capability.

2. When FDA-cleared improvements to test methodologies become available, these tests will be offered as a replacement at the same cost as the previous test, i.e., replacing Troponin

(cTn) with High Sensitivity Troponin (hs-cTn).

vi. Ancillary support equipment ‐ The Contractor shall provide, install and maintain through the life of the IDIQ , as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g., UPSs with line conditioner, cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, preventative maintenance and repair, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, tables/stands, etc.

vii. Interface Requirements

1. TCP/IP is the preferred connection with Data Innovations middleware. If a serial connection is required the contract is responsible for purchasing Lantronix boxes and appropriate cable from Data Innovations.

2. The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. The contractor will assist in the set-up of the interface to the Data Innovations middleware.

3. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the Data Innovations middleware.

viii. The contractor must assist in implementing a LIS auto-verification script to automatically verify instrument results transmitted from the instrument to the LIS.

ix. Commercial offerings ‐ The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g., Computer disc containing their procedure manual in CLSI format or an on‐line procedure manual in the instrument software.

x. Characterization of waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the

Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational

Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

1. The determination and description shall address the following:

2. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

3. Waste ignitability (Reference 40 CFR §261.21)

4 . Waste corrosivity (Reference 40 CFR §261.22)

5. Waste reactivity (Reference 40 CFR §261.23)

6 . Hazardous waste from non‐specific sources (F‐listed) (Reference 40 CFR §261.31)

7 . Discarded commercial products (acutely toxic or P‐listed and toxic or U‐listed) (Reference

40 CFR §261.33)

8 . Solid Waste (Reference 40 CFR §261.2)

9. Exclusions (Reference 40 CFR §261.4)

xi. The contractor will provide written instructions and training material to ensure IHS laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act

(RCRA) requirements for training as applicable to devices.

1. Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly

Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in

40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals

(F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e., mercury, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:

i. Barium (Total) ii.Cadmium (Total) iii. Chromium (Total)

iv. Copper (Total) v. Cyanide (Total) vi. Lead (Total)

vii. Mercury (Total) viii. Nickel (Total) ix. Silver (Total)

x. Zinc (Total) xi. Arsenic (Total) xii. Selenium (Total)

xiii. Tin (Total) xiv. pH xv. Flash Point (to higher than 200º F)

xvi. BOD; biochemical oxygen demand

2. The documentation the contractor provides will be used to determine whether or not the waste from each device can legally be disposed of via the sewerage system.

xii. Implementation/transition timeframe ‐ The implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award of the IDIQ contract. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 120-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

1. Upon award of an IDIQ, the transition period for the awarded contract to have all equipment and peripherals installed and operational shall be from date of award through

120 days. During this same period all initial training of IHS personnel in the operation and maintenance of said award shall also be completed.

2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 120 days for the transition of all services under the awarded IDIQ including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate IDIQ for cause under the Termination for Cause clause of the IDIQ.

1. At the end of 120 days from award of the IDIQ, the awarded Contractor shall have full and sole responsibility for services under the awarded IDIQ.

xiii. Optional Upgrade ‐ If the IHS laboratory information system, RPMS, is updated with a patch to allow autoverification. The contractor shall provide a consulting service for the setup of autoverification. At a minimum consultation should include autoverification workflows and/or an autoverification rules library to be used during setup. The contractor shall provide education to key personnel on how to maintain functionality of these operations. At minimum this education should include middleware training for standard operations and rules writing.

xiv. Standard and Quality of Performance‐ This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order IDIQ is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the

Contractor’s technical specification or as quoted in any IDIQ at an effectiveness level of 90% or more.

1. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day‐by‐day basis until the standard of performance is met for a total of 30 consecutive days.

2. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212‐4 entitled “Termination for cause.”

(The Contractor shall receive revenue for tests reported during the 90‐day acceptance period.)

3. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure.

Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition.

4. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

5. The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

6. During the term of the IDIQ, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination…