W91YTZ22Q0128-0001.pdf

W40M RHCO-ATLANTIC USAHCA

NORTHERN REG CONTR OFC NRCO

POC: FRANK A. WHORTON

6000 MACARTHUR BLVD

BETHESDA MD 20816

0011797335-0001

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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

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

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to provide a revised Table 1: Estimated Annual Volumes in the Statement of Need and to post Questions from Contractors w ith Government Responses.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 6

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

16C. DATE SIGNED

BY 04-Aug-2022

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

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

8. NAME AND ADDRESS OF CONTRACTOR (No., Street , County, State and Zip Code) X W91YTZ22Q0128

X 9B. DATED (SEE ITEM 11)

02-Aug-2022

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer 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 Items 8 and 15, and returning 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 telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

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

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

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

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

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

04-Aug-2022

CODE

W40M RHCO-ATLANTIC USAHCA

NORTHERN REG CONTR OFC NRCO

6021 5TH ST BLDG 1467

FORT BELVOIR VA 22060-5580

W91YTZ 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W91YTZ

FACILITY CODECODE

EMAIL:TEL:

W91YTZ22Q0128

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

STATEMENT OF NEED

STATEMENT OF NEED

Urinalysis Analyzer

Kenner Army Health Clinic (KAHC) 700 24th Street Bldg. 8130

Fort Lee, Virginia

SCOPE OF WORK:

1.1.1 This contract will provide the Kenner Army Health Clinic Laboratory

(KAHC) with one mid-volume fully automated urinalysis (UA) analyzer.

1.1.2 The analyzer will be located at the clinic’s main laboratory located at 700 24th

Street, Bldg. 8130, Fort Lee, Virginia, 23801. We request the ability to move/transfer analyzer based on the needs of the Government with the assistance of the contractor.

1.1.3 The contractor is required to provide scheduled preventive maintenance, telephonic technical support as well as in-house service as needed at no additional cost to the government.

1.1.4 The contractor is required to perform all required calibrations on-site in accordance with regulatory guidelines.

1.1.5 The systems must be compatible with the medical group’s laboratory information system (LIS) which is the Composite Healthcare System (CHCS) and Military Health System (MHS) Genesis and must include all normal ranges, reference intervals, and units of measurement for each assay.

1.1.6 The contractor shall guarantee delivery of one (1) fully automated urinalysis analyzer and reagents on a lease (cost per reportable result test) on a monthly basis. The duration of the contract will be for one (1) base period with same option for the next four (4) periods.

1.1.7 The vendor agrees to provide enough reagents, controls, calibrators, and all other consumables necessary to perform up to 6,000 tests per year.

1.1.8 Contractor shall provide a site coordinator and an installation specialist to assist laboratory personnel with the entire implementation/installation process, ensuring the installations and validations be completed within 30 days of contract award.

1.2 POINT OF CONTACT:

1.2.1 A point of contact and liaison will be provided for the laboratory staff at KAHC.

1.3 ORIENTATION:

1.3.1 Training required to operate this instrument will be provided by the manufacturer.

1.4 SPECIFIC EQUIPMENT REQUIREMENTS:

1.4.1 The KAHC laboratory operates a 5-workday schedule (Monday – Friday) with

0700-1600 (7AM to 4PM EST) business hours, with the exception of Federal holidays, which the laboratory is closed. Quality of results is mission critical.

1.4.2 Chosen analyzer must have minimal daily, weekly, and monthly maintenance and downtime.

1.4.3 Daily maintenance should not exceed 20 minutes hands-on time.

1.4.4 Weekly and/or monthly maintenance should not exceed 60 minutes hands-on time.

1.4.5 The instrument must have easy access (front and/or top of analyzer) for part replacement and the systems must use random access technologies that improve workflow.

1.4.6 The system must provide the following reportable parameters: Glucose, Protein, Bilirubin, Urobilinogen, pH, Specific Gravity, Blood, Ketones, Nitrite, Leukocyte, Color, Clarity, Color Compensation Pad, RBC, WBC, WBC Clumps, Squamous Epithelial Cells, Non-Squamous Epithelial Cells, Hyaline Casts, Unclassified Casts, Crystals, Bacteria, Yeast, Sperm, and Mucus.

1.4.7 The system must provide additional categories for sub-classification of unclassified casts (Granular, Cellular, Waxy, Broad, RBC, Epithelial Cell, and Fatty Casts).

1.4.8 The system must provide additional categories for sub-classification of crystals (Calcium Phosphate, Uric Acid, Calcium Carbonate, Leucine, Cystine, Tyrosine, Amorphous, Calcium Oxalate, and Triple Phosphate).

1.4.9 The system must provide additional categories for sub-classification of non-squamous epithelial cells (Renal and Transitional).

1.4.10 The system must provide additional categories for yeast (Budding Yeast and Yeast with Pseudohyphae).

1.4.11 The system must provide additional categories for other (RBC Clumps, Fat, Oval Fat Bodies, Trichomonas, and Dysmorphic RBCs).

1.4.12 Provide analyzer with auto-loader/continuous feed capability.

1.4.13 Analyzer must be supported by a minimum of 4 field service representatives within 100 miles radius.

1.4.14 A minimum of 10 similar instruments using exact reagents must be in operation within a

40 mile radius.

1.4.15 Analyzer must have a documented service record that shows continued performance without repair at longer intervals than competitors.

1.4.16 Analyzer must have sample throughput of at least 70 samples per hour for automated urine microscopy and over 200 samples per hour for automated urine chemistry to meet current workload needs.

1.4.17 Analyzer must have the ability to load multiple samples at once for a minimum of 50 samples with continuous feeds and have the ability to start the instrument and walk away during instrument analysis.

1.4.18 Reagents and calibrators must be ready to use and not require preparation prior to loading on the analyzer. Reagent kits must have 2D bar-coded labels.

1.4.19 Analyzer must feature error-proof reagent and commodity design with built in safeguards to prevent reagent mix-ups.

1.4.20 Analyzer will alert user if a reagent has exceeded on-board stability or has exceeded the lot expiration date.

1.4.21 The analyzer must include intuitive, icon-based software for ease of operation.

The analyzer will have STAT access and non-interrupted loading of reagents and consumables.

1.4.22 Patient sample racks must have a barcode that will allow the operator to track the rack and sample position number for each specimen through a display on the instrument monitor.

1.4.23 Analyzer must have QC notification capability to alert the user when QC is not acceptable or not performed.

1.4.24 On-board patient/QC files storage with actual sediment images available for display on demand must be included. Have data storage capabilities of at least 1000 results including controls.

1.4.25 The ability of the sediment analyzer to calculate dilution ratios and provide patient reports with the dilution ratios calculated in the patient results.

1.4.26 The ability to export and import patient files with actual sediment images from

CD-RW.

1.4.27 The ability for the technologist to see on instrument display of sediment images on an instrument display screen.

1.4.28 Provide analyzer that has a self-contained waste management and does not require water or plumbing.

1.4.29 The manufacturer will provide an uninterruptable power supply (UPS) for each analyzer capable to complete testing in progress as well as protection against electrical fluctuations.

1.5 SPECIFIC REAGENT/QUALITY CONTROL REQUIREMENTS:

1.5.1 The vendor will provide a copy of any product recalls for the requested assays within the last 12 months. All requested assays must be FDA approved.

1.5.2 Quality control frequency must not to exceed once per 8 hours.

1.6 ADMINISTRATIVE SUPPORT:

1.6.1 The vendor must complete the initial validation for each analyzer in accordance with

College of American Pathology regulations and any other state and federal requirements and provide completed record(s) of validation(s). The vendor shall provide any special items required during initial integration to include but not limited to: linearity materials (i.e. Maine Standards or other commercial standards), quality control materials, reagents, and consumables. The manufacturer will administer corrective action for failed performance during initial validation until rectified.

1.6.2 During initial implementation, the vendor will provide software necessary to meet specific customer requirements.

1.6.3 The vendor shall furnish interface assistance to ensure that the system is interfaced with the laboratory information system (LIS) prior to departure.

If purchasing of additional equipment is required to maintain the LIS system interface, an equipment credit must be allowed as a discount by the contractor. The system must have barcode capabilities and be able to fully interface to the CHCS and MHS Genesis.

1.6.4 A 24-hour response time (excluding weekends) from an on-site field service engineer will be required to ensure continuous service to the medical providers.

1.6.5 Technical updates and software upgrades must be provided for the analyzers and the reagents as applicable and as required by the manufacturer.

1.6.6 Vendor must replace any reagent, calibrator, and or quality control material at no cost if a recall or manufacture issues were encountered with the material (i.e. product recall).

1.7 EDUCATION AND TRAINING REQUIREMENTS:

1.7.1 Training and associated expenses (room, board, and airfare) for 2 key operators per instrument for the base year of the contract and 1 key operator per instrument for each option year is included.

1.8 REQUIRED SUPPLIES:

1.8.1 Quality Control (QC) materials:

1.8.1.1 QC materials are provided by the contractor on a bi-monthly drop-shipment, in quantities sufficient to perform volume of testing identified below in 1.8.2.2.

1.8.1.2 The QC material must have at least a two-month expiration upon receipt.

1.8.1.3 The QC material must be shipped at least two weeks prior to the expiration of the previous lot shipped.

1.8.1.4 Provide an Inter-Laboratory Quality Control Program with a peer group ≥ 100 laboratories.

1.8.1.5 Contractor must provide a schedule of expected deliveries each month for supply accountability. 1.8.2 Reagents:

1.8.2.1 All reagents and supplies will be delivered to the Kenner Army Health Clinic Laboratory on an evenly distributed monthly drop shipment for the reagents.

1.8.2.2 All reagents must be supplied in a monthly drop-shipment, in quantities sufficient to perform 400-600 tests per month.

1.8.2.3 All deliveries must be tracked by the contractor and provide the government notification of expected delivery and/or if delays are expected.

1.8.2.4 Additional compensation will not be provided for additional quantities shipped in error.

Table 1: Estimated Annual Volumes

Analyte

Annual Volume

Color 6000 Clarity 6000 Glucose 6000 Bilirubin 6000 Ketone 6000

Specific Gravity 6000 pH 6000 Blood 6000 Protein 6000 Urobilinigen 6000 Nitrite 6000 Leukocyte 6000

WBC 6000

RBC 6000

Bacteria 6000 Squamous Epithelial Cells 6000 Mucus 4000 Casts 4000 Crystals 4000

(End of Summary of Changes)