36C24521Q0403_1.docx

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

SET-ASIDE

VA Maryland Health Care System

P.O. Box 1000 Perry Point MD 21902

POINT OF CONTACT*

Rebecca Gobble

PLACE OF PERFORMANCE

Baltimore MD

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

EMAIL DESCRIPTION

DESCRIPTION

RFQ 24521Q0403

Responses due by 7-9-21 at 10 AM EST

Email responses to – Rebecca.Goble@va.gov Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2021-05.

This solicitation is set-aside for Full and Open Competition

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 with a small business size standard of 1,000 The FSC/PSC is 6640

Request for HgbA1C Point of Care Meters, Test kits and controls for the VA Maryland Health Care System, Baltimore, MD 21201.

Interested companies shall provide quotations for the following:

Supplies/Services

HgbA1C Meters

Five Year Extended Warranty for meters

HgbA1C Test Kits (15 tests per kit)

Statement of Work

STATEMENT OF WORK

hgbA1C Point of Care Testing FY21

I. GENERAL:

The Pathology and Laboratory Medicine Service requires Hgb A1C testing to be performed at the Point of Care. The contractor shall provide all supplies, equipment, new instrument validation, training and interface technology (which will allow direct transmission of specific information) necessary for A1C results to be generated at various patient locations.

II. BACKGROUND:

Point of Care HgbA1C is currently being performed at all VAMHCS facilities, including CBOCs. These sites include: VA-Baltimore, VA- Perry Point, Loch Raven CBOC, Glen Burnie CBOC, Fort Meade CBOC, Cambridge CBOC, Pocomoke CBOC and East Baltimore County VA Clinic (EBC). This SOW is to provide information for an additional HL7 interfaced module for HbA1C testing, as part of the VISN’s diabetic monitoring plan.

III. OBJECTIVE: The benefit to adding this module to the RALS test platform is multifold:

a. Decreases wait times for test results to chart to CPRS.

Explanation: Currently, manual entry of test results is required. This creates a delay in charting to CPRS. The new module will allow for the Providers to see the result in CPRS immediately.

b. Reduces clerical error. Enhances test result accuracy.

Explanation: Results automatically transmit to CPRS via HL7 messaging.

c. Protects Veterans Personal Identifiable Information.

Explanation: Paper logs are no longer needed to document manually entered results.

d. Real Time review of unusual test results.

Explanation: Meets regulatory compliance with immediate review of unusual Lab test results

e. Analyzer settings Explanation: The module allows for internal system settings that meet regulatory requirements such as: Operator Lockout, Quality Control Lockout, Lot approvals, Flagging of unusual test results, etc.

f. Reduces staff time spent in maintenance and quality control documentation.

Explanation: Maintenance logs are removed. All maintenance is auto recorded.

g. Provides ease of use and greater time management for laboratory review.

Explanation: Reports can be generated for statistical analysis and review as required for regulatory compliance in Quality Management.

IV. PERIOD OF PERFORMANCE:

Delivery within 30 days

V. PLACE OF PERFORMANCE:

A. Baltimore Facility (10 N. Greene Street, Baltimore, MD 212501)

1. Primary Care Clinic

2. Diabetic Clinic

3. Women’s Health

4. Mental Health B. Perry Point Facility (Bldg 361, VAMHCS-Perry Point, Perry Point, MD 21902)

1. Primary Care Clinic C. CBOC locations:

1. Loch Raven CBOC (3901 Alameda Drive, Baltimore, MD 21215)

2. Fort Meade CBOC (2479 Fifth Street, Fort Meade, MD 20755)

3. Glen Burnie CBOC (808 Landmark Drive, Suite 128, Glen Burnie, MD 21601)

4. Cambridge CBOC (830 Chesapeake Drive, Chesapeake, MD 21052)

5. Pocomoke CBOC (1701 Market Street, Rm 105, Pocomoke City, MD 21851)

6. East Baltimore County VA Clinic (EBC) – (5235 King Avenue, Rosedale, MD 21237).

VI. HOURS OF OPERATION:

Monday – Friday; 8:00am – 5:00pm

VII. EQUIPMENT DESCRIPTION:

A total of 21 FDA approved point of care meters with the ability to perform CLIA waived A1C testing on fingerstick or venous samples collected in EDTA, Heparin or Citrate.

VIII. PERFORMANCE REQUIREMENT:

The contractor shall provide reagents, external quality controls and leased meters on a cost per test basis. It is estimated that approximately 750 tests per month (9,000 tests per year) will be performed throughout the VAMHCS. Each device shall be initially validated by the contractor.

IX. MIDDLEWARE:

The meters shall have the ability to interface to the current VA LIS system (Vista), patient medical record (CPRS) and the POC data management system (UNIPOC). The devices must be interfaced to a single rules-based middleware. Licenses for adding devices to existing middleware will be provided by the VA.

X. REAGENT REQUIREMENTS:

The contractor must provide evidence of minimal or no hemoglobin variance interference. This will allow for acceptable CV of ≤3.5%.

XI. SUPPLIES:

The Contractor shall provide all required hardware, software, and related consumables supplies to support the transmission of electronic data for each ordering facility at no additional cost. Any necessary “additional required connections” shall be the responsibility of the Contractor. All equipment, software, and hardware remain the property of the Contractor. All risks of loss remains the responsibility of the Contractor. The government is not responsible for loss due to negligence, fire, water, or other natural disaster or damage from terrorism or war, and any other resultant damage to equipment, software, hardware and connections.

· Middleware capable of interfacing with POC HL7

· Capability to upload QC data remotely with USB

XII. SYSTEM TRAINING, SERVICE and MAINTENANCE:

A. Initial training shall be provided by the contractor for all sites.

B. Contractor shall be accessible for service and troubleshooting Monday – Friday from 8:00am – 5:30pm (excluding holidays).

C. Minimal maintenance requirements are preferred.

XIII. PRICING:

A Price for meters, test and controls shall be provided.

XIV. REFERENCES OF PAST PERFROMANCES:

A. Offerors must provide the names of at least two current end users for more than two years. While government contract references are preferred, they are not required. The assessment of an offeror’s past performance shall be used as a means of evaluating the relative capability of the offeror to successfully meet the requirements stated in the solicitation and as a measure of performance risk for this contract award.

Delivery terms are FOB destination and delivered to the VA Perry Point Warehouse at the below listed address.

Place of Performance/Place of Delivery

10 N Greene St Baltimore, Maryland

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Items”

2. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items”

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” 03/11/2021

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” 03/11/2021

The following subparagraphs of FAR 52.212-5 are applicable:

All quoters shall submit the following: Please see below information in accordance to FAR 52.212-1 (b).

Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government.

The following are the decision factors:

1. Vendor Must be able to provide all meters, test kits and controls

2. Vendor Must provide evidence of minimal or no hemoglobin variance interference.

3. The Meters must be able to connect to current VA LIS System (VISTA), patient medical records (CPRS) and the POC data management system (UNIPOC)

The award will be made to the response most advantageous to the Government.

Responses should contain your best terms, conditions.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show—

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender’s request and expense, unless they are destroyed during pre-award testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with subpart 4.10 of the Federal Acquisition Regulation), or alternative commercial items for satisfying the requirements of this solicitation. Each offer submitted will be evaluated separately.

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exception(s) and rationale for the exception(s), if any.

Submission of your response shall be received not later than 07/09/2021 at 10:00 A.M. EST. to Rebecca.Gobble@va.gov.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

(f) Late submissions, modifications, revisions, and withdrawals of offers.

(1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers, or revisions are due.

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.

Point of Contact Rebecca Gobble, Contract Officer, 410-642-2411 x26534, Rebecca.Gobble@va.gov

Combined Synopsis/Solicitation Notice