36C24225Q0178.docx

SUBJECT*

CAP Linearity Surveys

GENERAL INFORMATION

Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx NY 10468-3904

POINT OF CONTACT*

Contract Officer Clifford S. Harrison Clifford.Harison@va.gov

718.584.9000 Ext.4680

ADDITIONAL INFORMATION

Special Notice

Special Notice

DESCRIPTION

Special Notice

Department of Veterans Affairs, Network Contracting Office 2, is issuing this Notice of Intent to Sole Source in order to identify any potential sources that have the resources and capabilities to provide a comprehensive vehicle for CAP Linearity Surveys.

SERVICES REQUIRED

The contractor is the College of American Pathologists for the East Orange VA Medical Center during the term of December 23, 2024, through December 22, 2025. The Contractor shall provide services to the PLMS (Pathology & Laboratory Medicine Services).

INTERESTED & CAPABLE RESPONSES:

NCO 2 is seeking responses from businesses that are interested in this procurement and consider themselves to have the resources, rights, and capabilities necessary to provide these services. Please respond with your:

1. Business name, business type, socio-economic status (e.g., Veteran-Owned, Woman-Owned, Disadvantaged Small Business, 8(a), etc.), person of contact (including telephone number & email address), GSA Contract number if applicable, and DUNS number.

2. The Capability statement must provide detailed and specific information that would demonstrate a capability to perform the tasks as stated in the attached Statement of Work. Failure to tailor the capability statement to this specific requirement may result in your company being determined non-responsive.

Responses must be submitted by 12 PM EST December 17, 2024. Responses to the information requested above may be submitted via email to Clifford.Harrison@va.gov.

This Special Notice of Intent to sole source is for planning purposes ONLY. The results of this notice will assist in the development of (1) the requirement, and (2) the acquisition strategy (e.g., small business set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses submitted as a result of this notice.

A.1 STATEMENT OF WORK

A. Background The East Orange Veterans Affairs New Jersey Health Care System (EOVANJHCS) Department of Pathology & Laboratory Service (P&LMS) that performs testing on patients (human specimens) must subscribe to an external proficiency testing program as an enhancement to the internal quality control program that meets Clinical Laboratory Improvement Act (CLIA) 1988 and amendments to:

a. Ensure reliability of patient testing in the laboratory.

b. Meet accreditation requirements.

c. Must subscribe to external proficiency test (PT) programs for all analytes for which PT is available, including waived testing, provider-performed microscopy, and unregulated analytes.

d. VHA Handbook 1106.01, Page 24-25, Paragraph 8, section b (1), January 29, 2016 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169

PROFICIENCY TESTING

b. PT Requirements. The laboratory must perform, and report PT from a CMS ram approved by the VA National Enforcement Officer for every instrument/method (including backups) utilized for patient testing and for every site where patient testing is performed. All of these test systems must be formally evaluated by the provider for satisfactory performance.

(1) A separate PT kit must be ordered for each instrument, method, or site utilized for patient testing. All the challenges provided in one kit for a specific analyte must be run on the same instrument, method, or site to allow the tracking of the instrument, method, or site performance throughout the year.

. Clinical Lab Tool- CL.265.05 Is proficiency testing performed and reported on every instrument utilized for patient testing and for every site where patient testing is performed? PT must be performed and reported on each instrument in each of the following circumstances:

· When the lab has multiple instruments used interchangeably to perform patient testing.

· For any instrument or method that the lab would use as a backup to perform the patient test runs if the primary instrument is down.

· At each ancillary testing site.

· On each instrument at each ancillary testing site.

EOVANJHCS P&LMS performs clinical diagnostic tests on patients (human specimens) and in the event should any or all departments within the P&LMS should fail to meet the PT requirements as described in 42 CFR 493, Subpart H, or who have demonstrated deficiencies which pose a direct threat to patients may be instructed to terminate those particular diagnostic testing.

The vendor shall determine the analyte-specific evaluation criteria and target values used to grade PT results for regulated analytes. CLIA categorization is determined after the FDA has cleared or approved a marketing submission. The FDA determines the test’s complexity by reviewing the package insert test instructions submitted by the manufacturer and using a criteria “scorecard” to categorize a test as moderate or high complexity.

B. Scope The overall purpose of this requirement is to obtain a vendor to provide a CLIA’88-approved proficiency testing program so that EOVANJHCS P&LMS and ancillary testing sites that perform patient testing are in compliance with the VHA Handbook 1106.01 proficiency testing requirements for a term of 12 months (1 year).

EOVANJHCS P&LMS and ancillary testing sites perform patient testing in the following CLIA specialties/subspecialties: Arterial Blood Gases, General Immunology, Hematology, Routine Chemistry (serum and urine), and Urine Toxicology; as well as serum Alcohol, Ammonia, CRP, and Creatinine (eGFR) testing.

PT shall be performed in each department of the P&LMS and all ancillary testing sites that perform patient testing in accordance with the calendar of events or shipping table provided by the vendor. Each department/site must perform PT testing on every analyzer (including backup analyzers) for the primary test method for each test/assay performed on-site.

The PT program must be CLIA-approved for all aforementioned CLIA specialties/subspecialties.

All pertinent proficiency testing information shall be internally managed via the Microsoft database.

C. Period of Performance

1. The contract period of performance shall be a Base year (January 01, 2025, through December 31, 2025).

2. Place of performance see “F. Delivery Methods and Locations 2a through 2e.”

D. Type of Contract

1. The EOVANJHCS intends to award a Firm Fixed Price, Indefinite Delivery Indefinite Quantity (IDIQ) contract for the entire 12 months.

2. This is a “self-pay” EOVANJHCS hospital contract and cannot be attached to the National contract which is NOT a Blanket Purchase Agreement (BPA).

E. Vendor Responsibilities

1. The Vendor shall provide, at minimum, specimens for all CLIA specialties/subspecialties for which patient testing is performed in the EOVANJHCS.

2. The Vendor shall provide a mechanism to notify EOVANJHCS if proficiency testing updates become available and promptly notify the Ordering Contact in writing (mailed or electronic) of such updates.

3. The Vendor shall establish an event calendar and/or shipping table that identifies the date each proficiency testing deliverable is scheduled to be shipped to EOVANJHCS.

4. The Vendor shall have a method that allows EOVANJHCS to transmit proficiency testing results electronically (i.e., secured website, secure direct interface capability, facsimile, etc.)

5. The Vendor shall meet evaluation criteria (allowable limits and target values) determined by CLIA for each regulated analyte. For other than regulated analytes, the grading criteria may be determined by EOVANJHCS.

6. The Vendor shall include formal evaluation of results for each test. Formal evaluation reports must include:

a. A mechanism for each laboratory to compare its proficiency testing performance and/or results against peer laboratories using the same instrument/reagent system (when available).

b. A summary of the individual laboratory’s historic performance over the past three (3) proficiency testing events for each regulated analyte.

c. Overall performance summary report for each regulated analyte that indicates whether current performance is satisfactory, at risk pending future performances, or unsatisfactory.

d. A summary of peer participant results.

e. As applicable for each analyte: analyte tested, test methodology, reported results, graded score, peer statistics (such as mean and standard deviation) and EOVANJHCS determined intended result.

f. The reason any proficiency testing result was not scored/graded.

7. The Vendor shall oblige EOVANJHCS Ordering Contact and the respective Regional Medical Technologist:

a. Documentation of proficiency testing formal evaluations.

b. Written notification when proficiency testing results are not received by the vendor.

c. Written notification when analyte performance is scored as unacceptable.

d. Written notification when analyte overall performance is assessed as unsatisfactory.

8. The Vendor shall provide a plan for the replacement of defective or damaged deliverables (proficiency testing material/supplies).

9. The Vendor shall provide a glossary of terms if technical terminology is used. Otherwise, information must be phrased in audience-appropriate language.

10. The Vendor shall have an electronic method (i.e., website, facsimile, e-mail) for receipt of VA-furnished correspondence (i.e., proficiency testing results, VA facility demographics) that is required for the proficiency testing program. Contract prices should include any costs associated with electronic data transmission.

11. The Vendor shall provide the facility with the most current Food and Drug Administration (FDA) approved reagents, controls, calibration materials, and any consumables necessary for analyzing/testing on both primary and back-up analyzers. All requirements and provisions defined in the specification of this solicitation will apply to any vendor, i.e., branch, division, sub-Vendor, etc. supplying parts or reagents on behalf of the Vendor.

12. For reagents with hazardous constituents, vendor shall provide a mechanism for the Laboratory to meet local discharge requirements. The vendor shall supply information regarding any hazardous chemicals.

F. Delivery Methods and Locations

1. All mailed deliverables, which includes proficiency testing material/supplies, shall be shipped Freight on Board (FOB) Destination (paid by Vendor). The government is not responsible for freight charges.

2. Proficiency testing materials/supplies/specimens shall be delivered/shipped to:

a. CAP Number 1195301-01 East Orange Veterans Affairs Health Care System 385 Tremont Avenue Bldg. 1 East Orange, NJ 07018 Attention: Anjali V. Pawar -Laboratory

3. The package should be shipped according to the shipping table provided by the Vendor.

G. Billing

1. The vendor shall bill monthly in arrears upon receipt/acceptance of the supplies.

2. Each location shall be billed separately with the understanding that all payments shall be invoiced to and will be the responsibility of the Amarillo location.

Shipped to:

a. CAP Number 1195301-01 East Orange VA Health Care System East Orange VA Health Care System 385 Tremont Avenue

Bill to:

385 Tremont Avenue East Orange, NJ 07018 East Orange, NJ 07018 Attention: Anjali V. Pawar -Laboratory

3. The vendor shall use the Tungsten e-invoice system for all billings. www.tungsten-network.com Period of Performance shall be indicated on all invoices.

4. A Government customer termination agreement prior to the contract term of one year (12 months) the contract pricing awarded will be adjusted. Pricing published shall be based on a 60-month term. However, upon early termination, alternate pricing, which is part of this contract, shall apply.

5. A CCR number shall be maintained in addition to a current DUNS number for all Contractor information.

H. Licensing and Accreditation

1. The Vendor shall have all licenses, permits, accreditation and certificates required by law and or regulatory compliance and is approved for PT via CLIA.

2. Personnel assigned by the Vendor to perform these services covered under this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia.

I. Security

1. This contractor requires no access to EOVANJHCS or any VA information system.

2. NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

3. The C&A requirements do not apply. A Security Accreditation Package is not required.