SOURCES SOUGHT:



The Department of Veterans Affairs, VISN 6 Network Contracting Office (NCO) is conducting Market Research through this sources sought to help determine the availability of qualified Small Businesses (SB) registered under NAICS code 541380 capable of Environmental Culture Testing Services for the Richmond VAMC.



All specifications are attached below.



If the contractor can provide the above items, the contractor shall provide a letter from the manufacturer stating they are an authorized distributor/licenser of their products. Failure to submit an authorized distributor letter shall result in the product(s) potentially offered to be considered grey market and shall not be considered technically acceptable.



The capability statements received from this market research are for planning purposes only and will assist the Government in planning its acquisition strategy. This is strictly market research and the Government will not entertain questions concerning this market research. The Government will not assume any costs incurred by the contractor in the preparation of responses. All responses shall be submitted in writing no later than February 21, 2019 8:00 AM, EST to the attention of: Nicholas J. Ruppert, VA Medical Center, 27 Averill Avenue, Hampton, VA 23667. E-mail address: [email protected]































































Performance Work Statement

Environmental Culture Testing

DATE: February 14, 2019



Statement of Need



The Hunter Holmes McGuire VA Medical Center is in need of environmental cultures testing services for the purposes of infection control and surveillance recommendations developed by The U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and American Society for Microbiology (ASM), entitled Duodenoscope Surveillance Sampling and Culturing Protocols. The objective of the surveillance cultures is to detect bacterial contamination that may be present This surveillance will help identify aberrations in reprocessing of equipment.



1.1 Definitions and Acronyms



1.1.1 Contracting Officer (CO) - means a person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings. The term includes certain authorized representatives of the contracting officer acting within the limits of their authority as delegated by the contracting officer. Administrative contracting officer (ACO) refers to a contracting officer who is administering contracts. Termination contracting officer (TCO) refers to a contracting officer who is settling terminated contracts. A single contracting officer may be responsible for duties in any or all of these areas.



1.1.2 Contracting Officer s Representative (COR) - means an individual, including a contracting officer s technical representative (COTR), designated and authorized in writing by the contracting officer to perform specific technical or administrative functions.



1.1.3 Contractor Owned Equipment/Contractor-Acquired Property - means property acquired, fabricated, or otherwise provided by the contractor for performing a contract.



1.1.4 Delivery Order - means an order for supplies placed against an established vehicle or with Government Sources.



1.1.5 Equipment - means a tangible item that is functionally complete for its intended purpose, durable, nonexpendable, and needed for the performance of a contract. Equipment is not intended for sale, and does not ordinarily lose its identity or become a component part of another article when put into use. Equipment does not include material, real property, special test equipment or special tooling.



1.1.6 Government Property - Means all property owned or leased by the Government. Government property includes both Government-furnished property and contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.



1.1.7 Indefinite Delivery Indefinite Quantity (IDIQ) - contract provides for an indefinite quantity, within stated limits, of supplies or services during a fixed period. The Government places orders for individual requirements. Quantity limits may be stated as number of units or as dollar values.



2.0 Acronyms

This section lists acronyms that may be used in this Performance Work Statement and other parts of the solicitation.



CO Contracting Officer

COR Contracting Officer Representative

FAR Federal Acquisition Regulation

GFP Government Furnished Property

GP Government Property

IDIQ Indefinite Delivery Indefinite Quantity

POP Period of Performance

PWS Performance Work Statement

VAMC Veteran Affairs Medical Center



Scope of Requirement

The Contractor shall be responsible for Providing Environmental Testing Services on an as needed basis for the Richmond VA Medical Center. At a minimum, the contractor shall be responsible for providing all (to include, but not limited to) project management, labor, equipment, materials, hardware, software, special tooling, transportation, loading and unloading ensure the successful performance of all requirements contained within this Performance Work Statement (PWS).

Description of Requirement

The Contractor shall be responsible for providing all FDA approved materials for specimen collection and all required shipping materials,to include but not limited to::



1. Dey-Engley Neutralization Broth - 45 mL

2. Specimen labels and water-proof marker pens

3. Sampling fluid -Sterile non-bacteriostatic water, preferably sterile reverse osmosis or deionized water (45 mL)

4. Collection bottle

5. Syringe 30 mL - 2

6. Sterile brush (meeting dimensions that will fit through the duodenoscope channel) that is capable of having the brush head removed for microbiological culturing

7. Sterile pipettes or sterile plastic transfer bulbs with markings for a 1 mL volume (2 pipettes or bulbs)

8. Parafilm

9. Chain of Custody

10. Ice pack

11. Insulated box

12. Discounted Fedex shipping label



Shipping label and postage shall facilitate expedited shipping in order for specimens to be processed at the contractor s laboratory within 24 hours of collection at the VAMC. The contractor shall process the specimen in accordance with the culturing protocol defined by the CDC/FDA in the document entitled, Duodenoscope Surveillance Sampling and Culturing, Reducing the Risks of Infection available at:

https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/UCM597949.pdf



The entire endoscope sample shall be concentrated (either by membrane filtration or centrifugation)

Then endoscope sample (extract) shall be plated ona single blood agar plate and incubated at 35-37 degrees Celsius

The microbiology lab shall document growth at 24, 48, and 72 hours using standard methods and subcultured when growth is detected

If growth is observed, gram staining and other identification methods shall be conducted to identify potential high-concern organisms



The Contractor shall be required to report to the Infection Control Lead of the any positive results within 2 business days of identification. If any growth is observed (on plates or in broth), culturing staff shall immediately conduct gram staining and other identification to identify potential high concern organisms. The results of the culture and Gram stain shall be provided as an interim report to the Infection Prevention and Control staff. Electronic and verbal communication of culture results is preferred and email addresses/phone numbers will be provided at the time of contract finalization. Final results at 72 hours shall be documented and provided via email to the to appropriate staff within the Infection Prevention and Control Staff.



4.1 Microbiology Environmental Scope Culture Testing



The Contractor shall provide the minimally required information with the culture results. This includes the following:

4.1.1 All the information in the requisition form for sample.

4.1.2 Sample acquisition date and time (date and time when sample was received in laboratory).

4.1.3 Identification of laboratory staff members receiving the sample, or equivalent information to document receipt of sample.

4.1.4 Leaking sample containers or improper sample transport conditions.

4.1.5 Date and time of sample culturing.

4.1.6 Identifier of culturing staff (e.g., initials).

4.1.7 Culturing method.

4.1.8 Growth results at 24, 48, and 72 hours (including colony-forming units.)

4.1.9 Gram stain results at 24, 48, and 72 hours, if applicable.

4.1.10 Organism identification and identification method.

4.1.11 Date of results were sent to infection prevention and control staff or other designated management staff.

4.1.12 The contractor shall replace missing or broken components of the specimen collection kit

5.0 Invoicing

The Contractor shall be responsible for timely invoice submissions not to exceed 30 days after the invoicing cycle. At a minimum, invoices shall be submitted monthly to reflect actual costing incurred for that monthly period regardless of whether FDA approved materials has been ordered and the endoscopes have been tested. The contractor shall not submit an excess of one invoice per month per order placed against this IDIQ. At a minimum, invoices shall contain the follow information:



Invoice Number

Invoice Date

Contract Number.

Delivery/Task Order Number

PO number (i.e. 652-C9XXXX)

Billing Period (e.g. 7 Nov 2018 6 Dec 2018)

CLIN Number

Make, model & Serial Number

Unit Price

Total Price



6.0 Contracting Officer Representative (COR)



Contracting Officer Representatives (CORs) shall be appointed via separate letter for this contract. The COR shall be responsible for the effective oversight of this contract to ensure satisfactory contractor performance and protect the public trust. A copy of the COR Appointment letter shall be provided to the Contractor after contract award and shall contain detailed information in regards to the COR and their associated duties, responsibilities and authorities.



7.0 Reporting Requirements



The contractor shall be required to submit monthly reports to the COR via email no later than the time of invoice submission as a contract level monthly deliverable. Failure to submit a complete and accurate report may result in invoice rejection. This may be submitted as a single report if it contains all required information. At a minimum, Monthly Reports shall include, but not limited to, the following:



a. Finalized microbiological culture results

b. Any billing/invoice issues

c. Reflect a Declining Balance on Delivery/Task Order Level

d. Invoice Log on Delivery/Task Order Level.

e. A copy of all applicable invoices for reporting period that have been or will be submitted electronically for payment. This may be submitted for coordination prior to electronic submission for payment.



7.1 SERVICES SUMMARY Below is a matrix table listing a summary of the performance objectives and performance thresholds required by the government in contractor performance.

Performance Objectives

Reference

Performance Threshold

Method of Surveillance

Identification of laboratory staff members receiving the sample, or equivalent information to document receipt of sample.

Para 4.1.3

90% of the time

Periodic Inspection

The Contractor shall be responsible for reporting microbiological growth results at 24, 48, and 72 hours (including gram stain, colony-forming units, genus and species identification, and finalized culture results) for all positive cultures

Para 4.1.8

90% of the time

Periodic Inspection

The Contractor shall be responsible for providing all FDA approved materials in a kit for specimen collection in addition to required shipping materials. The contractor shall be responsible for providing 6-12 specimen collections kits per month.

Para 4.0

90% of the time

Periodic Inspection

The Contractor shall be required to report to Infection Control Lead to communicate positive results within 2 business days.

Para 4.0



90% of the time

Periodic Inspection