Sources Sought.docx

SOURCES SOUGHT NOTICE

This is not a solicitation but rather a Request for Information (RFI/Sources Sought) for market research purposes only. Veterans Health Affairs, Network Contracting Office 4, is issuing this Sources Sought in order to identify capable firms and obtain information for planning purposes only.

Veterans Health Affairs, Network Contracting Office 4, is issuing this Sources Sought in order to identify capable firms for Environmental Laboratory Specimen Sampling. Responses shall be submitted by 11:00 AM (EDT) June 24th, 2024. Responses shall be submitted via email to Kevin.Lake1@va.gov.

All Service-Disabled Veteran-Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) firms that respond shall include proof of their Vets First Verification via Home · VetBiz Portal (va.gov). All small business firms that respond shall include proof of small business status via their Representations and Certifications in accordance with FAR 4.1102 Policy.

While SDVOSB/VOSB contractors are preferred, all capable contractors are welcome to respond to this sources sought notice for market research purposes. All respondents shall include as part of their response a brief capability statement that covers the information in the following tentative statement of work, as well as answers to the below three (3) questions. All respondents shall be registered and active in SAM.gov | Home.

The results of this market research will assist in the development of (1) the requirement, and (2) the acquisition approach (e.g., socioeconomic set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses.

Suggested NAICS: 621511 (Medical Laboratories) Suggested PSC: Q301 (Medical – Laboratory Testing) Open to suggestions from industry as to a more proper NAICS and/or PSC, as well as any potential GSA/FSS Schedule SIN categories.

In addition to the information requested above, please include answers to the below 3 questions as part of your response to this Sources Sought:

1. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes.

2. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each.

3. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner?

Yes ___No ___ If yes, please identify which companies are considering a Joint Venture and the ownership of each company.

Intended Procurement Approach

PERFORMANCE WORK STATEMENT

A. GENERAL INFORMATION

1. Title of Project: Environmental Laboratory Specimen Sampling.

2. Purpose: To provide laboratory environmental microbiology testing of surfaces samples, media fill testing (MFT) and gloved fingertip (GFT) samples as required by Unites State Pharmacopeia (USP) Chapter 797 and the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) Pharmacy Department located at 3900 Woodland Avenue, Philadelphia PA 19104.

3. BACKGROUND: The Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) Pharmacy Department has a need for a commercial laboratory testing of employees, compounding rooms and equipment samples due to a recent notification from the Laboratory and Pathology office that determined that VA facility laboratories lack the necessary certification and therefore do not meet specific requirements to perform the microbiology testing and sample analysis.

4. SCOPE OF WORK: The Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) Pharmacy Department is seeking an Indefinite Delivery-Indefinite Quantity (IDIQ) contract with a commercial laboratory for USP 797 mandated Gloved fingertip test (GFT) and Media fill test (MFT), Surface testing of Direct Compounding Area (DCA) of pharmacy compounding personnel and monthly microbiology testing of Surface and Air samples of Compounding Cleanroom/Buffer room, Anteroom and Equipment

5. PERIOD OF PERFORMANCE: The period of performance will be for an initial base year with the possibility of four one-year options (exercised at government’s discretion ) if successful results are achieved per CMC VAMC’s evaluation.

6. Hours of Service: Work is to be done between the hours of 9:00am and 5:00pm, Monday through Friday excluding holidays and any other day specifically declared by the president of the United States to be a Federal Holiday.

Federal Holidays

When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by U.S Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday by U.S Government agencies.

7. Type of Contract: The contract will be a Firm Fixed Price contract.

8. INVOICING

· Payment to the Contractor shall be made upon receipt of a properly prepared detailed invoice by the contractor, validated by the Contracting Officer’s Representative (COR) and submitted electronically through ob-10 (https://portal.tungsten-network.com). Payment for services will be at the rates specified in the Price/Cost Schedule. All invoices from the contractor will be electronically submitted through the Tungsten Network within 15 days following the end of the month of services rendered.

· Contractor Electronic Invoice Submission Methods: Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

· The information page for the Financial Service Center (FSC) of the Department of Veterans Affairs that includes information regarding electronic invoice submission can be referenced at: http://www.fsc.va.gov/einvoice.asp

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-8971 Customer Support Help Desk (877-353-9791)

· If the Program POC refuses an invoice due to incorrect billing, subsequent changes or corrections to the monthly invoice shall be resubmitted by the Contractor with a corrected invoice.

· A properly prepared invoice will contain:

· Name and Address of Contractor

· Invoice Date and Invoice Number

· Contract Number and Obligation Number

· Identifier Information (Employee’s Identifier information {Initials}, sample location and/or identifier)

· Total Amount Due

· Supply or Service provided.

· Failure to comply with all terms and conditions of this contract shall result in invoices/claims submitted for reimbursement during that period to be considered incomplete. Interest penalties imposed under the Prompt Payment Act shall not apply to incomplete invoices or invoices received after the established invoice due date.

9. GOVERNMENT RESPONSIBILITIES

CMC VAMC personnel will conduct the required IV room surface and air sampling, media fill testing and gloved fingertip testing and ship directly to the lab for analysis. At the request of CMC VAMC, the laboratory will send personnel to conduct the assessment and collect samples from CMC VAMC employees, compounding rooms and equipment for the price disclosed in the contract (Concierge service will be billed only when requested and used by CMC VAMC).

10. PLACE OF PERFORMANCE

Laboratory testing services shall be provided Monday through Friday between the hours of 9:00am to 5:00pm, for the term of this contract. Service shall include sample receiving, analyzing, incubating, disposal and manual or electronic reporting of results. Samples shall be mailed via UPS to the Contractor’s testing facility from CMC VAMC via postal service or UPS.

11. CHANGES TO PERFORMANCE WORK STATEMENT

Any changes to this PWS shall be authorized and approved only through written correspondence from the Contracting Officer (CO). A copy of each change will be kept in a project folder along with all other documents. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

12. MINIMUM REQUIREMENT FOR SERVICE

· There will be no minimum or maximum order requirements, charges and/or penalties. CMC VAMC will be billed per the number of samples submitted, analyzed and reported.

· CMC VAMC will be responsible for purchasing and utilizing its own supply of sample testing paddles and plates from a commercial vendor of its choice. At the request of CMC VAMC, testing supplies such as plates or paddles can be ordered from the laboratory at the price disclosed in the contract. There will be no minimum or maximum order requirements, charges and/or penalties.

· Contractor must have an International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 certification from an external accrediting body to ensure quality and accuracy of the testing.

· CMC VAMC will mail out samples to the contractor using next day delivery via the postal service of its choice.

· Contractor will ensure that personnel is available during business hours to receive samples from CMC VAMC via the delivery service personnel.

· Contractor must be compliant with all applicable federal and local licensing boards.

· Samples will be stored, incubated, analyzed and reported according to USP Chapter 797 guidelines for the specific samples.

· Sample results will be reported with applicable identifier markers and information (such as employee identifier initials, sample location, cfu, genus of the microorganism, temperature and duration of incubation etc.. ) and mailed or electronically shared with CMC VAMC Pharmacy Service.

· CMCVAMC will be notified via email within 24 hours of growth exceeding allowable cfu/ml.

· Contractor will only invoice CMC VAMC for services requested and/or covered by the contract. The contractor is responsible for ensuring that services provided to CMC VAMC are covered by the contract and will bear responsibility for costs not covered.

B. GENERAL REQUIREMENTS

1. The laboratory must have ISO/IEC 17025 certification from an external accrediting body to ensure quality and accuracy of the testing.

2. Surface and Air sampling will be conducted once monthly for viable surface and air sampling. Surface sampling will also be conducted at the point of hiring and every 6 months for each employee during their bi-annual competencies. GFT sampling will be conducted at the point of hiring and every 6 months for employee competencies and on an as needed basis.

3. Media fill testing will be conducted initially (at point of hire) and every 6 months thereafter for employee competencies. Media fill test pouch will be tested for broad spectrum microorganisms. Any visible turbidity or visual manifestation of growth will be reported.

4. GFT samples will only be tested for total microbial counts. Species identification is not required. The total colony count will be reported.

5. Surface and Air samples will be tested for total microbial counts. Any growth over the action level (table 6 USP Chapter 797) will require identification. At minimum the genus of the microorganism must be identified.

6. Agar plates or Trypticase Soy Agar Paddle for GFT, Surface and Air sampling will be incubated as required in USP Chapter 797.

For Gloved Fingertip and Thumb Testing – (GFT)

· Incubate the media device at 30°–35° for 48 hour and then at 20°–25° for 5 additional days for a total of 7 days.

· Handle and store media devices to avoid contamination and prevent condensate from dropping onto the agar during incubation and affecting the accuracy of the cfu reading (e.g., invert plates).

· Record the number of cfu per sample.

· Report must contain Sample Identifier marker, clearly identify type of test and colony count in cfu/ml. ( e.g., garbing GFT and post media fill GFT)

· Formal GFT results must be reported to CMC VAMC via email within 7 days post analysis and signage by approving official.

For Media Fill Testing - (MFT)

· The Contractor must handle and store samples to avoid contamination and prevent condensate from dropping onto the agar during incubation and affecting the accuracy of the cfu reading (e.g., invert containers).

· Incubate the final containers at 30°–35° for 7 days followed by 20°–25° for an additional 7 days.

· Incubate at each temperature band to detect a broad spectrum of microorganisms. The order of the incubation temperatures must be described in the facility’s SOPs.

· Failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container closure unit(s) on or before 14 days.

· Formal results of Media fill test must be reported to CMC VAMC via email within 7 days post analysis and signage by approving official.

Air Sampling for Viable Particles

· The Contractor must handle and store media devices to avoid contamination and prevent condensate from dropping onto the agar during incubation and affecting the accuracy of the cfu reading (e.g., invert plates).

· Incubate the media device at 30°–35° for 48 hours. Examine for growth. Record the total number of discrete colonies of microorganisms on each media device as cfu per cubic meter of air on an environmental sampling form based on sample type (i.e., viable air), sample location, and sample date.

· Then incubate the media device at 20°–25° for addition 5 additional days for a total of 7 days. Examine for growth. Record the total number of discrete colonies of microorganisms on each media device as cfu per cubic meter of air on an environmental sampling form based on sample type (i.e., viable air), sample location, and sample date.

· Formal results of test must be reported to CMC VAMC via email within 7 days post analysis and signage by approving official..

Surface Sampling for Viable Particles

· The Contractor must handle and store media devices to avoid contamination and prevent condensate from dropping onto the agar during incubation and affecting the accuracy of the cfu reading (e.g., invert plates).

· Incubate media device(s) at 30°–35° for 48 hours. Examine for growth. Record the total number of discrete colonies of microorganisms on each media device as cfu per media device on an environmental sampling form based on sample type (i.e., surface), sample location, and sample date.

· Incubate the media device at 20°–25° for an additional 5 additional days for a total of 7 days. Examine for growth. Record the total number of discrete colonies of microorganisms on each media device (cfu per sample) on the environmental sampling record based on sample type (i.e., surface), sample location, and sample date.

· Final results of the test must be reported to CMC VAMC via email within 7 days post analysis and signage by approving official.

7. PRODUCT DESCRIPTION

Pharmacy Personnel

(Sample collection from left and right fingers)

(Sample collection from left and right fingers)

(Sample collection from surface of direct compounding area)

Compounding Equipment, Cleanroom/Buffer room and Anteroom

IF > 0 CFU/ML POST GARBING OR

IF > 3CFU/ML FOR MFT+SURFACE+ POST COMPOUNDING SAMPLES

TEST – WILL RETEST

IF > 3CFU/ML

Total of 6 samples

(4) GFTS, (2 post PPE garbing and 2 post compounding (MFT)

(1) media fill test (MFT)

(1) surface sample paddle Total of 6 samples

Certified compounding staff – every 6 months

(4) GFTS,

(1) media fill test (MFT)

(1) surface sample paddle Total of 6 samples

Equipment or cleanroom - monthly

4-6 paddles or plates for each compounding equipment/cleanroom

8. RESULT REPORTING

8.1 Signed/Endorsed reports will be delivered to the CMCVAMC by US Postal Service or electronically to the address below.

Order Delivery Address CMCVAMC Inpatient Pharmacy 2nd Floor Room A236 Building 1 3900 Woodland Avenue Philadelphia PA, 19104 Phone: 215-823-5800 Ext. 206593 Email: VHAPHIPHARMACYLABREPORTS@va.gov

8.2 Report will have the following information:

· Sample identifier markers - Employee initials, sample location, equipment number etc.

· Incubation temperature and duration

· CFU/ml count for individual samples

· Speciation Identification

· Name of the person analyzing the samples at each temperature

· Date and signature of approving official

9. COMPLIANCE, PERMITS, CERTIFICATIONS, & INSURANCE

· Throughout the duration of this service, the contractor shall follow the Statement of Work and all applicable federal, state, and local laws. The contractor shall be responsible for determining the latest applicable editions of all relevant federal, state, and local regulations.

· The contractor shall, without additional expense to the Government, be responsible for obtaining any necessary licenses, permits, and insurance to comply with any applicable federal and municipal laws, codes, and regulations in connection with the performance of this service.

· The contractor shall furnish the Contracting Officer (CO) with their Certificate of Insurance, containing an endorsement to the effect that cancellation or any material change in the policies which adversely affect the interest of the Government, shall not be effective unless a thirty (30) day written notice of cancellation or change is furnished to the Point of Contact (POC). The term “will endeavor” is not acceptable as issued by an insurance carrier.

10. CONTINGENCY SERVICE

· The contractor shall immediately (within 6 hours) notify the POC via a phone call or email to the provided distribution group of any service interruptions that may arise once identification. The contractor shall immediately (within 6 hours) notify the POC of breakdowns which may affect service. It is the responsibility of the contractor to provide contingency testing services to minimize any delay or inconveniences.

· The contractor shall immediately (within 24 hours) notify the POC via a phone call or email upon receipt of sample damaged during transit at no additional cost to the CMCVAMC.

· Weather: The contractor shall immediately notify the POC, if conditions exist (i.e., inclement weather) that may render testing sites unsafe to operate. However, this act of notification does not, of itself, provide authorization to discontinue services. The contractor shall receive a response from the POC within one (1) hour of notification as to whether to discontinue service.

· Future Delays: If the contractor foresees, they will not be able to provide service on a given day, they will provide advance (as soon as applicable) written explanation of why and provide it to the POC; this documentation must be signed by the contractor’s designated responsible POC. The POC, upon conference with the CO, will determine if service from another source is required. If this occurs, the POC will immediately notify the contractor once a decision is rendered.

· The Government will issue a Bill of Collections for any costs obtained if service is required from another source. Failure to pay as charged, within the timeframe specified in the Bill of Collections, may result in deduction of costs from the next month’s invoice.

11. CONTRACTOR COMMUNICATION

The contractor shall provide the CMCVAMC Inpatient Pharmacy Service with a reliable mailing address for sample drop off within the designated business hours.

The contractor shall maintain two-way communication between the CMCVAMC Inpatient Pharmacy Service and the contractor via phone and email during normal business hours. The contractor shall have access coverage to accept requests during the hours of 9:00am and 5:00pm Monday through Friday excluding Federal holidays.

12. INSPECTION

The Government reserves the right to inspect the contractor’s facility, Licenses, Certificates and equipment or require documentation of compliance with the SOW’s specifications. If conducted, such inspections do not constitute a warranty by the Government that the contractor’s facility, licenses, Certificates, and equipment are properly maintained.

13. DELIVERY SUMMARY: The Services Delivery Summary (SDS) represents the most important contract objectives that, when met, will likely indicate contract performance is satisfactory. Although not all SOW requirements are listed in the SDS, the contractor is expected to fully comply with all requirements in the SOW.

ACCEPTABLE PERFORMANCE LEVEL

b. GFT - Incubate the media device at 30-35 C for no less than 48 hours and then at 20-25 C for no less than 5 additional days for a total of 7 days. Results are reported to CMC VAMC via email within 7 days post analysis and signage by approving official.

c. MFT - Incubate the final containers at 20-25 C for 7 days then at 30-35 C for a minimum of 7 days for a total of 14 days. Formal results are reported to CMC VAMC via email within 7 days post analysis and signage by approving official.

d. Surface and Air sample are incubated the temperature range and duration set forth by USP Chapter 797 for no less than a total of 7 days.

Growth will require identification, at a minimum the microorganism must be identified.

Formal results are reported to CMV VAMC via email within 7 days post analysis and signage by approving official.

100% Inspection of deliverables.

Report must state Incubation temperature and duration of incubation.

All formal reports must contain signature of approving official.

All required information included 100% of the time.

Customer (VA) support satisfaction, having no more than 2 incidents of dissatisfaction.

Customer Feedback and Complaints based on interactions with the contractor.

Customer problems are resolved within the same business day; no more than 2 incidents spent by Government personnel in providing corrective feedback on unacceptable customer service/professionalism.

b. Contractor shall email a formal report to email distribution group and ensure all identifier markers and pertinent information are included in the report no later than 7 days after samples have been analyzed and signed.

c. Reports must contain pertinent information such as identifier markers, temperature range and duration of incubation, CFU/ml or growth and name and signatures of analyzer and approving supervisors.

d. Growth exceeding allowable limits is reported to CMC VAMC via email within 24 hours of identification.

b. Electronic invoicing transmitted to the payment center specified in the contract.

c. All supporting documentation, is provided with invoices to substantiate charges.

d. Contractor shall notify the Program POC, of any errors, recall and resubmit invoice

14. DEFECTIVE PRODUCTS

The Contractor shall be responsible for notifying Pharmacy Service of defective products/sample damaged during transit or incubation within 24 hours of observation at no additional cost to the Government.

15. DOCUMENTING PERFORMANCE

Acceptable Performance The Government shall document acceptable performance in accordance with the chart above. Any report may become a part of the supporting documentation for any contractual action.

Unacceptable Performance When unacceptable performance occurs, the Program POC shall inform the CO. This will always be in writing although when circumstances necessitate immediate verbal communication, that communication will be followed in writing. The Program POC shall document the discussion and place it in the Program POC file.

When the CO determines formal written communication is required, the Program POC shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor's program manager.

The contractor shall acknowledge receipt of the CDR in writing to the CO. The CDR will state how long after receipt the contractor must take corrective action. The CDR will also specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CO shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

16. JUST IN TIME DELIVERY

· Notification is sent to CMCVAMC via email immediately (within 24 hours) after defective or damaged samples are identified.

· Notification is sent to CMCVAMC via email immediately (within 24 hours) after growth exceeding allowable level (>3cfu/ml) is identified.

· Final Laboratory results and/or reports is emailed to CMCVAMC Inpatient Pharmacy no later than 7 days after samples have been analyzed and signed.

Order Delivery Address CMCVAMC Inpatient Pharmacy 2nd Floor Room A236 Building 1 3900 Woodland Avenue Philadelphia PA, 19104 Phone: 215-823-5800 Ext. 206593 Email: VHAPHIPHARMACYLABREPORTS@va.gov

17. DELIVERY TICKETS FOR REPORTS

Order deliveries under this agreement must be accompanied by delivery tickets (invoice) that contain the following minimum information:

· Name of Contractor

· Contractor’s Phone Number, Address, Tax ID Number, Invoice Number, PO Number,

· Identifier Information (Employee name, cleanroom location, equipment etc.)

· Quantity, Unit of Measure (cfu), Price, and Nomenclature (description of samples), incubation temperature, length/days of incubation, legends.

· Name and signature of sample analyzer.

18. PHYSICAL SECURITY: All request will be placed using applicable identifier information such as

· Employees: Initials of first and last name

· Equipment: location, EE number and type of PEC (BSC, LAFW, CACI, Pass-through window)

· Cleanroom/Buffer room and Anteroom – Room number, location (Inpatient or Oncology Pharmacy)

19. CONTRACT DEFINITION

Employee - Authorized Government personnel (Federal employees and PIV badge-holding contractors) and their accompanied guests.

Contract – Contract awarded as a result of this solicitation.

Financial Services Center VA (FSC) – Payment is made through electronic funds transfer - Department of Veterans Affairs, Financial Services Center, PO Box #149971, Austin, TX 78714-9971; FAX: 512-460-5540 (services).

Program Point of Contact (POC) – Corporal Michael Crescenz VAMC (CMC VAMC) official responsible for providing Contract oversight and technical guidance to the CO. Responsibilities include certifying invoices, placing orders for service, providing technical guidance, and overseeing technical aspects of the Contract. Also acts as member of the CSP inspection team. All contacting authority remains with the CO. Program POC information shall be provided at time of award.

Quality Assurance – Those actions taken by the Government to assure services meet the requirements of this Contract.

Quality Assurance Surveillance Plan – An organized written document used for quality assurance surveillance. The document contains specific methods for performing surveillance of the Contractor’s continuous performance.

Quality Control – Those actions taken by the Contractor to control the production of goods or services, so they will meet the requirements of a contract.

Business Hours/Days - Business hours/days are defined as the time of 9:00am and 5:00pm. Monday through Friday, except Federal holidays.

CSP(s) – compounded Sterile Preparation(s)

GFT – Gloved fingertip test

MFT – Media Fill Test is a simulation used to qualify processes and employees engaged in sterile compounding to ensure that the processes and employees are able to prepare CSPs without contamination.

Direct Compounding Area (DCA) - critical area within the ISO Class 5 PEC where critical sites are exposed to unidirectional HEPA-filtered air, also known as first air.

Primary engineering control (PEC) - A device or zone that provides an ISO Class 5 air quality environment for sterile compounding.

ISO class - An air-quality classification from the International Organization for Standardization.

SOW – Statement of Work