Attachment A - PWS.pdf

Performance Work Statement Environmental Laboratory Specimen Sampling

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. Acronyms/Definitions

Employee - Authorized Government personnel (Federal employees and PIV badge-holding vendors) 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 Vendor’s continuous performance.

Quality Control – Those actions taken by the Vendor 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 can 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.

PWS – Performance Work Statement

5. 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:

• Upon hiring and semi-annually, Gloved fingertip test (GFT) and Media fill test (MFT), Surface testing of Direct Compounding Area (DCA) of pharmacy compounding personnel

• Monthly microbiology testing and analysis of Surface and/or Air samples from Compounding Cleanrooms/Buffer rooms, Anterooms and Equipment.

6. PERIOD OF PERFORMANCE: The period of performance will be for a 5-year Indefinite

Delivery Indefinite Quantity (IDIQ).

Funding Year 1 Jan 15th, 2025 – Jan 14th, 2026

Funding Year 2 Jan 15th, 2026 – Jan 14th, 2027

Funding Year 3 Jan 15th, 2027 – Jan 14th, 2028

Funding Year 4 Jan 15th, 2028 – Jan 14th, 2029

Funding Year 5 Jan 15th, 2029 – Jan 14th, 2030

7. 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

New Year’s Day January 1st

Martin Luther King’s Birthday 3rd Monday in January

President’s Day 3rd Monday in February

Memorial Day Last Monday in May

Juneteenth June 19th

Independence Day July 4th

Labor Day 1st Monday in September

Columbus Day 2nd Monday in October

Veteran’s Day November 11th

Thanksgiving Day Last Thursday in November

Christmas Day December 25th

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.

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

9. GOVERNMENT RESPONSIBILITIES

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. CMC VAMC personnel will conduct the required surface and/or air samplings, media fill testing and gloved fingertip testing and ship directly to the lab for analysis. All samples mailed to the vendor shall be paid by CMCVAMC.

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 electronic reporting of results. Samples shall be mailed to the Vendor’s testing facility from CMC VAMC via US postal service, FedEx 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). Costs incurred by the vendor, outside the scope of the contract, shall be borne by the vendor.

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.

• Vendor 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. Vendor must be compliant with all applicable federal and local licensing boards.

• Vendor will ensure that personnel are available during business hours to receive and sign for samples from CMC VAMC via the delivery service personnel.

• 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 electronically shared with CMC VAMC Pharmacy Service.

VHAPHIPHARMACYLABREPORTS@va.gov

• CMCVAMC will be notified via email within 24 hours of growth exceeding allowable cfu/ml at VHAPHIPHARMACYLABREPORTS@va.gov

• Vendor will only invoice CMC VAMC for services requested and/or covered by the contract. The vendor 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. Samples from CMC VAMC will be received, analyzed and reported in accordance with

USP Chapter 797 guidelines to VHAPHIPHARMACYLABREPORTS@va.gov

2. Media fill testing will be conducted initially (at point of hire) and every 6 months thereafter for employee competencies. Examine the media fill bag/units for any visible mailto:VHAPHIPHARMACYLABREPORTS@va.gov mailto:VHAPHIPHARMACYLABREPORTS@va.gov turbidity or changes indicating growth at the conclusion of the full incubation against a white and black background in a well -lit area, record either and pass or fail result and report findings to CMC VAMC.

3. Gloved fingertip testing conducted initially (at point of hire) and every 6 months thereafter for employee competencies. Record the number of CFU per hand (left hand, right hand). Determine whether the CFU action level is exceeded by counting the total number of CFU on both hands. Species identification is not required, but the total colony count will be reported to CMC VAMC.

4. Surface and Air samples will be tested for total microbial counts. Growth exceeding the action level will require identification. At minimum the genus of the microorganism must be identified.

5. Agar plates or Trypticase Soy Agar Paddle for GFT, Surface and Air sampling will be incubated as required in USP Chapter 797. The order of incubation temperature must be described in an SOP. Results at each temperature must be documented.

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., left or right hand, 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.

Media Fill Testing - (MFT)

• The Vendor 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 20°–25° for 7 days followed by 30°–35° for an additional 7 days. Total days of incubation – 14 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 Vendor 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.

• Genus level and cfu/ml of microorganisms recovered must be reported.

• 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 Vendor 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.

• Genus level and cfu/ml of microorganisms recovered must be reported.

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

6. PRODUCT DESCRIPTION

Pharmacy Personnel -New Hire (>/= 11 samples depending on failures)

Item Descriptions Quantity Per Employee

Post-Hygiene and Garbing

GFT

Demonstrating Competency in Garbing and Hand Hygiene (No fewer than 3 separate times. The 3 successful completions must be in succession)

6 (Left and right hands)

Post-Hygiene and Garbing

GFT

Demonstrating Competency in Garbing and Hand Hygiene

2 (Left and right hands)

Post media fill GFT Assesses aseptic technique and related practices.

2 (Left and right hands)

Media Fill Demonstrating Competency in Aseptic Manipulation 1

Surface sample of DCA Assesses aseptic technique and related practices.

(Sample collection from surface of direct compounding area)

Pharmacy Personnel – Semiannual /Every 6 months (>/= 6 samples depending on failures)

Post-Hygiene and Garbing

GFT

Demonstrating Competency in Garbing and Hand Hygiene (Sample collection from left and right fingers)

2 (Left and right hand)

Post media fill GFT Assesses aseptic technique and related practices.

(Sample collection from left and right fingers)

2 (Left and right hand)

Media Fill Demonstrating Competency in Aseptic Manipulation 1

Surface sample of DCA Assesses aseptic technique and related practices.

(Sample collection from surface of direct compounding area)

Compounding Equipment, Cleanroom/Buffer room and Anteroom (>/=5 samples per location or equipment)

Item Descriptions Quantity

Viable Air Sampling Monitors air quality in the compounding cleanroom, buffer room and or equipment for viable air particles

NA

Surface Sampling Monitors surfaces in the compounding cleanroom, buffer room and or equipment for viable particles

NA

Control Sample Unopened paddles or plates inserted into the testing process and treated as if they were samples by being exposed to the same operating conditions.

NA

7. RESULT REPORTING VIA EMAIL

7.1 Signed/Endorsed reports will be delivered to the CMC VAMC electronically to the address below.

Email: VHAPHIPHARMACYLABREPORTS@va.gov

7.2 Report will have the following information:

• Sample identifier markers - Employee initials, sample location, equipment number, Left or right hand 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.

8. JUST IN TIME DELIVERY – VIA EMAIL (VHAPHIPHARMACYLABREPORTS@va.gov)

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

• Notification is sent to CMC VAMC via email immediately (within 24 hours) after growth exceeding allowable level is identified.

• Formal Laboratory results and/or reports is emailed to CMC VAMC no later than 7 days after samples have been analyzed and signed.

9. COMPLIANCE, PERMITS, CERTIFICATIONS, & INSURANCE

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

• The vendor 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 vendor 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 vendor shall immediately (within 6 hours) notify the POC via a phone call to the POC (215-823-5800 ext. 206593) and follow-up email (VHAPHIPHARMACYLABREPORTS@va.gov) of any service interruptions or breakdowns that arise. It is the responsibility of the vendor to provide contingency testing services to minimize any delay or inconveniences.

• The vendor shall immediately (within 24 hours) notify the POC via a phone call and email upon receipt of sample(s) damaged during transit.

• Weather: The vendor 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 vendor shall receive a response from the POC within one (1) hour of notification as to if services should be discontinued.

• Future Delays: If the vendor foresees they will not be able to provide service on a given day, vendor’s designated POC will provide advance email notification within a minimum of 24 hours, with the reason for lack of service to the email group.

• 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. VENDOR COMMUNICATION

The vendor shall provide the CMCVAMC with a reliable mailing address for mailing samples.

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

12. INVOICING

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

• Vendor 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.

https://portal.tungsten-network.com/

• 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 Vendor with a corrected invoice.

• A properly prepared invoice will contain:

➢ Name and Address of Vendor

➢ 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

➢ 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.

13. SPECIAL CONTRACT REQUIREMENTS:

13.1 Reports/Deliverables: The Contractor shall be responsible for complying with all reporting requirements established by the Contract. Contractor shall be responsible for assuring the accuracy and completeness of all reports and other documents as well as the timely submission of each. Contractor shall comply with contract requirements regarding the appropriate reporting formats, instructions, submission timetables, and technical assistance as required.

13.2 The following are brief descriptions of required documents that must be submitted by

Contractor: weekly; monthly; quarterly; annually, etc. identified throughout the PWS and is http://www.fsc.va.gov/einvoice.asp provided here as a guide for Contractor convenience. If an item is within the PWS and not listed here, the Contractor remains responsible for the delivery of the item.

14. DOCUMENTING PERFORMANCE - QASP

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

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