P01 PWS.docx

PERFORMANCE WORK STATEMENT

A. General Guidance

1) Performing United States Pharmacopeia (USP) chapter <797> mandatory competency/environmental testing for pharmacy sterile compounding services.

2) Scope of Work: Performing analysis and incubation of media fill and plates at an accredited clinical laboratory.

3) Background: Pharmacy is submitting a request for initiation of a contract with an accredited clinical lab to perform the analysis, incubation, and reporting results of compounding personnel competencies and environmental testing done in the sterile compounding areas. Those tests are required to comply with USP<797> 2023 version standards and VHA Directive 1108.12, Management and monitoring of pharmaceutical compounded preparations dated February 14, 2024. Currently, Salem VAHCS clinical lab does not have International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 certifications to perform those testing and 90% of VHA facilities send this testing to a certified lab external to their facility.

4)

5) Performance Period: 12/1/2025 – 11/30/2030 Base plus 4 Option Years

B. General Requirements:

The contract should cover the following tasks:

· Incubation and analysis of the media plates used for monthly surface sampling in pharmacy sterile compounding areas.

· Incubation and analysis of media samples and contact plates used for initial and ongoing competency testing required for sterile compounding personnel.

· Sending the analysis results to the pharmacy in a timely manner.

C. Special Requirements:

Service Requested, Incubation Temperatures and Timeframes:

30ºC -35ºC 14 days total

D. Government Responsibilities:

Salem VAHCS pharmacy will be responsible for the following tasks:

· Performing the competency and monthly surface sampling tests in the sterile compounding areas.

· Shipping the Media bags and plates in addition to any needed forms to the clinical lab.

· Documentation of the results appropriately.

E. Contractor (Lab) requirements:

Qualifications/Certifications:

· Per the Memorandum dated October 24th,2023 from the Assistant Under Secretary for Health for Clinical Services/Chief Medical Officer:

“The clinical lab must have an ISO/IEC 17025 certification from an external accrediting body (e.g., American Association for Laboratory Accreditation) to ensure quality and accuracy of the testing.”

· The clinical lab must perform their analysis and incubation per USP<797> 2023 version standards.

F. Equipment:

· All tools needed (contact plates and media samples) will be purchased by pharmacy and maintained in the recommended storage condition until use.

· Shipping labels (overnight) are to be provided by the Contractor.

G. Scheduling and Hours of Work:

· All tests will be done and sent to the clinical lab on demand via overnight shipping to ensure compliance with USP<797> standards.

B.4 SPECIAL CONTRACT REQUIREMENTS

BACKGROUND INVESTIGATIONS

A full background check is not required for this position; however, all contract employees must bring photo identification and advance notice from the requiring service to obtain a VA Badge to work on a VA facility.

CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS)

(a) FAR 42.1502 directs all Federal agencies to collect past performance information on contracts. The Department of Veterans Affairs has implemented use of the Contractor Performance Assessment Reporting System (CPARS) to comply with this regulation. One or more past performance evaluations will be conducted in order to record your contract performance as required by FAR 42.15

(b) The past performance evaluation process is a totally paperless process using CPARS. CPARS is a web-based system that allows for electronic processing of the performance evaluation report. Once the report is processed, it is available in the Past Performance Information Retrieval System (PPIRS) for Government use in evaluating past performance as part of a source selection action.

(c) Please furnish the Contracting Officer with the name, position title, phone number, and email address for each person designated to have access to your firm’s past performance evaluation(s) for the contract no later than 30 days after award. Each person granted access will have the ability to provide comments in the Contractor portion of the report and state whether or not the Contractor agrees with the evaluation, before returning the report to the Assessing Official. The report information must be protected as source selection sensitive information not releasable to the public.

(d) When your Contractor Representative(s) (Past Performance Points of Contact) are registered in CPARS, they will receive an automatically generated email with detailed login instructions. Further details, system requirements, and training information for CPARS are available at www.cpars.gov. The CPARS User Manual, registration for online training for Contractor Representatives may be found at this site.

(e) Within 60 days after the end of a performance period, the Contracting Officer will complete an interim or final past performance evaluation and the report will be accessible at www.cpars.gov Contractor Representatives may then provide comments in response to the evaluation or return the evaluation without comment. Comments are limited to the space provided in Block 22. Your comments should focus on objective facts in the Assessing Official’s narrative and should provide your views on the causes and ramifications of the assessed performance. In addition to the ratings and supporting narratives, blocks 1-17 should be reviewed for accuracy, as these include key fields that will be used by the Government to identify your firm in future source selection evaluations. If you elect not to provide comments, please acknowledge receipt of the evaluation by indicating, “No Comment” in Block 22, and then signing and dating Block 23 of the form. Without a statement in Block 22, you will be unable to sign and submit the evaluation back to the Government. If you do not sign and submit the CPAR within 30 days, it will automatically be returned to the Government and will be annotated: “The report was delivered/received by the contractor on (date). The contractor neither signed nor offered comment in response to this assessment.” Your response is due within 30 calendar days after receipt of the CPAR.

(f) The following guidelines apply concerning your use of the past performance evaluation:

(1) Protect the evaluation as “source selection information.” After review, transit the evaluation by completing and submitting the form through CPARS. If for some reason you are unable to view and/or submit the form through CPARS, contact the Contracting Officer for instructions.

(2) Strictly control access to the evaluation within your organization. Ensure the evaluation is never released to persons or entities outside of your control.

(3) Prohibit the use of or reference to evaluation data for advertising, promotional material, preaward surveys, responsibility determination, production readiness reviews, or other similar purposes.

(g) If you wish to discuss a past performance evaluation, you should request a meeting in writing to the Contracting Officer no later than seven days following your receipt of the evaluation. The meeting will be held in person or via telephone or other means during your 30-day review period.

(h) A copy of the completed past performance evaluation will be available in CPARS for your viewing and for Government use supporting source selection actions after it has been completed.

HOURS OF OPERATION

The services covered by this contract shall be furnished by the contractor as defined herein. The contractor shall not be required, except in case of emergency, to furnish such services on Federal Holidays or during off duty hours as described below.

Normal working hours are Monday through Friday, 8:00am-4:30pm, excluding federal holidays which are as follows:

Any other day specifically declared by the President of the United States to be a federal holiday. When one of the holidays falls on Sunday, the following Monday shall be observed as a Federal Holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

BILLING AND PAYMENT

Contractor shall submit invoice monthly in arrears via payment request in electronic form via VA’s Electronic Invoice Presentment and Payment system https://authentication.tungsten-network.com/login. The following information must be included on all submitted invoices. Invoices submitted without the following information may be rejected for payment. Invoices shall include at a minimum:

• Date of invoice

• Invoice number

• Contract number

• Obligation number

• Vendor name

• CLIN and dates of service

CONTRACT ADMINISTRATION

Notwithstanding the Contractor's responsibility for total management during the performance of this contract, the administration of the contract will require maximum coordination between the Government and the Contractor.

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes that shall affect price, quantity, or quality of performance of this contract.

The Facility POC shall be responsible for the overall technical administration of this contract.

IN THE EVENT THE CONTRACTOR EFFECTS ANY SUCH CHANGE AT THE DIRECTION OF ANY PERSON OTHER THAN THE CONTRACTING OFFICER WITHOUT AUTHORITY, NO ADJUSTMENT SHALL BE MADE IN THE CONTRACT PRICE TO COVER AN INCREASE IN COSTS INCURRED AS A RESULT THEREOF.

POINT OF CONTACT

Contracting Officer (CO) Zanona Pickett / 757-722-9961 ext 17596 / zanona.pickett@va.gov

Facility POC

TBD