S02 - Attachment A - Statement of Work.docx

COMBINED SYNOPSIS/SOLICITATION 36C24821Q0645

STATEMENT OF WORK

1.0 Introduction

Total parenteral nutrition (TPN) is an intravenous feeding method indicated for those patients who require complete bowel rest or fail to obtain nourishment from a dysfunctional gastrointestinal tract. The full daily caloric requirement can be met with parenteral delivery of macronutrients (carbohydrates, amino acids, and fats), as well as the replacement of micronutrients (electrolytes, minerals, vitamins, and other additives), tailored to the individual patient. The majority of calories are supplied with carbohydrates, followed by lipids, then amino acids. TPN can be a lifesaving treatment for patients who are not able to absorb nutrition from their gut, but it can also lead to many severe complications if not formulated and prepared appropriately.

2.0 Requirements

2.1 The contractor is required to be registered in good standing and as a Human Drug Compounding Outsourcing Facility under Section 503A of the Federal Food, Drug and Cosmetic Act (FD&C Act)

2.1.1 The contractor must notify the COR within ONE business day if an FDA Form 483 is issued by the FDA to the compounding facility the VA is utilizing during this contract.

2.2 Terms of contract

2.2.1 Effective May 1, 2021 through April 30, 2022; with four one-year options.

E. INSTRUCTIONS TO QUOTERS

Submitting your quote: Submit your company’s quote in writing and on paper to the address specified on page 1 of this Request for Quotes (RFQ) or via e-mail utilizing either PDF or Microsoft Word formats (8 Megabyte File Size Limitation). Vendors shall submit only one quote. If a concern submits more than one quote all quotes may be rejected from that concern. Quotes received that do not contain all of the following information being requested may be considered unacceptable.

Submission deadline: Your quote must be received at the address specified by the deadline specified on page 1. We will not consider any quote that we receive after the deadline unless we receive it before we issue an award and considering it will not delay the award. In case of an emergency that delays our operations and makes submission or receipt of your quote impossible, we will extend the deadline by one working day.

Terms and content of your quote: Quotes must be based on the terms of this RFQ. We may reject any quote that is not based on these terms in every respect. Your quote must contain all of the information described below.

Information to be submitted:

Put the following information on the first page of your quote:

1. RFQ Number: 36C24821Q0645

2. CONTRACTOR ________________________________________ (Contractor’s Name)

3. ADDRESS ________________________________________(Street)

4. ________________________________________ (City-State-Zip)

5. POINT OF CONTACT ________________________________________ (Name/Title)

6. PHONE NO. _____________________________________

7. E-MAIL ________________________________________

8. DUNS NUMBER ________________________________________

9. PAYMENT ADDRESS _______________________________________

Beginning on the second page of your quote, provide the following information in the following order:

1. All quotes shall include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the RFQ are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the RFQ are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

2. Provide a statement that your company’s Offeror Representations and Certifications are complete in SAM.gov.

3. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the synopsis solicitation numbered and dated as follows:

Add rows as needed.

The above amendment section must be filled-out in the event that an Amendment(s) is sent to the offeror or posted to www.fbo.gov and must be returned with the RFQ package. Failure to acknowledge amendment(s) may constitute the rejection of the quote.

To be considered for this award the Contractor must provide the following:

TECHNICAL

To be considered for this award, the prime contractor is to provide the following:

1. The contractor shall provide a State of Florida pharmacy license.

2. The contractor shall provide evidence that it is registered as a Human Drug Compounding Outsourcing Facility under Section 503A of the Federal Food, Drug and Cosmetic Act (FD&C Act).

3. The contractor shall not have any FDA-483(s) issued to its Outsourcing Facility suppling the VA under requirement within the last three years.

4. The contractor shall provide a listing of the pharmacists working for the contractor and copy of their State of Florida license.

5. The contractor shall provide a listing of the pharmacy technicians and a copy of their State of Florida pharmacist technician license.

6. The contractor must provide evidence that it meets or exceeds state required pharmacist-to-pharmacy technician ratios for State of Florida; see 64B16-27.410 of the Florida Administrative Code and Florida Administrative Register.

7. The contractor must provide a copy of its policy and procedure in place when validating new or changed facilities, equipment, processes, container types, to include sterility, and repeatability.

8. The contractor must provide a short narrative describing how it confirms that sterile media being used is certified by the manufacturer to be sterile and guaranteed to not promote growth. Narratives merely restating the requirement or stating that the requirement will be met, without providing supporting rationale will be determined unacceptable.

9. The contactor must provide a short narrative describing its monitoring techniques for surface microbiologicals and fungal environmental monitoring. Narratives merely restating the requirement or stating that the requirement will be met, without providing supporting rationale will be determined unacceptable.

10. The contractor shall provide a short narrative describing their process and procedures to ensure that the preparations leaving its facility retain their integrity and stability through the shipping cycle. Narratives merely restating the requirement or stating that the requirement will be met, without providing supporting rationale will be determined unacceptable.

11. The contractor shall provide a short narrative describing how they will deliver TPN bags within the three hours of an emergency order.

12. The contractor shall complete Attachment D – Limitation on Subcontracting Letter.

13. The contractor to provide a copy of their Certificate of Liability Insurance meeting or exceeding the following:

In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract:

I. Workers' compensation and employer’s liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

II. General Liability: $500,000.00 per occurrences.

III. Automobile liability: $200,000.00 per person; $500,000.00 per occurrence and $20,000.00 property damage.

PAST PERFORMANCE

Offeror shall be regularly established in the business of providing the services identified in the SOW and who have experience with commercial contracts of similar demand or greater, with conditions and scope as required for this contract.

Offeror’s submitting a quote shall provide three (3) identified references when submitting their quote. Emphasis will be on recent and relevant past performance. Recent is defined as work performed within the last three (3) years. Relevant is defines as work similar in scope of the work described in the PWS.

PRICE

1. The Government will review the price schedule for completeness and accuracy and will evaluate the reasonableness of the quoted prices. Normally, adequate price competition establishes a fair and reasonable price. Different analytical techniques and procedures may be used, singly or in combination, to ensure that the final price is fair and reasonable.

i. The quote's total price for the purpose of evaluation will include the base period, the first option, the second option, the third option, the fourth option and an additional six (6) months of the fourth option.

ii. To account for the option period(s) possible (maximum six months) under Clause 52.217-8, Option to Extend Services, the Government will add one-half of the quoted fourth option period price to the sum of all period total prices.

iii. Vendors are required only to price the base and four options. Vendors shall not submit a price for the potential six months extension of services period under Clause 52.217-8.

iv. Evaluation of options shall not obligate the Government to exercise the options.

All Offerors shall complete and return both Attachment B: Price/Cost Schedule and Attachment E: Limitations on Subcontracting. Not completing both will result in disqualification.

Offerors shall provide only one quote. Non-compliance with this requirement will result in disqualification of all quotes.

E9. ADDENDUM TO 52.212-2 EVALUATION - SIMPLIFIED ACQUISITION PROCEDURES

(a) Basis for Award. The Government will issue a purchase order to the responsible quoter whose quotation conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

The following factors shall be used to evaluate quotations:

(1) Technical

(2) Past performance

(3) Price

(b) Evaluation Approach. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2 (b) (3), where quotations will be compared to one another to determine which provides the best benefit to the Government. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotations may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation, but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government is not requesting or accepting alternate quotations. The evaluation will consider the following:

(1) Technical or Quality: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government’s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation.

(2) Past Performance: The past performance evaluation will assess the relative risks associated with a quoter’s likelihood of success in fulfilling the solicitation’s requirements as indicated by the quoter’s record of past performance. The past performance evaluation may be based on the contracting officer’s knowledge of and previous experience with the supply or service being acquired; Customer surveys, and past performance questionnaire replies; Contractor Performance Assessment Reporting System (CPARS) at http://www.cpars.gov/; or any other reasonable basis.

(3) Price: The Government will evaluate the price by adding the total of all line item prices, including all options. The Total Evaluated Price will be that sum.

(c) Options. The Government will evaluate quotations for award purposes by adding the total price for all options to the total price for the basic requirement. This includes options under FAR 52.217-8, Option to Extend Services, which applies to this solicitation. Evaluation of options under FAR 52.217-8 will be accomplished by adding six months of the quoter's price for the last potential period of performance under this contract to the quoter's total price. For example, if the contract includes option periods that are exercisable under FAR 52.217-9, the quoter's total price for the purpose of evaluation will include the base period, all option periods, and an additional six months of the last option period. Quoters must price only the base and option periods specified in the contract line item numbers (CLINs), and shall not submit a price for the potential six-month extension of services under FAR 52.217-8. The Government reserves the right to exercise the option under FAR 52.217-8 before the end of any of the contractor's performance periods and will be exercised at the price and/or rates in effect at the time the clause is exercised. Evaluation of options shall not obligate the Government to exercise the option(s).

(End of Provision)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

WAGE DETERMINATIONS

The DOL Wage Determination for the specific locality is available at www.beta.sam.gov. Please note the listing below is not all-inclusive wage determination of each area of performance. It is the contractor’s responsibility to obtain and evaluate each wage determination locality.

WD 2015-4572 (Rev.12) was first posted on www.betasam.gov on 6/18/2020 Area: Florida Counties of Hernando, Hillsborough, Pasco, Pinellas https://beta.sam.gov/wage-determination/2015-4572/12?keywords=2015-4572&sort=-relevance&index=wd&is_active=true&page=1

Point of Contact:

Contracting Officer Name: Annette Whitfield-Johnson Organization: NCO 8 Phone No.: (727) 399-3333 E-Mail Address: Annette.Whitfield@va.gov