SOURCES SOUGHT
65 -- Total Parenteral Nutrition
- Notice Date
- 9/9/2022 9:08:37 AM
- Notice Type
- Sources Sought
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- 262-NETWORK CONTRACT OFFICE 22 (36C262) Gilbert AZ 85297 USA
- ZIP Code
- 85297
- Solicitation Number
- 36C26222Q1717
- Response Due
- 9/15/2022 10:00:00 AM
- Archive Date
- 10/15/2022
- Point of Contact
- Hestia Sim, Contract Specialist
- E-Mail Address
-
Hestia.Sim@va.gov
(Hestia.Sim@va.gov)
- Awardee
- null
- Description
- This is a SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Responses to this sources sought notice must be in writing. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential businesses interested and capable of providing the supplies described below. VA San Diego Healthcare System located in 3350 La Jolla Village Drive, San Diego, CA 92161 is looking for a vendor to provide listed Total Parental Nutrition (TPN) medication for patient care listed on the Statement of Work (SOW). The order will be placed as needed basis and on the terms and conditions stated in this SOW. STATEMENT OF WORK General Requirements Vendor must have a local certified 503A pharmacy(c) with an active board of pharmacy license and FDA registered 503B Outsourcing Facilities that are licensed to ship into/within the State of California. Vendor must complete and meet all requirements for national VA Pharmacy Benefit Management (PBM) Compounded Sterile Products Assessment Guidelines. Vendor must be able to provide documentation of compliance with the standards outline in the current version of USP 797. vendor shall submit a cost proposal with an associated project management plan addressing the tasks associated with the SOW for below required medications. All written deliverables must be phrased in terms and language that can be easily understood by non-technical personnel, i.e. a person without subject matter expertise. All document deliverables, hard copy and electronic, must be in formats as specified-at a minimum, the formats must be in industry accepted standards. Vendor and/or its staff must have knowledge and expertise of the environment for which the work is to be performed. Vendor shall provide training for VASDHCS in using the online interface in how to enter a TPN prescription. All interested vendors must utilize amino acids, dextrose, sterile water for injection, lipids (intralipid and SMOF lipid) for macronutrients. Production Description: Vendor should have capabilities to add the following additives if VASDHCS formulates TPN based on patient s need. All interested vendors must be able to provide entire list of TPN drugs listed below on an as needed basis, and on the terms and conditions stated in this Statement of Work. If there is a shortage of products, vendors must provide notification or alert to VASDHCS, in a timely manner, regarding alternatives or omission. Drug Name Additive Classification Albumin 25% (50 mL Vial) Specialty Arginine HCL 10% Injection Specialty Ascorbic Acid 500 mg/mL Specialty Calcium Chloride 1.36 mEq/mL Specialty Calcium Gluconate 0.46 mEq/mL Specialty Chromic Chloride 4 mcg/mL Specialty Cupric Chloride 0.4 mg/mL Specialty Cupric Sulfate Inj 0.4 mg/mL Specialty Cyanocobalamin 1000 mcg/mL Specialty Cysteine HCL 5% (50 mg/mL) Specialty Erythropoietin 2000 units/mL Specialty Famotidine 10 mg/mL Specialty Famotidine 10 mg/mL PF Specialty Folic Acid 5 mg/mL Specialty Heparin PF 100 units/mL Standard (included) Hydrocortisone Sod Succ 100 mg Specialty Hyperlyte CR Standard (included) Insulin, Regular Standard (included) Iron Dextran 50 mg/mL Specialty Levocarnitine Inj 200 mg/mL Specialty Magnesium Sulfate 4.06 mEq/mL Specialty Manganese 0.1 mg/mL Specialty Metoclopramide 5 mg/mL Specialty Multitrace - Multrys Specialty Multitrace - Tralement Specialty MVI w/ Vitamin K Specialty Octreotide 100 mcg/mL Specialty Octreotide 1000 mcg/mL Specialty Octreotide 200 mcg/mL Specialty Octreotide 500 mcg/mL Specialty Ondansetron 2 mg/mL (generic Zofran) Specialty Pediatric MVI Specialty Phytonadione (Vit K) 10 mg/mL Specialty Phytonadione (Vit K) 2 mg/mL Specialty Potassium Acetate 2 mEq/mL Specialty Potassium Chloride 2 mEq/mL Specialty Potassium Phosphate 4.4 mEq K/3mmol PO4/mL Specialty Pyridoxine HCL 100 mg/mL Specialty Selenious Acid 4mcg/mL dilution Specialty Sodium Acetate 2 mEq/mL Specialty Sodium Chloride 4 mEq/mL Specialty Sodium Phosphate 4 mEq Na/3mmol PO4/mL Specialty Thiamine HCl 100 mg/mL Specialty Zinc 1 mg/mL Specialty **NOTICE: Remanufactures or gray market items/ supplies will not be acceptable. Interested parties of RFI/RFQ must be an authorized and licensed drug distributor. Verification can be provided by an authorization letter and via Verify Wholesale Drug Distributor Licenses | FDA. Medication shall be in accordance with the manufacturer s terms and conditions. No exceptions. Must be a manufacturer authorized distributor. ** Period of Performance: 10/1/2022 9/30/2023 Mandatory Tasks Vendor should provide and deliver the TPN prescriptions entered before the cutoff time by that day to prevent any delay in patient care. Vendor shall provide any changes to their formulary in a timely manner for VASDHCS to adjust their practice if needed. Hours of Operation Vendor needs to provide services as listed on their online website. Vendor will notify VASDHCS if there should be any interruptions to their capabilities in providing the TPN prescriptions on time. Acceptance Upon completion of training, the VASDHCS shall monitor and verify the TPN prescriptions being supplied by the vendor, and any prescription discrepancies will be addressed at the point of delivery of the TPN bags to the pharmacy. Vendor shall provide replacement bag if the product supplied is faulty or has discrepancy from the prescriptions that was submitted on the online interface. Vendor shall develop the QAP based on accepted industry standards such as the CMMI SM, ISO 9000, IEEE 12207, or other accepted industry QA standards. The QAP shall detail the processes, procedures, and metrics for assuring quality. The QAP shall also include, at a minimum, a description of the following key activities: Establishment of capable processes Development and implementation of procedures to identify, prevent, and ensure non-recurrence of defective services Establishment of mechanisms for feedback of performance Monitoring and control of critical processes Establishment of a designated point of contact (POC) to serve as the POC for quality control issues/complaints Establishment of reliable methods of record keeping and documentation of all corrective actions and process improvements undertaken during the acceptance period Vendor Responsibilities Vendor shall be responsible for compounding TPN prescriptions as entered by VASDHCS and to deliver the completed products in a timely manner to VASDHCS pharmacy on the same day to prevent delay in patient care. If there is an issue/compounding error with the bag that has been supplied, VASDHCS will contact the vendor to receive a replacement bag which should be remade and resent to VASDHCS. Vendor must keep up to date with their 503A certification to continually supply VASDHCS with TPN prescriptions. If you are interested and are capable of providing the required supplies, please provide the following information. (1) Company Name, Address, Point of Contact (2) Size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), HUBZone, Woman Owned Small Business (WOSB), Large Business, etc. (3) Is your company considered small under the NAICS code 325412 Pharmaceutical Preparation Manufacturing? (4) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract type and number. (5) If you are an FSS GSA/NAC or other federal contract holder, are the referenced items/solutions available on your schedule/contract? (6) Please provide general pricing and product lead time for your products/solutions for market research purposes. (7) Please submit a capability statement that addresses qualifications and verifies ability to perform work described above. The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought announcement. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. The VA is mandated by Public Law 109-461 to consider a total set-aside for Service Disabled Veteran Owned Small Businesses. However, if there are insufficient Service Disabled Veteran Owned Small Business responses, an alternate set-aside or full and open competition may be determined. No sub-contracting opportunity is anticipated. The North American Classification System (NAICS) code for this acquisition is 325412 (1,250 employees). Responses to this notice shall be submitted via email to hestia.sim@va.gov. Telephone responses will not be accepted. Responses must be received no later than 9/15/2022 10:00 AM Pacific Time. After review of the responses to this sources sought announcement, a solicitation may be published on the beta.sam.gov or GSA eBuy websites. Responses to this sources sought announcement will not be considered adequate responses to the solicitation. All interested offerors must respond to the solicitation in addition to responding to this sources sought announcement. Prospective bidders must be authorized re-sellers in order to participate in the solicitation process. Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM) at www.sam.gov. Additionally, all Service Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at www.vip.vetbiz.gov.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/fd2395608b804cbfbbad49e4be31bac7/view)
- Place of Performance
- Address: Department of Veterans Affairs VA San Diego Healthcare System 3350 La Jolla Village Drive, San Diego 92161, USA
- Zip Code: 92161
- Country: USA
- Zip Code: 92161
- Record
- SN06459959-F 20220911/220909230133 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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