PRESOL | 89 | Total Parenteral Nutrition (TPN)

FBO DAILY ISSUE OF DECEMBER 20, 2009 FBO #2948
SOLICITATION NOTICE

89 -- Total Parenteral Nutrition (TPN)

Notice Date: 12/18/2009
Notice Type: Combined Synopsis/Solicitation
NAICS: 325412 — Pharmaceutical Preparation Manufacturing
Contracting Office: Department of Veterans Affairs;Rocky Mountain Network;VISN 19 Contracting;4100 E. Mississippi Avenue, Suite 1110;Glendale CO 80246
ZIP Code: 80246
Solicitation Number: VA-259-09-RQ-0446
Response Due: 12/24/2009
Archive Date: 1/23/2010
Point of Contact: Aeonard BorelContracting Specialist
E-Mail Address: Contracting Officer's E-mail Address
(aeonard.borel@va.gov)
Small Business Set-Aside: N/A
Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Solicitation VA-259-09-RQ-0446 is issued as a request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-19. This is a competitive procurement under the North American Industrial Classification System (NAICS) Code 325412. The Eastern Colorado Health Care System (ECHCS) intends to solicit an indefinite delivery/indefinite quantity (IDIQ) contract for all necessary materials used in preparing the admixture solutions such as IV bags, transfer sets, TPN clips, needles, syringes, seals, swabs, gloves and sharps containers. as identified in the pricing schedule. Services shall be one year from date of award, plus the opportunity of four (4) option years. All payments by the Government to the contractor shall be made in accordance with FAR 52.212-4(i) Payments. Invoices shall be submitted in accordance with FAR 52.212-4(g) Invoices. All invoices from the contractor shall be submitted to the following address: Department of Veterans Affairs Financial Service Center, PO Box 149971, Austin TX 78714-8971. The pricing schedule will contain: (1) The description of the item to be provided, (2) The Government's estimated quantity of use per year by unit of issue, (3) The unit price, and (4) The estimated extended price (Government estimated quantity of use by unit of issue times the unit price). BASE YEAR CLIN 101 is described as CRRT, with an estimated quantity and unit of 120 BG..CLIN 102 IDPN is described as IDPN (Intradialytic Peritoneal Inj) with an estimated quantity and unit of 180 BG. CLIN 103 is described as TPN, Adult with a quantity and unit of 20 EA for 1-1000ml, 400 EA for 1001-2000ml, 1380 EA for 2001-3000ml. FIRST OPTION YEAR CLIN 201 is described as CRRT, with an estimated quantity and unit of 120 BG..CLIN 202 IDPN is described as IDPN (Intradialytic Peritoneal Inj) with an estimated quantity and unit of 180 BG. CLIN 203 is described as TPN, Adult with a quantity and unit of 20 EA for 1-1000ml, 400 EA for 1001-2000ml, 1380 EA for 2001-3000ml. SECOND OPTION YEAR CLIN 301 is described as CRRT, with an estimated quantity and unit of 120 BG. CLIN 302 IDPN is described as IDPN (Intradialytic Peritoneal Inj) with an estimated quantity and unit of 180 BG. CLIN 303 is described as TPN, Adult with a quantity and unit of 20 EA for 1-1000ml, 400 EA for 1001-2000ml, 1380 EA for 2001-3000ml. THIRD OPTION YEAR CLIN 401 is described as CRRT, with an estimated quantity and unit of 120 BG. CLIN 402 IDPN is described as IDPN (Intradialytic Peritoneal Inj) with an estimated quantity and unit of 180 BG. CLIN 403 is described as TPN, Adult with a quantity and unit of 20 EA for 1-1000ml, 400 EA for 1001-2000ml, 1380 EA for 2001-3000ml. FOURTH OPTION YEAR CLIN 501 is described as CRRT, with an estimated quantity and unit of 120 BG..CLIN 502 IDPN is described as IDPN (Intradialytic Peritoneal Inj) with an estimated quantity and unit of 180 BG. CLIN 503 is described as TPN, Adult with a quantity and unit of 20 EA for 1-1000ml, 400 EA for 1001-2000ml, 1380 EA for 2001-3000ml. SPECIAL CONTRACT REQUIREMENTS: Contractor shall provide 10% amino acids with 70% Dextrose in bags and will include additives such as vitamins, trace elements, electrolytes, and Insulin. Contractor shall provide all necessary materials used in preparing the admixture solutions such as IV bags, transfer sets, TPN clips, needles, syringes, seals, swabs, gloves and sharps containers. Mixing of TPN solutions shall be in compliance with the American Society of Hospital Pharmacies (ASHP) guidelines and USP 797 standards. Contractor shall label and number the TPN products with a label matching those currently used at the Denver VA Medical Centers. Usage records for each product admixed shall be provided by the Contractor on a monthly basis. Contractor shall provide quality assurance data as required by JCAHO, on a quarterly basis. Contractor shall provide a customer service representative, which will be available 24 hours a day. Ordering: Ordering facilities will fax requests to the contractor. STATEMENT OF WORK: 1. Veterans Administration Medical Center Expectations of Vendor A. Daily Schedule 1. Vendor hours of operations a) Vendor hours of operations are 7 days /week 08:30-16:30 or similar with contact phone number for all "after hours" inquiries. Veterans Administration Medical Center will be notified of any changes. 2. Order Transmission Times. TPN's will be ordered seven days per week. Vendor will receive orders throughout the day by fax with cutoff times for deliveries being 15:00 Vendor fax number is required for orders 3.Delivery Time a )TPN's ordered by 15:00 will be delivered by 19:00. 4. Nonstandard/Late Deliveries. Vendor will make every effort to accommodate late or early orders. Delivery or pick up will be arranged on per case basis. Vendor will notify Veterans Administration Medical Center if a delivery is late in leaving the Vendor pharmacy and may result in a late delivery to the hospital. B. Order Transmission 1. Veterans Administration Medical Center will fax orders to Vendor. Vendor Fax number is ___________ The Veterans Administration Medical Center Fax number is _____________ Point of Contact Phone number is _____________ C. Delivery Policies 1. Location of Delivery. a) Vendor will deliver all products to the central pharmacy on the 1st floor of the Denver VAMC 1055 Clermont St., Denver, CO 80220 1. Receipt of Delivery a)Upon receipt of the Vendor shipment, the receiving Veterans Administration Medical Center employee will sign the Vendor packing/delivery list as confirmation of receipt of the listed prescriptions and retain one copy. The Veterans Administration Medical Center employee will verify the count of TPN bags upon receipt. Packing lists will be provided with each delivery signed by Vendor and delivery personnel. D. Discontinued Dose Policy 1. If a TPN is discontinued and Vendor is notified 30 minutes before the delivery leaves Vendor, Veterans Administration Medical Center will not be charged for the dose. Veterans Administration Medical Center Policies and Procedures related to Vendor. 2. Veterans Administration Medical Center will have a 36-hr expiration date on all TPN and Vendor will label all bags as such. 3. Vendor will not release Veterans Administration Medical Center deliveries until a Veterans Administration Medical Center patient list/count is faxed by Veterans Administration Medical Center. Vendor will review the patient list/count against the Vendor packing list to ensure all active TPN patients have a corresponding bag. Vendor fax number is required. E. Labeling 1. Vendor will label all adult TPN bags with the agreed upon label definition by both entities. 2. Veterans Administration. Medical Center may modify label when changing order format. F. Minimum and Maximum Ranges for TPN Additives. Vendor will screen all orders using the Vendor standard Min/Max values. 1. Veterans Administration Medical Center may modify the Min/Max values to more or less conservative levels. All Min/Max changes must be agreed upon by Vendor. a) Vendor will provide Veterans Administration Medical Center with inventory information as necessary. G. Product Recall: Contractor shall notify the Contracting Officer administering the contract, within three (3) business days, of any recall, removal, modification, or defect of items supplied under contract, for appropriate action. Resolution in such circumstance may be made by replacement of item at no cost to the Government, full credit of item toward future purchase, or any other method agreeable to both parties. Any freight costs incurred as a result shall be borne by the Contractor, or credited to the Government, as appropriate. H. Any item found to be defective or technically unacceptable, as verified by the Contractor, shall be returned to the contractor and replaced or credited in the same manner as specified under Product Recall. Returns of items for any other reason shall be determined at the mutual discretion of the Government and the Contractor. The Contractor shall not be liable for replacement or crediting the Government for any item due to misuse or abuse by Government personnel. I. Product Vendor will: 1.Follow all standard operation procedures' and USP Chapter<797>. 2. Comply with all applicable local, state and federal rules and regulations.3. Use only fully trained and qualified employees. Training includes: a) Product Knowledge b)Procedures c) Aseptic Technique d) Process Controls f) Veterans Administration Medical Center Specific Requirements 4. All final products checked by Licensed Pharmacist J. Vendor Communication with Veterans Administration Medical Center 1. Daily communication with Veterans Administration Medical Center TPN pharmacist will occur as needed by telephone or fax to discuss prescription content, order entry, delivery exceptions and to confirm that all orders have been received. 2. Quarterly meetings will be held with the TPN Pharmacist and invited staff to discuss any existing problems, policy changes, to review QA reports, and to revise customer/Vendor expectations. K. Quality Improvement. 1. All Vendor staff participates in a continuous quality assessment and improvement program, which meets requirements, developed by JCAHO, the FDA and ISO 9000. 1. Vendor will meet all applicable Federal, State, and JCAHO requirements for quality assurance. L..Packing List/Invoice 1.Vendor will provide a packing list with all deliveries, which includes patient names and product being delivered M. Vendor on-call Cascade 1. Vendor phone number will be provided for normal business hours. 2. Vendor R.Ph. will provide pager number for a pharmacist who can return your call during off-hours. 3. Vendor will provide contact person/number for all additional inquires. Vendor Expectation of Veterans Administration Medical Center A. Order cutoff Times 1. Veterans Administration Medical Center will enter and transmit orders by fax. 2. Vendor expects Veterans Administration Medical Center to fax orders to Vendor at reasonable intervals throughout the day (so that entered orders don't accumulate until late in the compounding day). B.Veterans Administration Medical Center Changes 1. Veterans Administration Medical Center changes in policies, systems, order forms and formulary will be communicated to Vendor with sufficient time to respond to the changes. C. Order Clarification 1. Veterans Administration Medical Center shall respond to Vendor order clarification questions with at least one hour remaining before scheduled delivery. Clarifications can be directed to IV pharmacist at (303) 399-8020 x2416 D. Order Correctness. 1. Veterans Administration Medical Center will check all orders for therapeutic correctness as well as physical and chemical compatibility before faxing to Vendor. 2. Veterans Administration Medical Center personnel will check all Vendor TPNs against the original physician's orders before dispensing to the patient. E. Late Order Policy 1. Vendor will make every effort to accommodate late order transmissions. F. Veterans Administration Medical Center Primary Contacts and Phone/pager numbers: a. Main Pharmacy Phone: (303) 399-8020 Ext. 2413 b) V Room: (303) 399-8020 Ext. 2416 c) Pharmacy Purchaser: (303) 399-8020 Ext. 2415 d) Fax: (303)393-5267 2. Others a)Tonja Svensk, Inpatient Pharmacy Manager (303) 399-8020 Ext. 2974. Guaranteed Minimum Quantity: The quantities listed in the schedule of Supplies or Services and Price/Cost are estimates based on previous year's utilization. Notwithstanding the estimated quantities contained within the schedule, the Government is obligated to order only the minimum quantity of $1000.00 over the life of the contract. The maximum quantity to be ordered is not to exceed $50, 000 per year. Should the contractor be unable to provide delivery within the specified time period, the contractor shall immediately notify the COTR as to why he/she will be unable to perform as required by the contract. Notification shall be in sufficient time to allow the VA to seek other alternatives and remedies necessary to complete the services required. Should the contractor fail to furnish services within the specified time periods, after the receipt of a delivery order, the VA reserves the right to obtain the service from another source and to charge the Contractor for all costs in excess of those contained within the price schedule. The Contracting Officer or his/her designee shall be solely responsible for determining when to order service from another source. Furthermore, failure to provide services as set forth in this contract shall be grounds for termination for cause under the terms of FAR 52.212-4(m) Termination for Cause clause. The Contractor shall operate the facility ("Center"), which shall provide the services to Customer. The Center shall be operated consistent with applicable Federal and State licensing requirements, laws, and regulations established for such service. The Center shall operate in accordance with applicable Industry Manufacturing Practices, Drug Enforcement Agency requirements, as well as standard and customary commercial practices. If there is a question regarding the quality of an admixture, the admixture may be shipped to the Contractor for evaluation purposes only. For any admixture preparation which evaluation reveals was prepared in error by the Contractor, the Contractor shall provide Customer a full credit for the service. This contract applies only to services listed on the pricing schedule. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the base year. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful Contractor within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Offeror shall submit a minimum of three references from organizations with which they have provided previous services, providing the organization's name and point of contact, their address, and telephone number. FAR 52-216-1, Type of Contract, is prescribed (The Government contemplates award of a firm-fixed price contract resulting from this solicitation). The provisions at FAR 52.212-1, Instructions to Offerors-Commercial items applies to this acquisition with the following changes, items (e) and (h) of the standard clause are deleted. The following provisions are incorporated into 52.212-1 as an addendum to this contract. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial items, with their offer. The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, and clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text, and apply to this acquisition. Upon request, the Contracting Officer will make their full text available. The following clauses are incorporated into 52.212-4 as an addendum to this contract: 52.216-18, Ordering (Oct 1995) (which provides orders may be issued between October 1, 2007 and September 30, 2012); 52.216-19 (which provides a Minimum order less the $50.00; Maximum order for a single item in excess of $1,000.00; for a combination of items in excess of $5,000.00; a series of orders from the same ordering office within two(2), and the Contractor shall honor any order exceeding the maximum order limitations in defined in paragraph (b), unless the order (or orders) is returned to the ordering office within one (1) day(s) after issuance), and 52.216-22 Indefinite Quantity (Oct 1995), providing that the Contractor shall not be required to make deliveries under this contract after September 30, 2012. The following standard FAR clauses are incorporated and apply to this acquisition: 52.217-9 (which provides that the Government may extend the term of the contract within 60 calendar days, provided that the Government shall provide a preliminary notice of intent at least 60 calendar prior to the expiration date; and services under this contract shall not exceed five (5) years), 52.232-18 Availability of Funds (Apr 1984), and 52.232-19 (which provides that funds are not authorized past September 30 of any fiscal year, unless written authorization is received from the Contracting Officer).VAAR 852-233-70 Protest Content (Jan 1998), 852-233-71 Alternate Protest Procedure, 852-237-70 Contractor Responsibilities (Apr 1984) and VAAR 852.270-4 Commercial Advertising (Nov 1984). The following clauses are incorporated into 52.212-5 as an addendum to this contract: 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (July 2005); 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)); 52.219-28, Post Award Small Business Program Rerepresentation (APR 2009) (15 U.S.C 632(a)(2)); 52.222-3, Convict Labor (June 2003) (E.O. 11755); 52.222-19, Child Labor--Cooperation with Authorities and Remedies (AUG 2009) (E.O. 13126); 52.222-21, Prohibition of Segregated Facilities (Feb 1999); 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246); 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212); 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793); 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212); 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004) (E.O. 13201); 52.225-1, Buy American Act--Supplies (FEB 2009) (41 U.S.C. 10a-10d); 52.225-5, Trade Agreements (AUG 2009) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note); 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury); 52.232-34, Payment by Electronic Funds Transfer--Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332); 52.232-36, Payment by Third Party (May 1999) (31 U.S.C. 3332). Interested offerors may submit their proposals along with a completed copy of the provision at FAR 52.212-3 Offerors Representations and Certifications-Commercial Items, on or before 4:30 p.m., December 24, 2009. Quotations may be provided to the Contracting Officer at the address above or fax at (303) 691-6558
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VARMCCC/VARMCCC/VA-259-09-RQ-0446/listing.html)
Place of Performance: Address: Denver VAMC;1st Floor Pharmacy;1055 Clarmont Street;Denver CO; Zip Code: 80220
Record: SN02027491-W 20091220/091218235024-d0bef8ed8d31788810d748b5a46c2cc8 (fbodaily.com)
Source: FedBizOpps Link to This Notice
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89 -- Total Parenteral Nutrition (TPN)