SOURCES SOUGHT
65 -- The Pacific Region Tri-Service Regional Business Office (TRBO) Region 12 announces a Request for Regional Incentive Agreement Quotation (RFRIAQ) for the standardization of Pharmacy Bottles.
- Notice Date
- 10/22/2009
- Notice Type
- Sources Sought
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Pacific Regional Contr Ofc TAMC, ATTN: MCAA PC BLDG 160, 160 Krukowski Road, Honolulu, HI 96859-5000
- ZIP Code
- 96859-5000
- Solicitation Number
- W81K02-10-T-3100
- Response Due
- 11/13/2009
- Archive Date
- 1/12/2010
- Point of Contact
- Mary L. Summers, 8084333686
- E-Mail Address
-
Pacific Regional Contr Ofc TAMC
(mary.summers1@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- The primary objective of this program is to standardize the quality of care across the regions based on the critical balance of clinical efficacy and value. It is intended for this initiative to result in the standardization of a clinically preferred product and source at the best possible price. It is also intended that standardized products be obtained through the Department of Defense Prime Vendor Program. As a clinically driven program, vendors and products must meet specific technical criteria plus products must meet or exceed specific clinical performance expectations as a primary consideration. Selection will be based clinical, technical, and pricing factors. The selection will be determined utilizing best value/trade-off criteria. The major Medical Treatment Facilities (MTFs) in the Pacific Region, TRBO Region 12 area include but are not limited to Tripler Army Medical Center, U.S. Naval Hospital Okinawa, U.S. Naval Hospital Guam, U.S. Naval Hospital Yokosuka, MEDDAC-K Seoul, 374th Medical Group Yokota Air Base, 18th Medical Group Kadena Air Base. This standardization action is part of the Medical/Surgical Prime Vendor program executed by the Defense Supply Center Philadelphia (DSCP), Directorate of Medical Materiel. In order to participate, your company must have a Distribution and Pricing Agreement (DAPA) and a separate commercial agreement with the Prime Vendors for the program, both Cardinal Health and Amerisource Bergen. This is pursuant to the DAPA clause by which DAPA holders agree to the standardization process and to allow Prime Vendors to distribute their products. This RFRIAQ is a supplement to the Prime Vendor Program and is not a contract. For additional information regarding DSCPs Prime vendor program please access their web site at https://dmmonline.dscp.dla.mil The resulting Regional Incentive Agreement (RIA) will be for a base period of two years (24 months) from date of selection with three one-year (12 months) option periods. Anticipated selection date is Dec 2009. Products and vendors that pass the technical criteria and pass the clinical performance expectations will be considered clinically preferred products and sources. Among these clinically preferred products and sources price will be the determining factor for this initiative. The selection of a single vendor is anticipated. However, if no single vendor can meet the total requirement of the Region, the Government reserves the right to make two or more selections for RIAs. In this event, selection would be based on a combination of MTF clinical preference and product availability. Point of Contact: Mary Summers, TRBO Technical Director 808-433-3686, mary.summers1@us.army.mil Cheryl Janus, RN, TRBO Clinical Analyst 808-433-7985, cheryl.janus@amedd.army.mil B. Products & Performance Required. The Pacific Region is seeking product line items in the category of Pharmacy Bottles which at a minimum, includes the high volume lines below. Within this region, this product line has an estimated annual dollar requirement of $96,041.26. This forecast is based on historical prime vendor (both medical/surgical PV & pharmaceutical PV) sales during a recent 12-month period. The top 10 high volume usage lines for this project include: Pharmacy Bottles 16 Dram Vial W/CPSC cap, compliant w/USP light and air protection container; 30 Dram Vial W/CPSC cap, w/USP light and air protection container; CPSC Caps for 30/40 and 60 Dram Vials; CPSC Caps for 13 and 16 Dram Vials; 60 Dram Vial W/CPSC Cap; Bottle 2 Oz Oval, w/USP light and air protection container; Non Child-Resistant Caps for 9 Dram, 13 Dram, 16 Dram, 20 Dram, 30 Dram, 40 Dram and 60 Dram Vials; 16 Dram Ointment Container. At the request of the Pacific Region MTFs, vendors will provide conversion information, prime vendor order numbers, and itemization of the brands, types, and packaging information of the products supplied by the vendor. C. Instructions to Vendors Vendors interested in participating in this standardization initiative should email their (1) Company name and address, (2) Point of Contact (POC) (Name and Phone Number, Fax Number, and E-mail address) to mary.summers1@us.army.mil and cheryl.janus@amedd.army.mil. and (3) Identification of the RFQRIA to which the vendor is responding. Submissions must be received by 5:00 post meridiem (p.m.) Hawaii Standard Time (HST) on the specified closing date/time of this solicitation. Vendors that fail to meet this submittal deadline will be disqualified from participating. In a one step notification process, the Pacific Region TRBO will request responses to the technical/company criteria, no charge literature, no charge sample sets, and best available pricing from each interested vendor. Vendors will have 30 calendar days to 1.) respond to the Pacific Region TRBO with their responses to the technical/company criteria and submission of best value price quotes; and 2.) deliver no charge literature and no charge sample sets to all participating MTFs. No charge literature and no charge samples must be received by the participating MTFs by close of business (COB) 5:00 PM HST, 30 days after the date of request to supply samples. All vendors must send the Pacific TRBO verification regarding the date of shipment. Vendor responses to the technical criteria must be in a prescribed electronic spreadsheet format that will be provided by the Pacific Region TRBO. Best value pricing must be in a prescribed electronic spreadsheet format, based upon the total requirements of the Pacific Region. Vendors that fail to respond to the technical criteria, fail to provide a price quote or fail to deliver the no charge literature and no charge sample sets within the time prescribed will be disqualified from further consideration. Vendor quotes should contain the vendor's best product matches for the products or product lines requested in this announcement. Vendor quotes should contain the vendor's best responses to all technical criteria listed in this announcement. Vendor quotes should contain the vendor's best tiered-pricing discounts off of the vendor's DAPA pricing based on committed volume of 80% of the total requirements of the MTFs in the Pacific Region. As this process will require vendors to submit certain information electronically, vendors are strongly encouraged to confirm with the Regional POC (stated above) that their electronic submissions have arrived at the Regional TRBO. Vendors are advised to confirm receipt, allowing adequate time for resubmission before the deadline, should a problem have occurred with the first submission. All e-mails must be digitally signed. The no charge samples to be provided are as follows: Pharmacy Bottles 16 Dram Vial W/CPSC cap, compliant w/USP light and air protection container x10r; 30 Dram Vial W/CPSC cap, w/USP light and air protection container x10; CPSC Caps for 30/40 and 60 Dram Vials x10 each; CPSC Caps for 13 and 16 Dram Vials x10 each; 60 Dram Vial W/CPSC Cap x10 each; Bottle 2 Oz Oval, w/USP light and air protection container x10; Non Child-Resistant Caps for 9 Dram, 13 Dram, 16 Dram, 20 Dram, 30 Dram, 40 Dram and 60 Dram Vials x10 ; 16 Dram Ointment Container x10. The product line must meet the U.S. Pharmacopeia (USP) Standard for a container which provides protection, to the contents, from light, moisture and air exposure degradation. These requirements are defined in the General Notices and Requirements section of the USP. www.fda.gov/ohrms/dockets/dailys/03/Nov03/111203/03n-0361-c000038-vol5.pdf - 2003-12-08 The vendor is required to provide a line of caps (lids) which meet the FDA safety standards for CPSC Child-Resistant and Senior Access regulatory guidelines. This is cited in FDA requirement for tamper-resistant closure in 21 CFR 211.132 and the Consumer Product Safety Commission (CPSC) requirements for child-resistant closure in 16 CFR 1700. www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070551.pdf www.usp.org/pdf/EN/referenceStandards FDA Guideline: Submitting Documentation for Packaging for Human Drugs and Biologics, May 1999.Packaging Technical Committee of the Chemistry, Manufacturing, and Controls Coordinating Committee (CMC CC) in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). The no charge literature and no charge sample sets are required to be shipped to the following: Region Pacific TRBO Region 12 Tri-Service Regional Business Office ATTN: C. Janus, RN TPRB Evaluation Samples Bldg.161 Krukowski Road Room 16 Tripler Army Medical Center Medical Materials Honolulu, Hawaii 96859-5000 (808) 292-4118 Tripler Army Medical Center ATTN: Capt D. ONeill & George Fitzgerald TPRB Evaluation Samples Logistics Division, Materiel Branch Bldg 161 Krukowski Road Honolulu, Hawaii 96859-5000 (808) 433-5718 " US Naval Hospital Okinawa Japan TPRB Evaluation Samples Attn: LTJG D. Salinas, NC, USN Bldg 6000, Camp Lester Chatan-Cho, Nakagami-Gun, Okinawa, Japan 904-0103 011-81-611-743-7815 "US Naval Hospital Guam Farenholt Road Bldg 1, Room L103 Attn: Johnny Duenas & LCDR Hicks, NC, USN TPRB Evaluation Samples Agana Heights, Guam 96910 671-344-9671 "36th Medical Support Squadron/SGSL Attn: Capt F. Sherlin & Capt D. Luna TPRB Evaluation Samples Unit 14010, Bldg 26001, Carolines Avenue Andersen AB Yigo, Guam 96929 671-366-6646 "35th Medical Support Squadron/SGSL Bldg 99 Attn: Capt Jennifer Franks FM 5205 Misawa AB, Japan 1-Chome, Hirahata, Misawa-Shi Aomori-Ken, Japan 033-0012 011-81-311-766-6008 "US Naval Hospital Yokosuka Japan ATTN: Mr. Rockie Ramirez & CDR A. Acevedo, NC, USN TPRB Evaluation Samples Warehouse Bldg E-18 1-Chome, Honcho, Yokosuka, Kanagawa 238-0041 PO N68292 011-81-46-816-8592/7130 The region intends to evaluate quotes and select a vendor or vendors, on initial submission/quote, without discussion. However, the Region reserves the right to conduct discussions and request revised quotes, if it is determined to be necessary. The Region reserves the right to reject all quotes and cancel the RFQRIA if it is determined to be in the governments best interest. Price will be analyzed based on the vendors anticipated Post Standardization Costs. Post standardization costs will be calculated for each vendor by applying the vendors offered prices to the anticipated annual usage of the region. Unmatched items will be represented in the Post Standardization Cost at the current suppliers non-discounted price. Among the products and sources that are determined to be clinically preferred, the best price (Post Standardization Cost) will be the deciding factor. D. Source Selection Procedures The Tri-Service Product Review Board (TPRB) for the Pacific Region is the governing bodies of the standardization process and program. This board includes clinicians and logisticians from the MTFs within the Pacific Region. The board is chaired by the Designated Senior Logistician (DSL). They are the deciding officials for this initiative. The Pacific Region TPRB is Co-Chaired by a physician from Naval Hospital Yokosuka and an Air Force Nurse Corps officer assigned to the Hawaii Multi-Service Marketing Management Office (MSMMO). The Region intends to evaluate quotes and select a vendor or vendor(s), without discussion. E. Technical Criteria Evaluations The vendors responses to the technical criteria will be reviewed for acceptability. Acceptability is defined as follows: 1) based on the vendors responses, the evaluators have reasonable confidence that the vendor can meet the standard of each technical criterion; 2.) based on the vendors responses, the evaluators have reasonable confidence that the line of products and/or services submitted meet the medical standards of care of the community that are applicable to such products or services; and 3) the information provided by the vendor is factually correct. Any misrepresentation of information will disqualify the vendor from further consideration. Failure to provide any requested information will disqualify the vendor from further consideration. Vendors must achieve an acceptable rating on their responses to the technical criteria for continued consideration in this initiative. Vendors who do not achieve an acceptable rating will be disqualified. F. Technical/Company Criteria The TPRB and CPTs consists of physicians, pharmacists, nurses, allied health professionals, and technicians from the Pacific Region MTFs. During the pre-source selection procedures, the TPRB and CPT validated/approved the equally weighted company/technical criteria outlined below. These Technical/Company criteria reflect the TPRB and CPT members application of the regulatory guidelines for a safe Pharmacy Bottle product line from manufacturing to clinical application. 1.Vendors must manufacture and/or distribute a complete product line of Pharmacy Bottles. A complete line of product is defined as the MTFs requirements for usage items in the product line. Usage items are defined in the Medical Surgical Prime Vendor contract statement of work as DAPA items ordered at least once per month, and at least one unit per order. At a minimum, a complete product line includes the following products in the following sizes: Pharmacy Bottles 16 Dram Vial W/CPSC cap, compliant w/USP light and air protection container; 30 Dram Vial W/CPSC cap, w/USP light and air protection container; CPSC Caps for 30/40 and 60 Dram Vials; CPSC Caps for 13 and 16 Dram Vials; 60 Dram Vial W/CPSC Cap; Bottle 2 Oz Oval, w/USP light and air protection container; Non Child-Resistant Caps for 9 Dram, 13 Dram, 16 Dram, 20 Dram, 30 Dram, 40 Dram and 60 Dram Vials; 16 Dram Ointment Container. 2.Vendors must have a DAPA or be in the process of applying for a DAPA number for Pharmacy Bottles. Provide the DAPA number or proof of the application process with the initial submittal. This information is to be provided in response to the Technical/Company Criteria worksheet provided to the vendor. 3. Vendors must have an agreement with the Prime Vendor for the Pacific Region, Cardinal Healthcare. This information is to be provided in response to the Technical/Company Criteria worksheet provided to the vendor. 4. Vendors must submit discounts off DAPA for all products included in this standardization initiative. Vendors that fail to submit a discount from DAPA will be disqualified. Where lower uncommitted FSS prices are available, DAPA holders are required by previous agreement to provide the uncommitted FSS price as the DAPA price. Vendors shall not quote uncommitted FSS prices as the discounted price for purposes of this standardization initiative. 5. Vendors must provide latex free Pharmacy Bottles, both the containers and the lids/caps. This information is to be provided in response to the Technical/Company Criteria worksheet provided to the vendor. 6. Vendors must provide a line of containers which meet the USP standards for content protection from air and light degradation.. This information is to be provided in response to the Technical/Company Criteria worksheet provided to the vendor. 7. Vendors must provide a cap/lid product line which meets the FDA safety standard for Child Resistance, tamper proof. This information is to be provided in response to the Technical /Company Criteria worksheet provided to the vendor. 8. Vendor must provide a product line of lids/caps which are designated as Senior test compliant. This information is to be provided in response to the Technical/Company Criteria worksheet provided to the vendor. 9. Vendor must disclose the automation (dispensing and storage automation systems) compatibility for their Pharmacy Bottle product line. This information is to be provided in response to the Technical/Company Criteria worksheet provided to the vendor. 10. Vendor must provide vials and lids packed separately. This information is to be provided in response to the Technical/Company Criteria worksheet provided to the vendor. 11. Vendor must provide information on the caps/lids and closure devices for their Pharmacy Bottles. Distinguish between snap-on versus threaded devices and the container sizes that accept the caps/lids. This information is to be provided in response to the Technical /Company Criteria worksheet provided to the vendor. 12. Vendor must provide information on the recommended storage requirements and durability of their Pharmacy Bottle product line. Vendors must provide this information in response to the Technical Criteria request. G. Clinical Performance Evaluation: In the pre-source selection procedures above, the TPRB and CPT members determined/approved that both product literature and sample sets are required for the evaluation in a clinical/pharmaceutical setting. Based on this determination, the following procedures apply. 1. The TRBO office will request no-cost, sample sets from the vendors to be delivered directly to participating MTFs, and the Pacific Region TRBO. Vendors will be given 30 calendar days to deliver the literature and samples for clinical evaluation and review. Literature and product samples must be shipped to arrive at the MTFs by COB, 5:00PM Hawaii Standard Time (HST), 30 calendar days after the notice to ship. Vendors who do not meet the deadline to deliver the literature and product samples by the deadline will be disqualified from this standardization initiative. 2. All vendors must send the Pacific Region TRBO verification regarding the shipment of literature and samples. This information will include the date of shipment and tracking numbers and the carrier used by the vendor. All literature and samples MUST be shipped via FedEx or UPS or DHL. 3. Vendor will provide, the following product samples for clinical/performance evaluation: (Unused samples will not be returned. Pharmacy Bottles 16 Dram Vial W/CPSC cap, compliant w/USP light and air protection container x10r; 30 Dram Vial W/CPSC cap, w/USP light and air protection container x10; CPSC Caps for 30/40 and 60 Dram Vials x10 each; CPSC Caps for 13 and 16 Dram Vials x10 each; 60 Dram Vial W/CPSC Cap x10 each; Bottle 2 Oz Oval, w/USP light and air protection container x10; Non Child-Resistant Caps for 9 Dram, 13 Dram, 16 Dram, 20 Dram, 30 Dram, 40 Dram and 60 Dram Vials x10 ; 16 Dram Ointment Container x10. Failure to provide this defined product line will result in disqualification from the process. 4. The CPT will evaluate each vendors literature and samples against the Clinical/performance criteria in a non-clinical/non-patient care setting. All clinical/performance criteria are weighted equally. The clinical evaluation period will last three weeks and take place in a clinical/pharmaceutical setting. The evaluation responses will be in a Likert type scale with a 1-5 scoring range. The scale descriptors are: One (1) = Strongly Disagree; Two (2) = Disagree; Three (3) = Neutral; Four (4) = Agree; and Five (5) = Strongly Agree. The CPT will send the completed evaluations to the TRBO for data entry and analysis and the results will be forwarded to the TPRB for review. Clinical/performance evaluations will be tabulated by the Pacific Region TRBO, and results will be forwarded to the Pacific Region TPRB members for final review. H. Clinical/Performance Criteria: 1.The Child-Resistant cap/lid engages securely to the container.( Addresses Patient Safety) a.The use of a cap/lid which has met the criteria for Child Resistance can be expected to provide protection. b.This criterion will be evaluated in the pharmaceutical clinical setting. c.Evaluator will visually and manually inspect the cap/lid once it is seated on the container and find resistance to attempting to remove the lid/cap. 2.The instructions, for opening the container, on the Child-Resistant cap/lid (embossed or printed) are easily seen and can be easily implemented. (Addresses Patient Safety ) a. Instructions should be simple and easily identified on the lid/cap b.This criterion will be evaluated in the pharmaceutical clinical setting. c. Evaluator will visually inspect the instructions and then implement the steps 3. The Non Child-Resistant (CR) lids/caps adhere securely to the container. (Addresses Patient Safety and cost lid/cap provides protection to medication (no degradation due to light, moisture or air) and allows for ease of access. a. Lid should fit securely and protect contents and allow for ease of access to contents b. This criterion will be evaluated in the pharmaceutical clinical setting. c. Evaluator will visually inspect and manually remove and apply lid/cap
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA16/W81K02-10-T-3100/listing.html)
- Place of Performance
- Address: Pacific Regional Contr Ofc TAMC ATTN: MCAA PC BLDG 160, 160 Krukowski Road Honolulu HI
- Zip Code: 96859-5000
- Zip Code: 96859-5000
- Record
- SN01990583-W 20091024/091022235326-4ac266474e19c2e8040cf01db430cff6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |