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FBO DAILY ISSUE OF SEPTEMBER 19, 2009 FBO #2856
SOURCES SOUGHT

65 -- The TriService Reg.Business Offices Pacific Region 12; Southwest Region 9/10; Heartland Region 5 and Mid-Atlantic Region 2 announce a Request for Regional Incentive Agreement Quotation for the standardization of Irrigating Solutions.

Notice Date
9/17/2009
 
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
W81K02-09-T-3023
 
Response Due
10/13/2009
 
Archive Date
12/12/2009
 
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 Pacific Region Tri-Service Regional Business Office (TRBO) Region 12; Southwest Region TRBO Regions 9/10; Heartland Region TRBO Region 5 and Mid-Atlantic Region TRBO Region 2 announce a Request for Regional Incentive Agreement Quotation (RFRIAQ) for the standardization of Irrigating Solutions. 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 determination. This represents the clinically preferred product or source(s) at the best possible price, not the cheapest price. As a clinically driven program, products will be selected based on their ability to meet the clinical evaluation expectations as a primary consideration. Price is the second factor in the decision and will be considered with the potential goal of demonstrating cost containment, cost avoidance and/or cost savings. It is also intended that standardized products be obtained through the Department of Defense (DoD) Prime Vendor (PV) Program. The major Medical Treatment Facilities (MTFs) in the Pacific Region, TRBO Region 12 area includes 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. The major Medical Treatment Facilities in the Southwest Region, TRBO Region 9/10 area include but are not limited to the Naval Medical Center San Diego; David Grant Medical Center Travis Air Force Base, Naval Hospital Camp Pendleton, Robert E. Bush Hospital Twenty-Nine Palms, Weed Army Community Hospital Fort Irwin, Naval Hospital Lemoore, 9th Medical Group Beale Air Force Base, 30th Medical Group Vandenberg Air Force Base, the 61st Medical Squadron Los Angeles Air Force Base, and the 95th Medical Group Edwards Air Force Base. The major Medical Treatment Facilities in the Mid-Atlantic Region, TRBO Region 2 area include but are not limited to the Womack Army Medical Center, FT Bragg; 43rd Medical Group, Pope Air Force Base; Naval Medical Center Portsmouth; Naval Hospital Camp Lejeune. The major Medical Treatment Facilities in the Heartland Region, TRBO Region 5 area include but are not limited to Wright Patterson Air Force Base Ohio, Scott Air Force Base Illinois, Naval Health Clinics of Great Lakes Illinois, Blanchfield Army Community Hospital Ft Campbell Kentucky, Ireland Army Community Hospital Ft Knox, Kentucky, Naval Hospital Corps School Great Lakes Illinois, and USCG Air Station Traverse City, Michigan. 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. 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 Nov 2009. The evaluation will be based on technical, clinical, and pricing factors. The Technical/Company and Clinical/Performance evaluation factors, when combined, are considered significantly more important than cost or price. As the technical and clinical evaluation results become more equal, price will become a stronger component in the clinical business decision matrix. This balances the clinicians carefully considered and evaluated product choice and pricing, to result in the selection and procurement of the most clinically effective and reasonably priced product. The TPRBs will review all the data to support a selection of the best clinical value. As the Department of Defense Tri-Service Regional Standardization Program is centered on being a clinically focused program to select and procure the most appropriate medical surgical products based on clinical selection and cost (a balanced equation), the clinically preferred product may not match with the lowest Best Value Pricing offered by a vendor. The clinical performance will drive the choice of vendors. The TPRBs will vote on a standardized vendor for Irrigating Solutions. The selection will be determined utilizing best value/ trade-off criteria. 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, Southwest, Mid-Atlantic and Heartland Regions are seeking product line items in the category of Irrigating Solutions, which at a minimum, includes the high volume lines below. Within this region, this product line has an estimated annual dollar requirement of $649,026. This forecast is based on historical prime vendor sales during a recent 12-month period. The top 10 high volume usage lines for this project include: #2F7124, SODIUM CHLORIDE IRRIG 0.9 PRCNT 1000ML, 9925 Del Qty, $116,231.84 #2B7487, SOLUTION LACTATED RINGERS IRR 3000ML, 3987 Del Qty, $107,918.76 #2B7489, SOLUTION LACTATED RINGERS IRR 5000ML, 4284 Del Qty, $104,614.85 #2B7127, SODIUM CHOLRIDE.09% FOR IRRIG 3L BAG, 2600 Del Qty, $70,310.9 #2F7114, WATER STERILE FOR IRRIGATION 1000ML, 6634 Del Qty, $64,115.12 #R5200-01, SOLUTION IRR 0.9 PERCENT SODIUM CHLOR, 3643 Del Qty, $50,127.13 # 7972-08, SOLUTION IRRIG SODIUM CHLO 0.9% 3000ml BAG, 1247 Del Qty, $35,308.75 #2B7477, SOLUTION SOD CHL IRR 0.9 PRCNT 3000ML, 988 Del Qty, $29,048.54 #R5000-01, SOLUTION IV STERILE WATER FOR IRR, 1287 Del Qty, $16,812.8 #R5201-01, SOLUTION IRR 0.9 PERCENT SODIUM CHLOR, 662 Del Qty, $8.057.39 At the request of the Pacific, Southwest, Mid-Atlantic and Heartland Regional 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 DAPA holders 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. 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. All e-mail communications between vendors and the region will be digitally signed. This process will include vendor requirements to provide electronic responses to technical criteria, no charge product samples and literature for clinical evaluation, and submission of electronic best price quotes. Due to the potential for email to be lost in transmission from network security, etc., vendors are strongly encouraged to confirm with the Regional POC stated above that their initial submission, quotes, and literature or other requested information has actually arrived at the Regional TRBO via email. Each submitting vendor is advised to confirm receipt, allowing adequate time for resubmission before the due date/time, should a problem occur with the first submission. The region reserves the right to cancel, repost, or reissue the FBO if industry response is low. D. Source Selection Procedures The Tri-Service Product Review Boards (TPRBs) for the Pacific, Southwest, Mid-Atlantic and Heartland Regions are the governing bodies of the standardization process and program. These boards include clinicians and logisticians from the MTFs within the Pacific, Southwest, Mid- Atlantic and Heartland Regions. The boards are chaired by the Designated Senior Logisticians (DSLs). 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 Regions intend to evaluate quotes and select a vendor or vendor(s), without discussions. 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 and/or company questions 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). Additionally, the Region reserves the right to conduct discussions and request revised quotes, if it is determined to be necessary. If industry participation is unsatisfactory, the four Regional TPRBs will decide whether to proceed with or delay the project. Interested vendors are to respond to this Federal Business Opportunity (FBO) announcement by emailing their intent to participate to the above POC by the required response date. This source selection procedure is a one-step process. The Pacific Region TRBO will request responses to the technical/company criteria, the no charge literature and no charge sample set, and best value pricing from the vendor in a one-step source selection process. Vendors will have 30 calendar days to respond to the Pacific Region TRBO with their responses to the technical/company criteria, delivery of the no charge literature and no charge sample set to the participating MTFs, and submission of best value price quotes. Vendors technical criteria response will be in a prescribed electronic spreadsheet format. Best value pricing will be in a prescribed electronic spreadsheet format, based upon the total requirements of the Pacific, Southwest, Mid-Atlantic and Heartland Regions. Vendors that fail to respond to the technical/company criteria or fail to send the no charge literature and no charge sample sets or fail to provide a best value price quote will be disqualified from further consideration in the standardization initiative. 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. All communications of significant acquisition milestones (such as invitations to participate, or notices of disqualification) must be digitally signed. Vendors that have been disqualified will be notified in writing by e-mail at the conclusion of the process. Acceptability for purposes of evaluation of technical/company criteria is defined as follows: 1) based on the vendors responses, the evaluators have reasonable confidence the line of products and/or services submitted meet the medical standards of care of the community, applicable to such products or services, 2) the vendors information provided is factually correct. Any misrepresentation of information will disqualify the vendor from further consideration. Specific technical/company criteria will require an additional more specific definition of technical acceptability. The specific standard for technical acceptability will be set forth with the individual statement of each criterion, as required. The no charge samples to be provided are as follows: Irrigating Solutions - Solution Irrigating Lactated Ringers 3000 ml BAG; Solution Irrigating Sodium Chloride 0.9% 1000 ml BOTTLE; Solution Irrigating Sterile Water 1000 ml BOTTLE; Solution Irrigating Sodium Chloride 0.9% 3000 ml BAG; Solution Irrigating Glycine 1.5% 3000 ml or 4000 ml BAG; Solution Irrigating Sterile Water 1000 ml BOTTLE; Solution Irrigating Sterile Water 500 ml BOTTLE; Solution Irrigating Sterile Water 250 ml BOTTLE; Solution Irrigating Sterile Water 3000 ml BAG; Solution Irrigating Lactated Ringers 1000 ml BOTTLE; Solution Irrigating Sterile Water 1000 ml BAG. The no charge literature and no charge sample sets are required to be shipped to the following: Region Pacific TRBO Region 12 Tripler Army Medical Center ATTN: George Fitzgerald TPRB Evaluation Samples Logistics Division, Materiel Branch Bldg 161 Krukowski Road Honolulu, Hawaii 96859-5000 (808) 433-5718 U.S. Naval Hospital, Yokosuka, Japan 1-Chome, Honcho, Yokosuka, Kanagawa 238-0041 Attn: Rockie Ramirez & CDR A. Acevedo, NC, USN Warehouse BLDG E-18 TPRB Evaluation Samples Phone: 011-81-46-816-8592/7130 Mark for: PO N68292 US Naval Hospital Okinawa Japan TPRB Evaluation Samples Attn: LT Shane Knisley, MSC, USN & LT 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: LT Robert Morrison, MSC, USN & LCDR Hicks, NC, USN TPRB Evaluation Samples Agana Heights, Guam 96910 671-344-9671 18th Medical Group/SGSL Attn: Megumi Uehara & Capt Dale Desalis TPRB Evaluation Samples FM 5270 Bldg 626, Unit 5268, Davis Ave Kadena AB Okinawa City, Okinawa, Japan 904-0203 011-81-611-730-4175 Region Southwest TRBO Region 9/10 Family Practice Clinic/ SGOP 95th Medical Group/ MDOS 30 Nightingale Road Edwards AFB, CA. 93524-1730 ATTN: Linda Davis, RN Phone: (661) 275-2740 Robert E. Bush Hospital Main Operating Room Box 788250 MCAGCC Twenty-nine Palms, CA 92278-8250 ATTN: LCDR Mark Anderson Phone: (760) 830-2313 Tri-Service Regional Business Office Southwest Region 34800 Bob Wilson Dr., Suite 110 San Diego, CA 92134 ATTN: Cindy Ingrao, RN, MSN Phone: (619) 532-8517 Naval Hospital Camp Pendleton Bldg 100 Main Operating Room Camp Pendleton, CA 92055-5191 ATTN: CDR Loretta Howerton Phone: 760-725-1871 David Grant Medical Center ATTN: 1LT Suzanne Lewis 101 Bodin Circle, Bldg 777 Medical Logistics Warehouse Travis AFB, CA 94535 707-423-5280 FM4610 30th MED Group ATTN: CAPT Gonzales 338 South Dakota Avenue Vandenberg AFB, CA 93437-6307 805-605-1301 Region Mid-Atlantic TRBO Region #2 Womack Army Medical Center, FT Bragg, NC Womack Army Medical Center ATTN: MAJ Shane Crask TPRB Evaluation Samples CSS 2817 Reilly Road Fort Bragg, NC 28310 (910) 907-7287 43rd Medical Group, Pope AFB, NC Attn: TSgt Katherine Scott TPRB Evaluation Samples 43rd MDG/SGSL 383 Maynard Street Pope AFB, NC 28308 910-394-4646 Naval Medical Center Portsmouth, Portsmouth, VA ATTN: CDR Karen Ecarius TPRB Evaluation Samples Naval Medical Center Portsmouth Portsmouth, VA 23708 757-953-3294 Naval Hospital Camp Lejeune, Camp Lejeune, NC ATTN: LT James Driscoll TPRB Evaluation Samples Naval Hospital Camp Lejeune 100 Brewster Blvd Camp Lejeune, NC 28547 910-450-4876 Region Heartland TRBO Region #5 Wright Patterson Air Force Base Med Center ATTN: Capt Majella Brown, TSgt Leigh Taylor, Capt Julie Meek, Ms Peggy Ross TPRB Evaluation Samples 4881 Sugar Maple Dr. Bldg 830 Wright-Patterson AFB, OH 45433 937-257-3524 Blanchfield Army Community Hospital ATTN: 1st LT Marissa Bernadette TPRB Evaluation Samples Bldg 650 b, Level 1 1 Joel Dr Ft Campbell, KY 42223 270-798-8203 Ireland Regional Army Community Hospital ATTN: Capt Tonya Dickey & Maj Jack Jenkinson TPRB Evaluation Samples USA MEDDAC, MCXMLD 851 Ireland Ave Ft Knox, KY 40121 Specific Clinical Product Teams (CPTs), at the designated MTFs, will evaluate the clinical/performance criteria using a likert type scale, with a one to five rating. One (1) = Strongly Disagree; Two (2) = Disagree; Three (3) = Neutral; Four (4) = Agree; Five (5) = Strongly Agree. The evaluating CPTs, which consist of physicians, nurses, allied health professionals, and technicians from the participating MTFs will evaluate the products based on the evaluation criteria below. The TPRB CPT intends that clinical evaluations be conducted in a non-clinical (non-patient) setting. The Region intends to evaluate quotes and select a vendor or vendor(s), on initial submission/quotes. Vendor quotes should contain the vendor's best product matches for the products or product lines requested in the announcement. Vendor quotes should contain the vendor's best tiered-pricing discounts off the Vendor's DAPA pricing (based on committed volume of 80% of the total requirements of the MTFs in the Pacific Region). Pricing will be based on a committed volume for a two-year period with 3 possible one-year option periods not to exceed a total of 5 years. However, the Region reserves the right to request revised quotes, if determined necessary. The Region reserves the right to limit the number of quotes to the greatest number that will permit an efficient competition among vendors. Vendors that fail to submit price quotes will be disqualified from further consideration in this standardization initiative. Technical/Company and Clinical/Performance factors will be weighted more heavily than price. As the technical and clinical evaluation results become more equal, the vendors Best Value Pricing will become a stronger component in the clinical business decision matrix. This balances the clinicians carefully considered (and evaluated) product choice against pricing to result in the selection and procurement of the most clinically effective and reasonably priced product. The following elements will be considered in the pricing analysis: (1) Impact of RIA prices on the Region (Post-Standardization Costs), (2) Impact of Unmatched Lines, (3) Potential Cost Avoidance (this is included as a reporting metric) and (4) consideration of stockage keeping units (SKUs) by each vendor. SKU review will assess the number of line items a vendor is able to supply to the MTFs versus the number of currently used line items. Cost avoidance is used as a reporting metric, not as an element of the decision. Technical/Company Criteria: 1. Vendors must provide a complete line of Irrigating Solutions. A complete line of product is defined as the Military Treatment Facilities (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, but is not limited to: Solution Irrigating Lactated Ringers 3000 ml BAG; Solution Irrigating Sodium Chloride 0.9% 1000 ml BOTTLE; Solution Irrigating Sterile Water 1000 ml BOTTLE; Solution Irrigating Sodium Chloride 0.9% 3000 ml BAG; Solution Irrigating Glycine 1.5% 3000 ml or 4000 ml BAG; Solution Irrigating Sterile Water 1000 ml BOTTLE; Solution Irrigating Sterile Water 500 ml BOTTLE; Solution Irrigating Sterile Water 250 ml BOTTLE; Solution Irrigating Sterile Water 3000 ml BAG; Solution Irrigating Lactated Ringers 1000 ml BOTTLE; Solution Irrigating Sterile Water 1000 ml BAG. Failure to provide this defined product line will result in disqualification from the process. 2. Vendors must provide a complete list of the Irrigating Solutions supplied, including product literature. Vendors are required to supply all listed items. Vendors, who do not have a complete product line, including the minimum requirement listed in paragraph #1, will be disqualified. This information is to be provided in response to the Technical/Company Criteria worksheet provided to the vendor by the Pacific Region TRBO. 3. Vendors must have a DAPA or be in the process of applying for a DAPA number for the Irrigating Solutions product line. Vendors must provide the DAPA number or proof of the application process in response to this RFQ. Note that vendors that fail to have a DAPA or show a lack of progress in obtaining a DAPA will be disqualified. 4. Vendors must have a separate agreement with the current Prime Vendor for the Heartland and Mid Atlantic Regions, Owens & Minor, for distribution in the Heartland and Mid-Atlantic Regions; and, a separate agreement with the current Prime Vendor for the Pacific and Southwest Region Prime Vendor, Cardinal Healthcare. 5. 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. 6.Vendors must provide their history of recalls that occurred during the most recent 12-month period for the Irrigating Solutions, including dates, duration, cause, and resolution. 7. Vendors products must be manufactured in an ISO certified facility. Vendors must provide a statement confirming that their products are manufactured in an ISO certified facility in response to this RFQRIA. 8. Vendors response to this RFQRIA must confirm that their product line is totally latex free. 9. Vendors products and/or packaging must be clearly labeled as latex free. In response to this RFQRIA vendors must state where on the products and/or packaging the latex free declaration is located, i.e., on each Irrigating Solution bag or on the container. 10. Vendors must provide documentation if your Irrigating Solution containers contain PVC/DHEP (Di 2-ethylhexyl phthalate). This information is to be provided in response to the Technical/Company Criteria worksheet provided to the vendor by the Pacific Region TRBO. Failure to provide this information is a disqualifier. 11. Vendors must provide their empirical studies/data on any product which contains any amount of DEHP/PVC. Full disclosure is required as to the origin of the studies, i.e. research sponsored by their company versus FDA or FDA CDRH studies. Failure to provide this information will result in disqualification from this standardization initiative. 12. Vendors must use only non-toxic, color-fast dyes in the labeling process. 13. Vendors must provide documentation specifying measures taken to ensure the sterility of your Irrigating Solutions during the manufacturing, storage, distribution, and/or shipping process. This information is to be provided in response to the Technical/Company Criteria worksheet provided to the vendor by the Pacific Region TRBO. 14. Vendors must provide documentation specifying the shelf life of your Irrigating Solutions. This information is to be provided in response to the Technical/Company Criteria worksheet provided to the vendor by the Pacific Region TRBO. Failure to provide this information will result in disqualification from this standardization initiative. 15. Vendors must provide, in response to the Technical Criteria request, documentation specifying that their Irrigation Solutions do not change physical composition or chemically deteriorate when warmed or cooled. 16. Vendors must provide, in response to the Technical Criteria request, documentation specifying all safety alerts issued by any governmental or accreditation agencies regarding the safety of your Irrigating Solutions. Include any adverse outcomes reported to your company regarding the use of your Irrigating Solutions. Vendors with unresolved safety alerts and/or unresolved adverse outcome reports will be disqualified. 17. Vendors must provide all requested literature for Irrigating Solutions with the initial submittals in response to the Technical/Company Criteria worksheet provided. 18. Vendor must provide information on the ports and types of vial connectors that are compatible with each of the ports on the large volume Irrigating Solutions bags. This information is to be provided in response to the Technical/Company Criteria worksheet provided to the vendor by the Pacific Region TRBO. 19. Vendor must identify whether or not they use a fluid barrier overwrap for their respective large volume Irrigating Solutions bags. Vendors must provide this information in response to the Technical Criteria request. 20. Vendor must provide information in response to the Technical Criteria request, on the expiration/stability of the large volume Irrigating Solutions bags, once overwrap is removed. Clinical/Performance Criteria: 1.Type of fluid solution is easily identified from the fluid solution container. (Addresses Patient Safety administering the incorrect Irrigating Solution is potentially harmful to patients; and Cost avoid wastage due to inability to clearly read the container contents. a.Giving the wrong fluid can be harmful There are multiple Irrigating Solutions used in the clinical arena. The clinicians need a simple and easily visible way to identify the fluid in the container. b.This criterion will be evaluated in the non-clinical setting. c.Evaluator will visually inspect the fluids outer packaging and the fluid container and be able to easily read the type of fluid in that container. 2.The fluid container is optically clear, making it easy to determine the condition of the fluid. (Addresses Patient Safety any sediment, particle threads, opaque quality of the fluid, or foreign materials can be acutely and potentially deadly to a patient the solution is considered contaminated) a. Containers are optically clear in order to determine status of solution. It is essential for the fluid to remain uncontaminated and clear. b.This criterion will be evaluated in the non-clinical setting at least (2) times. c.Evaluator will visually inspect the fluid and confirm the container is both optically clear and the fluid is clear without cloudiness, turbidity and does not contain any sediment, particle threads, opacity or foreign materials. 3.Container labeling is easy to read and includes volume gradient and expiration date. (Addresses Patient Safety the incorrect Irrigating Solution is potentially injurious to a patient; expired solutions are not to be used in the clinical setting per FDA Regulations. a.Clinicians require the container labeling be easy to read with volume gradients and expiration dates clearly stamped on the container to insure the correct fluid is given, they can visually assess the amount of fluid in the container and confirm the fluid has not expired before it is given to the patient. b.This criterion will be evaluated in the non-clinical setting. c.Evaluator will visually inspect the container labeling of the fluid and confirm the label is clearly stamped on the container with the type of fluid, a gradient scale for volume and the expiration date of the fluid. 4.The large volume (1000 ml or more) Irrigating Solution bags are easily spiked with the tubing remaining secure with no leaking. (Addresses: Safety Difficulty identifying a port and/or difficulty inserting spike can contaminate the product; Addresses cost - a contaminated product requires using a new product and a new spike.) a.Clinicians need to be able to remove the access port cover and spike the port easily and without significant force. Removing the access port cover and spiking the port should take no more than 1 minute. b.This criterion will be evaluated in the non-clinical setting. c.Evaluator will visually identify the access port and cover, remove the access port cover and spike the port with the tubing in 1 minute or less. 5. The BOTTLE screw top replaces easily, threads engage to provide a tight re-seal with no leaking. (Addresses: Safety avoid contamination of contents; Addresses cost a contaminated solution will require replacement. a. Clinicians need to be able to replace the screw top of the bottle easily and without significant force. Bottle top screw threads should engage with minimum manipulation. Bottle screw top should engage completely and no leakage should occur when the clinician turns the bottle upside down. b. This criterion will be evaluated in the non-clinical setting. c. Evaluator will visually and manually identify the ease with which the screw top engages and observe whether or not the bottle leaks when turned upside down.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA16/W81K02-09-T-3023/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
 
Record
SN01959709-W 20090919/090918000953-2929be107d1f7fe058dc12a601bdf582 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
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