SOURCES SOUGHT
65 -- Sterilization Indicators & Tape
- Notice Date
- 4/29/2008
- Notice Type
- Sources Sought
- Contracting Office
- Department of the Army, U.S. Army Medical Command, Southeast Regional Contracting Office, Southeast Regional Contracting Office, ATTN: MCAA SE, Building 39706, Fort Gordon, GA 30905-5650
- ZIP Code
- 30905-5650
- Solicitation Number
- W91YTV-08-0003
- Response Due
- 5/27/2008
- Point of Contact
- HERMAN C MCELVEEN JR, 7067873881
- Description
- THIS IS A SOURCES SOUGHT NOTICE. FOR FURTHER INFORMATION CONTACT MS GINNY SLAYTON, 706-787-2019 Vorgomoa.slayton @us.army.mil A.General Information. The Southeast Region (TRBO Reg. 3 & 4), a military integrated delivery network, comprised of 46 Army, Navy, Air Force, Marine Corps, and U.S. Coast Guard Medical Treatment Facilities (MTFs) in the states of Alabama, Georgia, Florida, Mississippi, South Carolina, Tennessee, and affiliated MTFs in countries of Puerto Rico, Honduras, and Cuba announces a Request for Regional Incentive Agreement Quotation (RFRIAQ) for the standardization of Sterilization Indicators & Tape. The primary objective of this program is to standardize the quality of care across this region based on a best value determination that represents the clinically preferred product or source(s) at the best possible price. It is also intended that standardized product be obtained through the DoD Prime Vendor Program. The major facilities in the Southeast Region include, but are not limited to Eisenhower Army Medical Center (FT Gordon, GA), Winn Army Community Hospital (FT Stewart, GA), Martin Army Community Hospital (FT Benning, GA), Naval Hospital Jacksonville (NAS Jacksonville, FL), 96th Medical Group (Eglin AFB, FL), Naval Hospital Pensacola (Pensacola, FL), Naval Hospital Beaufort (Beaufort, SC), 81st Medical Group (Keesler AFB, MS) and the 6th Medical Group (MacDill AFB, FL). 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 year(s) (24 months) from date of selection with three 12-month option periods (not to exceed 5 years). Anticipated selection date is October 2008. The evaluation will be based on clinical, technical, and pricing factors. Clinical/performance and technical/company factors will be weighted more heavily than price. The Technical/Company and Clinical/Performance evaluation factors, when combined, are considered significantly more important than cost or price. As the evaluation results become more technically/clinically equal, price will become more important. The selection will be determined utilizing best value, lowest overall cost factors, with pricing being least important. 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. A multiple vendor RIA selection may provide the best-value, lowest overall cost alternative if: 1) The requirements of the Region for the Sterilization Indicators & Tape product line can be met in the most clinically effective manner by more than one vendor, and 2) The requirements of the Region for Sterilization Indicators & Tape product line can be met with the lowest overall cost, by more than one vendor. Point of Contact (Virginia.slayton@us.army.mil (706) 787-2094/2019) B.Products & Performance Required. The Southeast Region is seeking product line items in the category of Sterilization Indicators & Tape, which at a minimum includes the high volume lines below. Within this region, this product line has an estimated annual dollar requirement of $195,185.40. This forecast is based on historical prime vendor sales during a recent 12-month period. The top high volume usage lines for this project are shown in the Technical/Company Criteria below. At the request of the Southeast Regional (3 & 4) MTFs, vendors will provide on-site support and in-servicing during implementation, conversion information, prime vendor order numbers, MSDS information, 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 detailed responses to the technical/company criteria and (1) Company name and address, (2) POC (Name and Phone Number, Fax Number, and E-mail address) to Virginia.slayton@us.army.mil. Submissions must be received by 5:00 PM EST on the specified closing date/time of this sources sought notice. Vendors that fail to meet this submittal deadline will be disqualified from participating. This process will include vendor requirements to provide electronic responses to technical criteria, no cost samples 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 Region that its initial submission, quote and literature actually arrived at the Region 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. All email communications between vendors and the Region should be digitally signed by the issuer. D. Evaluation Criteria. The Tri-Service Product Review Board (TPRB) is the governing body of the standardization process. This board includes clinicians and logisticians from the Military Treatment Facilities within the Southeast Region. They are the deciding officials for this initiative. The Region intends to evaluate quotes and select a vendor or vendor(s), on initial submissions/quotes 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 Region). Additionally, the Region reserves the right to conduct discussions and 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. The Region reserves the right to make a down-selection during the evaluation process based on considerations of efficient competition. Phase I Technical/Company Evaluation Process. Interested vendors are to respond to this FBO announcement by emailing their detailed responses and required documentation to the above POC by the required response date. Vendors are required to meet/provide responses to the technical/company criteria stated below. All technical/company criteria are weighted equally. The responses will be reviewed by the Clinical Product Team (CPT) to determine the acceptability of each vendor. After the review of the technical/company criteria, those vendors who meet these criteria will be qualified/invited to participate in the clinical/performance evaluation. In general, acceptability for purposes of evaluation of technical/company criteria is defined as follows: (1) 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, 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. NOTE: 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. All communications of significant acquisition milestones (such as invitations to participate, or notices of disqualification) should be digitally signed. The following Technical/Company Evaluation Criteria have been established for this standardization initiative: 1.Vendor MUST provide a complete line of Sterilization Indicators & Tape products. 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. a.At a minimum this includes biological indicators, chemical indicators and indicator tape for a variety of sterilization processes: biological indicators for steam sterilization processes (i.e., flash, vacuum assisted, gravity, gravity displacement), and ethylene oxide (EO) process; available as indicator strips, enzyme based early read-out ampoules and self contained vials with a range of response /read-out times(i.e., 1hr, 3hrs, 24hrs, and 48 hrs); chemical indicators for steam processes (i.e., flash, vacuum assisted, gravity, gravity displacement), dry heat process and ethylene oxide process; available as strips with a range of monitoring parameters; chemical integrator indicators for steam processes(i.e., flash, vacuum assisted, gravity, gravity displacement) and ethylene oxide process; available as indicator strips in a variety of sizes ( 8 1 / 2 x 5/8, 7 1 / 2 x 3 / 8, 2 x 3 / 4, 9 x 3 / 8); indicator tape for steam and ethylene oxide processes; available in several sizes (1 / 2 x 60yds, 1 x 60yds, 2 x 60yds), with and without tape dispenser; bowie-dick type test pack for sterilizer testing. b.Vendor MUST provide a complete list of items supplied (catalog, etc.) and product literature in response to this RFQ with initial submittal. Vendors are required to supply all items listed in all sizes, indicator types, tape, and test pack listed above. (Vendors who do not have a complete product line as above will be disqualified in Phase I). c.Vendors MUST provide supporting documentation that all Sterilization Indicators & Tape that are manufactured and/or distributed are FDA approved and provide literature to support this requirement with the initial submittal 2.Vendor MUST have a DAPA for Sterilization Indicators & Tape product line. Provide the DAPA number with initial submittal. (Note that vendors without a DAPA number will be disqualified in Phase I). 3.Vendor MUST have a separate agreement with the prime vendor (currently, the prime vendor is Owens & Minor) for distribution of Sterilization Indicators & Tape in the Southeast Region. (Note that vendors whose products are not available through the regional PV will be disqualified in Phase I). Provide supporting documentation of agreement with Prime Vendor with initial submittal. 4.Vendor MUST submit discounts off DAPA for all products included in this standardization initiative. Note: vendors that fail to submit a discount from DAPA will be disqualified. Where lower uncommitted Federal Supply Schedule (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. Vendors are to provide a quote on discounts in response to this RFQ. Vendors who do not provide discounts off DAPA for ALL products in Phase III will be disqualified. 5.Vendor MUST have a local vendor representative for the Southeast Region Medical Treatment facilities to provide sufficient product implementation services and customer servicing to the multi-service regional facilities. Vendors MUST provide contact information, i.e. name, address, phone number, and e-mail address with initial submittal. 6.Vendor MUST provide all history of back orders and recalls that occurred during the most recent 12-month period for the Sterilization Indicators & Tape products, including dates, duration, cause, and resolution. Vendors will not have an opportunity to provide additional information on back orders and recall during any subsequent stage in this evaluation. Vendors are encouraged to submit all information deem relevant (i.e., positive resolutions, etc.) in response to this RFQ. The Government will not contact any provided points of contact in response to this question. Vendors should not provide point of contact information in response to this question. 7.Vendor MUST provide products that are Latex safe/free. Vendor MUST provide a complete list indicating their latex safe/free items supplied (catalog, etc,) in response to this RFQ with initial submittal. 8.Vendor MUST provide manufacturing guideline/instructions for testing, safety, and end-point values for all monitoring indicators. Provide manufacturing guidelines/instructions with initial submittal. Phase II Clinical/Performance Evaluation Process Following acceptability of the technical/company criteria, the TRBO, on behalf of the CPT, will request literature and product sample sets from the product group to be sent to select MTFs for evaluation. Vendors will be given 14 calendar days from the issue of the notice in which to deliver the no cost literature and samples to the designated MTFs. Literature and product samples must be shipped to arrive at the MTF by COB, 5PM EST, on the (14th) calendar day after the notice to ship. Vendors who do not meet the deadline to deliver the literature and samples will be disqualified from this standardization initiative. NOTE: all vendors must send the TRBO verification regarding the quantity, products, description of items, and date of shipment from the vendor, anticipated delivery date and individual who signed for literature and product sample sets. Vendors presence will not be required for in-servicing prior to the evaluations. Specific MTFs will evaluate the evaluate the vendors product sample sets against the clinical/performance criteria in a non-clinical (non-patient care) setting using a Likert scale format with a one to five scoring range. The scale descriptors are: one (1)-not acceptable, two (2)-minimally acceptable, three (3)-acceptable, four (4)-most acceptable and five (5)-highly acceptable. All clinical/performance criteria are equally weighted. The clinical/performance evaluation period will last for 15 calendar days. The CPT has established a target threshold of 3.0 for the Clinical Acceptability of products for standardization. The CPT will determine the actual Acceptability threshold for this standardization initiative -- at or near 3.0 -- depending on the location of any break in vendors average scores (i.e., a gap between vendors average scores). In addition, the CPT may consider how closely scores are clustered near the Acceptability target threshold of 3.0, in determining the actual Acceptability threshold. Vendors scoring below the actual Acceptability threshold will be determined to be clinically Unacceptable, and be disqualified from further consideration for this standardization initiative. To determine acceptability, a Clinical Product Team (CPT) comprised of medical professionals from multiple disciplines will evaluate the products based on the evaluation criteria below. The CPT intends that clinical evaluations be conducted in a non-clinical (non-patient care) setting. The following Clinical/Performance Evaluation Criteria have been established for this standardization initiative: 1.Clinical Acceptability Target Threshold: 3.0 2. Chemical process indicator will display a visual color change (per manufacture guidelines) when exposed to a sterilization process cycle. (Patient Safety) a. The chemical process indicator should clearly differentiate between processed and unprocessed products by color change (per manufacture guidelines.) b. This criterion will be evaluated by ten (10) trials in a non-clinical (non-patient care) setting. c. Before package is sterilized, a chemical process indicator strip is placed on the exterior of the package and placed in a sterilizing process cycle. Evaluator will visually inspect the indicator strip post process cycle for manufacture suggested color change. 3. Steam Integrator indicator placed in a package for sterilization (according to manufactures instructions) will confirm package sterility with a color change (per manufacture guidelines) to all monitoring areas on the indicator strip. (Patient Safety) a. Exposure to steam penetration, temperature and time (critical parameters for sterility), the integrator strip color change confirms that sterilization conditions have been met. b. This criterion will be evaluated by five (5) trials in the non-clinical (non-patient care) setting. c. Steam Integrator indicators will be placed in package/pouch for processing using a steam process cycle. The evaluator will visually inspect the integrator strip for manufacture suggested color change post steam process cycle. 4. Designate area on the surface of Indicator Tape for steam displays a specific color change (per manufacture guidelines) when exposed to a steam process cycle. (Patient Safety) a. If there is no color change to the indicator tape sealing the package for sterilization, the item has not been exposed to a sterilization process. b. This criterion will be evaluated by five (5) trials in the nonclinical (non-patient care) setting. c. Indicator tape will be used to seal pre-sterilized packaging and place in a steam process cycle. Post process cycle, the evaluator will visually inspect the tape for manufacture suggested color change to indicate exposure to a steam sterilization process. 5. A biological indicator read-out/result of negative growth post a sterilization process indicates sterility has been achieved which allows sterilized package item to be released for use. (Patient Safety) a. The biological indicator challenge the sterilization process with a known quantity of microorganisms impregnated in the indicator to be killed demonstrating the effectiveness of the sterilization process by the inability of the organisms to continue growth. b. This criterion will be evaluated by ten (10) trials in a non-clinical (non- patient care) setting c. The evaluator will place the biological indicator for steam processes in a package to be sterilized (per the manufacture instructions) and place the package in a steam sterilization process cycle. Post sterilization cycle the evaluator will incubate the indicator (per manufacture guidelines) and obtain the results from the incubator read-out. Phase III Pricing Analysis Process. After the clinical/performance evaluation is completed and analyzed, all vendors in the clinical evaluation group who met the minimum clinical acceptability target threshold (--at or near 3.0 depending on the location of any break in vendors average scores (i.e., a gap between vendors average scores) as determined by the CPT will be contacted to submit their lowest pricing quotes (as well as product cross-reference data) based on committed volume of 80% of the total Regional requirement. Vendors scoring below the actual Acceptability threshold will be determined to be clinically Unacceptable, and will be disqualified from further consideration for this standardization initiative. Vendors will be given 14 calendar days from the date of request, to submit RIA pricing quotes, in a prescribed electronic spreadsheet format, based upon the total requirements of the Southeast Region. The Region intends to evaluate quotes and select a vendor or vendor(s), on initial submissions/quotes. 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 Region). However, the Region reserves the right to conduct discussions and request revised quotes, if determined necessary. Price quotes must be received by 5:00 PM EST on the 14th calendar day. Those vendors that fail to respond as required by 5:00PM EST on the 14th calendar day will be disqualified from further consideration. Vendor MUST submit discounts off DAPA for all products included in this standardization initiative. Note: vendors that fail to submit a discount from DAPA will be disqualified. Where lower uncommitted Federal Supply Schedule (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. Vendors are to provide a quote on discounts in response to this RFQ. Vendors who do not provide discounts off DAPA for ALL products will be disqualified. Clinical/performance and technical/company factors will be weighted more heavily than price. The Technical/Company and Clinical/Performance evaluation factors, when combined, are considered significantly more important than cost or price. As the evaluation results become more technically/clinically equal, price will become more important. Pricing will be evaluated based on a best-value, lowest-overall-cost alternative to the government and will be based on a committed volume for a two (2) years (24 months) from date of selection with three (3) 12-month option periods not to exceed a total of 5 years. The following elements will be considered in the pricing analysis: (1) Impact of RIA prices on the Region. (Post-Standardization Costs). This represents the new estimated annual cost or the total cost post standardization and includes the vendors products, and the products that could not be matched. It reflects the amount the Region would pay the vendor using the RIA pricing. (2) Potential Cost Avoidance. Cost avoidance is calculated by subtracting the RIA price from the Distribution and Pricing Agreement (DAPA) price and multiplying by 12-months of usage. This is included as a reporting Matrix. (3) Impact of Unmatched Lines. The unmatched lines make it difficult to compare the prices of the various vendors, because the evaluator cannot compare similar product lines for each vendor. Those items that are considered in the high usage category will have a higher impact to the region for the unmatched product line and the end post-standardization costs. (4) Consideration of SKUs by each vendor. The Region intends to reduce the number of SKUs that must be handled per period. Vendors that can supply the complete range of clinically-required product, without unnecessary numbers of SKUs for minimally-differentiated products, will be more likely to provide the best-value solution for the Government in this standardization initiative. THE CLOSING DATE IS 27 MAY 2008 AT 1600 HOURS (4:00 PM EDT)
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- Address: TRI SERVICE SOUTHEAST REGIONAL BUSINESS OFFICE ATTN: BLDG 40707 STREET ROOM 105 Fort Gordon GA
- Zip Code: 30905-5650
- Zip Code: 30905-5650
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