SRCSGT | 65 | Steam Sterilization Indicators - Chemical

FBO DAILY ISSUE OF NOVEMBER 28, 2008 FBO #2559
SOURCES SOUGHT

65 -- Steam Sterilization Indicators - Chemical

Notice Date: 11/26/2008
Notice Type: Sources Sought
NAICS: 339113 — Surgical Appliance and Supplies Manufacturing
Contracting Office: Department of the Navy, Bureau of Medicine and Surgery, NMC San Diego, Bldg 1, 38400 Bob Wilson Drive, San Diego, California, 92134-5000
ZIP Code: 92134-5000
Solicitation Number: APP01-0810-003
Archive Date: 12/26/2008
Point of Contact: Larry Shaughnesy,, Phone: 202-782-3666, Tracy Martin-Tilghman,, Phone: 202-782-3663
E-Mail Address: larry.shaughnesy@us.army.mil, tracy.martintilghman@us.army.mil
Small Business Set-Aside: N/A
Description: 65-Medical Supplies-Request for RIA Quotation A.General Information. The Northeast Region, Tri-Service Regional Business Office (TRBO) REG 1, a military integrated delivery network, comprised of 44 Army, Navy, Air Force, Marine Corps, and U.S. Coast Guard Medical Treatment Facilities (MTFs) in the states of Maine, New Hampshire, Massachusetts, Rhode Island, Connecticut, New York, Pennsylvania, New Jersey, Delaware, Maryland, District of Columbia, and Virginia seeks to initiate the standardization process for Steam Sterilization Indicators – Chemical. Vendors MUST provide a complete list of items supplied (catalog, etc.) and product literature in response to this Request for RIA Quotes (RFRIAQ). Vendors are required to supply all items listed in all sizes and styles listed. Vendors who do not have a complete product line, as detailed below in usage items, will be disqualified in Phase I. 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(s) or source(s) at the best possible price. It is also intended that standardized product be obtained through the DoD Prime Vendor (PV) Program. The major facilities in the Northeast Region include, but are not limited to Walter Reed Army Medical Center, Washington, DC; National Naval Medical Center, Bethesda, MD; Malcolm Grow Medical Center, Andrews AFB, MD; Dewitt Healthcare Network, FT Belvoir, VA; Keller Army Community Hospital, Westpoint, NY; and Kimbrough Ambulatory Care Center, FT Meade, MD. This standardization action is part of the Medical/Surgical PV program executed by the Defense Supply Center Philadelphia (DSCP), Directorate of Medical Materiel. To participate, your company must have a Distribution and Pricing Agreement (DAPA) and a separate commercial agreement with the PVs for the program. This is pursuant to the DAPA clause by which DAPA holders agree to the standardization process and to allow PV to distribute their items. This RFRIAQ will result in Regional Incentive Agreements that supplement the PV Program. The RFRIAQ will not result in a contract award. For additional information regarding DSCP PV program, please access their web site at https://dmmonline.dscp.dla.mil. The resulting RIA will be for a base period of two (2) years (24 months) from date of selection with three (3) 12-month option periods for a maximum of five (5) years. Anticipated selection date is March 2009. 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 more important. 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 cased on a combination of MTF preference and product availability. The selected vendor(s) of the standardization initiative are to submit a copy of the signed RIA along with the DAPA log number to both the TRBO lead logistician and the DSCP COR when submitting the log. Point of Contact is Tracy Martin-Tilghman, Team Logistician, Phone: 202-782-3663, and email: tracy.martintilghman@us.army.mil. B.Products & Performance Required. The Northeast Region is seeking product line items in the category of Steam Sterilization Indicators - Chemical, which at a minimum includes the product lines below. Within this region, this product line has an estimated annual dollar requirement of $73,014. This forecast is based on historical PV sales during a recent 12-month period and includes the following top high volume usage lines for this project: PART # DESCRIPTION 61301658261STEAM STERILIZATION INTEGRATOR - SHORT (250/BAG) 266103AUTOCLAVE TESTING ONCE-A-DAY TEST-PAK PRE-ASSEMBLED DISPOSABLE BOWIE & DICK TYPE TEST PACK 1222-1N3M COMPLY STEAM INDICATOR TAPE, 1"X60 YARDS, BULK, 18 RL/CS NB113DART AIR REMOVAL TEST 50 PER BOX 1243B3M COMPLY CHEMICAL INTEGRATOR FOR STEAM. 10 PAK/CS 100 EA/PAK LCC008Verify Chemical Indicators for the SYSTEM 1 Sterile Processing System 001353M COMPLY BOWIE-DICK PLUS TEST PACK W/EARLY WARNING TEST SHEET. DISPOSABLE. 20 PK/BX 4 BX/CS S3095VERIFY BOWIE-DICK TEST MULTIPULSE 61301668650S.M.A.R.T. PACK TEST PACK (30 CARTON) 1255-1N3M COMPLY STEAM INDICATOR TAPE W/DISPENSER, 1"X60 YDS 18 RL/CS C.Instructions to Vendors. DAPA holders interested in participating in this standardization initiative should email their detailed electronic responses to the technical/company criteria with accompanying electronic product literature, and the following information--(1) Company name and address, (2) Company Point of Contact (POC Name and Phone Number, Fax Number, and E-mail address) to the following Northeast Region POC: larry.shaughnesy@us.army.mil (202-782-3666) and tracy.martintilghman@us.army.mil (202-782-3663) as a back up. All email communication between vendors and the region must be digitally signed. All communications of significant acquisition milestones (such as invitations to participate, or notices of disqualification) must be digitally signed as well. Submissions must be received by 4:00 PM EDT/EST on 18 December 2008. Vendors that fail to meet the submittal deadline will be disqualified from participating. This process will include the above vendor requirements to provide electronic responses to technical/company criteria, electronic product literature, no-cost samples for clinical evaluation when requested, and submission of electronic best value price quotes when requested. Due to the potential for email to be lost in transmission, from network security, etc., vendors are strongly encouraged to confirm with the Northeast Region POC stated above that their initial submission, product literature, and best price submissions when requested actually arrived at the Northeast Regional Tri-Service Business Office (TRBO) POC 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 Northeast Region must be digitally signed by the issuer. Additionally, vendors will be required to notify the Northeast Regional Tri-Service Business Office (TRBO) POC by phone upon the receipt of the email request for the no-cost sample sets. Voicemail messages for the confirmation of the receipt of the TRBO email request for the no-cost sample sets will NOT be accepted to meet this requirement. D. Evaluation Criteria. The Tri-Service Product Review Board (TPRB) is the governing board of the standardization process. This board includes clinicians and logisticians from the MTFs within the Northeast Region. They are the deciding officials for this initiative. Phase I – Technical/Company Evaluation Process. Interested vendors are to respond to this FBO announcement by emailing their intent to participate, the required company/company POC information, electronic product literature, and detailed responses to the technical/company criteria listed below 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 under the purview of the TPRB and the Clinical Product Team (CPT) to determine the acceptability of each vendor. After review of the technical/company criteria responses, those vendors who meet these criteria will be qualified/invited to participate in the clinical/performance evaluation. 1. In general, acceptability for purposes of evaluation of technical/company criteria is defined as follows: a. Based on the vendor’s responses, the evaluators have reasonable confidence that the line or products and/or services submitted meet the medical standards of care of the community, applicable to such products or services. b. The vendor’s information provided is factually correct. Any misrepresentation of information will disqualify the vendor from further consideration. 2. Each technical/company criteria below requires additional, more specific definition of technical acceptability. This specific standard for technical acceptability will be sent forth with the individual criterion. 3. The vendors who meet the following technical/company criteria will be qualified/invited to participate in the clinical/performance evaluation process via an email communication with each vendor. The following Technical/Company Evaluation Criteria have been established for the standardization initiative: 1. Vendor must provide a complete line of Steam Sterilization Indicators – Chemical products. A complete line of product is defined as the Military Treatment Facilities (MTF) 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, a complete product line includes Steam Sterilization Indicators – Chemical for Vacuum-Assisted and Gravity Displacement Steam sterilization processes as follows: i. Class 1 Process Indicators – External Tape in ½”, 1” and 2” widths with and without dispensers for wrapped trays. ii. Class 1 Process Indicators – External Tags for instrument pans iii. Class 2 Process Indicators (Bowie-Dick-type test) iv. Class 5 Integrator/Integrated Indicators b. Vendors must provide a complete list of items supplied (catalog, etc.) and product literature in response to this RFRIAQ. Vendors are required to supply all items listed above. Vendors who do not have a complete product line as listed above will be disqualified in Phase I. c. Vendors must provide supporting documentation that all Steam Sterilization Indicators – Chemical that are manufactured and/or distributed are FDA approved and meet current ANSO/AAMI standards for this product line. Provide literature to support this requirement with the initial submittal. d. Vendors must provide information on the reliability, safety, and performance characteristics of their products including the interpretation of the Indicators results, the endpoint-response maintenance during storage, the sterilization conditions that the Indicators will detect, the shelf life of the Indicators., and the storage requirements for the Indicators themselves before and after sterilization (ANSI/AAMI ST79P 2006) with the initial submittal. e. Vendors must provide manufacturing guidelines/instructions for testing, safety, and end-point values for all Indicators. Provide manufacturing guidelines/instructions with the initial submittal. f. Vendors must provide a statement indicating their products/packaging related to this product line is latex-safe/free with the initial submittal. Phase II – Clinical/Performance Evaluation Process Following acceptability of the technical/company criteria, the TRBO, on behalf of the Clinical Product Team (CPT), will request product sample sets and literature from the product group at no cost to the Government or POC recipient, to be sent to designated CPT members from participating MTFs for evaluation in a non-clinical setting. Vendors will be given fourteen (14) calendar days from the issue of the notice requesting the no-cost product sample sets in which to deliver the no-cost sample sets to the designated CPT members. NOTE: Vendors will be required to notify the TRBO, Clinical Analyst by phone upon the receipt of the email request for the no-cost sample sets. Voicemail messages for the confirmation of the receipt of the TRBO email request for the no-cost sample sets will NOT be accepted to meet this requirement. Requested no-cost product sample sets and literature must be shipped to arrive at the designated CPT member address no later than the 14th calendar day after the date of the notice requesting no-cost product sample sets. Vendors who do not deliver the no-cost product samples by 4:00 PM EDT on the 14th calendar day after the date of the notice requesting no-cost product sample sets 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 no-cost product sample sets. Vendor’s presence will not be required for in-servicing prior to the evaluations. The clinical/performance evaluation period will last for twenty-one (21) calendar days. Specific CPT members will evaluate the vendor’s product sample sets against the clinical/performance criteria in a non-clinical (sterile processing department) setting. The evaluation responses will be recorded using a Likert scale format 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. All clinical/performance criteria are weighted equally. The CPT has established a target threshold of 3.50 for the Clinical Acceptability of products for standardization. The CPT will determine the actual Acceptability threshold for this standardization initiative—at or near 3.50—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 3.50, 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. Following the manufacturer’s instructions/guidelines, the evaluation of Class I Chemical Process Indicators and Class V Chemical Integrator Indicators will take place at each Military Treatment Facility (MTF) evaluation site in a non-clinical environment (sterile processing department) using a Laparotomy Set (or similar instrument set) in an instrument pan, and using a Small Fragmentation Set (or similar instrument set) in a wrapped tray as sample test trays during five (5) regularly scheduled vacuum-assisted steam sterilization process cycles. Following the manufacturer’s instructions/guidelines, Evaluation of Class II Chemical Process Indicators (Bowie-Dick type test) will take place at each MTF evaluation site in a non-clinical environment (sterile processing department) during five (5) regularly scheduled vacuum-assisted steam sterilization process cycles (pack loads). Evaluators will evaluate the performance of each type of Indicator in the Sample Set with the sample test trays and pack loads during the five (5) sterilization process cycles using the following established Quality Control/Patient Safety category clinical/performance criteria with a Clinical Acceptability Target Threshold of 3.50: 1. The Class I, II, and V Chemical Steam Sterilization Indicator product packaging clearly indicates the type of Indicator for which type of steam sterilization process. a. Chemical Steam Sterilization Indicators are specific to the type of sterilization process to assure the successful sterile processing of surgical instruments. b. Evaluator will assess for the ease of determining the type of Chemical Steam Sterilization Indicator by examining the product packaging. 2. The Class I Chemical Process Indicators (Class I External Pack Tape and Tag) are easy to attach to sample test wrapped tray and instrument pan. a. Class I Chemical Process Indicators must attach easily and securely to determine the successful sterile processing of surgical instruments. b. Evaluator will attach Class I External Pack Tape and Tag Indicators to sample test wrapped tray and instrument pan and assess for ease/security of attachment. 3. After the sterilization process cycle is completed, the Class I Chemical Process Indicator (Class I External Pack Tape and Tag) response can be easily determined to assess for exposure to the sterilization process cycle. a. Class I Chemical Process Indicators must clearly indicate the success/failure of the exposure to the sterilization process cycle to assure the successful sterile processing of surgical instruments. b. Evaluator will visually inspect the Indicators for ease of determining exposure to the sterilization process cycle. 4. After the sterilization process cycle is completed the Class I Chemical Process Indicators (Class External Pack Tape and Tag) do not easily detach from sample test wrapped trays and instrument pans. a. Class I Chemical Process Indicators must remain securely attached to instrument packs to differentiate processed/unprocessed instrument packs in inventory/storage. b. Evaluate will assess for secure attachment of Indicators after the completed sterilization process cycle. 5. After the sterilization process cycle is completed the Class II Chemical Process Indicator (Bowie-Dick type test) response can be easily determined for exposure to the sterilization process cycle (pack load). a. Class II Chemical Process Indicators (Bowie-Dick type test) must clearly indicate the success/failure of the sterilization process cycle to assess the sterility of surgical instruments. b. Before pack load is sterilized, Class II Chemical Process Indicator is placed in pack load according to manufacturer’s guidelines/instructions. After process cycle is completed, evaluator will visually inspect the Indicator for ease of determining exposure of pack load to the sterilization process cycle. 6. After the sterilization process cycle is completed the Class V Chemical Integrator Indicator response can be easily determined as Safe/Sterile or Unsafe/Unsterile for sample test wrapped trays and instrument pans. a. Class V Chemical Integrator Indicators must clearly indicate the success/failure of the sterilization process cycle to assess the sterility of surgical instruments. b. Before sample test wrapped tray and instrument pan is sterilized, Class V Chemical Integrator Indicator is place inside sample test tray/pan according to manufacturer’s guidelines/instructions. After process cycle is completed evaluator will visually inspect the Indicators for ease of determining successful exposure to the sterilization process cycle. Phase III – Pricing Analysis Process. 1. The following elements will be considered in the pricing analysis: (1) Impact of RIA prices (Post-Standardization Costs) on the Northeast Region—represents the new estimated total annual cost including matched and unmatched products—and reflects the amount the Region would pay using the RIA pricing. (2) Impact of Unmatched Lines—unmatched products make vendor comparisons difficult and those in the high usage category has higher impact for post-standardization costs. (3) Consideration of SKUs by each vendor—reduction of the number of SKUs handled per period is the intent of the Region; therefore, vendors supplying the complete range of clinically-required product, without unnecessary numbers of SKUs for minimally-differentiated products, are more likely to provide the best-value solution for the Government in this standardization initiative. 2. Vendors that are determined to be Acceptable after review of their responses to the technical/company criteria, are qualified/invited to participate in the clinical/performance evaluation, and meet the clinical Acceptability target threshold of 3.50—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 requested to submit best value pricing, a competitive product cross reference, and value-adds based on a committed volume of 80% of the total requirements of the Northeast Region. The quote will be requested to be in a prescribed electronic spreadsheet format. Those vendors who do not meet the technical/company criteria, are not qualified/invited to participate in the clinical/performance evaluation, and do meet the clinical Acceptability target threshold of 3.50—depending on the location of any “break” in vendors’ average scores (i.e., gap between vendors’ average scores) as determined by the CPT—will not be requested to submit pricing quotes and will be disqualified from further consideration. Vendors that have been disqualified will be notified in writing at the conclusion of the standardization process. 3. Vendors will be given fourteen (14) calendar days from the date of the notice to submit RIA pricing quotes, the competitive product cross reference, and value adds in a prescribed electronic spreadsheet format. Price quotes, cross reference, and value adds must be received by 4:00 PM EDT on the 14th calendar day after the date of the notice to submit. Those vendors that fail to respond by the deadline date/time will be disqualified from further consideration. Vendors that have been disqualified will be notified in writing at the conclusion of the standardization process. 4. The Northeast Region intends to evaluate quotes and select a vendor or vendor(s), on initial submissions/quotes. Vendor quotes should contain the vendor's best product matches for the products or product lines requested in the notice to submit RIA pricing. Vendor’s 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 Northeast Region). The Northeast Region reserves the right to limit the number of quotes to the greatest number that will permit an efficient competition among vendors. The Northeast Region reserves the right to make a down selection during the evaluation process based on considerations of efficient competition. 5. 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 five (5) years. _____________________________________________________________________________ END
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65 -- Steam Sterilization Indicators - Chemical