SOURCES SOUGHT
65 -- Sterilization Indicators & Controls - Chemical
- Notice Date
- 6/12/2009
- 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
- APP9-10-0906-001
- Archive Date
- 7/18/2009
- Point of Contact
- Cynthia Ingrao, Phone: 619-532-8517
- E-Mail Address
-
cynthia.ingrao@med.navy.mil
(cynthia.ingrao@med.navy.mil)
- Small Business Set-Aside
- N/A
- Description
- A.General Information The Southwest Region will be standardizing Sterilization Indicators & Controls - Chemical. This is a re-evaluation of this product group. A multiple selection is only a possibility if no single vendor can meet the total requirements of the Region and would be based on a combination of MTF preference and product availability. In order to meet the total requirements of the Region a vendor must be able to offer a comprehensive product line (all items within a product category) available in the necessary quantities to meet all of the DoD MTFs’ needs. That is, the required products must be available in the required quantities. As stated previously, it is not the preference of this standardization to make a multiple selection, however, if necessary due to non-availability from a single source, a multiple selection would be made based on a combination of Regional Clinical preference as determined by the Clinical Product Team (CPT) and vendor product availability. The product category includes indicator strips, bowie-dick type tests, integrator packs, tapes in widths of ¾” and 1” with and without dispensers for wrapped trays, attest kits and smart packs for Vacuum-Assisted and Gravity Displacement Steam Sterilization processes. The entire category of Sterilization Indicators & Controls - Chemical has an annual demand of over $80,000. The primary objective of this standardization initiative is to achieve a best value determination that represents the clinically preferred product or source at the best possible price. It is also intended that standardized product be obtained through the DoD Prime Vendor Program, Cardinal, currently serving the Southwest Region. The secondary objective of this standardization initiative is the potential of decreasing the existing Stock Keeping Unit’s (SKUs) and thus dollars held as inventory. The below item detail of the products being purchased within the region will be used to target and cross-match product lists submitted by the vendor. This process will ensure the minimum requirements of the Region are met and help identify possible candidates for elimination (i.e. like product items), as well as potentially minimizing the number of SKUs included in a subsequent incentive agreement. The major facilities in the area include but are not limited to Naval Medical Center San Diego; David Grant Medical Center, Travis AFB; Naval Hospital Camp Pendleton; Robert E. Bush Hospital, Twenty-Nine Palms; Weed Army Community Hospital, Ft. Irwin; Naval Hospital Lemoore; 9th Medical Group, Beale AFB; 30th Medical Group, Vandenberg AFB; 61st Medical Squadron, Los Angeles AFB; 95th Medical Group, Edwards AFB. This standardization action is part of the Medical/Surgical Prime Vendor program executed by the Defense Supply Center Philadelphia, 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 Vendor of 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 items. This is a supplement to the Prime Vendor Program and it is not a contract. For additional information regarding DSCP’s Prime vendor program and obtaining a DAPA please access our web site at https://dmmonline.dscp.dla.mil The Tri-Service Regional Business Office (TRBO) will provide anticipated volume (quantity) based on historical usage/forecasted requirements. The agreement will be for a base period of two (2) years (24 months) from date of award with three (3) 12-month option periods. Anticipated award date is November 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 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 based on a combination of MTF preference and product availability. Point of Contact: Cindy Ingrao, RN, MSN at (619) 532-8517; Email- cynthia.ingrao@med.navy.mil B.Products & Performance Required The Southwest Region is seeking product line items in the category of Sterilization Indicators & Controls - Chemical. The product category includes indicator strips, bowie-dick type tests, integrator packs, tapes in widths of ¾” and 1” with and without dispensers for wrapped trays, attest kits and smart packs for Vacuum-Assisted and Gravity Displacement Steam sterilization processes. Within this region, this product line has an estimated annual dollar requirement of $80,000. This is a re-evaluation of this product group. A multiple selection is only a possibility if no single vendor can meet the total requirements of the Region and would be based on a combination of MTF preference and product availability. This forecast is based on historical prime vendor sales during a recent 12-month period. At the request of the Southwest Region Military Treatment Facilities vendors will provide on-site support and in-servicing, educational resources and tools for clinical use of the product, conversion information, prime vendor order numbers, MSDS information, and itemization of the brands, types and packaging information of the products offered by the vendor. C. Instructions to Vendors If you are interested in participating in this standardization initiative, email your (1) Company name and address, (2) POC (Name and Phone Number, Fax Number, E-mail address, your answers to the technical questions/criteria below and product literature to cynthia.ingrao@med.navy.mil no later than July 3, 2009. Submissions must be received by COB, 5:00 PM PDST on the specified closing date/time of this sources sought notice. Vendors that fail to meet the submittal deadline will be disqualified. If your product literature is more than 4MB in size, please mail your product literature to: Cindy Ingrao, RN, MSN Tri-Service Regional Business Office - Southwest Region 34800 Bob Wilson Drive, Suite 110 San Diego, CA 92134 Phone: (619) 532-8517 This process will include vendor requirements of electronic responses to technical criteria, no charge samples for clinical evaluation, and submission of electronic best price offers. Due to the potential for email to become lost in transmission due to network security, etc., the vendor is strongly encouraged to confirm with the Region that its quote and literature actually arrived at the Region via email. All e-mail communication between vendors and the region will be digitally signed by the issuer. We strongly recommend that each submitting vendor confirm receipt, allowing enough time for re-submission before the due date, if a problem should occur with the first transmission. D.Evaluation Criteria Phase I - Technical/Company Evaluation Process. Vendors will be required to provide detailed responses to the technical/company criteria and product literature. Amplifying information about your products may be requested by the Government. The responses will be reviewed under the purview of the TPRB to determine acceptability. All technical/company criteria are weighted equally. The vendors who meet the following technical/company criteria will be qualified/invited to participate in the clinical/performance evaluation process via e-mail communication with each vendor. All communications of significant milestones, such as invitations to participate, notices of disqualification, etc. must be digitally signed. The TPRB will review the responses from the vendors and determine which vendors meet the criteria and determine acceptability. Acceptability for purposes of evaluation of technical/company criteria: Generally, responses to all questions in this section demonstrate: (1) the vendor is a distributor or manufacturer of a complete line of the subject medical/surgical consumables; (2) 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; (3) the vendor has, or is obtaining a DAPA for the items (vendors that fail to have a DAPA will be disqualified); (4) the vendor has, or is obtaining, an agreement covering the items, with Cardinal, the Prime Vendor for the region (vendors whose products are not available through the regional PV will be disqualified); (5) the vendor intends to provide discounts off DAPA for all products included in this standardization initiative (vendors that fail to provide a discount from DAPA will be disqualified); and (6) the vendor’s information provided is factually correct. Any misrepresentation of information will disqualify the vendor from further consideration. Technical/Company Criteria 1.Vendor must provide a complete line of Steam Sterilization Chemical Indicators. At a minimum, a complete product line includes indicator strips, bowie-dick type tests, integrator packs, tapes in widths of ¾” and 1” with and without dispensers for wrapped trays, attest kits and smart packs for Vacuum-Assisted and Gravity Displacement Steam Sterilization processes. 2.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. 3.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. 4.Vendors must provide manufacturing guidelines/instructions for testing, safety, and end-point values including how exposure to sterilant is identified for all indicators with the initial submittal. 5.Vendors must provide a statement indicating their products/packaging related to this product line is latex-safe/free and heavy metal free with the initial submittal. 6.Vendors MUST provide specific product information (brand, model, cost, etc.) of the proprietary incubator used in response to this RFRIAQ. 7.Vendors must have a Distribution and Pricing Agreement (DAPA) with Defense Supply Center Philadelphia (DSCP) or be in the process of applying for a DAPA number for the Steam Sterilization Indicators – Chemical product line. Provide the DAPA number or proof of the application process in progress in response to this RFRIAQ. Vendors that fail to have a DAPA will be disqualified. 8.Vendors must have a separate agreement with the prime vendor (PV), Cardinal Health for distribution of Steam Sterilization Indicators – Chemical within the Southwest Region. Vendors whose products are not available through the current regional PV will be disqualified. 9.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. Vendors are to provide quote on discounts, in response to this RFRIAQ. Vendors who do not provide discounts off DAPA for all products in this product line will be disqualified. 10.Vendors must provide a local vendor representative for product implementation and customer servicing as required for the Medical Treatment Facilities (MTF) within the Southwest Region. Provide contact information, i.e. name, address, phone number, and email address in response to this RFRIAQ. 11.Vendor must provide proof of corrective actions(s)/resolution of all history of back orders and recalls that occurred during the most recent 12-month period for the Steam Sterilization Indicators – Chemical product line 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 standardization process. The Government will not contact any provided points of contact in response to this criterion. Vendors should not provide point of contact information in response to this criterion. Phase II - Clinical/Performance Evaluation Process. The TPRB will request samples and product literature from the product group to be clinically evaluated at selected Military Treatment Facilities. Vendors are required to ship samples directly to the designated MTFs. Vendors will be given 14 calendar days to ship samples. Samples must arrive at the MTF by COB, 5:00PM PDST, on the 14th calendar day after the notice to ship. Vendors failing to deliver by the deadline will be disqualified from further consideration in the standardization process. The MTFs will evaluate the clinical/performance criteria using a scale from one (1) to five (5) where 1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree and 5 = Strongly Agree. All clinical/performance criteria are weighted equally. The evaluations are conducted in a clinical setting. The CPT has established a target threshold of 3.0 for clinical acceptability of product for standardization. The CPT will analyze acceptability as being at or near 3.0 depending on the “break”, in the average scores and how closely the scores are clustered near the Acceptability Target Threshold of 3.0. Subject to this review, products below this threshold will be clinically unacceptable and be disqualified from further consideration for standardization. A Clinical Product Team (CPT) comprised of medical professionals from several disciplines will evaluate the products based upon on the following evaluation criteria to determine acceptability. Clinical/Performance Criteria 1.The chemical steam sterilization indicator product packaging clearly indicates the type of indicator for the type of steam sterilization process. a.Chemical steam indicators are specific to the type of sterilization process to assure the successful sterile processing of surgical instruments. b.This criterion will be evaluated in the clinical setting by use of the product at least 3 times. c.Evaluator will assess for the ease of determining the type of chemical indicator by examining the product packaging. 2.The chemical steam sterilization indicators are easy to attach to a sample test wrapped tray and instrument pan. a.Chemical steam indicators must attach easily and securely to determine the successful sterile processing of surgical instruments. b.This criterion will be evaluated in the clinical setting by use of the product at least 3 times. c.Evaluator will attach the 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 chemical indicator response can be easily determined to assess for exposure to the sterilization process cycle. a.Chemical steam 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.This criterion will be evaluated in the clinical setting by use of the product at least 3 times. c.Evaluator will visually inspect the indicators for ease of determining exposure to the sterilization process cycle. 4.After complete incubation with control, the chemical indicator and control response can be easily determined for exposure to the sterilization process cycle (No Growth of Chemical Indicator/Growth of Control). a.Chemical indicators must clearly indicate the success/failure of the sterilization process cycle to assess the sterility of surgical instruments. Controls must clearly indicate growth of chemical as a comparison. b.This criterion will be evaluated in the clinical setting by use of the product at least 3 times. c.After process cycle is completed and chemical indicator has completed the required incubation period, evaluator will visually inspect the indicator/control for ease of determining appropriate response (No Growth of Indicator/Growth of Control) indicating exposure of pack load to the sterilization process cycle. 5.After the sterilization process cycle is completed, the chemical indicators do not easily detach from the sample test wrapped trays and instrument pans. a.Chemical indicators must remain securely attached to instrument packs to differentiate processed/unprocessed instrument packs in inventory/storage. b.This criterion will be evaluated in the clinical setting by use of the product at least 3 times. c.Evaluator will assess for secure attachment of indicators after the completed sterilization process cycle. 6.After the sterilization process cycle is completed, the indicator (Bowie-Dick type test) response can be easily determined for exposure to the sterilization process cycle (pack load). a.Chemical indicators (Bowie-Dick type test) must clearly indicate the success/failure of the sterilization process cycle to assess the sterility of surgical instruments. b.This criterion will be evaluated in the clinical setting by use of the product at least 3 times. c.Before pack load is sterilized, the chemical indicator is placed in the 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. 7.After the sterilization process cycle is completed, the chemical integrator indicator response can be easily determined as Safe/Sterile or Unsafe/Unsterile for sample test wrapped trays and instrument pans. a.Chemical integrator indicators must clearly indicate the success/failure of the sterilization process cycle to assess the sterility of surgical instruments. b.This criterion will be evaluated in the clinical setting by use of the product at least 3 times. c.Before the sample test wrapped tray and instrument pan is sterilized, the 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. All vendors who provide samples for clinical evaluation will be asked to submit best value pricing for analysis. Vendors will be given 14 calendar days from the date of request to submit their best pricing, in a prescribed format, based upon the total requirements of the Southwest Region. The Region intends to evaluate pricing and select a vendor or vendor(s), without discussions. Vendor pricing should contain the vendor's best product matches for the products or product lines requested in this announcement. Vendor pricing 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 pricing, if it is determined to be necessary. Pricing will be evaluated based on best value to the government and will be based on a committed volume for a two-year period with possible one-year option periods (not to exceed 5 years). The following elements will be considered in the pricing analysis: (1) Impact of RIA prices on the Region (Post-Standardization Costs), (2) Potential Cost Avoidance, (3) Impact of Unmatched Lines, and (4) Consideration of SKUs by each vendor. The impact of RIA prices on the Region is considered more important than other pricing elements. 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 best value to the government and will be based on a committed volume for a two-year period with possible one-year option periods (not to exceed 5 years). Failure to submit a discount off the DAPA price will result in exclusion.
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