SOURCES SOUGHT
65 -- Disposable Protective Apparel (Non-Sterile Patient Exam & Staff Gowns)
- Notice Date
- 10/14/2009
- 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
- APP-9-10-0910-01
- Archive Date
- 11/19/2009
- 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 Disposable Protective Apparel (Non-Sterile Patient Exam & Staff Gowns). 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 disposable patient exam gowns (capes, shorts, gowns) for female and male patients and disposable staff gowns (isolation, lab coats, coveralls). The entire category of Disposable Protective Apparel (Non-Sterile Patient Exam & Staff Gowns) has an annual demand of over $190,000. 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 December 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 Disposable Protective Apparel (Non-Sterile Patient Exam & Staff Gowns). The product category includes disposable patient exam gowns (capes, shorts, gowns) for female and male patients and disposable staff gowns (isolation, lab coats, coveralls). Within this region, this product line has an estimated annual dollar requirement of over $190,000. 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 November 4, 2009. Submissions must be received by COB, 5:00 PM PT 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 manufacture and/or distribute a complete line of Disposable Protective Apparel (Non-Sterile Patient Exam & Staff Gowns) which are latex free; non-toxic and have non-fast dyes; are available in AAMI levels 1-4 and at a minimum barrier protection of AAMI level 2 (When tested for impact penetration and hydrostatic pressure, critical zone components must have a blotter weight gain of no more than 1.0 grams and a hydrostatic resistance of at least 20 cm; have an indication on the gown of the barrier protected regions; made of breathable and lightweight material that maintains the wearer’s normal body temperature; made of polyethylene-coated polypropylene or other laminate materials which offer better protection than those of non-coated materials; can withstand rubbing and abrasion throughout a procedure decreasing the generation of particulate contaminants and airborne bacterial transmission; must be low lint; have ties behind the neck and at the waist; have ribbed cuffs that are sewn or molded on and do not tear off the sleeve; can accommodate sizes ranging from extra small through XXL. Disposable Protective Apparel (Non-Sterile Patient Exam & Staff Gowns) that are lightweight, durable, latex free; can withstand rubbing and abrasion throughout a procedure decreasing the generation of particulate contaminants and airborne bacterial transmission and are low lint in styles to accommodate adult male and female patients in a range of sizes from extra small to XXL. A ‘complete line of product’ is defined as the MTFs requirements for usage items in the product line. Usage items are defined in the Medical/Surgical Prime Vendor contract statement of work as DAPA items ordered at least once per month, and at least one unit per order. At a minimum, a complete product line includes the following products in the following sizes, Cover Isolation Gown Universal size: Extra Small, Small, Medium, Large, and XX Large; Universal Impervious Open Back Knit Cuff size: Extra Small, Small, Medium, Large, and XX Large; Gown Exam Disposable size: Extra Small, Small, Medium, Large, and XX Large; Disposable Patient Short Non-Woven Elastic Waistband size: Extra Small, Small, Medium, Large, and XX Large. 2.Vendors must provide a complete list of items supplied (catalog, etc.) and product literature in response to this RFQ with the initial submittal. Vendors are required to supply all items listed in all sizes and styles listed above. (Vendors who do not have a complete product line as above will be disqualified in Phase I). 3.Vendors must provide supporting documentation that all Disposable Protective Apparel (Non-Sterile Patient Exam & Staff Gowns) that are manufactured and/or distributed are FDA approved, and provide supporting documentation to support this requirement with the initial submittal. Products will conform to the levels of barrier protection by the Association for the Advancement of Medical Instrumentation (AAMI) PB70:2003 guidelines for Liquid Barrier Performance and Classification of Protection Apparel and Drapes Intended for use in Health Care Facilities. 4.Vendors must have a DAPA or be in the process of applying for a DAPA number for the Disposable Protective Apparel (Non-Sterile Patient Exam & Staff Gowns) product line. Provide the DAPA number or proof of the application process with the initial submission. Vendors that fail to have a DAPA or show a lack of progress in obtaining a DAPA will be disqualified. 5.Vendors must have a separate agreement with the prime vendor Cardinal Health for distribution in the Southwest Region. Vendors whose products are not available through Cardinal Health will be disqualified. 6.Vendors must provide discounts off DAPA for all products included in this standardization initiative. Where lower FSS prices are available, DAPA holders are required by previous agreement to provide the FSS price as their DAPA price. Therefore, FSS prices do not represent a discount off DAPA. Vendors that fail to provide a discount from DAPA will be disqualified. 7.Vendors must have a vendor representative(s) available in the Southwest Region. Please provide contact information, i.e. name, address, phone number, and e-mail address with the initial submission. 8.Vendors must provide proof of corrective actions(s)/ resolution for any history of back orders and/or recalls that occurred during the most recent 12-month period. Vendors will not have an opportunity to provide additional information on back orders and recalls during any subsequent stage in this evaluation. 9.Vendors must describe how they identify if there is any latex in the gown or packaging. 10.Vendors must identify the brand(s) that your company manufacture and/or distribute your product. 11.Vendors must identify if your products are manufactured under FDA (TIR) standards. Please identify any other standards. 12.Vendors must provide information about how your company’s fabrics used Disposable Gowns perform in a surgical fire, i.e., Meets Consumer Product Safety Commission Standard for Flammability of Clothing Textiles (CPSC 16 CFR 1610). 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, 5:00 PM PT, 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 non-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 Non-sterile Staff Gowns/Coveralls/Lab Coats 1.The non-sterile staff gown’s/coverall’s/lab coat’s level of barrier protection is readily identifiable on the gown/coverall/lab coat and the packaging. a.The level of barrier protection for the non-sterile staff gown/coverall/lab coat must be identifiable allowing the clinician to wear the proper gown/coverall/lab coat for the procedure being performed. b.This criterion will be evaluated in the non-clinical setting by use of the product at least 2 times. c.Each non-sterile staff gown/coverall/lab coat will be visually inspected making sure the level of barrier protection is provided on the gown/coverall/lab coat and the packaging of the gown/coverall/lab coat. 2.The non-sterile staff gown/coverall/lab coat has adequate barrier protection and resists saturation and any penetration of liquids (fluid strikethroughs). a.The non-sterile staff gown/coverall/lab coat must effectively resist saturation and/or any liquid penetration to maintain protection for the patient and the clinician during the clinical procedure. b.This criterion will be evaluated in the non-clinical setting by use of the product at least 2 times. c.The non-sterile staff gown/coverall/lab coat will be inspected during and after the clinical procedure for visual signs of moisture and/or wetness (fluid strikethroughs). 3.The non-sterile staff gown/coverall/lab coat does not tear and/or perforate during the clinical procedure. a.The non-sterile staff gown/coverall/lab coat must effectively resist tears and/or perforations in order to maintain protection of the patient and the clinician during the clinical procedure. b.This criterion will be evaluated in the non-clinical setting by use of the product at least 2 times. c.The non-sterile staff gown will be inspected during and after the clinical procedure for visual signs of tears or perforations. 4.The construction of the non-sterile staff gown/coverall/lab coat is of good quality and fits the clinician well. a.The non-sterile staff gown’s/coverall’s/lab coat’s construction must have limited memory, is easy to don and take off, flexible enough to conform loosely to the clinician’s body, fits the wearer well (size, length, and cuff fit), closes in the back, is long enough to cover below knees, cuffs are long enough to cover hands for closed gloving, is low lint and lightweight, has breathability, gown fasteners and ties are constructed well and stay fastened during use and does not have an unpleasant odor. b.This criterion will be evaluated in the non-clinical setting by use of the product at least 2 times. c.Each non-sterile staff gown/coverall/lab coat will be donned according to the manufacturer’s guidelines and examined for ease of donning and removing, comfort and coverage, breathability, weight, conformity to the clinician’s body, closes in the back, is long enough to cover below knees, cuffs are long enough to cover hands for closed gloving, is low lint, fasteners and ties are constructed well and stay fastened during use and does not have an unpleasant odor. Patient Exam Gowns/Shorts 1.The barrier protection level of the patient exam gown/short is readily identifiable on the gown and packaging. a.The level of barrier protection for the patient exam gown/short must be identifiable allowing the clinician to choose the proper gown/short for the procedure being performed. b.This criterion will be evaluated in the non-clinical setting by use of the product at least 2 times. c.Each patient exam gown/short will be visually inspected making sure the level of barrier protection is provided on the gown/short and the packaging of the gown/short. 2.The non-sterile patient gown/short does not tear and/or perforate during the clinical procedure. a.The non-sterile patient gown/short must effectively resist tears and/or perforations in order to maintain protection of the patient and the clinician during the clinical procedure. b.This criterion will be evaluated in the non-clinical setting by use of the product at least 2 times. c.The non-sterile patient gown/short will be inspected during and after the clinical procedure for visual signs of tears or perforations. 3.The construction of the patient exam gown/short is of good quality. a.The construction of the patient exam gown/short must have limited memory, is flexible enough to conform loosely to the patient’s body, is lightweight, has breathability, and has a pleasant odor. b.This criterion will be evaluated in the non-clinical setting by use of the product at least 2 times. c.Each patient exam gown/short will be donned according to the manufacturer’s guidelines and examined for comfort, breathability, weight, conformity to the patient’s body and does not have an unpleasant odor. 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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