The Pacific Region Tri-Service Regional Business Office (TRBO) Region 12 and the Southwest Region TRBO Regions 9/10, two integrated delivery networks, comprised of Army, Navy, Air Force, and Marine Corps Medical Treatment Facilities (MTFs) in Hawaii, Guam, Okinawa, Japan, Korea, and California announce a Request for Regional Incentive Agreement Quotation (RFRIAQ) for the standardization of One Step Surgical Prep, Applicator Sponge Device, Povidone-Iodine and Isopropyl Alcohol (PVP-I W/IPA)- [0.5% to 0.75% Povidone-Iodine and 60-75% Isopropyl Alcohol].
The primary objective of this program is to standardize the quality of care across the regions 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 products be obtained through the Department of Defense (DoD) Prime Vendor (PV) Program.
The major Medical Treatment Facilities (MTFs) in the Regions include but are not limited to Tripler Army Medical Center, U.S. Naval Hospital Okinawa, U.S. Naval Hospital Guam, U.S. Naval Hospital Yokosuka, 121st Combat Support Hospital Seoul, 374th Medical Group, Yokota AB, 18th Medical Group Kadena AB, 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, and 95th Medical Group, Edwards AFB.
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 12-month option periods. Anticipated selection date is April 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 two Regions, 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.
Points 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 and Southwest Regions are seeking product line items in the category of One Step Surgical Prep, Applicator Sponge Device, Povidone-Iodine with Isopropyl Alcohol.
[0.5% to 0.75% Povidone-Iodine and 60-75% Isopropyl Alcohol].
Standardization action for this product line seeks to select a vendor for a new term Regional Incentive Agreement (RIA). This product line includes the following products in the following sizes: 1) an applicator sponge device which delivers a range of 5-10 ml solution; the solution contains a range of 0.5% to 0.75% Povidone-Iodine and 60-75% Isopropyl Alcohol; 2) an applicator sponge device which delivers a range of 15-30 ml solution; the solution contains a range of 0.5% to 0.75% Povidone-Iodine and 60-75% Isopropyl Alcohol.
At the request of the Pacific Regional Military Treatment Facilities, 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 meridian (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 no charge 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.
Please email product literature only to:
Cindy Ingrao, RN, MSN at cynthia.ingrao@med.navy.mil
Cheryl A. Janus, RN, MBA at cheryl.janus@amedd.army.mil
D. Source Selection Procedures
The Tri-Service Product Review Boards (TPRBs) for the Pacific and Southwest Regions are the governing body of the standardization process and program. These boards include clinicians and logisticians from the Military Treatment Facilities (MTF) within the Pacific and Southwest Regions. The Pacific and Southwest TPRBs are chaired by the respective Designated Senior Logisticians. They are the deciding officials for this initiative. 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. Additionally, the Regions reserve the right to conduct discussions and request revised quotes, if it is determined to be necessary. If industry participation is unsatisfactory, the two Regional TPRBs will decide whether to proceed with or delay the project.
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 best value price quotes. Vendors best value pricing will be in a prescribed electronic spreadsheet format, based upon the total requirements of the Pacific and Southwest Regions. Vendors that fail to respond to the technical/company criteria or fail to send the no charge literature and no charge sample set or fails to provide a best value price quote will be disqualified from further consideration in the standardization initiative. Literature and 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: One Step Surgical Prep, Applicator Sponge Device, Povidone-Iodine with Isopropyl Alcohol [0.5% to 0.75% Povidone-Iodine and 60-75% Isopropyl Alcohol ] A) applicators with 10-15 ml and instructional literature - 20 (twenty) applicators to Tripler Army Medical Center, 35th MDG Misawa Japan, Naval Hospital Guam, 374th MDG Yokota Japan, Naval Hospital Yokosuka Japan, Naval Hospital Okinawa Japan, David Grant Medical Center, and the Tri-Service Regional Business Office Southwest Region. 10 (ten) applicators to 10 (ten) applicators to Naval Hospital Camp Pendleton. 5 (five) applicators to Robert E. Bush Hospital, Naval Hospital Lemoore and Weed Army Community Hospital. 2) 25-30 ml applicators and instructional literature - 20 (twenty) applicators to Tripler Army Medical Center, 35th MDG Misawa Japan, Naval Hospital Guam, 374th MDG Yokota Japan, Naval Hospital Yokosuka Japan, Naval Hospital Okinawa Japan, David Grant Medical Center, and the Tri-Service Regional Business Office Southwest Region. 10 (ten) applicators to Naval Hospital Camp Pendleton. 5 (five) applicators to Robert E. Bush Hospital, Naval Hospital Lemoore and Weed Army Community Hospital.
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 clinical (patient) setting.
The Regions intend 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. Pricing will be based on a committed volume for a two-year period with possible one-year option periods not to exceed a total of 5 years. However, the Regions reserve the right to request revised quotes, if determined necessary. The Regions reserve 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, 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 2-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) 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. Vendor must manufacture and/or distribute a complete product line of One Step Surgical Prep, Applicator Sponge Device, Povidone-Iodine with Isopropyl Alcohol. [0.5% to 0.75% Povidone-Iodine and 60-75% Isopropyl Alcohol].
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: 1) an applicator sponge device which delivers a range of 5-10 ml solution; the solution contains a range of 0.5% to 0.75% Povidone-Iodine and 60-75% Isopropyl Alcohol; 2) an applicator sponge device which delivers a range of 15-30 ml solution; the solution contains a range of 0.5% to 0.75% Povidone-Iodine and 60-75% Isopropyl Alcohol.
Vendor must provide FDA certification, for clinical efficacy in meeting or exceeding the FDAs Tentative Final Monograph (TFM) standards for surgical preoperative patient skin prepping: Department of Health and Human Services Food and Drugs Administration, Center for Drug Evaluation and Research, March 23, 2005.
2. Vendors must have a Distribution and Pricing Agreement (DAPA) or be in the process of applying for a DAPA number for the One Step Surgical Prep, Applicator Sponge Device, Povidone-Iodine with Isopropyl Alcohol, product line. Provide the DAPA number or proof of the application process with the initial submittal. (Note that vendors that fail to have a DAPA or show a lack of progress in obtaining a DAPA will be disqualified).
3. Vendors must have a separate agreement with the prime vendor Cardinal Health for distribution in these two Regions and provide certification of this with the initial submittal. (Note that vendors whose products are not available through the regional PV will be disqualified).
4. 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 (Note that vendors that fail to provide a discount from DAPA will be disqualified).
5. Vendors must have a vendor representative available in the Regions. Provide contact information, i.e. name, address, phone number, and e-mail address with the initial submittal.
6. Vendors must provide any history of back orders and/or recalls that occurred during the most recent 12-month period for One Step Surgical Skin Prep Povidone-Iodine (PVP-I) and Isopropyl Alcohol products, including dates, duration, cause and resolution. Vendors will not have an opportunity to provide additional information on back orders and recalls during any subsequent stage in this evaluation. Vendors are encouraged to submit all information deemed relevant (i.e., positive resolutions, etc.) in response to this RFQ. The Government will not contact any points of contact provided in response to this question. Vendors should not provide point of contact information in response to this question.
7. Vendors must have a return goods policy, and should provide a copy of the policy with the initial submittal responding to this RFQ.
8. At a minimum, vendors must provide a standard industry warranty, and should submit evidence of the warranty policy with the initial submittals.
9. Vendors must provide Material Safety Data Sheet (MSDS) literature for each product offered.
10.Vendors must supply instructions/directions for use for all products to be supplies. Provide this information with the product literature submitted in response to this RFQ. Provide information explaining whether or not the instructions/directions are supplied with the individual item packaging, or are provided with the larger units of packaging only (i.e., per case, etc.)
11. Vendors must provide in-service staff training and identify company resources for such requirements with the initial submittals.
12. Vendors must provide educational tools and materials for One Step Surgical Prep, Applicator Sponge Device, Povidone-Iodine and Isopropyl Alcohol (PVP-I W/IPA)- [0.5% to 0.75% Povidone-Iodine and 60-75% Isopropyl Alcohol] products, and provide evidence of this with the initial submittals. For instance, provide literature on the tools/materials available.
13. Vendor must provide direct customer service and identify company resources for such support with the initial submittals. Direct customer service is described as a company resource available, via phone and/or email, with a response time within eight hours, Monday thru Friday. This reflects the challenges of the multiple time zones within the Pacific Region.
14. Vendors must provide One Step Surgical Prep, Applicator Sponge Device, Povidone-Iodine and Isopropyl Alcohol (PVP-I W/IPA)- [0.5% to 0.75% Povidone-Iodine and 60-75% Isopropyl Alcohol] products which are FDA approved for use in all clinical surgical skin preparation settings and provide literature to support this requirement with the initial submittals.
15. Vendors must provide a provide One Step Surgical Prep, Applicator Sponge Device, Povidone-Iodine and Isopropyl Alcohol (PVP-I W/IPA)- [0.5% to 0.75% Povidone-Iodine and 60-75% Isopropyl Alcohol] product which is latex free. Vendor must ensure that all such latex-free products are clearly labeled as such on all exterior and interior packaging, including the individual items.
16. Vendors must provide products with visible expiration dating on the labeling/packaging.


Clinical and Performance Criteria:
1. The product container wrapping is durable and intact and ensures no leakage
of the prep solution. (Maintain sterilization of contents, maintain
integrity of materials and eliminate the potential for degradation of
materials) [Addresses both clinician safety and cost]
a. The product wrapping is free of holes, punctures, splits in the heat sealed
edges and does not leak prep solution from any of the seams or edges.
b. This criterion will be evaluated in the clinical setting by use of the
product.
c. The evaluators will carefully scrutinize the entire package for any
punctures, tears or compromise to the sealed edges. The expectation is that
no evidence of breaks in the barrier of the packaging or evidence of liquid
seepage will be found.
2. The Prep Solution Applicator ensures an even application controlled flow
of solution- onto the patients skin area. (Maintain an even application of
the chemicals to the patients skin) [Addresses patient safety relative
to specific exposure to solution preparation chemicals and efficient use of
skin preparation tool]
a. The applicator controls the amount of solution delivered as the applicator
is applied to the skin area. No surges in the amount of liquid or leakage
from the applicator will occur.
b. This criterion will be evaluated in the clinical setting by use of the
product.
c. The evaluators will closely observe the applicator for any evidence of an
uneven delivery of solution. The expectation is that the applicator will
control the amount of solution delivered during use.
3. The Prep Solution Device contains an adequate amount of solution to prepare
the patients skin for surgery. (The solution amount completely covers the
surgical site area) [Addresses both Operating Room personnel efficiency
and cost]
a. A second applicator is not required to complete the skin prep.
b. This criterion will be evaluated in the clinical setting by use of the
product.
c. The clinicians using this product will directly observe the adequacy of the amount of solution provided. The expectation is that the device will
contain the adequate amount of prep solution.
4. The solution, when applied to the surgical site, will leave an easily
identified landmark. (Visualization of the prepped skin area is clearly
distinguishable from other skin areas) [Addresses patient safety and
infection control]
a. The prepped area of the skin will transition from a very shiny wet
appearance to a dull matted appearance.
b. This criterion will be evaluated in the clinical setting by use of the
product.
c. The clinicians will directly observe for this critical characteristic of
having prepped the surgical site. The expectation is that this transition
from a shiny skin appearance to a dull matted skin appearance will occur.
5. The drying time of the solution is within the time stated by the
manufacturer. (Excessive drying time interferes with the standard of
initiating the application of surgical drapes and protective barriers to
the patient) [Addresses efficiency of surgical time and patient safety
due to prolonged exposure of patients skin before draping]
a. The prep solution will dry in accordance with the stated drying time.
b. This criterion will be evaluated in the clinical setting by use of the
product.
c. The clinicians will directly observe for the anticipated drying time. The
expectation is that the solution will dry in accordance with the product
literature.