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Pharmaceutical Containers - Product Standardization
Program Summary
Title: Pharmaceutical Containers - Product Standardization
GovCB Opps ID : ADP12083631310001640
Document Type: Sources Sought
FSC Code: 65 - Medical, Dental, and Veterinary Equipment and Supplies
Solicitation No.: TMAR2-SS62
Source: https://www.fbo.gov/?s=opportunity&mode=form&id=b02eecf1512c81a01af3a15600c09192&tab=cor...
Place of
Performance:

Posted Date:
Apr 15, 2008
Last Update: Apr 17, 2008
Due Date: May 07, 2008

Description
Pharmaceutical Containers - Product Standardization
Solicitation Number: TMAR2-SS62
Agency: Department of the Navy
Office: Bureau of Medicine and Surgery
Location: NMC Portsmouth
Opportunity History
  • Original Synopsis
    Apr 15, 2008
Solicitation Number:
TMAR2-SS62
Notice Type:
Sources Sought
Synopsis:
Added: Apr 15, 2008 8:58 am
65-Medical Supplies-Potential Sources Sought
---------------
A. General Information

The Tri-Service Mid-Atlantic Region, a military integrated delivery network, comprised of Army, Navy, and Air Force medical commands and medical treatment facilities (MTFs) in the states of Virginia and North Carolina announces a Request for Regional Incentive Agreement Quotation (REFRIAQ) for the standardization of Pharmaceutical Containers to include, but not limited to:

1. Prescription Vials, Amber, Plastic, Reversible Child Resistant/Non-Child
resistant Caps to include 16, 30, 60, and 90 dram sizes
2. Pharmaceutical Bottles (with lids) available in multiple sizes to include 90,
120, and 150 dram sizes
3. Pharmaceutical Jars (with lids) available in multiple sizes to include 1, 2,
4, and 8 ounce sizes

The major facilities in the Mid-Atlantic Region include: 1st Medical Group, Langley AFB, VA; 43rd Medical Group, Pope AFB, NC; 4th Medical Group, Seymour Johnson AFB, NC; Womack Army Medical Center, FT Bragg, NC; McDonald Army Community Hospital, FT Eustis, VA; Kenner Army Health Clinic, FT Lee, VA; Naval Medical Center Portsmouth, Portsmouth, VA; Naval Hospital Camp Lejeune, Camp Lejeune, NC; Naval Hospital Cherry Point, Cherry Point MCAS, NC.

The primary objective of this standardization initiative 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 products be obtained through the DoD Prime Vendor Program.

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 for the Mid-Atlantic Region (Owens & Minor) or the Pharmacy Prime Vendor (Amerisource Bergen). 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 please access our web site at https://dmmonline.dscp.dla.mil

The Mid-Atlantic Tri-Service Regional Business Office (TRBO) will provide anticipated volume (quantity) based on historical usage. 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 July 2008. The evaluation will be based on clinical, technical, 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.

Point of Contact Robert Meinertzhagen, 757-953-2134, Bob.Meinertzhagen@med.navy.mil

B. Products & Performance Required

The Mid-Atlantic Region is seeking a complete product line of, Pharmaceutical Containers to include, but not limited to:

1. Prescription Vials, Amber, Plastic, Reversible Child Resistant/Non-Child
resistant Caps to include 16, 30, 60, and 90 dram sizes
2. Pharmaceutical Bottles (with lids) available in multiple sizes to include 90,
120, and 150 dram sizes
3. Pharmaceutical Jars (with lids) available in multiple sizes to include 1, 2,
4, and 8 ounce sizes

and includes at a minimum but is not limited to the high volume items indicated below.

Purchases in FY07
CdmiaMfgName CdmiaMfgPn Description
TRI STATE DISTRIBUTION TS-ONE16 VIAL, PRO ONE, 16 DRAM AMBER W
TRI STATE DISTRIBUTION TSONE16NC REVERSIBLE VIAL, 16 DRAM, AMBER, C/R-NON C/R, NO CAPS
TRI STATE DISTRIBUTION TS-ONE30 VIAL, PRO ONE, 30 DRAM AMBER W
TRI STATE DISTRIBUTION TS-ONE38LA CAP, REVERSIBLE, 38MM C/R-NON
TRI STATE DISTRIBUTION TS-ONE40NC REVERSIBLE VIAL,C/R-NON C/R CL
TRI STATE DISTRIBUTION TS-ONE60 VIAL, PRO ONE, 60 DRAM AMBER W
TRI STATE DISTRIBUTION TS-ONE60NC REVERSIBLE VIAL,C/R-NON C/R CL
TRI STATE DISTRIBUTION TSPRO90C VIAL, PRO PLUS, 90 DRAM AMBER
TRI STATE DISTRIBUTION TS-ONE40 VIAL, PRO ONE, 40 DRAM AMBER W

The approximate total annual purchase volume of all types of Pharmaceutical Containers for the Mid-Atlantic region is $93,330 based upon the historical usage of standardized Pharmaceutical Containers over a one year period. The overall evaluation will be based upon clinical, technical and pricing factors. The final award recommendation will be determined by utilizing the best value and trade off criteria.

At the request of the Mid-Atlantic Region Military Treatment Facilities, vendors will provide on-site support and in-servicing, educational resources and tools for clinical use of these products, 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

DAPA holders interested in participating in this standardization initiative, email your response to Bob.Meinertzhagen@med.navy.mil and provide: (1) Company name and address, (2) Point of contact information (Name and Phone Number, Fax Number, and E-mail address) (3) your company s Distribution and Pricing Agreement (DAPA) number and (4) your company s responses to the questions under Technical/Company Criteria below. Your email will include your agreement to provide for your products necessary technical criteria, no charge samples for clinical evaluation, and submission of electronic best price offers that represent a discount from your companies base uncommitted DAPA pricing. If required, any postal mailings should be sent to the following address:

Robert Meinertzhagen
Tri-Service Regional Business Office
Financial Operations Department, Bldg. 250
Naval Medical Center Portsmouth
620 John Paul Jones Circle
Portsmouth, VA 23708

Email responses must be received no later than 4:00 P.M. (EST) on the specified closing date/time of this Sources Sought FBO Notice. Failure to respond within this timeframe will result in your company being excluded from participation in this standardization effort.

This process will include vendor requirements to provide electronic responses to technical criteria, no charge 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. Vendors that do not meet the deadline of 4:00 PM EST on the date listed for closing (per the FBO RFQ), will be disqualified from further consideration in the standardization initiative. All email communications between vendors and the Region will be digitally signed by the issuer.

Emails and correspondence may be sent to Bob.Meinertzhagen@med.navy.mil .

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 all of the Military Treatment Facilities within the Mid-Atlantic Region. They are the decision makers for this initiative. Vendors will be required to provide responses to the technical/company criteria.

The Region intends to evaluate price 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 (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 it is determined to be necessary. If a down-selection is made during the evaluation process, the Region may limit the number of quotes to the greatest number that will permit an efficient competition among vendors.

Vendors are required to provide responses to the technical/company criteria stated
below. The responses will be reviewed under the purview of the Clinical Product Team (CPT) to determine the acceptability of each vendor. After review of the technical/company criteria, the Region will eliminate those vendors who fail to meet the criteria. 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

For those companies that meet the requirements above and the criteria below under Technical/Company Criteria, the CPT will request samples from the product group to be clinically evaluated at select Military Treatment Facilities (MTFs). Vendors are required to ship samples direct to the MTFs. Vendor samples must be received no later than 4:00 P.M. (EST), fourteen (14) calendar days after the request for samples is issued to the vendors. Vendors failing to comply by the deadline will be disqualified from further consideration in the standardization process.

1. To determine acceptability, a CPT comprised of medical professionals from the MTFs will evaluate the products based on the evaluation criteria below. It is intended that clinical evaluations shall be conducted in a non-clinical setting.

2. The CPT will evaluate the products provided with the clinical/performance criteria identified in this announcement. The clinical/performance evaluation period will last for 30 calendar days. CPT teams will evaluate the product against the clinical/performance criteria. The evaluation responses will be in a Likert scale format with a 1-5 scoring range. The scale descriptors are: One (1) -- Not Acceptable; Two (2) -- Minimally Acceptable; Three (3) Acceptable; Four (4) Acceptable (High Side); and Five (5) -- Highly Acceptable. The CPT has established a target threshold of 3.00 for the Clinical Acceptability of products for standardization. The CPT will determine the actual Acceptability threshold for this standardization initiative -- at or near 3.00 -- 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 3.00, 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.

3. After the clinical/performance evaluations are completed and analyzed, all vendors in the
clinical evaluation group who met the 3.00 threshold will be asked to submit their best pricing offer representing a discount from their DAPA pricing based on a minimum committed volume of 80% of the total requirements for MTFs in the Mid-Atlantic Region. Vendors that fail to offer pricing that is discounted from their DAPA pricing will be eliminated from further consideration. Vendor Product and Price Proposals will be in the Excel template provided by the government. The vendors will provide their completed Excel template by email to Bob.Meinertzhagen@med.navy.mil.

Pricing responses must be received by 4:00 P.M. (EST) fourteen (14) calendar days from the date the request is initiated by the TRBO. Failure to respond within this timeframe will result in your company being excluded from further participation/consideration

Technical/Company Criteria:

The CPT will review the following technical criteria responses from each vendor and determine acceptability.

a. In general, acceptability for purposes of evaluation of technical/company criteria is defined as follows:

Generally, responses to all questions in the technical/company criteria demonstrate that:
(1) based on the vendor s 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; and
(2) the vendor s 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 below, as required.

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. All communications of significant acquisition milestones (such as invitations to participate, or notices of disqualification) must be digitally signed.

Vendors must provide a response to each criterion listed below:

1. Vendors must provide a complete line of Pharmaceutical Container 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. The ability for
the vendor to provide these items is considered critical and failure by them to do so will result
in the vendor not being included in this standardization effort

a. At a minimum, a complete product line includes:

1. Prescription Vials, Amber, Plastic, Reversible Child Resistant/Non-Child
resistant Caps to include 16, 30, 60, and 90 dram sizes
2. Pharmaceutical Bottles with lids available in multiple sizes to include 90,
120 and 150 dram sizes
3. Pharmaceutical Jars with lids available in multiple sizes to include 1, 2, 4, and 8
ounce sizes

b. Vendors are to provide a complete list of items supplied (catalog, etc.) and product
literature in response to this RFQ

Vendors are to provide a complete list of items supplied (catalog, etc.) and product literature in response to this RFQ.

2. Vendors must have a DAPA or be in the process of applying for a DAPA number for the
Pharmaceutical Container 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, or be obtaining, a separate agreement with either the Med/Surg or
Pharmacy prime vendors (currently, Owens and Minor and Amerisource Bergen respectively)
for distribution in the Mid-Atlantic Region. (Note that vendors whose products are not
available through the regional PVs will be disqualified.) Provide documentation of agreement
with Prime Vendor.
4. Vendors 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. Note:
Where lower FSS prices are available, DAPA holders are required by previous agreement to
provide the FSS price as the DAPA price. Vendors shall not quote FSS prices as the
discounted price for purposes of this standardization initiative.) Vendors are to provide a
quote on discounts, in response to the FBO RFQ
5. Vendors must have a local vendor representative for the Mid-Atlantic Region. Provide contact
information, i.e. name, address, phone number, and e-mail address.
6. Vendors must provide any history of back orders and/or recalls that occurred during the most
recent 12-month period for the Pharmaceutical Container 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 in-service staff training and identify company resources for such
requirements with the initial submittals. Provide literature, if available on the training.
10. Vendors must provide educational tools and materials for Pharmaceutical Container
products, and provide evidence of this with the initial submittals. For instance, provide
literature on the tools/materials available.
11. Vendors must provide a copy of their company s customer service policy and program.
12. Vendors must provide products that meet the FDA standards used in manufacturing
Pharmaceutical Container products. In response to this RFQ, vendors must provide these
standards and the independent studies, and efficacy test results, certifying that all quoted
products meet these standards. Vendors must provide Pharmaceutical Container products that
are FDA approved for use in all clinical settings, and provide literature to support this
requirement with the initial submittals.
13. Vendors must provide an option to obtain products that are latex-free or otherwise hypo-
allergenic.
14. Vendors are required to provide the brands your company manufactures and/or distributes.
15. Vendors are required to provide a list of types and sizes for the products your company offers.
16. Vendors must provide packaging with visible labeling identifying the type, size, and
expiration dating (as appropriate).
17. Vendors must agree that, when requested, they will provide electronic and hard copy
proposed pricing and competitive product cross reference in electronic Microsoft Excel
format.
18. Vendors must be able to provide product available in either glass or plastic.
19. Vendors must be able to provide product that is light resistant.
20. Vendors must be able to provide personalization of products.
21. Vendors must provide product compatible with, or adaptable to, various robotic systems to
Include, but not limited to, ScriptPro, Pharmassisit, AutoMed R800, Parata RDS, and Autoscript III.

Clinical/Performance Criteria:

1. The pharmaceutical vial/cap combination is durable.
a. The pharmaceutical vial/cap combination must be able to withstand normal wear and
tear encountered from filling the prescription to daily usage by the patient.
b. This criterion will be evaluated by technician/clinician assessment when
handling the vial/cap during normal usage.
2. The conversion of the cap from child resistant to easy open , and visa versa, is easily
accomplished.
a. The ease of conversion is critical to promoting proper use of the cap by parents of
small children and for the ease of access to the medication by elderly and/or dexterity
challenged patients.
b. The technician/clinician will evaluate this criterion by converting the cap from child
resistant to easy open , and visa versa.
3. The quality of the cap seal is sufficient to prevent accidental/unintentional opening of the vial.
a. The pharmaceutical vial must remain securely closed to provide containment of the
medication until access is required.
b. To accomplish the evaluation of this criterion, the technician/clinician will fill the vial.
place the cap on, and shake the vial.
3. The exterior surface of the vial provides for secure adherence of a label.
a. Correct identification of the contained medication form the label on the vial is essential
to patient safety.
b. The technician/clinician will evaluate this criterion by applying a standard
pharmaceutical label utilized by the facility to the vial and attempting to remove it.
4. The pharmaceutical vials perform satisfactorily when used with robotic systems.
a. Robotic systems allow the pharmacies to meet the clinician/patient demand for
prescription medication. The vials must be able to be utilized with minimal, or no,
process disruption.
b. The vials will be used with the robotic systems to evaluate this criterion.
5. The Pharmaceutical Bottle is durable and the lid provides a satisfactory, secure seal.
a. The bottle must be able to withstand normal wear and tear encountered from filling the
prescription to daily usage by the patient.
b. This criterion will be evaluated by technician/clinician assessment when
handling the vial/cap during normal usage.
6. The Pharmaceutical Jar is durable and the lid provides a satisfactory, secure seal.
a. The jar must be able to withstand normal wear and tear encountered from filling the
prescription to daily usage by the patient.
b. This criterion will be evaluated by technician/clinician assessment when
handling the vial/cap during normal usage.

Contracting Office Address:
54 Lewis Minor St
Portsmouth, Virginia 23708-2297
Place of Performance:
Naval Medical Center 620 John Paul Jones Circle
Portsmouth, Virginia 23708
United States
Primary Point of Contact.:
Lisa J Price,
Contracting Officer
Phone: 757-953-5737
Fax: 757-953-5738
Secondary Point of Contact:
Peggy K Klingensmith,
Supervisory Contract Specialist
Phone: 757-953-7547
Fax: 757-953-5738
General Information
Notice Type:
Sources Sought
Posted Date:
April 15, 2008
Response Date:
May 07, 2008 5:00 pm Eastern
Archiving Policy:
Automatic, 15 days after response date
Archive Date:
-
Classification Code:
65 -- Medical, dental & veterinary equipment & supplies
NAICS Code:
423 -- Merchant Wholesalers, Durable Goods/423450 -- Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers




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