TAB 5 JA-FDB (005) Correct Legal (002).pdf

SOURCE SELECTION INFORMATION – SEE 2.101 AND 3.104

DEFENSE LOGISTICS AGENCY

DLA CONTRACTING SERVICES OFFICE - PHILADELPHIA

700 ROBBINS AVENUE

PHILADELPHIA, PENNSYLVANIA 19111-5092

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Upon the basis of the following justification, I hereby approve the issuance of the contractual action described below using other than full and open competition, pursuant to the authority cited herein.

1. IDENTIFICATION OF THE REQUIRING AGENCY AND CONTRACTING

ACTIVITY

Agency Requiring Activity

Defense Logistics Agency (DLA)

Medical Directorate

700 Robbins Avenue

Philadelphia, PA 19111

POC: Linda Stipa

(215) 737-2174

E-Mail: Linda.Stipa@dla.mil

Contracting Activity

DLA Contracting Services Office at Philadelphia (DCSO-P)

700 Robbins Avenue

Philadelphia, PA 19111

2. NATURE AND/OR DESCRIPTION OF THE ACTION BEING APPROVED.

Pursuant to 10 U.S.C. 2304(c)(1) and Federal Acquisition Regulation (FAR) 6.302-

1(a)(2)(iii)(A), this justification for other than full and open competition authorizes and approves the procurement of a sole-source/brand name pharmaceutical product classification license for use at DLA Troop Support Medical Directorate to support 170

Medical Master Catalog (MMC) user sites. The required license subscription is for First

Databank (FDB) MedKnowledge Descriptive and Pricing Information, for a period of 12 months plus two 12-month option terms, under a Firm Fixed price contract.

3. DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET

THE AGENCY’S NEEDS (INCLUDING THE ESTIMATED VALUE).

The DLA Troop Support Medical Directorate has a requirement to renew its existing data subscription license agreement for FDB MedKnowledge Descriptive and Pricing

Information from First Databank, Inc. This license is required to provide drug databases mailto:Linda.Stipa@dla.mil

Justification and Approval for Other than Full and Open Competition

FDB MedKnowledge

SOURCE SELECTION INFORMATION – SEE 2.101 AND 3.104

that include descriptive drug information and classification in support of pharmacy procurement and analysis, which promises to lower healthcare costs and improve patient care. The database is required to provide critical classification data for DLA Troop

Support on a weekly basis to enable cross references of products or equivalent products such as therapeutically equivalent products, pharmaceutically equivalent products, etc.

FDB product information is also required in numerous DLA Troop Support Medical system applications as well as in downstream service customer systems and catalogs.

The data subscription license agreement must cover the Government’s 170 DODAACs that receive MMC data which includes the FDB data feed.

The estimated dollar value for this procurement for a base year data subscription with two

12-month option terms is $285,709.00.

4. IDENTIFICATION OF THE STATUTORY AUTHORITY PERMITTING

OTHER THAN FULL AND OPEN COMPETITION.

The statutory authorities permitting other than full and open competition are 10 U.S.C.

2304(c)(1) and FAR 6.302-1(a)(2)(iii)(A): The supplies or services required by the requiring agency are available from only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements. The services are deemed to be available only from the original source in the case of this follow-on medical/surgical product pricing data subscription contract for the continued provision of highly specialized data feeds because it is likely that award to any other source would result in substantial duplication of cost to the Government that is not expected to be

SOURCE SELECTION INFORMATION – SEE 2.101 AND 3.104

recovered through competition due to higher reprogramming labor costs as well as the potential for higher data subscription costs.

5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE

QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES

USE OF THE AUTHORITY CITED.

The follow-on nature of this requirement for the renewal of an expiring pharmaceutical data feed license that comprises critical data feeds for so many Defense Medical

Logistics Standard Support-Wholesale (DMLSS-W) processes necessitates the use of the authority cited above. The logistics and acquisition communities rely on DMLSS-W system functionalities on a daily basis.

FDB owns various copyrighted databases. DLA Troop Support currently uses FDB’s

MedKnowledge Enhanced Package (formerly the National Drug Data File (NDDF)

Package). FDB MedKnowledge Enhanced combines drug descriptive and pricing information with an extensive array of clinical decision-support modules. It encompasses every drug approved by the FDA plus information on over-the-counter (OTC) and alternative therapy agents such as herbals, nutraceuticals, and dietary supplements. Based on the widely accepted industry standard, the FDB MedKnowledge Descriptive Pricing

Information re backed by the most clinically verifiable evidence gathered to date.

The following are a few of the most critical elements provided by the FDB data feed:

The American Hospital Formulary Service (AHFS) therapeutic class code that identifies the pharmacologic therapeutic category of the product, where more than one AHFS code is possible, especially for combination products, is determined by

FDB in consultation with the AHFS staff

Dosage forms (e.g. Capsule – Soft, Hard, etc.)

Drug Strength Description and Number for drug potency in metric units and volume, e.g. for gram, milligram, percentage, etc.

Hierarchical Ingredient Code for active ingredient identification

Hierarchical Therapeutic Class Code and Hierarchical Therapeutic Class

Description

Generic Name and Generic Code Number Sequence Number

DESI Drug Indicator for marking a particular drug as being declared less than effective by the Food and Drug Administration (FDA)

Drug Class for availability to the consumer per Federal specifications

Drug Form Code indicates the basic drug measurement unit for performing price calculations.

The classification data provides cross referencing of products or equivalent products such as therapeutically equivalent products, pharmaceutically equivalent products, etc. As noted above, FDB product information is used in DLA Troop Support system applications as well as downstream service customer systems and catalogs to research

SOURCE SELECTION INFORMATION – SEE 2.101 AND 3.104

and compare available products to make clinical and purchasing decisions. Continued use of FDB’s subscription services is essential to the Government’s requirement.

FDB’s classification system maintains greater capabilities for the Department of Defense

(DoD) than any other available source. While other sources can provide similar data, their classification systems are incompatible with the system in place. If the decision were made to utilize an alternative competitor service offering, each DMLSS-DLA application would require the Government to incur separate and time-consuming analyst and developer labor costs for redesign and recoding in order to incorporate a different file format. The reprogramming costs associated with the implementation of another classification system would be cost prohibitive and, even if DLA were to make such an investment, it would not yield commensurate value to the Government. Therefore, no alternative source can provide the highly specialized data feeds needed to satisfy this requirement without a substantial duplication of costs incurred by the Government.

FDB provides extensive distributor information current systems can use, while other sources’ distributor information is either limited or unavailable. Additionally, FDB’s codes add value to the Government’s medical readiness posture by providing increased substitutability information.

Demonstrably, renewal of DLA’s data subscription license agreement for FDB

MedKnowledge Descriptive and Pricing Information is essential to the Government’s requirement, thereby precluding consideration of data service offerings from alternate sources. Only one responsible source – FDB – can provide the required drug databases that include descriptive drug information and classification in support of pharmacy procurement and analysis.

6. DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE

SOLICITED FROM AS MANY POTENTIAL SOURCES AS IS PRACTICABLE,

INCLUDING WHETHER A NOTICE WAS OR WILL BE PUBLICIZED AS

REQUIRED BY SUBPART 5.2 AND, IF NOT, WHICH EXCEPTION UNDER

5.202 APPLIES.

A synopsis will be posted to beta.SAM.gov website to provide all commercial entities an opportunity to submit proposals for this requirement. The current action will be issued as a Combined Synopsys/Solicitation-Request for Proposal (RFP) posted to the Federal

Business Opportunities website (https://beta.sam.gov/) in accordance with FAR 5.201(b).

All responsible parties will be given an opportunity to submit an offer.

7. DETERMINATION BY THE CONTRACTING OFFICER THAT THE

ANTICIPATED COST TO THE GOVERNMENT WILL BE FAIR AND

REASONABLE.

As the Contracting Officer, I hereby determine that pricing will be fair and reasonable based on a pricing analysis in accordance with FAR 15.404-1. It is anticipated that the

Government will use various prices analysis techniques including, but not limited to: (1) http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/05.htm#P56_9614 http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/05.htm#P67_10773

SOURCE SELECTION INFORMATION – SEE 2.101 AND 3.104

a comparison of the proposed price with prices charged to the third party contractor previously responsible for procuring the medical/surgical product pricing data feed in the

Research and Development phase of the MedPDB, as well as a comparison to other raw data subscription providers, less data normalization and/or benchmarking services; (2) comparison with competitive published price lists (reference FAR 15.404-1(b)(2)(iv); (3) comparison of proposed prices with prices obtained through market research of the same or similar items (reference FAR 15.404- 1(b)(2)(vi); (4) comparison of proposed prices to historical prices paid, whether by the Government or other than the Government, for the same or similar items (FAR 15.404-1(b)(2)(ii)); and/or (5) comparison of proposed prices with the Independent Government Cost Estimate (FAR 15.404-1(b)(2)(v)), in order to obtain a fair and reasonable price.

8. DESCRIPTION OF THE MARKET RESEARCH CONDUCTED (SEE PART

10) AND THE RESULTS OR A STATEMENT OF THE REASON MARKET

RESEARCH WAS NOT CONDUCTED.

The DLA Medical Directorate conducted Market Research to compare service offerings of the incumbent vendor (FDB) with alternative solutions existing in the industry.

Market research techniques included a review of Acquisition History for contracts used by the directorate to procure similar services and searching the beta.SAM.gov and GSA websites for other vendors with similar data service offerings. Primary comparative factors used to analyze alternatives included technical service offerings, functional familiarity, and cost to the Medical Directorate.

Alternative subscription services considered included the Medi-Span Product and IQVIA

(Formerly IMS).

The results of this market research revealed that only one responsible source and no other supplies or services will satisfy agency requirements. The FDB data is deemed to be available only from the original source in the case of this follow-on pharmaceutical product classification license for the continued provision of highly specialized data feeds and it is likely that award to any other source would result in substantial duplication of cost to the Government, which will not be recovered through competition.

9. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL

AND OPEN COMPETITION

The DMLSS-DLA Program has no budget or business approvals for reengineering the data feed.

10. LISTING OF THE SOURCES, IF ANY, THAT EXPRESSED, IN WRITING,

AN INTEREST IN THE ACQUISITION.

The following firm has expressed interest in this requirement: First Databank, Inc..

SOURCE SELECTION INFORMATION – SEE 2.101 AND 3.104

11. STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO

REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION BEFORE

ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES

REQUIRED.

DLA has exercised, and continues to exercise, competition as often as possible and is required to conduct ongoing reviews to keep abreast of new technology, both in industry and the Government. As a continuing effort, DLA utilizes a variety of vendors, manufacturers, and contracts/orders to fulfill its requirements and will continue the practice of surveying the market to ensure full and open competition to the maximum extent practicable.

12. CONTRACTING OFFICER CERTIFICATION THAT THE JUSTIFICATION

IS ACCURATE AND COMPLETE TO THE BEST OF THE CONTRACTING

OFFICER’S KNOWLEDGE AND BELIEF.

Technical and Requirements Certification:

I hereby certify that the supporting data provided for which I am responsible and which form a basis for this justification are complete and accurate:

Linda Stipa Date

Contracting Officer’s Certification:

I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.

Date

Contracting Officer