Redacted_J&A.pdf

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity.

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD on behalf of the DHA, Joint Medical Logistics Functional Development Center (JMLFDC), Army, Air Force, and Navy.

2. Description of the action being approved.

The proposed action is the award of a contract on a sole source basis to provide for a Medical Logistics Authoritative Data Exchange and Medical Logistics Database Subscription, except for those items specified as Government furnished property and services, as defined in any resultant contraction action. Immediately upon award, the Contractor shall be able to strictly adhere to the standards within any resultant contract action. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Emergency Care Research Institute DBA ECRI Institute (ECRI), 5200 Butler Pike, Plymouth Meeting, PA, 19462 (CAGE: 4K872).

3. Description of the Supplies/Services.

Using industry standard data, the objective is to normalize, cleanse and structure an authoritative equipment and supply data standardization mapping process. Data normalization is the process of organizing information, eliminating redundancies and removing inconsistent dependencies within a database.

Normalization will solidify knowledge of the comprehensive Military Health System (MHS) Medical Devices and Equipment (MDE) baseline, enhance audit readiness, increase efficiencies of future procurement actions, streamline Risk Management Framework (RMF) processes, unencumber product Hazard, Alerts, and Recall (HAR) identification and resolution, and prevent unnecessary data duplication.

To meet the objective, an authoritative data exchange and database subscription service is required to continue support in the areas of modernization and data standardization in Health Alerts and Equipment Management Lines of Business (LOBs).

Through the use of an internet-based portal, the following database subscription services are required at a minimum:

A. A repository of all hazards, alerts, and recalls for Government Medical Devices and Equipment (MDE) with sortable data points, to include: accession number, priority, subject/headline, device code, manufacturer, common model, publication date, status, status date, and U.S. Food & Drug Administration (FDA) class of recall.

B. MDE procurement and cost analytics tool sets and services, to include: comparative product evaluations, price benchmarking data, vendor proposal analyses, service/maintenance contract analyses, consumable/reagent contract analyses, fair market value analyses, market share/sector intelligence, request for proposal analysis, request for proposal (RFP) templates, user experience reviews, justification analysis, capital budget reviews.

C. Dynamic ranking/comparative matrices of highly prevalent industry manufacturers’ product line common models within a device code.

D. Product identification tool sets for industry functional equivalents of medical-surgical supplies and implants, to include pricing analytics.

E. Utilization analytics.

The base one (1) year period of performance of this contract shall commence on 30 September 2019 and end 29 September 2020. Subsequent to the base year, four (4) individual one-year option periods shall be available until 29 September 2024.

Log #19-10037

4. Statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 41 U.S.C.

1901. See also FAR 13.501(a) Sole source (including brand name) acquisitions.

5. A rationale justifying the use of cited statutory authority.

ECRI is only company that provides independent analysis of medical devices and technology, which is compiled, updated and made available in real time through an online subscription-based portal. Health Devices Gold, SELECTplus, TruVu, Alerts Tracker, CrossCheq, and Biomedical Benchmark are all ECRI Institute proprietary subscription products. The subscriptions will assist in identifying how DOD medical treatment facilities (MTFs) compare to others of similar size and circumstances, allowing the services to identify areas in need of improvement, examples of optimization methods, and independent Government procurement analysis.

The ECRI database, including their medical logistics authoritative data exchange and medical logistics database subscription, provide the same nomenclatures and device codes used to populate the DMLSS. This information is used in the process of Medical Material Quality Control Program, and each of the Services’ life-cycle logistics plans for procurement of medical devices and materiel. The in-depth level of information provided enables the Services to accurately track deficient medical devices and medical materiel. Patient safety is greatly increased due to the information provided from ECRI Institute through each of these products.

Additionally, ECRI Institute is the sole vendor able to provide the medical logistics authoritative data exchange services required in accordance with DoDI 8320.02, utilized by the Defense Medical Logistics Standard Support (DMLSS) program, the Accountable Property System of Record (APSR) of accountable property and medical equipment maintenance for the Air Force, Army, Navy and Defense Health Agency

(DHA).

6. Description of efforts made to solicit offers from as many offerors as practicable.

Market research was conducted by technical experts in June 2019. This research consisted of reviews of similar previous procurements (N62645-14-P-2091) and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized included Google, Federal Business Opportunities (FBO), General Services Administration (GSA) Advantage, DLA’s Electronic catalog (ECAT), and the National Institutes of Health (NIH) United States National Library of Medicine.

In the review, it was found that there have been many medical device nomenclature hierarchical schema or classification/grouping standards over the years. They include the Food and Drug Administration (FDA) Classification Names for Medical Devices (CNMD), FDA Global Unique Device Identification Database (GUDID), European Diagnostic Manufacturers Association (EDMA), International Organization for Standardization (ISO) 9999, the Japanese Nomenclature Standard (JFMDA/JMDN), the Norwegian Nomenclature Standard (NKKN), Universal Medical Device Nomenclature System (UMDNS), Global Medical Device Nomenclature (MDN), and United Nations Standard Products and Services Code

(UNSPSC).

The FDA CNMD or “Product Classification” has roughly only 2,000 device classifications and is largely used for classifying a device in preparation for FDA premarket, 510(k), De Novo, and humanitarian device exemption (HDE) approval. The EDMA classification structure is used only to code in vitro diagnostic medical devices. ISO 9999 is restricted to only classification and terminology of assistive products for persons with disabilities. JMFDA/JMDN was created for use by medical device companies in the classification of their technology prior to approval by the Japanese Pharmaceutical and Medical Device Agency (PMDA). Fluency in Japanese is essential to determine a device's code; this is inappropriate for use in the United States and even for use outside of the Continental United States at medical treatment facilities requiring strict adherence to US regulations (FDA, Joint Commission). Similarly, the NKKN was structured for use in Norway. UNSPSC, while including a limited set of product taxonomy, also includes naming of medical services and procedures for use in eCommerce. Therefore, its use is inapplicable to the medical devices recorded in the DOD’s APSR, DMLSS/LogiCole. These limited classification and inappropriate naming schema do not meet the minimum requirements of the Government.

The FDA GUDID is a database repository to include unique identifiers for every single net-new FDA-approved medical device; it is not a classification/grouping system and therefore does not meet the minimum requirements.

Historically, UMDNS has been the accepted nomenclature standard for DOD accountable medical property for over 20 years. In addition to structuring a complete medical technology nomenclature schema, ECRI services have been and are used to populate the Defense Medical Logistics Standard Support (DMLSS) for equipment repair and maintenance planning. Choosing to divert to an alternate vendor for the required services would essentially require re-classification and re-work of the entire Defense Health’s portfolio of medical devices. It would be fiscally irresponsible and unnecessarily burdensome to the Government to restart an effort to re-classify all technology already normalized to the current schema.

Additionally, ECRI is only company that provides independent analysis of medical devices and technology, which is compiled, updated and made available in real time through an online subscription-based portal.

Health Devices Gold, SELECTplus, TruVu, Alerts Tracker, CrossCheq, and Biomedical Benchmark are all ECRI Institute proprietary subscription products. These subscription services will assist in identifying how DOD medical treatment facilities (MTFs) compare to others of similar size and circumstances, allowing the services to identify areas in need of improvement, examples of optimization methods, and independent Government procurement analysis.

In searching GSA Advantage, ECRI Institute does have a GSA contract, GS-10F-063CA. However, this contract is for personal/non-personal services consulting, specific to certain position descriptions.

No vendor other than ECRI Institute can offer the nomenclature schema, real-time data exchange services and real-time subscription services to meet the minimum requirements of the Government.

A Notice of Intent to Sole Source was posted to FedBizOpps 3 July 2019. To date, no other sources have written to express an interest. Any sources expressing interest in response to the synopsis will receive consideration. This requirement will be posted to FedBizOpps in accordance with FAR 5.202.

7. Determination of fair and reasonable cost.

The Contracting Officer has determined the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable.

8. Actions to remove barriers to future competition.

Future requirements will be synopsized in accordance with FAR 5.203. For the reasons set forth in Paragraph 5, Naval Medical Logistics Command has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMLC) will assess whether competition for future requirements is feasible.

Text6: 24 Sept 2019