J_A - USNS Mercy_Redacted.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 U.S. Navy to meet requirements for two (2) ) STAGO STA Compact Max with cap piercing hemostasis analyzers for the USNS MERCY (T-AH 19).

2. Description of the Action Being Approved.

Award of a contract on a sole source basis to support the acquisition of two (2) STAGO STA Compact Max cap piercing hemostasis systems for the USNS MERCY (T-AH 19). This acquisition will facilitate the ongoing mission of USNS MERCY to continue to provide first-rate critical day-to-day patient care services to military personnel. This equipment will replace the existing inventory of Coagulation TOP ACL Elite Pro hemostasis equipment currently being used on the USNS MERCY (T-AH 19). The Government intends on awarding a Firm Fixed Price (FFP) contract. The proposed source is Diagnostica Stago Inc., 5 Century Drive, Parsippany, NJ 07054-4607. CAGE: 0TH01.

3. Description of Supplies/Services.

The USNS MERCY (T-AH 19) has a requirement need for two (2) STAGO STA Compact Max cap piercing fully automated, benchtop hemostasis analyzers (P/N: 58989) in the lab aboard the USNS MERCY to perform critical same day tests. This procurement includes two (2) STA Compact Max with cap piercing systems, accessories, and training for one key operator. Diagnostica Stago Inc. is the original equipment manufacturer (OEM), located in Parsippany, NJ. They are the sole distributor of the STA Hemostasis product line.

The USNS MERCY (T-AH 19) has a requirement for the following items as indicated in Table 1 and narrative below.

Item Product Description Quantity Product Number

001 STA Compact Max with Cap Piercing with 12-month Warranty Plan 2 58989

002 1215 – Assistance to Method Verification Routine 1 08428

003 Training for One Key Operator – STA Compact Max, in Parsippany, NJ 1

004 LIS Interface Maximum amount per instrument 2 005 Instrument Freight Cost 1

Table 1.

The desired delivery schedule is 30 days After Receipt of Order (ARO).

The vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service shall be provided in accordance with the OEM terms and conditions.

The equipment, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The equipment shall be installed in compliance with Occupational Safety and Health Administration (OSHA)

4. Statutory Authority Permitting Other Than Full and Open Competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C.

2304(c)(1) and FAR 13.106-1(b)

5. Rationale Justifying Use of Cited Statutory Authority.

The circumstances that justify the restriction to the STAGO STA Compact Max cap piercing hemostasis system are considered mission critical and imperative to maintaining patient care. The USNS MERCY medical treatment facility (MTF) staff require hemostasis tests within the same day to provide critical treatment decisions during missions. The STA Compact Max cap piercing is a fully automated, moderate-throughput benchtop hemostasis workstation capable of performing clotting, chromogenic, and immunological assays simultaneously in random access mode. The system’s unique method of sample management offers moderate throughput and rapid processing of STAT Management samples without the need to interrupt current throughput testing. The hemostasis analyzer system must be capable of performing the following verification Assays: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, Thrombin Time (TT), D-dimer, and Anti-Xa testing to include use of the analyzer, reagents, and service.

The STA hemostasis analyzer should have 96 sample position multiple tubes and allow for continuous sample access. It must hold up to 45 reagent positions, have on-board temperature control, and be capable of performing most routine and specialty tests. The hemostasis analyzer system must have fully barcoded assay management; tracking should include patient ID, lot numbers, volume vial size, onboard stability, expiration date, and provide International Sensitivity Index (ISI) value for PT reagents. The system should have a dimension width of 38.18 inches, a depth of 28.73 inches, a height of 27.75 inches, and weight of 309 lbs. (140.18 kg). The analyzer should allow for host-query Bi-directional Laboratory Information System (LIS) interface connection.

The equipment listed on this Technical Data Package (TDP) is the same make and model as listed on the USNS MERCY (TAH -19) and USNS COMFORT (T-AH 20) Authorized Medical Allowance List (AMAL) approved by Fleet Surgeon. COMUSFLTFORCOM/COMPACFLT INSTRUCTION 6700.13 (Management and Procurement of Authorized Medical and Dental Allowance Lists) establishes responsibilities for development, maintenance, and review of AMAL and ADAL, based on unit’s required operational capabilities and the projected operational environment (ROC/POE) for health services and standard of care provided. The Fleet Type Commander (TYCOM) Health Services Support (HSS) staffs, under the direction of the TYCOM Surgeon, perform market surveys, market analysis and operational testing before selection of equipment and materiel are placed on the AMAL. Standardization will allow cross training, back-up support, and efficiency of equipment use.

From a cost perspective, it is not advantageous to the Government to procure a new product from another source; equipment contained within the authorized AMALs and ADALs is analyzed and procured to meet operability, maintainability and sustainment for operations at sea and in expeditionary ashore environments. Integrated Logistics Support (ILS) documentation is developed to support each piece of equipment that includes an Authorized Parts List (APL), Preventative Maintenance System (PMS) procedures, Navy Technical Manual number assignment to the vendor to provide Commercial Off the Shelf (COTS) operator and service manuals. APL development costs the Government between $2K-$6K per APL depending on complexity of equipment. PMS development costs the Government between $4K- $8K depending on complexity of equipment. The assignment of Navy Technical Manual numbers incurs government costs of approximately $1K-$5K per manual depending on the size of manuals. These ILS products are a requirement for onboard equipment in accordance with OPNAV INST 4790.4D (Ship’s Maintenance and Material Management (3M) System Policy).

Purchase of any other manufacturer’s equipment would incur additional and unnecessary time and expense in developing new Integrated Logistics Support (ILS) documentation. Additionally, this would require retraining of staff, new Standard Operating Procedures, and competency. This would cause serious delays in patient care. Maintaining standardization and continuity will maximize USNS MERCY’s ability to provide critical and timely healthcare service to military personnel throughout the area of responsibility.

6. Description of efforts made to solicit Offers from as Many Offerors as Practicable.

The original requirement intended to replace the existing inventory with two ACL TOP 350 (Closed-Tube Sampling) CTS hemostasis diagnostics systems from Werfen USA, LLC. In order to solicit offers from as many sources as practicable, in accordance with 5.201, a notice of intent to sole source was posted on 16 June 2021 to the Government-wide point of entry, SAM.gov, Contracting Opportunities, for 15 days.

A capability statement was received from Diagnostica Stago, Inc. in response to the notice that provided a quote for two STA Compact Max with Cap Piercing hemostasis systems and stated that they are the current vendor for this equipment on the USNS Comfort (T-AH 20). The Government evaluated the capability statement and adjusted the acquisition strategy accordingly. Based on these results, the Naval Operating Forces’ Authorized Medical Allowance List (AMAL) was updated and approved by the Fleet Surgeon to align and standardize the USNS Mercy (T-AH 19) equipment with the USNS Comfort (T-AH 20).

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. Description of the market research conducted and the results, or a statement of the reasons a market survey was not conducted.

Market research was conducted by technical experts in the May-July 2021 timeframe. This research consisted of reviews of previous procurements for CTS hemostasis diagnostics systems including preventive maintenance and service contracts. Additionally, market surveys were conducted through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Bing, GSA.gov, and FPDS.gov using the following search words: “Hemostasis diagnostics systems”, STA Compact”, “ACL TOP 350 CTS hemostasis diagnostics systems”, “CTS hemostasis diagnostics systems”, “ACL TOP CTS hemostasis diagnostics systems installation”, “ACL TOP CTS hemostasis diagnostics operator training”, “hemostasis diagnostics unit warranty”. Emergency Care Research Institute (ECRI) only synopsizes original equipment end items. Diagnostica Stago, Inc. is the Original Equipment Manufacturer (OEM) and is the only provider of their genuine OEM parts and certified technicians. There are vendors advertising sale options for the Diagnostica Stago, Inc. STA Compact Max with Cap Piercing, but only Diagnostica Stago, Inc. can provide OEM certified installation, service, and operator training. Consequently, the Government’s technical experts determined that Diagnostica Stago, Inc. is the only source that can meet the Government’s requirements.

9. Actions to Remove Barriers to Future Competition.

For the reasons set forth in Paragraph 5, NMLC 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.

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CERTIFICATIONS AND APPROVAL