JA-21-0008 FINAL - Redacted.pdf

11/18/2020 JA-

FOR OFFICIAL USE ONLY· Source Selection Information - See FAR 2.101 and 3.104

Justification and Approval (J&.A) 'for Federal Acquisition Regulation (FAr{) Subpart 6.3

Other Than Full and Open Competition

Title:

J&A Number:

Fetal Monitor Systems

JA-21-0008

1. Identification of the agency and contracting activity:

Specify the contracting activity responsible for this action, I Nalional Capita! Region Contracting Division vi Defense Hea!th Agency, Falls Church, Virginia 22042, National Capital Region Contracting Division (NCR-CD), 2, Nature and/or Description of Action being Approved:

State whether approval is being requested for a new contract or bridge action, and whether It Is an Individual or c/assjus//ffcatlon.

(sae DHA PGI 206.3)

@new contract omodlflcatlon lo an existing contract I @Individual

QC!ass f,l\pprOV:ils-reques18d rOr a·new-sore -s-oUrc6 ·corJif8Ct"fOrlh0 prOcUreme;i~fl-d·m~interla~ce Of .GEHealihc~-;;, ·1~~- COro~SirJC; "i:59CX Fala, MO~itor s}'St;;;.,s io-r use at F~rt ·se1vo!reommun1ty I Hospital (FBCH) and Waller Reed National MIiitary Medical Center (WRNMMC). This Is not a class justification but rather Is an lndfv!dua[ justification.

3. Description ofSupplles/ Services:

Describe the supplies and seJV/ces. Prov/de the period of performance for the base and all options, and the estimated value by base, option, and the total, Including any extension of services, as applicable. Include type of contract (e.g., Fixed Price or Cost Reimbursement), type of funds to be usqd, (Department of Defense, Veterans Affairs, Joint Incentive Fund-No Year (DoDNA J/F-NY), Operations & Malnlenance (O&M), Research, Development, Test & Evelual/on (RDT&E), Other Procurement (OP), or Revolving Funds-NY) and, when applicable, the estimated share end ceiling arrangements, and fee and/or profit. If the requirement Is for a repair part, address whether or not if has been screened. /flhe repair part hes been screened, provide the Acquisition Method Code (AMC) end Acqu/sftlon Method Suffix Code (AMSC), Provide the approximate date the technical data package w/11 be available.

Descrlp!lon of Supplies and Services:.

Procurement of 32 each GE Heal/hcare, Inc. Corometrics 259cx Fetal Monitor Sys/ems. 32 of the 48 GE Hea/lhcere, Inc. Corometrics 259cx Fetal Monitor Systems presently on-hand at FBCH

,and WRNMMC are currenny at end-of-life (EoL). The procurement of 32 each GE Heallhcare, Inc. Coromelrics 259cx Fetal Monitor Sys/ems are funded with Other Procurement (OP) funds. This

'procurement will be completed on a Firm Fixed Price (FFP) contract with a total anticipated cost of $833,117.30.

TOTAL Contract V11lue

POP; From 13/1/2021

EstimatedValue 1833,117.30

Type of Contract (Primary):

j FAR 16,202 Flrm-F!xed-Prlce

Funding Type:

I other Procurement (OP) lo j 3131/2021 I ;:, vj vj

POP: From

Estimated Value ~----~

O OPTIONS - Check this box ff there are options to

O Extension of Services - Check this box if there Is an extension clause

4. Statutory and Regulatory At1fhorlty Permlttrng Other Than Full and Open Competition (see FAR 6.302), or the Specification of the Statutory and Regulatory Provision Provldlng Exception to 8(a) Program Competitive Requirements (see FAR 19,805-1):

j 10 U,S,C, 2304(c)(1) 6,302-1 -- Only One Responslb!e Source and No Other Supplies or Services Wit! SaUsfy Agency Requ!rements

5. Rationale Justifying Use of the Statutory Authority Cited:

Provide sufficient facts and ral/one/e Justifying use of the specific authority cited under Item 4 above (Sea FAR 6.302, FAR 8.303-2, and FAR 19,805-1).

,When the supplies or services required by the agency are available from only one responsible source, or, for DoO, NASA, and the Coast Guard, from only one or a limited number of responslble

'sources, and no other type of suppl!es or services will satisfy agency requirements, full and open competition need not be provided for. The GE Healthcare Corometrlcs 259cx Fatal Monitor

:system Is Iha only product capable of meeting the 15 salient characteristics as written the 2020 National Capital Region's (NCR) Medical Treatment Facllilles (MTF) Informatics Steering

Committee's (ISC) fetal monltor Equipment Review Document (see attachment 1 to this J&A), The 15 saUent characteristics that need to be met by a fetal monitor system manufacturer to be

:considered as a potential source to address the NCR MTF-ISC's fetal monitor system need are:

System shall Interface with Essanlrls System shall Interface with C!inlComp System shall Interface with f.1HS GENESIS Shall be MHS GENESIS compallb!e Shall be Cyb er compl!ant or recefve an ATO within 180 days after award Shall measure 02 sat, Pulse, Temperature (Temporal), and ECG Shall monllor maternal contractions via Tocodynameter (TOCO) and Intra Uterine Pressure Catheter (!UPC) Shall provide printout of contraction and Fetal Heart patterns Shall monitor 2 patients slmultaneausly https:llinfo.health.mil/sites/DOP/PAC/SitePages/JA/MyForms.aspx 1/3

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Shall allow adjusted lnleNals for non-Invasive blood pressure Shall monitor Fetal Heart Rate via Ultrasound and Fetal Scalp Electrode (FSE) Shall seamlessly populate patient medical records (current and future) Shall display patient physiology status Shall measure contractions Invasive and non-lnvaslvely

JA-

Only the GE Healthcare Corometn'cs 259cx Fala/ Monitor System can meet these 15 salient characteristics and no other fetal monitor systems presently exist which can be modified to meet these

,15 salient characteristics without extensive dupllcaUon or fmplementatlon costs for this commercial ltem. Sha!! ma!ntaln a hardcopy for records

6. Efforts to Obtain Competition: Describe efforts made lo ensure that offers are sol/cited from as many potential sources as is practicable, Including whether a notice was orw/11 be publicized as required at FAR Subpart 5.2 and, if not, which ex caption under 5.202 ls appllcable to Iha requirement. Justifications citing the authority at FAR 6.302·1 permitting the use of other than full and open competitron, shall include the results of the request for Information or sources sought no/Ice posted in accordance with DFARS PG! 206.302·1 (unless Iha requfrement to post has been waived);

end for non-compel/live follow-on acquisitions of supplies or services previously awarded on a non-competitive basis, Include a copy of the previous Justification with the current Jusfiflcallon review package to essist the approval authority In determining whether /he planned actions to remove any barriers to competition cited on the previous Justificel/on were completed.

The NCR-CD posted a Sources Sought for Fetal Monitor system (FMS) was posted lo SAM from 18 Seplember-17 October 2020

(!J.llps:/Jbeta.sam.gQYlQP.P.l4e3414fdaa9e4c6d962810a37e5af3a6(vlew#c!assiflcallon) seeking potential FMS sources that could meet the 15 sallant characteris!lcs written ln paragraph 5 above, This office was not contacted by any vendors In response to this Sources Sought nor did any company identify themselves as an interested vendor al the website.

7. Determination that Anticipated Cost to the Government wlll be Fair and Reasonable: Describe how the contracting officer de/ermined or will determine that the anticipated cost to the Government will be fair and reasonable.

,The cost to the Government rs deemed fair and reasonable based on comparative price analysis, GE Healthcare, Inc. 's quoted prices are less than the prices received rrom internet searches for

"Corometrics 259cx Fetal Monitor". Additionally, an Independent Government Cost Estimate (IGCE) was performed, and !he IGCE was greater than the proposed price from GE Healthcare Inc.

8. Market Research: Describe the extent of the market research conducted and when conducted, method ulil/zed, and results, or, If market research was not conducted, provide the rationale (see FAR Perl 10 Techniques for Conducflng Market Research). The market research conducted or rationale provided In this section should help support the ralfona/e justifying the use of the Statutory and Regulatory Authority In Section 5 above.

Prior to proceeding with thls procurement as a sole source action, Fetal Monitor System (FMS) market research was conducted In early 2020 by the NCR MTF lSC (see paragraph 5 above}.

:Add!lionally a Sources Sought for Fetal Monitor systems was conducted by Iha NCR-CD from 18 September - 17 October 2020 (see paragraph 6 above) with no alternative lo the GE Hea/lhcare, Inc. Corometrics 259cx Fetal Monitor System ldentlfied. Based on this market research, the NCR MTF ISC has determined the GE Healthcare, Inc. Corometrics 259cx Fetal Monitor System addresses the 15 salient characteris!lcs needed of a fetal monitoring system and Clinlcal staff and Biomedical Maintenance Technicians already have a working knowledge of the GE Healthcare, Inc. Corometrlcs 259cx Fetal Monitor System as these are presently on-hand and operating at both MTF locations.

9, Other Facts: Lisi any other facts supporting the use of other then full and open competition, such as an explanation as to why technical data packages, specificelians, engineering descriptions, statements of work, or purchase descriptions suitable for full and open competition have not been developed or are not available.

_NIA

1~. ln!!r~~.te~ ~o_~~c_e_~~ ~n_clu_~~-a 1/stlnfl_ of t/I~~ource,s, _I( ~nl'!_ ~.!!_ic_h_ ~~_ve exp!6,S!_'!!!_'. ~'!. ~ril!~f!• an lf_lt~"!~( ~n __ t~e, ~~q_~~sil/on.

A Sources Sought for Fetal Monitors was published on beta.SAM.gov (lillri~·/lbc1a.snm i:i2.\Wnn/4g34!4fdaa9e4cljd')6?S 10n}7c5cQn6/view#cfo~~ilicatfon) from 18 Septcmber-17 October 2020. This Sources

Sought informed of this office's intent to procure GE Corometrlcs 259cx Fe/a/ Mo11//ors, barring any other source's ability to provide a like fetal monitor capable of meeting the 15 salient characteristics published within the Sources Sought. This office was not contacted by any vendors in response to this Sources Sought nor did any company identify themselves as an interested vendor Pt tbe FBO website.

11. Actions to overcome barriers: Describe the actions, If any, the agency may take, or is taking, to remove or overcome any barriers to competition before any subsequent acquisition for the suppl/es or services required.

,Toe;e are presently no ba~rieIB.-Pr8S6ntiy o-;:;iY!ha GE-H~llh~re~ ,;;c ... CorOmetr/~s 259cx fetalmonitOr';y----;f~mcan satisfy Iha need as research~d;;d co~~urr'GCfrO by th~CR MrF 1sC - - .

(attachment 1). On an annual basis the NCR MTF lSC will monitor the marketplace for other potential sources as they become available to satisfy future fetal monitor system need(s).

Coordi1rn~lon & Approval

12. Technical/Functional Representatlve:

I certify that the information provid d In this Justification is accurate and complete to the best of my knowledge and belief.

Nam ,I S~"~P~P~ly~M~a~o~ag~e~m~e~o~t ~Sp~•~o~la~ll~st:c-~~--------------' (Program Manager, Functional Service Manager, etc.)

A roved:

Harper, Brenda• Friday, October 23, 2020

13. Requirements Certification:

I certify that the lnfiormatlon provided In this justification !s accurate and complete to the best of my knowledge and bellef

Name: ~-------"I ~~ .

Title: I Supply Management Special!st

(Responsible J Director) J Director (or deslgnee)

J-Dlrectora\e Office: ! Walter Reed National Mil!tary Medical Center

A roved:

Friday, October 23, 2020

14. Fair and Reasonable Cost Determination: Provide the basis for this determination (e.g., describe techniques uli/ized, or to be u/1/ized, to determine cos I/price fair and reasonab/eness, such as cost analysis, price analysis, audit, should cost, Independent Government estimate). As pert of this basis, Indicate whether certified cost or pricing data will be required or If one oft he exceptions In FAR Part 15.403 wlll apply. Contracting Officer to include the following determination:

i'otlolpated Cost to the Gove,omoot will be Fair;,;, Rees;oeble)~IAW FAR 15.403- 1(b)(3)oertlfiad oost of p,lolog date will oot ba req,lred forthasa oommarolal services

I have determined that the antlc!paled cost to the Government for this contract action is fair and reasonable.

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Name: TIiie: Contracting Officer, National Capital Region Contracting Division

· A roved:

Friday, October 23, 2020

15. Legal Review:

I have reviewed thls Justification and have found II to be legally sufflc!ent. (Note: All J&As must be reviewed by Office of General Counsel (OGC)/Legal Review,)

Name: Title: I Office of Genera! Counsel

Ap roved:

-17 Nov 2020, 12:35:26 t certify th al this justification is accurate and complete to the best of my knowledge and belief.

Name: r: Title: Contracting Officer, National Capital Region Contractlng Division

A roved:

- Friday, October 23, 2020

17, Competition Advocate: Based on /he faregofng}usJificalion, J hereby approve the procurement of Fetal Monitor Systems(state supplies/services being procured) on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304{c)(1) 6,302-1 - Only One Responsible Source and No Olher Suppl/es or Services Will Sallsfy Agency Requirements, subject ta avai!abili/y of funds, and provided that the suppl/es end/or services herein described have otherwise been authorized for acquisition.

Name: j Tille: I Competition Advocate (J-4)

A roved:

Tuesday, November 17, 2020 https://info.health.mil/sites/DOP/PAC/SilePages/JA/MyForms.aspx 3/3