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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 19, 2016 FBO #5444
DOCUMENT

Q -- UW Pathology Laboratory Services IDIQ - Justification and Approval (J&A)

Notice Date

10/17/2016
 

Notice Type

Justification and Approval (J&A)
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 20;5115 NE 82nd Ave, Suite 102;Vancouver WA 98662
 

ZIP Code

98662
 

Solicitation Number

VA26016Q0964
 

Archive Date

10/31/2016
 

Point of Contact

Laura Patterson
 

E-Mail Address

laura.patterson3@va.gov
(laura.patterson3@va.gov)
 

Small Business Set-Aside

N/A
 

Award Number

VA260-17-D-0017
 

Award Date

10/1/2016
 

Description

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>$150K) Acquisition Plan Action ID: VA260-16-AP-6299 1.Contracting Activity: Department of Veterans Affairs (VA), VISN 20, Puget Sound Health Care System Station 663, requesting office: Pathology and Laboratory Medicine Histology section. 2.Nature and/or Description of the Action Being Processed: This requirement is for a new contract to provide Pathology Laboratory Testing Services from the University of Washington (UW), the UW has entered into an afflifiate relationship: a program of education and training of health personnel, with the VA under the guidance of 38 USC 8153 and 38 USC 7302. This proposed contract will be an Indefinite Delivery Indefinite Quantity (IDIQ), Firm Fixed Price contract for commercial services to process laboratory specimens for the VA Pathology and Laboratory Medicine Histology section. The VA does not have capabilies to perform all of the required tests, in the time frames required, and in the quantities required to meet the mission of the Pathology and Laboratory Medicine. There is currently a Single Source IDIQ contract, VA260-12-D-0028, in place for these same services with the UW. FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for Pathology Laboratory Testing Services in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. 3.Description of Supplies/Services Required to Meet the A gency's Needs : This requirement is for a base year plus 3 one-year option periods. The base year is 01 OCT 2016 - 30 SEP 2017, with 3 option years, issued under 52.217-9, ending 30 SEP 2020. An option to extend services up to 6 months will also be included, via 52.217-8. This contract incoporates option years becauseto avoid a potential break in service as there is a continuous need for these services which have the potiential of treating diseases and saving lives as a result of the diagnosises and tests. In the past, this contract has picked up additional laboratory tests that the VA has required when its in-house capabilities have been reduced due to VA attrition, when new tests have been approved for use, or for increased demand for these specialized laboratory tests have occured. Attachment A, at the end of this J&A, includes Tables A-D which identifies all the current tests that can be purchased via Task Orders under the IDIQ; new and additional tests may be approved to be added at a later date. 4.Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1. ( X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1 as implemented by 13.501; FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2). 5. Demonstr ation that the C ontr ac tor's Unique Qualificati ons or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The VA Seattle Pathology and Laboratory Medicine Histology section has the instrumentation to do immunostaining, but is not set up to do all types of stains needed for diagnosis of some diseases and illnesses. Specific laboratory tests are sent to the University of Washington Department of Lab Medicine (UWDLM); for a listing of the tests see Attachment A at the end of this J&A. VA Physicians request a specific continuity of care for veteran patients, due to the medical condition of specific patients, tracking and medication effectiveness cannot be analyzed if switched to a different laboratory. Additionally, UWDLM provides a quality of service to deliver fast, accurate reporting of labs to determine condition of veteran patient. There is currently a requirement for the UWDLM to provide all results back to the VA within 72 hours or 3 business days. The contract also requires that the vendor pick up the specimuns from the VA in Seattle, WA. There is no other know commercial vendor who can meet this requirement for all required tests. Other commercial labs may be able to perform all the lab test, but cannot meet the delivery requirements which insure patient diagnosis are timely. Accordingly, UWDLM is the only source capable of providing the services described above without the VA experiencing unacceptable delays in fulfilling its requirements. 6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Notice of Intent to Award a Sole Source Contract : A Notice of Intent to Award a Sole Source Contract was issued on 12 SEP 2016, originally under Special Notice number VA260-16-N-0960, it was reposted on 13 SEP 2016 under Special Notice number VA260-16-Q-0969, with the exact same information due to an eCMS system issue that could not easily be resolved with the initial notice. Responses were requested within 5 days from the initial posting on 16 SEP 2016, as this is a commercially available service. The notice identified all the tests currently ordered under the IDIQ. In answer to a question received, an amendment to this notice was posted on 15 SEP 2016 identifying the quantities of tests ordered for the previous 3 months of the current contract. The notice requested responses from interested parties to idenitify capabilities to perform all tests and to describe abilities to offer turnaround of all tests within 72 hours or 3 business days. Other Actions: The Pathology and Laboratory Medicine Histology section are familiar with commercial labs in the Puget Sound area and are monitoring the market place for viable vendors; in the future the VA will continue to monitor the Pathology lab services available in order to identify other potential vendors that could fulfill this requirements. Additionally, the award notice and the J&A will be posted in accordance with the requirements of the FAR. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The costs of the tests will be determined to be fair and reasonable prior to award and documented in accordance with FAR requirements, 8.Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: GSA was searched and no services of this type were offered. Ability One was reviewed and no services of this type were offered. VetBiz was searched and only 4 vendors were identified using the phrase "Pathology Lab Test," in the State of Washington, with the NAICS code 621511. 3 of the 4 were outside of the State of Washington and thus could not meet the requirement of the contract to pick up the specimiums at the VA in Seattle, WA. The other vendor was located in Spokane, WA, according to the company website is a staffing service providing heathcare employee services and legal services. Neither of which is a requirement of this contract action. Additionally, the Small Business Dynamic Search website was used in order to search for capable small businesses, using the NAICS code, Washington State, and the phrase "Pathology Lab Test." No company results were returned. A Market Research Summary Report is in the contract file which documents all the information provided here. 9.Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A 10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: 11.A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The VA will review the requirements periodically to ensure that all the requirements of the contract reflect the minimum requirements of the Pathology and Laboratory Medicine Histology section. This contract includes option years to avoid a potential break in service because there is a continuous eed for the potientially life saving results of the tests. 12.Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. 13.Approvals in accordance with the VHAPM, Volume 6, Chapter VI: OFOC SOP. a.Contracting Officer or Designee's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Laura K. PattersonDate Contracting Officer Network Contracting Office (NCO) 20 b.Director of Contracting Designee (Required over$150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition. Tom GuyerDate NCO 20 Division 1 Chief Network Contracting Office (NCO) 20 Attachment A Table A: General Anatomic Pathology Reference Lab Test List CPT Description 84311-TCSPECTROPHOTOM ETRY 87491-TCCHLAMYDIA TRACHOMATIS,AMPLIFIED PROBE TECHN IQUE 87591-TCNEISSERIA GONORRHOEAE,AMPLIFIED PROBE TECHNIQUE 87621-TCIADNA PAPLMVIRUS HUMAN AMP PRB 88104-TCCYTP FLU WASHGS/BRUSHI NGS XCPT CIV SMRS INTERPJ 88104-26CYTP FLU WASHGS/BRUSHI NGS XCPT CIV SMRS INTERPJ 88108-TCCYTP CONCENTRATION SMRS&INTERPJ 88108-26CYTP CONCENTRATION SMRS&INTERPJ 88112-TCCYTP SLCTV CELL ENHANCEMENT INTERPJ XCPT CIV 88112-26CYTP SLCTV CELL ENHANCEMENT INTERPJ XCPT CIV 88120-TCCYTP INSITU HYBRID URINE SPEC 3-5 PROBES EA MNL 88120-26CYTP INSITU HYBRID URINE SPEC 3-5 PROBES EA MNL 88125-TCFORENSIC CYTOPATHOLOGY 88125-26FORENSIC CYTOPATHOLOGY 88141-TCCYTOPATH CIV INTERPRET 88142-TCCYTP CIV FLU AUTO THIN MNL PHYS 88143-TCCYTP CIV FLU AUTO THIN MNL SCR&RESCR PHYS 88150-TCCYTOPATH CIV MANUAL 88153-TCCYTOPATH CIV REDO 88160-TCCYTOPATH SMEAR OTHER SOURCE 88160-26CYTOPATH SMEAR OTHER SOURCE 88162-TCCYTOPATH SMEAR OTHER SOURCE 88162-26CYTOPATH SMEAR OTHER SOURCE 88164-TCCYTOPATH TBS CIV MANUAL 88165-TCCYTOPATH TBS CIV REDO 88172-TCCYTP FINE NDL ASPIRATE IMMT CYTOHIST STD DX 1ST 88172-26CYTP FINE NDL ASPIRATE IMMT CYTOHIST STD DX 1ST 88173-TCCYTP FINE NDL ASPIRATE l&R 88173-26CYTP FINE NDL ASPIRATE l&R 88177-TCCYTP CIV AUTO THIN LYR PREPJ ADEQUACY EA EVAL 88177-26CYTP CIV AUTO THIN LYR PREPJ ADEQUACY EA EVAL 88182-TCFLO CYTOMETRY CELL CYCLE/DNA ALYS 88182-26FLO CYTOMETRY CELL CYCLE/DNA ALYS 88184-TCFLO CYTOMETRY CELL SURF MARKER TECHL ONLY 1ST 88185-TCFLOWCYTOMETRY/ TC ADD-ON 88230-TCTISS CUL NON-NEO DISORDERS LYMPHOCYTE 88237-TCTISS CUL NEO DISORDERS B1 MARROW BLD CELLS 88239-TCTISS CUL NEO DISORDERS SOLID TUM 88262-TCCHRMSM CNT 15-20 CLL 2KARYOTYP BANDING 88264-TCCHRMSM ANALYZE 20-25 CELLS 88271-TCMOLEC CYTOGENETICS DNA PRB EA 88273-TCMOLEC CYTG CHRMOML ISH 10-30 CLL 88275-TCMOLEC CYTG INTERPHASE ISH ANALYZE 100-300 CLL 88291-26CHROMOSOME STUDY ADDITIONAL 88302-TCLVL II-SURG PATH GROSS&MCRSCP XM 88302-26LVL II-SURG PATH GROSS&MCRSCP XM 88304-TCLEVEL III-SURG PATH GROSS&MICROSCOPIC XM 88304-26LEVEL III-SURG PATH GROSS&MICROSCOPIC XM 88305-TCLVL IV-SURG PATH GROSS&MCRSCP XM 88305-26LVL IV-SURG PATH GROSS&MCRSCP XM 88307-TCLVL V-SURG PATH GROSS&MCRSCP XM 88307-26LVL V-SURG PATH GROSS&MCRSCP XM 88309-TCLVL VI-SURG PATH GROSS&MCRSCP XM 88309-26LVL VI-SURG PATH GROSS&MCRSCP XM 88311-TCDECALCIFICATION PX 88311-26DECALCIFICATION PX 88312-TCSPECIAL STAINS GROUP 1 MICROORGANISMS I&R EACH 88312-26SPECIAL STAINS GROUP 1 MICROORGANISMS I&R EACH 88313-TCSPECIAL STAINS GROUP II ALL OTHER I&R EACH 88313-26SPECIAL STAINS GROUP II ALL OTHER I&R EACH 88314-TCSPECIAL STAINS HISTOCHEMICAL W/FROZEN SECTION 88314-26SPECIAL STAINS HISTOCHEMICAL W/FROZEN SECTION 88319-TCDETERMINATIVE HCHEM/CCHEM ID NZM EA 88319-26DETERMINATIVE HCHEM/CCHEM ID NZM EA 88321-26CONSLTJ&REPRT SLIDES PREPARED ELSEWHERE 88323-TCCONSLTJ&REPRT MATRL REQ PREPJ SLIDES 88323-26CONSLTJ&REPRT MATRL REQ PREPJ SLIDES 88325-TCCOMPREHENSIVE REVIEW OF DATA 88329-TCPATH CONSULT INTROP 88331-TCPATH CONSLTJ SURG 1ST BLK FROZEN SCTJ 1 SPEC 88331-26PATH CONSLTJ SURG 1ST BLK FROZEN SCTJ 1 SPEC 88332-TCPATH CONSLTJ SURG EA BLK FROZEN SCTJ 88332-26PATH CONSLTJ SURG EA BLK FROZEN SCTJ 88333-TCPATH CONSLTJ SURG CYTOLOGIC XM 1ST SIT 88333-26PATH CONSLTJ SURG CYTOLOGIC XM 1ST SIT 88334-TCPATH CONSLTJ SURG CYTOL XM EA ADDL 88334-26PATH CONSLTJ SURG CYTOL XM EA ADDL 88341-TCIMHISTOCHEM/CYTCHM INIT ANTIBODY STAIN PROCEDURE 88341-26IMHISTOCHEM/CYTCHM INIT ANTIBODY STAIN PROCEDURE 88342-TCIMCYTCHM TISS IMMUNOPROXIDASE EA ANTB 88342-26IMCYTCHM TISS IMMUNOPROXIDASE EA ANTB 88346-TCIMFLUOR STD EA ANTB DIR METH 88346-26IMFLUOR STD EA ANTB DIR METH 88348-TCELECTRON MIC DX 88348-26ELECTRON MIC DX 88350-TCIMMUNOFLUORESCENCE PER SPEC ADD SINGL ANTB STAIN 88350-26IMMUNOFLUORESCENCE PER SPEC ADD SINGL ANTB STAIN 88360-TCTUMOR IMMUNOHISTOCHEM/MA NUAL 88360-26TUMOR IMMUNOHISTOCHEM/MA NUAL 88362-TCNRV TEASING PREPJS 88362-26NRV TEASING PREPJS 88363-TCEXAM & SELECT ARCHIVE TISSUE MOLECULAR ANALYSIS 88365-TCSITU HYBRIDIZATION EA PRB 88365-26SITU HYBRIDIZATION EA PRB 88368-TCM/PHMTRC ALYS ISH EA PRB MNL 88368-26M/PHMTRC ALYS ISH EA PRB MNL 88387-TCTISS EXAM MOLECULAR STUDY 88387-26TISS EXAM MOLECULAR STUDY 88388-TCTISS EX MOLECUL STUDY ADD-ON 88388-26TISS EX MOLECUL STUDY ADD-ON TC = Technical Component 26 = Professional Component Table B:Northwest ainical Genomics Lab Test Ust CPT(s)Test Description 81415Amyotrophic Lateral Sclerosis (ALS) Exome Panel 81415Cardiac Arrhythmia Exome Panel 81415Cardiomyopat hy Exome Panel 81415Comprehensive Cardiac Arrhythm ia / Cardiomyopathy Exome Panel 81415Comprehensive Dementia,Parkinson's, ALS Exome Panel 81415Dementia Exome Panel 81415Exome Panel On Demand 81415Exome Sequence Analysis 81415Exome Sequence Comparator 81417Exome Re-evaluation of Previously Obtained Sequence 81415Genome Sequence Analysis 81426Genome Sequence Analysis Comparator 81426Genome Re-evaluation of Previously Obtained Sequence 81415Parkinson's Disease Exome Panel 81417REFLEX to Exome Sequencing 81403 or 81479Testingfor Known Pathogenic Varia nt Table C:Collagen Diagnostic Laboratory Test List Test NameGene(s)CPT(s) COL1A1 and COL1A2 gDNA SequencingCOL1A1,COL1A281408 x 2 Dominant 01 PanelCOL1A1,COL1A2,IFITMS81408 x 2,81479 x l Dominant 01 Panel plus PLS3COL1A1,COL1A2,IFITMS,PLS381408 x 2,81479 x 2 Recessive 01 Panel plus ALPLCRTAP,FKBP10,LEPREl,PPIB,PLOD2, SERPINH,SERPINF,SP7,SMPl, TMEM38B,WNTl,CREB3L1,ALPL81479 Autosomal Dominant and Recessive 01 PanelCOL1A1,COL1A2,IFITMS,PLS3, CRTAP,FKBP10,LEPREl,PPIB,PLOD2, SERP INH,SERPINF,SP7,SMPl, TMEM38B,WNTl,CREB3L1,ALPL81479 Classical EDS PanelCOLSAl,COLSA281479 Core EDS PanelCOLSAl,COLSA2,COL3A181479 Core FamilialAneurysm PanelACTA2,COL3A1,TGFBRl,TGFBR2, TGFB2,SMAD3,FBN,MYH11,MYLK, PRKGl,SLC2A10,TGFB3,NOTCH,SKI, FBN2,FOXE381410 Marfan Syndrome and Loeys- Dietz PanelFBNl,TGFBRl,TGFBR2,TGFB2,TGFB3, SMAD381479 Extended Marfan-Related Disorders PanelFBNl,TGFBRl,TGFBR2,TGFB2,TGFB3, SMAD3,SKI,FBN281479 Alport PanelCOL4A3,COL4A4,COL4AS81408 x 2,81407 x l Hereditary angiopathy/lncracranial hemorrhageCOL4A1,COL4A281408,81479 FBNl genomic sequencingFBNl81408 COL3A1 genomic sequencingCOL3A181479 TGFBRl and TGFBR2 genomic sequencingTGFBRl,TGFBR281405 x 2 Bruck SyndromeFKBP10,PLOD281479 x 2 Caffey DiseaseTargeted COL1A181403 HypophosphatasiaALPL81479 X-Linked OsteoporosisPLS381479 EDS type VIExon 6 COL1A1and COL1A281479 x 2 FKBP14-Related EDSFKBP1481479 Chapter VI: Other Than Full and Open Competition (OFOC) SOP Attachment 3: Request for Sole Source Justification Format >$150K IFITM5 genomic sequencingIFITM581479 PLOD1 genomic sequencingPLOD181479 ACTA2 genomic sequencingACTA281405 SMAD3 genomic sequencingSMAD381479 SLC2A10 genomic sequencingSLC2A1081479 TGFB2 genomic sequencingTGFB281479 TGFB3 genomic sequencingTGFB381479 MYH11 genomic sequencingMYH1181408 MYLK genomic sequencingMYLK81479 PRKG1 genomic sequencingPRKG181479 BMP1 genomic sequencingBMP181479 FKBP10 genomic sequencingFKBP1081479 CREB3L1 genomic sequencingCREB3L181479 CRTAP genomic sequencingCRTAP81479 P3H1 genomic sequencingP3H181479 PLOD2 genomic sequencingPLOD281479 PPIB genomic sequencingPPIB81479 SERPINF1 genomic sequencingSERPINF181479 SERPINH1 genomic sequencingSERPINH181479 SP7/OSX genomic sequencingSP7/OSX81479 TMEM38B genomic sequencingTMEM38B81479 WNT1 genomic sequencingWNT181479 X-Linked Alport SyndromeCOL4A181408 Prenatal TestingAll genes81479 Testing for Familial Pathogenic VariantKnown Mutation Testing of COL1A1, COL1A2, TGFBR1, TGFBR2, FBN1 and ACTA281403 Testing for Familial Pathogenic VariantKnown Mutation Testing of all other genes (COL2A1, SMAD3, P3H1, etc.)81479 Deletion/Duplication AnalysisAll genes81228 Deletion/Duplication Analysis (additional gene)G0452 Maternal Cell Contamination Studies81465 COL1A1 and COL1A2 gDNA SequencingCOL1A1, COL1A281408 x 2 Dominant OI PanelCOL1A1, COL1A2, IFITM581408 x 2, 81479 x 1 Dominant OI Panel plus PLS3COL1A1, COL1A2, IFITM5, PLS381408 x 2, 81479 x 2 OFOC SOP Revision 05Page 9 of 10 Original Date: 03/22/11 Revision 05 Date: 05/02/2016 Chapter V I: Other Than Full and Open Competition (OFOC) SOP Attac hment 3: Request for Sole Source Justification Format >$150K Recessive 01 Panel plus ALPLCRTAP,FKBP10,LEPREl,PPIB,PLOD2, SERPINH,SERPINF,SP7,SMP, TMEM38B,WNTl,CREB3L1,ALPL81479 Classic EDS PanelCOLSAl,COLSA281479 Alport PanelCOL4A3,COL4A4,COL4AS81408 x 2,81407 x l FBNl genomic sequencingFBNl81408 COL3A1 genomic sequencingCOL3A181479 Table D: ainical Cytogenomics/Array Lab Test Ust Test NameGenesCPT(s) Constitutional Cytogenomic Microarray AnalysisWhole Genome81229, G0452 Neoplasia Cytogenomic Microarray AnalysisWhole Genome81229, G0452 Y Chromosome Microdeletion Ana lys isAMELY,CDYl,DA,DBY,HSFY, RBMY,SRY, USP9Y81403 OFOC SOP Revision 05 Original Date: 03/22/ 11 Revision 05 Date:05/02/2016 Page 10 of 10
 

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Document(s)

Justification and Approval (J&A)
 

File Name: VA260-16-Q-0964 VA260-16-Q-0964_2.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3059320&FileName=VA260-16-Q-0964-004.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3059320&FileName=VA260-16-Q-0964-004.docx

 

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Record

SN04305470-W 20161019/161017234011-3b2a9a3a4a2858e343b932f95bdae25d (fbodaily.com)
 

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