UW Pathology Laboratory Services IDIQ

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. Patterson Date

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 Guyer Date

NCO 20 Division 1 Chief

Network Contracting Office (NCO) 20









Attachment A





Table A: General Anatomic Pathology Reference Lab Test List



CPT

Description

84311-TC SPECTROPHOTOM ETRY

87491-TC CHLAMYDIA TRACHOMATIS,AMPLIFIED PROBE TECHN IQUE

87591-TC NEISSERIA GONORRHOEAE,AMPLIFIED PROBE TECHNIQUE

87621-TC IADNA PAPLMVIRUS HUMAN AMP PRB

88104-TC CYTP FLU WASHGS/BRUSHI NGS XCPT CIV SMRS INTERPJ

88104-26 CYTP FLU WASHGS/BRUSHI NGS XCPT CIV SMRS INTERPJ

88108-TC CYTP CONCENTRATION SMRS&INTERPJ

88108-26 CYTP CONCENTRATION SMRS&INTERPJ

88112-TC CYTP SLCTV CELL ENHANCEMENT INTERPJ XCPT CIV

88112-26 CYTP SLCTV CELL ENHANCEMENT INTERPJ XCPT CIV

88120-TC CYTP INSITU HYBRID URINE SPEC 3-5 PROBES EA MNL

88120-26 CYTP INSITU HYBRID URINE SPEC 3-5 PROBES EA MNL

88125-TC FORENSIC CYTOPATHOLOGY

88125-26 FORENSIC CYTOPATHOLOGY

88141-TC CYTOPATH CIV INTERPRET

88142-TC CYTP CIV FLU AUTO THIN MNL PHYS

88143-TC CYTP CIV FLU AUTO THIN MNL SCR&RESCR PHYS

88150-TC CYTOPATH CIV MANUAL

88153-TC CYTOPATH CIV REDO

88160-TC CYTOPATH SMEAR OTHER SOURCE

88160-26 CYTOPATH SMEAR OTHER SOURCE

88162-TC CYTOPATH SMEAR OTHER SOURCE

88162-26 CYTOPATH SMEAR OTHER SOURCE

88164-TC CYTOPATH TBS CIV MANUAL

88165-TC CYTOPATH TBS CIV REDO

88172-TC CYTP FINE NDL ASPIRATE IMMT CYTOHIST STD DX 1ST

88172-26 CYTP FINE NDL ASPIRATE IMMT CYTOHIST STD DX 1ST

88173-TC CYTP FINE NDL ASPIRATE l&R

88173-26 CYTP FINE NDL ASPIRATE l&R

88177-TC CYTP CIV AUTO THIN LYR PREPJ ADEQUACY EA EVAL

88177-26 CYTP CIV AUTO THIN LYR PREPJ ADEQUACY EA EVAL

88182-TC FLO CYTOMETRY CELL CYCLE/DNA ALYS

88182-26 FLO CYTOMETRY CELL CYCLE/DNA ALYS

88184-TC FLO CYTOMETRY CELL SURF MARKER TECHL ONLY 1ST

88185-TC FLOWCYTOMETRY/ TC ADD-ON

88230-TC TISS CUL NON-NEO DISORDERS LYMPHOCYTE





88237-TC TISS CUL NEO DISORDERS B1 MARROW BLD CELLS

88239-TC TISS CUL NEO DISORDERS SOLID TUM

88262-TC CHRMSM CNT 15-20 CLL 2KARYOTYP BANDING

88264-TC CHRMSM ANALYZE 20-25 CELLS

88271-TC MOLEC CYTOGENETICS DNA PRB EA

88273-TC MOLEC CYTG CHRMOML ISH 10-30 CLL

88275-TC MOLEC CYTG INTERPHASE ISH ANALYZE 100-300 CLL

88291-26 CHROMOSOME STUDY ADDITIONAL

88302-TC LVL II-SURG PATH GROSS&MCRSCP XM

88302-26 LVL II-SURG PATH GROSS&MCRSCP XM

88304-TC LEVEL III-SURG PATH GROSS&MICROSCOPIC XM

88304-26 LEVEL III-SURG PATH GROSS&MICROSCOPIC XM

88305-TC LVL IV-SURG PATH GROSS&MCRSCP XM

88305-26 LVL IV-SURG PATH GROSS&MCRSCP XM

88307-TC LVL V-SURG PATH GROSS&MCRSCP XM

88307-26 LVL V-SURG PATH GROSS&MCRSCP XM

88309-TC LVL VI-SURG PATH GROSS&MCRSCP XM

88309-26 LVL VI-SURG PATH GROSS&MCRSCP XM

88311-TC DECALCIFICATION PX

88311-26 DECALCIFICATION PX

88312-TC SPECIAL STAINS GROUP 1 MICROORGANISMS I&R EACH

88312-26 SPECIAL STAINS GROUP 1 MICROORGANISMS I&R EACH

88313-TC SPECIAL STAINS GROUP II ALL OTHER I&R EACH

88313-26 SPECIAL STAINS GROUP II ALL OTHER I&R EACH

88314-TC SPECIAL STAINS HISTOCHEMICAL W/FROZEN SECTION

88314-26 SPECIAL STAINS HISTOCHEMICAL W/FROZEN SECTION

88319-TC DETERMINATIVE HCHEM/CCHEM ID NZM EA

88319-26 DETERMINATIVE HCHEM/CCHEM ID NZM EA

88321-26 CONSLTJ&REPRT SLIDES PREPARED ELSEWHERE

88323-TC CONSLTJ&REPRT MATRL REQ PREPJ SLIDES

88323-26 CONSLTJ&REPRT MATRL REQ PREPJ SLIDES

88325-TC COMPREHENSIVE REVIEW OF DATA

88329-TC PATH CONSULT INTROP

88331-TC PATH CONSLTJ SURG 1ST BLK FROZEN SCTJ 1 SPEC

88331-26 PATH CONSLTJ SURG 1ST BLK FROZEN SCTJ 1 SPEC

88332-TC PATH CONSLTJ SURG EA BLK FROZEN SCTJ

88332-26 PATH CONSLTJ SURG EA BLK FROZEN SCTJ

88333-TC PATH CONSLTJ SURG CYTOLOGIC XM 1ST SIT

88333-26 PATH CONSLTJ SURG CYTOLOGIC XM 1ST SIT

88334-TC PATH CONSLTJ SURG CYTOL XM EA ADDL

88334-26 PATH CONSLTJ SURG CYTOL XM EA ADDL

88341-TC IMHISTOCHEM/CYTCHM INIT ANTIBODY STAIN PROCEDURE

88341-26 IMHISTOCHEM/CYTCHM INIT ANTIBODY STAIN PROCEDURE





88342-TC IMCYTCHM TISS IMMUNOPROXIDASE EA ANTB

88342-26 IMCYTCHM TISS IMMUNOPROXIDASE EA ANTB

88346-TC IMFLUOR STD EA ANTB DIR METH

88346-26 IMFLUOR STD EA ANTB DIR METH

88348-TC ELECTRON MIC DX

88348-26 ELECTRON MIC DX

88350-TC IMMUNOFLUORESCENCE PER SPEC ADD SINGL ANTB STAIN

88350-26 IMMUNOFLUORESCENCE PER SPEC ADD SINGL ANTB STAIN

88360-TC TUMOR IMMUNOHISTOCHEM/MA NUAL

88360-26 TUMOR IMMUNOHISTOCHEM/MA NUAL

88362-TC NRV TEASING PREPJS

88362-26 NRV TEASING PREPJS

88363-TC EXAM & SELECT ARCHIVE TISSUE MOLECULAR ANALYSIS

88365-TC SITU HYBRIDIZATION EA PRB

88365-26 SITU HYBRIDIZATION EA PRB

88368-TC M/PHMTRC ALYS ISH EA PRB MNL

88368-26 M/PHMTRC ALYS ISH EA PRB MNL

88387-TC TISS EXAM MOLECULAR STUDY

88387-26 TISS EXAM MOLECULAR STUDY

88388-TC TISS EX MOLECUL STUDY ADD-ON

88388-26 TISS EX MOLECUL STUDY ADD-ON



TC = Technical Component

26 = Professional Component



Table B:Northwest ainical Genomics Lab Test Ust

CPT(s) Test Description

81415 Amyotrophic Lateral Sclerosis (ALS) Exome Panel

81415 Cardiac Arrhythmia Exome Panel

81415 Cardiomyopat hy Exome Panel

81415 Comprehensive Cardiac Arrhythm ia / Cardiomyopathy Exome Panel

81415 Comprehensive Dementia,Parkinson's, ALS Exome Panel

81415 Dementia Exome Panel

81415 Exome Panel On Demand

81415 Exome Sequence Analysis

81415 Exome Sequence Comparator

81417 Exome Re-evaluation of Previously Obtained Sequence

81415 Genome Sequence Analysis

81426 Genome Sequence Analysis Comparator

81426 Genome Re-evaluation of Previously Obtained Sequence

81415 Parkinson's Disease Exome Panel

81417 REFLEX to Exome Sequencing

81403 or 81479 Testingfor Known Pathogenic Varia nt





Table C:Collagen Diagnostic Laboratory Test List

Test Name Gene(s) CPT(s)

COL1A1 and COL1A2 gDNA

Sequencing COL1A1,COL1A2 81408 x 2

Dominant 01 Panel COL1A1,COL1A2,IFITMS 81408 x 2,81479

x l

Dominant 01 Panel plus PLS3 COL1A1,COL1A2,IFITMS,PLS3 81408 x 2,81479

x 2

Recessive 01 Panel plus ALPL CRTAP,FKBP10,LEPREl,PPIB,PLOD2, SERPINH ,SERPINF ,SP7,SMPl, TMEM38B,WNTl,CREB3L1,ALPL 81479

Autosomal Dominant and Recessive 01 Panel COL1A1,COL1A2,IFITMS,PLS3, CRTAP,FKBP10,LEPREl,PPIB,PLOD2, SERP INH ,SERPINF ,SP7,SMPl, TMEM38B,WNTl,CREB3L1,ALPL 81479

Classical EDS Panel COLSAl,COLSA2 81479

Core EDS Panel COLSAl,COLSA2,COL3A1 81479

Core FamilialAneurysm Panel ACTA2,COL3A1,TGFBRl,TGFBR2, TGFB2,SMAD3,FBN ,MYH11,MYLK, PRKGl,SLC2A10,TGFB3,NOTCH ,SKI, FBN2,FOXE3 81410

Marfan Syndrome and Loeys- Dietz Panel FBNl,TGFBRl,TGFBR2,TGFB2,TGFB3, SMAD3 81479

Extended Marfan-Related Disorders Panel FBNl,TGFBRl,TGFBR2,TGFB2,TGFB3, SMAD3,SKI,FBN2 81479

Alport Panel COL4A3,COL4A4,COL4AS 81408 x 2,81407

x l

Hereditary angiopathy/lncracranial hemorrhage COL4A1,COL4A2 81408,81479

FBNl genomic sequencing FBNl 81408

COL3A1 genomic sequencing COL3A1 81479

TGFBRl and TGFBR2 genomic sequencing TGFBRl,TGFBR2 81405 x 2

Bruck Syndrome FKBP10,PLOD2 81479 x 2

Caffey Disease Targeted COL1A1 81403

Hypophosphatasia ALPL 81479

X-Linked Osteoporosis PLS3 81479

EDS type VI Exon 6 COL1A1and COL1A2 81479 x 2

FKBP14-Related EDS FKBP14 81479



Chapter VI: Other Than Full and Open Competition (OFOC) SOP Attachment 3: Request for Sole Source Justification Format >$150K



IFITM5 genomic sequencing IFITM5 81479

PLOD1 genomic sequencing PLOD1 81479

ACTA2 genomic sequencing ACTA2 81405

SMAD3 genomic sequencing SMAD3 81479

SLC2A10 genomic sequencing SLC2A10 81479

TGFB2 genomic sequencing TGFB2 81479

TGFB3 genomic sequencing TGFB3 81479

MYH11 genomic sequencing MYH11 81408

MYLK genomic sequencing MYLK 81479

PRKG1 genomic sequencing PRKG1 81479

BMP1 genomic sequencing BMP1 81479

FKBP10 genomic sequencing FKBP10 81479

CREB3L1 genomic sequencing CREB3L1 81479

CRTAP genomic sequencing CRTAP 81479

P3H1 genomic sequencing P3H1 81479

PLOD2 genomic sequencing PLOD2 81479

PPIB genomic sequencing PPIB 81479

SERPINF1 genomic sequencing SERPINF1 81479

SERPINH1 genomic sequencing SERPINH1 81479

SP7/OSX genomic sequencing SP7/OSX 81479

TMEM38B genomic sequencing TMEM38B 81479

WNT1 genomic sequencing WNT1 81479

X-Linked Alport Syndrome COL4A1 81408

Prenatal Testing All genes 81479

Testing for Familial Pathogenic Variant Known Mutation Testing of COL1A1, COL1A2, TGFBR1, TGFBR2, FBN1 and ACTA2 81403

Testing for Familial Pathogenic Variant Known Mutation Testing of all other genes (COL2A1, SMAD3, P3H1, etc.) 81479

Deletion/Duplication Analysis All genes 81228

Deletion/Duplication Analysis (additional gene) G0452

Maternal Cell Contamination Studies 81465

COL1A1 and COL1A2 gDNA

Sequencing COL1A1, COL1A2 81408 x 2

Dominant OI Panel COL1A1, COL1A2, IFITM5 81408 x 2, 81479

x 1

Dominant OI Panel plus PLS3 COL1A1, COL1A2, IFITM5, PLS3 81408 x 2, 81479

x 2

OFOC SOP Revision 05 Page 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 ALPL CRTAP,FKBP10,LEPREl,PPIB,PLOD2, SERPINH ,SERPINF ,SP7,SMP , TMEM38B,WNTl,CREB3L1,ALPL 81479

Classic EDS Panel COLSAl,COLSA2 81479

Alport Panel COL4A3,COL4A4,COL4AS 81408 x 2,81407

x l

FBNl genomic sequencing FBNl 81408

COL3A1 genomic sequencing COL3A1 81479



Table D: ainical Cytogenomics/Array Lab Test Ust

Test Name Genes CPT(s)

Constitutional Cytogenomic

Microarray Analysis Whole Genome 81229, G0452

Neoplasia Cytogenomic

Microarray Analysis Whole Genome 81229, G0452

Y Chromosome Microdeletion Ana lys is AMELY,CDYl,DA,DBY,HSFY , RBMY ,SRY, USP9Y 81403





































































OFOC SOP Revision 05 Original Date: 03/22/ 11 Revision 05 Date:05/02/2016



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