Q301--Anatomic Pathology

SOURCES SOUGHT NOTICE This is not a solicitation but rather a Request for Information (RFI/Sources Sought) for market research purposes only. Veterans Health Affairs, Network Contracting Office 4, is issuing this Sources Sought in order to identify capable firms and obtain information for planning purposes only. Veterans Health Affairs, Network Contracting Office 4, is issuing this Sources Sought to identify capable firms for Wilkes Barre VAMC and Philadelphia VAMC. Responses shall be submitted by 12:00 PM (EST) September 18th, 2023. Responses shall be submitted via email to Amanda.Saunders@va.gov in the Subject line: Anatomic Pathology 36C24423I1212/(Your Organizations Name). All Service-Disabled Veteran-Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) firms that respond shall include proof of their Vets First Verification via Home  · VetBiz Portal (va.gov). All small business firms that respond

shall include proof of small business status via their Representations and Certifications in accordance with FAR 4.1102 Policy. As determined by the VAAR in section 852.219-73 and 852.219-75, Service-Disabled Veteran Owned Small Businesses need to meet specified requirements, while limiting the amount of subcontracting provided during a given contract. Failure to meet the required stipulations can result in suspension, debarment, fines, and/or prosecution. While SDVOSB/VOSB contractors are preferred, all capable contractors are welcome to respond to this sources sought notice for market research purposes. All respondents shall include as part of their response a brief capability statement that covers the information in the following tentative performance work statement (PWS), as well as answers to the below three (3) questions. All respondents shall be registered and active in SAM.gov | Home. The purpose of this sources sought is to elicit feedback from industry on our intended procurement approach. The results of this market research will assist in the development of (1) the requirement, and (2) the acquisition approach (e.g., socioeconomic set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses. Suggested NAICS: 621511 (Medical Laboratories) Suggested PSC: Q301 (Medical-Laboratory Testing) Open to suggestions from industry as to a more proper NAICS and/or PSC, as well as any potential GSA/FSS Schedule SIN categories. In addition to the information requested above, please include answers to the below 3 questions as part of your response to this Sources Sought: 1. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. 2. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each. 3. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? Yes ___No ___ If yes, please identify which companies are considering a Joint Venture and the ownership of each company. 4. If responding to this sources sought as an SDVOSB, please provide information to support your ability to comply with the limitations on subcontracting per VAAR in section 852.219-73 and 852.219-75. 5. If responding to this sources sought as a VOSB, please provide information to support your ability to comply with the limitations on subcontracting per VAAR in section 852.219-74 and 852.219-75. 6. A copy of the current CLIA License that is specifically for Histopathology, Cytology, Cytogenetics and Oral Pathology. Updates to the License will be provided as needed. (when previous certificate has expired) 7. A copy of Laboratory Accreditation from either College of American Pathologists (CAP) or The Joint Commission (JC) will be provided along with the Laboratory s Activity Menu that was submitted to the Accrediting Body. Accreditation must include Histology, Cytology, Cytogenetics, Molecular Pathology and Oral Pathology. Intended Procurement Approach Performance Work Statement Specialized Services and Testing for Anatomic Pathology and Cytology Specimens Contractors are required to provide a firm fixed monthly price based on each facilities estimated testing usage. The firm fixed monthly price shall include all costs (including shipping) covering: a full range of referral laboratory services for Anatomic Pathology to include surgical pathology, molecular pathology, cytopathy, histology, histochemistry, hematopathology, Immunohistochemistry Stains, Cytochemical Stains, Flow Cytometry, FISH testing, Cancer Marker Testing, diagnostic electron microscopy, and other esoteric testing to the Wilkes-Barre VA (WBVAMC) located at 1111 East end Boulevard, Wilkes-Barre, PA 18711 and the Michael J. Crescenz VA Medical Center (CMCVAMC) located at 3900 Woodland Ave., Philadelphia, PA 19104. Basic services shall include the transportation/shipping of anatomic pathology specimens to the Contractor s laboratory, performance of technical procedures and/ or professional procedures, return of stained slides, reporting of results for the professional services, and consultative services as required to provide a full scope of its laboratory. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notifications of any delays in shipment as well as any or all technical/advisory/recalls/Alerts, prior to or simultaneously with field alerts should be forwarded to the station point of contact. Contractor must ensure the security of the specimen, contains and protects against the accessibility of the specimens and the information that accompanies the specimens. The package specimens shall be according to the guidelines required by the contractor. Contractor shall provide all necessary supplies for biomedical materials to be transported, to include shipping, from the VA Medical Centers Laboratory to the Contractor s laboratory. These supplies shall include, but may not be limited to: Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor s laboratory. Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 49 CFR Part 72, CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates. Contractor must provide documentation of a current CLIA License for the testing provided for Pennsylvania and Delaware. It is also the responsibility of the Reference Laboratory to update the license as needed and provide the updated license to the Wilkes-Barre VA Medical Center (WBVAMC) Laboratory and to the Michael J. Crescenz VA Medical Center (CMCVAMC) Laboratory. The CLIA License must include the following: Histopathology (610) Cytology (630) Cytogenetics (900) Oral Pathology (620) 5. The Reference Laboratory must be Accredited by either the College of American Pathologist or The Joint Commission. The Accreditation must be for Histology, Cytology, Cytogenetics, Molecular Pathology and Oral Pathology. 6. Contractor must ensure the security of the specimens and protect against the accessibility of the specimens and the information that accompanies the specimens. The information shall comply with all HIPPA regulations. 7. Specimens will be picked up by the contractor Monday Friday, except for Federal Holidays and delivered to the Contractor s Laboratory. Federal Holidays are as follows: New Year s day, Martin Luther King Day, President s Day, June Teenth, 4th of July, Labor Day, Columbus Day, Veterans Day, Thanksgiving and Christmas. Wilkes-Barre VA (WBVAMC): Specimen pick-up times will be late afternoon between 3PM 4PM. Specimens must be picked up by the vendor s courier. Pick-up of specimens will be from the Histology Laboratory, currently located on 3rd Floor, room A3-55. Location of the Histology Laboratory may change. Michael J. Crescenz VA Medical Center (CMCVAMC): Specimen pick-up times will be late afternoon between 5PM 7PM. Vendor may transport specimens by courier or via FED-X/ UPS. If using FED-X or UPS, the vendor will supply pre-paid envelopes for shipping specimens. Pick-up of specimens will be from the Histology Laboratory, currently located on 3rd Floor, room 3b132. 8. The contractor shall furnish and deliver any specimen collection and transportation supplies that are required to send specimens to the Contracting Laboratory. The VA will request replenishment of supplies from the contractor on an as-needed basis. 9. All Blocks or slides will be returned to: Wilkes-Barre VA (WBVAMC): Located at 1111 East End Boulevard, Wilkes-Barre, PA 18711 Attention: Pathology & Laboratory Medicine (114) via courier drop-off or UPS or FEDX. These blocks and slides shall be returned within 7 days after final diagnosis is reported. Michael J. Crescenz VA Medical Center (CMCVAMC): Located at 3900 Woodland Ave, Philadelphia, PA 19104 Attention: Pathology & Laboratory Medicine (113) via courier drop-off or UPS or FEDX. These materials shall be returned within 7 days after completion of diagnostic studies. 10. Contractor must provide a phone number for consultation Pathology services regarding test results. Services will be minimally Monday through Friday from 9AM 4PM for Wilkes-Barre VA Medical Center and Services will be minimally Monday through Friday, excluding Federal Holidays, 9AM 5PM for Philadelphia VA Medical Center. 11. Contractor test reports must contain the following information at a minimum: Patient s full name Patient s identification number (e.g., social security number) Physician s name VA Laboratory accession number Submitting Laboratory Name (VA Medical Center, Wilkes-Barre) Submitting facility account number Patient s location (clinic/ ward) Tests(s) ordered Date/ time of specimen collection Date/ time test completed Test result (if applicable) Reference intervals (if applicable adjusted for age, sex or race) Interpretation of Results if applicable Name and address of testing laboratory Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing. Wilkes-Barre VA (WBVAMC): Hard copy Reports should be sent with a courier to 570-819-5115. An on-line account for the Pathologists should also be made available if possible. Michael J. Crescenz VA Medical Center (CMCVAMC): Hard copy Reports should be sent via secure fax to 215-823-4271. An on-line account for the Pathologists should also be made available to access results via lab s website. 12. Results and or stained slides shall be available within the listed turnaround times. Turnaround time will be from the time the specimen leaves: Wilkes-Barre VA (WBVAMC): Test Name Turnaround Time Immunohistochemistry Stains 24 Hours with slides in hands of the Pathologist Flow Cytometry 24 Hours Morphology 48 Hours FISH 4 Days Cytogenetics 7 Days Molecular 7 Days Michael J. Crescenz VA Medical Center (CMCVAMC): Test Name Turnaround Time Immunohistochemistry Stains 1-2 Days Flow Cytometry 2 Days Morphology 3-4 Days FISH 6 Days Cytogenetics 8 Days Molecular 8 Days 13. The Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period: Routine questions and clarifications regarding collection requirements Inquiries regarding the status of pending orders Result interpretation inquires/Consultative services Inquiries regarding supplies 14. Immunohistochemistry Stains, the slides will be sent to WBVAMC/CMCVAMC for the Pathologists to read. 15. Contractor shall be reimbursed per technical component, professional component or Global component, of the applicable CPT code, depending on the services rendered. CPT codes will include with the projected annual volumes of each: Wilkes-Barre VA (WBVAMC): Test Name CPT Projected Annual Volume +8,-5/5Q-,-7/7Q-,20Q-, FISH 88367,88373,88374 2 -7/7Q- BY FISH 88374 4 10 COLOR FLOW SHORT 88184,88185,88188 2 ACUTE 10 COLOR PANEL 88184,88185,88189 171 ACUTE LEUKEMIA PROFI 88305,88341,88342 2 ADDT'L IHC STAIN X10 88341 19 ADDT'L IHC STAIN X11 88341 4 ADDT'L IHC STAIN X12 88341 3 ADDT'L IHC STAIN X13 88341 26 ADDT'L IHC STAIN X1 88341 43 ADDT'L IHC STAIN X2 88341 22 ADDT'L IHC STAIN X3 88341 39 ADDT'L IHC STAIN X4 88341 22 ADDT'L IHC STAIN X5 88341 17 ADDT'L IHC STAIN X6 88341 14 ADDT'L IHC STAIN X7 88341 23 ADDT'L IHC STAIN X8 88341 8 ADDT'L IHC STAIN X9 88341 7 ADDT'L IHC W/ INTERP X2 88341 1 ADDT'L IHC W/ INTERP X4 88341 2 ADVANCED MELANOMA NGS 81445 2 AML DIAGNOSTIC BY FISH 88374 1 AUTOMATED UROVYSION BY FISH 88121 151 BCL1,T(11;14),FISH 88374 3 BCR/ABL 88374 7 BM MORP.CLOT ONLY- PC 88305,88313 1 BONE MARROW SLIDE CONSULT. 88321 25 BRAF RFLX NEG TO MLH1 81210 1 BRAF SEQUENCING 81210 1 CANCELLED CASE 99999 3 CHRONIC 10 COLOR PANEL 88184,88185,88189 48 CLARIFICATION REQUIRED 99999 7 CLL CANCER NGS PANEL 81450 9 COMP. BONE MARROW REPORT 99999 23 CUTANEOUS IMMUNO 88346,88350 4 EGFR BY NGS 81235 1 FGFR3,RB1,BCL1,P53,1Q21 88367,88373,88374 5 FIP1L1-PDGFRA 88377 3 FISH, FGFR1, 8P11-12 88374 1 GENE FUSION 81449 1 H. PYLORI BY IHC - TC 88342 117 HER-2/NEU, IHC 88361 1 HISTOCHEMICAL STAIN (1)-TC 88313 8 HISTOCHEMICAL STAIN (2) - TC 88313 5 HPV HIGH BY ISH STAIN ONLY 88365 2 HPV HIGH/LOW BY ISH STAIN ONLY 88364,88365 2 IGH, FISH 88377 2 IGH, NGS 81261 9 IGH, PCR 81261 11 IGVH MUTATION ANALYSIS 81263 4 IHC 1 ANTIBODY/STAIN ONLY 88342 28 IHC 2 ANTIBODIES/STAIN ONLY 88341,88342 39 IHC 3 ANTIBODIES/STAIN ONLY 88341,88342 57 IHC 4 ANTIBODIES/STAIN ONLY 88341,88342 69 IHC 5 ANTIBODIES/STAIN ONLY 88341,88342 236 IHC ANTIBODY 2 W/INTERP. 88341,88342 6 IHC ANTIBODY 3 W/INTERP 88341,88342 6 IHC ANTIBODY 4 W/INTERP. 88341,88342 3 IHC ANTIBODY 5 W/INTERP 88341,88342 4 IHC SINGLE AB W/INTER. 88342 3 IMMUNOHISTOCHEMISTRY 99999 13 ISH SINGLE ANTIBODY STAIN 88365 4 MANUAL UROVYSION FISH 88120 3 MM NGS PANEL 81450 2 MSI BY IHC, TC 88341,88342 20 MSI BY IHC 88341,88342 2 ONCOLOGY CHROMOSOME ANALYSIS 88237,88262,88291 23 ONKOSIGHT MPN PANEL 81450 1 ONKOSIGHT MY PANEL 99999 1 ONKOSIGHT MYD88 81305 1 ONKOSIGHT MYELOID DISORDER PANEL 81450 2 OSA MYD88 & CXCR4 81305,81479 1 OSA NGS JAK2/MPL/CALR 81219,81270,81279,81338 1 OSA NGS MYELOID 81450 15 P53/D13S319/ATM/+12 88367,88373 6 PANCREATICOBILIARY NGS 81445 1 PATH CONS ON REF.BLK/SLD GLOB. 88323 11 PATHOLOGY CONSULT 88321 17 PD-L1 22C3 (GI/GE) 88360 1 PD-L1 KEYTRUDA 88360 3 PDGFRB BY FISH 88374 1 PLASMA 10 COLOR 88184,88185,88189 1 PLASMA CELL DYSCRASIA IMMUNO. 99999 1 PML/RARA,T(15;17),FISH 88374 1 PROCESS/HOLD >CYTOG 99999 1 PROCESS/HOLD FOR FISH 88237 14 PROSTATE CANCER (STAIN ONLY) 88344 39 PROSTATE IHC TRIPLE-TC 88344 1 QNT.,RT-PCR,BCR/ABL1 81206,81207 1 SPECIAL STAINS, OTHER 88313,88313 6 STAT REQUEST 99999 4 TCR GAMMA, NGS 81342 5 TCR-GAMMA, PCR 81342 18 TP53 SEQUENCING 81352 1 Michael J. Crescenz VA Medical Center (CMCVAMC): Test Name CPT Historical Annual Volumes ALK by FISH (NSCLC) 88271x2; 88274 33 APL(PML-RARA) Quant 81315 3 B-Cell Gene Rearrangement, PCR 81261 2 BCR-ABL1, CML/ALL, PCR, Quant 81206; 81207 12 Breast IHC P2-IHC 88360x3 1 Breast IHC/FISH Profile 1 88360x1; 88377 3 CALR Mutation Analysis 81219 4 CEBPA Mutation Analysis 81218 4 Chromosome Analysis, Bone Marrow 88237;88264 32 Chromosome, Leukemic Blood 88237; 88264 26 c-KIT Mutation, Liquid Tumor 81272 6 Colorectal Cancer 7 88342; 88341 x3 17 Consult EGL Slides 88323 2 EGFR FISH 88271 (x2) 88274 2 EGFR Mutation Analysis, NSCLC 81235 6 EGFR Mutations 81235;88381 30 Factor II, DNA Analysis #N/A 1 Factor V Leiden Mutation #N/A 1 FISH analyze 100-300 cells additional probes 88275 347 FISH analyze 100-300 cells 1 88275 21 FISH DNA Probe additional probe 88271 116 Flow Comprehensive Screening 88184; 88185x23; 88189 4 Flow Cyto Interp (16+ Markers) 88189 1 Flow Cyto Interp (2-8 Markers) 88187 5 Flow Cyto Interp (9-15 Marker) 88188 4 Flow Cytometry PNH FLAER 88184; 88185x7; 88187 5 Flow Cytometry, Ea Add Marker 88185 16 Flow Cytometry, Ea Add Marker Blood/ Bone Marrow 88185 427 Flow Cytometry, Ea Add Marker Tissue and/or Fluids 88185 111 Flow Cytometry, First Marker 88184 10 Flow Plasma Cell 88184; 88185x16; 88189 13 Flow Tissue/Fluid Tissue and/or Fluids 88184; 88185x18; 88189 54 Flow Tissue/Fluid 8 Color Blood/ Bone Marrow 88184; 88185x23; 88189 114 FLT3 Inter.Tandem Dup(ITD) PCR 81245; 81246 4 Handling/Conveyance of Spec 99001 62 HER2 by FISH 88377 6 HER2 IHC 88360 4 HPV Subtype- 1st probe GLBL 88365 1 IDH1 and IDH2 Mutation, Exon 4 #N/A 1 IgVH Mutation Analysis 81263 7 IHC 1st Antibody - TECH ONLY 88342-TC 900 IHC ea addl AB Stain x1 GLBL 88341- Interpretation 558 IHC ea addl AB Stain x2 TECH 88341-TCx2 6 IHC ea Addl Single - TECH ARUP 88341-TCx1 4 IHC ea Addl Single - TECH Professional 88341-TCx1 50 IHC each Addtl AB - TECH ONLY 88341-TC 2108 IHC Multiplex x1 Tech 88344-TCx1 11 IHC Prog/Pred TS/EGFR/p27/p53 88360 13 IHC Prog/Pred TS/EGFR/p27/p53 88360 1 IHC Tumor Tech Component ONLY 88360-TC 3 IntelliGEN(SM) 81445;88381 1 ISH 1st Probe TECH Only 88365-TC 26 ISH Addtl Probe TECH Only 88364-TC 19 ISH Addtl Probe TECH Only 88364-TC 4 JAK2 Exon 12 Mutation Analysis 81403 5 JAK2 V617F Mutation Detection 81270 25 KRAS Mutation Analysis 81275 5 KRAS Mutation Analysis, CRC 81275 5 Microdissection - Global 88381 6 Microsatellite Instability 81301;88381 2 MM Enrich CMA #N/A 3 Morp Ana, Tumor IHC Manual 88360 1 MPL Mutation Analysis 81402 5 MYD88 L265P Mutation Det. PCR #N/A 6 MYD88 Mutation Detection PCR 81479 2 Myeloid Malignancies Mut NGS #N/A 1 NPM1 Mutation Analysis 81310 5 P53 Mutation Analysis 81404 12 PDGFRA Analysis in GISTs #N/A 1 PD-L1 by IHC (Keytruda (R)) 88342 17 Reveal (R) SNP CMA - Oncology 81406 15 ROS1 Oncology FISH 88271x2; 88275 8 Special Stains-Group II TC 88313-TC 15 T-Cell Gene Rearrangement, PCR 81340; 81342 5 TCRB Gene Clonality #N/A 2 SECTION B SAMPLE SUPPLIES OR SERVICES AND PRICE The Government is exploring the possibility of procuring testing services on a fixed-price basis per month.). We believe this will help the Government simplify the ordering process for testing services and reduce certain administrative burdens. We are seeking your input regarding this idea. Specifically, we would like to hear your thoughts regarding whether this pricing structure is standard industry practice for these testing services (i.e., whether you are aware if this type of pricing methodology is utilized in the commercial sector). If you do not believe the fixed-monthly pricing approach can be considered a customary commercial practice, please explain why (and describe the various customary ways this service is priced). Additionally, we are soliciting any suggestions for an alternative type of pricing structure. For any recommendations about alternative pricing methodologies, please explain the basis for why the recommendation is consistent with customary commercial practice. Finally, if the Government were to proceed with the contemplated pricing arrangement, please indicate how likely you would be to submit a proposal in response to a solicitation that includes this type of fixed-monthly pricing structure. B.1 SAMPLE PRICE SCHEDULE Note: This is just a sample price schedule to showcase the Monthly Firm-Fixed Priced CLIN and subsequent information SLINs. Any resultant solicitation, when based on this pricing methodology, will include both VA facilities CLINS and all the potential tests as information SLINs underneath each CLIN (refer to full test listing attachment to this Source Sought Notice within the Performance Work Statement). ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 12.00 MO $_________________ $_________________ Anatomic Pathology Testing Services for Wilkes Barre VAMC. Contract Period: Base POP Begin: 06-28-2023 POP End: 06-27-2024 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing MANUFACTURER PART NUMBER (MPN): Various LOCAL STOCK NUMBER: Various 0001AA EA $_________________ +8,-5/5Q-,-7/7Q-,20Q-, FISH; 88367,88373,88374 Contract Period: Base POP Begin: 06-28-2023 POP End: 06-27-2024 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing MANUFACTURER PART NUMBER (MPN): Various LOCAL STOCK NUMBER: Various 0001AB EA $_________________ -7/7Q- BY FISH; 88374 Contract Period: Base POP Begin: 06-28-2023 POP End: 06-27-2024 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Laboratory Testing MANUFACTURER PART NUMBER (MPN): Various LOCAL STOCK NUMBER: Various 0002 12.00 MO $_________________ $__________________ Anatomic Pathology Testing Services for Philadelphia VAMC Contract Period: Base POP Begin: 11-01-2023 POP End: 10-31-2024 0002AA EA $_________________ ALK by FISH (NSCLC); 88271x2; 88274 Contract Period: Base POP Begin: 11-01-2023 POP End: 10-31-2024 0002AB EA $_________________ APL(PML-RARA) Quant; 81315 Contract Period: Base POP Begin: 11-01-2023 POP End: 10-31-2024 GRAND TOTAL $_________________