Q301--Anatomic Pathology

DISCLAIMER: THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS SYNOPSIS IS NOT A REQUEST FOR QUOTE, PROPOSAL, OR BID. This notice is not a solicitation as defined by FAR 2.101, therefore it shall not be construed as a commitment by the Government to enter into a contract, nor does it restrict the Government to an acquisition approach. All information contained in this Request for Information (RFI) is preliminary as well as subject to amendment and is in no way binding on the Government. Information submitted in response to this notice is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. The Government is requesting that restrictive or proprietary markings not be used in response to this notice. If a solicitation is released, it will be synopsized in the Federal Contract Opportunities website or GSA. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this RFI. STATEMENT OF WORK Routine and Specialized Services and Testing for Anatomic Pathology and Cytology Specimens Contractor shall provide all employees, supervision, supplies and equipment necessary to perform routine and specialized services for Anatomic Pathology specimens to include Immunohistochemistry Stains, Cytochemical Stains, Flow Cytometry, FISH testing, Cancer Marker Testing, and other esoteric testing for the Michael J. Crescenz VA Medical Center (CMCVAMC) located at 3900 Woodland Ave., Philadelphia, PA 19104. The term of this contract will be a base plus 4 option years. The CMCVAMC will package specimens according to the guidelines required by the contractor. Contractor shall provide all necessary supplies for biomedical materials to be transported from the CMCVA Medical Center, 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 ensure the security of the specimen contains and protect against the accessibility of the specimens and the information that accompanies the specimens. Routine transportation services shall occur once per day, Monday Friday, except for Federal Holidays. 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. All Blocks and prepared slides will be returned to the 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. Contractor must provide a phone number for consultation Pathology services regarding test results. Services will be minimally Monday through Friday, excluding Federal Holidays, 9AM 5PM. Contractor test reports must contain the following information at a minimum: Patient s full name Patient s identification number (e.g., social security number/ DOB) Physician s name VA Surgical Pathology accession number Submitting Laboratory Name Submitting facility account number Patient s location (clinic/ ward) Tests(s) ordered. Date/ time of specimen collection Date/ time test completed. Test result Reference intervals (if applicable adjusted for age, sex or race) Interpretation of Results if applicable Name and address of testing laboratory Any other information the laboratory has that may indicate a questionable validity of test results. Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing. 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. Results will be available within the listed turnaround times. Turnaround time will be from the time the specimen leaves the CMCVAMC Laboratory 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 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 In addition to routine GI, GU and GYN anatomic pathology support the 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: TEST_NAME CPT TOTAL ESTIMATED ANNUAL QUANTITY 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 additonal 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 Quality Assurance Monitoring Contractor must have and maintain licensure and certifications required to operate its laboratory. Monitoring of contractor s performance shall be demonstrated through clinical and administrative record reviews. Services will be monitored through one or a combination of the following mechanisms: Surgical Pathology/ Cytology Department will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Services such as: Specimen pick-up is minimally daily and not earlier than 5PM. Compliance rate for this is minimally 90%. Turn-around times for resulting of tests are at a minimal compliance rate of 90%. Documentation of services performed will be reviewed prior to certifying payment. VA will pay only for services actually provided, and in accordance with the pricing schedule. Quality Factors that will be monitored. PERFORMANCE OBJECTIVE TASKS: PERFORMACE STANDARD ACCEPTABLE (MINIMAL) QUALITY LEVEL MONITORING METHOD Ensure the safety and integrity of specimens No loss or destruction of specimens 100% of the time Contractor reporting; Government inquiries Testing services will be performed in accordance with the defined turnaround times (TAT) Results will be reported within the TAT as stated in the contract 90% of the time 10% of randomly selected tests Pick-up times for specimens are within the designated times +/- 30 min Contractor pick-up specimens with the designated time +/- 30 min 90% of the time Direct Observation 3. Responses Requested: The following questions must be answered in response to this RFI. Answers that are not provided shall be considered non-responsive to the RFI: a. Are they FDA approved. Vendor must attach documentation of this information to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice. Vendor must attach documentation of this to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice. c. Is the Vendor an authorized distributor services which may be required in performance of this requirement? d. Name of potential Contractor that possess the capability to fulfill this requirement. Contractors shall also provide the following: Point(s) of contact name: _______________________________________________ Address: ___________________________________________________ Telephone number: ___________________________________________ Email address: _______________________________________________ Company's business size: ________________________________________________ SAM UID#: _______________________________ e. Is your company considered a small business concern, SB, SDVOSB, VOSB, HUBZone, or 8A concern, with the requisite 621511 Medical Laboratories NAICS code? Please provide proof of qualifications. f. Is your company available under any Government Wide Agency Contract (GWAC), General Services Administration (GSA) Schedule, Indefinite Delivery Indefinite Quantity (IDIQ), and/or Blanket Purchase Agreement (BPA)? If so, please identify the contract number for the Government to review as part of this Market Research. 4. Opportunity/Market Pricing: The PVAMC is seeking information from potential vendors on their ability to provide the required items/service. THIS IS A SOURCES SOUGHT REQUEST FOR INFORMATION (RFI) ONLY. Small Business Concerns are encouraged to provide responses to this RFI in order to assist the PVAMC in determining potential levels of competition and general market pricing available in the industry. Therefore, vendors are requested to submit estimated market research pricing along with their responses to the above. The estimated pricing will be considered when determining the procurement strategy for the forthcoming solicitation. 5. Instructions and Response Guidelines: Questions regarding this RFI shall be submitted no later than 12:00pm (EST), August 22, 2023, via email to debra.willard@va.gov no phone calls excepted. 7. Contact Information: Debra Willard debra.willard@va.gov Your response to this notice is greatly appreciated!