Q301--Anatomic Pathology Services (Wilkes Barre)

This is a SOURCES SOUGHT NOTICE only. Responses to this notice will be used for information and planning purposes. No quotes are being requested or accepted at this time with this notice. The Department of Veterans Affairs has a request for information (36C24423Q0650) for Specialized Services and Testing for Anatomic Pathology & Cytology Specimens for Wilkes Barre VAMC. The station is not to be contacted; all responses and communication MUST go through Amanda Saunders at via email: Amanda.Saunders@va.gov The North American Industry Classification System (NAICS) code being considered for this procurement is 621511 Medical Laboratories and the Product Service Code (PSC) is Q301 Medical Laboratory Testing Below is a draft copy of the Performance Work Statement Responses to this notice should include the following: Company Name Unique Entity Identifier (UEI) Data Universal Numbering System (DUNS) Number Company s address Point of

Contact information (i.e. title, phone number and email address) Company s capability to meet this requirement and any pertinent information which demonstrates the company s ability to meet the above requirements. GSA Federal Supply Schedule contract number, if within scope of this effort (if applicable- Identify and report if ALL tests in Attachment 1 are on your schedule OR if only a portion of them). 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. 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. 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 Example: Specialized Services and Testing for Anatomic Pathology & Cytology Specimens Company s type of business (small or large) and socioeconomic status whether Service Disable Veteran Owned, Veteran Owned, Hubzone, 8(a), Women Owned, Small Disadvantaged, etc. If applicable, Service-Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) must be verified in www.VetBiz.gov , and be able to meet the limitation on subcontracting in accordance with 13 CFR 125.6; if applicable. All responses shall be submitted in writing via email no later than 15:00 EST, on April 3rd, 2023, to Mrs. Amanda Saunders at Amanda.Saunders@va.gov SUBJECT LINE: Specialized Services and Testing for Anatomic Pathology & Cytology Specimens E-mail: Amanda.Saunders@va.gov. Facsimile or telephonic responses will not be accepted. Simply responding as an interested party in beta.SAM.gov does not constitute your company as a source. Offeror must provide the above requested information. After review of the responses to this sources sought notice, a solicitation announcement may be published in the near future. Responses to this sources sought announcement are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the forthcoming solicitation announcement, in addition to responding to this sources sought notice. All interested parties must be registered with System for Award Management (SAM) at beta.SAM.gov in order to be eligible for award of Government contracts. Performance Work Statement Specialized Services and Testing for Anatomic Pathology & Cytology Specimens Contractor shall provide all employees, supervision, supplies and equipment necessary to perform specialized services for Anatomic Pathology specimens to include Immunohistochemistry Stains, Cytochemical Stains, Flow Cytometry, FISH testing, Cancer Marker Testing and other estoteric testing for the Wilkes-Barre VA Medical Center (WBVAMC) located at 1111 East End Boulevard, Wilkes-Barre, PA 18711. The government is seeking a monthly firm-fixed price, five (5) year BPA. The term of this contract shall begin: Base 06/28/2023 to 06/27/2024 Option 1 06/28/2024 to 06/27/2025 Option 2 06/28/2025 to 06/27/2026 Option 3 06/28/2026 to 06/27/2027 Option 4 06/28/2027 to 06/27/2028 The WBVAMC 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 VA 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. Specimens will be sent along with a copy of the VA Standard Form 515, which will contain all the patient and specimen information. Contractor must provide documentation of a current CLIA License for the testing provided. 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 Laboratory. The Reference Laboratory must be Accredited by either the College of American Pathologist or The Joint Commission. A copy of this accreditation must be provided to the VA Medical Center Laboratory. Contractor must ensure the security of the specimen contains and protect against the accessibility of the specimens and the information that accompanies the specimens. 7. Routine transportation services shall occur once per day, Monday Friday, except for Federal Holidays. Specimen pick-up times will be late afternoon between 3PM 4PM. 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 A3-55. Location of the Histology Laboratory may change. Pick-up location will change with any moves of the laboratory. 8. All Blocks or slides will be returned to the 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 materials shall be returned within 7 days after final diagnosis is reported. 9. 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. Federal Holidays are as follows: New Year s Day, Martin Luther King, Jr. s Birthday, Washington s Birthday, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day designated as a holiday by the Federal Government during the course of the year. 10. 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 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 with a courier or alternately faxed to 570-819-5115. An on-line account for the Pathologists should also be made available if possible. On-line account is not a mandatory requirement. 11. Results will be available within the listed turnaround times. Turnaround time will be from the time the specimen leaves the Wilkes-Barre VAMC Laboratory Test Name Turnaround Time Flow Cytometry 3 Days Morphology 5 Days FISH 6 Days Cytogenetics 8 Days Molecular 8 Days 12. 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 13. 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/ Profile CPT Code Projected Annual Volume Flow Cytometry, TC, first marker 88184 50 Flow Cytometry, TC, additional markers 88185 25 Flow Cytometry, Interp for 2-8 markers 88187 14 Flow Cytometry, Interp 9-15 markers 88188 30 Flow Cytometery, Interp 16+ markers 88189 30 Flow Cytometry, DNA analysis, TC 88182 10 PNH Flaer, TC 88184 X1, 88185 X 6 8 Plasma Cell Myeloma Panel, TC 88184 X1, 88185 X11 8 Lymphoproliferative Panel, TC 88184, 88185 X17 10 Myeloid/ Lymphoid Panel, TC 88184 X1, 88185 X27 20 PNH Flae, Global 88184 X1, 88185 X6, 88187 5 Plasma Cell Myeloma Panel, Global 88184 X1, 88185 X 11, 88188 8 Melanoma NGS Panel 81210 X 1, 891235 X 1, 81275 X 1, 81403 X 1, 81404 X 2 10 Myeloid & Lymphoid Analysis 88184 X1, 88185 X13, 88188 12 Lymphoproliferative Panel, Global 88184 X1, 88185 X 17, 88189 20 Myeloid/ Lymphoid Panel, Global 88184 X 1, 88185 X27, 88189 8 Cytogenetics 88237 X1, 88262 X 1 50 Array CGH Molecular Karotyping 81228 35 Immunohistochemistry, first antibody, TC 88342-TC 500 Immunohistochemistry, Global 88342 500 Immunohistochemistry, TC, each additional antibody 88341 150 Immunohistochemistry, Global, each additional 88341 150 Special Stain (eg, iron, trichrome), TC 88313-TC 25 Special Stain (eg, iron, trichrome), Global 88313 25 Breast Marker analysis, TC, manual 88360-TC 5 Breast marker analysis, Global, manual 88360 5 Breast Marker analysis, TC, computer assisted 88361-TC 5 Breast marker analysis, Global, computer assisted 88361 5 ER/ PR, TC 88361 -TC X 2 5 ER/ PR/ HER2, TC 88361-TC X 3 5 HER2 by IHC, TC 88361-TC X 1 35 Microsatellite Stability (MSI), TC 88342-TC X 4 15 ER/ PR, Global 88361 X 2 10 ER/ PR/ HER2, Global 88361 X 3 10 HER2 by IHC, Global 88361 X 1 35 HER2 FISH Gastric Cancer 88374 X 1 5 Microsatellite Stability (MSI), TC 88342 X 4 10 FISH, imaged, TC 88367 -TC 50 FISH, Global 88367 50 FISH, manual, TC 88368-TC 10 FISH, Global 88368 10 ISH, each probe, TC 88365-TC 40 ISH, Global 88365 40 BCR/ ABL, TC 88367-TC X2 30 HER2 by FISH, TC 88367-TC X2 20 MDS Panel, TC 88367-TC X 4 5 CLL Prognostic FISH Panel, TC 88367-TC X 4 10 Plasma Cell Myeloma FISH Panel, TC 88367 - TC X 8 10 BCR/ ABL, Global 88368 X 2 30 HER2 by FISH, Global 88367 x 2 10 EML4-ALK, Global 88368 X 2 10 MDS Panel, Global 88368 X 4 10 CLL Prognostic FISH Panel, Global 88368 x 4 10 Plasma Cell Myeloma FISH Panel, Global 88368 x 8 20 BCR/ ABL by RT-PCR 81206 X 1, 81207 X 1 25 BRAF V600E variant 81210 X 1 3 EGFR gene analysis 81235 X 1 10 IgVH 81263 X 1 2 JAK2 exon 12 sequence 81403 X 1 5 JAK2 gene analysis 81270 X 1 45 KRAS 81403 X 1, 81275 X 1 10 MSI 81301 X 1 5 UroVysion FOR Bladder Cancer, TC 88121- TC X 1 25 Colon NGS Panel 81210 X 1, 81235 X 1, 81275 X1, 81403 X 1, 81404 X 2 10 Solid Tumor NGS Panel 81210 X 1, 81403 X 4, 81235 X 1, 81402 X 1, 81275 X 1, 81404 X 4, 81405 X 1 10 Meyloid Disorders NGS Panel 81401 x 1, 81210 X 1, 81403 X 6, 81245 X 1, 81270 X81402 X 2, 81275 X 1, 81310 X 1, 81404 X 1, 81405 X 1 10 Tumor Genotyping 81210 X 1, 81235 X 1, 81275 X 1, 81403 X 2, 81323 X 1, 81404 X 3 50 Tumor Genotyping for Lung 81210 X 1, 81235 X 1, 81275 X 1, 81403 X 2, 81323 X 1, 81404 X 3, 88342 X 1, 88368 X 2 25 Decalcification 88311 X 1 10 Bone Marrow, smear interpretation 85097 X 1 30 Surgical Pathology Gross and Micro 88305 X 1 100 Immunofluorescence per specimen, add N proc, Global 88350 10 Immunofluorescence each Ab, Direct 33846 10 Electron Microscopy, Global 88348 10 MDS NGS Panel 81479 X 4, 81403 X 3, 81270 X 1, 81275 X 1, 81404 X 1 10 AML NGS Panel 81479 X 4, 81403 X 4, 81245 X 1, 81246 X 1, 81402 X 1, 81275 X 1, 81310 X 1, 81404 X 1 10 Lung NGS Panel 81210 X 1, 81235 X 1, 81275 X 1, 81479 X 2, 81403 X 1, 81404 X 1, 81405 X 1 10 MPN NGS Panel 81401 X 1, 81479 X 4, 81270 X 1, 81403 X 2, 81402 X 1 10 Slide consult (prepared elsewhere) 88321 X 1 20 Slide consult comprehensive (prepared elsewhere) 88325 X 1 2 Blood Smear, peripheral 85060 X 1 2 Bone Marrow Comprehensive: Core, Clot, Smears 88313 X4, 88311 X1, 85097 X 1, 88305 X 2 50 Bone Marrow Clot only 88305 X1, 88313 X2 10 Bone Marrow Core Only 88305 X 1, 88313 X 2, 88311 X 1 8 Histology Processing 88305 1 Imaged PAP 88175 10 HPV Plus 87621 10 DNMT3A 81403 2 FLT3 81245, 81246 2 IDH1 81403 2 IDH2 81403 2 KIT 81402 2 MPL 81402, 81403 2 NPM1 81310 2 NRAS 81404 2 TP53 81405 2 ASXL1 81479 2 DNMT3A 81403 2 EZH2 81479 2 RUNX1 81479 2 TET2 81479 2 SF3B1 81479 2 CALR 81479 2 CTNNB1 81403 2 PDGFRA 81404 2 PIK3CA 81404 2 RET 81404 2 TP53 81405 2 MET 81479 2 ERBB2 81479 2 Quality Assurance Surveillance 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 3PM. Compliance rate for this is minimally 90%. Turn-around times for resulting of tests are at a minimal compliance rate of 90%. Quality of the slides and reports will be monitored by the pathologists 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 Quality of the slides and reports must be adequate Pathologists will review the slides and reports to ensure adequacy for making a diagnosis 100% of the time the quality will be maintained Reading of slides and reports 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