GENERAL INFORMATION FOLLOWED BY A TENTATIVE STATEMENT OF WORK NOTICE: This is not a solicitation but rather a Request for Information (RFI) (Sources Sought) to determine capability of potential sources and is for information and planning purposes only. Veterans Health Affairs, Network Contracting Office 4, is issuing this request for information/sources sought notice in order to identify capable small businesses firms to perform services for the Wilkes-Barre VA Medical Center (WBVAMC) located at 1111 East End Boulevard, Wilkes-Barre, PA 18711. Responses must be submitted by 4:00 PM (EST) March 10, 2017. Submit responses to the information requested above via email to [email protected] . All small business firms that respond shall include proof of small business status via their Representations and Certifications (per FAR 4.1102 Policy), and as part of their response a brief capability statement that covers the information in the following tentative statement of work. The results of this market research will assist in the development of (1) the requirement, and (2) the acquisition strategy (e.g., socioeconomic set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses. TENTATIVE STATEMENT OF WORK Specialized Services and Testing for Anatomic Pathology and 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 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 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 3PM 4PM. Vendor may transport specimens by courier only. Pick-up of specimens will be from the Histology Laboratory, currently located on 1st Floor, room N1-96A. Location of the Histology Laboratory may change. Pick-up location will change with any moves of the laboratory. 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. 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) 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 Results will be available within the listed turnaround times 90% of the time. Turnaround time will be from the time the specimen leaves the Wilkes-Barre VAMC Laboratory. Test Name Turnaround Time (TAT) TAT is in Business Days Immunohistochemical Stains 1 Day with slides to be read (Not images) Flow Cytometry 1 Day Morphology 2 Days FISH 3 Days Cytogenetics 7 Days Molecular 5 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 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 100 Flow Cytometry, TC, additional markers 88185 50 Flow Cytometry, Interp for 2-8 markers 88187 50 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 2 Plasma Cell Myeloma Panel, TC 88184 X1, 88185 X11 8 Lymphoproliferative Panel, TC 88184, 88185 X17 12 Myeloid/ Lymphoid Panel, TC 88184 X1, 88185 X27 20 PNH Flae, Global 88184 X1, 88185 X6, 88187 2 Plasma Cell Myeloma Panel, Global 88184 X1, 88185 X 11, 88188 8 Myeloid & Lympoid 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 3 Breast marker analysis, Global, manual 88360 3 Breast Marker analysis, TC, computer assisted 88361-TC 3 Breast marker analysis, Global, computer assisted 88361 3 ER/ PR, TC 88361 -TC X 2 10 ER/ PR/ HER2, TC 88361-TC X 3 20 HER2 by IHC, TC 88361-TC X 1 35 Microsatellite Stability (MSI), TC 88342-TC X 4 1 ER/ PR, Global 88361 X 2 1 ER/ PR/ HER2, Global 88361 X 3 1 HER2 by IHC, Global 88361 X 1 35 Microsatellite Stability (MSI), TC 88342 X 4 1 FISH, imaged, TC 88367 -TC 53 FISH, Global 88367 50 FISH, manual, TC 88368-TC 20 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 25 MDS Panel, TC 88367-TC X 4 5 CLL Prognostic FISH Panel, TC 88367-TC X 4 15 Plasma Cell Myeloma FISH Panel, TC 88367 - TC X 8 15 BCR/ ABL, Global 88368 X 2 35 HER2 by FISH, Global 88367 x 2 15 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 15 BCR/ ABL by RT-PCR 81206 X 1, 81207 X 1 25 BRAF V600E variant 81210 X 1 20 EGFR gene analysis 81235 X 1 20 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 40 MSI 81301 X 1 5 UroVysion FOR Bladder Cancer, TC 88121- TC X 1 10 Tumor Genotyping 81210 X 1, 81235 X 1, 81275 X 1, 81403 X 2, 81323 X 1, 81404 X 3 10 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 3 Decalcification 88311 X 1 1 Bone Marrow,m smear interpretation 85097 X 1 15 Surgical Pathology Gross and Micro 88305 X 1 1 Slide consult (prepared elsewhere) 88321 X 1 10 Slide consult comprehensive (prepared elsewhere) 88325 X 1 10 Blood Smear, peripheral 85060 X 1 2 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 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%. 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

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