Department of Veterans Affairs Veterans Health Administration Sources Sought Notice - Cytopathology and Surgical Pathology Consultative Services This is a Sources Sought notice and not a request for quotes. This request is solely for the purpose of conducting market research to enhance VHA's understanding of your company's offered services and capabilities. The Government will not pay any costs for responses submitted in response to this Sources Sought Notice. This Sources Sought notice provides an opportunity for respondents to submit their notice of ability, and their available products in response to the requirement described below. Vendors are being invited to submit information relative to their potential of fulfilling the requirement below, in the form of a capability response that addresses the specific requirement identified in this Sources Sought. The Veterans Health Administration (VHA) is seeking a vendor to provide consultative services for selected cytopathology and surgical pathology cases and selected clinical laboratory tests. This would include associated services needed to complete the consultation, listed in Attachment A with estimated volumes. Refer to the General Requirements section below for the requested service description. This Sources Sought is to facilitate the Contracting Officer's review of the market base, for acquisition planning, size determination, and procurement strategy. General Requirements: The Contractor Laboratory shall provide the following services: 1. Shall perform consultation services entirely upon their premises. 2. Shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations. 3. Provide consultation report that includes the laboratory's name that performed the consultation, laboratory specific accession number, the date and time a specimen was collected, received by the laboratory and completed, and the pathologist signature and technologist initials, where appropriate. 4. Provide faxed test results as well as hard copy to the requesting VA laboratory within 48 hours of receipt. 5. The contractor laboratory shall not release patient's records that include test results, without the specific written consent to release such information as provided by the patient, to any person other than the ordering healthcare provider or designee. All member records shall be treated as confidential so as to comply with all state and federal laws regarding the confidentiality of patient's records. This provision shall survive termination of the resulting contract award. 6. Shall certify and ensure that all employees, officers, or agents do not use Protected Health Information received from any VAMC site that would constitute a violation of any applicable provision in standards set forth in the Health Insurance Portability and Accountability Act (HIPAA). ? Licensing and Accreditation - Contractor Laboratory: 1. Shall have all licenses, permits, accreditation certificates required by Federal law and State law in the states of MA, ME, RI, CT, VT and NH. 2. Shall be accredited by the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988 (CLIA) or the College of American Pathologists (CAP). Copies of all professional certifications, licensures and renewal certifications will be provided and updated as needed to the Contracting Officer. To include the contractor laboratory's Laboratory Director and/or Medical Director. 3. Medical Director must have suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP standards. 4. Contractor Personnel assigned by the Contractor to perform the services covered by this contract shall be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board. 5. Must submit a copy of the professional certification and/or licensure of the Laboratory Director and/or Medical Director with the proposal. 6. Must comply with the regulatory requirements of the Centers for Medicare & Medicaid Services (CMS). 7. Must notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure. Quality Control: 1. The contractor must operate a successful quality control program as required by CLIA and CAP. Services are to be performed in accordance with this PWS. The quality control program must include procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor's quality control program is the means by which the contractor laboratory assures that work complies with the requirement of the contract. A quality control program will be submitted as part of an offer and put into place upon final contract award. After acceptance of the quality control plan the contractor shall receive the contracting officer's acceptance in writing of any proposed change to this QC system. 2. The VA will maintain an Internal Quality Control Program to monitor the quality of test results received from Contractor Laboratory. Locations: The following VA Medical Centers plan on utilizing these services: o VA Boston, 1400 VFW Parkway, West Roxbury, MA 02132 o VA Togus, 1 VA Center, Augusta Me, 04330 o VA Manchester, 718 Smyth Road, Manchester, NH 03104 o VA White River Junction, 215 North Main Street, White River Junction, VT 05009 o VA Providence, RI, 830 Chalkstone Ave, Providence, RI 02908 o VA Connecticut, West Haven Campus, 950 Campbell Ave, West Haven, CT 06516 ? RESPONSE COMMITMENT I. NOTES: A. All questions, comments or concerns shall be directed to [email protected] B. Submittals furnished will not be returned to the sender. No debriefs will be conducted. Eligibility to participate in a future acquisition does not depend upon a response to this notice. C. Proprietary information is neither requested nor desired. If such information is submitted, it must clearly be marked "proprietary" on every sheet containing such information, and the proprietary information must be segregated to the maximum extent practicable from other portions of the response (e.g., use an attachment or exhibit). II. TIMELINE: A. This request will close on stated date within the FBO site. III. Requested information: Interested parties shall provide the following information in addition to your capability response: A. Format: 1. MS Word or pdf format (please ensure email is under 5 mb) 2. Page limit - 2-4 pages (please make the response as brief and concise as possible) 3. Company name and Sources Sought number listed on each page B. Specifics: 1. In your response, please provide the following information based on the requirement. a. Your company's capability of fulfilling this requirement as it is described. 2. Please also provide name of company, company address, a contact person's name, telephone number, fax number and email address. 3. DUNS number, and indicate if actively registered on System for award management (SAM) 4. Contractual vehicles the company holds, such as NAC or GSA schedules. 5. Socio-economic Status & NAICS Code: State the size of your company [e.g., 8(a) (including graduation date), HUBZone-certified small business, Service- Disabled Veteran-Owned small business, small business, large business, etc.]. ? Notes: 1. This Sources Sought is for planning purposes only, and does not constitute a commitment, implied or otherwise, that a procurement action will follow. The Department of Veterans Affairs will use the information submitted in response to this notice at its discretion and will not provide comments to any submission; however, The Department of Veterans Affairs reserves the right to contact any respondent to this notice for the sole purpose of enhancing The Department of Veteran Affairs understanding of the notice submission. 2. The content of any responses to this notice may be reflected in any subsequent solicitation, except for content marked or designated as business confidential or proprietary which will be fully protected from release outside the government. The Department of Veteran Affairs Contracting Office Point of Contact: Valerie DeAngelis Contract Specialist Email: [email protected] ? Attachment A - Estimated Annual Usage Based on Fiscal Year 2014 data Surgical Pathology - Technical Component Cost Per Test Code Estimated Units Description Surgical Pathology 88305 36 Immunoflourescence 88346 330 Immunocytochemistry 88342 16 Electron Microscopy 88348 27 Special Stain 88312 2 Special Stain 88313 77 Special Stain 88314 24 Determ Histoche- muscle biopsy 88319 34 Surg path (margins reviewed) 88307 2 In Situ Hybridization 88365 Surgical Pathology - Professional Component Surgical Pathology 88305 34 Immunoflourescence 88346 349 Immunocytochemistry 88342 11 Electron Microscopy 88348 26 Special Stain 88313 81 Special Stain 88314 9 114.40 Slide Consultation 88321 18 Surg Path, Gross/Micro level V 88307 1 Determinative Histochemistry 88319 9 Special Stains (SEP) 88312 4 Clinical Pathology Factor VIII Assay 85240 1 B Cell Total 86355 T Cell Total 86359 Absol CD4 & CD8 86360 Nat Killers 86357 Flow Cytometry Tech 88184 Flow Cytometry Tech 88185 Platelet Aggregation 85576 x 6 Ristocetin 85576 x 5 ANA titer 86039 5 NRNP 86235 3 SM 86235 3 SS-A 86235 3 SS-B 86235 3 Anti-DS-DNA 86225 4 Carboxyhemoglobin 82375 Methemoglobin 83050 ANA-Hep 2 substrate (screen) 86038 10 Factor IX assay 85250 1 Factor V Assay 85220 Factor X Assay 85260 Factor II assay 85210 Factor VII assay 85230 Factor XI assay 85270 1 Methotrexate 80299 10

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