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FBO DAILY - FEDBIZOPPS ISSUE OF FEBRUARY 26, 2015 FBO #4842
DOCUMENT

66 -- SIN 621-200 Anatomic Pathology and SIN 621-202 Cytogenetics Cost-Per-Test Coverage in New England Region for Veterans Affairs Medical Centers - Attachment

Notice Date

2/24/2015
 

Notice Type

Attachment
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Veterans Affairs;VA Boston Healthcare System;Contracting Officer (90C);940 Belmont Street;Brockton MA 02301
 

ZIP Code

02301
 

Solicitation Number

VA24115Q0234
 

Response Due

3/5/2015
 

Archive Date

3/15/2015
 

Point of Contact

Heather Simpson, Contract Specialist
 

Small Business Set-Aside

N/A
 

Description

Department of Veterans Affairs Veterans Health Administration, Network Contracting Office 1, New England Sources Sought Notice - SIN 621-200 Anatomic Pathology & 621-202 Cytogenetic 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. 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 vendor(s) to provide the following services for the list of test codes, as stated in Attachment A. The contractor shall provide the following services: 1.Diagnostic Immunohistochemistry markers- technical component only 2.Immunohistochemistry morphometric analysis, tumor immunohistochemistry quantitative or semi quantitative- technical component only. 3.Immunohistochemistry markers- technical component only specific for colorectal cancer. 4.Cytogenetic Karyotype and FISH testing services. This would also include consultative services and associated services to complete the consultation. If analysis cannot be performed due to culture failure then only a culture fee will be charged rather than a fee for a completed analysis. 5.ERCC1 - Lung carcinoma marker testing services 6.Her2 by FISH testing services 7.In situ Hybridization testing services 8.Molecular Diagnostics for KRAS mutation analysis and microsatellite Instability by PCR. 9.Support West Roxbury pathology lab during times when high volume and/or staffing shortages. West Roxbury pathology lab serves as the consolidated lab in VISN 1 for special stains, immunohistochemistry markers and flow cytometry. The Contractor shall be responsible for the pick-up and transportation of specimens to the contractor's laboratory. The contractor shall be responsible for transporting in such a manner as to ensure the integrity of the specimen. The contractor shall supply special preservatives as required for specimen preservation and packing material capable of maintaining temperature requirements for specimens until they reach the Contractor's laboratory under the terms of this agreement. The Contractor shall provide return transportation of specimens/slides to the ordering site when required such as slides designated as technical components only. Locations Include: VA Boston HCS, West Roxbury Campus, 1400 VFW Parkway, West Roxbury, MA 02132 VA Connecticut HCS, West Haven Campus, 950 Campbell Ave., West Haven, CT 06516 VA Providence, 830 Chalkstone Avenue, Providence, RI 02908 VA Maine HCS, 1 VA Center, Augusta, ME 04330 VA White River Junction, 215 North Main Street, White River Junction, VT 05009 VA Manchester, 718 Smyth Road, Manchester, NH 03104 The Contracting Laboratory: 1.Shall perform consultation and technical services entirely upon their premises. 2.Contractor's Medical Staff will be available to VISN 1 as a resource for education about disease conditions and testing options. 3.Hard copy results and consultative reports shall provide individual patient-chartable test result reports meeting CLIA requirements and must be electronically transmitted to each POC for local printing. Printed reports will include: "The name and address of the contract laboratory where each test was performed "The specimen accession number of the contract laboratory "The name of the contract Laboratory Director or Medical Director "The date and time a specimen was received by the laboratory and completed "The pathologist or technologist signature as appropriate "A phone number to contact the Contract Laboratory concerning the test results "The Contract Laboratory's CLIA certification number "The patient's name "The patient's SSN "The patient's age or date of birth "The patient's sex "The Medical Center/CBOC specimen identification number "The specimen collection date "The Contractor's report date and time "The test name "The test result(s) "The unit of measurement for quantitative tests "The normal or expected range (reference range adjusted for age, sex, or race when appropriate). "The report status (i.e., final or interim) "Other interpretive information appropriate for the test(s) "CPT code 4. In cases of malfunction of the Contractor-supplied electronic reporting method lasting more than 24 hours, the Contractor must, without additional charge, provide express overnight shipping or courier delivery of printed reports to each POC until the auto- mated information system is properly functioning. 5. Must provide running history for lab results by patient when requested. 6. Must provide appropriate requisition forms and unique supplies needed for special- ized collection of samples at no additional charge. 7. Slides designated as technical component only- Slides will be made, stained and shipped back to the sending site on the same day they were received at Contractor's Lab. 8. Shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations. 9. 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's signature. 10. Must certify and ensure that all employees, officers, or agents do not use Protected Health Information received from any VISN 1 site that would constitute a violation of any applicable provision in standards set forth in the Health Insurable Portability and Accountability Act (HIPAA). 11. Must accept specimens on Monday through Saturday, 7am - 6pm EST. Contractor will designate shipping vendor which will pick up specimens at sites included in this agreement during normal working hours. Contractor laboratory must be able to accept and process specimens upon delivery by shipping vendor. Normal working Hours are 7am to 6pm. 12. If lab results are not performed within the attached timeframe, it is up to the COR, to be named, to track the late results and track specific instances in the Quality Assurance Worksheet for Quest to review. 13. Test result and/or report corrections shall be made with corrected reports sent to the ordering location within 3 business days of correction request. 14. The Contractor shall notify the originating laboratory by telephone of specimens not processed due to unacceptability (e.g. volume, specimen container, identification, loss of specimen, etc.). 15. The contractor shall, upon completion of testing, retain all specimens as required by regulatory agencies. Upon request by the ordering activity COR or designee, the contractor shall provide a copy of the regulatory requirements for each participating regulatory agency. 16. The contractor shall contact the facility POC within a minimum of 5 calendar days after Award to coordinate the furnishing and delivery of specimen collection and trans-portation supplies, and any communication connections or equipment that might be required. The facility POC will request replenishment of supplies from the contractor on an as needed basis. LICENSING AND ACCREDITATION- CONTRACTING LABORATORY 1.Must maintain all licenses, permits, accreditation certificates required by law. 2.Must be accredited by the CLIA or the College of American Pathologists. 3.Medical Director must be licensed Physician with suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP standards. 4.Copies of the professional certification and/or licensure of the Laboratory Directors and/or Medical Directors must be provided by Contracting Lab. 5.Must comply with the regulatory requirements of the Centers for Medicare and Medicaid Services (CMS). SERVICE: 1.CONTRACTING LABORATORY must provide a current Laboratory Manual containing the following information: "Department hours of operation "Accreditation "Technical Staff "Service Departments (Method of contracting, phone numbers, hours of availability) "Quality Assurance Information such as but not limited to specimen labeling and rejection criteria "Billing Procedures & fee schedules for services provided "Procedures and criteria for phoning reports and other important information "Report forms 2.CONTRACTING LABORATORY must provide telephone number(s) and contact person(s) to be used by the VA Medical Center to make specimen problem inquiries and problem solving at all times including weekends and holidays. Also include names and telephone number(s) of technical Directors and Pathologists available for consultation. 3.CONTRACTING LABORATORY agrees to maintain the minimum acceptable service, reporting systems, and quality control as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency. The Government will: 1.Perform specimen collection to obtain acceptable specimens from patients unless otherwise specified in which case will be negotiated with the contractor. 2.The Government will provide biologic specimens that have been collected and processed (labeled, and preserved) per the Contractor's published pre-analytical requirements, and in accordance with good laboratory practices (GLP). 3.Order required tests in, VISTA, or other LIS, if available, and provide the Contractor with test requests, lists or work documents with required patient demographics and ordering information. For these automated sites, the Government will not complete additional Contractor's forms, data entry or test requisitions in the Contractor's automated laboratory system. 4.For each test requisition, Government personnel will provide: Patient's Account Number SA Accession Number Date of Specimen Collection Date Specimen shipped Test(s) Requested/Code and Name Ordering Physician's Name Ordering Remarks/Comments (if clinically appropriate) Patient's Age or Date of Birth Patient's sex Type of Specimen Patient's location (clinic/ward) The Government will ensure specimen readiness for timely transportation and delivery to the CONTRACTING LABORATORY. Any issues will be brought to the COR's attention immediately. RESPONSE COMMITMENT I.NOTES: A.All questions, comments or concerns should be directed to Heather.Simpson@va.gov B.Submittals furnished will not be returned to the sender. No debriefs will be conducted. Eligibility in participating 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 - 5-8 pages (please make the response as brief and concise as possible) 3.Company name and Sources Sought number listed on each page 4.Proprietary information MUST be marked as such, on a page-by-page basis. 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. Including but not limited to; coverage of medical facilities listed, turnaround time from each facility covered and specific testing covered, as outlined in Attachment A 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 POC: Heather Simpson Contract Specialist Email: heather.simpson@va.gov ATTACHMENT A - TESTING REQUIRED Test Name 1.IHC W/INT 2.IHC W/O INT 3.Prostate Triple Stain, IHC W/O Interpretation 4.PROGESTERONE RECEPTOR IHC W/O INTERPRETATION 5.FISH FOLLICULAR LYMPHOMA, IGH/BCL2,t(14) 6.FISH, AML M3, PML/RARA, TRANSLOCATION 15, 17 7.FISH, B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA PNL 8.FISH, CML/ALL, BCR/ABL TRANSLOCATION 9,22 9.FISH, MALT LYMPHOMA, API2 MALT1,T(11:18) 10.FISH, MULTIPLE MYELOMA, IGH/FGFR3,T(4 11.FISH, MULTIPLE, IGH/MAF T(14) 12.FISH,ALL/NHL,MYC-BA,8q24 REARRANGEMENT 13.FISH,ALL/NHL/MYC,TRANS LOCATION, 8,14 14.FISH,MALT LYMPHOMA, MALT1 REFLEX API2,MALT1,T(11:18) 15.FISH,MANTLE CELL LYMPHOMA IGH/CCND1,t(11) API2,MALT1,T(11:18) 16.FISH,MLL,11Q23 REARRANGE MENT 17.FISH,MULTIPLE MYELOMA 13Q-,17P-,REA 14Q32 18.FISH,ALL,EXTENDED PANEL 19.FISH,ALK,2P23 REARRANGE 20.LUNG CANCER(NSCLC),ALK 2P23 REARRANGEMENT, FISH 21.CHROMOSOME FISH, CBFB FOR 16Q22 REARRANGEMENT 22.CHROMOSOME FISH,T(8 21) 23.BRAF MUTATION ANALYSIS 24.MELANOMA, BRAF V600 MUTATION, COBAS 25.EPIDERMAL GROWTH FACTOR RECEPTOR MUTATIONS 26.KRAS MUTATION ANALYSIS 27.T-CELL RECEPTOR (TCR)GENE REARR.QL(DEL 9/23/13) 28.NRAS MUTATION ANALYSIS 29.CHROMOSOME COMMUNICATION 30.SPECIAL STAIN MICRO-ORGANISMS 31.SPECIAL STAIN CHEMICAL COMPONENT 32.SPECIAL STAIN MISCELLANEOUS 33.CUTANEOUS DIRECT IMMUNOFL UORESCENCE (DERMPATH) 34.ER/PR, PARAFFIN BLOCK 35.HER2 (HERCEPTEST-TM) IHC, W/INTERPRETATION 36.HER2 (HERCEPTEST[R]) IHC WITH REFLEX TO FISH 37.EPSTEIN-BARR VIRUS, ISH WITH INTERPRETATION 38.HPV ISH LOW/HIGH RISK W/INTERP 39.KAPPA/LAMBDA LIGHT CHAIN ISH WITH INTERP 40.FISH,HER-2/NEU,PARAFFIN BLOCK 41.THYROID CANCER MUTATION PANEL 42.LUNG CANCER MUTATION PNL (EGFR,KRAS,ALK) 43.FLT3 ITD AND TKD MUTATION 44.B-CELL RECEPTOR IGH GENE REARRANGEMENT, PCR 45.MICROSATELLITE INSTABILIT 46.NPM(EXON 12) MUT ANALYSIS CELL-BASED 47.T-CELL RECEPTOR (TCR) GAMMA GENE REARRANGE, PCR 48.EML4-ALK GENE FUSION, PCR 49.BCL-2/JH T(14 18) GENE 50.CEBPA MUTATION ANALYSIS 51.C-KIT MUTATION ANALYSIS, CELL-BASED 52.C-KIT MUTATIONS W/REFLX TO PDGFRA AND GIST 53.PDGFRA MUTATION ANALYSIS (SJC 16859) 54.STONE ANALYSIS (SLI Z4161) 55.LEUKEMIA/LYMPHOMA EVAL 56.CHROMOSOME ANALYSIS, HEMA TOLOGIC MALIGNANCY 57.ERCC1, IHC W/INTERP 58.ER/PR/HER2, FISH 59.HER2 (HERCEPTEST-TM), IHC PARAFFIN BLOCK W/O 60.INTERP 61.FISH, OLIGODENDROGLIOMA 1p/19q 62.EPSTEIN BARR VIRUS (EBV) ISH, WITHOUT INTERP 63.HPV ISH HIGH RISK W/O INT 64.HPV ISH LOW/HIGH RISK W/O INTERP. 65.KAPPA/LAMBDA LIGHT CHAIN, ISH W/O INTERP
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BoVAMC/VAMCCO80220/VA24115Q0234/listing.html)
 

Document(s)

Attachment
 

File Name: VA241-15-Q-0234 VA241-15-Q-0234.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1881729&FileName=VA241-15-Q-0234-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1881729&FileName=VA241-15-Q-0234-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03650688-W 20150226/150224235711-a104bcb0ba3e88ee65b010cec0c8b0fa (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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