DOCUMENT
Q -- Immunohistochemistry Lab Consultative Services VA Maine - Attachment
- Notice Date
- 1/25/2016
- Notice Type
- Attachment
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Veterans Affairs;VAMC Providence;830 Chalkstone Avenue;Providence RI 02908
- ZIP Code
- 02908
- Solicitation Number
- VA24116Q0196
- Response Due
- 1/29/2016
- Archive Date
- 4/28/2016
- Point of Contact
- Valerie DeAngelis
- E-Mail Address
-
9-4760
- Small Business Set-Aside
- N/A
- Description
- Department of Veterans Affairs Veterans Health Administration Sources Sought Notice - Immunohistochemistry Consultation 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. 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 Immunohistochemistry Consultation Services for the VA Medical Center (VAMC) Togus located at 1 VA Center, Augusta, ME 04330. 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 shall provide Immunohistochemistry Consultation services, to include courier transportation of these specimens. Contractor shall provide professional and technical services to include materials, supplies, equipment and qualified supervision specified herein. All Immunohistochemistry consultation services shall be performed at the Contractor's facility. Contractor must accept specimens Monday through Saturday 7am-6pm EST/EDT and be able to process specimens upon delivery by the transport vendor. The Contractor Laboratory shall: 1.Perform consultation and technical services entirely upon their premises. for the following: "Diagnostic Immunohistochemistry markers- technical component only "Immunohistochemistry morphometric analysis, tumor immunohistochemistry quantitative or semi quantitative- technical component only "Immunohistochemistry markers- technical component only specific for colorectal Cancer "Professional consultation for select cases 2.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 VA Lab when required such as slides designated as technical components only. Patient specimens (blocks and slides) will be returned to the VA Lab. 3.Notwithstanding anything to the contrary in this PWS or otherwise, the CONTRACTOR LABORATORY shall not release patient's records that include test results 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 Contract. 4.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). 5.Contractor's Medical Staff will be available to all VAMCs as a resource for education about disease conditions and testing options. 6.Telephone any abnormal or unexpected results to the Chief of Pathology and Laboratory Medicine Service at the VA facility on the same day the result is verified by the contractor laboratory. 7.Hard copy results and consultative reports shall provide individual patient-chartable test result reports meeting Clinical Laboratory Improvement Act of 1988 (CLIA) requirements and must be electronically transmitted to each Point of Contact (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 collected at the VAMC "The date and time a specimen was received by the contractor 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 age or date of birth "The patient's sex "The Medical Center/CBOC specimen identification number "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 8.In cases of malfunction of the Contractor-supplied electronic reporting method lasting more than 24 hours, the Contractor shall, without additional charge, provide express overnight shipping or courier delivery of printed reports to each POC until the automated information system is properly functioning. 9.Provide running history for lab results by patient when requested. 10.Provide appropriate requisition forms and unique supplies needed for specialized collection of samples at no additional charge. 11.Pick up patient specimens no earlier than 11 AM EST at VA Maine Healthcare System, process the specimens at the contractor's facility and transport the stained slides and blocks back to the VA laboratory to be received no later than 11 AM EST the following business day. 12.Carry out its functions hereunder in full compliance with all local, state, and Federal laws or regulations. 13.If lab results are not performed within 2 days, it is up to the facility point of contact to track the late results and track specific instances in the Quality Assurance Worksheet for submission to the National Consolidated Laboratory (NCL) for quarterly review with the contractor. 14. Test result and/or report corrections shall be made with corrected reports sent to the VA Lab within 3 business days of correction request. 15. 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.). 16. The contractor shall, upon completion of testing and reporting, return all specimens. 17. The facility POC will request replenishment of supplies from the contractor on an as needed basis. 18. Must provide a current Laboratory Manual containing the following information: "Department hours of operation "Accreditation "Technical Staff "Service Departments (Method of contacting, 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 19. Must 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. 20.Must assign a specific local account representative. 21.Must advise COR of any changes in methodology, procedure or reference ranges. 22.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. LICENSING AND ACCREDITATION: 1.Shall have all licenses, permits, accreditation certificates required by Federal law and State law in the state of Maine. 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 Health and Human Services Health Care Financing Administration, Centers for Medicare and Medicaid (CMS). 7.Must notify the Contracting Officer immediately, in writing, upon its loss (of any of its subcontractors) of any required certification, accreditation, or licensure. QUALITY CONTROL: The contractor must operate a successful quality control program as required by 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 assurance surveillance program will be submitted as part of an offer and put into place upon final contract award. After acceptance of the quality assurance plan the contractor shall receive the contracting officer's acceptance in writing of any proposed change to this Quality Control system. QUALITY ASSURANCE: The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint Commission and regulations applicable for performing the type of services required. The government shall evaluate the contractor's performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s). RESPONSE COMMITMENT I.NOTES: A.All questions, comments or concerns should be directed to Valerie.DeAngelis@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 - 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: Valerie.DeAngelis@va.gov TestMenu Item Description Annual Est. Quantity 1ALPHA 1-ANTITRYPSIN, IHC W/O INTERPRETATION_88342-TC0-1 2ALPHA-FETOPROTEIN, IHC W/O INTERP_88342-TC4 3AMYLOID A,IHC W/O INTERP _88342-TC1 4ANAPLASTIC LYMPHOMA KINAS 1 IHC W/O INTERP_88342-TC12 5ANDROGEN RECEPTOR, IHC W/O INTERPRETATION_88342-TC0-1 6ANNEXIN, IHC W/O INTERP _88342-TC0-1 7B72.3, IHC W/O INTERPRETA _88342-TC0-1 8B-CELL RECEPTOR IGH GENE REARRANGEMENT, PCR_81261, 849990-1 9BCL-2,IHC W/O INTERPRETA _88342-TC9 10BCL-6, IHC W/O INTERPRETA _88342-TC9 11BETA CHORIONIC GONADOTRO PIN, IHC W/O INTERP_883421 12BEREP4, IHC W/O INTERP _88342-TC3 13BOB1, IHC W/O INTERP _88342-TC2 14BRAF MUTATION ANALYSIS _812100-1 15CA125, IHC W/O INTERP _88342-TC0-1 16CA19-9, IHC W/O INTERP _88342-TC6 17CD 10, IHC W/O INTERP _88342-TC38 18CD 117-CKIT, IHC W/INTERP _883420-1 19CD 117-CKIT, IHC W/O INTERPRETATION_88342-TC9 20CD 1A, IHC W/O INTERP _88342-TC0-1 21CD138, IHC W/O INTERP _88342-TC13 22CD15, IHC W/O INTERPRETA _88342-TC5 23CD163,IHC W/O INTERP _88342-TC5 24CD2, IHC W/O INTERPRETATN _88342-TC0-1 25CD20, IHC W/O INTERPRETA _88342-TC42 26CD21, IHC W/O INTERP _88342-TC2 27CD23, IHC W/O INTERPRETA. _88342-TC3 28CD3, IHC W/O INTERPRETA _88342-TC40 29CD30, IHC W/O INTERPRETAT _88342-TC11 30CD31, IHC W/O INTERP _88342-TC0-1 31CD34, IHC W/O INTERP _88342-TC25 32CD38, IHC W/O INTERP _88342-TC0-1 33CD4, IHC W/O INTERPRETATI _88342-TC0-1 34CD43, IHC W/O INTERP _88342-TC0-1 35CD44, IHC W/O INTERP _88342-TC1 36CD45, IHC W/O INTERP _88342-TC19 37CD45RO (UCHL-1), IHC W/O INTERPRETATION_88342-TC0-1 38CD5, IHC W/O INTERP _88342-TC9 39CD56, IHC W/O INTERPRETAT _88342-TC15 40CD57, IHC W/O INTERPRETA. _88342-TC1 41CD61, IHC W/O INTERP _88342-TC8 42CD68, IHC W/O INTERP _88342-TC1 43CD7, IHC W/O INTERP _88342-TC0-1 44CD71, IHC W/0 INTERP _88342-TC0-1 45CD8, IHC W/O INTERP _88342-TC0-1 46CD99,IHC W/O INTERPRETA. _88342-TC2 47CDX2,IHC W/O INTERP _88342-TC16 48CEA, MONOCLONAL IHC W/O INTERP_88342-TC0-1 49CEA, POLYCLONAL, IHC W/O _88342-TC11 50CEBPA MUTATION ANALYSIS, EXTRACTED DNA_81403-900-1 51CHROMOGRANIN, IHC W/O INT _88342-TC19 52CK14, IHC W/O INTERP _88342-TC0-1 53C-KIT MUTATION ANALYSIS, CELL-BASED_81404-900-1 54CLARETININ,IHC W/O INTERP _88342-TC7 55COLORECTAL CANCER MUT PANEL_81210, 81275, 814040-1 56COPPER, LIVER TISSUE _82525-900-1 57CYCLIN D1 (BCL-1), IHC W/O INTERPRETATION_88342-TC12 58CYTOKERATIN 19, IHC W/O INTERPRETATION_88342-TC4 59CYTOKERATIN 20, IHC W/O INTERP_88342-TC44 60CYTOKERATIN 5/6, IHC W/O INTERPRETATION_88342-TC37 61CYTOKERATIN 7, IHC W/O IN _88342-TC48 62CYTOKERATIN 8 & 18(CAM5.2 IHC W/O INTERP_88342-TC9 63CYTOKERATIN AE1/AE3, IHC W/O INTERPRETATION_88342-TC28 64CYTOMEGALOVIRUS, IHC W/O INTERP_88342-TC1 65D2-40, IHC W/O INTERP _88342-TC3 66DBA44 HAIRY CELL IHC W/O INTERP_883421 67DESMIN,IHC W/O INTERPRETA TION_88342-TC4 68DOG1, IHC W/O INTERP _88342-TC0-1 69E-CADHERIN, IHC W/O INTER _88342-TC7 70EML4-ALK GENE FUSION, PCR _81401-900-1 71EPIDERMAL GROWTH FACTOR RECEPTOR MUTATIONS _812350-1 72EPITHELIAL MEMBRANE AG IHC W/O INTERP_88342-TC20 73EPSTEIN BARR VIRUS (EBV) ISH, WITHOUT INTERP_88365-TC7 74ER/PR, PARAFFIN BLOCK _883603 75ESTROGEN RECEPTOR (ER) IHC, W/O INTERP_88360-TC3 76FACTOR 13A, IHC W/O INTER _88342-TC9 77GLIAL FIBRILLARY ACIDIC PROTEIN, IHC W/O INTERP_88342-TC1 78GLYCOPHORIN A, IHC W/O INTERP_88342-TC11 79GLYPICAN 3,IHC W/O INTERP _88342-TC0-1 80GRANZYME B, IHC W/O INTER _88342-TC0-1 81GROSS CYSTIC DISEASE FLUD 15, IHC W/O INTERP_88342-TC1 82HELICOBACTER PYLORI, IHC W/O INTERP_88342-TC29 83HEPATITIS B CORE, IHC W/O INTERPRETATION_88342-TC0-1 84HEPATITIS B SURFACE ANTIGEN,IHC W/O INTERPRET_88342-TC0-1 85HEPPAR-1, IHC W/O INTERPR _88342-TC8 86HER2 (HERCEPTEST[R]) IHC WITH REFLEX TO FISH_883607 87HER2 (HERCEPTEST-TM) IHC, W/INTERPRETATION_883603 88HER2 (HERCEPTEST-TM), IHC PARAFFIN BLOCK W/O INTERP_88360-TC0-1 89HERPES SIMPLEX VIRUS 2 IHC,W/O INT (DEL 3/9/15)_88342-TC0-1 90HERPES SIMPLEX VIRUS TYPE 1 AND 2, IHC W/O INTERP_88342-TC0-1 91HHF35 MUSCLE ACTIN, IHC W/O INTERP_88342-TC0-1 92HMB45, IHC W/O INTERPRETA _88342-TC13 93HPV ISH LOW/HIGH RISK W/INTERP._88364-90, 88365-903 94HSV 1, IHC W/O INTERP (DELETED 3/9/15)_88342-TC0-1 95IGA, IHC W/O INTERP _88342-TC0-1 96IGG4. IHC W/O INTERP. _88342-TC0-1 97IMMUNOHISTOCHEMISTRY W/IN TERPRETATION_883420-1 98IMMUNOHISTOCHEMISTRY W/O INTERPREATION_88342-TC16 99INHIBIN, IHC W/O INTERP _88342-TC3 100INI-1,IHC W/O INTERP _88342-TC0-1 101IRON-LIVER TISSUE _83540-900-1 102KAPPA/LAMBDA LIGHT CHAIN ISH WITH INTERP_88364, 883650-1 103KAPPA/LAMBDA LIGHT CHAIN, ISH W/O INTERP_88365-TC, 88366-TC9 104KI67, IHC W/O INTERP _88342-TC9 105KI-67/MART-1, IHC W/O INTERPRETATION_88342-TC0-1 106KRAS MUTATION ANALYSIS _812750-1 107LAMBDA, IHC W/O INTERP _88342-TC0-1 108LUNG CANCER MUTATION PNL (EGFR,KRAS,ALK)_81235, 81275, 88271, 882745 109LYNCH SYNDROME TUMOR PANEL, IHC W/O INTERP._88341-TC, 88342-TC0-1 110LYSOZYME, IHC W/O INTERP _88342-TC0-1 111MA903 CYTOKERATIN 34BE12 IHC W/O INTERP_88342-TC1 112MAMMAGLOBIN,IHC W/O INTE RP_88342-TC0-1 113MANTLE CELL LYMPHOMA BCL-1/JH_81401-900-1 114MAST CELL TRYPTASE, W/O INTERP_88342-TC0-1 115MELAN-A, IHC W/O INTERPRE _88342-TC0-1 116MELANOMA ANTIGEN RECOG BY T CELLS, IHC W/O INTERP_88342-TC32 117MELANOMA, BRAF V600 MUTATION, COBAS_812100-1 118MICROSATELLITE INSTABILIT _81301-900-1 119MLH1, IHC W/O INTERP _88342-TC0-1 120MOC-31,IHC W/O INTERPRETA TION_88342-TC1 121MSH2,IHC W/O INTERP _88342-TC0-1 122MSH6, IHC W/O INTERP _88342-TC0-1 123MUM1, IHC W/O INTERP _88342-TC3 124MYD88, MUTATION ANALYSIS _814790-1 125MYELOPEROXIDASE, IHC W/O INTERP_88342-TC12 126MYO D1, IHC W/O INTERPRET _88342-TC0-1 127MYOGENIN, IHC W/O INTERPR _88342-TC0-1 128NAPSIN A, IHC W/O INTERP _88342-TC0-1 129NEUROFILAMENT PROTEIN,IHC W/O INTERPRETATION_88342-TC5 130NEURON-SPECIFIC ENOLASE IHC W/O INTERPRETATION_88342-TC8 131NPM(EXON 12) MUT ANALYSIS CELL-BASED_81310-900-1 132NRAS MUTATION ANALYSIS _814040-1 133P16, IHC W/INTERP _883420-1 134P16, IHC W/O INTERPRETA TION_88342-TC1 135P504S,IHC W/O INTERPRETA _88342-TC3 136P53, IHC W/O INTERPRETATI _88342-TC7 137P63, IHC W/O INTERP _88342-TC29 138PAX2,IHC W/O INTERP _88342-TC7 139PAX-5, IHC W/O INTERP _88342-TC4 140PAX8,IHC W/O INTERP _88342-TC4 141PD-1, IHC WITH INTERP. _883423 142PLACENTAL ALAKALINE PHOS. IHC, W/O INTERPRETATION_88342-TC1 143PMS2, IHC W/O INTERP _88342-TC0-1 144PROGESTERONE RECEPTOR IHC W/O INTERPRETATION_88360-TC3 145PROSTATE TRIPLE STAIN,IHC W/O INTERPRETATION_88344-TC126 146PROSTATIC ACD PHOSPHATASE IHC W/O INTERPRETATION_88342-TC4 147PROSTEIN, IHC W/O INTERPRETATION_88342-TC0-1 148PSA, IHC W/O INTERPRETA. _88342-TC7 149RENAL CELL CARCIN W/O INT _88342-TC15 150S-100,MONO,IHC W/O INTERP _88342-TC0-1 151S-100,PLOY,IHC W/O INTERP _88342-TC19 152SMOOTH MUSCLE ACTIN W/O INTERPRETATION_88342-TC13 153SPECIAL STAIN CHEM COMPONENT_883131 154SPECIAL STAIN MICRO-ORGANISMS_883120-1 155SPECIAL STAIN MISCELLANEOUS_8831327 156SPECIAL STAIN-ENZYMES _883191 157SYNAPTOPHYSIN, IHC W/O IN TERPRETATION_88342-TC23 158T-CELL RECEPTOR (TCR) BETA GENE REARRANGEMENT_81340, 849990-1 159T-CELL RECEPTOR (TCR) GAMMA GENE REARRANGE, PCR_81342, 849990-1 160TERMINAL DEOXYNUCLEIC TRANSFERASE, IHC W/O INTE_88342-TC0-1 161THROMBOMUDULIN,IHC W/O IN TERP_88342-TC0-1 162THYROGLOBULIN, IHC W/O IN _88342-TC0-1 163THYROID CANCER MUTATION PANEL_814450-1 164THYROID TRANSCRIPTION FAC -1, IHC W/O INTERPRETATIO_88342-TC46 165TIA1,IHC W/O INTERP _88342-TC0-1 166UROPLAKIN,IHC W/O INTERP _88342-TC0-1 167VILLIN,IHC W/O INTERP _88342-TC1 168VIMENTIN, IHC W/O INTERPR _88342-TC16 169WILMS' TUMOR-1, IHC W/O INTERPRETATION_88342-TC0-1 170Professional Consultation 88321 0-1
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