Department of Veterans Affairs Medical Center (VAMC) Sources Sought Notice - STAT and Non-STAT Testing 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 STAT and Non-STAT testing for all items listed in the Test Menu, Attachment A, for the VA West Haven, CT on an as needed basis for a 12 month base plus four option year IDIQ contract. 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. Perform testing services entirely upon their premises. 2. Analyze samples: Contractor is required to perform analytical testing for VAMC patients for the tests defined in the Test Menu. The Contractor shall bill only for the tests specified in the request sent by the VAMC Laboratory service. The Contractor is required to provide a reference test manual, and report of analytical test results and consultative services as required assimilating the full scope of its laboratory operations. 3. Testing methodology for a test must be defined in the contactor's laboratory user's manual. 4. Shall provide VAMC with appropriate laboratory supplies not customarily utilized by the VAMC. These supplies are to be used by the VAMC only in connection with specimens being sent for testing to the contractor. 5. Shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations. 6. All test result reports shall be immediately faxed to the send-out office of the VA Connecticut Healthcare System's Clinical Laboratory for entry into the VA electronic medical record. 7. Shall provide a consultation report and at a minimum shall contain the following information: o Patient's full name, o Patient's date of birth o Patient's full social security number or unique hospital identification number o Ordering Physician's name, o Date/time of specimen collection, o Date test completed, o Test name, o Test result, o Flag abnormal results, o Reference range, o testing laboratory name, address and CLIA number, o Type of specimen, " Contractor accession number o Any additional comments related to test provided by ordering physician, o Any other information the laboratory has that may indicate a questionable validity of test results, o Unsatisfactory specimen shall be reported with regard to its unsuitability for testing. 8. Shall consult VAMC on test results by telephone as needed. 9. The contractor shall provide a printed or electronic Laboratory Manual containing the following information: o Testing methodology for a test must be defined in the laboratory user's manual o Department hours of operation o Accreditation o Technical Staff o Service Departments (Method of contacting, phone numbers, hours of availability) o Quality Assurance Information o Billing Procedures & fee schedules for services provided o Procedures and criteria for phoning reports and other important information o Report forms 10. The contractor shall 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. *NOTE: Also include names and telephone number(s) of Technical Directors and Pathologists available for consultation. 11. Contractor 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. 12. Contractor shall assign a specific local account representative. 13. Contractor shall advise facility of any changes in methodology, procedure or reference ranges. 14. 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. 15. 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 at the time of quote submission. 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 shall 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 comply with the regulatory requirements of Health and Human Services Health Care Financing Administration, Centers for Medicare and Medicaid (CMS). 6. Must notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure. Contract Performance Monitoring: Quality Control: The contractor must operate a successful quality assurance program as required by CAP/CLIA. Services are to be performed in accordance with this Performance Work Statement (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. o The VA Medical Center will maintain an Internal Quality Control Program to monitor the quality of test results received from the contractor. The method used for monitoring is at the discretion of the VA Medical Center and may include, but is not limited to , unidentified split specimens sent periodically to the contractor for testing, split specimen sent to another reference laboratory for comparison, or monitoring of turn-around-time. o The contractor's facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the VAMC at any time during the life of the contract. Quality Assurance: The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint commission and regulations required as required 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. 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 [email protected] 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: [email protected] Attachment A - Test Menu :::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Description/Part Number* Estimated Annual Qty Stats Acetaminophen 82003 1 Albumin 82040 1 Albumin/Globulin Ratio 1 Alcohol, Serum 84600 21 Alkaline Phos 84075 1 Ammonia 82140 1 Amylase 82150 3 Anion Gap 1 Benzodiazepine, urine G0431 1 Bilirubin Direct 82248 1 Bilirubin Total 82247 1 Calcium 82310 1 Calcium, Ionized plasma 82330 2 Carboxyhemoglobin 82375 21 Chem 19_80265 1 Chloride 82435 1 CO2 1 Complete Blood Count with differential_85025 1 Complete Blood Count without differential _85027 1 C-Reactive Protein 86141 1 Creatinine 82565 1 Creatinine Kinase 82550 1 Ethanol 80255 1 Ethylene Glycol 82693 22 Fibrinogen 85384 3 Fluid cell count 89051 2 Globulin 1 Glomerular Filtration Rate (GFR) 1 Glucose 82947 1 Glucose, CSF 82945 1 HCG Quantitative 84702 3 Lipase 83690 1 Magnesium 83735 1 Partial Thromboplastin Time 85730 1 Potassium 84132 1 Protein, Total CSF 84157 1 Protein. Total 84155 1 Prothrombin Time 85610 1 Salicylate 80196 1 SGOT (AST) 84450 1 SGPT (ALT) 84460 1 Sodium 84295 1 Tricyclic Screen G0431 1 Troponin 84484 1 TSH Thyroid Stimulating Hormone 84443 1 Urea Nitrogen 84520 1 Urine Amylase 82150 1 Urine Calcium 82340 1 Urine Chloride 82436 1 Urine Creatinine 82570 1 Urine PO4 84150 1 Urine Sodium Potassium 84133 1 Urine Sodium Urine 84300 1 Urine Urea Nitrogen 84540 1 Non-Stats and other selected Tests Accuprobe 10 Acid Fast Stain 87206 38 AFB Conc 87015 43 Amiodarone 82492 1 Amylase, timed Urine 81050/82150/82570 3 ANCA Screen (Negative or Positive) 86021 1 Antiplatelet Antibody Panel 86022 4 B Cell Gene Rearrangement w/Amp Blood/ marrow) 83894/83898/83890 11 Bacterial Identification 87077 1 Basic Metabolic Panel 80048 3 BCR/ABL Screen blood or marrow 83896/83890/83898/83902/83901 5 Beta Hydroxybutarate 82010 3 Bone Marrow Aspiration 85008 14 Bone Marrow Iron Stain 88313 1 B-type Natriuretic peptide 83880 5 Caspofungin E-Test Mic 87186 1 CBC 85207 1 CBC with Diff 85025 1 CEA Fluid 82378 1 Comprehensive Met Panel 80053 3 Cortisol 82533 3 Cryptococcal Antigen 86403 1 Cyclin D1 (Blood or Marrow) 83898, 83902,83896, 83890 13 Cyclosporine 80158 6 Cytomegalovirus CSF 87496 1 Cytomegalovirus, Quant PCR 87497 1 Dilute Russell Viper Venom 85613 1 Direct bilirubin 82248 3 Direct probe for M. Tuberculosis 87556 1 Epstein Barr Virus CSF 87798 2 Factor II, Activity 85210 2 Factor IX Activity 85250 7 Factor V Activity 85220 2 Factor VII Activity 85230 2 Factor VIII Activity 85240 2 Factor X Activity 85260 4 Factor XI Activity 85270 2 Factor XII Activity 85280 2 Factor XIII Screen 85290 1 Flow Cytometry (fluid, tissue,blood,marrow) 88184/88185 170 Fungal Culture (skin) 87101 1 Fungal MIC-E (Ampho) 87181 1 Fungal MIC-E (Fluconazole) 87186 1 Fungal Susceptibility Variable 87186 1 Heparin Mediated Platelet A 86022 1 Herpes Simplex Virus DFA 87274/87290 2 HHV-6 CSF 87532 1 HIV-1 Genotyping 87901 1 HSV by PCR lesion 87529 2 HSV culture 87252 1 Inhibitor Assay 85335 1 Lactic Acid 83605 3 LDL83721 3 Lidocaine 80176 1 Light transmission platelet aggregometry 1 Lipase 83690 3 Lipid Profile 80061 3 Lipoprotein Profile 1 Lupus Anticoagulant Panel 85613/85705/85730 1 Magnesium 83735 3 Methemoglobin 83050 3 Methotrexate 80299 1 Micro Billing for 1 Etest 87081 16 Micro Billing for 2 & 3 Etest 87181 21 Micro Billing Kirby-Bauer 87184 2 Mixing Study 85732 1 Nitroblue Tetrazolium 86384 1 Norovirus RNA RT-PCR 87798 74 Parathyroid hormone 83970 1 Parathyroid hormone, mineral 83971 1 Phenycylidine,PCP, urine G0431 1 Phospholipid Neutralization 85705 1 PML-RARA Quant 83890/83896/83898/83902 1 PML-RARA Quant, Marrow 83890/83896/83898/83902 1 PML-RARA Screen 83890/83896/83898/89302 1 PML-RARA Screen, Marrow 83890/83896/83898/83902 1 Porphobilinogen, Qual 84106 1 Prolactin 84146 1 PTT 1:1 Mix 85732 1 Reticulated Platelet Count 85055 84 Reticulocyte Count 85045 1 Ristocetin Cofactor 85245 5 Rotovirus 87425 10 Stool Culture 87045/87046 1 Streptex Group D 87147 1 Superficial Wound 87070 1 Susceptibility Testing 87186 1 T Cell Gene Rearrangement (blood/Marrow) 83890/83894/83898 2 Tacrolimus (FK-506) 80197 43 TSH Thyroid Stimulating Hormone 84443 3 Thyroxine Binding Capacity 84479 1 Thyroxine Total 84436 1 Tobramycin 80200 2 Urine Culture 87086 1 Varicella- zoster Virus 86787 3 Varicella- zoster Virus CSF 87798 1 Varicella- zoster Virus DFA 87290/87274 2 Varicella- zoster Virus PCR,Lesion 87798 2 Von Willebrand Factor Antig 85245 1

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