Lab Testing Services
Added: Jul 27, 2017 7:43 pm COMBINED SYNOPSIS/SOLICITATION This is a combined synopsis/solicitation ("synopsitation" hereafter), which is expected to result in award of a Blanket Purchase Agreement (BPA) for commercial service, Expert Second Opinion for Pathology Consultation Services, Ancillary Diagnostic Immunohistochemical (IHC) Testing, Prognostic and Therapeutic Testing, and Electron Microscopy(EM), Direct Immunofluorescence, and Microscopic exam of Brain/Nerve, Renal, Muscle, and Hematopathology for Anatomic Pathology. as described under the paragraph below titled "Performance Work Statement." The synopsitation is prepared in accordance with the format in the Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. One or more BPAs may be awarded and a BPA may be awarded for all or only some of the items an offeror proposes to provide. To be eligible for award: •(a) the offeror's proposal must conform to the requirements of the synopsitation;•(b) each item to be included in a resulting BPA must receive a rating of "Acceptable" on the Technical evaluation factor;•(c) the unit price of each item to be included in a resulting BPA must be determined to be fair and reasonable based on price analysis, as described in FAR 13.106-3(a); and•(d) the offeror must be determined to be responsible based on the standards in FAR 9.104 Proposal evaluation does not permit tradeoffs between price and non-price factors. The Government reserves the right to (1) award without discussions or make no award at all depending upon (1) the quality of proposals received and (2) whether proposed prices are determined to be fair and reasonable. Synopsitation Number: FA8601-17-R-0060. Set Aside: Not Set Aside NAICS Code: 621511: Medical Pathology Laboratories Small Business Size Standard: 32.5 MILLION Acceptable means of Submission: All submissions must be submitted electronically to the following email address isaiah.steward@us.af.mil by 9 August 2017 by 9:00 a.m. EST. Any correspondence sent via e-mail must contain the subject line "Synopsitation FA8601-17-R-0060" The entire proposal must be contained in a single e-mail that does not exceed 5 megabytes including attachments, if any. E-mails with compressed files are not permitted. Note that e-mail filters at Wright-Patterson Air Force Base are designed to filter e-mails without subject lines or with suspicious subject lines or contents (i.e., .exe or .zip files). Therefore, if the specified subject line is not included, the e-mail may not get tough the e-mail filters. Also be advised that .zip or .exe files are not allowable attachments and may be deleted by the email filters at Wright-Patterson. If sending attachments with email, ensure only .pdf, .doc, .docx, .xls or .xlsx documents are sent. The email filter may delete any other form of attachments. This solicitation incorporates FAR provisions and clauses in effect tough Federal Acquisition Circular (FAC) Fac 2005-95, effective 19 Jan 2017; Defense Federal Acquisition Regulation Supplement (DFARS) Publication Notice (DPN) 20161222, effective 22 Dec 2016; and Air Force Federal Acquisition Regulation Supplement (AFFARS) Air Force Acquisition Circular (AFAC) 2017-0127, effective 27 Jan 2017. Address questions regarding this synopsitation to Isaiah Steward via e-mail at isaiah.steward@us.af.mil. A detailed description of the requirement, specific instructions for submission of proposals, and how proposals will be evaluated are provided below. The draft BPA, including applicable provisions and clauses, representations and certifications and other terms and conditions is an integral part of this synopsitation and is attached. Upon award, the Additional Instructions to Offerors, Evaluation Factors, provisions, and representations and certifications in the synopsitation (including in the draft BPA) will be removed from the award document. Delivery Schedule: As scheduled following award Delivery Destination: 88 MDSS/SGSM Attn: Robert T Dawalt 4881 Sugar Maple DriveWright-Patterson AFB, OH 45433 Delivery Type: FOB Destination (As defined in FAR 2.101-Definitions, the seller or consignor is responsible for the cost of shipping and risk of loss.) Inspection and Acceptance: Both inspection and acceptance will be by the Government at Destination.Performance Work Statement: •I. Statements Applicable to All Contractors •1. Contractor shall have licensure/certification with the College of American Pathologists, and Health Care financing agencies such as Medicaid and the Clinical Laboratory Improvement Amendments (CLIA) Program, and contractor shall have State licensure where required. Any secondary laboratory used by the contractor to provide services to WPAFB shall also have appropriate licensure/certification. •2. The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the Air Force via a secure data collection site. The contractor is required to completely fill in all required data fields at http://v.rww.ecmra.mil. •3. Reporting inputs will be for the labor executed during the period of performance for each Government fiscal year (FY), which runs 1 October tough 30 September. While inputs may be reported any time during the FY, all data shall be reported no later than 31 October* of each calendar year. Contractors may direct questions to the CMRA help desk."•a. *Reporting Period: Contractors are required to input data by 31 October of each year. •4. Uses and Safeguarding of Information: Information from the secure web site is considered to be proprietary in nature when the contract number and contractor identity are associated with the direct labor hours and direct labor dollars. At no time will any data be released to the public with the contractor name and contract number associated with the data. •5. User Manuals: Data for Air Force service requirements must be input at the Air Force CMRA link. However, user manuals for government personnel and contractors are available at the Army CMRA link at http://www.ecmra.mil. •II. Expert Second Opinion for Pathology Consultation Services, Ancillary Diagnostic Immunohistochemical (IHC) Testing, Prognostic and Therapeutic Testing, and Electron Microscopy(EM), Direct Immunofluorescence, and Microscopic exam of Brain/Nerve, Renal, Muscle, and Hematopathology for Anatomic Pathology. •1. Contractor shall furnish all supplies, transportation, processing facilities, equipment and any repair/maintenance incidental to providing medical laboratory tests beyond the capability of the histopathology/clinical laboratories, 88th Medical Group, Wright Patterson AFB, Ohio 45433. •2. The contractor shall provide a listing of, in house:•a. Expertise for second opinion consultation services.•b. Immunohistochemical diagnostic (LHC) stains.•c. Molecular Diagnostic, Prognostic and Therapeutic laboratory tests currently available.•d. A complete list of comprehensive services covering Brain/Nerve, Renal, Muscle tissue, Hematopoietic, and Direct Immunofluorescence (skin).•e. The listing shall also reflect current price of each test/service. All tests on any order form must be available.•f. If you cannot provide a price for all tests on the provided sample price list leave that position blank and fill in the prices of the tests you are available to perform. •3. The contractor shall work tough the histopathology laboratory referral section at the USAF Medical Center, WPAFB, for services and interaction with contractor in regard to logistics of sample transportation, supplies and inquiries on status. •4. The contractor shall present a consolidated invoice of services rendered on at least a monthly basis. Invoice will include name of patient, patient's social security number, date of service, contractor lab identification number, test performed, test fee and WPAFB pathology laboratory accession number of patient. All materials returned (slides, blocks, reports) will contain WPAFB laboratory accession number of patient. Monthly summary reports shall be provided detailing month-to-date volume by contractor test codes. CPT4 coding information may be required. •5. Contractor shall have the ability in-house to perform test required (the capability to do tests in one of the laboratories owned by the contractor versus referring the test to another reference laboratory). Should tests require referral to another reference laboratory, the contractor shall forward the specimen to another appropriately licensed , accredited laboratory, with no transfer fees charged to the 88th Medical Group. •6. Contractor shall provide client services representative to be accessed by toll free telephone or email for any questions, problems, or changes. •7. Contractor shall provide the pathology laboratory at WPAFB with the following documents:•a. Comprehensive Laboratory Guide that lists test, instruction for collection of specimens, and any special handling requirements (web-based information acceptable).•b. Test schedule showing routine expected turnaround time. A normal turnaround on routine cases is required to be two days. •8. For expert second opinion consultation service, Contractor shall provide consultative expert service representatives who are accredited health care professionals trained to provide in-depth information on all testing listed in para a, below. For anatomic pathology ancillary testing the contractor shall provide service representatives who are accredited health care professionals trained to provide in- depth information on all testing listed in para b, below. Ancillary testing is often performed to allow 88 MDG pathologists the information needed to render a diagnosis without requiring outside expert opinion or to provide extra information in pathology reports that is needed for cancer therapeutic decisions. Contractor may bid on one of the four service categories or all. All service sets will be required to fulfill the needs of the Pathology Laboratory. These representatives shall be accessible to WPAFB tough contractor client services. •a. Expert second opinion consulting service: Contractor shall provide, expertise in these subspecialties of diagnostic pathology: Soft Tissue, Bone, Hematopathology , Gynecologic Pathology, Dermatopathology, Gastrointestinal Pathology, Urologic Pathology, Head and Neck Pathology, Cytopathology, Endocrine Pathology, Pulmonary Pathology, Renal Biopsy, Breast Pathology, and Neuropathology. •b. Ancillary testing Contractor shall provide, a list of and availability of the following ancillary tests, for: Immunohistochemical Diagnostic Antibody stains: A-AT, ACTH, Actin, Adeno, AEI , AEl /AE3, AE3, AFP, ALK,ALK-1 ,AMYLOID A, ANNEXfN A l , B72.3, BCL­l (Cyclin D I ), BCL-2, BCL-6, B-CATENfN , BER-EP4, BOB.l,C4d, CA l 9.9,CA125(0Cl 25), CAIX, CALCITONIN, CALDESMON , CALPONIN , CALRETININ , CAM 5.2, CAM5.2/AE1 , CO i a, CD2, CD3, CD4, CD5 (4C7), CD7, CDS, CDlO, CD15, CD20, CD21, CD22, CD23, CD25, CD30, CD31, CD33, CD34, CD35, CD43, CD45, CD45RO, CD56, CD57, CD61 , CD68, CD71, CD79a, CD99, COi 17, CD123, CD138, CD163, CDX2, CEA (M), CEA(P), CHROMOGRANIN , CHROMOTRYPSIN, CK5, CK5.6, CK7, CK l4, CK l 7, CK19, CK20, CK903, c-MET, CMV, COLL IV, 02-40, DBA44 , DESMIN , DOG I , EBY, E-CADHERIN , EGFR, EMA, ER, FACTOR V I 11, FACTOR V l I l a, FLI-1, FSH, GALECTIN-3, GASTRIN , GCDFP-15, GFAP, GH, GLUCAGON , GLYPICAN-3, GPH-A, GRANZYME B, HEMAGLOBIN A, HP B CORE, HEP B SURF, HBME-1, I-IBP (H. pylori), HCAg, HCG, HEP PAR 1, HER2, HHV8, HLA-DR, HMB-45, HPAP, HPL,HSV, IgA, IgD, IgG, IgG4, IgM, INHIBIN, INSULIN,Ki-67, LH, LIPASE, MAMMAGLOBIN, MART-I , M-CELL TYRPTASE, MELAN-A, MITF, MLH-1, MOC31, MPO, MSH-2, MSH-6, MUC-1, MUC-2, MU M!, MURA, MYODI , MYOGENIN, NAPSIN-A, NEU-N, NEU ROFILAMENT, NKI, N PM, NSE, OCT-2, OCT3/4, P l 6, P504S, P53, P57, P63, P120, Pan Melanoma, PAX2 , PAXS, PAX8, PC, PD I,PIN-4, PLAP, PML, PMS- 2, PNRA (RCC), PR, PROLACTIN, PTS (Prostate Triple Stain), PSA, PTH, RB, Sl OO, SEROTONIN , SMA, SMM, SOMA, SP-A, SYNAPTOPHYSIN, TAU, TCL-1 , TOT, THROMBOMODULIN, THYROGLOBULIN, TIA-1, TOXO, TRAP, TRYPSIN, TS, TSH, TTF-1,UBIQUITIN, UROPLAKIN III, VIMENTIN, VZV, WT-1 C-terminus, WT-1 N-terminus, ZAP-70. •c. Additional Diagnostic , Prognostic and Therapeutic testing to include: ER, PR, HER2 by IHC and FISH, Ki-67, p53, EGFR, DNA plyoidy/S-Phase, E-Cadherin, Circulating Tumor Cells, HERmark, Tamoxifen, BRAF (PCR), KRAS(PCR), NRAS(PCR), MSI(PCR), EGFR(FISH), TS, DNA, EGFR(IHC), Circulating Tumor Cells, Lynch Syndrome (HNPCC), MLH l /MSH2/MSH6/PMS2 (II-IC), MSI (PCR), ALK(FISH), ROSI (FISH), RET (FISH), BRAF Mutation Analysis (cobas), c-Kit Mutation Analysis, PDGFRA Mutation Analysis(PCR), 1p19q deletions (FISH), MGMT Methylation, TP2A (FISH),DNA (Cell Cycle Analysis),PIK3CA(PCR),Lynch Syndrome, Microsatellite lnstability(MSI) FFPE, NSCLC(FISH), REA(FISH)EGFR(PCR),EML4-ALK(PCR),PIK3CA(PCR),ALK 2p23 Rearrangement NSCLC (FISH), ERCC 1 (IHC), VYSIS (FISH), Chomosome Analysis (Lymphnode/Solid Tumor), Sarcoma Mutation Analysis(pediatric PCR),Melanoma (BRAF V600 Mutation), BRAF(Mutation Analysis), HPV Low and High Risk DNA (FISH),Flow Cytometry (Leukemia/Lymphoma Phenotyping), Flow Cytometry (ZAP-70 Analysis), Flow Cytometry (PNH Evaluation), Cytogenetics (Comosome Analysis), Cytogenetics/FISH(Comosome Analysis),AML l/ETO(PCR)quantitative, CBFB/MYH 11 inv( 16)(PCR) quantitative, CEBPA Mutation(PCR), FLT3 (PCR), NPM 1 Mutation(PCR), PML/RARA quantitative(PCR) , Wilms Tumor (WTI )mutation (PCR), IgVH Mutation Status, p53 Mutation Analysis, BCL2/JH t(14;18), BCR-ABL 1 Gene Rearrangement quantitative, ABLI Kinase Domain mutation, ABLI T3151 mutation in CML, JAK2 V617F, JAK2 V617, JAK2 exons 12,13, MPL analysis only, Lympocyte Clonality Panel (PCR), Qualitative B-Cell Gene Rearrangement, Qualitative T-Cell Gene Rearrangement , BCL l/JH T( 11;14). •d. Specialized testing for Electron Microscopy (EM), Direct Immunofluorescence (skin), and Microscopic exam of Brain/Nerve, Renal, Muscle, and Hematopathology Tissues. •III. Referral Laboratory Testing for Clinical Laboratory Consultation Services. •1. Vender must be able to perform specialized tests not performed in-house as well as tests not performed by Department of Defense Laboratories. Examples of testing include Lymphocyte Mitogen Proliferation, Synovasure, Flow Cytometry, and Genetic and Coagulation testing. •2. Contractor shall provide the pathology laboratory at WPAFB with the following documents:•a. Comprehensive Laboratory Guide that lists test, instruction for collection of specimens, and any special handling requirements (web-based information acceptable).•b.Test schedule showing routine expected turnaround time. A normal turnaround on routine cases is required to be two days. The Government may award several BPA(s) resulting from this solicitation to the responsible Offeror(s) whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. Technical Capability and Price will be used to evaluate all offers. The quotations may be in any format but MUST include: 1. Proposing company's name, address, DUNS number, Cage Code, and TIN2. Point of contact's name, phone, and email 3. Quotation number & date 4. Timeframe that the quote is valid5. Price list for items (Sample price list attached)6. Completed copy of FAR 52.212-3 Alternate I (attached)7. Completed copy of FAR 52.222-22 and FAR 52.222-25 (attached) Important Notice to Contractors: Quotations MUST also contain a complete description of items offered and any technical manuals or literature to clearly show that the items meet or exceed the requirements listed above. The Contracting Officer will review quotations based on the factors listed in this solicitation and the information furnished by the Offeror. Before price is considered, the proposal must meet the technical specifications of this solicitation. Important Notice to Contractors: All prospective awardees are required to register at the System for Award Management (SAM) and to maintain active registration during the life of the contract. SAM can be accessed at https://www.sam.gov. Any award resulting from this solicitation will include DFARS Clause 252.232-7003, Electronic Submission of Payment Requests. Section 1008 of the National Defense Authorization Act of Fiscal Year 2001 requires any claims for payment (invoices) under DoD contract to be submitted in electronic form. Wide area Workflow- Receipt and Acceptance (WAWF-RA) is the DoD system of choice for implementing this statutory requirement. Use of the basic system is at no cost to the contractor. Contractors must complete vendor training, which is also available at no cost at http://www.wawftraining.com. Prior to submitting invoices in the production system, contractors must register for an account at http://wawf.eb.mil/. Proposal Detail: The proposal shall be clear, concise, and shall include sufficient detail for effective evaluation and for substantiating the validity of stated claims. The proposal should not simply repase or restate the Government's requirements, but rather shall provide convincing rationale to address how the offeror intends to meet the listed requirements. Offerors shall assume that the Government has no prior knowledge of their facilities and experience, and will base its evaluation on the information presented in the offer submitted. Embellishments Not Desired: Elaborate brochures or documentation, binding, detailed artwork or other embellishments are unnecessary and are not desired. Technical Proposal: Describe how the offeror will provide the Expert Second Opinion for Pathology Consultation Services, and any other supplies necessary described above under "Performance Work Statement". Price Proposal: Price List: The offeror shall complete a price list (Attachment 7) that includes a priced line item for each of the primary tests, listed above under "Performance Work Statement." The price list must include a price for all tests listed. If there is a test you cannot, or do not perform, please mark "N/A" in the "Cost per Service Count" column. The price list must specify an effective date, which shall be the date that proposals are due and have an expiration date no earlier than one year from the date that proposals are due. The price list must list the unit of issue, and the unit price (cost per service count). Prices should be proposed as F.O.B. destination per the definition in FAR 2.101-Definitions, which can be accessed at http://farsite.hill.af.mil/vffara.htm. Representations and Certifications: Offerors shall submit the following representations and certifications, which are incorporated into the draft BPA with its price proposal. FAR 52.212-3-Offeror Representations and Certifications-Commercial Items (April 2016) with its Alternate I (October 2014) DFARS 252.209-7992 Representation by Corporations Regarding an Unpaid Delinquent Tax Liability or a Felony Conviction under any Federal Law-Fiscal Year 2015 Appropriations. If the offeror has not completed the representations and certifications listed above online in the System for Award Management (http://www.sam.gov), the offeror shall complete these representations and certifications (as prescribed therein) and submit them with the offeror's price proposal. EVALUATION FACTORS The Government will use Simplified Acquisition Procedures permitted by FAR 13.5-Test Program for Certain Commercial Items to evaluate proposals submitted in response to the solicitation. The factors that shall be used to evaluate proposals are Technical and Price, as expounded below. FACTOR 1 - Technical: Pursuant to evaluation of all requirements, the Technical factor will receive and overall rating of either "Acceptable," or "Unacceptable" using the rating and descriptions in the table below: RatingDescription AcceptableProposal clearly meets the minimum requirements of the solicitation. Unacceptable Proposal does not clearly meet the minimum requirement of the solicitation. In determining whether a technical proposal is Acceptable or Unacceptable, the Government will consider the extent to which the technical proposal demonstrates the offeror's ability to: 1. Meet all evaluation factors as listed under "Performance Work Statement". FACTOR 2 Price: Price lists will be evaluated to determine if unit prices are fair and reasonable using the techniques described in FAR 13.106-3(a). Evaluation Process: •(a) The Government will initiate concurrent evaluation of all evaluation factors on all proposals.The Government will consider, toughout the evaluation, the "correction potential" of a proposal including whether any proposal deficiency can be rectified and whether any uncertainty can be resolved. The judgment of such "correction potential" is within the sole discretion of the Government. •(b) If pursuant to initial evaluation, the Government rates the Technical factor as "Unacceptable" or if the Government determines that there is some other deficiency or uncertainty relative to an offeror's proposal, and in the Government's judgment, the deficiency is rectifiable or the uncertainty is resolvable; the Contracting Officer (CO) may open discussions and may continue discussions as long as, in the Government's judgment, the deficiency is rectifiable or the uncertainty is resolvable. •(c) For the purpose of conducting discussions, if the Government rates the Technical factor as "Unacceptable" or if the Government determines that there is some other deficiency or uncertainty relative to an offeror's proposal, the entire proposal will be rated "Unacceptable." At the conclusion of discussions, if the Technical factor is rated "Unacceptable" or if any deficiency or uncertainty relative to the proposal has not been resolved, evaluation of that proposal will be considered final. The entire proposal will be rated "Unacceptable" and no further consideration will be given to that proposal for award. •(d) For the purpose of award without discussions, if pursuant to initial evaluation, the Government rates the Technical factor as "Unacceptable" or if the Government determines that there is some other deficiency or uncertainty relative to an offeror's proposal, notwithstanding that any deficiency may be rectifiable or any uncertainty may be resolvable, the entire proposal will be rated "Unacceptable," the initial evaluation will be the final evaluation, and no further consideration will be given to that proposal for award. Unless the Government has received a prior written notice that an offeror has withdrawn its proposal, the Government may accept the proposal in whole or in part before the proposal's expiration date. Attachment:•1. Provisions and Clauses•2. Performance Work Statement•3. FAR 52.222-22•4. FAR 52.222-25•5. FAR 52.209-2•6. FAR 52.212-3•7. Price List
FA8601-17-R-0060 Department of the Air Force Materiel Command Lifecycle Management Center Wright Patterson Air Force Base
7/27/17, 7:43 PM