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SUPPLIES OR SERVICES The purpose of this contract is to provide to veteran patients quality laboratory services. Contractor is to provide healthcare resources in accordance with Public Law 104.262 and... SUPPLIES OR SERVICES The purpose of this contract is to provide to veteran patients quality laboratory services. Contractor is to provide healthcare resources in accordance with Public Law 104.262 and 38 U.S.C. 8153. Contractor agrees to provide the following laboratory procedures/tests in support of the VA North Texas Health Care System (VANTHCS) in Dallas, Texas. Pricing includes all labor, materials, equipment and supplies necessary to perform certain human laboratory procedures/tests. Contractor shall perform and provide results for, but not limited to, the following procedures/tests. Additional tests may be added or removed as needed during contract period as required. Reference Lab Test Items as of 7/3/2018      Turn Around Perform Lab Detail Charge Description Order Mnemonic CPT Code  CoPath 88341 IHC, each add'l per specimen NP 88341  CoPath 88341 IHC, each add'l per specimen IHC 88341  VIROLOGY ADENOVIRUS ANTIBODY VADEN 86603  VIROLOGY  VARBGM   VIROLOGY CALIFORNIA (LACROS) ENCEP VARBGM 86651  VIROLOGY CALIFORNIA VIRAL ANTIBODY IGG VARBGM 86651  VIROLOGY EASTERN EQUINE ENCEP VARBGM 86652  VIROLOGY EASTERN EQUINE ENCEPH AB VARBGM 86652  VIROLOGY ST LOUIS ENCEPH IGG TITER VARBGM 86653  VIROLOGY ST LOUIS ENCEPH IGM TITER VARBGM 86653  VIROLOGY WESTERN EQUINE ENCEP VARBGM 86654  VIROLOGY WEST EQ ENCEPHALITIS VIRAL ANT VARBGM 86654  AP Process block + H&E IHC 978068  VIROLOGY CALIFORNIA VIRAL ANTIBODY IGG VCAEG 86651  VIROLOGY  VCMVAG   VIROLOGY SPIN FLUID CONCENTRATION VCMVAG 87015  VIROLOGY CMV BY DFA ANTIGENEMIA VCMVAG 87271  VIROLOGY  VCMVC   VIROLOGY CYTOMEGALOVIRUS CULTURE VCMVC 87252  VIROLOGY  VCMVGM   VIROLOGY CMV IGG TITER VCMVGM 86644  VIROLOGY CMV IGM TITER VCMVGM 86645  VIROLOGY CMV IGG TITER VCMVG 86644  VIROLOGY CMV IGM TITER VCMVM 86645  CoPath Default 88325 Consult, comprehensive NP 88325  CoPath Default 88325 Consult comprehensive NP 88325  CoPath Default 88325 Consult comprehensive IHC 88325  AP Dystrophin panel 88342x4 IHC 88342 1 day CoPath 88344 each multiplex antibody stain procedure IHC 88344 1 day CoPath 88344 each multiplex antibody stain procedure NP 88344 1 day CoPath 88344 IHC multiplex, per specimen IHC 88344 1 day CoPath 88344 IHC multiplex, per specimen NP 88344  VIROLOGY EASTERN EQUINE ENCEPH AB VEEEG 86652  VIROLOGY EASTERN EQUINE ENCEPH AB VEEEM 86652  VIROLOGY EBV VIRAL CAPSID IGM VEBVM 86665  VIROLOGY EB VIRUS EARLY ANTIGEN VEBVEA 86663  VIROLOGY EBV EARLY ANTIGEN VEBVNA 86664  VIROLOGY EBV VIRAL CAPSID IGG VEBVG 86665  VIROLOGY  VEBV   VIROLOGY EB VIRUS EARLY ANTIGEN VEBV 86663  VIROLOGY EPSTEIN-BARR EBNA IFA VEBV 86664  VIROLOGY EBV VIRAL CAPSID IGM VEBV 86665  VIROLOGY EBV VIRAL CAPSID IGG VEBV 86665  CoPath 88348-52 Electron Microscopy: Embed only NP 88348-52  CoPath 88348 Electron Microscopy: Complete NP 88348  CoPath 88348-52 Electron Microscopy: Embed and NP 88348-52  CoPath 88348-52 Electron Microscopy: Embed only IHC 88348-52  CoPath 88348 Muscle Bx,Electron Microscopy NP 88348  CoPath 88348 Muscle Bx,Electron Microscopy IHC 88348  CoPath 88348 Electron Microscopy: Complete IHC 88348  CoPath 88348-52 Electron Microscopy: Embed and IHC 88348-52  MOLECULAR MFVLED MFVLED 81241  AP Frozen section, first block IHC 88331  AP Hematoxylin & eosin IHC 978069  MICRO BIOLOGY HERPES SIMPLEX CULTURE VHSVC 87252  VIROLOGY  VHSVIG   VIROLOGY HSV I IGG TITER VHSVIG 86695  VIROLOGY HSV II IGG TITER VHSVIG 86696  VIROLOGY HERPES SIMPLEX 1 AG, IF VHSV1D 87274  VIROLOGY HSV I IGG TITER VHSVG 86695  VIROLOGY HSV 2 IGG TITER VHSVG2 86696  VIROLOGY HSV 2 IGM TITER VHSVM2 86694  VIROLOGY HERPES SIMPLEX 1 AG, IF VHSV1A 87274  MICRO BIOLOGY  VHSVFA   MICRO BIOLOGY HERPES SIMPLEX 1 AG, IF VHSVFA 87274 6 days CoPath 88361 Image Analysis - Computer Assisted NP 88361 6 days CoPath 88361-Image Asstd Morph Analy-Tumor NP 88361 6 days CoPath 88361 Image Asstd Morph Analy-Tumor NP 88361 6 days CoPath 88360 Image Analysis - Manual NP 88360 6 days CoPath 88347 Immunofluorescence - Indirect NP 88347 6 days CoPath 88342 Immunohistochemistry - IHC NP 88342 6 days CoPath 88342 Immunohistochemistry - IHC IHC 88342 6 days CoPath 88342 IHC, initial per specimen NP 88342 6 days CoPath 88342 IHC, initial per specimen IHC 88342 6 days CoPath 88343 Immunohisto Antibod Add Stain1 - s IHC 88343 6 days CoPath 88343 Immunohisto Antibod Add Stain1 - s NP 88343 6 days CoPath 88364 Insitu Hybridization Each Addtl Probe NP 88364 6 days CoPath 88364 ISH, each add'l per specimen NP 88364 6 days CoPath 88365 Insitu Hybridization Each Probe NP 88365 6 days CoPath 88365 ISH, initial, each probe per speci NP 88365 6 days CoPath 88364 Insitu Hybridization Each Addtl Probe IHC 88364 6 days CoPath 88364 ISH, each add'l per specimen IHC 88364 6 days CoPath 88365 Insitu Hybridization Each Probe IHC 88365 6 days CoPath 88365 ISH, initial, each probe per speci IHC 88365  VIROLOGY EIA QL MLT AG VULGNL 87449  CoPath 88305 Muscle Biopsy NP 88305  CoPath 88305 Muscle Biopsy IHC 88305  VIROLOGY MEASLES IGG TITER VMEASG 86765  VIROLOGY MEASLES IGM TITER VMEASM 86765  VIROLOGY  VMVC   VIROLOGY MISC VIRAL CULTURE VMVC 87252  VIROLOGY INTERFERON NEUTRAL. ABY VMVC 87253  AP Morphometric analysis, in situ hybridization, manual NP 88368  VIROLOGY MUMPS IGG TITER VMUMPG 86735  VIROLOGY MUMPS IGM TITER VMUMPM 86735  CoPath 88314 Muscle/Nerve Bx,Histochem 88314 NP 88314  CoPath 88314 Muscle/Nerve BxHistochem 88314 NP 88314  VIROLOGY MYCOPLASMA IGG TITER VMYCOG 86738  VIROLOGY MYCOPLASMA IGM TITER VMYCOM 86738  CoPath 88319 Nerve BxAddnl Det Enz Histochem NP 88319  CoPath 88319 Nerve BxAddnl Det Enz Histochem NP 88319  MICRO BIOLOGY  VPCPS   MICRO BIOLOGY SPIN FLUID CONCENTRATION VPCPS 87015  MICRO BIOLOGY PNEUMOCYSTIS STAIN VPCPS 87281  AP ProcessBlock IHC 88399  MOLECULAR MPROTH MPROTH   MOLECULAR MPROTH MPROTH 81240  MICRO BIOLOGY RSV SCREEN VRSV 87280  CoPath Default 88312 Special Stain Micro NP 88312  CoPath 88313 Muscle Bx,Histochem IHC 88313  CoPath 88313 Special Stain IHC 88313  CoPath 88313 Muscle Bx,Histochem NP 88313  CoPath 88313 Special Stain NP 88313  CoPath 88319 Special Stains Group III, enzyme constituents NP 88319  CoPath Default 88319 Special Stains Group III, enzyme c NP 88319  CoPath Default 88319 Special Stains Group III, enzyme c NP 88319  CoPath 88319 Special Stains Group III, enzyme constituents NP 88319  VIROLOGY ST LOUIS ENCEPH IGG TITER VSLEG 86653  VIROLOGY ST LOUIS ENCEPH IGM TITER VSLEM 86653  CoPath 88362 NerveBx, Teased Fiber Prep NP 88362  CoPath 88362 NerveBxTeased Fiber Prep NP 88362  CoPath 88362 NerveBx,Teased Fiber Prep NP 88362  AP Unstained sections IHC 978070  Draw Stn VENIPUNCTURE DVP 36415  Draw Stn VENIPUNCTURE DVP 36415  VIROLOGY VZV IGG TITER VVZVG 86787  VIROLOGY VGV IGM TITER VVZVM 86787  VIROLOGY  VWNEC   VIROLOGY WEST NILE VIRUS IGG ANTIBODY VWNEC 86788  VIROLOGY WEST NILE VIRUS IGG IGM VWNEC 86789  HEMOSTASIS  VWBPLX   HEMOSTASIS FIBRIN OR COAG SCRN W I&R VWBPLX 85390  HEMOSTASIS 2 MICRO G COLLAGEN VWBPLX 85576  VIROLOGY WEST EQ ENCEPHALITIS VIRAL ANT VWEEG 86654  VIROLOGY  VWNE   VIROLOGY WEST NILE VIRUS IGG ANTIBODY VWNE 86788  VIROLOGY WEST NILE VIRUS IGG IGM VWNE 86789  VIROLOGY WEST NILE VIRUS IGG ANTIBODY VWNEMR 86788 3 days CYTOGENETICS Chromosome Analysis (Bone Marrow) *Specimen must arrive at laboratory within 24 hrs.   6 days CYTOGENETICS FISH STUDIES    Reproductive Endocrinology Semen Analysis ***Patient reports to RE lab to collect and submit specimen. Specimen must be tested within one hour of collection.   1-3 days HEMOSTASIS Platelet Aggregation - specimen must arrive at laboratory within 1 hr. of collection.   STATEMENT OF WORK Contractor shall provide laboratory services to the Pathology & Laboratory Medicine Service of the VA North Texas Health Care System, Department of Veterans Affairs Medical Center, located at 4500 S. Lancaster Road, Dallas, Texas. Tests will be performed as prescribed by the VA attending physician. Contractor shall provide laboratory services to include daily scheduled specimen transportation, analysis and reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation. Results are to be accessible through the contractor s electronic database by P&LMS personnel. Contractor will supply test kits, collection containers, and specimen transport supplies. Supplies will be delivered at no charge at the request of P&LMS personnel and/or through vendor s automated inventory system. Contract shall cover a period from October 1, 2018 through September 30, 2023. Contract will be renewable for (4) option years. Pricing will be provided for the base year and each option year. Base Period TBD Option 1 October 1, 2019 through September 30, 2020 Option 2 October 1, 2020 through September 30, 2021 Option 3 October 1, 2021 through September 30, 2022 Option 4 October 1, 2022 through September 30, 2023 VA North Texas Health Care System (VANTHCS) may award multiple contracts. The test and/or volumes listed are independent government estimates and VANTHCS makes no guarantee as to what volume of tests, if any, the contractor may receive. VANTHCS reserves the right to request additional tests other than those listed within. If additional tests are added, either by the contractor or VANTHCS, the contractor will provide appropriate CPT codes for the new tests. Contractor shall provide all labor, equipment, and materials required to perform procedures/tests as stated herein. These procedures/tests shall be performed to the satisfaction of VA North Texas Health Care System (VANTHCS) Pathology & Laboratory Medicine Service, Chief of Staff, and the Contracting Officer s Technical Representative (COTR). Services rendered will be verified by a record keeping system maintained by Pathology & Laboratory Medicine Service and Fiscal Service at VANTHCS, which assures that the VA pays for only those services actually requested, and only for valid patients of VANTHCS. Contractor shall provide to the COTR the methodology and ranges for results on any tests that are requested. Security Requirements: VA Protected Health Information is provided to the vendor under this contract. This contract is to enable a HIPAA Covered Entity to provide clinical services on behalf of VA.  A patient s consent is not required (1605.1P24). The vendor is required to secure the PHI as required by HIPAA. SECTION B: DESCRIPTION/SPECIFICATIONS DEFINITIONS: LAB ADVISORY COMMITTEE: An individual or group of laboratory directors (Chiefs) or their designees that evaluate the medical/technical/service/quality qualifications of offerors labs. During the life of the contract, this group monitors the quality and service provided by the contractor. SPECIAL HANDLING: Unusual circumstances may dictate the need for a specimen to be picked up specially, run out of sequence or at a special time, or reported within a shorter than usual time. CONTRACTING OFFICER: The Contracting Officer (CO) named below is responsible for the overall administration of this contract. Contractor is advised that only the Contracting Officer, acting within the scope of his/her duties and responsibilities, has the authority to make changes to the contract, which affect contract prices, terms and conditions of this contract: VA North Texas Health Care System Contracting Officer 90C 4500 S. Lancaster Road Dallas, Texas 75216 Roseburg OR 97470 (214) 857-0036 CONTRACTING OFFICER TECHNICAL REPRESENTATIVE: A Technical Representative of the Contracting Officer (COTR) will be designated to represent the Contracting Officer in furnishing technical guidance and advice under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to Contractor relative to the financial or legal aspects of the contract. Those matters are the responsibility of the Contracting Officer and shall not be delegated. LAB REPORTS: All lab reports shall contain at a minimum the following information: Patient s full name Physician name Type of specimen Patient s Social Security Number Patient Date of Birth Requesting Facility REPORTING OF LAB REPORTS RESULTS: All lab reports shall be reported via fax, and a hard copy of all lab results shall be sent via courier. In extenuating circumstances which will not allow for the Contractor to report results via fax or sent by courier, reports can be reported via mail. CLINIC CONTACTS: Contractor shall consult with the VANTHCS Laboratory Manager on test results via phone as needed. The contractor can contact the providers at: (214) 857-0666. CONTRACTOR POINT OF CONTACT: Contractor shall provide the following point (s) of contact when immediate inquiry regarding the status of a pending test (s) is required: A) Person (s) name (s): ____________________________________________________ B) Telephone number: ____________________________________________________ C) Fax number: _________________________________________________________ PAYMENT: The VA shall not be responsible for payment for services which were not requested in accordance with contract. TRANSPORTATION OF SPECIMENS: Contractor shall transport specimens in such a manner as to ensure the integrity of the specimen. Frozen specimens shall be shipped on dry ice, provided by contractor. Contractor is also responsible for completing hazardous goods forms and proper labeling. LICENSING AND ACCREDITATION: Contractor shall have all licenses, permits, accreditation and certificates required by law. Personnel assigned by the contractor to perform these services covered under this contract shall be licensed in a State, Territory or Commonwealth of the United States or the District of Columbia. The lab must be accredited by the College of American Pathologist (CAP) or have JCAHO and Clinical Laboratory Improvement Amendments (CLIA) (Public Law 100-578) certifications or C LIA waiver. Contractor must submit proof of JCAHO and CLIA certifications/waiver along with their offer. Laboratory Director shall be a licensed pathologist, physician, or biologist. By the end of each month following the end of the quarter, the contractor shall provide to the Laboratory Manager and COR a cumulative (year-to-date) summary report by test. The report shall include at minimum the following Number of tests performed Number of test rejections with reason for rejection TAT for each test order during that quarter The VA shall have access to inspect the contractor s facilities, equipment and records. The results of these inspections shall be published and given to the contractor. Contractor shall immediately advise the Laboratory Manager and COR of any changes in methodology, procedure, reference ranges and any new test introduced, including CPT code. Contractor shall provide the following information annually during the life of the contract: Indication of average monthly volume of specified tests listed in this contract. Provide address of processing sites under contract, including subcontracted testing location sites. Proficiency testing data shall include a list of tests outside of the -+2SD range for the past two (2) years. Contractor shall notify lab of any test falling outside -+2SD range during contract period. Contractor agrees to maintain the satisfactory service, reporting systems and quality control as specified herein. Acceptable performance will be determined annually by the criteria listed below. Scoring Average score value per category: Exceptional 4 Very Good 3 Satisfactory 2 Marginal 1 Unsatisfactory <1 Standard Task ID (CPARS) Indicator Acceptable Quality Level Method of Surveillance Incentive Minimal unsuccessful performance due to instrument or reagent issues. Quality Assurance 1.1 Successful peer group comparison 90% satisfactory performance to peer group. Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85% CAP survey reports Exercise of Option Period Result delays are minimal. 1.2 Turn around time 90% within established turn around time annually. Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85% Problem records Sendout records TAT reports Telephone Support is responsive. 1.3 Telephone inquiries 100% Issues resolved Exceptional: 100% Very Good: 98-99% Satisfactory: 95-97% Marginal: 85-89% Unsatisfactory: <85% Problem records Exercise of Option Period Invoices are submitted monthly. Cost Control 3.1 Invoice Accountability 100% Invoices received through OLCS via Austin, Texas Invoice records Exercise of Option Period Invoices are itemized by service or product received. 3.2 Invoice Verification 80% Invoices contain all necessary information for proper processing. Excellent: 95-100% Very Good: 90-94% Satisfactory: 85-89% Marginal: 80-84% Unsatisfactory: <80% Invoice records Exercise of Option Period Contractor will provide proactive notification of changes. 3.3 Notification of significant changes in reagent and equipment modifications 100% Proactive notifications. Quality Bulletins Customer Letters Customer Contact Exercise of Option Period Timely recall notification of reagent and supplies. 3.4 Recall Notification 100% Recall notifications within 1 month of issuance. Quality Bulletins Customer Letters Customer Contact Exercise of Option Period Works with customer to resolve complaints. Customer Satisfaction 7.1 Substantiated complaints No unresolved substantiated customer complaints per year Order records Invoice records Customer communications Problem records Troubleshooting records Exercise of Option Period Timely follow-up on complaints. 7.2 Complaint Handling 90% Complaint follow-up within 24 hours of initial complaint or within agreed upon timeframe. Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85% Order records Invoice records Customer communications Problem records Troubleshooting records Exercise of Option Period The contractor must also include names and telephone numbers of technical directors and pathologists available for consultation. Contractor shall assign a specific account representative to each facility. The Government may evaluate the quality of the professional and administrative services provided, but retains no control over the medical professional aspects of services rendered (e.g. professional judgments, diagnosis for specific medical treatment). CANCELLATION: The government may terminate this contract at any time upon at least 30 days written notice by the contracting officer to the contractor. The contractor, with written consent of the contracting officer, may terminate this contract upon at least 30 days written notice to the contracting officer. INVOICING: Invoices must contain at a minimum the following information. Contractor shall provide this information on one original invoice: Invoice number Contract number Proper CPT and LOINC Code Unit Cost Total Cost Date of Service GOVERNING LAW: This contract shall be governed, construed and enforced in accordance with Federal Law. MARKETING: Contractor shall not advertise or use any marketing material, logos, trade names, service marks, or other material belonging to the VANTHCS without the VANTHCS consent. ORDER OF PRECEDENCE: The terms, conditions, and attachments referenced herein, including any formal written modifications thereto, constitute the complete agreement between the parties and take precedence over any other language, oral or written. RECORDS MANAGEMENT All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTHCS) and must be returned to VANTHCS at the end of the contract. 653-26-05 5-6 NARA RM Language Clause to be included in contracts, as necessary: 1. Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 21 , 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. 2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. 3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. 4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. 5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract or identified in the RCS 10-1. 6. The Government Agency owns the rights to all data/records produced as part of this contract. 7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. 8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. 9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. 10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. References: VHA Directive 6300 VA Handbook 6300.1 North Texas VA Medical Center Policy VA Directive 6500 36 CFR Part 1222.32 (b)