LABORATORY TESTING & INTERPRETATION OF SPECIMENS FOR CANCER, COAGULATION AND SPECIALIZED DISEASE For PORTLAND VA MEDICAL CENTER 3710 SW US VETERANS HOSPITAL RD PORTLAND, OREGON 97239 1.0 GENERAL: 1.1 Authority: This contract is entered into under the authority of Public Law 104-262 and 38 U.S.C.8153. The contractor agrees to provide Health Care services in accordance with the terms and conditions stated herein at the Portland VA Medical Center (PVAMC). 1.2 Services Required: Department of Veterans Affairs (VA) Medical Center, 3710 SW US Veterans Hospital Road, Portland, Oregon (hereinafter called PVAMC) requires laboratory testing for Cancer, Coagulation and specialized disease and the interpretation of these tests. 1.3 Place of Performance: The contractor will perform testing and interpretation at the contractors site. 1.4 Period of Performance: This will be a base period plus four 1-year options that may be exercised by PVAMC. No services shall be performed by the contractor after the base period without written approval from the contracting officer. 1.5 Scope of Work: a. This contract is only for PVAMC. It will be a fixed firm price with estimated quantities. The contractor will be paid on a monthly basis for each month's pathology aid services in arrears. b. Services outside the scope of work: Services outside the scope of this contract shall not be performed unless and until specifically authorized by the contracting officer. Any services performed without this authorization, (whether written or verbal), will be at the expense of the contractor. c. The contractor performs testing and interpretation of PVAMC specimens. 1.5.1. Contractor's Specific Requirements: 1. Work Hours: NA 2. Personnel Policy: NA 3. Record Keeping: NA 4. Contract Performance Monitoring: see 7.1 Oversight of Service/Performance Monitoring 5. Key Personnel and temporary emergency substitutions: NA 2.0 PERSONNEL: NA 2.1. Qualifications: The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, interpretation of patient specimen testing listed below. All requirements and provisions defined in the specification of this solicitation will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the Reference Laboratory. 2.2 Technical Direction: 1. Invoices: Invoices shall be submitted monthly in arrears with the following information a. Contract number and purchase order number. b. Station ID (648) c. Date and times of service d. Invoices will be billed as individual line items as they are listed in the price schedule 2. Monthly invoice(s) will contain only those items numbers used for that month. Invoices not received in proper format will be returned. 3. Marketing: Contractor shall not advertise or use any marketing material, logos, trade names, service marks, or other material belonging to the VA without consent. 2.3 Non-Personal Services: NA 3.0 HOURS OF OPERATION: NA 4.0 CONTRACTOR RESPONSIBILITIES: The contractor shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, interpretation of patient specimen testing listed below. All requirements and provisions defined in the specification of this solicitation will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the Reference Laboratory. Task 1. Contractor is responsible for providing requisition forms, special instructions, and current list of tests with reference ranges, turn-around-times and specimen requirement. Task 2. Contractor is responsible for providing a secure interconnection between PLMS and the reference lab. The connection will transmit data to a dedicated printer at PLMS. The contractor will provide the dedicated printer and perform any maintenance the printer requires. This interconnection shall be protected through the use of VA approved encryption algorithms and products as required. Connections at each end shall be located within a controlled access site. All access shall be controlled by authentication methods to validate approved users. Task 3. Contractor agrees not to use or disclose Protected Health Information (PHI) other than as permitted or required by the agreement or as required by law. Task 4. Contractor agrees to use appropriate safeguards to prevent use or disclosure of the PHI other than is provided for by this agreement. Task 5. Contractor agrees to report immediately any breach of safeguards and to mitigate any harmful effect related to the use or disclosure of PHI by the Reference Laboratory or any of its agents, including subcontractors. Task 6. Contractor agrees to provide services during and after working hours. Task 7. If applicable, the contractor agrees to transport samples in such a manner as to insure the integrity of the specimen. Task 8. The contractor will comply with reporting test results with the specified time frame in accordance with the nature of the testing, following all regulatory requirements for reporting of patient results. Test results shall be reported within the specified times established by the Reference Laboratory. Critical value test results shall be reported immediately by telephone. Results will be sent to the VA via a secure means and in compliance with HIPPA guidelines. Task 9. The contractor will consult with PLMS on test result by telephone as needed. Task 10. The contractor will provide PLMS with means of communication to the contractor to permit immediate inquiry regarding the status of pending tests. Task 11. The contractor will provide data on tests not performed due to issues such as sample type, quantity or stability. Task 12. The contractor will have the ability to provide test related information that can be used to help select the proper test and interpret results readily available and easy to access. Task 13. The contractor will pick-up all specimens, at no-charge to the government. LAB TESTING 1 Oct 2014 - 31 May 2015 Description Est Qnty for 1 yr Est $/ea Base Period Program Hormone Receptors, ER, PR, EA 230 Cancer IMMUNOHISTOCHEMISTRY 230 Cancer MSI MULTIPLEX PCR 230 Cancer MSI MULTIPLEX PCR 1ST 2 230 Cancer MYELOPEROXIDASE STAIN 208 Cancer SPECIAL STAIN OTHER 100 Cancer IN SITU HYBRIDIZATION 230 Cancer interphase 100-300 cells 245 Cancer METHOTREXATE 230 Cancer RETICULATED PLATELETS 100 Cancer SUDAN BLACK B STAIN LEUKOCYTE 100 Cancer SURFACE MARKER AB ADDL 100 Cancer SURFACE MARKER AB FIRST 98 Cancer T CELL QUANT (T,B AND NK) 100 Cancer Addl Karyotype simple 230 Cancer Bone Marrow Chromosome 250 Cancer ABL SEQ MOLE SEP BY CAP ELE 230 Cancer BCR lysis of cells 230 Cancer BCR NUCLEIC ACID PROBE 230 Cancer BCR REVERSE TRANSICPTION 230 Cancer BCR SIGNAL AMPLIFICATION 230 Cancer JAK2 extraction HP 230 Cancer JAK2 PCR 230 Cancer JAK2 separation 230 Cancer molecular probe 230 Cancer EOSINOPHILS Fish Probe 230 Cancer DVV confirm ratio 230 Coagulation DVVT 230 Coagulation Butyrate Esterase Stain 230 Coagulation CNT 15-20 cells 2 karyotype 230 Coagulation DECALIFICATION 230 Coagulation Hem onc bld chromo 230 Coagulation ANTI-B2-GLYCOPROTIEN ICG 230 Coagulation ANTICARDIOLIPIN IGG or IGM 230 Coagulation ANTITHROMBIN ACTIVITY 230 Coagulation APTT 1"1 MIX 0 MIN 230 Coagulation APTT PLASMA 60 MIN 230 Coagulation FACTOR II ACTIVITY 230 Coagulation FACTOR IX ACTIVITY 230 Coagulation Factor V Activity 230 Coagulation Factor V inhibitor 230 Coagulation Factor VII Activity 230 Coagulation FACTOR VIII COAG ACTIVITY 230 Coagulation FACTOR VIII VWF AG 230 Coagulation FACTOR X CHROMOGENIC 230 Coagulation FACTOR XI ACTIVITY 230 Coagulation FACTOR XII ACTIVITY 230 Coagulation FACTOR XIII QUAL 230 Coagulation HEPARIN EITHER STD/LMW 230 Coagulation HEPARIN PLT AB LUMI AGG 250 Coagulation HEXAGONAL PL APTT 230 Coagulation PLATELET FACTOR 4 W/REFLEX TO HAL 100 Coagulation Platelet Function Analysis 100 Coagulation VONWILL/RAF 100 Coagulation OSMOLALITY, PLASMA 100 Instrument Backup OSMOLALITY, URINE 100 Instrument Backup PREP SURG SPEC LEVEL IV 100 Specialized Pathology ELECTRON MICROSCOPY 250 Specialized Pathology G6PD QUANT 230 Specialized Pathology HISTOCHEMICAL STAIN WITH FS 230 Specialized Pathology IMMUNOFLUORESCENCE (EA) 230 Specialized Pathology MONOSPOT 230 Specialized Pathology INTERPRETATION 1 Oct 2014 - 31 May 2015 Description CPT Est Quantity Base Period Molecular diagnosis: interpretation and report 83912 400 Blood Smear peripheral interpretation with report 85060 380 Bone marrow smear interpretation, with or without differential cell count 85097 380 Cytopathology, concentration technique, smears and interpretation 88108 380 flow cytometry, interpretation; 2-8 markers 88187 300 flow cytometry, interpretation; 9-15 markers 88188 300 flow cytometry, interpretation; 16 or more markers 88189 300 Cytogentics and molecular cytogenetics, interpretation and report 88291 300 Level IV surgical pathology, gross and microscopic examination 88305 300 Special Stains, group II 88313 300 Special Stains, histochemical staining with frozen sections 88314 300 Determinative histochemistry or cytochemistry to identify exzyme constituents 88319 300 Consultation and report on referred slides prepared elsewhere 88321 298 immunocytochemistry (including immunoperoxidase) each antibody 88342 350 Immunoflourescent study, each antibody, direct method 88346 365 Electron microscopy, diagnostic 88348 395 Morphometric analysis, in situ hybridization 88368 396 Macroscopic examination, dissection, and preparation of tissue for non-microscopic analytical studies (nucleic acid-based molecular studies) 88387 400 5.0. DIRECT PATIENT CARE: NA 6.0. ADMINISTRATIVE: NA 7.0 GOVERNMENT RESPONSIBILITIES: 7.1 Oversight of Service/Performance Monitoring: 1. Oversight and performance monitoring will be accomplished by following the attached QASP. Services rendered will be verified PLMS staff, which assures the VA pays for only those services actually requested. 2. The services specified in this contract may be changed by written modification to this contract. The modification will be prepared and approved by the VA contracting officer prior to becoming effective. 3. 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. 4. Contracting Officer: The Contracting Officer (CO) 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: 5. Governing Law: This contract shall be governed, construed and enforced in accordance with Federal Law. 8.0 Performance Standards, Quality Assurance And Quality Improvement. The contractor shall: " Address all patient safety events as defined in VHA Handbook 1050.1 which include: Adverse events, Sentinel Events, Close Calls and intentionally unsafe acts. " Ensure that upon notification of an unconfirmed patient safety event, it is immediately reported to the Contracting Officers representative. " Ensure that patient safety events are confirmed, investigated, and resolved. " Ensure that the Contracting Officers representative is informed throughout all investigations and that all findings and conclusions are reported to the Contracting Officers representative. 8.1 Methods of Surveillance: In accordance with the QASP. 8.2 Performance Standards: Contract personnel shall be subject to the following standards and acceptable quality levels. 8.2.1 Standard 1 - Provides required service as specified in the contract. Standard 1 - AQL: 100% 8.2.2 Standard 2 - Complies with all contract security requirements. Standard 2 - AQL %100 8.2.3 Standard 3 - Completes all testing in a timely fashion in accordance with the contractors published Test Menu.. Standard 3 - AQL 100% 7.0. Special Contract Requirements: NA 7.1. Contractor Security Requirements: NA

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