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Q -- Labcorp Reference Test Services 4/1/18 to 09/30/2018 - Attachment

Notice Date
Notice Type
621511 — Medical Laboratories
Contracting Office
00504;Department of Veterans Affairs;Contracting Section;7201 I-40 West Suite 100;Amarillo TX 79106
ZIP Code
Solicitation Number
Response Due
Archive Date
Point of Contact
Department of Veterans Affairs
E-Mail Address
Small Business Set-Aside
14 NOTICE OF INTENT TO AWARD: The purpose of this Notice is to provide Fair Opportunity in accordance with FAR 16.505, Ordering. Department of Veterans Affairs (VA) Network Contracting Office 17 (NCO 17) intends to award a Task Order from its Western States Network Consortium (WSNC) Reference Laboratory Blanket Purchase Agreement (BPA) contract VA260-16-A-0008 to LabCorp. This requirement is to provide all necessary service and support for Laboratory Fee Basis Testing IAW the statement of work (SOW) The NAICS Code is 621511, with a Size Standard of $32.5M and the PSC Code is Q301. THIS NOTICE IS NOT A REQUEST FOR QUOTES; however, any firm that believes it can meet the requirements may give written notification prior to the response due date and time. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to perform the requirements. Responses received will be evaluated; however, proposed procurement based upon responses to this notice is solely within the discretion of the Government. If no responses are received, the Government will proceed with the award. Responses are due by March 14, 2018 by 12:00 noon (CST). Responses shall be submitted via e-mail to Ronalda.ohio@va.gov. Telephone requests or inquiries will not be accepted. DESCRIPTION/SPECIFICATIONS/WORK STATEMENT LABORATORY CORPORATION OF AMERICA STATEMENT OF WORK: Contractor agrees to furnish all personnel, labor, transportation, equipment, materials and supplies necessary to provide Laboratory Fee Basis Testing and guidance in Clinical Pathology Procedures as specified herein for eligible VA beneficiaries of the VA Texas Valley Coastal Bend Health Care System. Laboratory requests will be entered into the VA Veterans Health Information Systems and Technology Architecture (VISTA) by the VA VBC Pathology and Laboratory Medicine Service Processing Section. Once laboratory requests are processed by the Contractor, the results will be returned to the VA VBC PLMS via secure fax or secure computer work station for entering results in VISTA by VA lab staff personnel. Information will then be made electronically available to the clinicians by VA VCB labs. Laboratory procedures that have not been assigned a log number will not be paid by the VATVCBHCS or performed by the Contractor. INVOICING: Payment to be made monthly in arrears by certified invoices and must contain the contract number and obligation number in addition to the requirements detailed in 52.212-4 (G) to be considered valid. Invoices shall also contain a line item for each test and quantities billed for. VATVCBHCS will not pay for tests that are not clearly identified by accession number on the Contractors invoice. LabCorp shall provide Company with a detailed monthly invoice. Payment must be submitted within thirty (30) days of the invoice date. WORK HOURS: Contractor shall be responsible for providing services in between the hours of 8:00am and 4:30pm Monday through Friday excluding Federal Holidays. Federal Holidays are as follows: New Year s Day, Martin Luther King s Birthday, President s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day and any other day specifically designated as a national holiday by the President of the United States. SCOPE OF WORK: Contractor shall provide laboratory services to include pickup and transport of specimens to its laboratory; pre-analytic processing as defined in its laboratory user s manual; analysis, reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation. The contractor shall provide the following services, provide all necessary supplies, not limited to the following: Requisition forms Specimen containers Dry ice and appropriate container Special instructions Current list of tests with reference ranges and specimen requirements Specimen carriers All forms, including Chain of Custody forms Special media or tubes for viral samples All supplies for special tests (e.g., but not limited to, viral studies) Provide specimen pick up services as defined in the contract. Transport samples in such a manner as to ensure the integrity of the specimen. Contractor shall supply any special preservatives required for specimen preservation. Analyze samples. Routine test results shall be reported within 24 hours of specimen testing. STAT test results shall be reported within 2-4 hours or less of specimen testing. Critical Value test results shall be reported immediately. Provide test report summaries by the 3rd workday of each month following the month in which service was delivered. Consult with Laboratory on test results by telephone as needed. Provide VCB Laboratories with a means of communication to permit immediate inquiry regarding the status of pending tests. Billing and test report summaries shall begin the first day of the month and include the last day of the month. CONFIDENTIALITY AND NONDISCLOSURE: The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by the VA which has been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. Press releases, marketing material or any other printed or electronic documentation related to this project shall not be publicized without the written approval of the Contracting Officer CONTRACTOR PERSONNEL SECURITY REQUIREMENTS: All contractor employees who require access to the Department of Veterans Affairs computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance.   In addition, other Contractor personnel may require background investigations depending upon a risk assessment to be accomplished by the VA Using Service in coordination with the VA s Information Security Officer.   This requirement is applicable to all subcontractor personnel requiring the same access.   The Contractor shall be responsible for ensuring that all necessary documentation is submitted for his/her employees and the employees of his/her subcontractors. Information Systems Officer, Information Protection:   The contractor will follow the Memorandum of Understanding/Interconnection Security Agreement between Department of Veterans Affairs and Laboratory Corporation of America Holdings (June 20, 2014) to document the terms and conditions for sharing data and information resources in a secure manner. The information within the MOU will define the purpose of the interconnection, identify relative authorities, specify the responsibilities of both organizations, and define the terms of the agreement. The contractor will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services.   Position Sensitivity The position sensitivity has been designated as High Risk. Background Investigation The Level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries. Contractor Responsibilities The contractor shall bear expenses of obtaining background investigations.   The VA facility will pay for investigations in advance.   The contractor will reimburse the VA facility within 30 days.   The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and can read, write, speak, and understand the English language.   The Contractor shall submit or ensure that their employees submit the required information to the Contracting Officer and Contracting Officer s Representative (COR).   The Contractor shall submit the required forms to the VA Security and Investigations Center within 5 days of receipt of the e-mail they receive with instructions to do so.   The Contractor shall not allow Contractor personnel who require a background investigation to start performing until the Contractor has received written confirmation from the Contracting Officer that the SIC has initiated a background investigation. The Contractor, when notified of and unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract. The Contractor shall ensure that all personnel requiring computer access will complete the VA s Cyber Security Training and Privacy training prior to obtaining computer access and annually thereafter. Failure to comply of with the contractor personnel security requirements may result in termination of the contract for default. PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL: If required, Contracting Officer Representatives will be responsible for coordination with Human Resources Management Services (HRMS) to obtain identification badges for contract personnel working under contract for which he/she has responsibility.   Contractors will wear/display issued identification badges in a visible manner while on VATVCBHCS property. These procedures implement Homeland Security Presidential Directive-12 (HSPD-12), Office of Management and Budget (OMB) guidance M-05-24, and Federal Information Processing Standards Publication (FIPS PUB) Number 201, for contracts requiring contractor to have physical access to a federally-controlled facility or access to a Federal information system. HIPPA COMPLIANCE: Contractor must adhere to the provision of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI).   As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA).   In accordance with 45 CFR 164.502(e), the Privacy Rule includes exceptions to the Business Associate Standard.   This requirement meets the exception and does not require a Business Associate agreement in order for Covered Entity to disclose Protected Healthcare Information to a health care provider for treatment. Contractor will provide health care to patients seeking such care from or through VA.   As such, contractor is considered part of the Department health activity for purposes of the following statutes and the VA regulations implementing these statutes:   the Privacy Act, 5.U.S.C. § 552a, and 38 U.S.C. §s 5701, 7705 and 7332.   Contractor and its employees may have access to VA patient medical records to the extent necessary for the contract or to perform this contract.   Notwithstanding any other provision of this contract, contractor and its employees may disclose patient treatment records only pursuant to explicit disclosure authority from VA.   Contractor and its employees are subject to the penalties and liabilities provided statutes and regulations for unauthorized disclosures of such records and their contents. Records created by the contractor in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations.   Upon the expiration of this contract or termination of the contract, the contractor will promptly provide the VA with the individually identified VA patient treatment records.   VA has unrestricted access to the records generated by the contractor pursuant to this contract. JOINT COMMISSION, VHA, QM AND OTHER STANDARDS: The Contractor must perform the required work in accordance with Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), the College of American Pathologists (CAP) and Veterans Health Administration Standards. The JCAHO website is: http://www.jointcommission.org/.   The Contractor must comply with all annual updates as issued. Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Failure to comply with the specified terms and conditions and/or adverse reports from external monitoring agencies that indicate poor quality of care may be grounds for termination of the contract. Contract shall provide immediate notification, within 24 hours, to the responsible VA Official of any adverse action by a regulatory agency. CONTRACTOR AUTOMATION SECURITY REQUIREMENTS: Unless written authorization is issued by the Contracting Officer, contractor employees will not use any form of removable storage media when providing services under the terms of this contract.   Removable storage media includes, but is not limited to, USB thumb drives, MP3 Players, and external hard drives.   Should the Contractor determine that the use of removable storage devices is required they must submit a written request with full justification to the Contracting Officer.   For Contractor employees who have access to and stores VA information, the Contracting Officer must receive written permission from a VA supervisor and VA Information Security Officer (ISO) before authorizing Contractor employees to use such devices, and if used to store sensitive information, the device must contain protective features that have the approval of the local senior Office of Information and Technology (OI&T) official.   Unless and until this written authorization is received, Contractor personnel are not authorized to use any form of removable storage media when providing services under the terms of this contract. VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE (VA Handbook 6500.6 Appendix B): 1. SUBPART 839.2 INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS 839.201 Contract clause for Information and Information Technology Security: a. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). b. In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources. 2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008) As prescribed in 839.201, insert the following clause: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE (VA Handbook 6500.6 Appendix C) (See attachment below) CONTRACT CLOSEOUT: The Contractor will furnish a statement in writing to the Contracting Officer at close out of the contract to include summary of the contractor actions and statement that all requirements of the contract were fulfilled as agreed. A summary evaluation of contract performance based upon the compliance or noncompliance of contract to include a summary of contractor actions and statement that all requirements of the contract were fulfilled as agreed. CONTRACTING OFFICER S REPRESENTATIVE: The Contracting Officer s Representative (COR) is identified as the Administrative Officer (or designee) for Pathology and Laboratory Medicine Service. Prior to contract award, the Contracting Officer shall designate a VA Medical Center employee as the Contracting Officer's Representative (COR). All work coordination shall be made through the COR. The Contractor shall be provided a copy of the letter of delegation authorizing the COR at the commencement of the term of this agreement. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such changes at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. GOVERNMENT INHERENT FUNCTIONS: The contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy. GENERAL DUTIES, REQUIREMENTS AND EXPECTATIONS: Services provided under the terms of this contract are required to be in compliance with the American Association of Blood Banks (AABB) and College of American Pathologists (CAP) accreditation policies and all applicable Federal, State and Government laws. MONITORING RECORD/KEEPING: Procedures performed at the LabCorp will be monitored and validated against billings using the VISTA Laboratory Package, VISTA Imaging, PCE (Patient Care Encounter), and PTF (Patient Treatment File). These systems will be used to verify statistics reflecting Current Procedural Terminology (CPT) codes that will be used to validate services provided under the terms of the contract. Records Manager:   There will be federal records created, maintained, used or disposed with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.]. The COR will track and record difficulties such as poor turnaround time. Any noted difficulties or deficiencies will be reported to the contracting officer for appropriate action and remedy. Scope of Work: Contracting with LabCorp is necessary to submit testing required/requested by the health care providers that is not performed routinely by the Laboratories within VCB. The Contracting Officer Representative (COR): The COR will track and record difficulties such as poor turnaround time. Any noted difficulties or deficiencies will be reported to the contracting officer for appropriate action and remedy. Contractor shall provide the following information upon request: Indication of average monthly volume of specified tests listed in this contract. Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs. Provide address of processing sites under contract, including subcontracted testing location sites. Contractor Point of Contact: Contractor shall provide a point of contact for inquiries regarding pending test results status. The following information for the point of contact shall be provided: Name & Phone number. Orders: Facility will collect and process specimens per LabCorp guidelines to assure specimen integrity. Specimen will be submitted to LabCorp using the appropriate requisition form completed LICENSING and ACCREDITATION: Contractor shall have all licenses, permits, accreditation and certificates required by law before starting work under this contract. Technologist, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology acceptable to the United States Surgeons General must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction; and shall have provided pathology services a minimum of 24 months within the past 36 months and pathology consultation services a minimum of 36 months within the past 48 months. 16.2 The Contractor shall maintain current licenses and certificates and provide copies of such to VA upon reasonable written request. 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 Stated 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. Contractor must submit proof of JCAHO and CLIA certifications along with their offer. Laboratory Director shall be a licensed physician. NARA RM Language Clause: 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. 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. PROCEDURE GUIDANCE: The Contractor shall not introduce new medical procedures and services for specimens provided by VA without prior recommendation to, and approval of, the COR, or authorized laboratory representative. The Contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy (per all applicable regulatory agency [RA] guidelines). The standard deviation and daily control records are to be available for review upon request by the Contracting Officer or contracting officer s representative. The Contractor shall perform repeat tests at no charge to the government if the results do not, in the government requesting physician's opinion; fit the clinical picture of the patient. When requesting these tests, the government requesting physician or representative will explain the conditions of the patient or any discrepancies observed. Repeat tests shall be the same test originally ordered. The Contractor shall notify the VA COR or designee of instances in which, in the professional judgment of the Contractor, the patient requires services or tests, which were not originally requested. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government. Contractor shall fill out and maintain for specimens the VA provided test request form necessary to meet clinical and administrative requirements of VA at no additional expense to the government. The Contractor shall contact the VA COR to coordinate the furnishing and delivery of specimen collection and transportation supplies. The Contractor shall provide to the VA facilities the supplies within two (2) work days after receipt of the delivery order. The VA COR will request replenishment of supplies from the Contractor on an as needed basis. SPECIMEN PICK-UP TIMES: STAT/Emergency- the Contractor shall pick up STAT/emergency specimens within one (1) hour of notification of specimen availability. Routine. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA COR but not less than once each day. The VA COR or designee shall notify the Contractor during weekends (if not already scheduled) and federal holidays, via telephone, when a pick-up courier is required. TEST RESULTS: STAT/Emergency. The Contractor shall provide telephonic or fax response with test interpretation within no more than two to four (2-4) hours of specimen testing in Contractor s testing facility. The Contractor shall report all STAT and abnormal test results to VCB upon completion of testing. Routine. The Contractor shall provide routine test results to the ordering VA facility within twenty-four (24) hours following test completion, except when specimens are picked up the day before a weekend or holiday (in which case the results will be provided the following business day). Test procedures requiring a turnaround time longer than 24 hours (excluding the above exceptions) shall be identified by the Contractor before contract award and approved by the Contracting Officer. Reference values will be provided for all tests conducted, as appropriate. Telephone Consultation. The Contractor shall consult with the VA COR, requesting Clinician or designee at the VAMC by telephone as needed. The Contractor shall immediately telephone the respective VA COR; requesting Clinician or designee to report Critical Values or test result that may indicate a life-threatening condition. Reporting of Results. A report is defined as a printed final copy in duplicate of laboratory testing results. This report shall be received by remote terminal where applicable. If results are telephoned, the report must include the name of the individual notified of the results. Each test report shall at minimum indicate the following information: -Patient's name and/or identification code (Social Security number if provided) -Physician's name (if supplied) -Medical record number (if supplied) - Facility Name -Patient's location (clinical/ward), (if supplied) -Date/time specimen received in Reference Lab -Test ordered -Date/time of specimen collection (when available) -Date test completed -Test result -Flag abnormals -Reference range -Toxic and/or therapeutic range where applicable -Testing laboratory specimen number -Name of testing laboratory (contractor and/or subcontractor) -Type of specimen -Any additional comments related to test provided by submitting labs. -Any other information the laboratory has that may indicate a questionable validity of test results. -Unsatisfactory specimen shall be reported with regard to its unsuitability for testing. SLIDES: The Contractor shall return representative slides, anatomic, hematologic, etc., for quality control review when requested. Quality control slides shall represent duplicate copies original slides prepared by the Contractor from permanent tissue blocks. The Contractor shall provide quality control slides to the participating VAMC or clinics at the same time the contractor submits the final reports. The Contractor shall prepare additional blocks and slides, in quantities specified by the participating VAMC for review by pathologists. For malignant cases, the Contractor shall call results to the submitting VAMC, and prepare paraffin blocks and slides review by the Joint Pathology Center (JPC) or other Government Pathology Organization (GPO). For benign cases, the Contractor shall prepare slides for review by participating VA. STORAGE OF SPECIMENS: The Contractor shall store all specimens as required by regulatory agencies (RA) Upon request by the VA COR or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA. In the absence of RA requirements, the Contractor shall store specimens, after all testing has been completed: clinical specimens seven (7) days, surgical specimens six (6) months, cytology and histopathology slides indefinitely; and paraffin blocks for five (5) years. TEST SAMPLES: Upon provision of sample slides by the government, the Contractor shall provide interpretation of sample slides. The sample may include, at a minimum, breast biopsy, thyroid biopsy, mastectomy with nodes, colon resection, lymph node biopsy, and gynecology and non-gynecology cytology. SERVICE: The contractor shall provide telephone number(s) and contact person to be used by the VA facilities to make specimen problem inquiries and problem solving at all times including weekends and holidays. The contractor shall include names and telephone numbers of technical Directors and Pathologists available for consultation. 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 (RA). Contractor shall assign a specific local account representative to each VA facility. Contractor shall advise facility of any changes in methodology, procedure, reference ranges, delays in testing, and any new tests introduced within a timely manner and prior to changes are made. In the event that the contractor changes the assay procedure of a critically important component of an assay (e.g., and antibody, purified antigen, etc.), the contractor shall notify the VA COR prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged or be improved when desirable for all tests. All new tests shall have CPT codes and LIONC coding. Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the CO/COR. If it is deemed that the removal of the test from the test menu is required, due to any changes by the contractor, then it will be communicated by the CO, COR or designee. TESTING METHODOLOGY & REFERENCE: Testing methodology and reference ranges for a test must be defined in the laboratory user manual. CONTRACT QUALITY ASSURANCE/QUALITY CONTROL: To ensure proper handling and test performance, the contractor shall provide the following updated information upon request during the life of contract: For quality purposes, tests routinely performed in duplicate should be indicated. Indication of average monthly volume of specified tests in the schedule that the laboratory performs. Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs. Proficiency testing data shall include a list of tests outside of the acceptable range for past 2 years. Contractor shall provide address of processing sites under contract, including subcontracted testing location sites. 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 government upon prior written notice and during normal business hours during the life of the contract. GENERAL DEFINITIONS: Critical Value. A test result that requires evaluation by a physician or other health care provider as soon as verified. Failure to take appropriate action as a result of a critical value might cause harm or undue suffering for a patient. A list of critical values is to be made available to each VA facility upon request. Frozen Section. A biopsy specimen that is immediately frozen and cut with cryostat; then mounted on a slide, stained, and examined by a pathologist. Frozen sections provide a rapid diagnosis to the physician during surgery. Paraffin Block. A tissue specimen that has been embedded in paraffin wax that the sections can be cut for histologic examination. Reference or Referral Laboratory. The contract laboratory that provides testing, and examination of specimens provided by the medical treatment facility. Reference Value. A range of test values expected for a designated population of individuals. Slides. Glass surface containing biological material to be analyzed. Specimen. A body fluid or tissue sample removed for medical examination and analytical testing. STAT. A designated category of tests that requires immediate processing to expedite results to physicians handling potentially life-threatening cases. Surgical Specimen. A sample or part of an organ or tissue removed during surgery for medical examination and analytical testing. Tests. Diagnostic assays to evaluate a patient's physiological condition. Routine Test - A test that is usually performed at high volume in which the result is required in 24 hours generally. Specialized Test - A test that is performed in low volume but the technology, expense, or time-consuming nature of each test, is such that some delay is expected. However, results should be received within a reasonable amount of time to meet patient care needs. The delay usually occurs to allow tests received from different enters to be batch to make the operation cost-effected. Esoteric Test - A test that is similar to specialized tests, except they can only be done in a few laboratories throughout the country. TAT - The length of elapsed time between pick-up or dispatch of specimen from the contractor s laboratory until the receipt of the completed printed/ electronically transmitted report back in the lab. Exception: For STAT tests, the TAT shall begin at the time of notification by the VAMC laboratory to the contractor. These definitions apply whether the contractor or a subcontractor performs the test. Special handling - Unusual circumstances may dictate the need for a specimen to be picked up, run out of sequence at a special time, or reported within a shorter than usual time. Overflow - A test usually performed in the VAMC lab, which might be referred to the contractor s laboratory in case of instrument breakdown or other circumstances interfering with the VAMC s ability to analyze the specimens. Proficiency Testing - An assessment of the accuracy of testing by a laboratory based on the analysis of an unknown specimen analyzed by a large number of other labs. The proficiency survey is conducted by an organization or agency authorized by the Department of Health and Human Services to do so. SAMPLE PREPARATION: Each VA facility will provide laboratory specimens prepared according to the contractor's laboratory user s manual, identified, and labeled for testing. The contractor shall be responsible for transporting and storing specimens according to industry standards. Contractor shall supply any special preservatives required for specimen preservation. Each VA facility is responsible for packaging the specimens for transport. PERFORMANCE PERIOD: This contract agreement between Texas Valley Coastal Bend Health Care System and LabCorp is for a period of six months. The effective date of the contract shall be from 04/1/2018-09/30/2018. 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.
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