36C25225R0052.docx

VA69D-16-D-0087

GENERAL INFORMATION

Great Lakes Acquisition Center (GLAC) 3001 Green Bay Road North Chicago IL 60064

POINT OF CONTACT*

Contract Specialist Donald St. Onge donald.st.onge@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Special Notice Special Notice

DESCRIPTION

Special Notice

The Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) in Milwaukee, WI intends to negotiate a sole source contract with Quest Diagnostics to provide Reference Laboratory Testing Services for the James A. Lovell Federal Health Care Center (FHCC).

This contract will be for a six-month base period, with no options to extend services. The period of performance for these services is 1 April 2025 through 30 September 2025. This procurement is being conducted in accordance with FAR 13.106-1(b)(2). The contract will be firm fixed price Indefinite Delivery Indefinite Quantity and the NAICS code is 621511. The purpose of this sole source contract is to provide stability and continuity of reference laboratory testing services while a solicitation for a competitive long-term contract prepared and issued. Quest Diagnostics is the only vendor whose catalog of pricing is currently entered into the system at FHCC. To input a different vendor’s catalog into the systems would require substantial time and extensive additional costs. Additionally, a new vendor would be required to have a Business to Business (B2B) connection that would likely take several months to put in place. This sole source contract would provide sufficient time to competitively solicit for a long-term contract for these services.

This Notice of Intent is not a request for competitive proposals. No solicitation documents are available and telephone requests will not be honored. However, if a firm believes it can meet the requirements it must furnish information about its products, services and capabilities as well as references from other customers who are using these products and services to provide reference laboratory testing services, to the contract specialist NLT 10:00AM Central, 7 March 2025. Supporting evidence must be submitted in sufficient detail to demonstrate their pricing catalog is currently entered into the CERNER system at the FHCC facility listed in the attached draft Performance Work Statement, they possess the required B2B connection, and they provide all the services listed in the attached Performance Work Statement, including performing all of the 120 tests required. Information must be sent to Donald St. Onge via email at Donald.st.onge@va.gov. Responses received will be evaluated; however a determination by the Government to not compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. If no responses are received, the GLAC will proceed with the sole source negotiation with Quest Diagnostics.

B.3 PERFORMANCE WORK STATEMENT

Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide Reference Laboratory Testing Services to FHCC as described herein. Reference Laboratory Services include but are not limited to: specimen preparation and storage, transportation of clinical laboratory specimens, anatomic pathology specimens/paraffin blocks/glass slides, and microbiology cultures to the testing laboratories; performance of analytical testing as defined by the Contractor’s reference test manual; the reporting of analytical test results within the required timeframes defined by the FHCC; specimen processors, and consultative services as required.

I. Specimen Preparation and Storage

1. Contractor shall supply each Government facility with its commercial laboratory reference test manual (either hard copy or electronic) to ensure that the collection and storage of specimens are in accordance with Contractor’s requirements. The FHCC will provide laboratory specimens properly prepared, identified and labeled for testing.

B. Contractor shall provide at no additional charge an adequate supply of specimen collection materials necessary to collect and preserve specimens that are destined to the testing laboratories. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory such as dry ice, stabilizing tablets, ice packets, etc. Contractor will be responsible for storing specimens in such a manner to ensure no loss of specimen or the integrity of the specimen during transport.

C. Contractor may also be requested to assist with technical slide preparation for surgical pathology specimens (i.e., tissue processing, embedding, sectioning, H/E staining, special stains, and IHCs) along with other special studies (i.e. ER/PR/HER2/FISH) requiring contractor’s pathologists’ interpretations.

D. The Contractor shall store the specimens a minimum of three days after the test result is reported in the event that subsequent action is necessitated (i.e. problem solving and/or repeat testing).

E. If a medico legal specimen is submitted, the contractor shall provide its own special forms and special handling procedures to maintain a valid “chain-of-custody possession” and develop the formal documentation necessary for that purpose. Contractor’s testing personnel who performed the analysis may be required to provide court testimony. Contractor testimony shall be provided as required at no additional expense to the Government.

1. Transportation Services

1. Contractor shall provide reference laboratory testing courier services of primarily biomedical materials including patient specimens and microbiology cultures originating from the FHCC and destined to the contracted commercial reference laboratories. These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in such a manner that the safety and integrity of the biomedical materials are maintained.

1. Routine transportation services shall occur twice per day 7 days per week (Monday-Sunday) as well as federal holidays, including last minute declared holidays, from the following Government facility:

J.A. Lovell FHCC Main Campus Laboratory Building 133CA 3001 Green Bay Rd.

North Chicago, IL 60064

Routine transportation services shall occur once per day Monday-Friday from the following Government facilities:

Red Rover Clinic Laboratory Building 1523 1020 11th Ave Great Lakes, Il 60088

Fisher Clinic Laboratory Building 237 2410 Sampson St.

Great Lakes, IL 60088

Specimen pick-up times will be mutually agreed upon between the FHCC and the contractor after contract award.

1. The contracted commercial reference laboratory shall be responsible for complying with the most current version of the accreditation standards as it relates to the transport of specimens to ensure that all transport personnel are properly trained and that their competency is regularly assessed in the appropriate safety, packaging, and environmental control procedures suitable to specimen type and distances transported. This also includes issues such as adherences to regulations for transport of biohazards, use of rigid containers where appropriate, temperature control, notification procedures in case of accident or spills, etc. During the term of this contract, this contractor program may need to be updated or revised to comply with regulatory requirements. This documentation should be made available to the FHCC upon their request.

1. Contractor shall provide, at no additional cost, all necessary supplies for biomedical materials necessary to distribute, transport, and deliver specimens from the FHCC to the testing laboratories. These supplies shall include, but not limited to:

1. Shipping and packaging containers and/or bags. Packing material must be capable of maintaining temperature requirements for specimens until they reach the testing laboratories.

1. Required labels/stickers and packaging materials for shipping specimens via courier for testing, which are infectious or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.

1. Preprinted test request forms with the appropriate Shipping Section details and account information.

1. Test request forms for specialized testing (i.e. Cytogenetics, FISH, Immunohistochemistry Stains, Special Stains, Molecular testing, etc.).

E. Upon each pick-up or delivery of testing specimens by the contractor, a transfer list shall be provided detailing specimen identification, source and destination information. In addition, it shall be the responsibility of the contractor to ensure that its or any subcontracted transport personnel shall comply with all policies and procedures for tracking specimens. Site-specific handling procedures will be mutually agreed upon between the FHCC and the contractor and will include, but is not limited to, documentation of dispatch and receipt of specimens, condition of specimens upon receipt, etc.

F. Emergency transportation services shall be equal in quality to the routine transportation services provided, and be available 24 hours per day, seven days per week including federal holidays. The estimated number of emergency transportation services per year is one. Specimen pick-up response times for emergency transportation service requests shall be within 4 hours.

1. The contractor and/or subcontractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute all required tests as annotated in Attachment A (approximately 1692 tests). Contractor shall make available the test information below and notify the FHCC when any modifications to this information occur during the contract period.

1. Requisition form requirements

1. Alphabetized test name list

1. Contractor Test order code

1. Specimen collection and preservation requirements

1. Test method employed (indicate if testing performed in duplicate) and interpretations

1. Test reference intervals adjusted for age, sex or race, when required

1. Test specific sensitivity, specificity and interferences, when required

1. Result code

1. Test critical values, if any

1. Policy for critical value notification

1. CPT coding for test

1. Contractor test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between receipt of specimen by the Contractor and receipt of results by the FHCC.

1. Schedule of test performance (specific days of week/frequency indicated)

1. Location of test performance by test name (i.e. name of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory must be cited)

B. Contractor shall provide accurate, timely, and appropriate testing of patient specimens as requested by the FHCC. For most tests, the required test result turnaround time (TAT), is within 24 hours following specimen pickup either by hard copy or electronic report transmission. It is recognized that certain test procedures will require a longer turnaround time than the 24 hours. Under these circumstances, test results shall be delivered no later than 1 hour after the verification of the test result.

C. The FHCC has identified several tests that require strict compliance to different, faster TAT timeframes when sent from the FHCC Red Rover Laboratory. These tests and applicable TATs are identified below.

D. The FHCC has identified several tests that require strict compliance to different, faster TAT timeframes when sent from the FHCC Main Laboratory. These tests and applicable TATs are identified below.

E. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

F. Contractor shall notify the COR and FHCC Laboratory personnel of any test information/methodology changes no later than two weeks prior to the implementation date of the test change. If any of these changes affect availability (i.e. discontinued) of the test, price or other information on Attachment A, the Contracting Officer shall also be notified. These changes shall be reflected via contract modification. Any increases in test price must be negotiated and/or approved by the Contracting Officer via contract modification.

G. Additional tests may be added via contract modification. Any new test(s) not listed in Attachment A must be added to the contract through modification by the Contracting Officer (the COR and FHCC Laboratory personnel do not have this authority) prior to specimen being tested. If a test is not listed on Attachment A, it must be billed under a non-contracted account number.

IV. Specimen Retention

1. A medico legal specimen shall be retained indefinitely. This type of specimen will be identified by the Government in writing or through telephone communication.

1. All anatomic pathology materials (e.g., paraffin blocks, slides, or other diagnostic material) generated by the VA and sent to the Contractor laboratory for processing, staining, testing, and diagnostic evaluation shall be returned within 5 days after final diagnosis is reported. Slides and blocks sent for immunohistochemistry and special stains should be sent back the same day as the stained slides.

V. Reporting of Test Results

1. The primary transmission of laboratory test results shall be through electronic host to host computer interface. Laboratory test results that are not interfaced must be immediately available through the Contractor’s electronic web-based portal that the Government facility has access to. In unusual circumstances where electronic delivery either via interface or web-portal is not possible, the Contractor shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing and/or transportation services by hand within 24 hours, or by telephone facsimile to a protected machine identified to the Contractor by the FHCC. Delivery by electronic mail i.e. MS Outlook, etc. is prohibited. Additionally, any test result that includes a pathologist interpretation must be transmitted to a dedicated fax machine at the ordering FHCC facility and when possible, available electronically via an online portal.

Specifications outlining the requirements of the computer system interfaces including computer hardware, maintenance and supply requirements are defined in Section B3.X., Telecommunication Requirements below.

1. Each test report generated in printed form or through electronic transmission shall, at minimum, include the following information:

1. Patient's full name

1. Patient’s identification number, e.g. MRN (medical record number), DOB (date of birth), FIN (financial information number), and DoD ID, if specimen is collected from an active duty patient.

1. Physician’s name (if provided)

1. FHCC medical record number or laboratory accession number (if provided)

1. FHCC ordering facility name

1. FHCC Account number

1. Test(s) ordered

1. Date/time of specimen collection (when available)

1. Date/time test completed

1. Test result

1. Reference intervals (adjusted for age, sex or race, when appropriate)

1. Toxic and therapeutic ranges (if applicable)

1. Flagged abnormal results

1. Reference laboratory accession umber

1. Name and address of testing laboratory

1. Any other information the laboratory has that may indicate a questionable validity of test results.

1. Specimen inadequacy (if applicable) with documentation to support its unsuitability for testing.

1. Test results determined by the contractor to be a critical value, as well as test results determined by the Illinois Department of Public Health to be Reportable Diseases, shall be communicated by telephone to a designated FHCC contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic report transmission.

1. Contractor shall provide a daily report by 1:00 p.m. listing all incomplete testing from the Red Rover TAT list that will not be resulted by the required timelines.

VI. Specimen Processors A. Contractor shall provide three (3) full-time equivalent Specimen Processing Technicians to the FHCC (two assigned to Red Rover and one assigned to the Main Campus) laboratories to assist with the processing of specimens, e.g. centrifuging, packaging, shipping, ordering, etc. The technicians will need access to Oracle Health (Cerner) for transfer specimen applications to build and send transfer lists for samples to the reference lab. The technician shall also be responsible for retrieving laboratory results, obtaining test information, contacting customer service to obtain results and resolve inquiries, running and reconciling incomplete test lists. The specimen processing technicians will work Monday through Friday, excluding federal holidays, from 6:00 a.m. – 2:30 p.m. for Red Rover Laboratory and 7:00 a.m. – 3:30 p.m. for the Main Campus Laboratory. Lunch breaks will be a half-hour in duration. No overtime is anticipated or approved under this contract.

B. Contractors must have Tier 3 Favorable background investigation and cleared by FHCC Informatics. Contractors must complete required training in compliance with DHA physical access and network or information security and privacy requirements.

C. Contractor shall provide enough back-up personnel to perform services during absences of the primary Specimen Processing Technicians for any reason. Contractor shall also provide for the permanent replacement of a primary Specimen Processing Technicians, if necessary.

D. The Contractor shall provide a full initial comprehensive orientation and training of all Specimen Processing Technicians who will work at the FHCC Main Laboratory and Red Rover. This training will encompass all policies, procedures, and software related to services provided by the contractor and utilized by the FHCC. However, in the event of a change to the procedures, method, regulation, etc., on the part of either the Government or the Contractor occurring after the initial implementation period, a mutual exchange of training/information shall be accomplished. All on-site contractor personnel must complete all security requirements prior to providing services under this contract.

E. The Government will provide a work area to be used for administrative functions by the Contractor’s employees (Specimen Processing Technicians).

F. All contract employees performing work on a government facility shall observe and comply with all local rules and regulations prescribed by the installation and other federal authorities concerning fire, safety, sanitation, security and possession of firearms or other lethal weapons. No contract employee will be permitted on the installation when his/her presence could be detrimental to the security of the installation or safety to themselves. Specimen processors working on-site at the FHCC shall be subject to an ANACI background investigation.

G. Contractor shall obtain all local, state and federal government licenses, passes and permits necessary to enter the government installation, to include motor vehicle registration and insurance, as required by the FHCC.

H. The Government reserves the right to require removal from the job site any contract employee who endangers persons or property and whose continued employment is inconsistent with the interest of government security. In such cases, the Contracting Officer or COR will advise the Contractor of the reason for requesting an employee’s removal or withdrawing their permit to enter the installation.

I. The Contractor shall remove from duty any contractor employee found to be incapacitated or under the influence of alcohol or drugs, or other incapacitating agents and shall not return such an employee to duty until such employee is fully able to perform the normally assigned duties. Removal of employee(s) for such causes does not relieve the Contractor of the requirement to provide sufficient personnel to adequately perform services specified under this contract.

J. Neither the Contractor, nor any of its employees, shall disclose or cause to be disseminated any information concerning military activity operations.

K. Neither the Contractor, nor any of its employees, shall disclose private medical information concerning patients to third parties other than those personnel designated by the FHCC. Results shall be handled as private medical records in accordance with Privacy Act Requirements for Medical Records Systems.

L. All inquiries, comments or complaints pertaining to patient information or government information, arising from any matter observed, experienced, or discovered as a result of, or in connection with, the performance of this contract shall be directed to the COR for resolution.

VII. Customer Service

1. Contractor shall provide toll-free telephonic customer service 24 hours per day, 7 days per week to assist Government staff with tracking and resolving related issues/problems that may arise in the performance under this contract.

1. Upon award, contractor shall assign a local area account representative and alternate representative to provide direct and on-site support for each of the FHCC facilities. Contractor shall provide the name(s) and telephone number(s) of these representatives and other contractor employees who will address the following customer services throughout the contract performance period:

1. Telephone Inquiries – Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government’s minimum time expectation for meeting this service.

1. Specimen Collection

1. Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call.

1. Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within ½ hour of the initial call.

1. Testing

1. Inquiries regarding the status of pending results shall be addressed at the time of the initial call.

1. Esoteric inquiries when information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two business hours of the initial call.

c. Technical Expertise

1. Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call.

1. Result interpretation inquiries shall be addressed within four business hours of initial call.

3) Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call.

4) The contractor shall provide names and telephone numbers of technical directors and pathologists available for consultation.

d. Account follow-up

1. Information general in nature yet specific to the account, e.g. test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call.

1. The Contractor shall notify the originating laboratory by telephone, of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc.

1. The Government will notify contractor of the need for additional specimen collection and transportation supplies by telephone or through written or electronic methods.

1. Contractor shall conduct timely interface testing when there is a change in test reporting and codes.

VIII. Consultative Services/Reports

1. Contractor shall provide consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.

1. Upon request, contractor shall provide a statistical analysis of the FHCC facility’s workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the FHCC on mechanisms to reduce its costs.

C. The following reports may be requested by FHCC and shall be delivered to the FHCC by the 20th of the month following the close of the reporting month:

1) A monthly cumulative summary alphabetically by patient indicating patient’s name, test ordered, date specimen received and ordering physician.

2) A monthly summary sheet by test frequency for each FHCC Laboratory listing patient name, volume of tests ordered, unit charge, total charges for this month and year to date.

3) A summary sheet listing the type and volume of testing sent to a subcontracted reference laboratory.

4) A monthly summary sheet by dollar volume listing tests in descending order of dollar volume with volume of tests ordered, unit charge for each test, total charges for months and year to date.

5) A utilization summary sheet by test frequency of both FHCC Laboratories listing all tests ordered, the volume of tests ordered, unit charge per tests, total charges and percent abnormal results for the period.

6) A monthly summary sheet of all telephone notifications of specimens cancelled because of unacceptability, i.e. volume, specimen container, identification, loss of specimen, etc.

D. Contractor shall provide a cumulative workload summary report of tests performed on a monthly basis. The summary must include the facility account number, the test name, the test ordering code, monthly test volume, year-to-date test volume, unit test cost, monthly test expenditures and year-to date test expenditures. A copy of the report shall be delivered electronically to the Contracting Officer and COR by the 20th of the month following the close of the reporting month.

E. All reports shall be submitted in an electronic spreadsheet format and have the capability to sort by four (4) different methods:

F. Contractor shall provide a monthly listing of any tests listed in Attachment A that are no longer performed by contractor and shall be removed from Attachment A. This listing shall include, at a minimum, contractor test name and test ordering code.

G. The Contractor shall provide, a daily cumulative report retrievable by collection date(s) that details patient identifying demographics and the associated test results for the Red Rover Laboratory as identified in B.3.III.C. Designated government contact personnel must be notified when it’s available. The daily report shall be available prior to the turnaround time deadline.

IX. Data Management System

A. Contractor shall provide to the FHCC and Oracle Health (Cerner) all necessary laboratory test parameters (parameters are required for each test contained in a panel) to ensure accurate test result transmission between the FHCC’s and the Contractor’s databases. Required test parameters are listed below.

1. Ordering code

1. Logical Observations Identifiers Names and Codes (LOINC) code

1. CPT code(s)

1. Interface code

1. Test cost

1. Reference ranges

1. Units of measurement

1. Test result interpretation or interpretive remarks, if appropriate

1. Testing site (if not performed at the contractor’s main laboratory facility

1. Test methodology

1. Specimen types

1. Specimen collection and handling requirements

1. Instrument Performing test (if more than one Instrument)

1. Indication whether test is a panel/profile test, list of tests included in panel/profile If test is a panel or profile test, list the tests included (NOTE: the above parameters are required for each test contained in a panel).

The parameters for all tests in the contractor’s database shall be kept current and be available to the FHCC throughout the performance period of the contract. Updates to test parameter information must be provided to FHCC and Oracle Health (Cerner) no less than 2 weeks prior to the implementation of any changes in the following situations: when new tests are developed and introduced into the contractor’s test menu, testing parameters have changes or when tests are discontinued or replaced by other tests. The Contractor shall provide telephone access to a technical representative to respond to any question(s) regarding the laboratory test parameter information.

B. The Contractor shall provide a data management system that meets the following requirements:

1. Test ordering must be accomplished through a menu that is intuitive, has minimal options and uses a mouse or touch screen. Upon selection of the test, the computer shall alert (flag) the user to the type of specimen required and the storage conditions. It must also alert the user to the location of the laboratory that will be performing the test.

1. Test definition, test information and test requirements must be complete, available, and easily accessible.

3) Accepts FHCC Oracle Health (Cerner) generated transfer lists that identify specimens sent to the contractor’s testing laboratories, transportation conditions, and testing ordered.

4) The status and the results of testing must be available within published timeframes and easily retrievable by various methodologies. At a minimum, these options must include sort by patient name; sort by date; sort by test; and sort by incomplete test. Incomplete tests must have an indication of the pending time until completion. Alert messages, or other notifications, must be generated when testing is delayed beyond required and/or published timeframes.

5) FHCC must be able to print test results from the contractor’s web-based portal as well as retransmitting results to post in the patient’s record.

C. A test catalog shall be published on an annual basis and made available to the FHCC. Addendums/updates to the test catalog shall be made available (either electronically or in hard copy) to the FHCC. The test catalog shall include all test information as required by regulatory requirements. A reference guide to test interpretation shall also be available.

Telecommunication Interface Requirements

1. Contractor is responsible for the preventive maintenance and repair of Contractor furnished hardware, software, and associated communication lines. In addition, throughout the performance period of the contract, the Contractor shall repair or replace any malfunctioning hardware or software at no additional cost to the Government.

H. Interface with Oracle Health (Cerner). This connection is required for all samples sent from DOD or VA FHCC Laboratories.

1) Contractor shall develop and program an interface connection to electronically transmit orders, specimen status, and test results between the Contractor’s host computer system and FHCC’s host computer system, Oracle Health (Cerner). Contractor must do Interface development work with Oracle Health (Cerner EHRM). It is preferred the contractor have a current VA nationally approved Business Partner Gateway (BPG), Interconnection Security Agreement (ISA), and a Memorandum of Understanding (MOU); but the agreements may also be established directly with the FHCC.

2) Contractor shall ensure all necessary preparations, including ability to electronically transfer data correctly, are performed for full contract services prior to contract performance/effective date.

a) Contract personnel needing privileged-level account for administrative/maintenance support of systems/applications on the network, will meet DoD requirements for a privileged-level account before being provided access to DoD systems (see B.5.XVI). Contractors must also undergo a successful security screening and background investigation prior to access being granted.

I. Since the FHCC has changed to Cerner, contractor must be capable of transmitting information through Oracle Health (Cerner). Oracle Health (Cerner) is a joint VA and DoD Electronic Medical Record (EMR/EHR) System.

1) Oracle Health (Cerner) will still require a connection through Reference Lab Network (RLN) to the vendor.

2) Awardee will need to establish the test data bases and have the ability to fully operate on Oracle Health (Cerner).

J. The following information shall be provided for any interface order(s) or downtime:

1. Date and time of downtime

2. Systems involved

3. Expected system restoration

4. Scope of impact

5. Cause or Information around scope of downtime and resolution

6. Contractor shall provide 24/7 interface and electronic order/resulting support for all equipment and software.

7. Contractor shall provide a mechanism to retransmit results after any interface communication error or downtime.

XI. Test Database Build & Validation

A. Contractor must have test database validated upon award of contract. There is no time to create a new test database during this bridge contract.

B.4 SPECIAL CONTRACT REQUIREMENTS

I. Services

1. The services specified herein may be changed by written modification to this contract. The VA Contracting Officer will prepare the modification (reference FAR clause 52.212-4(c) Changes) and, prior to becoming effective, must be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

1. The Government will not sign any separate agreements from the contractor for equipment, web-tools, or specimen processors that will be utilized in the performance of this contract.

1. This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor’s employees. Contractor personnel are not subject to the supervision and control of a Government officer or employee. Rather, contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. Personnel who furnish services under this contract are subject to Government technical oversight of the services rendered. The Government retains the right to reject services for contractual non-performance.

1. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

1. Contractor is required to maintain medical liability insurance for the duration of this contract. Medical Liability insurance must cover the provider(s) for services in all states where services are rendered by the provider. Contractor must indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance.

1. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract.

1. Contractor shall not, under any circumstances, furnish laboratory reports directly to patients.

II. Period of Performance: 4/1/2025 – 9/30/2026

III. Federal Holidays

Contractor is required to provide transportation of specimens from the main campus on Federal Holidays, twice per holiday, to include last minute declared holidays.

IV. Qualifications/Requirements of Laboratory & Contractor Personnel

2) Offerors, including subcontractor(s), must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The testing laboratories must maintain valid certifications during the entire performance period of this contract.

3) Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this solicitation. In addition, as these documents are reissued or re-awarded, the awarded Contractor must supply a copy to the CO and COR. The above documents must also be supplied for each testing laboratory that is a subcontractor of the primary contractor.

4) Contractor must notify immediately the COR in writing, upon its/any subcontractor’s loss of any required certification, accreditation or licensure.

1. Contractor shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

1. The Government reserves the right to physically inspect the testing laboratories prior to a contract award and at any time during the contract period to ensure the testing laboratory’s compliance with accreditation and quality assurance practices and requirements. The Government will not be liable for any expenses incurred by the contractor as a result of these inspections.

1. Contractors requiring a privileged-level account for administrative/maintenance support of systems/applications on the network, will meet DHA requirements for a privileged-level account before being provided access.

2) Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification.

1. Personnel assigned by the contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402).

1. Contractor shall comply with any new regulatory requirements for mandatory education and/or competency assessment, which occur during the contract period. These items must be completed by the individual contractor employee(s) within a mutually agreed upon timeframe between the FHCC and the Contractor.

1. Contractor couriers entering any Government facility must be attired in a contractor-issued uniform that bears the name of the Contractor’s company. In addition, all contractor representatives shall prominently display a contractor-issued identification badge.

1. Specimen Processing / Data Entry Technician(s) personnel, who will be working on-site at the MTFs, will initiate and complete base-access requirements, per local procedure, which includes, but is not limited to, initiating a background check, obtaining a CAC Card, and completing required online training.

1. HHS/OIG

To ensure that the individuals providing services under the Contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (https://exclusions.oig.hhs.gov/) for each person providing services under this contract. Any healthcare provider or entity that employs or enters into contracts with excluded individuals or entities may have a Civil Monetary Penalty (CMP) imposed against them. By signing the proposal, the Contractor is certifying that all persons listed in the contractor’s proposal have been compared against the OIG list and are NOT listed as of the date the proposal was signed.

II. Record Keeping – Contractor

Contractor must establish a record keeping system of all tests performed per regulatory guidelines.

III. Medical Records

Clinical or other medical records (i.e. test results) of FHCC veteran patients treated by Contractor under this contract are owned by the FHCC. If requested, test results will be mailed to the FHCC at no additional cost. Mail shall be sent in accordance with VA Directive 6609, Mailing of Sensitive Personal Information. If a subpoena or court order is received for the production of a medical record/test result, the contractor shall notify the Contracting Officer that a subpoena or court order was received.

IV. Confidentiality of Patient Records

A. The Contractor is a FHCC contractor and will assist in the provision of health care to patients seeking such care from or through FHCC. As such, the Contractor is considered as being part of the department health care activity. Contractor is considered to be a FHCC contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of FHCC records access and patient confidentiality, Contractor is considered to be a FHCC contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7332. Therefore, contractor may have access, as would other appropriate components of FHCC, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the department, and not withstanding any other provisions of the contract, the contractor is restricted from making disclosures of FHCC records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from FHCC has been received or disclosure is required by law. The contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as FHCC.

B. The records referred to above shall be and remain the property of FHCC and shall not be removed or transferred from FHCC except in accordance with 5 U.S.C.552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or its designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to FHCC’s records, at FHCC’s place of business on request during normal business hours, to inspect and review and make copies of such records.

V. HIPAA Compliance

Contractor…