VISN 7 REF LAB SOL 36C24724R0031.docx

36C24724R0031

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

2-12-2025 Chelsea Smith 334-590-9891 03-14-2025

EDT

Department of veterans Affairs VISN 7 Network Contracting Activity CAVHCS-East Campus 2400 Hospital Ro.

Tuskegee AL 36083

X

621511 $41.5 Million

Net 30

N/A

Department of Veterans Affairs

As directed by individual orders.

See the Statement of Work below.

Department of veterans Affairs VISN 7 Network Contracting Activity CAVHCS-East Campus 2400 Hospital Ro.

Tuskegee AL 36083

Department of Veterans Affairs

FMS-VA-2 (101)

Financial Services Center P.O. Box 149971 Austin TX 78714-9971

See CONTINUATION Page The purpose of this requirement is to procure Reference Laboratory Services for the VISN 7 Facilities.

Period of Performance: 09/1/2025 to 08/31/2030

Please review page 48 for INSTRUCTIONS TO OFFERORS.

See CONTINUATION Page

Chelsea L. Smith Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Chelsea L. Smith Contracting Officer 36C247 Department of Veterans Affairs VISN 7 Network Contracting Activity CAVHCS-East Campus 2400 Hospital Ro.

Tuskegee AL 36083

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 STATEMENT OF WORK

DEPARTMENT OF VETERANS AFFAIRS HEALTH CARE SYSTEMS

Southeastern Network (Alabama, Georgia, and South Carolina (VISN 7)

MEDICAL LABORATORY TESTING AND ANALYSIS SERVICES

1. DESCRIPTION OF THE INDEFINITE-DELIVERY/INDEFINITE QUANITY CONTRACT:

1.1 The Department of Veterans Affairs, Southeastern (VISN7) intends to establish a 5-Year IDIQ for “Cost Per Reportable Test” medical laboratory testing, analysis, and diagnostic evaluation services with a 5-year term with 1-year pricing periods. Each pricing period will be issued on a Task Order by the Contracting or Administrating Contracting Officer. This IDIQ Contract aims to standardize and consolidate the referral laboratory services for all medical centers in the VISN7 catchment area and to increase the VA’s flexibility in providing Laboratory services to Veterans while decreasing the associated costs. Additionally, the purpose of this contract is to establish a Referral Laboratory source to coordinate, manage, and facilitate all non-VA performed required testing and analysis and, when necessary (due to an emergency as determined by the individual facility), to provide VA performed testing, analysis, and other services normally provided within a VA facility.

1.2 This IDIQ will increase the VISN’s ability to support veterans’ care by providing access to tests/services unavailable to the VA Medical Centers. There are various tests that are not accessible to VAMC due to the cost of reagents or equipment, the esoteric technology or method, specialized practices, or the development of emerging tests. The intent is to award this IDIQ to a Single Primary contractor to ensure continuous availability of required Laboratory services.

1.3 This IDIQ does not supersede higher-level contracts and/or National Contracts, active contracts, or contracts outside of VISN7.

1.4 The contact information and points of contact for each medical center facility covered are listed below, and the attached pricing list provides estimated volumes for all facilities combined. Estimated volumes are reviewed annually and are tracked by the COR for solicitation requirements. As requirements change, facilities within the Southeastern network may be added or deleted as required to accommodate growth or reorganization within the network of VA Medical Centers.

Decatur, GA 30033 Jerald Lapalm jerald.lapalm@va.gov (404)321-6111 x202048

Augusta, GA 30904 Jasmine Cage Jasmine.Cage@va.gov 706-733-0188 ext. 31720

Birmingham, AL 35233 Ina J. Nicholson ina.nicholson@va.gov 205-933-8101 ext. 6557

Robert.haynes@va.gov.

843-789-7531.

Columbia, SC 29223 Jerry Lamb Jerry.Lamb@va.gov 803-776-4000 ext. 7252

Dublin, GA 31021 Ruth Simmons Ruth.Simmons@va.gov 478-272-1210 Ext 72479

Montgomery, AL 36109 Anita Lewis Anita.lewis2@va.gov 334-272-4670 ext. 34412

Tuskegee, AL

2400 Hospital Road Tuskegee, AL 36083 Anita Lewis Anita.lewis2@va.gov 334-272-4670 ext. 34412

Tuscaloosa, AL 354 Michael Burroughs michael.burroughs@va.gov

(205) 554-2000 x2776

2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

2.1 General Definitions.

2.1.1 Contracting Officer’s Representative (COR) and Alternate COR– A Federal employee who assists the ordering/issuing agency contracting officers in administering task orders under this contract. The COR is primarily responsible for the day-to-day program management of the ordering activity’s tasks or orders. The Alternate COR may be assigned by the service to “act in place of” and or “work along with” the COR in the full range of responsibilities delegated to the COR.

2.1.2 VISN 7 – Veterans Integrated Service Network comprises the VA Medical Centers in Alabama, Georgia, and South Carolina.

2.1.3 Critical Value – (Critical Value, Panic Value, or Life-Threatening Value) - Those test results that require evaluation by a physician or other health care provider as soon as the test result is verified. Failure to take appropriate action due to a failure to notify the proper VAMC of a Critical Value might cause harm to a patient.

2.1.4 Reportable Disease Result Notification – Those results of communicable diseases designated by state and federal laws/regulations as “notifiable” must be communicated appropriately and documented on the result.

2.1.5 Esoteric Tests are like specialized tests, except they can only be done in a few laboratories nationwide.

2.1.6 Cost-per-Test – The amount charged for each test, including all costs (technical and professional components and facility costs, as applicable).

2.1.7 Overflow - A test usually performed in the ordering activity lab, which might be referred to the contractor’s laboratory in case of instrument breakdown, declared emergency, or other circumstances interfering with the ordering facility’s ability to analyze the specimens.

2.1.8 Paraffin Block - A tissue specimen embedded in paraffin wax that the sections can be cut for histological examination.

2.1.9 Reference or Referral Laboratory - The contract laboratory that tests and examines specimens, blocks, and/or slides provided by the medical treatment facility.

2.1.10 Reference Value - A range of test values expected for a designated average population of individuals.

2.1.11 Routine Test - A test usually performed at high volume in which the result is required within twenty-four (24) hours of specimen pick up.

2.1.12 Slides - Glass surface containing biological material to be analyzed, reviewed/evaluated for diagnoses, as appropriate.

2.1.13 Specimen - A body fluid, tissue sample, paraffin block, or glass slide removed/submitted for medical examination, analytical testing, and diagnostic evaluation, as appropriate.

2.1.14 Special handling—Unusual circumstances may dictate the need for a specimen to be picked up outside the normal run time of a courier, analysis performed out of sequence at a special time, or reported within a shorter than usual time.

2.1.15 Specialized Test - A test performed in low volume, but the technology, expense, or time-consuming nature of each test is such that some delay is expected. The delay usually occurs when tests received from different centers are batched to make the operation cost-effective.

2.1.16 STAT Test- A designated category of tests that requires immediate processing to expedite results (results needed within 2 hours of sample pick-up) to physicians handling potentially life-threatening cases.

2.1.17 Surgical Specimen - A sample or part of an organ or tissue removed during surgery for medical examination, diagnostic evaluation, and analytical testing.

2.1.18 Tests - Diagnostic assays to evaluate a patient's physiological condition.

2.1.19 Turnaround Time (TAT) - The length of elapsed time between pick-up or dispatch of specimen from the government ordering activity’s laboratory and the receipt of the completed printed report received by the government ordering activity’s laboratory.

2.1.20 Proficiency Testing—An assessment of a laboratory's accuracy in testing based on the analysis of an unknown specimen analyzed by many other labs. The Department of Health and Human Services shall approve the proficiency testing survey conducted by the contracted reference laboratory.

2.1.21 P&LMS – Pathology & Laboratory Medicine Service

2.1.22 Using Service - The P&LMS at any VA Medical Center within VISN 7 and additional facilities may be added.

2.1.23 VISTA System – Veterans Information System Technology and Architecture; Veteran Health Administration Electronic medical record/information system.

2.1.24 HIPAA – Health Insurance Portability and Accountability Act of 1996.

2.2 GENERAL REQUIREMENTS FOR REFERENCE LABORATORY SERVICES

2.2.1 The Contractor shall coordinate, manage, and facilitate all non-VA required laboratory testing, analysis, and related diagnostic services.

2.2.2 Contractor shall have a system or platform to assess lab test cost and utilization in real-time. The Contractor will provide a utilization report for each participating facility. The report will be submitted monthly to include, but not limited to, an itemized report identifying the number of tests and professional services, average total cost per test and service, test/service number, name, CPT code, and cost for each test/service and total cost for all services by facility to each participating facility’s COR.

2.2.3 The contractor shall provide the appropriate personnel for a specimen processor for each participating facility at no cost to the government. The on-site contracted personnel shall provide pre-analytical processing as defined in the contractor’s laboratory manual, coordination of packaging, pickup, and transport of specimens, post-analytical receipt of reports of tests, and interpretation for clinical and anatomical pathological specimens sent to the contractor. The contracted personnel shall assist facility personnel in looking up and/or ordering specialized testing in Clinical Pathology sections such as chemistry, coagulation, genetics, hematology, immunology, microbiology, molecular, toxicology, urinalysis, virology, and Anatomic Pathology sections such as cytology, histology, and immunohistochemistry including specimen requirements, test name/number, expected cost, expected TAT and location of performing laboratory.

2.2.3.1 The appropriate personnel for each facility are based on test volume.

2.2.3.2 The appropriate FTEE for each facility may be reviewed and or adjusted annually.

2.2.4 The Contractor shall provide the full range of anatomical pathology, clinical pathology, cytology, molecular, microbiological, serological, and immunological, and genetic diagnostic testing capabilities (either on-site or through their reference laboratories) to execute the requested tests plus other new tests as developed. All clinical testing shall be executed in accordance with industry standards. All test methods shall be FDA-approved. Any non-FDA-approved methods being performed shall have a documented validation plan made available to the COR or designee upon request. The contractor shall provide a standard catalog (printed and electronic) of all testing services available and a price list of the amount to be billed to the government to each ordering facility each time a new catalog is revised or issued. Any changes to testing will be electronically communicated to each facility designee at least 2 weeks before the effective date. Any new testing capabilities and pricing shall be made available to all facilities in this SOW. At a minimum, the compendium shall include:

· Ordering Code (contractor’s identification code)

· LOINC Code (Logical Observation Identifier Names and Codes)

· CPT Code

· Interface Code

· Test Name/Synonyms

· Test/Assay Methodology

· Specimen Types

· Specimen collection and handling requirements

· Test result interpretation or interpretive remarks

· Testing site (if not performed in the contractor’s main laboratory facility)

· Maximum Turnaround Time (TAT), excluding the required repeat assay time. For those tests offered on a STAT basis, TAT should be listed separately.

· Assay schedule- must state “MWF” for tests set up Monday, Wednesday, and Friday; “MTWTF” for Monday- Friday; “TT” for Tuesday and Thursday; “Daily” for every day.

· Number of days required for completing an assay and reporting a result.

· Reference Ranges

· Any limitation on the number of tests per day that may be requested.

· Unit price and discount offered to the government.

· Unit price updates for new testing when developed or acquired.

2.2.5 Pickup and Transportation of Samples. The contractor shall be responsible for picking up and transporting specimens to the contractor’s laboratory(ies).

2.2.5.1 Routine. Scheduled pickup days and times will be mutually agreed upon between the contractor and each ordering facility. Pickup days may include Sunday through Saturday, as determined by each ordering facility.

2.2.5.2 Expedited, Weekends or Federal Holiday Pick-up. The ordering activity COR or designee will notify the contractor via telephone when a pickup courier is required to maintain specimen integrity and/or testing time limits.

2.2.6 The contractor shall be responsible for transporting the specimen in such a manner as to ensure its integrity. The contractor shall supply any special preservatives required for specimen preservation and packing material capable of maintaining temperature requirements for specimens until they reach the Contractor’s laboratory under the terms of this agreement. Specimen pickup and delivery tracking must be available for weekday and weekend pickups.

2.2.7 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. The Contractor’s testing personnel that performed the analysis/evaluation may be required to provide court testimony. Contractor testimony shall be provided at no additional expense to the Government. If a specimen is needed for medicolegal issues at the request of the Government, the specimen shall be retained indefinitely.

2.2.8 The contractor shall be responsible for ensuring Subcontractor Laboratories (Contractor’s Reference Laboratories) meet the following:

· All appropriate regulatory agency requirements, accreditation, and documentation are provided to the Contractor and are available to each facility’s COR when requested.

· Single point of contact for all service-related communications and requests. The Contractor will not delegate this single point of contact to a third-party Vendor.

· No additional transfer expense or charge to the government for the contractor’s referred testing.

· Contractor shall comply with Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note). CFR 52.204-10 Reporting Executive Compensation and First-Tier Subcontractor Awards (Jul 2020)

· Contractor shall ensure each subcontractor maintains the same certifications, accreditations, and Medical Malpractice Insurance as required of the Contractor.

2.2.9 Supplies. The contractor shall provide all necessary supplies usually offered to its commercial customers, not limited to the following:

· Requisition forms

· Specimen containers and pour off tubes.

· Dry ice and appropriate container

· Special instructions

· Current list of tests with reference ranges, specimen requirements, and test descriptions.

· Specimen carriers.

· Special media or special tubes for samples.

· All forms necessary for specimens.

· All supplies for special tests.

· All printers, fax machines, computer hardware, computer software, and replacement parts (toner cartridges, etc.) to support the performance of the equipment required for test ordering, resulting in ongoing support.

2.2.10 The contractor will ensure that personnel at each VAMC adhere to VA and all regulatory agency compliance, personnel standards, and technical and administrative oversight.

2.2.11 Test Results.

2.2.11.1 Critical Value/critical results/Reportable results. The contractor shall report all Critical Value/critical results or communicable disease reportable results or critically abnormal test results, or test results that may indicate a life-threatening condition to the designated Government contact person at the ordering facility immediately upon completion of testing. The contractor shall immediately telephone the ordering activity COR or designee to report any critical values or test results that may indicate a life-threatening condition. The contractor shall notify the ordering facility designee for all communicable disease reportable results per national and state requirements. Documentation of verbal notification shall be placed on the result to include the date, time, name of the individual notified, and confirmation of the back of the result. Upon award of IDIQ, individual site points of contact, phone numbers, fax numbers, and after-hours points of contact will be provided to the contractor.

2.2.11.2 Routine. The contractor shall provide routine test results to the ordering facility in accordance with the testing specifications defined in the contractor’s commercial specimen collection guide, 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).

2.2.11.3 Expedited /Priority testing. The contractor shall provide priority test processing or attempt to expedite a test result at the request of the individual VA facility if deemed medically necessary on a case-by-case basis by the individual VA facility.

2.2.11.4 Repeat Testing for Confirmation of Test Results. The contractor shall provide all repeat testing upon the request of the ordering facility at no additional charge to the government.

2.2.11.5 Test result and/or report corrections shall be made with corrected reports sent to the ordering location within 3 business days of a correction request.

2.2.11.6 The Contractor shall notify the originating laboratory by telephone, with documentation of verbal notification to include the date, time, and name of the individual notified, if specimens are not processed due to unacceptability (e.g., volume, specimen container, identification, loss of specimen, etc.).

2.2.12 Reporting of Results. A report is a final printed copy or host-to-host electronic transmission of laboratory testing/diagnostic results. The contractor shall deliver these reports by electronic report transmission via a computer interface. Electronic delivery of reports by computer interface is the required receipt method. In those cases where electronic delivery is not possible, the Contractor shall deliver a hard copy of the report by hand, mail, or facsimile. Delivery by electronic mail (e.g. Microsoft Outlook) is prohibited. Suppose the electronic reporting requirements of this contract are unavailable for use. In that case, the Contractor shall provide, without additional charge, expedited overnight courier shipping, mailing, and/or transportation services to return printed copies of completed test results. Each test report shall include, as a minimum:

· Patients name and identification number (social security number)

· Physician’s name (if supplied)

· Test Accession Number assigned by the facility.

· Facility name

· Patients’ location clinic/ward (if supplied)

· Date/Time specimen received in a reference lab.

· Test ordered.

· Date/Time of specimen collection (if available)

· Date test completed.

· Test/diagnostic result

· Flagged abnormal.

· Reference range

· Toxic/Therapeutic range (where applicable)

· Testing laboratory specimen number

· Name, address, and CLIA number of the testing facility (contractor and/or subcontractor)

· Type of specimen

· Any additional comments related to the test provided by submitting labs.

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

· Unsatisfactory specimens shall be reported about their unsuitability for testing.

2.2.13 For test results being returned to VA laboratories running Vista Lab, Referral laboratories are to include a VA ICN or EDIPI number with patient reports as an identifier. VA referring Vista laboratories are to supply the patients VA ICN or VA EDIPI with each lab order to enable the referral laboratory to include it with results returned to the VA.

2.2.14 Retention of Specimens. Upon completion of testing, the contractor shall retain all specimens as required by regulatory agencies. Upon request by the ordering activity COR or designee, the contractor shall provide a copy of the regulatory requirements for each participating regulatory agency.

2.2.15 Implementation and Transition. Implementation must take place within 120 days of award for all eight facilities. The contractor shall contact the COR and Point of Contact at each facility within a minimum of 5 calendar days after award to coordinate the transition and implementation of services at the eight (8) identified government facilities, starting with the furnishing and delivery of specimen collection and transportation supplies, communication terminal and connections, and installation of equipment. The contractor shall supply the supplies to the ordering facility within a minimum of ten (10) workdays after receipt of the task order. The COR or designee will request replenishment of supplies from the contractor on an as-needed basis.

The contractor’s submitted plan shall not exceed 120 days for the transition of all services at eight (8) facilities under the awarded contract, including installation and training of personnel, the transition of all testing materials and supplies, etc., and the performance of all correlations and validations. The contractor shall provide in-house support to assist in building the new tests in Vista and the training required for transition. Failure of the Contractor to conform to the transition period shall be considered sufficient cause to terminate the contract for cause under the Termination for Cause clause of the contract.

Implementation of the services/requirements described in this solicitation shall be completed no later than 120 days after the award of the contract. This timeline is based on the Contractor's reasonable attempt to complete all the necessary implementation requirements within the stated timeframe. The contractor shall not be penalized for implementation timelines that extend beyond the 120-day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government.

Upon award of a contract, the transition period for the contract must be completed with all equipment and peripherals installed and operational no later than 120 days from the date of award. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

At the end of 120 days from the contract award, the awarded Contractor shall be responsible for services under the awarded contract.

2.2.16 Ancillary Equipment and Maintenance. The Contractor shall provide, install, and maintain, as indicated, all ancillary support equipment necessary to order tests and receive or transmit patient test/diagnostic reports. This shall include any battery backups, printers, communication managers, modems, and phone lines necessary to electronically transmit orders or results. The contractor shall provide routine preventive and as-needed maintenance on any installed ancillary equipment or terminal at the facility within 72 hours of notification by COR or designee at no additional charge to the government. Emergency requests and issues affecting patient care will be resolved within 24 hours.

2.2.17 Equipment provided and/or installed will be new, unused, of the current model, and the Contractor shall provide the most current upgrades (hardware or software) for all provided equipment at no additional costs to the government. The Contractor shall replace equipment in a timely manner if such equipment is deemed obsolete or outdated at no additional cost to the government.

2.2.18 Customer Service. At the time of award, the Contractor shall provide the name, phone number, and email address of a project manager who will act as a single point of contact for all concerns; however, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period:

2.2.18.1 Specimen Collection

2.2.18.1.1 Routine inquiries, questions, and clarifications regarding collection requirements shall be addressed during the initial call.

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

2.2.18.3 Testing

2.2.18.3.1 Status of Ordered Testing– inquiries regarding the status of pending orders shall be addressed during the initial call.

2.2.18.3.2 Esoteric inquiries where information is requested regarding methodology, correlation, interferences, reflex tests, etc., shall be addressed within two (2) hours of the initial call.

2.2.18.4 Technical Expertise

2.2.18.4.1 Test utilization inquiries regarding the most appropriate test to be ordered shall be addressed within two (2) business hours of the initial call.

2.2.18.4.2 Result interpretation inquiries shall be addressed within four (4) business hours of the initial call.

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

2.2.18.4.5 Information Technology Expertise for questions or issues regarding loinc and test codes, point-to-point communication, website, electronic results, or electronic reports shall be addressed within 4 hours.

2.2.18.4.6 Account follow-up that requires general information specific to the account, e.g., test pricing, equipment repair, supply ordering, etc., shall be addressed within four hours of the initial call.

2.2.18.4.7 The Contractor shall notify the originating laboratory by telephone, with documentation of verbal notification to include the date, time, and name of the individual notified, of specimens canceled due to unacceptability, e.g., volume, specimen container, identification, loss of specimen, etc. Notification to ordering location within 24 hours from when the test was canceled.

2.3 INTERFACING/COMMUNICATION REQUIREMENTS:

2.3.1 The Contractor shall provide an integrated system approach to facilitate and streamline all specimen ordering, testing, and reporting aspects. As such, the Contractor shall provide and program an interface system to electronically receive and/or transmit orders, specimen status, and test results between the Contractor’s host computer system and the VA’s host computer system (VistA). The Contractor shall contact the COR within a minimum of 5 calendar days after the award to coordinate the transition and implementation of the test interface.

2.3.2 The expense of the electronic message connectivity is borne by the Contractor, including any and all necessary hardware, software, and license fees.

2. 3.3 All electronic messaging between the two (Contractor and VistA) computer systems shall conform to VistA Health Level Seven (HL7) and Laboratory’s HL7 technical specifications. Health Level 7 (HL7) is a registered trademark of Health Level Seven, Inc., is a Standards Developing Organization accredited by the American National Standards Institute to author consensus-based standards. Information regarding HL7 transmission protocols may be accessed through the Health Level Seven, Inc. website, www.HL7.org.

0.

2.3.4 Data connectivity between the Contractor and the VA will be accomplished through the use of either a Client to Site (C2S) connection, Site-to-Site (S2S) connection, or via the VA’s Private Extranet Internet Cloud according to standards required by the VA’s Network Security and Operations Center (NSOC) and as approved by the VA’s Enterprise Change Control Board (ESCCB) in accordance with VA Directive and Handbook 6500 requirements. To support the contract, the Information Security Office will coordinate the requirements with the Contracting Officer Representative (COR) and the Contracting Organization POC. Typical connections are by Site-to-Site VPN. Business Partners may access designated internal VA servers if granted a client VPN account. A Client VPN requires the signing of VA National Rules of Behavior and VPN Rules of Behavior by each approved connection user. However, if a large number of Business Partner users are approved for this, it may be more efficient to build a Site to Site (S2S) VPN with the Business Partner.

2.3.4.1 Each type of connection (C2S or S2S) requires all contractors to complete Background Investigations (required by FIPS 201) and must initially and annually thereafter participate in the VA Information Security Awareness and VA Privacy training programs.

2.3.4.2 A Site-to-Site VPN enables a VA Business Partner to access specific resources on the VA WAN securely. It establishes a Virtual Private Network (VPN) connection between the Business Partner network and one of the VA Trusted Internet Connection (TIC) Internet Gateways. Traffic that may pass over this connection is limited, so only specific VA and Business Partner systems may communicate with each other. An S2S is used only if a client-to-site VPN connection cannot meet business needs. The Business Partner must support encryption compliant with Federal Information Processing Standard (FIPS) 140-2. The Business Partner must sign a legal agreement with the VA (ISA/MOU for a S2S. Communication must be limited to explicit VA and Business Partner systems, using limited ports, protocols, and services. An S2S requires an Interconnection Security Agreement, which is used to support a Memorandum of Understanding/Agreement (MOU/A) that establishes the requirements for data exchange between two organizations. The MOU/A documents the business and legal requirements necessary to support the business relations between the two organizations.

2.3.4.3 Each VA TIC gateway has Cisco Adaptive Security Appliance (ASA) devices used for Site-to-site VPN connections. They use IP Security (IPSec) with Triple Digital Encryption Standard (3DES) or Advanced Encryption Standard (AES) for encryption and ISAKMP for authentication and integrity. The devices are FIPS 140-2 compliant. This capability establishes a secure, end-to-end encrypted tunnel that protects the VPN data flows from the Gateway VPN components to all VPN-enabled sites. The Gateway VPNs are configured to allow only IPSec-protected data flows and only when they originated from and were sent to authorized peers. The Business Partner must use a FIPS 140-2 compliant solution for their end of the Site-to-Site VPN. If they do not have a VPN solution, the vendor will work with VA Information Security, NSOC, and the ESCCB to establish the appropriate VPN connection type. The VA is not responsible for problems with equipment owned by the Business Partner.

2.3.5 After the contract award and annually thereafter, the contractor shall provide the VA with all necessary laboratory test parameters to ensure accurate test result transmission between the VA and the vendor’s database. Required test parameters to include are as follows:

· Ordering code.

· LOINC code.

· CPT code.

· Interface code.

· Test cost.

· Reference ranges.

· Units of measurement.

· Test result interpretation or interpretive remarks, if appropriate.

· Testing site (if not performed at the vendor’s main laboratory facility.

· Test methodology.

· Specimen types.

· Specimen collection and handling requirements.

· Whether the test is a panel or profile test, a list of tests is included.

(NOTE: above parameters are required for each test contained in a panel)

2.3.6 The parameters for all tests in the Contractor’s database shall be kept current and available to the VA sites throughout the contract's performance period. Updates to the test parameter information must be provided to VA sites before testing changes in the following situations: new tests are developed and introduced into the Contractor’s test menu; testing parameters have changed; or when tests are discontinued or replaced by other tests. The contractor shall provide information to VA sites no less than 2 weeks before the implementation of the test change. To maintain accurate and timely test information, the Contractor shall provide telephone access to a COR to respond to any question(s) regarding the laboratory test parameter information.

2.3.7 VistA Laboratory Electronic Data Interchange (LEDI) identifies VA-specific content and encoding tables for HL7 message protocol conventions. The LEDI specification closely follows the HL7 standard. LEDI identifies encoding tables and HL7 message protocol conventions.

2.3.7.1 VistA LEDI identifies the commercial reference laboratory vendor shipping lists containing required specimen demographics and requested tests to be performed. This list will be provided in printed format.

2.3.7.2 VistA LEDI software will provide an HL7 acknowledgment for the receipt of test results from the vendor. Hard copy specimen results and electronic transmission of results will be required. The hard copy must contain VA’s assigned specimen identification, where specimen identification is defined as a unique VA-assigned 10-digit number that is associated with each specimen. This specimen identification number will appear on the test order form, specimen label, and shipping manifest during implementation. This information is also available in electronic HL7 format if required.

2.3.7.3 The Contractor shall provide the VA with specimen status in response to electronic and verbal queries. A formatted HL7 message containing specimen results with the VA’s assigned specimen identification shall be returned to the requesting medical center upon testing completion.

2.3.7.4 The Contractor shall conduct preventive maintenance and repair of contractor-furnished hardware, software, and associated communication lines. In addition, throughout the contract's performance period, the Contractor shall repair or replace any malfunctioning hardware or software.

2.3.7.5 The Contractor shall provide in-service training for the routine loading and care of printers and other hardware on-site. The training will ensure that the VA can perform routine hardware servicing.

2.3.7.6 The Contractor shall install and, if necessary, remove all interface communication equipment and associated hardware.

2.3.7.7 The contractor shall address interface questions within two hours of the initial inquiry where information is required to update, maintain, and support the services of the host-to-host linkage between the VA and the Contractor. All issues affecting patient care will be resolved within 24 hours or as approved by the local COR.

2.3.8 Data Management System/Communication Manager or Internet Database System. The contractor shall have a system or platform to assess lab test costs and utilization in real time. The contractor shall provide a data management system or internet database system available for each medical facility listed on page 6 of the statement of work. The system shall meet the following requirements:

2.3.8.1 The test order must be accomplished through an intuitive menu with minimal options that use a mouse or touch screen. Upon selecting the test, the computer shall alert (flag) the user to the type of specimen required and the storage conditions.

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

2.3.8.3 Status and testing results must be available within published timeframes and easily retrievable using varying options. At a minimum, the options must include Sort by patient name, sort by date, sort by test, and some kind by incomplete test. Incomplete tests must indicate the pending time until completion.

2.3.8.4 Reports of test results must be immediately available upon verification. The system must also be able to print test results and reprint retrospective test results within a defined timeframe.

2.4 QUALIFICATION REQUIREMENTS:

2.4.1 Licensing and Accreditation. Only fully licensed and accredited laboratories shall actively provide the specific services, and laboratory testing outlined in this contract will be considered. The contractor shall have all licenses, permits, accreditations, and certificates required by law. The reference laboratory must be licensed and accredited by the College of American Pathology (CAP) and/or other state regulatory agencies and mandated by federal and state statutes. In addition, the laboratory must be certified to meet the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.

2.4.2 Any proposed changes to a subcontractor’s licensures and accreditation during the contractor performance period must obtain prior approval by the Contracting Officer (CO). A bilateral modification will address changes to the requirements.

2.4.3 Malpractice Liability Insurance. Malpractice liability insurance shall be provided by a commercial insurance company that provides the required insurance coverage of not less than $1,000,000.00 per occurrence (See Clause 852.237-70). The contractor shall provide a copy of the Medical Malpractice Insurance Certificate annually or after any modifications.

2.4.3.1 The contractor shall notify the CO in writing of any malpractice investigation or licensure or certificate suspension that concerns the contractor or any of its employees within 24 hours of notification of investigation or suspension.

2.4.4 Contractor Personnel. The contractor shall maintain current accreditation and notify the CO of any lapsed in-state license, CLIA certification, or clinical pathology certification. The contractor shall also provide the CO with a copy of the renewed licenses/certificates before expiration.

2.4.5 Subcontractors. Each subcontractor must maintain the same certifications, accreditations, and Medical Malpractice Insurance as the Contractor requires.

2.5 SAFETY REQUIREMENTS:

2.5.1 The 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 and Prevention (CSC).

2.5.2 The Contractor shall submit a verbal property damage report to the CO and COR, within 24 hours, for any accident caused by Contractor employees working at Government facilities that damage Government property.

2.5.3 The Contractor shall submit a written property damage report to the CO and COR, within 72 hours, for any accident caused by Contractor employees working at Government facilities that damage Government property.

2.6 INFORMATION SECURITY, PRIVACY, AND OTHER SPECIAL REQUIREMENTS:

2.6.1 The Contractor must adhere to Public Law 104-191 provisions, the 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 use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA) and the Department of Defense (DoD). The VA has recognized that Diagnostic Laboratory Testing Facilities are Health Care Providers, and the PHI is being disclosed and/or used for the treatment of an individual, and are entities that do not require a Business Associates Agreement (BAA) with their contractors if they are conducting health care on behalf of the VA.

2.6.2 The Contractor is a Government Provider for the Privacy Act of 1974 purposes. The treatment and administrative patient records created by, or provided to, the Contractor under this contract is covered by the VA system of records entitled “Patient Medical Records-VA” (24VA136). Medical records shall be secure, complete, legible, accurate, accessible, organized, and maintained in a format that facilitates information retrieval. Information from VA medical records requested by the patient or any other third party shall be referred to Health Information Services (HIMS) at CAVHS in accordance with the Privacy Act of 1974, Title 38 of United States Code (U.S.C.) (U.S.C 5701, 5705 and 7332), as well as other Federal law, embodied elsewhere in the U.S. Code that bears directly on the privacy of personal data. The Contractor is restricted from disclosures of Government records or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from the Government has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as the Government.

2.6.3 The Contractor shall adhere to the VA SUBPART 839.1. 839.105-71 Liquidated damages—protection of information in information technology-related contracts.

Contracting officers shall insert the liquidated damages clause as prescribed in information technology-related contracts at 811.503-70.

839.106-70 Information security and privacy contract clauses.

(a) Contracting officers shall insert the clause at 852.239-70, Security Requirements for Information Technology Resources, and the clause at 852.239-71, Information System Security Plan and Accreditation, in all solicitations, contracts, and orders exceeding the micro-purchase threshold that include information technology services.

(b) Contracting officers shall insert the clause at 852.239-72, Information System Design and Development, in solicitations, contracts, orders, and contract where information system design and development services are required.

(c) Contracting officers shall insert the clause at 852.239-73, Information System Hosting, Operation, Maintenance or Use, in solicitations, contracts, orders, and contract where services to perform information system hosting, operation, maintenance, or use are required.

(d) Contracting officers shall insert the clause at 852.239-74, Security Controls Compliance Testing, in solicitations, contracts, orders, and contract, when the clause at 852.239-72 or 852.239-73 is inserted.

2.7 SERVICES:

2.7.1 This is a non-personal services contract. There is no employer-employee relationship between the Government and the contractor or the contractor’s employee(s). The Services Contract Act of 1965 applies to this agreement. Current Wage Determinations can be found at: http://www.wdol.gov/sca.aspx.

2.8 QUALITY ASSURANCE:

2.8.1 The Government reserves the right to inspect the reference laboratory(s) before the award physically and at any time during the award period to ensure the reference laboratory’s compliance with accreditation and quality assurance practices and requirements; however, the Contractor shall have sole responsibility to maintain CAP accreditation and must immediately notify the VA of testing, analysis, and or accreditation concerns. The Government will not be liable for any expenses incurred by the Contractor due to these inspections.