36C24822R0071.docx

36C24822R0071

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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

36C24822R0071 06-29-2022 Paul Jarrett 813-972-2000 ext. 3107 07-28-2022 09:00

EDT

Y Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Suite 525 Tampa FL 33637 X 621511 $35 Million N/A X Department of Veterans Affairs James A. Haley Veterans Hospital (90C) 13000 Bruce B. Downs Blvd Tampa FL 33612 00248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Tampa FL 33637

Contractor shall submit invoices via:

Tungsten Network https://www.tungsten-network.com

See CONTINUATION Page Contractor shall provide Reference Laboratory Testing to VISN 8 Medical Facilities in accordance with the PWS.

See CONTINUATION Page X X Paul Jarrett, 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: Contracting Officer 36C248 Paul Jarrett Department of Veterans Affairs Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy Suite 525 Tampa FL 33637

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 See attached document: SCHEDULE.

The quantities listed in the Price Schedule are estimates only and are not to be considered a minimum or maximum. The guaranteed minimum contract amount, including the base year and any option years exercised is $11,000,000.00, and the maximum contract amount, including the base year and any option years exercised, shall not exceed $87,000,000.00. A task order shall be issued at the start of each performance period.

ESTIMATED QUANTITIES: All quantities listed herein are estimated annual quantities. The Government is not obligated to purchase any specified amount of services under this contract, but will be obligated to make payment for all services requested and received in the quantities and of the quality requested. The Government does not guarantee or imply that any fixed number of orders/referrals for services will be placed under the resultant contract.

ORDERING PROCEDURES: The VA Contracting Officer may place Task Orders utilizing any of the procedures to the Ordering Clause.

36C24822R0071

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B.3 PERFORMANCE WORK STATEMENT

REFERENCE LABORATORIES TESTING

1. INTRODUCTION

Veterans Integrated Services Network 8 (VISN 8) has a requirement for reference laboratory testing for any required tests from the associated VISN 8 Veterans’ Affairs Medical Centers (VAMC) (also referred to as government, VA, VISN, Government Facilities or Medical Facilities, Site), consultative services, specimen processing services as applicable, and the transportation of clinical laboratory specimens to the contractor’s laboratory(s).

The VAMC’s are located in Florida, part of Georgia and Puerto Rico and include the following:

· Miami VAMC.

· Bay Pines VA Healthcare System (C.W. Bill Young VA Medical Center and Lee County VA Healthcare Center).

· James A. Haley Veterans’ Hospital (Tampa VAMC and New Port Richey VA Outpatient Clinic).

· Caribbean VA Healthcare System (San Juan, Puerto Rico VAMC).

· North Florida/South Georgia Veterans Health System [Malcom Randall VA Medical Center (Gainesville), Lake City VA Medical Center, Jacksonville Outpatient Clinic, Sergeant Ernest I. “Boots” Thomas VA Clinic (Tallahassee), and The Villages Outpatient Clinic].

· West Palm Beach VAMC.

· Orlando VA Healthcare System [Lake Nona Orlando VAMC, Viera VA Healthcare Center, and William V. Chappell, Jr. VA Multispecialty Community Based Outpatient Clinic (CBOC)].

See Attachment E - Locations for a map with specific locations and addresses. The Government may add or delete locations and will modify the contract as appropriate.

2. BACKGROUND

Anatomic and surgical pathology tests and clinical laboratory tests are essential diagnostic tools for the physicians to use to improve patient care. A reference laboratory is required to provide the testing services that cannot be performed within the facilities of the VISN, to provide confirmation of tests that are performed within the facilities of the VISN and to provide consultations on pathology specimens.

3. SCOPE OF WORK

All requirements and provisions defined in this scope of work will apply to any laboratory, i.e. branch, division, sub-contractor, etc., performing reference testing on behalf of the contractor and will include any and all new facilities acquired into VISN 8 during the contract. Services shall include:

· Reference laboratory testing provided by an accredited laboratory as described in section 4.1 Performance Requirements of the PWS.

· Evidence of a Quality Management Plan and Customer Service structure

· Reference laboratory testing for all tests listed on government’s Attachment D (VISN 8 Reference Lab Line Items) as well as all esoteric tests as defined by the contractor’s reference test manual.

· Reference laboratory testing that meets or exceeds contractor’s published Turn Around Time (TAT).

· Transportation of clinical laboratory specimens to the contractor’s laboratory(s),

· Reporting of clinical and anatomic analytical test results and consultative services as required to assimilate the full scope of its laboratory operations to the VISN 8, and

· Establishment of an interconnection with the VA for transfer of laboratory test results directly into a VA computer system via the appropriate Laboratory Electronic Data Interchange protocol.

· The contractor shall provide at least one specimen processor at each participating Medical Facility for the processing and packaging of laboratory specimens in preparation for transport to the contractor’s laboratory. Contract tests will be a cost per test to provide services at the request for any tests listed in Attachment D (VISN 8 Reference Lab Test Line Items). The contractor shall provide access to the tests, if needed, on any test listed on Attachment D. At the request of any VISN 8 facility, the contractor shall provide the results for reference lab to the respective site. A firm fixed price will be applied for specimen processor(s) at participating Medical Facility(ies). This option will be listed as a separate contract Line Item for each participating Medical Facility and will be the sole responsibility of that participating Medical Facility as well as their designated Contracting Officer Representative (COR). See Attachment F for list of participating sites.

· The contractor shall provide information into the following columns: Unit Price (“I”), Amount (“J”), Packaging Multiple (“N”), Item Part Number (“O”), and OEM Name (“Q”) of the VISN 8 Reference Lab Line Items (Attachment D). The term “OEM Name” is a required field in the VA’s contracting module and shall be used as the name of the vendor providing the tests for this requirement.

4. PERFORMANCE REQUIREMENTS

4.1 Contractor and any subcontractors thereof shall be licensed/accredited by the Clinical Laboratory Improvement Act (CLIA) of 1988 or College of American Pathologists (CAP) or The Joint Commission (TJC).

4.1.2 Contractor shall furnish Government Facilities with an electronic/computerized method to request tests and receive results.

4.1.3 Contractor shall confirm and provide all tests listed in Attachment D (VISN 8 Reference Lab Line Items). The contractor shall include the Contractor’s National Test Codes (NTC) and the Center for Medicare and Medicaid (CMS) Current Procedural Terminology (CPT) codes. NTC shall be placed in column (“O”) as the “ITEM PART NUMBER.” The CMS CPT codes shall be identified in column (“P”) as the “MANUFACTURER PART NUMBER.” Attachment J provides a list for test panel components for the contractor to provide accurate test matches for items missing a CMS CPT code in column (“P”).

4.1.4 Any testing listed on Attachment D (Reference Lab Line Items) and available through the Contractor, shall immediately be orderable as needed and at quantity required by each participating Medical Facility.

4.1.5 The contractor shall provide an actual test volume on the lab testing requirements for each VISN 8 facility on a quarterly basis. A continuous review on testing will be established to obtain test volume requirements including those tests necessary for patients, repeats, controls and others under routine operating conditions. Tests that are not listed on Attachment D (Reference Lab Line Items) shall be provided as a model for market research purposes. A semi-annual contract administration review will be conducted to confirm/adjust all elements of the Price/Schedule, to include overall contract performance vs actual volumes and utilization efficiencies. New test(s) offered by the contractor shall be available to the Government upon VISN 8’s request. A contract modification shall be in place to add new test(s) to Attachment D, VISN 8 Reference Lab Line Items. The Government shall have capacity to order all tests the contractor provides to the commercial marketplace.

4.1.6 Contractor shall provide a test report for each test requested. A report is defined as a printed final copy in duplicate of laboratory testing results or host-to-host electronic transmission of test results. For test results being returned to VA laboratories running VISTA Lab, Referral labs are to include a VA internal control number (ICN) or VA electronic data interchange personal identifier (EDIPI) number with patient reports as an identifier. VA referring VistA labs are to supply the patients VA ICN or VA EDIPI with each lab order to enable the referral lab to include it with results returned to the VA. This report will be provided by either messenger delivery or computer interface. Each test report shall at minimum indicate the following information:

Patient's name and/or identification number Physician’s name (if supplied) VISN 8 medical record number or laboratory accession number (if supplied) VISN 8 submitting facility name Patient's location (clinic/ward) (if supplied) Test ordered Date/time of specimen collection (when available) Date/time test completed Test result Reference intervals Toxic and therapeutic ranges, if applicable Flagged abnormal values Reference laboratory specimen number Name and address of testing laboratory if other than contractor Any other information the laboratory has that may indicate a questionable validity of test results Comments related to the test provided by the submitting lab Unsatisfactory specimen shall be reported with documentation supporting its unsuitability for testing Anatomic and Surgical reports shall be in synoptic format

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

4.1.8 Test definitions, test information and test requirements shall be complete, available and easily accessible. Contractor shall ensure test reports will be available via the VistA/contractor interface, at least 95% of the time. For all non-interfaced tests, ordering shall be accomplished through contractor’s secure online ordering system that is client-based with applicable menu options. Upon selection of the test, the ordering system shall alert or provide option for user to access type of specimen required including storage and shipping conditions. It shall also alert the user to the location of the laboratory that will be performing the test.

4.1.9 Contractor shall always provide notification by telephone to the submitting Government Facilities of test results identified as critical values upon verification of the critical test result. A hard copy result must follow any telephonic reporting either by fax or computer-generated report.

4.1.10 In the case that a subcontracted laboratory is used, contractor shall ensure that each subcontracted laboratory maintains the same certifications, accreditation and medical malpractice insurance as required of the contractor.

4.1.11 Contractor shall provide all test results to the ordering facility in accordance with the testing specifications defined in the contractor's commercial specimen collection guide.

4.1.12 Emergency testing services (STAT), to include pick-up, shall be available for all procedures deemed necessary on an emergent basis. Contractor shall provide emergency transportation services 24 hours per day, seven days per week including Government holidays. Response time for emergency pick up shall be within 1 hour of notification of specimen availability. Results for emergency test requests shall be reported to the requesting VISN 8 facility immediately upon completion of testing.

4.1.13 Tests referred to a subcontracted laboratory shall be at no additional transfer expense or charge to the Government.

4.1.14 Contractor shall provide all repeat testing, upon the request of the ordering facility, at no additional charge to the Government.

4.1.15 Contractor shall provide written notification about changes to methodology, specimen requirements, turnaround times, reference ranges, and test availability 30 days in advance of the effective date.

4.1.16 Notification of specimens cancelled due to unacceptability, i.e. volume, specimen container, identification, loss of specimen, etc. shall be communicated to the submitting VISN 8 laboratory upon discovery.

4.1.17 Contractor shall provide a statistical analysis of the VISN 8 Medical Facilities’ workload testing volumes to assist in the monitoring of ordering trends and utilization patterns.

4.1.18 Contractor shall provide anatomic and surgical pathology consultation regarding selection, collection, transportation, and result interpretation of pathology specimens when required. Contract shall provide electronic email notification of preliminary or final anatomic pathology report when they are available for review. A Pathologist shall be on call at all times and available for emergency consultation after hours. Complex issues that cannot be resolved by the Pathologist on call shall be referred immediately to the Pathologist specializing in the appropriate area. The reference testing of anatomic and surgical pathology specimens includes but is not limited to:

· Immunohistochemistry technical only;

· Immunohistochemistry technical and professional;

· In situ hybridization technical only;

· In situ hybridization technical and professional;

· Fluorescent in situ hybridization technical only;

· Fluorescent in situ hybridization technical and professional;

· Molecular PCR technical and professional;

· Flow Cytometry technical only;

· Flow Cytometry technical and professional;

· Cytopathology technical only;

· Cytopathology technical and professional.

4.1.19 The Government reserves the right to physically inspect the reference laboratory(s) at any time to ensure the reference laboratory’s compliance with accreditation and quality assurance practices and requirements.

4.1.20 Contractor shall take all precautions necessary to protect persons and property from injury or damage during the performance of this contract. Contractor personnel shall be responsible for any injury to employees or others as well as for any damage to personal or public property that occurs during the performance of this contactor that is caused by the negligence of the contractor or its employees. The contractor shall maintain personal liability and property damage.

4.1.21 Any equipment provided by the contractor to VA which contains a storage device such that when the device is powered down, VA sensitive data remains on it must become the property of the Federal Government and remain on Federal property or must be destroyed by VA and in accordance with Department of Veterans’ Affairs regulations at the time of removal (device decommissioning). Data required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to remain on equipment located on contractor’s property must be safeguarded in accordance with HIPAA and this information must be destroyed in accordance with VA requirements when no longer required by HIPAA to be held by the vendor.

4.1.22 Contractor shall ensure the confidentiality of all patient information being transported and will be held liable in the event of a breach of confidentiality. The contractor shall comply with the provision of the Federal Privacy Act of 1974 (Public Law 93-579), HIPAA (Public Law 104-191), and the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment and Rehabilitation Act of 1972 (Public Law 93-255), as well as any other statutes regarding confidentiality of patient information during and after the execution of the contract. The contractor shall obtain a signed confidentiality certificate from each employee that may have access to medical record information prior to allowing them to work on this contract.

4.1.23 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 their performance are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the services. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials. No information shall be released by the contractor. Any request for information presented to the contractor shall be submitted to the CO for response. Press releases, marketing material, or any other printed or electronic documentation related to these services shall not be publicized without the written approval of the CO.

4.1.24 Government Facilities will provide a secure fax line and a computer system to receive test reports from the reference laboratory.

4.1.25 Government Facilities reserve the right to select other testing methodologies than offered by the contractor’s laboratory for appropriate reasons, i.e. better clinical quality, research studies, or those determined for performance at VISN 8 centers of excellence. VISN 8 facilities that identify such a testing methodology not meeting their testing criteria must submit a request for review to a VISN 8 adjudicating panel with sufficient justification to warrant an exemption from the contract. These rare test exemptions will be re-referred to another reference laboratory and the costs borne by VISN 8.

4.1.26 All contractor employees who require access to the VAs’ computer systems and Protected Health Information shall be the subject of a background investigation and must receive a favorable adjudication prior to contract performance. See paragraph 7. Personnel Security for additional information.

4.1.27 The contractor shall provide telephone inquiries support. Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the VA’s minimum time expectation for meeting this service.

a. Specimen Collection

i. Routine inquiries, where the reference laboratory performs the testing and further clarification on the collection requirements are needed, shall be addressed at the time of the inquiry.

ii. Esoteric inquiries, where the information on the availability and/or requirements of the questioned test requires further research, shall be addressed within ½ hour of the initial inquiry.

b. Testing

i. Status of ordered testing inquiries regarding pending orders shall be addressed at the time of the inquiry.

ii. Esoteric inquiries, where information is requested regarding methodology, correlation, interferences, reflex tests, etc., shall be addressed within two hours of the initial inquiry.

c. Technical Expertise

i. Test utilization inquiries, where information is required as to the most appropriate test to be ordered, shall be addressed within two hours of initial inquiry.

ii. Result interpretation inquiries shall be addressed within four hours of initial inquiry.

iii. Consultative services, where information is required regarding the clinical significance of tests, shall be addressed within twenty-four hours of the initial inquiry.

iv. Computer interface questions, where information is required to update, maintain, and support the services of the host-to-host linkage between the VA and the contractor, shall be addressed within two hours of the initial inquiry.

d. Account follow-up that requires information general in nature yet specific to the account, e.g. test pricing, courier service problems, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial inquiry.

4.1.28 Contractor shall provide a detailed plan within their proposal describing their performance improvement activities/plans in relation to serving Government Facilities. This plan shall minimally address the quality aspects representative to the testing process, i.e. pre-analytical, analytical and post-analytical variables and include a description of monitoring and evaluation activities. This plan shall also include a description of their procedure for responding to issues, problems and/or concerns identified by the VISN 8 laboratories and specific information as to whom and in what timeframe the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event.

4.2 Contractor shall provide daily transportation of clinical laboratory specimens to the contractor’s laboratory(s). Service shall include at least one (1) pick-up per day at each facility, regardless of the number of specimens to be picked up. Routine scheduled pickup times will be mutually agreed upon between the contractor and each ordering Government Facility. Services shall be automatically extended to any and all new VISN 8 facilities acquired during the contract period. A point of contact(s) shall be designated for immediate response to daily transportation service issues.

4.2.1 The associated VISN 8 Veterans’ Affairs Medical Facilities will ensure proper collection of the specimens for shipping and prepare specimens for shipping by the contractor to the reference laboratory in accordance with all State and Federal shipping and transportation rules and regulations. All specimens will be properly labeled and collected in the proper tube/container. All specimens will be stored in accordance with the policies and procedures of the reference lab.

4.2.2 The courier service and the shipping initiator must comply with all transportation, shipping rules and regulations, employee training and infection control guidelines established by State and Federal agencies.

4.2.3 Contractor shall transport and store specimens in such a manner to ensure the integrity of the specimen. In addition, the contractor will provide additives required for collection of specimens in unit packages to facilitate collection in CBOCs and Outpatient Clinics (OPCs). Material Safety Data Sheets will be provided to sites for supplies containing hazardous chemicals (e.g. boric acid tablets, acids).

4.2.4 Contractor shall provide a shipping manifest that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered.

4.2.5 Contractor shall provide through direct on-line ordering specimen collection and transportation supplies. The contractor shall provide at no additional charge an adequate supply of specimen collection materials for such testing that is destined to the commercial reference laboratory for analysis and requires specialized handling as dictated by the commercial reference laboratory’s specimen collection requirements, i.e. dry ice, stabilizing tablets, ice packets, etc.

4.2.6 Contractor shall be responsible for ensuring that all transport personnel are trained and that their competency is regularly assessed in appropriate safety and packaging procedures suitable to specimen type and distances transported. This includes issues such as adherence to regulations for transport of biohazards, use of rigid containers where appropriate, temperature control, notification procedures in case of accident or spills, etc.

4.2.7 Contractor’s training records shall include: employee’s name, completion date of most recent training, name and address of Health Improvement Performance Management (HIPM) and hazmat trainer and certification that the employee has been trained and tested within 90 days of initial employment and annually thereafter.

4.2.8 Contractor shall provide all training and copies of Training Certificates to the COR as soon as training has been completed.

4.3 Contractor shall develop and establish a bidirectional computer interface with the current version of the VA VistA System for transfer of laboratory test orders and results via the appropriate Laboratory Electronic Data Interchange (LEDI) HL7 protocol.

4.3.1 In the case in which a contract is awarded to a contractor that does not have a fully operational bidirectional interface in place with the listed Government Facilities, a transition plan to establish the bidirectional interface will be developed between the Government, the new contractor and the incumbent contractor. Completion of fully operational bidirectional interface must be in place within six (6) months of contract effective date.

4.3.2 Regardless of any transition period, the contractor shall have the bidirectional interface fully operational at all the listed Government Facilities, all tests establishment and validation completed no later than six (6) months from contract effective date.

4.3.3 Contractor shall use the manifest and test labels of the host lab and receive orders and send results via the VA VistA/contractor interface; with at least 95% of all test reports available via the VistA/contractor interface. All hardware and software needed for the interface shall be provided by the contractor. Printed copies of results will also be made available via an in-house printer to confirm interfaced data.

4.3.4 The configuration must provide the required security of the Government host computer system. The actual electronic connection between the Government host computer system and the contractor’s host system is of the contractor’s choosing. The initial and continual expense of the electronic message connectivity and maintenance shall be borne by the contractor throughout the performance of the contract. Contractor shall provide technical support should the current system changes.

4.3.5 Contractor shall provide, install, maintain, repair and, if necessary, remove all required telecommunication equipment, hardware, software and related consumable supplies to support the transmission of electronic data to all Government Facilities. This may include, but is not limited to:

· Generic Instrument Manager (GIM) for the interface connection

· Shipping list printers

· Bar-code printers

· Back-up result printers connected directly to Contractor’s computer system

· Any required communication lines

· Software to receive and send orders, display status of and/or test results

· Consumable supplies to maintain the operation of the equipment listed above, e.g. toner/ink, paper, labels, etc.

4.3.6 Contractor shall be responsible for all annual recurring costs associated with support and maintenance of interface connection including all GIM equipment, software and instrument connections.

4.3.7 Contractor shall conduct 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.

4.3.8 Contractor shall address within two hours of initial inquiry, interface connection questions where information is required to update, maintain and support the services of the host-to-host linkage between the Government and the contractor.

4.3.9 Contractor shall provide in-service training required for the routine loading and care of printers and other hardware located on-site. The training will ensure that Government staff are capable of performing routine servicing of hardware.

4.3.10 Contractor must meet all Enterprise Cyber Security Infrastructure Project (ECSIP) requirements in order to establish the interconnection with the VA for transfer of laboratory test results. There are three basic types of authorized connections. The ECSIP team will have the ultimate decision on which connection type is appropriate. The connection types are described below. More information can be obtained from the VA Information Security Officer at any facility.

4.3.11 External users shall be classified in one of three distinct categories: 1) client-to-site virtual private network (VPN), 2) site-to-site VPN, or 3) Business Partner Gateways. The items below can be utilized in assisting users to determine which category a particular connection may best be identified.

4.3.12 Client-to-Site VPNs satisfy remote connectivity for small groups of external users (IE <50) that require access to VA internal resources. Non-VA users are restricted to specific internal IP addresses identified by the Contracting Officer Representative (COR). External business partners should have access to the minimum resources required to meet contractual obligations.

4.3.13 Site-to-Site VPNs are connections to external business partners, which terminate in an ECSIP gateway. These connections will then be routed across the VA WAN to the requisite VA facility resources as defined by firewall policy.

4.3.14 Business Partner Gateways (BPGs) are connections to external business partners, which terminate at the requisite VA facility and do not traverse the VA WAN. These connections will be limited in number based on the definitions of the Chief Information Officer requirements.

4.3.15 Specifications outlining the requirements of this computer interface including computer hardware, maintenance, and supply requirements are defined in the telecommunication requirements listed below.

Numerous Users – Having a significant number of client-to-site user accounts to manage may justify a site-to-site VPN.

X

Persistent Connection Required – The need to maintain continuous connectivity can usually be supported with a site-to-site VPN.

High Bandwidth – A large volume of traffic may be a valid need to establish or maintain a Business Partner Gateway (BPG) connection to prevent certain traffic from traversing the VA WAN. As an example, a medical teaching University supported by a VA Hospital that sends large radiological images on a regular basis. This could have a detrimental impact on the VA WAN if that traffic traverses the WAN through a VPN connection.

X

Service Level Agreements – SLAs that guarantee specific levels of support to contracted agencies that could not be provided using a One-VA VPN may also justify a BPG connection.

X

High Availability – Availability of critical business processes, such as financial and medical applications, may justify maintaining a BPG to minimize the risk of financial and personal health data loss.

X

Data Sensitivity – Data Sensitivity – Every effort should be made to protect sensitive information. Although protection mechanisms are in place, there are still risks associated with transmitting sensitive data across any network, to include the VA WAN. Although the One-VA VPN satisfies this requirement, the sensitivity of the data may be such that additional precautions are warranted.

Server-to-Server Connections – In most cases, a site-to-site VPN can be used to support external server connections.

LAN Extensions – LAN extensions to the VA WAN may be supported with a site-to-site VPN. In order to qualify for a LAN extension, VA must control both physical AND logical security at the site.

X

Requirements – A requirement for protocols not currently supported in the VA firewall policy and would be a significant security risk to the VA WAN is a candidate for a site-to-site VPN connection.

Data protection - Requirements - The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated, per VA policy.

Non-VA Owned Systems Contractors will not access, transmit, or store remotely any VA sensitive information that is not encrypted using VA approved encryption per VA policy HB 6500.

X (Vendor needs to ensure client workstations are FIPS encrypted) X (VA VPN tunnel is FIPS com-pliant)

5. INVOICES AND PAYMENTS

5.1 Contractor shall submit two (2) monthly invoices, per account number as follows:

· One (1) combined-sum invoice to the Financial Service Center in Austin, TX. Patient information must be excluded.

· One (1) detailed invoice (including patient information) to a Government representative (to be determined after contract award) at each of the ordering VA Medical Facilities. The contractor shall submit invoices consistent with line item number prices. Invoices shall include the referential data elements (information provided from column N to Q of Attachment D – VISN 8 Reference Lab Line Items) for the cost-per-test module, be accurate, and shall display chronologically by date of receipt by the contractor: the name of the patient, the date of specimen collection, date of specimen receipt, date the services were rendered (test completion / result reported) detailed list of the test performed on each patient, Packaging Multiple, Contractor’s NTC for each test, CMS CPT code, the unit cost, and total testing costs.

5.2 The two invoices shall be sent out at the same time. The combined-sum invoice sent to Austin shall equal the total amount on the invoice sent to the Government representatives at each of the ordering VA Medical Facilities.

5.3 Contractor shall submit a monthly invoice per site for services rendered no later than 10 days following the close of the month in which the test result was reported.

5.4 Payments will be made in arrears by the VA Finance Services Center upon receipt of a properly prepared invoice submitted by the contractor. All invoices shall reference the contract number and appropriate purchase order number.

5.5 Contractor shall not charge VISN 8 facilities for repetitive testing performed on a specimen to verify questionable initial results.

6. DELIVERABLES

6.1 Contractor shall provide the Government representative at each of the ordering VA Medical Facilities two copies of the following general test information in hard copy test catalog format, and available electronically (e-mail) as requested. Submit not later than 5 working days after contract award and immediately if this information changes.

· Requisition form requirements

· Alphabetized test name list

· Reference lab test number

· Specimen collection requirements

· Test method used (indicate if testing performed in duplicate)

· Test reference intervals

· Test critical values, if any

· Policy for critical value notification

· CPT coding

· Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between pick-up of specimen by the contractor and receipt of results by a VISN 8 facility

· Logical Observation Identifier Names and Codes (LOINC)

· Frequency of test performance (specific days of week indicated)

· Location of test performance by test name. Provide name and address of the laboratory facility if any test is performed outside your own)

6.2 Contractor shall provide the Government representative at each of the ordering VA Medical Facilities via e-mail a listing of incomplete specimens received from the prior day. Submit daily by 12:00 P.M.

6.3 Contractor shall provide the Government representative at each of the ordering VA Medical Facilities via e-mail current performance improvement monitors that at the minimum include: demonstration of number of lost specimens, number of cancelled specimens, delays in turnaround times, and transportation (courier) route delays/cancellations. Submit not later than the 15th working day after the close of each month’s business.

6.4 Contractor shall provide the Government representative at each of the ordering VA Medical Facilities via e-mail a list of the availability of community-based specimen collection sites. Submit 5 working days after contract award and immediately when this information changes.

6.5 Contractor shall provide the COR via e-mail evidence of training and annual competency programs annually. Specific date and delivery method to be mutually determined after contract award.

6.6 Contractor shall provide the COR via e-mail the following documentation in accordance with CLIA and CAP requirements. Submit not later than 5 working days after contract award and annually thereafter.

· Professional Staff Curricula Vitae

· Technical Staff Competency Skills Assessment

· Proficiency Exam Participation

· Proficiency Exam Exception Reports for the past two years

· Description of Performance Improvement (Quality Assurance) Program

6.7 Contractor shall provide the Government representative at each of the ordering VA Medical Facilities via e-mail the following reports. Submit no later than the 15th working day after the close of each month’s business.

· Summary utilization sheet listing (1) all tests ordered, (2) volume of test ordered and (3) percent abnormal results for the period.

· Summary sheet listing the type and volume of testing sent to a sub-contracted reference laboratory.

· Summary sheet listing, alphabetically, (1) patient’s name, (2) test ordered, (3) date specimen received and (4) ordering physician.

· A consolidated report of the above information including all facilities shall be provided only to the COR.

6.8 Contractor shall provide the COR via e-mail a monthly report of sales. Report shall include the data per each ordering VA Medical Facility. Submit not later than the 15th working day after the close of each month’s business.

· Report shall list (1) test code, (2) test name, (3) test volume, (4) cost per test pricing and (5) total cost for all testing.

6.9 Contractor shall provide the COR via e-mail a current list of the pathologists with whom they have current contracts and reference agreements. Submit 5 working days after contract award and immediately when this information changes. A list of suggested specialties is below:

· Amyloid testing

· Lung and Mediastinum

· Soft tissue tumors and Surgical Oncology

· GYN pathology

· Breast

· Bone Pathology

· Prostate and Urinary Pathology

· Gastrointestinal Pathology

· Neuropathology

· Endocrine Pathology

· Hematopathology

· General Surgical Pathology

· Head and Neck Pathology

· Uropathology

· Dermatopathology

· Pulmonary

· Head and Neck Pathology

6.10 Contractor and subcontractors accessing VA information shall sign and return to the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior (VA Handbook 6500.6 Appendix D) (Attachment G) for each applicable employee. Submit via e-mail within 5 working days after contract award; and annually thereafter.

6.11 As relevant permits/licenses and certifications, inclusive of any sanctions current or pending throughout the U.S., are reissued or reworded, the contractor shall supply the revised copy to the COR immediately.

7. BACKGROUND INVESTIGATION (BI) AND SPECIAL AGREEMENT CHECK (SAC)

The below material is in accordance with VA Directive 0710, VA Directive 0735 and VHA Directive 0710.

7.1 All contractor employees are subject to the same level of investigation as VA employees who have access to VA Sensitive Information. This requirement is applicable to all subcontractor personnel requiring the same access.

7.2 The position sensitivity has been designated as Low Risk. The level of background investigation commensurate with the level of access needed to perform under the terms of the awarded contract is: National Agency Check (NACI) with written inquiries.

7.3 BI and SAC screening shall be initiated prior to contract performance and the cost of the investigations will be the responsibility of the contractor.

7.4 A SAC must be adjudicated while the BI (NACI) is completed and prior to the issuance of a Personal Identity Verification (PIV) card.

7.5 The contractor can begin work and access the VA system, while waiting for the BI (NACI) adjudication, after the following has taken place:

· Received a favorable adjudication on the SAC (fingerprint-verified),

· Submitted the BI (NACI) package to the VA’s Security and Investigation Center (SIC) and received written notification that SIC has accepted it,

· Submitted access request to the ISO and provided verification of mandatory training completion TMS course #10176.

7.6 Contractors who will be on-site or need access to a VA system/information will be required to obtain a PIV card. The determining factor as to the type of PIV card issued is an examination of a contractor’s access requirements for physical and/or logical VA resources. The local PIV office will provide more details.

7.7 Electronic Questionnaire for Investigations Processing (E-QIP). The use of E-QIP is mandated by the Office of Management and Budget (OMB) and OPM pursuant to the E-Government Act of 2002, P.L. 107-347. E-QIP allows applicants to electronically enter, update, and transmit their personal investigative data over a secure Internet connection to their employing agency for review and approval. E-QIP must be used for all investigative types for employees, contractors, affiliates, volunteers and other designated individuals who will need a background investigation.

7.8 Contractor shall contact the CO and COR immediately after contract award for further instructions in the process to request the required SAC, BI and PIV cards. 7.9 The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract. 7.10 Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

7.11 The contractor shall prescreen all personnel requiring access to the computer systems to ensure they are able to read, write, speak, and understand the English language.

7.12 Staff must be operating within the borders of the U.S.A. and its territories.

8. QUALITY CONTROL

8.1 The contractor shall exercise quality control and maintain a Quality Assurance Plan (QAP) related to the reference laboratory services covered under this contract.

8.2 Contractor shall also participate in a joint Quality Assurance Surveillance Plan (QASP) with the Government Facilities. This program must minimally address the quality aspects representative to the testing process, i.e. pre-analytical, analytical and post-analytical variables and include a description of monitoring and evaluation activities. There must be a mutually agreed upon procedure for responding to issues, problems and/or concerns identified by the Government with details as to whom and in what timeframe the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event. The contractor will meet or communicate with the Medical Facility staff for process review and improvement of contract performance on an as needed basis.

8.3 Quality factors that VA may…