STATEMENT OF WORK (SOW)

REFERRAL AND SPECIALIZED LAB TESTING

1. DESCRIPTION:

Veteran’s Integrated Network (VISN) 2, South Pathology and Laboratory Medicine Service (PLMS) is seeking to procure covered testing Referral and Specialized Lab Testing services which must include, but not be limited to, Reference Laboratory, Esoteric Testing, Oncology Testing, and Molecular Diagnostic Testing. The services must also include the following:

a. Pickup and transport of specimens to laboratory

b. Pre-analytic Processing

c. Analysis as defined by the Contractor’s Reference Test Manual

d. Reporting of analytic results

e. Consultation regarding:

1) Test Selection

2) Specimen Collection

3) Transportation of samples

4) Result interpretation

The performance will be for five (5) years - Requirements – Firm-Fixed-Price.

Services must be continuously available 24 hours a day, 7 days a week, 365 days a year, unless otherwise specified by the Government. In periods where the Referral and Specialized Lab Testing services are not needed, the Contractor will be notified accordingly.

2. PARTICIPATING VA MEDICAL CENTERS DEFINED IN APPENDIX A:

a. James J. Peters Department of Veterans Affairs Medical Center

b. VA New Jersey Healthcare System

c. VA Hudson Valley Healthcare System

d. VA New York Harbor Healthcare System

e. Northport VA Medical Center

3. SERVICES:

The Contractor must provide covered testing for referral and specialized lab testing services to include, but not be limited to, Reference Laboratory Testing, Esoteric Testing, Oncology Testing, and Molecular Diagnostic Testing necessary to meet all required and available tests under this contract. Test menus will be provided in Attachment A (Government known test list) and Attachment B (additional available in-scope tests).

The Contractor MUST provide the following services:

a. The Contractor must supply each facility with their current Commercial Laboratory, but not limited to, Reference Laboratory, Esoteric, Oncology, and Molecular Diagnostic Test Manual and any subsequent updates for the life of the contract.

b. All necessary materials required to collect and preserve specimens, including but are not limited to the following and a reliable method for ordering supplies:

1) Specimen containers

2) Any special preservatives required for specimen preservation (e.g., trasylol)

3) All supplies to maintain the integrity of the specimen (e.g., dry ice, hot packs, cold packs)

4) All supplies for special tests (e.g., quantiferon)

5) Required requisition forms.

6) Printer, Paper and toners for printing hard copy of reports.

7) An after-hours phone number for Emergency or Stat requests.

c. Specimens pick up service as defined below under “Transportation Services.”

d. Transportation of samples in a manner that ensures the integrity of the specimen.

e. Storage of specimens as defined below under “Specimen Retention.”

f. Timely (defined by the expected turnaround times detailed in the test listing) and appropriate analysis of patient specimens (See “Testing” and “Test Result” details below)

g. A toll-free customer service help desk/telephone hotline available 24/7, 365 days that must permit immediate inquiry regarding the status of pending samples, sample results and test requirements.

h. Names and telephone numbers of technical Directors and Pathologists available for consultation.

Their availability should be from 9am-5pm Monday through Friday.

i. Must maintain the minimum acceptable service, reporting systems and quality control as specified herein.

j. Immediate (within 24 hours) notification must be given to VA upon adverse action by a

Regulatory Agency (RA).

k. Contractor must assign a specific local/regional account representative for each VA facility. The representative must communicate with each laboratory account quarterly, at a minimum, with either a visit or phone call.

l. Critical results must be reported immediately by telephone directly to the ordering VAMC Laboratory

m. Must provide each VAMC Laboratory with a monthly turnaround time report for all performed testing.

n. Provide each VAMC Laboratory with a monthly workload testing volume report in a standard spreadsheet format that corresponds directly to the monthly invoices, meaning that all the charges on the invoice are included on that month’s spreadsheet.

o. Provide each VAMC Laboratory with a monthly report of testing not performed, and details of reason testing was cancelled.

p. Provide patient reports that contain all necessary information (See “Test Results” below)

q. Provide a monthly invoice, per location, containing all necessary information (See “Billing” below)

r. The contractor(s) facilities, methodologies (defined as the principal of the method and the reference ranges), and quality control procedures may be examined by representatives of the Government upon prior written notice during normal business hours during the life of the contract.

s. Provide upon request proficiency testing data to include a list of tests outside the acceptable range for the past 2 years.

t. Provide Clinical Laboratory Improvement Amendments (CLIA), New York State Department of Health (NYSDOH), and New Jersey Department of Health (NJDOH) numbers of processing and testing sites under this contract, including subcontracted testing location sites.

u. The Contractor shall maintain accreditation from a CMS‑approved laboratory accreditation organization with deemed status for all laboratory services performed under this contract.

v. Provide an easy to use, accurate and up to date public website that provides easy reference for researching test information (test number/CPT coding, patient preparation, sample requirements, sample handling/storage, rejection criteria, test utility, result interpretive guidelines)

w. Provide a method to contact IT support Monday – Friday, 7am – 5pm for questions and problem resolution of interface connection issues and result transmission.

x. Provide an interface of the most up-to-date technology between contractor computer system and the VA VistA software to allow the direct transfer of ordering information from VistA to the contractor system to include the ability for the direct download of testing results from the contractor system to the VA VistA system. (see “Telecommunications and Computer Services” below)

y. The Contractor must consistently maintain the required licensing and accreditation throughout the life of the contract.

z. At least monthly, provide a list of all test code updates; customized to each VAMC Laboratory’s test menu. Test code updates not included in contract for that laboratory should not be included.

aa. The Contractor must provide upon request, specimens to VAMC Laboratories for the purpose of validation studies.

4. LICENSING AND ACCREDITATION:

1. The Contractor must continuously maintain all licenses, permits, accreditations, and certificates required by law in active and current status throughout the life of the contract.

a. This includes CLIA, NJDOH, and NYSDOH for both the primary lab and all subcontracted labs

b. CLIA-waived licenses and accreditations shall not be accepted for the Prime Contractor or any subcontracted laboratory. All testing under this contract must be performed by CLIA-certified high‑complexity laboratories holding all required Federal, State, and CAP accreditations.

2. Maintain accreditation through a Centers for Medicare & Medicaid Services (CMS)-approved accreditation organization with deemed status for the laboratory services performed under this contract (This includes but not limited to CAP, The Commission on Laboratory Accreditation (COLA), The Joint Commission (TJC), Association for the Advancement of Blood & Biotherapies (AABB)).

3. Laboratory Director must be a licensed American Board of Pathology certified Pathologist or appropriately certified Bio-Analyst.

4. Contractor must immediately (within 24 hours) notify the Contracting Officer (CO) and the Contracting Officer Representative (COR), in writing, of any loss of any license, permit, accreditation, or certificate or adverse action by an RA.

Failure to provide notification as required shall constitute a material breach of contract and may result in suspension of work, withholding of payments, a Contractor Performance Assessment Reporting System (CPARS) negative rating, or termination for cause, at the discretion of the Contracting Officer.

5. TELECOMMUNICATIONS AND COMPUTER SERVICES

1. Each VAMC Laboratory MUST have the capacity to order lab testing in the following manner.

a. Telecommunications linkage:

i. The Contractor must have a secure web-based portal available to allow test ordering and result retrieval.

ii. The Contractor must show that this portal meets VA requirements for encryption of sensitive patient information: FIPS-140-2 (http://csrc.nist.gov/groups/STM/cmvp/standards.html)

iii. The Contractor is responsible for all supplies required for transmission of orders and test results and the preventive and necessary maintenance of the system.

iv. The Contractor must also be available to train VAMC staff in use of the system.

v. An alternate method of sending orders/receiving results must be in place in the event of this system downtime.

http://csrc.nist.gov/groups/STM/cmvp/standards.html

vi. A shipping manifest must be able to be generated that identifies the specimens sent to the reference laboratory, transportation conditions, and testing ordered.

b. An electronic interface capability (bi-directional) system:

i. The Contractor must meet all cyber security requirements to establish an interconnection with the VA system for transfer of test ordering and test results via the appropriate VistA Laboratory Electronic Data Interchange (LEDI) protocol. The VistA host computer system supports Universal Interface (UI) and a Generic Instrument Manager (GIM).

1. Protocol requires a national MOU/ISA (Memorandum of Understanding/ Interconnection Security Agreement) with all current CRISP (Continuous Readiness in Information Security Program) and FIPS 140-2 (Federal Information Processing Standard) language relevant for connections through site-to-site VPN or a web-based internet connection.

2. There are three basic types of authorized connections. (The connection types are described below in Section 2 - External Users). The Electronic Cyber Security Information Processing (ECSIP) team will have the ultimate decision about which connection type is appropriate.

ii. The interface must be designed for single data interface access for all of VISN 2

iii. The interface must allow generation of manifests to identify the specimens to be sent to the reference lab.

iv. Upon receipt of test results, VA staff must be able to review/validate test results before release.

v. The Contractor must be responsible for the purchase of any licenses for middleware software products and the hardware for any middleware or interface structure.

vi. Timeline for implementation of the interface - within the first three (3) months of contract award, the following must be completed:

1. Contractor must assist VISN 2 Lab staff with the update of the test database by providing all information required to create new test files for required tests (example of needed information; sample requirement, shipping temperature, reference ranges, CPT codes, LOINC codes…etc.)

2. Interface portal must be connected and approved including any required hardware such as dedicated printers for labels and results.

3. Interface validation must be completed on the tests that have been updated in the database during that three (3) month time period.

c. Provide a process for manual requisitions in the event of computer system down time or unusual test requests.

2. External users must be classified in one of three distinct categories: 1) client-to-site VPN, 2) site-to-site VPN, or 3) Business Partner Gateways.

Table 1.1 below must be utilized to assist users to determine the category for a particular connection.

a. 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 Laboratory Information Manager where external business partners should have access to the minimum resources required to meet contractual obligations.

b. Site-to-Site VPNs are connections to external business partners that 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.

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

Table 1.1

Connectivity Requirement Client-to-Site

VPN

Site-to- Site

VPN

Business Partner Gateway

Small Number of Users- If the number of user accounts the Information Security Officer (ISO) must administer it is manageable. A client-to-site connection will usually suffice.

X

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. X X

High Bandwidth- A large volume of traffic may be a valid need to establish or maintain a Business Partner Gateway (BPG) connection (0 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

Sensitive Information- 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.

X X

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

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 10the VA WAN is a candidate for a site-to-site VPN connection.

X X

3. Any Contractor personnel who require administrative or programmer access to a Federal computer system during the set up or maintenance of the computer interface must have a background investigation commensurate with the level of access granted as determined by VA personnel. Additional VA security training must be required before access is granted, and annually as applicable. The cost of a background investigation must be the responsibility of the contractor.

4. The Contractor must provide a single knowledgeable point of contact for researching correct test information; point of contact(s) for developing, testing, and implementing a client/vendor interface; and an ongoing point of contact for troubleshooting interface problems.

5. Any equipment provided by the Contractor to VA that contains a storage device that when the device is powered down the VA sensitive data remains on it must be sanitized prior to removal from the VA premises, must become the property of the Federal Government and remain on Federal property, or must be destroyed in accordance with Department of Veterans Affairs regulations at the time of removal (device decommissioning).

a. Data required by the Health Insurance Portability and Accountability Account of 1996 (HIPAA) to remain on equipment located on the 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.

6. The Contractor’s Laboratory Testing is to include, but not be limited to, Reference Laboratory Testing, Esoteric Testing, Oncology Testing, and Molecular Diagnostic Testing must meet VA information security and HIPAA requirements and must be able to interface with the current or any new interface partner of the Laboratory Information System (LIS).

a. The Contractor must require all personnel with VA computer access to complete the VHA privacy training prior to starting service and annually provide completed training certificates to the COR of record.

b. For Contractor personnel without VA computer access, personnel must complete the VHA National Privacy Training or other similar training as defined by the VA.

7. The Contractor must notify the facility Privacy Officer (PO) immediately with the list of patient names if any breach of computer security or privacy incident is suspected.

8. The Contractor must provide the following interface requirements:

a. LIS physical connection and translation (drivers)

b. Any required (additional) interface connection license(s)

c. Documentation of successful interfacing with other VA facilities (provide two VAMC references)

d. Interface must transmit test results to the host computer via automatic upload.

9. A completed and signed Business Associate Agreement (BAA) may be required from the contractor prior to start of services.

6. TRANSPORTATION SERVICES FOR REFERENCE TESTING SPECIMENS

1. The Contractor must provide specimen transportation services between the VISN 2 facilities noted in “Appendix A” and the contracted laboratory.

The Contractor must provide specimen pick‑up at each facility every day, with the capability to perform more than one pick‑up per day when required. Pick‑up services must be available 24 hours a day, 7 days a week, 365 days a year, including all Local, State, and Federal holidays.

Federal Holidays are New Year's Day (January), Martin Luther King’s Birthday (January), President’s Day (February), Memorial Day (May), Juneteenth Day (June), Independence Day (July), Labor Day (September), Columbus Day (October), Veteran’s Day (November), Thanksgiving Day (November) and Christmas Day (December).

This also includes any day that the President of the United States declares as a Holiday.

a. In order to maintain the integrity of laboratory samples, specimens must be transported by the Contractor in a manner that must not interfere with specimen integrity or quality.

b. The Contractor must arrange a pickup time with each VISN 2 laboratory site that is determined to be suitable by each facility to ensure the best test result turnaround times.

c. The Contractor must provide a uniformed courier with prominently displayed contractor-issued identification badge to transport laboratory samples.

d. The contractor transport personnel must sign a manifest at pickup confirming specimens/samples received, at any transfer stations, and upon receipt at final destination for tracking purposes.

e. The contractor must provide Emergency or STAT transportation of specimens within four (4) hours of notification for the Bronx, Northport, NYHHC, and NJ, and within six

(6) hours for Hudson Valley, Castle Point, and Montrose. Emergency/STAT transportation services must be available 24 hours per day, 7 days per week, including all Government holidays.

2. It must be the responsibility of the Contractor to ensure that the transport personnel comply with all policies and procedures for tracking specimens. This must include, but may not be limited to, detailed documentation of receipt of specimens.

7. TESTING

1. The Contractor must provide the list of current testing with collection/processing and transport instructions that contain the testing reference ranges and specimen requirements.

2. The Contractor must ensure that all procedures performed demonstrate acceptable accuracy and precision. Performance characteristics, validation data, quality control results and proficiency testing results must be made available for review by the Contracting Officer or Contracting Officer’s representative, if requested.

3. The Contractor must provide phone notification to the site Client Services Supervisor within 48 hours of specimen pick-up of any rejected specimens.

4. The Contractor must perform repeat tests at no charge to the government if the results do not, in the VA physician's opinion, fit the clinical picture of the patient.

a. When requesting repeat tests, the VA physician or designated representative must explain the condition(s) of the patient, or any discrepancies observed.

5. The Contractor must notify the VA COR or designee of instances that in the professional judgment of the Contractor, the patient requires services or tests that were not originally requested.

6. Any changes to test codes, test names, test methodology, specimen requirements and reference ranges must be communicated to the VAMC Laboratories at least 30 days prior to implementation.

8. TEST RESULTS

1. The Contractor must provide routine test results to the ordering VA facility within twenty-four

(24) hours following test completion.

a. The Contractor is required to meet all established turnaround times for every test listed in the test menu. Failure to meet the required turnaround times may result in corrective action deemed appropriate by the Contracting Officer.

b. It is required that hard copies of each final report, whether test request was sent through the interface or web portal, must automatically print at the ordering site once it is finalized.

2. A report is defined as a printed final copy of laboratory testing results. This printed report must be received by remote terminal where applicable. If results are telephoned, the final printed report must include the name of the individual notified of the results. Each test report must at a minimum indicate the following information:

a. Two patient identifiers: Patient's full name and patient identification number (Social

Security number if provided)

b. Physician's name (if supplied)

c. Government laboratory accession number (if applicable)

d. Submitting Facility Name

e. Submitting Facility Account number

f. Patient’s location (clinic/ward) (if applicable)

g. Date/time specimen was collected, received by reference lab, and reported.

h. Test ordered

i. Test result

j. Abnormal results flagged appropriately.

k. Reference range

l. Toxic and/or therapeutic range (if applicable)

m. Testing laboratory specimen number

n. Name of testing laboratory (contractor and/or subcontractor)

o. Type of specimen (e.g., serum, urine, plasma, etc.)

p. Reference laboratory accession number

q. Any additional comments related to test provided by submitting labs.

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

s. Specimen inadequacy with documentation supporting its unsuitability for testing.

t. Tests routinely performed in duplicate or diluted should be indicated.

9. SPECIMEN RETENTION

1. All clinical pathology specimens (e.g. blood, urine, stool, fluid, CSF, and respiratory swabs) must be retained for a minimum of seven (7) days following final result reporting.

2. In limited cases, upon request, samples must be returned to the collecting facility via overnight courier utilizing conditions that must maintain sample viability.

10. CONTRACTOR PERSONNEL QUALIFICATIONS

1. The Contractor must provide and ensure personnel have current and valid professional certifications before starting work under this contract.

a. Technologists, Medical Technicians, and Cytotechnologists must meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines.

b. Pathologists must have graduated from an approved school of medicine or osteopathy, completed a residency or fellowship in pathology acceptable to the United States Surgeons General, and must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction.

1.) Must have provided pathology services with a minimum of 24 months within the past 36 months and pathology consultation services with a minimum of 36 months within the past 48 months.

2. The contractor must maintain current licenses and certificates and must provide copies of such to VA upon written request.

11. RELEASE OF MEDICAL INFORMATION

1. The Contractor must not release any medical information obtained during the course of this contract to anyone outside the VA unless authorized in writing by the VA Privacy Officer and the patient, as required by applicable law.

12. BILLING

1. All invoices from both the primary contractor’s laboratory and any subcontracted laboratories must be submitted by the primary contractor only.

2. Monthly Invoices must contain at a minimum the following information:

a. Account number

b. Invoice number

c. Purchase order number (one purchase order number per invoice)

d. Two (2) patient identifiers (e.g., Name and ID number) must be HIPPA compliant

e. Test Cost with test code

f. Date of Service

g. Specific Test Number and Name Description

3. The Contractor is prohibited from increasing prices for testing not performed in-house that is referred to another reference laboratory for the length of the contract.

4. For special VA billing procedures, the Contractor must supply a clear listing of billing agreements with outside reference laboratories so client can accurately determine which testing can be forwarded to a third party via the contractor and billed through the contractor.

5. The Contractor must provide a single, accurate point of contact for determining correct test pricing, resolving pricing/billing inquiries, and researching new test pricing – immediate or prompt replies should constitute normal business.

13. UNAUTHORIZED OR UNPRICED SERVICES AND TESTS

The Contractor shall perform only those services and laboratory tests that are within the scope of this Contract and are authorized in accordance with the Contract's terms and ordering procedures.

A laboratory test or service that is not identified in the Contract, including the applicable CLINs, attachments, schedules, or other incorporated documents, shall not, solely by reason of its omission, be considered authorized for performance or payment. When performance of an unlisted test or service requires a change to the terms, scope, pricing, or other requirements of the Contract, the Contractor shall obtain written authorization from the Contracting Officer before commencing performance.

Where a bilateral contract modification is required to authorize the test or service, the Contractor shall not commence performance until the bilateral modification has been executed by the Contractor and the Contracting Officer. A request, recommendation, direction, or approval from the Contracting Officer's Representative (COR), requiring activity, medical personnel, laboratory personnel, Government employee, or other person who has not been delegated contracting authority shall not constitute authorization to modify the Contract or obligate the Government.

The Contractor shall promptly notify the Contracting Officer when it determines that a requested test or service is not covered by the Contract or requires a modification. The Contractor shall provide the Contracting Officer with the information necessary to determine whether the requested test or service is within the scope of the Contract and, when applicable, to establish the appropriate contract price before performance.

Unless otherwise expressly authorized by the Contracting Officer in writing, any test, service, or other work performed by the Contractor that is outside the scope of the Contract, is not otherwise authorized by the Contract, or is performed before the required Contract modification has been executed, shall be performed at the Contractor's own risk. The Contractor shall bear all costs and expenses associated with such unauthorized performance, and the Government shall have no obligation to reimburse the Contractor for such costs or expenses, except to the extent otherwise required by applicable law or properly authorized and ratified by the Government.

The Contractor's performance of an unauthorized or unpriced test or service shall not, by itself, constitute an agreement by the Government to modify the Contract, establish a price, or authorize payment for such performance.

Nothing in this provision shall be construed to prevent the Contracting Officer from issuing a written direction or modification authorized under the Contract.

APPENDIX A

Location of facilities

BRONX

James J. Peters Department of Veterans Affairs Medical Center (Bronx Campus) 130 West Kingsbridge Road Bronx, New York 10468-3904

NEW JERSEY

VA New Jersey Healthcare System (East Orange Campus) East Orange VA Medical Center 385 Tremont Avenue East Orange, NJ 07018-1023

VA New Jersey Healthcare System (Lyons Campus) Lyons VA Medical Center 151 Knollcroft Road Lyons, NJ 07939-5001

HUDSON VALLEY

VA Hudson Valley Healthcare System (Montrose Campus) Franklin Delano Roosevelt Hospital 2094 Albany Post Road Montrose, NY 10548-1454

VA Hudson Valley Healthcare System (Castle Point Campus) Castle Point VA Medical Center 41 Castle Point Road Wappingers Falls, NY 12590-7004

NEW YORK HARBOR HEALTHCARE SYSTEM

VA NY Harbor Healthcare System Margaret Cochran Corbin VA Campus (New York Campus) 423 East 23rd Street New York, NY 10010-5011

VA NY Harbor Healthcare System (Brooklyn Campus) 800 Poly Place Brooklyn, New York 11209-7104

VA NY Harbor Healthcare System (St. Albans Campus) 179-00 Linden Boulevard

Queens, NY 11424-1468

NORTHPORT

Northport VA Medical Center 79 Middleville Road Northport, NY 11768-2200