36C24221R0001_1.docx

36C24221R0001

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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

Various by VISN2N Location 36C24221R0001 08-05-2020 Harsch, Michelle Michelle.Harsch@va.gov 716-862-7373 09-16-2020 3:00 pm Department of Veterans Affairs Network Contracting Office (NCO) 2 2875 Union Road Suite 3500 Cheektowaga NY 14227 X 621511 $35 Million N/A X Department of Veterans Affairs Upstate NY Healthcare System c/o Buffalo VAMC 3495 Bailey Avenue Buffalo NY 14215 Department of Veterans Affairs Network Contracting Office (NCO) 2 2875 Union Road Suite 3500 Cheektowaga NY 14227

Tungsten Network http://www.tungsten-network.com/us/en /veterans-affairs

See CONTINUATION Page Reference Lab Send-Out Testing Services for Upstate NY Medical Center Laboratories as specified in the Statement of Work included herewith.

See CONTINUATION Page X X X One Cheryl Brimmer Contracting Officer Table of Contents

B.2 STATEMENT OF WORK………………………………………………………………….5

B.3 PRICE SCHEDULE……………………………………………………………………….12

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 36C242 Cheryl Brimmer Department of Veterans Affairs Network Contracting Office (NCO) 2 2875 Union Road, Suite 3500 Cheektowaga NY 14227

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.

Tungsten Network http://www.tungsten-network.com/us/en/veterans-affairs

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

36C24221R0001

B.2 REFERENCE LABORATORY STATEMENT OF WORK

1. Description:

VISN 2 North, Upstate New York Healthcare System Laboratory Departments have a requirement for the provision of referral laboratory services to include the following:

a. Pickup and transport of specimens to Contractor laboratory

b. Pre-analytic processing

c. Analysis

d. Reporting of analytic results

e. Consultation regarding:

1) Test Selection

2) Specimen Collection

3) Transportation of samples

4) Result interpretation

2. Participating VA Medical Centers:

VA Western New York Healthcare System, 3495 Bailey Avenue, Buffalo, NY 14215 Syracuse VA Medical Center, 800 Irving Avenue, Syracuse, NY 13210 Albany Stratton VA Medical Center, 113 Holland Avenue, Albany, NY 12208 Bath VA Medical Center, 76 Veterans Avenue, Bath, NY 14810 Canandaigua VA Medical Center, 400 Fort Hill Avenue, Canandaigua, NY 14424

3. Services:

The contractor shall provide the following services:

a. All necessary supplies, including but 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 for special tests (e.g., quantiferon)

4) Required requisition forms

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

b. Specimen pick up services as defined below under “Transportation Services”

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

d. 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)

e. A customer service help desk/telephone hotline available Monday – Friday from 7am-5pm that will permit immediate inquiry regarding the status of pending samples, sample results and test requirements.

f. Names and telephone numbers of technical Directors and Pathologists available for consultation. Their availability should be from 9am -5pm Monday through Friday.

g. Maintain the minimum acceptable service, reporting systems and quality control as specified herein.

h. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency (RA)

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

j. Critical results shall be reported immediately by phone directly to the ordering VAMC laboratory

k. Provide each VAMC Laboratory a monthly turnaround time report for all performed testing

l. Provide each VAMC Laboratory a monthly workload testing volume report

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

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

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

p. 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

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

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

s. 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)

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

u. Provide an interface of the most up-to-date technology between the 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)

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

4. Licensing and Accreditation:

1. Contractor shall have all licenses, permits, accreditation and certificates required by law.

a. To include CLIA and NYSDOH for both the primary lab and all subcontracted labs

2. Contractor shall be accredited by the College of American Pathologists (CAP).

3. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst.

5. Telecommunications and Computer Services

1. Each VAMC Laboratory shall 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 as-needed maintenance of the system.

iv. Contractor shall also be available to train VAMC staff on use of the system.

v. An alternate method of sending orders/receiving results shall be in place in the event of this system down time.

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 Laboratory Electronic Data Interchange protocol.

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). The Electronic Cyber Security Information Processing (ECSIP) team will have the ultimate decision which connection type is appropriate.

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

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

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

v. The contractor shall 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 shall 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 shall 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 Contracting Officer Representative (COR) 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

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 (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.

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

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

4. The contractor shall provide a single knowledgeable point of contact for researching correct test information; point(s) of contact 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 reference laboratory 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 shall require all personnel with VA access complete the VHA privacy training prior to starting services.

7. The contractor shall 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 shall 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

1. The contractor shall provide specimen transportation services between the VISN 2 primary VA facilities noted in “2. Participating VA Medical Centers” above and the contracted laboratory. Service shall include daily pick-up at each facility, Monday - Friday excluding holidays (holidays for the purpose of this requirement shall be defined as: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day and Christmas Day).

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

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

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

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

7. Testing

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

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

3. The contractor shall 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 shall explain the condition(s) of the patient or any discrepancies observed.

4. The contractor shall 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.

5. Any changes to 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 shall provide routine test results to the ordering VA facility within twenty-four (24) hours following test completion.

a. Expected turnaround time for tests on the test list must be met.

b. It is required that hard copies of each final report, whether test request was sent through the interface or web portal, will 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 shall 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 shall 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. Facility Name and Account number

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

e. Test ordered

f. Test result

g. Abnormal results flagged appropriately

h. Reference range

i. Toxic and/or therapeutic range where applicable

j. Testing laboratory specimen number

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

l. Type of specimen (e.g. serum, urine, plasma…)

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

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

o. Unsatisfactory specimen shall be reported with regard to its unsuitability for testing.

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

9. Storage of Specimens

1. The contractor shall store all specimens after all testing has been completed in the event of required repeat or add on testing for at least one (1) week at conditions that will maintain sample viability.

2. Upon request, samples shall be returned to the collecting facility via overnight courier utilizing conditions that will maintain sample viability.

3. All Anatomic Pathology specimens (i.e. slides, blocks, etc.) shall be returned within two (2) weeks of test completion.

10. Contractor Personnel

1. The contractor shall make sure personnel have current and valid professional certifications before starting work under this contract.

a. Technologist, medical technicians, and cytotechnologist shall 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.) Shall have provided pathology services a minimum of 24 months within the past 36 months and pathology consultation services a minimum of 36 months within the past 48 months.

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

11. Release of Medical Information

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

12. Billing

1. All invoices from all primary contractor labs and subcontracted laboratories must be submitted through the primary contractor.

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

a. Account number

b. Invoice number

c. Purchase order number

d. 2 patient identifiers

e. Test Cost

f. Date of Service

g. Specific Test Number and Name

3. 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 contractor shall 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. Contractor shall 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.

B.3 PRICE SCHEDULE (TO BE COMPLETED FOR EACH THE BASE PERIOD PLUS 4 OPTION PERIODS)

Tests

TOTAL ANNUAL:

Base Period $__________________________

Option Period 1 $__________________________

Option Period 2 $__________________________

Option Period 3 $__________________________

Option Period 4 $__________________________

TOTAL: Base plus 4 Options $___________________________

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those…