36C24124Q0194-Q1 - VISN 1 Primary Reference Laboratory - 1.31.25.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C24124Q0194 01-31-2025

Cynthia Thompson 603-624-4366 03-03-2025

04:00PM EST

Department of Veterans Affairs

VAMC Manchester

718 Smyth Road

Manchester NH 03104

X

621511

N/A

X

Financial Services Center http://www.fsc.va.gov/einvoice.asp

See VAAR 852.232-72

Austin TX 78714-9971

See CONTINUATION Page

****This Solicitation is a Request for Quotes (RFQ)****

The Department of Veterans Affairs intends to award a

Fixed Priced award for VISN1 Reference Laboratory Testing

Services with specimen and transport service IAW the

Performance Work Statement.

Any questions shall be submitted to the Point of Contact, Cynthia Thompson, in writing to cynthia.thompson2@va.gov no later than Friday, February 14, 2025.

See Attachments

Attachment A - Test Menu

Attachment B - Facility Locations

Attachment C - Other Services

Attachment D - QASP

Attachment E - Contractor Reference Form

Attachment F – Wage Determinations

See CONTINUATION Page

X X

X 1

Cynthia Thompson

VA-VHA-RPOE-2022-224335

36C24124Q0194

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATIVE DATA ..................... Error! Bookmark not defined.

B.2 PRICE/COST SCHEDULE ITEM INFORMATION ..... Error! Bookmark not defined.

B.3 DELIVERY SCHEDULE ............................................ Error! Bookmark not defined.

B.2 PERFORMANCE WORK STATEMENT ................... Error! Bookmark not defined.

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...43

C.4 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.5 IT CONTRACT SECURITY

C.6 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.7 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.9 VAAR 852.204-70 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL (MAY 2020)

C.10 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEMS SECURITY

(FEB 2023)

C.11 VAAR 852.208-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS – ORDERS or BPAs (JAN

2023) (DEVIATION)

C.12 VAAR 852.208-71 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTOR COMMITMENTS-ORDERS AND

BPAS (JAN 2023) (DEVIATION)

C.13 VAAR 852.211-70 EQUIPMENT OPERATION AND MAINTENANCE MANUALS

(NOV 2018)

C.14 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.15 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)

C.16 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023) ...66

C.17 VAAR 852.212-72 GRAY MARKET AND COUNTERFEIT ITEMS—

INFORMATION TECHNOLOGY MAINTENANCE ALLOWING OTHER-THAN-NEW

PARTS (FEB 2023)

C.18 52.216-18 ORDERING (AUG 2020)

C.19 VAAR 852.219-70 VA SMALL BUSINESS SUBCONTRACTING PLAN MINIMUM

REQUIREMENTS (NOV 2022)

C.20 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.21 52.237-3 CONTINUITY OF SERVICES (JAN 1991)

C.22 VAAR 852.239-70 SECURITY REQUIREMENTS FOR INFORMATION

TECHNOLOGY RESOURCES (FEB 2023)

C.23 VAAR 852.239-73 INFORMATION SYSTEM HOSTING, OPERATION,

MAINTENANCE, OR USE (FEB 2023)

C.24 VAAR 852.239-74 SECURITY CONTROLS COMPLIANCE TESTING (FEB 2023)

C.25 VAAR 852.239-76 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY (FEB 2023)

C.26 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ..76

C.27 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.28 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

E.6 52.227-15 REPRESENTATION OF LIMITED RIGHTS DATA AND RESTRICTED

COMPUTER SOFTWARE DEC 2007

E.7 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.8 VAAR 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST (OCT 2020) .99

E.9 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.10 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE

RESOLUTION (OCT 2018)

E.11 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.12 VAAR 852.239-71 INFORMATION SYSTEM SECURITY PLAN AND

ACCREDITATION (FEB 2023)

E.13 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

E.14 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.15 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

a) CONTRACT ADMINISTRATION: All contract administration matters will be handled by the following individuals:

CONTRACTOR: Name: ________________________ Title: _________________________ Company: _____________________ Address: ______________________ Telephone#: ___________________

FAX #: ________________________

E-mail address: _________________

GOVERNMENT: Cynthia Thompson, Contracting Officer

Department of Veterans Affairs NCO 1 Contracting 718 Smyth Rd Manchester, NH 03104 Telephone: 603.624.4366

E-mail: Cynthia.thompson2@va.gov Sheryl.anthony@va.gov

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

[X] 52.232-33, Payment by Electronic Funds Transfer - System for Award Management (SAM), or

[N/A] 52.232-36, Payment by Third Party

B.1.3. GOVERNMENT INVOICE ADDRESS: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] MONTHLY IN ARREARS

B.1.4. GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be submitted electronically to the VA Financial Services Center for payment processing, free of charge. For any questions about the e-invoicing program, please contact the FSC at the phone number or email address listed below:

• OB10/Tungsten e-Invoice Setup Information: (877) 752-0900

• OB10/Tungsten e-Invoice email: USClientServices@ob10.com

• FSC e-Invoice Contact Information: (877) 353-9791

• FSC e-invoice email: vafsccshd@va.gov

• The following two codes will be required when creating a vendor profile in OB10:

• OB10 Buyer Number AAA544240062

• Promo Code: VAPC7Y18 mailto:Cynthia.thompson2@va.gov mailto:Sheryl.anthony@va.gov mailto:USClientServices@ob10.com http://vafsccshd@va.gov

B.1.5. DUNS NUMBER: Please provide the Dun and Bradstreet Number assigned to your firm in the space provided: _______________________

B.1.6. CONTRACTOR’S UNIQUE ENTITY ID (SAM): Please provide the Contractor’s Unique Entity ID number to be utilized for this contract: _________________________

B.1.7. TAX IDENTIFICATION NUMBER: Please provide the tax identification number to be utilized for this contract: _________________________

B.1.8. PERIOD OF PERFORMANCE: Services required herein shall be for the following time period: April 1, 2025, through September 30, 2025

B.1 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

6.00 MO __________________ __________________

Primary Ref. Lab Testing for VISN 1 - per the PWS and attachments in the RFQ Contract Period: Base POP Begin: 04-01-2025 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

1.00 MO __________________ __________________

in the RFQ Contract Period: Option 1 POP Begin: 10-01-2025 POP End: 10-31-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories in the RFQ Contract Period: Option 2 POP Begin: 11-01-2025 POP End: 11-30-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories in the RFQ Contract Period: Option 3 POP Begin: 12-01-2025 POP End: 12-31-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory in the RFQ Contract Period: Option 4 POP Begin: 01-01-2026 POP End: 01-31-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories in the RFQ Contract Period: Option 5 POP Begin: 02-01-2026 POP End: 02-28-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories in the RFQ Contract Period: Option 6 POP Begin: 03-01-2026 POP End: 03-31-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

GRAND TOTAL __________________

B.2 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001 SHIP TO: NCO1 - West Haven VAMC 950 Campbell Ave --- SEE PWS for all facilities & locations West Haven, CT 06516 2770

USA

6.00 09/30/2025

MARK FOR: Wendy Strollo 203-841-5591 Wendy.Strollo@va.gov

FOB: DESTINATION

1001 SHIP TO: NCO1 - West Haven VAMC 950 Campbell Ave --- SEE PWS for all facilities & locations West Haven, CT 06516 2770

USA

1.00 10/31/2025

MARK FOR: Wendy Strollo

1002 SHIP TO: NCO1 - West Haven VAMC 950 Campbell Ave --- SEE PWS for all facilities & locations West Haven, CT 06516 2770

USA

1.00 11/30/2025

MARK FOR: Wendy Strollo

1003 SHIP TO: NCO1 - West Haven VAMC

--- SEE PWS for all facilities & locations West Haven, CT 06516 2770

USA

1.00 12/31/2025

MARK FOR: Wendy Strollo

1004 SHIP TO: NCO1 - West Haven VAMC

--- SEE PWS for all facilities & locations West Haven, CT 06516 2770

USA

1.00 01/31/2026

MARK FOR: Wendy Strollo

1005 SHIP TO: NCO1 - West Haven VAMC

--- SEE PWS for all facilities & locations West Haven, CT 06516 2770

USA

1.00 02/01/2026

MARK FOR: Wendy Strollo

1006 SHIP TO: NCO1 - West Haven VAMC

--- SEE PWS for all facilities & locations West Haven, CT 06516 2770

USA

1.00 03/31/2026

MARK FOR: Wendy Strollo

B.4 PERFORMANCE WORK STATEMENT

I- REQUIREMENTS FOR REFERENCE LABORATORY SERVICES

A. GENERAL

1. Contractors shall provide a full range of reference laboratory services in accordance with the specifications outlined below for the VISN1 VA NEW ENGLAND HEALTHCARE SYSTEM, (herein designated as VISN 1) and included in Attachment A (Test Menu). Attachment B is a list of VISN 1 sites participating in this contract.

The contractor shall provide all professional and technical personnel, materials, equipment, supplies, facilities, specimen transport, tools, information technology, materials, qualified supervision, and other items and services necessary to perform specimen collection, transportation, and laboratory testing. This contract shall include tests with CPT codes 80000-90000 and generic codes for newly implemented tests.

2. All requirements and provisions defined in the specifications of this solicitation will apply to any current or future laboratory, i.e., branch, division, sub-contractor, etc.

involved in performing reference services on behalf of the Contractor.

3. Services shall include:

a. Transportation of clinical laboratory specimens, originating from the VISN 1

Medical Centers and community-based outpatient clinics (CBOC) listed in Attachment B destined to the contracted commercial reference laboratory.

b. IntraVISN transportation of clinical laboratory specimens originating from the VISN

1 Medical Centers and community-based outpatient clinics (CBOC) listed in Attachment B destined to VA West Roxbury or VA West Haven.

c. Performance of analytical testing.

i.Contractor shall provide the full range of laboratory testing capabilities to execute all required test orders as annotated in this contract.

d. Reporting of analytical test results.

e. Consultative services.

f. Telepathology capabilities.

g. Specimen Collection Facilities within VISN 1 area for phlebotomy services.

h. Laboratory Information System (LIS) Interface with current VISTA LIS and future

VA LIS systems without the need for vendor required middleware.

i. Integrated electronic directory of service.

4. Tests shall be performed and tested entirely upon the premises of the Contractor, or within the Contractor's network of laboratories, or subcontracted to a fully qualified laboratory in accordance with the terms of this contract. The services shall be provided in a state-of-the-art civilian medical laboratory facility. Contractor referrals to a secondary (subcontractor) laboratory shall be kept to a minimum for control and uniformity purposes. Once a particular test is designated (at contract award) for performance by a particular subcontractor, then all future test performance of that test method shall be done by the same subcontractor unless notification is received at least 30 days in advance, in writing and there is concurrence from the government. All billing must come through primary vendor and will not be accepted from the subcontractor.

a. Testing for all VISN 1 sites must be equivalent in methodology, reference ranges, reporting units, turnaround time, sample requirements, sample stability and performance. There must be uniformity in testing and reporting across the VISN 1 sites to maintain continuity of patient care.

5. If a VISN 1 laboratory cannot or chooses not to perform a laboratory test in-house or at another Government-owned laboratory, the facility will refer the test to the Contractor. Each facility reserves the right to determine the tests sent to the Contractor, to add tests not previously sent or remove tests subsequently brought within a VISN 1 laboratory or VA Network of laboratories.

6. Attachment A: Test Menu is a list of tests with volumes that have been referred out for testing as a part of the 2022-2023 Reference Lab Contract. This is not an all-inclusive list; tests and the volumes are estimates and are subject to change based on fluctuating medical need. CPT codes 80000-90000 shall be included as well as generic codes when new tests are implemented.

7. The Contractor shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations concerning specimen testing and program management.

B. Licensing and accreditation – Contracting Laboratory, including subcontractors shall:

1. All licenses, permits and accreditation certificated must be kept current and copies must be provided for both contractor and subcontractor laboratories.

a. CLIA certifications shall include at minimum:

• Histocompatibility (010)

• Bacteriology (110)

• Mycobacteriology (115)

• Mycology (120)

• Parasitology

• Virology (140)

• Syphilis Serology (210)

• General Immunology (220)

• Routine Chemistry (310)

• Urinalysis (320)

• Endocrinology (330)

• Toxicology (340)

• Hematology (400)

• Histopathology (610)

• Oral Pathology (620)

• Surgical Pathology

• Molecular Biology

• Cytology (630)

• Radiobioassay (800)

• Cytogenetics (900)

2. Must be accredited by a VA-approved laboratory accreditation program with CMS-deemed status, such as CAP or TJC.

3. Have a Medical Director with suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA, TJC and CAP standards.

4. Be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses.

Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board.

5. Notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractor’s loss) of any required certification, accreditation, or licensure.

6. Notify the Contracting Officer in writing of all malpractice investigation or licensure or certification suspension that concerns the Contractor or Contractor personnel, or any discovery of any disciplinary action taken against laboratory performing under the contract within 24 hours of notification of an investigation or suspension.

7. Laboratory Director and/or Medical Director possess all of the licensure and certifications required per applicable regulations.

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

C. Description of Test Information

1. The contractor shall make available either through its electronic catalog or upon request the following information:

a. Requisition form requirements

b. Alphabetized test name list

c. Reference lab test number/Test order code

d. Specimen collection and preservation requirements

e. Test method used (indicate if testing performed in duplicate) and interpretations

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

g. Test critical values if any

h. Policy for critical value notification

i. CPT coding

j. Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between receipt of specimen by the Contractor and receipt of results by a VISN 1 facility.

k. Frequency of test performance (specific days of week indicated)

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

m. Logical Observation Identifiers Names and Codes (LOINC code)

2. Contractor shall have an electronic test menu submission system as the preferred test submission avenue with limited specialty tests to be submitted on paper test submission forms.

3. Contractor must provide and maintain a user-friendly public website which allows easy reference for researching test information (test number/CPT coding, patient preparation, test utility, result interpretive guidelines. For tests not listed on public website Contractor shall provide access to their database for client research test information.

4. Contractor shall notify each VISN 1 facility of any planned test information (see C.1.

above) modifications no later than 30 days prior to the implementation date of the change. In the event that 30 days notification is not possible due to emergency, contractor shall notify each VISN 1 facility contact as soon as possible. A VA contact list will be distributed upon award.

D. Specimen Preparation and Storage AT VISN 1

1. The Contractor shall provide at no additional charge an adequate supply of specimen collection materials for testing and handling as dictated by the commercial reference laboratory’s specimen collection requirements, i.e., dry ice, stabilizing tablets, ice packets, etc.

2. The Contractor shall be responsible for transporting and storing specimens in such a manner to ensure the integrity and security of the specimens. The Contractor shall provide a specific transport contingency plan during periods of inclement weather. Procedures for notification of affected VISN 1 sites will be incorporated into the plan.

3. If a medico legal specimen is submitted, the Contractor shall provide its own special forms and special handling procedures to maintain a valid “chain-of-custody possession” and develop the formal documentation necessary for that purpose.

Contractor’s testing personnel who performed the analysis may be required to provide Court testimony. Contractor testimony shall be provided as required at no additional expense to the Government.

E. Transportation Services for Reference Testing Specimens

1. Transported items will be primarily biological substances (patient specimens). These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents.

Microbiology cultures, stocks and regulated medical waste that are also in Division

6.2 will be transported. Contractor to provide a specific transport process for each specimen type (refrigerated, frozen, room temperature). Contractor should have a validated temperature monitoring process in place and provide temperature monitoring logs as requested.

2. Routine transportation services shall occur once per day, with pick-up occurring between 4:00PM and 7:00PM, local time, unless a different time is mutually agreed upon the by VISN 1 facility and the Contractor, Monday- Friday including Federal Holidays upon request.

a. The Government reserves the right to adjust the courier pick-up days and times as necessary, provided a two-week notice has been provided and acknowledged by the Contractor at no additional charge to the Government.

3. Drop-offs are scheduled for VA West Haven and VA West Roxbury. These will occur between 5:00am and 7:00am, local time, for West Haven and between 12:30am and 2:00am, local time, for West Roxbury.

4. Emergency transportation services shall be available 24 hours per day, seven days per week including Government holidays. Response time for emergency transportation services shall be within 3 hours after notification by any VISN 1 facility.

5. Specimen loss due to breakage, spillage, insufficient dry ice or other temperature related problem, misplacement, mishandling or any other Contractor-related problem(s) will be considered unacceptable. Repeated problems with compromised specimens may be grounds for termination of the contract. Contractor shall provide follow-up and corrective action, if applicable, for each issue reported to minimize reoccurrence.

6. Any specimens that have been broken, leaked, or otherwise compromised during transit shall be reported to the appropriate VISN 1 facility immediately upon unpacking at the Contractor’s laboratory. The Contractor shall be required to pick-up the new specimen at no additional cost to the Government. The pick-up of the new specimen will be made during the routine courier pick-up times unless emergency pick-up is requested.

7. The Contractor shall provide point to point specimen tracking and specimen reconciliation for each individual specimen with the aid of barcode technology including intraVISN transportation utilizing government provided customized bags.

Proof of tracking and reconciliation shall be available to any VISN 1 laboratory employee upon request.

F. Specimen Testing

1. The Contractor shall provide timely and appropriate testing of patient specimens as requested by VISN 1 facilities.

2. The Contractor shall log specimens into their system within 24 hours of receipt of specimen at the facility.

3. Contractor shall have a laboratory presence within VISN 1 territory to provide STAT and downtime/contingency testing.

4. The VA has estimated the quantity of tests that will be needed for the entirety of the agreement, including all option years. Quantities may increase or decrease based on the Government’s needs. Quantities are not guaranteed.

5. All tests and reflex tests shall be listed in the award with established test codes and pricing.

6. All reference laboratory testing is preferred to be tested using test methods that are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

7. Problem resolution for specimens not immediately processed/tested or needing further clarification must be handled by contacting the sending site, at the Contractor’s processing facility, using the contact information in Attachment B. If it is after normal business hours this may be handled the next business day after receipt of specimen.

8. Contractor will not change requests for pass-throughs to alternate vendors without permission from the requesting VA site first.

G. Specimen Retention

1. Specimens shall be stored by the Contractor for at least fourteen 14 days after the reporting of results. VISN 1 may request repeat determinations or add-on tests by telephone during this 14-day period. When test results do not fit the clinical picture of the patient, repeat testing may be requested and must be performed at no cost to the Government. Specimen retention applies to blood, serum, CSF, urine, and other body fluids. A medico legal specimen shall be retained indefinitely. This type of specimen will be identified by the VISN 1 site in writing or through telephone communication.

2. All anatomic pathology specimen(s) (e.g., blocks, slides or other diagnostic material) must be returned by courier or expedited shipping methods to the submitting facility within seven (7) days after final diagnosis at no additional cost to the government.

Point to point tracking will be required to ensure safe and secure delivery of these specimens.

a. The Contractor shall return representative slides, anatomic, hematologic, etc., for quality control review when requested. Quality control slides shall represent duplicate copies of original slides prepared by the Contractor from permanent tissue blocks. The Contractor shall provide quality control slides to the facility or clinics at the same time the Contractor submits the final reports. The Contractor shall prepare additional blocks and slides, in quantities specified by the facility for review by pathologists. For malignant cases, the Contractor shall call results to the submitting facility, and prepare paraffin blocks and slides for review by the Joint Pathology Center (JPC) or other Government Pathology Organization (GPO). For benign cases, the Contractor shall prepare slides for review by the facility. Upon provision of sample slides by the facility, the Contractor shall provide interpretation of sample slides. The sample shall include, at a minimum, breast biopsy, thyroid biopsy, mastectomy with nodes, colon resection, lymph node biopsy, and gynecology and non-gynecology cytology.

H. Reporting of Results

1. A report of laboratory testing results is defined as host-to-host electronic transmission of test results. The Contractor shall deliver these reports by electronic report transmission via computer interface. Specifications outlining the requirements of this computer interface including computer hardware, maintenance and supply requirements are defined in the Lab Interface Requirements below.

2. Each test report shall, at minimum, include the following information:

a. Patient’s full name

b. Patient’s date of birth

c. Patient’s full social security number, unique hospital identification number, and/or ICN#

d. Ordering Physician’s name

e. Date/time of specimen collection, when available

f. Date/time test completed

g. Test(s) ordered

h. Test result(s)

i. Flagged abnormal results

j. Type of specimen/source

k. Any additional comments related to test provided by ordering physician, if applicable

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

m. VAMC Lab accession number, if supplied

n. VAMC submitting facility name

o. Patient location if supplied

p. Date/time specimen receipt

q. Abnormal intervals/Toxic & therapeutic ranges, if applicable

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

s. VAMC facility account number

t. Contractor accession number

u. Contractor address

v. Contractor CLIA number

w. Reference intervals

x. Testing laboratory name, address and CLIA#

3. The test results must be received by each VISN 1 facility in accordance with the test set-up schedule submitted with the offer and made a part of this contract.

Electronically transmitted test results shall be received by the VISN 1 facility within 1 hour or less of test completion. Preliminary reports shall be delivered for those tests requiring such, as specified by the test schedule. Numeric test results or test results suitable for the result field in the VA Lab interface shall be sent via a discrete test field rather than transmitted via a comment.

4. Results should be provided in a standard template rather than placed within a comment field, unless where this cannot be avoided, to ensure results are accurately and appropriately electronically transmitted into the patients EHR.

5. The contractor shall provide a contingency plan in the event the electronic transmission of results is disabled or not functioning.

6. Critical test results as defined by the Contractor’s commercial reference test manual shall be communicated by telephone to a designated VISN 1 contact person(s) at the originating VISN 1 laboratory facility upon verification of the critical test result. The VISN 1 laboratory will provide the contractor with point of contact information for critical test results at each site. Each VISN 1 laboratory is responsible for communicating critical test results received from the contracted commercial reference laboratory to the ordering clinician or designee.

7. The status and the results of testing shall be available within contractor published timeframes as described in the electronic Contractor Directory of Services and accessible electronically through the contractor’s online account for each VISN 1 site. At a minimum, the options must include by site: Sort by patient name; sort by date; sort by test; sort by incomplete test. Incomplete tests must have an indication of the pending time until completion. Alert messages must be generated when testing is delayed beyond published timeframes, when specimens require additional testing (reflex), or specimens are cancelled due to unacceptability.

8. Reports of test results shall be immediately available upon verification of the test result. The contractor shall offer an online portal in order to print test results, download pdf test result reports, on demand and reprint retrospective test results according to a defined timeframe.

I. Lab Interface Requirements

1. A VHA 6550 and any required MOUs will be required.

2. After contract award, the commercial reference laboratory contractor shall provide to

VISN 1 all necessary laboratory test parameters to ensure accurate test result transmission between VISN 1 and the contractor’s database. Required test parameters include:

a. Ordering code

b. LOINC code

c. CPT code

d. Interface code

e. Test cost

f. Reference ranges

g. Units of measurement

h. Test result interpretation or interpretive remarks, if appropriate

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

j. Test methodology

k. Specimen types

l. Specimen collection and handling requirements

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

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

3. The parameters for all tests in the Contractor’s database shall be kept current and be available on demand to the VISN 1 sites via website throughout the performance period of the contract. Updates to the test parameter information shall be provided to VISN 1 sites prior to any testing changes in the following situations: new tests are developed and introduced into the Contractor’s test menu; testing parameters have changes; or when tests are discontinued or replaced by other tests. The contractor shall provide information to VISN 1 sites no less than 30 days prior to the implementation of the test change. To maintain accurate and timely test information, the Contractor shall provide telephone access to a Contractor’s representative 24/7 to respond to any question(s) regarding the laboratory test parameter information.

4. Contractor must be able to interface with VA LIS immediately upon award. Test orders and results must seamlessly cross from VA LIS to vendor LIS utilizing HL7 messaging.

5. Contractor shall begin implementation of the interface connection requirements described in this solicitation immediately after the award of the contract. Failure to complete the interface connection within 30 days is grounds for termination of the contract. The validation of the test transmissions through the interface connection will be required. Creation of a test interface with VA Test LIS will be required. Contractor shall have staff available to assist Monday – Friday 8am-5pm EST.

6. VA LIS will send electronic manifest containing required specimen demographics and requested tests to be performed. Printed manifest that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered will also be sent with the specimens.

7. In the event that electronic communication is disrupted, the contractor shall provide hard copy of specimen results upon demand. The hard copy shall contain VISN 1’s assigned specimen identification where specimen identification is defined as a unique VISN 1-assigned 10-digit number that is associated with each specimen. This specimen identification number will appear on the test order form, on the specimen label and on the shipping manifest.

8. The Contractor shall provide VISN 1 with specimen status in response to electronic and verbal query. Upon testing completion, a formatted HL7 message containing specimen results with VISN 1’s assigned specimen identification shall be returned to the requesting medical center.

9. The 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, equipment, or software within 24 hours. Any updates to the interface including IP/ports will be communicated at least 2 weeks in advance so that updates to the VPN tunnel can be completed.

10. The 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 VISN 1 is capable of performing routine servicing of hardware.

11. The Contractor shall provide, install, maintain, and if necessary, remove all telecommunication equipment, printers and associated hardware at no additional cost to the government.

12. Contractor shall address within two hours of initial inquiry, interface questions where information is required to update, maintain, and support the services of the host-to-host linkage between the VISN 1 and the Contractor.

13. The interface configuration between the vendor and VA LIS must provide the required security of the Government host computer system. The initial and continual expense of the electronic message connectivity and maintenance shall be borne by the Contractor throughout the performance of the contract.

14. Contractor shall provide, install, and if necessary, remove, all required telecommunication equipment, hardware, software, and related consumable supplies to support the transmission of electronic data to all VISN 1 sites included in this contract.

This may include, but is not limited to:

a. Shipping list printers

b. Bar-code printers

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

d. Any required communication lines

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

f. Consumable supplies to maintain the operation of the equipment listed above, e.g., toner.

15. All electronic messaging between the two (Contractor and Government) host computer systems shall utilize VA LIS Health Level Seven (HL7) technical specifications. Version of HL7 shall be current VA standard. Health Level 7 (HL7) is a registered trademark of

Health Level Seven, Inc, a Standards Developing Organization accredited by the

American National Standards Institute to author consensus-based standards.

Information regarding HL7 transmission protocols may be accessed through the Health

Level Seven, Inc website, www.HL7.org.

16. The Contractor shall certify in writing successful LIS test validation at completion of current test menu being interfaced.

J. Customer Service

1. The Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period. Customer service will be accessible by toll free telephone service 24 hours per day, 7 days per week to assist VISN 1 staff for tracking and resolving related issues that may arise in the performance under this contract. Contractor to provide a communication plan in their offer to include the following at a minimum:

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

i. Specimen Collection

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

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

ii. Testing

1. Status of Ordered Testing – inquiries regarding the status of pending orders shall be addressed at the time of the initial call.

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

3. Set-up fees will not be charged by the Contractor for cytogenetic tests showing no growth.

iii. Technical Expertise

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

http://www.hl7.org/

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

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

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

b. Billing Reviews

i. Monthly billing reviews with the Network Consolidated Lab (NCL) staff to review and ensure correct contract pricing prior to submission of invoices.

c. The Contractor shall notify the originating laboratory by telephone or email of specimens cancelled due to unacceptability, e.g. volume, specimen container, identification, loss of specimen, etc. the same day the specimen was received.

i. The contractor shall provide a problem log by email, to the sending VA site, which electronically documents communications between the contractor lab and the VA sending site regarding test inquiries.

ii. The contractor shall follow-up by phone call or email to ensure any issues are resolved.

iii. The VISN 1 will place orders for specimen collection and transportation supplies by telephone or through written or electronic methods.

K. The Contractor shall only accept add-on written or verbal orders from authorized laboratory personnel.

L. Utilization Reports – These reports will be at no additional cost to the government.

1. The Contractor shall provide a statistical analysis of the VISN 1 facilities’ workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities and/or VISN 1 COR on mechanisms to reduce their costs. The analysis will be for each VISN 1 sending institution as well as a VISN 1 rollup. This utilization management tool can help control expenses and improve clinical care. It will ensure that clinicians are ordering the right tests and that the VISN 1 is getting the proper return for laboratory testing dollars. The management tool supports clinicians in delivering evidence-based care that improves quality metrics, which leads to improved financial performance. The utilization report can drill down to organization or provider level to view utilization trends and patterns on a daily, monthly, quarterly, or annual basis.

2. The contractor shall electronically distribute reports (In a sortable Microsoft Excel format) to the COR/ VISN 1 Network Consolidated Laboratory office by the 15th of the month following the close of the reporting month:

b. A monthly cumulative summary of tests performed, by dollar volume, for each facility. Summary must indicate the tests in descending order based on dollar volume, volume of tests ordered, unit price for each test, monthly expenditures and year to date expenditures. The data from each site shall be rolled up into a VISN 1 Master Summary.

c. A cumulative summary of tests performed sorted by test frequency for the entire VISN 1. Summary must include a break-down of the tests ordered by each facility, the volume of tests ordered, unit charge per tests, and total charges.

M. Miscellaneous Responsibilities- The Contractor shall keep each facility, COR and other key personnel informed of the most recent developments in clinical laboratory methods used and medical interpretation of laboratory tests through periodic newsletters, reports, data sheets, and/or Continuing Medical Education (CME) presentations. The Contractor shall provide updates at least quarterly.

N. Contractor is required to maintain medical liability insurance for the duration of this contract.

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

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

II. REQUIREMENTS FOR PATIENT PHLEBOTOMY

A. Vendor owned Specimen Collection Facilities shall be located within 5 miles of the outpatient center it will serve. The Specimen Collection Facilities will provide specimen collection and specimen processing as agreed upon. Please see Attachment C.

1. Specimen Collection –Veteran patients shall be correctly identified using two VA- Accepted forms of identification. Full Name and Full SSN or Full Name and Full Date of Birth are acceptable.

2. Specimens shall be labeled with VA printed labels when available; handwritten labeling is strongly discouraged. VA patient orders may be communicated to the Specimen Collection Facilities via fax or the patient bringing in their own VA lab labels.

3. Security – Specimen Collection Facilities shall ensure the security of VA Patient specimens, Personally Identifiable Information (PII), Protected Health Information (PHI) and VA Sensitive Information shall be safeguarded at all times. VA patient specimens and paperwork will be secured in tamper evident specimen bags, or locked containers until handed off to a trusted courier.

4. Becton Dickinson collection tubes are used at the VISN 1 facilities and are preferred.

The contractor shall provide a list of collection tubes that will be used at the Specimen Collection Facilities. Vendor shall supply any collection supplies needed for testing at VISN 1 facilities. The VISN 1 contacts will be notified immediately of any collection supply changes after the contract is awarded.

5. The Contractor shall offer both a mechanism for VA patients to schedule specimen collection appointments in order to decrease wait times and walk in options for VA patients. Hours of blood draw for Veterans shall be posted at patient draw locations.

See Attachment C.

III. REQUIREMENTS FOR COURIER SERVICES

A. General

1. The Contractor shall provide, in accordance with the specifications outlined below, courier services for the VISN 1 locations in Attachment B and C. Courier Services will be required between VISN 1 locations and the contractor lab, as well as intra- VISN 1 transportation.

2. All requirements and provisions defined in the specifications of this solicitation will apply to any entity, i.e., branch, division, sub-contractor, etc. performing courier services on behalf of the Contractor.

B. Description of Services

1. Transported items shall be primarily biological substances (patient specimens).

These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Microbiology cultures, stocks and regulated medical waste that are also in Division 6.2 shall be transported. Other incidental items (not included in Division 6.2) that may be transported include, but may not be limited to, laboratory testing reagents and supplies (of limited size and quantity), IT equipment, Holter monitors, x-rays, patient reports or other paperwork.

2. The VISN 1 facilities shall be responsible for the processing of biological substances in preparation for transportation. VISN 1 will provide a shipping manifest minimally detailing the dates and times of receipt and delivery and the number of patient specimens transported by temperature category.

3. The Contractor shall provide point to point specimen tracking and specimen reconciliation for each individual specimen with the aid of barcode technology. Must be able to utilize barcodes on government provided biohazard bags for intraVISN specimen tracking.

C. Requirements

1. The Contractor shall provide safe transport of all biological substances. This must include the proper receipt, distribution, storage, and security of patient specimens in accordance with all federal* regulations governing the safe transport of these materials including, but not limited, to the following:

a. Department of Transportation 49 CFR Parts 171-180 – Hazardous Materials:

Infectious Substances; Harmonization with the United Nations Recommendations, Final Rule.

b. Department of Health and Human Services 42 CFR Parts 72 and 73 – Interstate Shipment of Etiologic Agents and Select Agents and Toxins

c. Department of Labor/OSHA 29 CFR, Section 1910.1030-Bloodborne Pathogens

d. Health Information Portability and Accountability Act (HIPAA) Privacy Rule 45 CFR

Parts 160 1st 164.

* State and local regulations may be applicable if more stringent and do not conflict with the federal regulations.

2. The Contractor shall include a program that ensures the accountability and integrity of all biological substances from the point of possession to the point of delivery with their offer. Critical elements of the program are as follows:

a. Education of all transport personnel on the policies and procedures for the receipt, tracking and delivery of these packages.

b. Overall and day to day coordination of the courier schedule to include dispatch, timeliness, and communication.

c. Provision of a contingency system to insure 100% courier route performance.

d. Provision of a specimen tracking system that prevents any loss of specimens. Any loss of a specimen is considered serious and has negative clinical impact. The tracking system will be point to point with individual specimen reconciliation using barcode technology.

e. Monitoring its proper handling of the specimens to ensure their quality and integrity.

f. Provision of emergency contact information to address inter-route issues that occur. A direct contact (other than the courier/employee) must be designated for immediate response to courier service issues. This contact must be available for emergency response within the timeframes covered in the courier route plan and throughout extended time periods when the courier is not able to meet the stated delivery times. In addition, this contact must have the capability to be in immediate communication with the courier employee performing the services in cases of emergency or to determine location. The contact information, i.e. name(s) and/or offices and telephone number(s), for these emergency contact personnel must be available at the time of award.

g. Designation of a minimum of two…