36C26321R0091.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. 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 91

36C26321R0091 09-20-2021

Daniel Vagts 651-293-3040 10-14-2021

11:59AM EST

DEPARTMENT OF VETERANS AFFAIRS

NETWORK 23 CONTRACTING OFFICE

ATTENTION: Daniel Vagts

316 ROBERT ST N STE 506

SAINT PAUL MN 55101

621511

$35 Million

N/A

N/A

X

Department of Veterans Affairs

Minneapolis VA Medical Center

One Veterans Drive, Building 70

Minneapolis MN 55417

NETWORK 23 CONTRACTING OFFICE

ATTENTION: Steven Porwoll

316 ROBERT ST N. STE 506

SAINT PAUL MN 55101

Y

Department of Veterans Affairs

Financial Services Center

PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

Referral Laboratory Services for the Department of Veterans Affairs (VISN)

See Schedule of Items - Section B.2, page 6.

See Performance Work Statement - Section B.3, page 7.

See CONTINUATION Page

X

X ONE

Daniel Vagts

Contract Officer

36C26321R0091

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 SCHEDULE OF ITEMS - PRICING – See Section D: D.5 – Attachment 5 – Schedule of Items –

Price List

B.3 PERFORMANCE WORK STATEMENT

SECTION C - CONTRACT CLAUSES

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

C.2 52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL (JAN 2011)

C.3 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN

2016)

C.4 52.216-18 ORDERING (AUG 2020)

C.5 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.6 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.7 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.8 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.9 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997)

C.10 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.11 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

C.12 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.13 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.14 VAAR 852.219-9 VA SMALL BUSINESS SUBCONTRACTING PLAN MINIMUM REQUIREMENTS

(DEC 2009)

C.15 VAAR 852.219-71 VA MENTOR-PROTÉGÉ PROGRAM (DEC 2009)

C.16 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE

(JUL 2018)

C.17 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE (JUL 2018)

C.18 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

C.19 VAAR 852.237-7 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (JAN 2008)

C.20 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (OCT 2019)

C.21 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL ITEMS (AUG 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 List of Attachments

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020)

E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.3 52.216-1 TYPE OF CONTRACT (APR 1984)

E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.6 VAAR 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST (JAN 2008)

E.7 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL

BUSINESS EVALUATION FACTORS (OCT 2019)

E.8 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008)

E.9 VAAR 852.271-70 NONDISCRIMINATION IN SERVICES PROVIDED TO BENEFICIARIES (JAN

2008)

E.10 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (AUG

2020)

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 36C263

NETWORK 23 CONTRACTING OFFICE

ATTENTION: Daniel Vagts

316 ROBERT ST N STE 506

SAINT PAUL MN 55101

2. 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, or [] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] MONTHLY

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.

Department of Veterans Affairs

Financial Services Center

PO Box 149971

Austin TX 78714-9971

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the

Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 SCHEDULE OF ITEMS - PRICING – See Section D: D.5 – Attachment 5 – Schedule of Items – Price

List

Period of Performance:

Base Period: 11-01-2021 – 10-31-2022 - $

Option Period One: 11-01-2022 – 10-31-2023 - $

Option Period Two: 11-01-2023 – 10-31-2024 - $

Grand total for Base and all Option Periods. $

In accordance with FAR 16.504(a)(1), The guaranteed minimum and maximum dollar amounts are listed in the table below. These amounts cover the base contract. The maximum dollar amounts listed shall not be exceeded.

IDIQ Established MIN and Max dollar amounts for Base Period and all Option Periods:

Minimum $2,000.00

Maximum $13,900,000.00

Ordering Procedures

Each ordering vehicle will document the quantity, and other pertinent data to ensure the services provide the appropriate level of patient care to the maximum order allowable under the resultant contract. No additional services are authorized without prior approval through the Administrative Contracting Officer and/or Contracting Officer.

B.3 PERFORMANCE WORK STATEMENT

VISN 23 REFERRAL LABORATORY TESTING

1. GENERAL REQUIREMENTS:

1.1. The Department of Veterans Affairs, VISN 23, has a requirement for medical laboratory and testing analysis services. The Contractor shall be responsible for performing pre-analytic processing as defined in its laboratory manual, analysis, and reporting of analytical results and interpretation for clinical and anatomical pathology specimens as requested by participating facilities (listed below) during the contract period. Services shall include the transportation of clinical laboratory specimens to the Contractor’s laboratory/laboratories, performance of pre-analytical specimen processing support services, the performance of analytical testing as defined by the Contractor’s reference test manual, the reporting of analytical test results, and consultative services as required to provide the full scope of its laboratory services to the ordering facility. The Contractor shall provide varying levels of support service depending on the unique characteristics presented by each Medical Center or Outpatient Clinic.

Services furnished under the contract shall be ordered by issuance of a task order for results to be delivered to the site designated on the task order and in accordance with standards, clauses, and provisions of this document. One task order will be issued for each participating facility.

Participating Facilities:

• VA Black Hills Health Care System, Hot Springs, SD

• VA Black Hills Health Care System, Ft. Meade, SD

• Fargo VA Health Care System, Fargo, ND

• VA Nebraska-Western Iowa Health Care System, Omaha, NE

• VA Nebraska-Western Iowa Health Care System, Lincoln, NE

• VA Nebraska-Western Iowa Health Care System, Grand Island, NE

• St. Cloud VA Healthcare System, St. Cloud, MN

• Sioux Falls VA Health Care System, Sioux Falls, SD

• Iowa City VA Health Care System, Iowa City, IA

• Minneapolis VA Health Care System, Minneapolis, MN

• VA Central Iowa Health Care System, Des Moines, IA

Required services include but are not limited to: specimen preparation and storage, transportation of clinical laboratory specimens, microbiology cultures, and stocks; performance of analytical testing;

reporting of analytical test results; and consultative services.

1.2. The Contractor shall provide electronic access to data elements necessary to populate the data tables associated with result reporting within the Veterans Affairs Hospital Information System (HIS) or current Government Laboratory Information System (LIS). This information, at a minimum, shall include the following data elements:

1.2.1. Test name including synonyms

1.2.2. Ordering Test Code (Contractor’s Identification Code)

1.2.3. Billing Code (if separate from the orderable test code)

1.2.4. LOINC – Logical Observation Identifier Names and Codes

1.2.5. CPT Code – Current Procedural Terminology

1.2.6. Interface Code/Test Mapping

1.2.7. Test methodology

1.2.8. Test Description, including reference ranges (when appropriate, age and sex adjusted) and units of measurement

1.2.9. Therapeutic or diagnostic reference ranges (when appropriate)

1.2.10. Specimen collection and handling requirements

1.2.11. Test result interpretation or interpretive remarks, if appropriate

1.3. All testing shall be performed on the Contractor’s premises, or within the Contractor's network of laboratories (affiliate or qualified Subcontractor). Under no circumstances shall the Contractor allow any patient information or lab testing samples to be sent outside the confines of the internationally recognized borders of the United States of America. Contractor referrals to a secondary (Subcontractor) laboratory shall be kept to a minimum for control and uniformity purposes. Subcontractors shall be held to the same quality standards as specified in the contract.

1.4. Citizenship related Requirements: While performing services for the VA, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. The Contractor must return a signed certification at the time of proposal that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to the VA. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001 and is applicable to the entire period of performance.

1.5. If a VISN 23 laboratory cannot or chooses not to perform a laboratory test in-house or at another

Government-owned laboratory, the facility reserves the right to determine which tests are sent to the

Contractor. Tests may be added and removed from the contract via modification.

2. GENERAL QUALIFICATIONS:

2.1 Licensing and Accreditation

2.1.1 Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor shall have all licenses, permits, accreditation and certificates required by law. The reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP). In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.

2.1.2 The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of all sanctions current or pending throughout the United States of America prior to contract award. In addition, the Contractor shall be responsible for providing a written guarantee or evidence that all Subcontractors have appropriate licensure and accreditation to perform tests that the primary Contractor cannot perform prior to contract award. All proposed Subcontractor changes during the contract performance period must have prior approval by the Contracting Officer (CO). Changes to the requirements shall be addressed by bilateral modification.

2.1.3 Contractor Personnel assigned by the Contractor to perform the services covered by this contract shall 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.

2.2 Contractor policies and procedures shall comply with Health Insurance Portability and Accountability

Act (HIPPA).

2.3 The Contractor shall 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/laboratories performing under the contract within 24 hours of notification of an investigation or suspension.

2.4 Contractor Personnel: The Contractor shall maintain current accreditation and notify the Contracting

Officer of all lapses in state license, Clinical Laboratory Improvement Amendments (CLIA) certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses/certificates to the Contracting Officer before expiration.

3. CONTRACTOR’S RESPONSIBILITIES:

3.1. Procedure Guidance:

3.1.1 The testing methodology and reference ranges for a test must be defined in the Contractor’s laboratory user manual. The Contractor shall provide change notice prior to implementation of each new medical procedure and service. The Contractor’s laboratory user manual shall be made available to a Contracting Officer’s Representative if requested.

3.1.2 The Contractor shall ensure that all tests performed meet the currently acceptable standard deviation and that have daily controls conducted to determine testing accuracy. Upon request by the Contracting Officer (CO) or assigned Contracting Officer’s Representative (COR) for the applicable facility and the Contractor shall make available quality assurance information on specific testing procedures for review.

3.1.3 Tests referred within the Contractor-owned laboratory network or subcontracted laboratories shall be at no additional transfer charge or confirmation charge to the Government

3.2. Supplies: The Contractor shall provide all necessary supplies for testing including:

3.2.1. Requisition forms, as desired

3.2.2. Specimen containers

3.2.3. Appropriate shipping container, if required

3.2.4. Special instructions

3.2.5. Current list of tests with reference ranges and specimen requirements

3.2.6. Specimen carriers

3.2.7. All forms, to include Chain of Custody

3.2.8. Special media or tubes for samples

3.2.9. All supplies for special tests (e.g. viral studies)

3.3. The Contractor shall contact the assigned point of contact for each participating facility within a minimum of five (5) calendar days after award to coordinate the furnishing and delivery of specimen collection and transportation supplies, communication terminal and connections, and the installation of equipment.

3.4. The Contractor shall provide each participating facility supplies and equipment within five (5) business days after receipt of the order. The assigned point of contact for each facility will request replenishment of supplies from the Contractor on an as needed basis.

3.5. Test Results:

3.5.1. The Contractor shall provide test results to the ordering facility in accordance with the testing specifications defined in the Contractor’s commercial specimen collection guide, except when specimens are picked up the day before a weekend or holiday (in which case the results will be provided the following business day).

3.5.1.1 Contractor shall provide electronic transmission (computer to computer transmission required with teleprinter or fax as back-up) of all completed and partial test results to the ordering facility within published Turnaround Time (TAT), except where specified.

Contractor shall provide all required hardware, software, and related consumable supplies to support the transmission of electronic data for each ordering facility at no additional charge.

3.5.2. Critical Values: The Contractor shall immediately telephone the assigned point of contact for the applicable facility, requesting Clinician or designee, when results of certain tests fall within established alert or critical ranges.

3.5.3. Test Report: A report is defined as a final copy of laboratory testing results. This report shall be received by remote terminal. If results were previously telephoned, the report must include the name of the individual notified of the results. Contractor shall provide a copy of its policy concerning corrected or amended reports. Contractor will supply a list of critical values.

Contractor shall work with each VISN 23 Laboratory to determine a reporting process for Critical

Values. Each test report shall indicate the following information:

3.5.4.1. Patient's name and identification code (this may include multiple identifiers such as social security number, VA ICN, and VA EDIPI)

3.5.4.2. Physician's name (if supplied)

3.5.4.3. Test Accession Number assigned by facility

3.5.4.4. Facility Name

3.5.4.5. Patient's location (clinical/ward), (if supplied)

3.5.4.6. Date/time specimen received in Reference Lab

3.5.4.7. Test ordered

3.5.4.8. Date/time of specimen collection

3.5.4.9. Date test completed

3.5.4.10. Test result

3.5.4.11. Flag abnormal values and critical values

3.5.4.12. Reference range

3.5.4.13. Toxic and therapeutic range where applicable

3.5.4.14. Testing laboratory specimen number

3.5.4.15. Name and address of testing laboratory (Contractor and Subcontractor)

3.5.4.16. Type of specimen

3.5.4.17. All additional comments related to test provided by submitting labs.

3.5.4.18. All other information the laboratory has that may indicate the questionable validity of test results.

3.5.4.19. Unsatisfactory specimen shall be reported with reason of unsuitability for testing.

3.6. The Contractor shall provide telephone consultation with the assigned point of contact for the participating facility, requesting Clinician, or designee as needed.

3.7. Upon completion of the testing, the Contractor shall retain all specimens as required by regulatory agencies (RA). Upon request by the ordering facility, the assigned point of contact for the participating facility, or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA. In the absence of RA requirements, the Contractor shall retain specimens after all testing has been completed in accordance with the most current versions of GEN 20425 Record

Retention Phase I and ANP 12500 Record Retention Phase II. If the laboratory ceases operation, the specimens, slides, blocks, and documentation must be transferred to the VA facility where the testing was originally requested.

3.8. The Contractor shall provide a copy of the specimen rejection policy.

3.9. Documentation: The Contractor shall ensure that all required documentation is timely, legible, and accurate. Contractor personnel shall indicate responsibility for the content and correctness of all prepared and transcribed reports by affixing the Contractor personnel’s own signature to the documents and validating their contents.

3.10. The Contractor shall provide a monthly testing summary to each participating facility. The summary shall be electronic and include the following:

3.10.1. CPT Code and Contractor’s test code

3.10.2. Test name

3.10.3. Current test price

3.10.4. Monthly test volume

3.10.5. Year-to-date test volume

3.10.6. Monthly test cost

3.10.7. Year-to-date test cost

3.11. Quarterly cost savings reports are a significant condition of this contract. If the Contractor fails to provide a complete cost savings report within the allowable time frames, this contract may be terminated by the Government without cost or penalty. The Contractor shall provide a quarterly cost savings report showing the contract price and total number of individual laboratory tests ordered quarterly to determine savings. The report is due within twenty (20) business days after the close of each quarter’s business. Reports shall be sent to the following addresses:

jill.johnson2@va.gov or designee

Report periods are as shown below:

1st quarter: October 1 – December 31

2nd quarter: January 1 – March 31

3rd quarter: April 1 – June 30

4th quarter: July 1 – September 30

4. SERVICE AND MAINTENANCE:

4.1 Service

4.1.1 The Contractor shall provide telephone number(s) and contact person to be used by the ordering activity to make specimen problem inquiries and provide problem solving at all times including weekends and holidays. The Contractor shall include names and telephone numbers of technical directors and pathologists available for consultation.

4.1.2 The Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Within 24 hours, notification must be given to the assigned COR for the applicable facility and Contracting Officer upon adverse action by a regulatory agency. Contractor shall assign a specific local account representative to each ordering activity. Contractor shall advise facility of any changes in methodology, procedure, reference ranges and all new tests.

4.1.3 In the event that the Contractor changes the assay procedure or a critically important component of an assay (e.g., antibody, purified antigen, etc.), the Contractor shall notify the CO and assigned COR for the applicable facility prior to the intended change. Changes in the assay materials or procedure shall be sufficient cause for changing to an alternate

Contractor for the assay(s) for the duration of the contract.

4.2. Maintenance:

4.2.1 The Contractor shall provide preventive and as-needed maintenance on any installed terminal or data fax system at the facility or clinic at no additional charge to the

Government. The Contractor shall provide preventative (routine) maintenance within 72 mailto:jill.johnson2@va.gov hours of notification by the assigned COR for the applicable facility or designee and respond to emergency maintenance calls within 24 hours.

4.2.2 The Contractor shall provide an alternate route of transmission (i.e. telephone, or courier service) for test results to be provided to the participating ordering facility or clinic to be used in the case of a failure of the primary system. Specific information regarding when and how the system will be used will be provided to the assigned COR for the applicable facility. The back-up plan is required to comply with all response times required by the contract.

5. QUALITY ASSURANCE/QUALITY CONTROL:

5.1. The Contractor facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the government at any time during the term of the contract.

5.2. The Contractor shall comply with all applicable OSHA, Regulatory Agency, and Federal, State, or local laws as required for performing the type of services required.

5.3. Contractor shall provide a statistical analysis of the Government facilities’ workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities on mechanisms to reduce their costs.

5.4. Contractor shall provide monthly a cumulative workload summary report of tests performed. The summary must include the facility account number, the test name, the test ordering code, monthly test volume, year-to-date test volume, unit test cost, monthly test expenditures and year-to date test expenditures.

5.4.1. A copy of the report shall be delivered electronically to the Contracting Officer and COR by the 10th of the month following the close of the reporting month.

5.4.2. All reports shall be submitted in electronic spreadsheet format and have the capability to sort by four (4) different methods:

• Facility account number

• Test names listed alphabetically

• Test names listed in order of year-to-date test frequency (highest to lowest)

• Test names listed in order of year-to-date total test cost (highest to lowest)

5.5 Contractor shall provide a monthly listing of any tests performed not listed in Attachment A. This listing shall include, at a minimum, the test name and/or test ordering code, quantity of each test performed, and proposed pricing.

5.6 Contractor shall provide a monthly listing of any tests listed in Attachment A that are no longer performed by contractor and shall be removed from Attachment A. This listing shall include, at a minimum, test name and/or test ordering code.

5.7 The Contractor shall comply with the following Quality Assurance guidelines relating to shipping and test performance:

5.7.1 Number of lost specimens by vendor: 1 per month per facility

5.7.2 TAT: 90% of monthly results will be reported within established contractor published TAT

5.7.3 Revised reports not due to incorrect requisition information: 1 per month per facility

5.8 The assigned point of contact for the participating facility may perform surveillance of services by:

5.8.1 Monitoring turnaround times (TATs)

5.8.2 Observing actual performance;

5.8.3 Checking pick up times by the Contractor;

5.8.4 Inspecting the services to determine whether or not the performance meets the performance standards;

5.8.5 Review of any other appropriate electronic records.

5.9 As part of the surveillance plan, the assigned point of contact for the participating facility will review and approve all invoices prior to payment.

5.10 Surveillance will not be so intrusive as to impact the Contractor’s successful accomplishment of the mission.

5.11 When unacceptable performance occurs, the assigned point of contact for the participating facility will notify the COR and Contracting Officer. This notification shall normally be in writing unless circumstances necessitate verbal communication. The COR and/or Contracting Officer will inform the Contractor, document the discussion, and provide a copy of the document to the

Contractor and Contracting Officer. When the COR and/or Contracting Officer determines formal written communication is required, the assigned COR for the applicable facility shall prepare a

Contract Discrepancy Report (CDR) and present it to the Contractor's program manager and the

Contracting Officer. The Contractor shall acknowledge receipt of the CDR in writing. The CDR shall specify if the Contractor is required to prepare a corrective action plan to document how the

Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR shall also state how long after receipt the Contractor has to present this corrective action plan to the assigned

COR for the applicable facility. The COR and Contracting Officer shall review the Contractor's corrective action plan to determine acceptability. All CDRs may become a part of the supporting documentation for any action deemed necessary by the Contracting Officer.

5.12 Quality assurance monitoring documentation shall become an official Government record of the

Contractor’s performance.

6. TRANSPORTATION:

6.1 Specimen Pick-up Times

6.1.1 Routine: The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the ordering activity. The ordering facility assigned point of contact for the applicable facility or designee shall notify the Contractor during weekends and Federal holidays, via telephone, when a pick-up courier is required.

6.1.2 Sample Preparation: Each ordering activity shall prepare and package laboratory specimens in accordance with the requirements defined in the Contractor's laboratory user’s manual.

The Contractor shall provide at no charge an adequate supply of requisition forms, specimen collection materials, dry ice and appropriate container, special instructions, and a current list of tests with reference ranges and specimen requirements. These requirements shall be defined in the laboratory user manual. The Contractor shall be responsible for transporting in such a manner as to ensure the integrity of the specimen.

The Contractor shall supply any special preservatives, collection kits, or transport media required for specimen preservation. Each ordering facility is responsible for packaging the specimens.

6.2 Shipping Biological and Infectious Substances:

6.2.1 Regulatory Requirements. The regulations governing the packaging and shipment of biological, infectious, and hazardous substances are primarily found in 49 CFR parts 100-

185 and 397. The parts of 49 CFR specifically dealing with biological and infectious specimens are 107, 171, 172, and 173. While the majority of shipments packaged and processed by the clinical laboratories are classified as diagnostic specimens, all specimens, as well as any select agents and toxins that are identified, must be packed, and shipped in accordance with the applicable guidance provided in 49 CFR. Contractor or Subcontractors that package, transport, or ship biological, infectious, and hazardous substances shall comply with all laws, regulations, and policies of Federal, State, and Local governments, the

Centers For Disease Control (CDC), Department of Transportation (DOT), International Air

Transport Association (IATA), and the Department of Veterans Affairs.

6.2.2 Hazardous Materials and Security Training. Contractor or Subcontractors transporting or shipping hazardous materials (hazmat) must be aware of the potential use of hazmat for acts of terrorism and are required to have documented transportation security awareness training. As many biological specimens are now classified as hazmat, it is important for all personnel that are involved in the packing and shipping of laboratory specimens to have hazmat training. The Contractor shall ensure that all personnel who deal with specimen transportation and shipment have the training and certification required by law and regulation. Failure to maintain compliance shall be reason for the Government to terminate the contract.

7. RELEASE OF MEDICAL INFORMATION:

The Contractor shall release medical information obtained during the course of this contract to authorized VISN 23 staff.

8. INTERFACING/COMMUNICATION REQUIREMENTS:

8.1. The Contractor shall provide an integrated system approach to facilitate and streamline all aspects of specimen ordering, testing, and reporting. As such, the Contractor shall provide and program an interface system to electronically transmit orders, specimen status and test results between the Contractor’s host computer system and the VA’s host computer system (VistA).

8.2. The expense of the electronic message connectivity leading up to the VA middleware and communicating correctly according to VA protocols is borne by the Contractor.

8.3. All electronic messaging between the two (Contractor and VistA) computer systems shall conform to VistA Health Level Seven (HL7) and Laboratory’s HL7 technical specifications. Health

Level 7 (HL7) is a registered trademark of Health Level Seven, Inc, is a Standards Developing

Organization accredited by the American National Standards Institute to author consensus-based standards. Information regarding HL7 transmission protocols may be accessed through the Health Level Seven, Inc web-site, www.HL7.org.

8.4. Data connectivity between the Contractor and the VA will be accomplished through the use of either a Client to Site (C2S) connection, Site to Site (S2S) connection or via the VA’s Private

Extranet Internet Cloud according to standards required by the VA’s Network Security and

Operations Center (NSOC) and as approved by the VA’s Enterprise Change Control Board

(ESCCB) in accordance with VA Directive and Handbook 6500 requirements.. The Information

Security Office will coordinate the requirements with the Contracting Officer Representative

(COR) and the Contracting Organization POC for the supporting the contract. Typical connections are by Site to Site VPN. Business Partners may access designated internal VA servers if they are granted a Client VPN account. A Client VPN requires signing of VA National

Rules of Behavior and VPN Rules of Behavior by each approved user of the connection.

However, if there is a large number of Business Partner users that are approved for this, it may be more efficient to build a Site to Site (S2S) VPN with the Business Partner.

8.4.1 Each type of connection (C2S or S2S) requires that all contractors must have

Background Investigations completed (required by FIPS 201) and must initially and annually thereafter participate in the VA Information Security Awareness and VA

Privacy training programs.

8.4.2 A Site to Site VPN enables a VA Business Partner to securely access specific resources on the VA WAN. It does this by establishing a Virtual Private Network

(VPN) connection between the Business Partner network and one of the VA Trusted

Internet Connection (TIC) Internet Gateways. Traffic that may pass over this http://www.hl7.org/ connection is limited, so only specific VA and Business Partner systems may communicate with each other. A S2S is used only if business needs cannot be met with a Client to Site VPN connection. The Business Partner must support encryption that is compliant with Federal Information Processing Standard (FIPS) 140-2. The

Business Partner must sign a legal agreement with the VA (ISA/MOU for a S2S.

Communication must be limited to explicit VA and Business Partner systems, using a limited set of ports, protocols, and services. A S2S requires an Interconnection

Security Agreement, used to support a Memorandum of Understanding/Agreement

(MOU/A) that establishes the requirements for data exchange between two organizations. The MOU/A is used to document the business and legal requirements necessary to support the business relations between the two organizations.

8.4.3 Each of the VA TIC gateways has Cisco Adaptive Security Appliance (ASA) devices used for Site to Site VPN connections. They use IP Security (IPSec) with Triple Digital

Encryption Standard (3DES) or Advanced Encryption Standard (AES) for encryption and ISAKMP for authentication and integrity. The devices are FIPS 140-2 compliant.

This capability establishes a secure, end-to-end encrypted tunnel that protects the report Gateway VPNs are configured to allow only IPSec protected data flows, and only when originated from and sent to authorized peers. The Business Partner must use a FIPS 140-2 compliant solution for their end of the Site to Site VPN. If they do not already have a VPN solution in place, the vendor will work with VA Information

Security, NSOC and the ESCCB to establish the appropriate VPN connection type.

The VA is not responsible for problems with equipment owned by the Business

Partner.

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

• Ordering code

• LOINC code

• CPT code

• Interface code

• Test cost

• Reference ranges

• Units of measurement

• Test result interpretation or interpretive remarks, if appropriate

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

• Test methodology

• Specimen types

• Specimen collection and handling requirements

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

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

8.6. The parameters for all tests in the Contractor’s database shall be kept current and be available to the VA sites throughout the performance period of the contract. Updates to the test parameter information must be provided to VA 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 VA sites no less than 2 weeks prior to the implementation of the test change. In an effort to maintain accurate and timely test information, the Contractor shall provide telephone access to a COR to respond to any question(s) regarding the laboratory test parameter information.

8.7. VistA Laboratory Electronic Data Interchange (LEDI) identifies VA-specific content and encoding tables to be used with HL7 message protocol conventions. The LEDI specification follows very closely the HL7 standard. LEDI identifies encoding tables and HL7 message protocol conventions.

8.7.1 VistA LEDI identifies to the commercial reference laboratory vendor shipping lists containing required specimen demographics and requested tests to be performed.

This list will be provided in printed format.

8.7.2 VistA LEDI software will provide a HL7 acknowledgement of receipt of data packets.

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

8.7.3 Upon testing completion, a formatted HL7 message containing specimen results with VA’s assigned specimen identification shall be returned to the requesting medical center.

8.7.4 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 of any malfunctioning hardware or software.

8.7.5 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 VA is capable of performing routine servicing of hardware.

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

8.7.7 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 VA and the Contractor.

8.7.8 The Contractor shall have an operational interface connection with all facilities within 45 days of the contract award. The establishment of the test database will be the responsibility of the Government and will begin as soon as the Contractor notifies the Government of an operational interface connection. The validation of the test transmission through the interface connection will be the joint responsibility of the Government and Contractor.

8.8. Data Management System/Communication Manager or internet database system. The contractor shall provide a data management system or internet database system available for each medical facility and outpatient clinic listed. The system shall meet the following requirements:

8.8.1 Test ordering must be accomplished through a menu that is intuitive, has minimal options and uses a mouse or touch screen. Upon selection of the test, the computer shall alert (flag) the user to the type of specimen required and the storage conditions.

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

8.8.3 The status and the results of testing must be available within published timeframes and easily retrievable by the use of varying options. At a minimum the options must include: 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.

8.8.4 Reports of test results must be immediately available upon verification of the test result. The system must be able to print test results and reprint retrospective test results according to a defined timeframe.

9. CONTRACTING OFFICER’S REPRESENTATIVE:

9.1. Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer the designated representative for this contract is Jill Johnson, VISN 23 Health System Specialist or designee.

9.2. The Contracting Officer Representative (COR) is authorized to act within the limitations specified herein and written restrictions specifically imposed under the terms of the order and by the

Contracting Officer.

9.3. This designation does not include authority to direct changes in scope, price, terms or conditions of the contract or order. The authority herein also does not include authority to execute modifications to the contract or order, which require the signature of the Contracting Officer, or to bind the

Government by agreement in terms of a proposed contract change.

10. SERVICES:

10.1 “Contractor personnel” is defined as personnel of the prime Contractor or of any subcontractor, affiliate, partner, joint venture, or team members the Contractor is associated. It also includes consultants engaged by any of those entities.

10.2 The services specified in this contract may only be changed by written modification which will be prepared and executed by the VISN 23 Contracting Activity. The following actions are the sole responsibility of the Contracting Officer for this contract; no other personnel are authorized:

10.2.1 Make changes to provisions and clauses listed in the agreement. This includes changes involving increases to pricing, decreases to pricing, and no cost changes.

10.2.2 Require extras or work outside the scope of the agreement.

10.2.3 Authorize delivery or disposition of Government property not authorized by the agreement.

10.2.4 Extend the completion time established in the agreement.

10.2.5 Terminate the agreement in whole or in part.

10.2.6 Render a decision under the Disputes Clause.

10.2.7 Issue instructions to the Contractor to stop or start work, to exclude scheduling of services.

10.3 Other necessary personnel for the operation of the services agreed to at the VAMC shall be provided by the VAMC at levels mutually agreed upon which are compatible with the safety of the patient and personnel and with quality medical care programming.

10.4 The services to be performed by the Contractor shall be performed in accordance with the

VAMC policies and procedures.

11. National Holidays:

The 10 holidays observed by the Federal Government are New Year’s Day, Martin Luther King’s Birthday, Presidents Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, Christmas, and any other day specifically declared by the President of the United States to be a national holiday.

12. PERSONNEL POLICY:

The Contractor shall be responsible for protecting the personnel furnished services under this agreement. The parties agree that the Contractor, Contractor Personnel, agents, and Subcontractors shall not be considered VA employees for any purpose. The Contractor shall provide or cause the provision of the following for these personnel:

• Workers compensation

• Professional liability insurance

• Health examinations

• Income tax withholding, and

• Social security payments

13. RECORD KEEPING:

13.1. For services performed at the VAMC, the following shall apply:

13.1.1 The VAMC shall establish and maintain a record keeping system that will record the services performed by the Contractor’s personnel(s) to ensure that required services have been received by the VAMC.

13.1.2 Contractor’s personnel(s) shall report to the Contracting Officer’s Representative, Administrative Officer, or designee upon initial arrival at the VAMC.

13.2. Documentation of services performed shall be reviewed prior to certifying payment. The VAMC shall pay for services actually performed and in strict accordance with the price schedule and statement of work. Agreement monitoring and record-keeping procedures shall be sufficient to ensure proper payment and allow audit verification that services were provided.

14. KEY PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS:

Contractor shall provide a central call-in telephone number and point(s) of contact to include name, telephone number, and email for each medical center serviced under this contract. The purpose is to provide efficient and timely communication.

15. QUALITY IMPROVEMENT:

The Contractor, upon request, shall provide quality data and information related to services provided and participate in the VAMC’s performance improvement programs when requested to do so.

16. ACCESS TO FILES AND MEDICAL RECORDS:

16.1. In performance of official duties under this agreement, the Contractor’s personnel(s) have regular access to printed and electronic files containing sensitive data, which must be protected under the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), Freedom of Information Act and other applicable laws, Federal Regulations, Veterans Affairs statutes, and policies. The Contractor’s personnel(s) are responsible for protecting that data received in the performance of services under this agreement from unauthorized release or from loss, alteration, or unauthorized deletion and following all applicable regulations and instructions regarding access to the VA’s computerized files, release of VA access codes, etc., as set out in VHA Directives, and computer access agreement Rules of Behavior (or equivalent) which the Contractor’s personnel(s) must sign. The Contractor’s personnel are required to protect VA patient information within the departmental office and keep it secure.

16.2. Contractor shall ensure and maintain computer competency for all Contractor personnel performing services under this agreement to include completion of VA departmental documentation in

VISTA/Computerized Patient Record System (CPRS) or other VA systems. The agreement is subject to termination if this requirement is not met.

16.3. Contractor will provide health care laboratory services for patients seeking such care from or through VA. As such, Contractor is considered part of the Department health activity for purposes of the following statutes and the VA regulations implementing these statutes: the Privacy Act, 5.U.S.C. § 552a, and 38 U.S.C. §s 5701, 5705 and 7332. Contractor personnel may have access to VA patient medical records to the extent necessary for performance under this agreement.

Notwithstanding any other provision of this agreement, Contractor personnel may disclose patient treatment records only pursuant to explicit disclosure authority from VA; provided, however, that the Contractor shall disclose such information as necessary to other authorized providers, to VA

Utilization, Quality Assurance and other review committees or to governmental authorities as required by law or as otherwise required by this agreement. Contractor personnel are subject to the penalties and liabilities provided by statutes and regulations for unauthorized disclosures of such records and their contents. Records created by the Contractor in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable federal law and regulations. These patient records shall be governed by FAR Clause 52.224-1, Privacy Act Notification and 52.224-2, Privacy Act.