SOLICITATION AA.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 71

504-20-3-094-0090

36C25720Q1018 07-21-2020

EDDIE CLARK 210-694-6339 07-31-2020

Department of Veterans Affairs Contracting Section 7201 I-40 West Suite 100 Amarillo TX 79106

X

621511

$35 Million

N/A

X

THERE ARE MULTIPLE DELIVERY LOCATION.

SEE (PWS) Department of Veterans Affairs

Contracting Section 7201 I-40 West Suite 100 Amarillo TX 79106

This is accomplished through the Tungsten Network located at:

http:www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

Please see Section B for Statement of Work and Price/Cost Schedule.

Please submit all questions to eddie.clark@va.gov by 07/27/2020.

THERE ARE MULTIPLE DELIVERY LOCATION. SEE (PWS)

See CONTINUATION Page

X X

X X X 1

Contracting Officer

36C25720Q1018

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 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.219-9 SMALL BUSINESS SUBCONTRACTING PLAN (JUN 2020)

C.2 52.219-16 LIQUIDATED DAMAGES—SUBCONTRACTING PLAN (JAN 1999)

C.3 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.5 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN

2008)

C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.7 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.8 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (MAR 2020)

C.9 52.216-18 ORDERING (OCT 1995)

C.10 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.11 52.216-22 INDEFINITE QUANTITY (OCT 1995)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)

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 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.8 VAAR 852.273-70 LATE OFFERS (JAN 2003)

E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

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

E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (MAR 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 36C257

Department of Veterans Affairs

Contracting Section

7201 I-40 West Suite 100

Amarillo TX 79106

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.

This is accomplished through the

Tungsten Network located at:

http:www.fsc.va.gov/einvoice.asp

This is mandatory and the sole method for submitting invoices

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

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVIC

ES

QUANTIT

Y

UNI

T UNIT PRICE AMOUNT

0001 30,000.00 EA ________________

Service Agreement for COVID-19 (SARS-CoV-2) Testing for a Combination of Symptomatic and Pre-operative Veteran Patients for the Amarillo Texas Veterans Health Care System.

Contractor Shall Provide COVID-19 (SARS-CoV-2) Testing In Accordance With the Attached Statement of Work.

ESTIMATED QUANTITY

GRAND TOTAL ________________

B.3 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

0001 SHIP TO: Multiple Delivery Locations See PWS

UNITED STATES

30,000.00

Statement of Work (SOW)

Amarillo VAHCS Clinical Laboratory Support Services Drive Through COVID-19 Services (Collections, Courier/transport, Testing, and Reporting)

36C25720Q0108 0001_1 07/28/2020

I. SCOPE

The Amarillo Veterans Affairs Health Care System (AVAHCS) Department of Pathology & Laboratory Service (P&LMS) requires an emergent support from an external contractor/reference laboratory for an drive through collection, processing/courier/transport, and testing services for RT-PCR SARS-CoV-2 on symptomatic and/or non-symptomatic pre-op and pre-procedure patients from the main VA facility in Amarillo Texas, as well as the four (4) outlying Community Based Outpatient Clinics (CBOC) that are located in Dalhart Texas, Childress Texas, Lubbock Texas, and Clovis New Mexico. The contractor/reference lab shall provide all personnel, equipment, supplies, PPE, facilities, tools, materials, supervision, and other items and services necessary to provide services as defined in the requirements except for those items specified as government furnished property and services. The contractor/reference laboratory shall provide, in accordance with all applicable federal, state and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, contractor/reference laboratory testing to the Amarillo VAHCS P&LMS in accordance with the Statement of Work herein. The contractor/reference laboratory shall provide services to include:

An estimated minimum total of 75 collections per day, the transporting of, and testing of RT- PCR SARS-CoV-2 samples for a period of 260 business days (12 months) for the five (5) facilities within the AVAHCS. Monday through Friday 8:00AM to 5:00PM except for federal holidays. (Refer to Section IV., A, 1-5)

24-36 hour or less Turn Around Time (TAT) from receipt of samples at the lab to reporting out results via fax and/or electronically providing secure and/or encrypted HIPPA transmissions.

Contractor’s location of choice to setup and provide a drive through area (within the limits of the AVAHCS locality) for collection services to be performed to facilitate patient access, social distancing, and safety in the local VA facility locations.

Must be FDA approved EUA RT-PCR-SARS-CoV-2 testing methodology.

Needs to start Monday, August 10, 2020.

All requirements and provisions defined in the specification of this solicitation will apply to any laboratory, i.e., branch, division, sub-Reference Laboratory, etc. performing reference testing on behalf of the Reference Laboratory. AVAHCS is requesting the contractor/reference laboratory to cover a period of 12 months starting August 1, 2020 through July 31, 2021. Pricing shall remain a constant during the period and AVAHCS makes no guarantee as to what volume of tests, if any, the contractor/reference laboratory may receive. AVAHCS reserves the right to request additional tests other than those listed within. If additional tests are added, either by the contractor/reference laboratory or AVAHCS, the reference laboratory will provide appropriate CPT codes for the new tests.

II. BACKGROUND

*Excerpt from DUSHO memo dated May 14, 2020

The Veterans Health Administration (VHA) Moving Forward Plan includes screening and testing for COVID-19 to ensure safe care. VHA routinely screens all individuals requesting entrance into a VHA facility and during virtual visits. To date, VHA has tested over 91,000 Veterans and 36,000, or 10% of, employees. Testing for COVID-19 continues to expand and by next week, VHA capacity for testing will approach 60,000 tests per week. The increase in capacity of diagnostic viral testing means that VHA can provide testing to Veterans and employees who are asymptomatic and request testing. Testing under this scenario should not be performed by a rapid test method, reserving those supplies for Veterans and staff who have symptoms of COVID-19 (screen positive), Veterans admitted to the hospital and/or Veterans who are scheduled for surgery or certain high-risk procedures. Veterans and staff should be informed that test results may take several days. Facilities should be prepared to offer COVID-19 diagnostic viral (but not serologic) testing by August 18, 2020.

III. DEFINITIONS

A. Analytical testing: The reporting of analytical test results and consultative services regarding selection, collection, transportation and result interpretation as required to assimilate the full scope of its laboratory operations to AVAHCS.

B. Lab Advisory Committee: An individual or group of laboratory Technical Specialists and/or designees that evaluate the medical/technical/service and quality qualifications of offerors labs.

During the life of the contract, this group monitors quality and service provided by the Contractor/Reference Laboratory.

B. Special Handling/STAT: Unusual circumstances may dictate the need for a specimen to be picked up specially, run out of sequence or at a special time, or reported within a shorter than usual turnaround time. This will be referred as STAT testing and will be synonymous to special handling.

C. Contracting Officer (CO): The CO named below is responsible for the overall administration of this contract. Contractor/Reference Laboratory is advised that only the CO, acting within the scope of his/her duties/responsibilities has the authority to make changes to the contract, which affect contract prices, terms, and conditions of this contract:

See PWS

D. Contracting Officer Representative (COR): A Representative of the Contracting Officer will be designated to represent the CO in furnishing technical guidance and advice under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice/information to the Contractor/Reference Laboratory relative to the finical or legal aspects of the contract. Those matters are the responsibility of the CO and shall not be delegated.

E. Contractor/Reference Laboratory: The term used throughout this document will be Reference Laboratory and will be considered synonymous to Contractor and/or Vendor.

F. Report: Is defined as a printed final copy in duplicate of laboratory testing results or host-to-host electronic transmission of test results. This report as defined by the AVAHCS shall be received by either; computer interface, fax, and/or messenger delivery according to the published turnaround times of the Reference Laboratory. If results are telephoned the report must include the name of the individual notified of the results. Specification outlining the requirements of this computer interface including computer hardware, maintenance and supply requirements are defined in section V. Computer Interface of this solicitation.

IV. REFERENCE LABORATORY RESPONSIBILITIES:

The Reference Laboratory shall provide collection services and courier services to and from the Reference Laboratory’s facility along with documented hazardous material shipping and handling training to transport samples in such a manner as to ensure the integrity of the specimens from any and/or all pre-analytic processing errors as defined in their laboratory user manual, analysis reporting of analytic results, and interpretation from the following

AVAHCS facilities:

Amarillo VA Health Care System, 6010 Amarillo Blvd., West, Amarillo, TX 79106.

a). Collections to be set up: Monday-Friday from 8am-4pm b). Transport collected samples to Reference laboratory testing site.

c). Test the samples with an FDA approved EUA RT-PCR-SARS-CoV-2 testing methodology.

d). Report results e). Call immediately tests resulted as Positive”, “Reactive”, and/or “Detected” to the main AVAHCS lab at (806)354-7870.

Lubbock CBOC, 6104 Avenue Q South Drive, Lubbock, TX 79412 a). Collections to be set up: Monday -Friday from 9am-5pm b). Transport collected samples to Reference laboratory testing site.

c). Test the samples with an FDA approved EUA RT-PCR-SARS-CoV-2 testing methodology.

d). Report results e). Call immediately tests resulted as Positive”, “Reactive”, and/or “Detected” to the main AVAHCS lab at (806)354-7870.

Childress VA OPC, 100 Highway 83 North, Childress, TX 79201 a). Collections to be set up: Monday and Tuesday from 8am-4pm b). Transport collected samples to Reference laboratory testing site.

c). Test the samples with an FDA approved EUA RT-PCR-SARS-CoV-2 testing methodology.

d). Report results e). Call immediately tests resulted as Positive”, “Reactive”, and/or “Detected” to the main AVAHCS lab at (806)354-7870.

Dalhart VA OPC, 325 Denver Ave., Dalhart, TX 79022 a). Collections to be set up: Wednesday and Thursday from 8am-4pm.

b). Transport collected samples to Reference laboratory testing site.

c). Test the samples with an FDA approved EUA RT-PCR-SARS-CoV-2 testing methodology.

d). Report results e). Call immediately tests resulted as Positive”, “Reactive”, and/or “Detected” to the main AVAHCS lab at (806)354-7870.

Clovis CA OPC, 921 East Llano Estacado, Clovis NM 88101 a). Collections to be set up: Tuesday, Wednesday, and Thursday from 8am-4pm.

b). Transport collected samples to Reference laboratory testing site.

c). Test the samples with an FDA approved EUA RT-PCR-SARS-CoV-2 testing methodology.

d). Report results e). Call immediately tests resulted as Positive”, “Reactive”, and/or “Detected” to the main AVAHCS lab at (806)354-7870.

B. All samples/specimens collected shall be properly identified and labeled for testing in view of the patient.

C. Provide specified times: specified times for courier pickup of samples from each of the AVAHCS facilities to be sent to the Reference laboratory facility, and specified times for testing;

M-F during normal business hours unless specified; Exceptions will be the ten (10) Government holidays below and those holidays declared by the President of the United States on an as needed basis.

New Year’s Day

Martin Luther King

President’s Day

Memorial Day Independence Day

Labor Day Columbus Day Veterans Day

Thanksgiving Day

Christmas Day

D. The Reference Laboratory shall analyze samples and maintain the minimum acceptable service, reporting systems, and quality control measures as specified herein.

E. No additional charge to the government.

F. The Reference Laboratory shall provide all necessary supplies, not limited to the following:

Primary/secondary specimen containers and to include lids/caps for secure closure from leakage.

Special media swabs or primary/secondary tubes for viral samples.

All supplies for specialized testing (e.g. not limited to viral studies)

All specialized preservatives required for specimen preservation.

Secondary transport bags are marked with biohazard signs/symbols as required for transportation of specimens to their laboratory.

Secondary Transport bags shall be of dual usage- able to house the sample within sealed closures and house the paper documents in the same bag but not in the same compartment in order to prevent contamination of documents through leakage of samples.

All required PPE for contractor/reference lab staff and patients.

Requisition forms (if applicable).

Dry ice as required for frozen sample(s) and tertiary specimen transport containers.

10. Special instructions and items required for collection and/or transportation of samples.

G. The Reference Laboratory shall provide a current pricing and CPT codes for the following:

1. VA employee will observe contractor while they perform.

2. The Reference Laboratory shall not introduce new medical procedures/services for specimens provided by AVAHCS without prior recommendation to and approval of, the

COR or authorized laboratory representative/designee.

3. Advise AVAHCS of any planned changes in methodology, codes, or new procedures at least 14 days prior to changes. If a two-week notification is not possible due to an emergency, contractor shall notify AVAHCS as soon as possible. If additional tests are added, either by the Reference Laboratory or AVAHCS, the reference laboratory will provide appropriate CPT codes for the new tests.

4. Tests shall be performed to the satisfaction of the AVAHCS P&LMS Chief and the

Contracting Officer’s Representative (COR).

5. Test menus shall include reference ranges.

6. Test menus shall clearly spell out specimen requirements per test.

H. The Reference Laboratory shall assign a specific local account representative to AVAHCS and the four (4) CBOC’s (same person is acceptable).

I. A copy of the published price list shall be submitted and maintained throughout the life of the contract.

J. The Reference Laboratory shall permit consultation on test results by telephone as needed without cost to the Government.

K. Analyze samples with limited specialized subcontractors to which testing would be sent out.

1. Pricing shall bill to the Reference Laboratory for subcontractor’s performance.

2. Third party pricing to AVAHCS must reflect current fee schedule

3. Tests shall be performed to the satisfaction of the AVAHCS P&LMS Chief and the Contracting Officer’s Representative (COR).

L. The Reference Laboratory shall comply with reporting tests results within the specified time frame in accordance with the nature of the testing, following all regulatory requirements for reporting of patient results.

All results identified as Positive and/or Detected will be verbally communicated immediately (less than 24 hours) to AVAHCs Laboratory at the time of identification. Results shall be sent via a secure interconnectivity line, in compliance with Health Portability and Accountability Act (HIPPA) guidelines.

2. Provide AVAHCS P&LMS with a means of communication to permit immediate inquiry regarding the status of any and/or all pending tests.

a). The Reference Laboratory shall provide point(s) of contact (POC) when immediate inquiry regarding the status of a pending test(s), specimen problem inquires and problem solving at all times, including weekends and holidays, is required:

i. Person(s) name(s): _________________

ii. Telephone number: _________________

iii. Fax number: _______________________ b). The Reference laboratory shall provide names and telephone number of technical directors and pathologists available for consultation:

i. Technical Director name: _________________

ii. Telephone number: _________________

iii. Pathologist name: _________________

iv. Telephone number: _________________

M. The Reference Laboratory shall provide a quarterly quality assurance data report to include:

The specimen result turnaround time for ordered tests per facility location.

This will be defined as the date a specimen was received by the Reference Laboratory until the preliminary report was available to AVAHCS.

A summary list of all testing volume and costs for each test ordered.

N. The Reference Laboratory shall be in compliance with the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (Public Law 104-191).

V. BILLING AND INVOICING

A. Monthly billing to be made in arrears test report summaries shall begin on the first day of the month and include the last day of the month. A monthly invoice shall include a line item for each test and quantities billed for and dates of service. AVAHCS will not pay for tests that are not clearly identified by accession number on the contractor’s invoice.

Contract number

POP will be clearly documented on all invoices (Referring dates of service)

Patient name

Test name

Accession Number

CPT code

Number of CPT codes Charge of each CPT

Total charge for each patient

B. Services rendered will be verified by a record keeping system maintained by P&LMS and Fiscal Service’s at AVAHCS, which assures that the VA pays for only those services actually requested and only for valid patients of AVAHCS.

1. AVAHCS shall not be responsible for payment of services which were not requested in Accordance with the contract.

2. AVAHCS will not pay for tests that are not clearly identified by accession number on the Reference Laboratory invoice.

3. Invoices are to be separate for Amarillo, Lubbock, Childress, Dalhart, and Clovis facilities but the usage of the same PO number is acceptable for billing purposes.

C. Invoices will be electronically submitted to the Tungsten website at:

http://ww.tungsten-network.com/uk/en/

Tungsten direct vendor support number is 877-489-6135 for VA contracts.

The VA-FSC pays all associated transactions fees for VA orders. During implementation (technical set-up) Tungsten will confirm your Taxpayer ID number with the VA-FSC.

All invoices submitted through Tungsten to VA-FSC should mirror your current submission of Invoice.

VA-FSC shall require the following information in compliance with the Prompt Pay Act and Business Requirements.

Your Taxpayer ID number (TIN)

Your “Remit Address” information

The VA Purchase Order (PO) number

Your contact information: (Personal name, Email, and Phone)

Your VA Point of contact information (Personal name, Email, and Phone)

The Period of Performance dates (POP Beginning and Ending)

All discount information if applicable (Percent and Date Terms)

5. Department of Veterans Affairs Financial Service Center:

Phone:1-877-353-9791

Email: vafscched@va.gov

VI. REPORTING OF TEST RESULTS

A. Each test report shall at a minimum indicate the following information:

Clinical Laboratory Improvement Amendment (CLIA) number

Name of testing laboratory (contractor or subcontractor), mailing address, telephone and fax numbers

Case number

Referring physician name (if supplied) http://ww.tungsten-network.com/uk/en/ mailto:vafscched@va.gov

Patient’s full name and/or identification code (Social security Number)

Medical Record number (if supplied)

Patient’s location (clinic/ward, if supplied)

Patient’s age

Physicians name

Date collected specimen collected

Date/time specimen received in reference lab

Test ordered

Type of specimen

Date testing completed

Test results

Flag abnormal test results

Reference range

Testing laboratory specimen number

Date reported

Date/time/laboratory personnel name who was called at AVAHCS to report Positive and/or Detected results (if applicable) less than 24 hours.

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

Unsatisfactory specimen(s) shall be reported with data regard to its unsuitability for testing such as sample type, quantity or stability.

B. Telephone consultation: The Reference Laboratory shall consult with the AVAHCS COR, requesting clinician and/or designee at AVAHCS by telephone as needed.

C. The Reference laboratory shall not introduce new medical procedures/services for specimens provided by AVAHCS without prior recommendation to and approval of, the COR or authorized laboratory representative/designee.

D. The References Laboratory shall notify AVHCS COR or designee of instances in which, in the professional judgment of the Reference laboratory, the patient requires services /tests, which were not originally requested.

E. The Contractor/Reference Laboratory shall not release patient records that includes test results to anyone other than the AVAHCS laboratory staff. All records shall be treated as confidential, to comply with all state and federal law as regarding the confidentiality of patient records. This provision shall survive termination of the resulting contract award.

F. The Reference Laboratory shall immediately telephone the VAHCS laboratory personnel of any positive and/or Detected results. (less than 24 hours)

VII. QUALITY CONTROL MEASURES

A. Reference Laboratory shall immediately advise the COR of any changes in CPT codes, methodology, procedure, reference ranges, and any new test introduced at least 14 days prior to changes. If a two-week notification is not possible due to an emergency, contractor shall notify AVAHCS as soon as possible.

B. Reference Laboratory shall provide the following information upon request during the life of the contract:

1. For quality purposes, testing performed is for RT PCR SARS-CoV-2 methodology.

2. Indication of average monthly volume of specified tests listed in this contract.

3. Provide address of processing sites under contract, including subcontracted testing location sites Proficiency Testing (PT) data shall include a list of tests that are unacceptable for the past two (2) years. The Reference Laboratory shall notify AVAHCS COR of any test falling outside the unacceptable range during contract period.

4. The Reference Laboratory shall ensure that all procedures performed are current and with at least (minimum) daily quality controls conducted to determine procedure accuracy.

5. The contractor shall operate a successful quality assurance program as required by CAP/CLIA. Quality control program shall include procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s QC program is how the contractor laboratory assures that work complies with the requirement of the contract.

6. The Government may evaluate the quality of the professional and administrative services provided but retains no control over the medical professional aspects of services rendered (e.g. professional judgements and diagnosis for specific medical treatment).

7. Certify and ensure that all employees, officers, or agents comply with standards set forth in the Health Insurance Portability and Accountability Act (HIPAA)

VIII. CHANGES/CANCELATIONS

A. Any proposed subcontractor changes from what is proposed under this contract must have prior approval by the CO.

B. The Reference Laboratory shall be responsible for assuring all subcontracts have Appropriate licensure and accreditation to perform the test that the Reference Laboratory cannot perform.

C. The Reference Laboratory shall notify CO and COR of change of subcontract laboratory.

Any change shall be submitted to the CO for review and approval.

D. AVAHCS may terminate this contract at any time upon at least 30 days written notice by the CO to the Reference laboratory.

E. The Reference laboratory, with written consent of the CO may terminate this contract upon at least 30 days written notice to the CO.

IX. RECORDS MANAGEMENT

A. The Reference Laboratory shall be responsible for creating, maintaining, and disposing of only those Government required records. If requested, by the AVAHCS COR, the contractor shall provide the original record, or a reproducible copy of any such record, within two (2) business days of receipt of the request.

B. All records (administrative and program specific) created during the period/life of this contract belong the AVHCS and must be returned to AVHCS at the end of the contract.

C. National Archives and Records Administration (NARA) Records Management Language Clause to be included in contracts, as necessary:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government ‘IT’ equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract or identified in the

RCS 10-1.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

X. SAFETY/PERSONAL SECURITY VERIFICATION ACCESS

A. The Reference Laboratory shall comply will all applicable OSHA, Federal, State laws and regulations as required for performing the type of services required.

B. Notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure.

C. The performance of this contract may require the Reference Laboratory employee/representative to have routine, unescorted access to AVAHCS facility.

1. All such employee/representative who do not already possess a current Security Badge or PIV card acceptable to VA shall be required to provide personal information, undergo and FBI National Criminal History Fingerprint Check, and obtain a Security Badge or PIV card prior to being permitted access to the facility in performance of this contract.

2. No Reference Laboratory employee/representative shall be permitted routine, unescorted access to AVAHCS facility without proper Security Badge or PIV card.

D. AVAHCS shall have and exercise full and complete control over granting, denying, withholding, and terminating access of the Reference Laboratory employee/representative to the facility or systems.

1. The COR will notify the Reference Laboratory immediately when AVAHCS has determined that an employee/representative is unsuitable or unfit to be permitted access to AVAHCS. The Reference Laboratory shall immediately notify such employee/representative that he/she no longer has access to AVAHCS, shall retrieve the employees Security Badge or PIV card from the employee and shall provide a suitable replacement employee/representative.

2. AVAHCS will not give the Reference Laboratory the reason for requiring the removal of the unsuitable employee/representative but can provide the applicant the phone number to call the FBI to receive a copy of the SAC report used for this determination.

3. The Government shall not be responsible for any costs incurred by the Reference Laboratory as a result of removing such employee/representative from the contract.

XI. PRIVACY/SECURITY OF VA SENSITIVE INFORMATION

A. The C&A requirements do not apply. A Security Accreditation Package is not required.

The information contained in the memorandums below will be considered this process.

SEE ATTACHMENTS

B. The Reference Laboratory shall not release any medical information obtained during the course of this contract to anyone outside the VAHCS, unless authorized by the AVAHCS

COR.

C. The Reference Laboratory shall have access to patient health Information (PHI) but will not have the capability of accessioning information from the VA System during the services provided to VAHCS.

D. The Reference Laboratory will not have access to VA Desktop computers, nor will they have access to online resources belonging to the Government while conducting services. If removal of equipment from the VA is required, any memory storage device, such as hard drives, solid state drives and non- volatile memory units will remain in the VA control and will not be removed from the VA custody.

E. The Reference Laboratory agrees to report immediately any breach of safeguards and to mitigate nay harmful effect related to the use or disclosure of PHI by the Reference laboratory or any of its agents, including subcontractors.

F. Upon completion or termination of the contract, the Reference Laboratory will either provide all copies of all VA information to the VA or certify that has destroyed all copies of all VA information as required by VA in a method specified by VA, at VA’s option.

1. Medical records of any kind including notes shall be returned to the VA.

2. Where immediate return or destruction of the information is not practicable, the Reference Laboratory will return or destroy the information within 30 days of completion or termination of the contract.

3. All provisions of this contract concerning security and protection of VA information that is the subject of this contract will continue to apply to VA information for as long the Reference Laboratory retains it, regardless of whether the contract has been completed or terminated.

G. Prior to any disclosure pursuant to a court order, the Reference Laboratory shall promptly notify VA of the court order upon its receipt by the Reference Laboratory, provide VA with a copy by fax or email, whichever is faster, and notify by telephone the VA individual designated in advance to receive such notices.

1. If the Reference Laboratory cannot notify VA before being compelled to produce information under court order, the Reference Laboratory will notify VA of the disclosure as soon as practical and provide a copy of the court order, including a copy of the court order, a description of the records provided pursuant to the court order, and to whom he Reference Laboratory provided the records under the court order.

2. If the VA determines that it is appropriate to seek retrieval of information released pursuant to a court order before the Reference Laboratory notified the VA of the court order, the Reference Laboratory will assist VA in attempting to retrieve the VA information involved.

G. All Reference Laboratory employees and all subcontractor employees are subject to the same level of investigation as VA employees who have access to VA sensitive information.

The level of background investigation commensurate with the level of access needed to perform the Performance Work Statement (PWS).

1. The Reference Laboratory shall bear the expense of obtaining background investigations.

2. If the investigation is conducted by the Office of Personnel management (OPM) the Reference Laboratory shall reimburse the VA within 30 days from receipt of a bill of collection.

3. The Reference Laboratory shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and area able to read, write, speak and understand the English language.

XII. LICENSING AND ACCREDITATION

A. The Reference Laboratory shall have all licenses, permits, accreditation and certificates required by law and/or regulatory compliance. (VHA Handbook 1106.1)

B. The /Reference Laboratory shall be accredited by the College of American Pathologists (CAP) and/or The Joint commission (TJC) as well as having Clinical Laboratory Improvement Amendments (CLIA) (Public Law 100-578) certifications (VHA Handbook 1106.1)

C. The Reference Laboratory must submit proof of CAP and/or TJC and CLIA certifications to AVAHCS on an annual basis. (VHA Handbook 1106.1)

D. The Reference Laboratory shall be accredited by the Centers for Prevention and Disease Control (CDC) under CLIA if Contractor/Reference Laboratory is engaged in interstate commerce. (VHA Handbook 1106.1)

E. Laboratory Service Chief shall be a licensed American Board of Pathology certified or Board eligible pathologist. The Contractor/Reference Laboratory must submit proof of certifications to AVAHCS.

F. The Medical Director shall have suitable Molecular Genetics qualifications and experience to direct laboratory providing consultation services under this contract according to CLIA and CAP standards.

G. All personnel assigned by the Reference Laboratory or to their subcontractors to perform these collections, processing, courier/transporting, and testing services covered under this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia The Reference Laboratory must submit proof of certifications to AVAHCS. (VHA Handbook 1106.1)

H. Comply with the regulatory requirements for Health and Human Services Health Care Financing Administration, Centers for Medicare and Medicaid (CMS).

SECTION C - CONTRACT CLAUSES

FAR

Number

Title Date

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS

OCT 2018

C.1 52.219-9 SMALL BUSINESS SUBCONTRACTING PLAN (JUN 2020)

(a) This clause does not apply to small business concerns.

(b) Definitions. As used in this clause—

Alaska Native Corporation (ANC) means any Regional Corporation, Village Corporation, Urban Corporation, or Group Corporation organized under the laws of the State of Alaska in accordance with the Alaska Native Claims Settlement Act, as amended (43 U.S.C. 1601, et seq.) and which is considered a minority and economically disadvantaged concern under the criteria at 43 U.S.C. 1626(e)(1). This definition also includes ANC direct and indirect subsidiary corporations, joint ventures, and partnerships that meet the requirements of 43 U.S.C.

1626(e)(2).

Commercial item means a product or service that satisfies the definition of commercial item in Federal Acquisition Regulation (FAR) 2.101.

Commercial plan means a subcontracting plan (including goals) that covers the offeror's fiscal year and that applies to the entire production of commercial items sold by either the entire company or a portion thereof (e.g., division, plant, or product line).

Electronic Subcontracting Reporting System (eSRS) means the Governmentwide, electronic, web-based system for small business subcontracting program reporting. The eSRS is located at http://www.esrs.gov.

Indian tribe means any Indian tribe, band, group, pueblo, or community, including native villages and native groups (including corporations organized by Kenai, Juneau, Sitka, and Kodiak) as defined in the Alaska Native Claims Settlement Act (43 U.S.C.A. 1601 et seq.), that is recognized by the Federal Government as eligible for services from the Bureau of Indian Affairs in accordance with 25 U.S.C. 1452(c). This definition also includes Indian-owned economic enterprises that meet the requirements of 25 U.S.C. 1452(e).

Individual subcontracting plan means a subcontracting plan that covers the entire contract period (including option periods), applies to a specific contract, and has goals that are based on the offeror's planned subcontracting in support of the specific contract, except that indirect costs incurred for common or joint purposes may be allocated on a prorated basis to the contract.

Master subcontracting plan means a subcontracting plan that contains all the required elements of an individual subcontracting plan, except goals, and may be incorporated into individual subcontracting plans, provided the master subcontracting plan has been approved.

http://www.esrs.gov/

Reduced payment means a payment that is for less than the amount agreed upon in a subcontract in accordance with its terms and conditions, for supplies and services for which the Government has paid the prime contractor.

Subcontract means any agreement (other than one involving an employer-employee relationship) entered into by a Federal Government prime Contractor or subcontractor calling for supplies or services required for performance of the contract or subcontract.

Total contract dollars means the final anticipated dollar value, including the dollar value of all options.

Untimely payment means a payment to a subcontractor that is more than 90 days past due under the terms and conditions of a subcontract for supplies and services for which the Government has paid the prime contractor.

(c)(1) The Offeror, upon request by the Contracting Officer, shall submit and negotiate a subcontracting plan, where applicable, that separately addresses subcontracting with small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns. If the Offeror is submitting an individual subcontracting plan, the plan must separately address subcontracting with small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns, with a separate part for the basic contract and separate parts for each option (if any). The subcontracting plan shall be included in and made a part of the resultant contract. The subcontracting plan shall be negotiated within the time specified by the Contracting Officer. Failure to submit and negotiate the subcontracting plan shall make the Offeror ineligible for award of a contract.

(2)(i) The Contractor may accept a subcontractor's written representations of its size and socioeconomic status as a small business, small disadvantaged business, veteran-owned small business, service-disabled veteran-owned small business, or a women-owned small business if the subcontractor represents that the size and socioeconomic status representations with its offer are current, accurate, and complete as of the date of the offer for the subcontract.

(ii) The Contractor may accept a subcontractor's representations of its size and socioeconomic status as a small business, small disadvantaged business, veteran-owned small business, service-disabled veteran-owned small business, or a women-owned small business in the System for Award Management (SAM) if—

(A) The subcontractor is registered in SAM; and

(B) The subcontractor represents that the size and socioeconomic status representations made in SAM are current, accurate and complete as of the date of the offer for the subcontract.

(iii) The Contractor may not require the use of SAM for the purposes of representing size or socioeconomic status in connection with a subcontract.

(iv) In accordance with 13 CFR 121.411, 124.1015, 125.29, 126.900, and 127.700, a contractor acting in good faith is not liable for misrepresentations made by its subcontractors regarding the subcontractor's size or socioeconomic status.

(d) The Offeror's subcontracting plan shall include the following:

(1) Separate goals, expressed in terms of total dollars subcontracted, and as a percentage of total planned subcontracting dollars, for the use of small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns as subcontractors. For individual subcontracting plans, and if required by the Contracting Officer, goals shall also be expressed in terms of percentage of total contract dollars, in addition to the goals expressed as a percentage of total subcontract dollars. The Offeror shall include all subcontracts that contribute to contract performance, and may include a proportionate share of products and services that are normally allocated as indirect costs. In accordance with 43 U.S.C. 1626—

(i) Subcontracts awarded to an ANC or Indian tribe shall be counted towards the subcontracting goals for small business and small disadvantaged business concerns, regardless of the size or Small Business Administration certification status of the ANC or Indian tribe; and

(ii) Where one or more subcontractors are in the subcontract tier between the prime Contractor and the ANC or Indian tribe, the ANC or Indian tribe shall designate the appropriate Contractor(s) to count the subcontract towards its small business and small disadvantaged business subcontracting goals.

(2) A statement of—

(i) Total dollars planned to be subcontracted for an individual subcontracting plan; or the Offeror's total projected sales, expressed in dollars, and the total value of projected subcontracts to support the sales for a commercial plan;

(ii) Total dollars planned to be subcontracted to small business concerns (including ANC and Indian tribes);

(iii) Total dollars planned to be subcontracted to veteran-owned small business concerns;

(iv) Total dollars planned to be subcontracted to service-disabled veteran-owned small business;

(v) Total dollars planned to be subcontracted to HUBZone small business concerns;

(vi) Total dollars planned to be subcontracted to small disadvantaged business concerns (including ANCs and Indian tribes); and

(vii) Total dollars planned to be subcontracted to women-owned small business concerns.

(3) A description of the principal types of supplies and services to be subcontracted, and an identification of the types planned for subcontracting to—

(i) Small business concerns;

(ii) Veteran-owned small business concerns;

(iii) Service-disabled veteran-owned small business concerns;

(iv) HUBZone small business concerns;

(v) Small disadvantaged business concerns; and

(vi) Women-owned small business concerns.

(4) A description of the method used to develop the subcontracting goals in paragraph (d)(1) of this clause.

(5) A description of the method used to identify potential sources for solicitation purposes (e.g., existing company source lists, SAM, veterans service organizations, the National Minority Purchasing Council Vendor Information Service, the Research and Information Division of the Minority Business Development Agency in the Department of Commerce, or small, HUBZone, small disadvantaged, and women-owned small business trade associations). A firm may rely on the information contained in SAM as an accurate representation of a concern's size and ownership characteristics for the purposes of maintaining a small, veteran-owned small, service-disabled veteran-owned small, HUBZone small, small disadvantaged, and women-owned small business source list. Use of SAM as its source list does not relieve a firm of its responsibilities (e.g., outreach, assistance, counseling, or publicizing subcontracting opportunities) in this clause.

(6) A statement as to whether or not the Offeror included indirect costs in establishing subcontracting goals, and a description of the method used to determine the proportionate share of indirect costs to be incurred with—

(i) Small business concerns (including ANC and Indian tribes);

(ii) Veteran-owned small business concerns;

(iii) Service-disabled veteran-owned small business concerns;

(iv) HUBZone small business concerns;

(v) Small disadvantaged business concerns (including ANC and Indian tribes); and

(vi) Women-owned small…