36C26323Q0856.pdf

PAGE 1 OF 1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

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

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

SEE ADDENDUM

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

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

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

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

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

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

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

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

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

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C26323Q0856 7/20/2023

Joshua Imdacha 319-339-7017 8/09/2023

4PM

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

X

621511

$41.5 Million x

N/A

X

DEPT OF VETERANS AFFAIRS

FARGO VA HEALTHCARE SYSTEM

2101 ELM STREET

FARGO ND 58102

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

X

See CONTINUATION Page

Offsite Reference Laboratory Services IDIQ (5 years)

See section B.2 for info.

This solicitation utilizes simplified acquisition procedures.

This solicitation is being conducted by the NCO 23 Contracting Office for the FARGO VA Health Care System (HCS)

FOR CONSIDERATION ALL QUESTIONS MUST BE RECEIVED 72 HOURS

BEFORE DATE STIPULATED IN BLOCK 8 OF THIS FORM EMAIL ALL

QUESTIONS AND RESPONSES TO JOSHUA.IMDACHA@VA.GOV

SIGN SF1449 AND RETURN ALL PAGES WITH OFFER SUBMISSION

See CONTINUATION Page N/A

X X

X 1

Joshua Imdacha Contracting Officer

36C26323Q0856

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 SCHEDULE OF SERVICES

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (DEC 2022)

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

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

C.8 VAAR 852.211-76 LIQUIDATED DAMAGES - REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023)

C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.10 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 34

C.11 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JUN 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

See attached document: D.1 SCHEDULE OF SERVICES See attached document: D.2 IT SECURITY See attached document: D.3 IMMIGRAT_CERT See attached document: D.4 ORG_CONFLICT_CERT See attached document: D.5 WD 2015-4969

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (MAR 2023)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

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

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

E.5 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.6 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.8 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

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

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

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.

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

REFERENCE LABORATORY

1. Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide Reference Laboratory Services to the Fargo VA Health Care System (VAHCS). Reference Laboratory 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.

Third party orders are allowed.

2. Specimen Preparation and Storage for Reference Testing Specimens

2.1. Contractor shall supply each Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor’s requirements.

2.2. Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen.

3. Transportation Services for Reference Testing Specimens

3.1. Contractor shall provide transportation of primarily biomedical materials that include patient specimens and microbiology cultures and stocks, originating from Government facilities and destined to the contracted commercial reference laboratory. These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained.

3.2. Routine transportation services shall occur at a minimum of once per day excluding weekends and Government Holidays from the Fargo VA Health Care System. Specimen pick-up times will be negotiated after contract award.

Delivery of samples to contracted lab will be within one hour of routine pick-up from the Fargo VA HCS.

3.3. Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor’s laboratory. These supplies shall include, but may not be limited to:

3.3.1. Test request forms

3.3.2. Test request forms for specialized testing (i.e. cytogenetics, tissue, etc.).

4. Transportation beyond routine pick-up: services shall be available 24 hours per day, seven days per week including Government holidays. Response time for stat transportation specimen pick-up services shall be within 1(one) hour of notification by the Fargo VA. Testing of the sample must begin immediately upon receipt with stat core lab testing completed within 2 hours of receipt by the testing lab. Core lab would be hematology and chemistry areas.

5. Specimen Testing

5.1. The Contractor and/or subcontractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute all required tests as annotated in Attachment 1 – CPT Code Listing – Local Reference Lab.

Contractor shall make available the following test information:

5.1.1. Requisition form requirements

5.1.2. Alphabetized test name list

5.1.3. Test order code

5.1.4. Specimen collection and preservation requirements

5.1.5. Test method employed (indicate if testing performed in duplicate) and interpretations

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

5.1.7. Test specific sensitivity, specificity and interferences, when required

5.1.8. Test critical values if any

5.1.9. CPT coding

5.1.10. Test turnaround times (minimum and maximum times indicated);

where the turnaround time is defined as the time between pick-up of specimen by the Contractor and receipt of results by a government facility.

5.1.11. Schedule of test performance (specific days of week indicated)

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

5.2. Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change.

5.3. Any new test(s) not listed in Attachment 1 – CPT Code Listing – Local Reference Lab must be added to the contract through modification by the Contracting Officer (CORs and Government facility representatives do not have this authority) prior to specimen testing being paid.

5.4. All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee.

5.5. The Contractor shall ensure the accurate and timely performance (defined in Section 5.1.10) of laboratory testing services on the biomedical materials.

Minimum Testing Capabilities

DESCRIPTION Specimen Type Required Turn Around

Times (TAT)* from courier pickup to result fax

Blood Bank ABO/Rh Blood

4 hr Blood Bank Antibody ID Blood

2 hr Blood Bank Antibody Screen Blood

8 hr Blood Bank Antibody Titer Blood

8 hr Blood Bank DAT Complement Blood

8 hr Blood Bank Direct Coombs Blood

8 hr Blood Bank Direct Coombs, IgG Blood

8 hr Blood Bank Eluated Antibody Interpretation Blood

48 hrs HistologyCassette Processing only Tissue

48 hrs HistologyCytology Specimen Processing Body Fluid

48 hrs HistologyDecalcify Tissue Tissue

48 hrs Histology-Immunohistochemical stain, various markers Tissue

48 hrs Histology-Non-GYN Cytology micro exam Body Fluid

48 hrs Histology-Special Stains Tissue

48 hrs Histology-Tissue Exam Tissue

48 hrs Histology-Tissue Micro Exam Tissue

48 hrs Histology-Tissue Processing Embedding Tissue

48 hrs Histology-Tissue Processing Microtomy Tissue

4 hr Lab- Cell Count and Differential, CSF CSF

4 hr Lab- Cell Count and Differential, synovial fluid Body Fluid

4 hr Lab- Digoxin Blood

2 hr Lab- Lipid Panel Blood

8 hr Lab- Malaria Screen Blood

2 hr Lab-Acetone = Beta Hydroxy-Butyrate Blood

2 hr Lab-Albumin Blood

24 hr Lab-Albumin, body fluid Body Fluid

2 hr Lab-Alkaline Phosphatase Blood

2 hr Lab-ALT Blood

24 hr Lab-Amylase, body fluid Body Fluid

2 hr Lab-Anti-Xa for unfractionated heparin (UF) Blood

2 hr Lab-APTT Blood

2 hr Lab-AST Blood

2 hr Lab-Basic Metabolic Panel Blood

24 hr Lab-Beta-hydroxybutyrate Blood

2 hr Lab-Bilirubin, Direct Blood

2 hr Lab-Bilirubin, Total Blood

48 hrs/prelim Lab-Bone Marrow Evaluation Bone Marrow/Blood

2 hr Lab-BUN Blood

2 hr Lab-Calcium Blood

2 hr Lab-Calcium, 24-Hour Urine Urine

4 hr Lab-CBC Blood

4 hr Lab-Cell Count and Differential, body fluid Body Fluid

2 hr Lab-Chloride Blood

2 hr Lab-Cholesterol Blood

2 hr Lab-CK Blood

2 hr Lab-CO2 Blood

2 hr Lab-Comprehensive Metabolic Panel Blood

2 hr Lab-Cortisol PM Blood

2 hr Lab-Cortisol AM Blood

2 hr Lab-Cortrosyn- Stimulation Baseline Blood

2 hr Lab-Cortrosyn- 30 Minute Post Dose Blood

2 hr Lab-Cortrosyn- 60 Minute Post Dose Blood

2 hr Lab-Creatinine Blood

2 hr Lab-Creatinine, urine Urine

2 hr Lab-CRP (Inflammation) Blood

2 hr Lab-CRP, High Sensitive (Cardiac) Blood

4 hr Lab-Cryptococus Antigen Screen Blood

4 hr Lab-Crystals, body fluid Body Fluid

24 hr Lab-Cyclosporine- Trough Blood

24 hr Lab-Cyclosporine- 2 Hour Post Dose Blood

2 hr Lab-D-Dimer Blood

2 hr Lab-Electrolyte Panel Blood

2 hr Lab-Erythrocyte Sedimenation Rate (ESR) Blood

2 hr Lab-Fibrinogen Blood

2 hr Lab-Free T4 Blood

2 hr Lab-GGTP Blood

2 hr Lab-Glucose Blood

2 hr Lab-Glucose, body fluid/CSF Body Fluid/CSF

2 hr Lab-HCG, qualitative Blood

2 hr Lab-HCG, qualitative urine Urine

2 hr Lab-HCG, quantitative Blood

2 hr Lab-HDL Blood

2hr Lab-Hemoglobin, plasma Plasma

2 hr Lab-Heparin Platelet Factor 4 (PF4) Blood

4 hr Lab-Hepatitis B Surface Antibody Blood

4 hr Lab-Hepatitis B Surface Antigen Blood

4 hr Lab-Hepatitis Core Antibody Blood

4 hr Lab-Ionized Calcium Blood

2 hr Lab-Lactic Acid Blood

2 hr Lab-LDH Blood

2 hr Lab-LDH, body fluid Body Fluid

2 hr Lab-LDL

2 hr Lab-Lipase Blood

2 hr Lab-Magnesium Blood

4 hr Lab-Mononucleosis Screen (Monotest) Blood

4 hr Lab-Osmolality, serum Blood

4 hr Lab-Osmolality, urine Urine

24 hr Lab-Phenobarbital Blood

2 hr Lab-Phosphorus Blood

2 hr Lab-Potassium Blood

2 hr Lab-Prealbumin Blood

2 hr Lab-Protime/INR Blood

2 hr Lab-PTH Blood

2 hr Lab-Sodium Blood

2 hr Lab-Sodium, body fluid/urine Body Fluid/ Urine

24 hr Lab-Tacrolimus Blood

24 hr Lab-Tegretol/Carbamazapine Blood

24 hr Lab-Theophylline Blood

2 hr Lab-Total Protein, body fluid Body Fluid

2 hr Lab-Total Protein, urine Urine

2 hr Lab-Triglycerides body fluid Body Fluid

2 hr Lab-Troponin Blood

4 hr Lab-TSH Blood

2 hr Lab-UA, Dipstick with reflex to micro Urine

2 hr Lab-Uric Acid, 24-Hour Urine Urine

24 hr Lab-Vitamin B12 Blood

48 hr Lab-Water Sterility Testing Water

48 hr Microbiology- Blood Culture Blood

48 hr Microbiology- Blood Culture, fungal Blood

48 hr Microbiology- Bordetalla Pertussis/Parapertussis

48 hr Microbiology- Bordetalla Pertussis/Parapertussis

48 hr Microbiology- Culture Screen for Single Pathogen Body Fluid

24 hr Microbiology- Encephalitis/Meningitis PCR Panel CSF

72 hr Microbiology- Gram Negative Body Fluid

72 hr Microbiology- Gram Positive Body Fluid

48 hr Microbiology- Referred isolate for ID, Aerobic Varies

48 hr Microbiology- Referred isolate for ID, Anaerobic Varies

8 weeks Microbiology-Acid Fast Culture

24 hr Microbiology-Acid Fast Stain

24hr Microbiology-Antimicrobial Susceptibility Varies

24 hr Microbiology-Culture, Aerobic Respiratory w/gram stain

48 hr Microbiology-Culture, Aerobic Respiratory Varies

48 hr Microbiology-Culture, Aerobic Urine Urine

48 hr Microbiology-Culture, Aerobic Other w/gram stain Varies

48 hr Microbiology-Culture, Aerobic Other Varies

48 hr Microbiology-Culture, Anaerobic 0009 Varies

2 weeks Microbiology-Fungus ID Varies

24 hr Microbiology-Herpes Simplex, DNA Probe CSF

24 hr Microbiology-Herpes Simplex, DNA Probe Non-CSF

72 hr Microbiology-Lab Agar Dilution Varies

24 hr Microbiology-Parasite Identification Arthropod without preservative

24 hr Microbiology-Pinworm Exam Stool

24 hr Microbiology-TB/RIF PCR Body Fluid

24 hr Microbiology-Worm Identification Worm preserved in formalin

**Base price. Additional CPT subject to additional charges depending on case.

6. Specimen Retention

6.1. A medico legal specimen shall be retained indefinitely. This type of specimen will be identified by the Government in writing or through telephone communication.

6.2. All anatomic pathology materials (e.g., histology blocks, slides or other diagnostic material) generated by the VA shall be returned within 7 days after final diagnosis is reported.

7. Reporting of Results

7.1. The results of testing shall be reported within the prescribed turnaround times provided by the Contractor as part of the test information (defined in Section 5.1.10).

7.2. A report of laboratory testing results must be issued either as a printed final copy or through the host-to-host electronic transmission of the test results. The results can be faxed to the Fargo VA secure fax phone number 701-237-2646.

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

7.3.1. Patient's full name

7.3.2. Patient’s identification number, e.g. social security number (SSN)

7.3.3. Physician’s name (if supplied)

7.3.4. Submitting facility name

7.3.5. Test(s) ordered

7.3.6. Date/time of specimen collection (when available)

7.3.7. Date/time test completed

7.3.8. Test result

7.3.9. Reference intervals (adjusted for age, sex or race, when appropriate)

7.3.10. Toxic and therapeutic ranges, if applicable

7.3.11. Flagged abnormal results

7.3.12. Name and address of testing laboratory

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

7.3.14. Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing.

7.4. Test results determined by the contractor to be critical, shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission.

8. Customer Service

8.1. Contractor shall provide customer service that is accessible by toll-free telephone service 24 hours per day, 7 days per week to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract.

8.2. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period:

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

8.2.1.1.1. Specimen Collection

8.2.1.1.1.1. Routine inquiries, questions and clarifications

regarding collection requirements shall be addressed at the time of the initial call.

8.2.1.1.2. Testing

8.2.1.1.2.1. Inquiries regarding the status of pending orders shall be addressed at the time of the initial call.

8.2.1.1.3. Technical Expertise

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

8.3. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc.

9. Consultative Services/Utilization Reports

9.1. Contractor shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.

9.1.1. A copy of the report shall be delivered electronically to the Contracting Officer, Lead COR, and each Government facility COR by the 10th of the month following the close of the reporting month.

10. SPECIAL CONTRACT REQUIREMENTS

10.1. Services

10.1.1.The services specified herein may be changed by written modification to this contract. The VA Contracting Officer will prepare the modification (reference FAR clause 52.212-4(c), Changes) and, prior to becoming effective, shall be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized, and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

10.1.2. This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor’s employee(s). Contractor personnel are not subject to the supervision and control of a government officer or employee.

Rather, contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare provider who furnishes services under this contract is subject to Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance.

10.1.3. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

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

10.1.5. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract.

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

10.2. Federal Holidays

10.2.1. Contractor is not required to provide routine daily transportation of specimens on federal holidays. The 10 holidays observed by the Federal Government are: New Year’s Day (January 1st), Martin Luther King’s Birthday (3rd Monday in January), Presidents’ Day (3rd Monday in February), Memorial Day (last Monday in May), Juneteenth (June 19th), Independence Day (July 4th), Labor Day (1st Monday in September), Columbus Day (2nd Monday in October), Veterans Day (November 11), Thanksgiving Day (4th Thursday in November), Christmas Day (December 25th) and any other day specifically declared by the President of the United States to be a national holiday.

10.2.2. When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S.

Government agencies.

10.3. Qualifications/Requirements of Laboratory & Contractor Personnel

10.3.1. Laboratory

10.3.1.1. Offeror must have at least three years of experience in providing laboratory testing services and must have at least one year experience in transporting biomedical materials.

10.3.1.2. Offerors, including subcontractor(s), must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory (ies) must maintain valid certifications during the entire performance period of this contract.

10.3.1.3. Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this solicitation. In addition, as these documents are reissued or re-awarded, the awarded Contractor must supply a copy to the Contracting Officer’s Representative assigned to each Government facility. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary Contractor.

10.3.1.4. Contractor must notify immediately the Contracting Officer’s Representative (COR) at each of the Government facilities in writing, upon its loss of any required certification, accreditation or licensure.

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

10.4. Personnel

10.4.1. Contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, or other accrediting organizations and State standards.

10.4.2. Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification.

10.4.3. Personnel assigned by the contractor to perform the services covered by this contract shall be proficient in written and spoken English (38

USC 7402).

10.4.4. Contractor couriers entering any Government facility must be attired in a contractor-issued uniform that bears the name of the Contractor ‘s company. In addition, the Contractor representative shall prominently display a contractor-issued identification badge.

10.5. Record Keeping – Contractor

10.5.1. Contractor must establish a record keeping system of all tests performed.

10.6. Medical Records

10.6.1. Clinical or other medical records (ie. test results) of VA veteran patients treated by Contractor under this contract are owned by the VA. If requested, test results will be mailed to the VA at no additional cost. Mail shall be sent in accordance with VA Directive 6609, Mailing of Sensitive Personal Information. Contractor may obtain a copy of VA Directive 6609 at the following website: http://www1.va.gov/vhapublications/index.cfm. If a subpoena or court order is received for the production of a medical record/test result, the contractor shall notify the Contracting Officer that a subpoena or court order was received.

10.7. Confidentiality of Patient Records

10.7.1. The Contractor is a VA contractor and will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7332.

Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment http://www1.va.gov/vhapublications/index.cfm records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

10.7.2. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records.

10.8. HIPAA Compliance

10.8.1. Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). The VA has recognized Diagnostic Laboratory Facilities as healthcare providers and that the PHI is being disclosed and/or used for treatment. Therefore, no BAA is required for Reference Laboratory Services.

10.9. Designation of Contract Representatives

10.9.1. The Laboratory Manager – VISN 23 Pathology & Laboratory Medicine Services (P&LMS), Fargo, ND, will be designated as the Contracting Officer Representative (COR) to represent the Contracting Officer in furnishing guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting

Officer. The extent and limitations of the COR designation will be provided in the COR Delegation Memo.

10.10. Contract Performance Monitoring

10.10.1. Contractor's employee(s) shall report to the designated location, upon arrival at the VA for specimen pickup.

10.10.2. Monitoring of contractor’s performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying contract compliance. Contracting Officer's Representative(s) (COR) will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms:

10.10.2.1. Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.

10.10.2.2. Documentation of services performed will be reviewed prior to certifying payment. The COR will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services actually provided, and in strict accordance with the Price Schedule/Attachment A. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

10.10.2.3. Departments being served, through the COR(s), will provide a written statement annually to the Contracting Officer to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary evaluation will be submitted 45 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable).

10.11. Quality Assurance Monitoring

10.11.1. Contractor shall maintain a Quality Assurance Program related to Reference Laboratory services covered under this contract.

10.11.2. Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the Government facilities. This program must minimally address the quality aspects representative to the testing process, i.e. pre-analytical, analytical and post-analytical variables and include a description of monitoring and evaluation activities. There must be a mutually agreed upon procedure for responding to issues, problems and/or concerns identified by the Government with details as to whom and in what timeframe the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event. The contractor will meet or communicate with the facility/VISN 23 staff for process review and improvement of contract performance on an as needed basis.

10.11.3. Copies of licensure/certifications are also required to be submitted upon request by the VA.

10.11.4. Quality factors that VA may consider when monitoring quality of care may include, but are not limited to: security/privacy, adverse event reporting, turn-around times, timeliness to customer service requests, missed/delayed routes, etc.

PERFORMANCE

OBJECTIVE

TASKS:

PERFORMANCE

STANDARD

ACCEPTABLE

(MINIMAL

QUALITY LEVEL

(AQL)1

MONITORING

METHOD

Ensure the safety and integrity of specimens

No loss or destruction of specimens

1/month Report of cancelled tests due to lost/damaged specimens

Testing services will be performed in accordance with the defined turnaround times (TAT)

Results will be reported within the TAT listed in the contractor’s laboratory reference test manual per test

90% of the time Notification of employee/provider concerns

Courier Courier Pick-Up 1/month Notification of issues with courier pick-up to the lab supervisors or lab manager

Revised Reports Not due to incorrect requisition information

1/month Notification of revised report as reported by provider lab

1 AQL’s of 100% are based on the fact that all circumstances outside of the contractor’s control have been accounted for in the performance work statement. For instance, loss or destruction of specimens and missed routes are “justified” in the case of force majeure events and therefore are not included in determining the contractor’s acceptable quality level of performance.

11. CONTRACT SECURITY REQUIREMENTS

11.1. General

12. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

12.1. Contractor Personnel Security Requirements

13. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

14. Contractor shall certify that all its employees and subcontractor employees having access to VA sensitive information (ie. laboratory technicians, administrative personnel) during the performance of this contract have successfully passed a contractor employee background check.

14.1.1.1. Position Sensitivity - The position sensitivity has been designated as Low Risk.

14.1.1.2. Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries.

14.1.1.3. Contractor Responsibilities

14.1.1.3.1. The contractor shall bear the expense of obtaining background investigations. If the Office of Personnel Management (OPM) conducts the investigation, the contractor shall reimburse VA within 30 days. If timely payment is not made within 30 days from date of bill for collection, then VA shall deduct the cost incurred from the contractors 1st month’s invoice(s) for services rendered.

NARA Records Management Language for Contracts (July 10, 2019) https://www.archives.gov/records-mgmt/policy/records-mgmt-language

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes [Agency] records.

https://www.archives.gov/records-mgmt/policy/records-mgmt-language

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C.

chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. [FACILITY] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [FACILITY] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [FACILITY]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [FACILITY] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [FACILITY] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [FACILITY] policy.

8. The Contractor shall not create or maintain any records containing any non-public [FACILITY] information that are not specifically tied to or authorized by the contract.

9. The 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 from public disclosure by an exemption to the Freedom of Information Act.

10. The [FACILITY] owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S.

Government for which [FACILITY] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [FACILITY]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flow down of Requirements to Subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

B.3 SCHEDULE OF SERVICES

FILL OUT/COMPLETE ATTACHMENT D.1 SCHEDULE OF SERVICES

Per FAR 16.504

The Department of Veterans Affairs has set the ceiling limitation for this IDIQ at $300,000.00 for the lifetime of this contract. The total of all orders placed against this IDIQ will not exceed this ceiling of $300,000.00.

The guaranteed minimum value of this contract is set at $9,000.00

SECTION C - CONTRACT CLAUSES

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

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the…