36C26319R0139-001.docx

DOCX document 141 KB Posted

Attached to
Specialized Laboratory Testing and Consultation Services Federal contract opportunity
Solicitation number
36C26319R0139
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 23

About this file

36C26319R0139 36C26319R0139.docx

View the file

Other files for this federal contract opportunity

Other files attached to Specialized Laboratory Testing and Consultation Services, newest first.
File Type Posted
36C26319R0139-006.xlsx XLSX spreadsheet
36C26319R0139-004.pdf PDF
36C26319R0139-005.pdf PDF
36C26319R0139-003.pdf PDF
36C26319R0139-002.pdf PDF
36C26319R0139-000.docx DOCX document

On GovTribe

Work with this file on GovTribe

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

36C26319R0139

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

618-19-4-106-0001 36C26319R0139 07-15-2019 Daniel Vagts 651-293-3040 08-05-2019 1pm CST

DEPARTMENT OF VETERANS AFFAIRS

NETWORK 23 CONTRACTING OFFICE

ATTENTION: Daniel Vagts

316 ROBERT ST N STE 506

SAINT PAUL MN 55101

X $32.5 Million X N/A X Department of Veterans Affairs Minneapolis VA Medical Center One Veterans Drive, Building 70 Minneapolis MN 55417

DEPARTMENT OF VETERANS AFFAIRS

NETWORK 23 CONTRACTING OFFICE

ATTENTION: Daniel Vagts

316 ROBERT ST N. STE 506

SAINT PAUL MN 55101

Y Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Specialized Laboratory and Consultation Services for the Minneapolis VA Medical Center.

See Schedule of Items - Section D - Attachment 5 See Statement of Work (pg.

See CONTINUATION Page 618-3690160-106-822300-2560 0100223P5 X X

ONE

Daniel Vagts Contract Officer Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS1
SECTION B - CONTINUATION OF SF 1449 BLOCKS4
B.1 CONTRACT ADMINISTRATION DATA4
B.2 SCHEDULE OF ITEMS - PRICING – See Section D: D.5 – Attachment 5 – Schedule of Items - Pricing6
B.3 STATEMENT OF WORK7
SECTION C - CONTRACT CLAUSES20
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)20
C.2 52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL (JAN 2011)25
C.3 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN 2016)26
C.4 52.216-18 ORDERING (OCT 1995)28
C.5 52.216-19 ORDER LIMITATIONS (OCT 1995)28
C.6 52.216-22 INDEFINITE QUANTITY (OCT 1995)28
C.7 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)29
C.8 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)29
C.9 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997)29
C.10 SUPPLEMENTAL INSURANCE REQUIREMENTS30
C.11 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)30
C.12 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)31
C.13 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)31
C.14 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009)31
C.15 VAAR 852.219-9 VA SMALL BUSINESS SUBCONTRACTING PLAN MINIMUM REQUIREMENTS (DEC 2009)32
C.16 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016)(DEVIATION)32
C.17 VAAR 852.219-11 VA NOTICE OF TOTAL VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016)(DEVIATION)33
C.18 VAAR 852.219-71 VA MENTOR-PROTÉGÉ PROGRAM (DEC 2009)34
C.19 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)35
C.20 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE (JUL 2018)35
C.21 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)36
C.22 VAAR 852.237-7 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (JAN 2008)37
C.23 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)38
C.24 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2019)39
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS47
D.1 List of Attachments47
SECTION E - SOLICITATION PROVISIONS48
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)48
E.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)54
E.3 52.216-1 TYPE OF CONTRACT (APR 1984)56
E.4 52.233-2 SERVICE OF PROTEST (SEP 2006)56
E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)56
E.6 VAAR 852.209-70 ORGANIZATIONAL CONFLICTS OF INTEREST (JAN 2008)57
E.7 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (JUL 2016)(DEVIATION)58
E.8 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008)58
E.9 VAAR 852.271-70 NONDISCRIMINATION IN SERVICES PROVIDED TO BENEFICIARIES (JAN 2008)58
E.10 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)59
E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (OCT 2018)62

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

DEPARTMENT OF VETERANS AFFAIRS

NETWORK 23 CONTRACTING OFFICE

ATTENTION: Daniel Vagts

316 ROBERT ST N STE 506

SAINT PAUL MN 55101

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

[X]
52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or
[]
52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[X] MONTHLY

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO
DATE

Page 1 of

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

SCHEDULE NOTES

1. Additional Tests

It may occur that the VAMC laboratory will require a test not listed in the Schedule of Items but that is available from the contractor’s catalog of tests, or a new test becomes available that is not listed in the Schedule of Items. If a test is required that is not listed in the Schedule of Items, the VA and the contractor will negotiate a firm fixed price. The new tests will be added to the contract accordingly via a contract modification. These tests will be considered as part of the overall contract value and together with the other tests cannot exceed the total estimated contract value.

2. Estimated Quantities Th quantities as listed in the “Schedule of Items” are estimated requirements for a twelve (12) month contract period with four (4) possible twelve (12) month options. The Government estimates, but does not guarantee, that the volume of purchases under this contract will be an estimated ceiling amount $1,400,000.00 for the entire 5-year contract period. The VAMC attempts to be as accurate as possible when providing estimated quantities, however, actual quantities required may vary from the quantities listed. The Government is obligated only to the extent of the minimum contract guarantee. During the period specified FAR clause 52.216-18, ORDERING, the Government shall place orders totaling a minimum of $50,000.00 for a 12-month contract period.

B.3 STATEMENT OF WORK

1. SCOPE OF WORK

The Minneapolis VA Health Care System, hereinafter referred to as MVAHCS intends to secure a stat highly specialized laboratory testing and consultation services for the MVAHCS Pathology and Laboratory Medicine Service (P&LMS) located at One Veterans Drive, Minneapolis, MN 55417. All services provided shall be in accordance with the costs, terms and conditions of this contract.

2. CONTRACT TYPE AND TERM

The VA will award a firm, fixed-price, indefinite delivery indefinite quantity commercial services contract for all items listed in the Schedule of Items. Contract use will be limited to the Minneapolis VA Medical Center only; no other VAMC may use this contract. The Base year effective period of the contract shall begin September 1, 2019 with the options to extend the contract for additional 12 month periods, at the discretion of the VA, for up to four (4) additional years. Total contract will not exceed five years.

3. STATEMENT OF WORK

The MVAHCS, requires the services of a contractor to provide highly specialized and specific diagnostic testing needs not provided by the Minneapolis VA Health Care System.

Testing needs may consist of but are not limited to stat and emergent drug levels and beta-2-tranferrin assays; quantitative cryoglobulin levels with identification; HLA typing; coagulation factor assays, consultation on complex anatomic pathology cases, including transplant pathology; and gross and microscopic neuropathology evaluations. See Schedule of items, 3.A., for more extensive list of required testing.

The laboratory must be able to determine levels of the following on a stat or emergent basis:

Amikacin Cyclosporine (by HPLC) Methotrexate Quinidine Sirolimus (by HPLC) Tacrolimus (by HPLC) Tobramycin Beta-2-transferrin Amytriptyline/Nortriptyline Everolimes Procain/NAPA

See Section 8. Turn around Times for defined acceptable times of the STAT and emergent testing requirements. Turnaround times are of the utmost importance and the contractor will receive a higher level of evaluation grade for meeting these times. To meet these needs the contractor is required to be no more than 1 hour from pick-up at MVAHCS Laboratory to arrival at the contractor’s laboratory for testing.

The contractor’s laboratory must be able to provide services Monday through Sunday 24 hours a day.

Contractor shall provide laboratory testing services to include: List of tests with reference ranges, specimen requirements, processing and analysis of the specimen; and reporting of stat specimen results through a phone call within 4 hours of carrier pickup (carrier pick up is expected with 30 minutes of requesting) and a faxed copy sent to the Minneapolis VA laboratory following the called results. Consultation regarding selection, collection, transportation and result interpretation shall also be provided when required. The contractor must provide the following services:

(a) Provide the following for transport of the specimens to include:

(1) Lab test request forms (it is possible that vendor may need to customize forms to include information required by MVAHCS)

(2) Special instructions for handling of specimen.

(3) Specimen collection supplies for specialized testing.

(4) Provide the courier service for transport of specimens.

(b) Analyze samples.

(c) Contractor shall provide a monthly billing for tests provided each month following the month in which the service was delivered.

(d) Contractor shall consult with MVAHCS Laboratory personnel on test results by telephone as needed.

(e) Provide the MVAHCS Laboratory with a means of communication to permit immediate inquiry regarding the status of a pending test.

3. A. Schedule of items (testing needs of MVAHCS):

CPT CODE
Description/Part Number*
84311
Adenosine Deaminase, Pericardial
80150
Amikacin Level
80335
Amitriptyline/Nortriptyline
86334
Beta-2 Transferrin
81370
HLA ABDssop (BMT HLA DR/DQ) Panel
81376 (x3)
HLA-LowRes Class II 1 Loci
86162
Complement CH50, Total
82595
Cryoglobulin, Quantitative
86334
Cryoglobulin Identification
80158
Cyclosporin
80169
Everolimus
83520
Granulocyte Colony Stimulating Factor
83520
Granulocyte Macrophage CS Factor
86828
HLA PRA (Screen)
86832
HLA PRA (Class 1)
86833
HLA PRA (Class 2)
80299
Methotrexate
82657
Porphobilinogen Deaminase, RBC
80188
Primidone
80192
Procainamide & N-Acetylprocainamide (NAPA)
80194
Quinidine
80195
Sirolimus
80299
Sulfonylurea Screen
80197
Tacrolimus
80200
Tobramycin
82710
Fat, Feces, Quantitative, Timed Collection
82705
Fat, Feces, Qualitative, Random Collection
85307
Activated Protein C
85379
D-Dimer, Quantitative
85260
Factor 10, Chromogenic
85270
Factor 11 Activity
85280
Factor 12 Activity
85240
Factor 8 Activity
85250
Factor 9 Activity
85210
Factor 2 Activity
85220
Factor 5 Activity
85230
Factor 7 Activity
85260
Factor 10 Activity
85384
Fibrinogen Activity
85520
Arixtra (Fondaparinux) Assay
86022
Heparin Induced Thrombocytopenia
85520
Heparin (10a) Level
85730 (PTT)
Lupus Anticoagulant Panel
85732 (PTT Mix)
Partial Thromboplastin Time (PTT) Mixing Study
85597 (PLTNEU)
Platelet Neutralization
85613 (DRVVT Screen)
Dilute Russell’s viper Venom time (dRVVT) Screen
85613 (DRVVT Mix)
Dilute Russell’s viper Venom time (dRVVT) Mix
85613 (DRVVT Confirm)
Dilute Russell’s viper Venom time (dRVVT) Confirmation
85525 (Hepzyme if required)
Hepzyme inhibitor to be used as needed to determine heparin contamination
85420
Plasminogen Activity
85576
Platelet Aggregation Tests
85576 Col/EPI
Platelet Function Closure Time
85576 Col/ADP if performed
Reflex: Platelet Function Closure Time ADP
85730
Partial Thromboplastin Time (PTT)
85610
Protime/INR
85670
Thrombin Time
85576
Platelet Function P2Y12 (Verify Now)
85335 (Bethesda assay)
Bethesda Assay for Factor 8 with Normal Plasma
85335 (Bethesda assay)
Bethesda Assay for Factor 9 with normal plasma
87801
Bordetella pertussis/parapertussis PCR
87496
Cytomegalovirus qual PCR (CSF)
87496
Cytomegalovirus qual PCR (Bone Marrow)
87497
Cytomegalovirus quantitative PCR
87498
Enterovirus PCR (CSF)
87799
Epstein-Barr Virus PCR
87529x2
Herpes Simplex Culture w/typing test
87529x2
Herpes Simplex Virus PCR test (CSF)

Influenza A & B culture and rapid test

87109
Mycoplasma Culture test
87109
Ureaplasma culture test
87633
Respiratory Virus Panel test (PCR, extended)
87798
Varicella-Zoster Virus PCR test -non blood
87252
Viral Culture-Non-Respiratory
87253
Viral Culture-non-Respiratory Reflex to ID
87252
Viral Culture-Respiratory
87253
Viral Culute-Respiratory Reflex to ID
87798
Varicella-Zoster Virus PCR test Qualitative (Blood)
87254
Viral Culture, Rapid Resipratory

Fondaparinux

Stat Fondaparinux (Additional $200 for stat)

87624
Human Papillomavirus Detection HPVMD
88342
TC initial, ImmunohistoChemistry stain
88343
TC additional, ImmunohistoChemistry stain

Neuropathological Gross Exam

88312
Organism Stain (group 1)
88312-26
Organism Stain (group 1), interp.
88313
Organism Stain (group 2)
88313-26
Organism Stain (group 2), interp.
88323
Path block consult PC
88323
Path Consult & Report w/slide prep
88321
Path Consult & Report, Outside Cases (Brains)
88321
Review Outside Slides Pro Free
6051014
Doctor Neuropathology Autopsies
88231
Specialized Consulti with Dr. Snover specifically- Review outside slides (TC & PF Charges)
88235
Path Comprehensive Consult with Dr. Snover Specifically
36832
PRA Single Antigen, IgG Glass I and Class II
86833
PRA Single Antigen, IgG Glass I and Class II
LAB6605
Epidermal Nerve fiber Density
85246
Von Willebrand Factor Activity
85290
Factor 13 Antigen Subunit A
83520
Interleukin-5 by Multiplex Bead Assay
83945
Oxalate
835202x2
Interleukin 3
LAB6605
ENF: Skin Biopsy for Nerve Density; Confocal microscopy
85290
Factor XIII Activity-TC 2006182
83051
Hemoglobin, Plasma
Misc
Misc line item used for rare occurance <1x/year, or new tests that have been developed and not on contract yet.

4. Licensing and Accreditation The Contractor’s shall assure compliance of all procedures and practices by the following accrediting agencies, and the facility and employees shall have all licenses, permits, accreditation, professional certifications and qualifications required by federal and state law to provide laboratory testing and consult services. This includes:

(a) Accreditation by the College of American Pathologists (CAP)
(b) CLIA accreditation

5. Contractor Qualification Requirements

(a) The pathologists for interpretive reports and/ or on-site consultation must have an unrestricted license to practice medicine in one of the states or territories of the United States of District of Columbia.

(b) The pathologist(s) providing neuropathology consultation must be board-certified in neuropathology. It is desired the pathologist(s) have at least 5 years experience in neuropathology.

(c). Consultant anatomic pathologists must have national reputations in their areas of specialization, as evidenced by ongoing publication in academic journals and/ or presentations at national pathology meetings. Special attention will be paid to expertise in transplant and gynecologic pathology.

The qualifications of such personnel shall also be subject to review by VA Medical Center Laboratory Director. VA reserves the right to approve the assignment of individual personnel furnished by the Contractor to perform the functions specified in the contract.

6. Test Sample Preparation The MVAHCS laboratory shall be responsible to provide laboratory specimens prepared in accordance with the contractor’s Laboratory User’s Manual. All specimens will be properly identified and labeled for testing. The contractor shall provide an adequate supply of requisition forms, special instructions and a current list of tests with reference ranges and specimen requirements. These requirements shall be defined in the laboratory user’s manual. The contractor’s laboratory must supply paper requisition forms to use in ordering.

7. Transport of Specimens In order to allow for stat testing of drug levels, the transport time for the specimens to the contractor is required to be no more than 1 hour from pick-up at MVAHCS to arrival at the contractor’s laboratory for testing. (Carrier pick up shall be within 30 minutes of request.)

8. Acceptable Turn Around Times A. STAT: Results called to MVAHCS laboratory within 2 hours of specimen receipt.

B. Urgent: Results called to Minneapolis VA laboratory within 24hrs of specimen receipt.

a. Tests that fall under this category: cyclosporine, sirolimus, everolimus, and tacrolimus.

C. Special:

a. Faxed report for Surgical Pathology consultation, completion within 4 working days, unless other testing such as immunohistochemistry or molecular gene rearrangement studies is required.
b. Final results of quantitative cryoglobulin levels with Identification are to be reported the Minneapolis VA laboratory within 7 days.

D. Routine: To be performed as a part of regular testing procedures at the contractor’s laboratory

a. All tests not specified as STAT or Urgent at time of need fall into this category, except for cyclosporine, sirolimus, everolimus, and tacrolimus, Amikacin, Methotrexate, Quinidine, Tobramycin, Beta-2-transferrin, Amytriptyline/Nortriptyline, and Procain/NAP-these tests will always be considered special priority.

9. Reporting of Test Results A report is defined as a printed final copy of pathology interpretive consult. Consult reports shall be sent by contractor to secured MVAHCS Laboratory FAX # 612-727-5945 located in the MVAHCS Pathology & Laboratory Medicine Chemistry Laboratory. If results are telephoned prior to sending, the written report must include the name of the individual notified of the results, date and time of telephone report. Each consult report shall at a minimum indicate the following information:

(a)Patient’s name and identification code
(b)Physician’s name (if supplied)
(c)VA Medical Center name
(d)Patient’s location, e.g. clinic, ward (if supplied)
(e)Test ordered
(f)Date/time of specimen collection
(g)Date/time specimen received in Reference Lab
(h)Date test completed
(i)Test result
(j)Flag abnormal results
(k)Reference Range
(l)Toxic and/or therapeutic range where applicable
(m)Name of testing laboratory (contractor and/or subcontractor)
(n)Testing laboratory specimen number
(o)Type of specimen
(p)Comments related to the test provided by the submitting lab
(q)Information that may indicate a questionable validity of test results
(r)Unsatisfactory specimen shall be reported with reason as to its unsuitability for testing

A. If the vendor has a web-based portal for ordering and sending results, this can only be utilized by MVAHCS if the ISO (Informational Security Officers) find the web portal to be acceptable for use by MVAHCS. If the ISO’s determine the portal is not acceptable, no additional charges will be incurred to the government for the use of FAX and paper copies for ordering and receiving test results.

10. Quality Control To ensure proper handling and test performance, the contractor shall provide the following updated information upon request during the life of the contract:

(a)For quality purposes, tests routinely performed in duplicate should be indicated.
(b)Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs.
(c)Proficiency testing data shall include a list of tests outside of the ± 2 SD range for the past two years. Contractor shall notify the laboratory of any test falling outside ± 2 SD range during the contract period.
(d)Contractor shall provide address of processing sites under contract, including subcontracted testing location sites.
(e)The contractor(s) facilities, methodologies (defined as the principal of the method and references), and quality control procedures may be examined by representatives of the VA at any time during the life of the contract.
(f)Contractor agrees to maintain the minimum acceptable service, reporting systems and quality controls as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency.

11. Testing Summaries Contractor shall provide the MVAHCS a testing summary report each month following the month in which the testing service was provided. At the end of each contract year a cumulative (year-to-date) report shall be submitted to the VA providing the name of test ordered, price of test, cumulative totals and a total of all funds spent by that VA facility on laboratory testing services.

12. Testing Changes The Contractor shall advise the MVAHCS of any changes in assay methodology, procedures, reference ranges and any new tests introduced.

In the event that the contractor changes the assay procedures or a critically important component of an assay (e.g., an antibody, purified antigen, etc.) the contractor shall notify the VA Contracting Office and the MVAHCS Laboratory Director prior to the intended change. He shall provide documentation that the quality and efficacy of the test will remain unchanged or be improved.

Changes in the assay material, testing procedures or methodology that have not been reviewed and pre-approved by MVAHCS Laboratory Director and mutually agreed upon in writing between the contractor and the VA Contracting Officer, may be sufficient cause for the MVAHCS to use an alternate contractor for that specific test for the duration of the contract.

13. Contractor Telephone Numbers Contractor shall provide telephone number(s) and contact person(s) to be used by the VAMC Pathology & Laboratory Medicine Service for specimen inquiries, and Lab Technical/Pathologist consultation. There must be someone available at the number(s) provided at all times including weekends and holidays.

Phone Number Specimen Inquiries: __________________________

Lab Technical Director/Pathologists: __________________________

14. SUBCONTRACTING APPROVAL

If Contractor intends to use a subcontractor to provide any of the testing required under this contract, Contractor shall be responsible for finding a subcontractor laboratory with appropriate licensure and accreditation. Contractor shall notify the VA Contracting Office of any plan to use a subcontractor or make a subcontractor change, and request a prior acceptance and approval from VA.

Contractor will use the following subcontractor(s):

15. CHANGES

Changes in the terms and conditions of this contract may be made only by written agreement of both parties. Contractor must submit requests for changes in writing to the VA Contracting Office. Any and all modifications to this contract must be approved and prepared by the VA Contracting Officer for signature.

16. QUALITY ASSURANCE

The government will evaluate the Contractor’s performance under this contract and the Contractor performance will be monitored to determine if it meets the contract standards. A variety of methods may be used. Nonperformance or substandard task performance will be documented if and when it occurs. The Technical Representative will follow the methods of surveillance specified in the Performance Measures.

17. Government Roles And Responsibilities The MVAHCS shall designate a Technical Representative to coordinate and monitor the work to be completed under this contract. Amy Colbaugh, Laboratory Contract Liaison has been designated as the representative to coordinate these services. Her contact information is listed below.

Technical Representative:

Amy Colbaugh, MT (ASCP) Senior Medical Technologist, Laboratory Super COR Department of Veterans Affairs Medical Center One Veterans Drive, P&LMS (113) Minneapolis, MN 55417

18. Performance Measures The following performance measures will be regularly tracked and monitored throughout the effective period of this contract by the Technical Representative and reported to the Contracting Officer. Acceptable performance on these measures, along with other factors, will be primary indices of contractor performance and a key consideration in contract renewal decisions. Performance will be monitored using the following criteria:

Action/Test/Report
Turnaround time (TAT)
Acceptable Performance
Stat test for drug levels (amikacin, tobramycin, methotrexate, beta-2-transferrin levels, Amytriptyline, Nortrytyline, Everolimus, Procain, NAPA)
Within 2 hours of specimen receipt.
80% of all stat tests submitted
Urgent drug levels (cyclosporine, sirolimus, tacrolimus, everolimus)
Within 24 hours of specimen receipt.
80% of all urgent tests submitted
Quantitative cryoglobulin levels with identification
Within 7 days of specimen receipt
80% of all tests submitted
Final surgical pathology consultation report completion
Within 4 working days of specimen receipt for cases not requiring additional studies
80% of all consults submitted

19. ORDERING PROCEDURES

This contract does not obligate any funding; therefore, the Contractor shall provide services under this contract only as directed in task orders. Task orders for bulk dollar amounts will be issued during the contract period. Any warranted VA Contracting Officer is authorized to issue task orders under this contract. The Minneapolis laboratory personnel may place verbal orders with the contractor to meet their testing needs, up to the bulk task order total. The contractor will be required to inform the VA contract specialist or contracting officer when each task order reaches 80% of the total bulk dollar amount.

In accordance with FAR 16.505, each task order will include the following: (i) Date of order (ii) Contract number and order number (iii) Contract item number and description, quantity, and unit price or estimated cost or fee (iv) Delivery or performance date (v) Place of delivery or performance (including consignee) (vi) Packaging, packing, and shipping instructions, if any (vii) Accounting and appropriation data (viii) Method of payment and payment office, if not specified in the contract (ix) Any other pertinent information.

Invoices shall be sent to:Department of Veterans Affairs
Financial Services Center
P O Box 149971
Austin TX 78714-9971
Customer Service Phone: 877-353-9791

Contractor must furnish a designated point of contact for placing orders. Orders for laboratory testing services shall be sent to Contractor through the contact person listed below at the following address:

(Offeror to complete) Vendor’s Contact Person: ____________________ Telephone Number: _______________ FAX Number: ______________ Address: _____________________

20. SAFETY AND SECURITY REQUIREMENTS

HIPAA Compliance and Requirements Contractor will adhere to the applicable 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, use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). As defined in the Health Insurance Portability and Accountability Act (HIPAA) Public Law 104-191, your company may be required to execute a Business Associate Agreement.

21. EVIDENCE OF INSURANCE COVERAGE

In accordance with FAR clause 52.237-7, the Contractor must have all necessary insurance coverage to operate a Pathology Laboratory. Contractor healthcare professionals and physicians providing services under this contract must be covered by medical liability insurance. Contractor must furnish to the VA prior to award, with a certificate of insurance from his insurance company indicating that the coverage outlined in this document has been obtained. The certificate of insurance shall demonstrate the contract physicians and facility have medical malpractice insurance, general liability, and any other pertinent special insurance certificates. The insurance coverage may not be changed or canceled without a thirty (30) day written notice to the VA Contracting Officer.

SECTION C - CONTRACT CLAUSES

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

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those 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 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 appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

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

(a) The Contractor shall comply with agency personal identity verification procedures identified in the contract that implement Homeland Security Presidential Directive-12 (HSPD-12), Office of Management and Budget (OMB) guidance M-05-24, and Federal Information Processing Standards Publication (FIPS PUB) Number 201.

(b) The Contractor shall account for all forms of Government-provided identification issued to the Contractor employees in connection with performance under this contract. The Contractor shall return such identification to the issuing agency at the earliest of any of the following, unless otherwise determined by the Government:

(1) When no longer needed for contract performance.

(2) Upon completion of the Contractor employee's employment.

(3) Upon contract completion or termination.

(c) The Contracting Officer may delay final payment under a contract if the Contractor fails to comply with these requirements.

(d) The Contractor shall insert the substance of this clause, including this paragraph (d), in all subcontracts when the subcontractor's employees are required to have routine physical access to a Federally-controlled facility and/or routine access to a Federally-controlled information system. It shall be the responsibility of the prime Contractor to return such identification to the issuing agency in accordance with the terms set forth in paragraph (b) of this section, unless otherwise approved in writing by the Contracting Officer.

(End of Clause) C.3 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION SYSTEMS (JUN 2016)

(a) Definitions. As used in this clause— Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

Federal contract information means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public Web sites) or simple transactional information, such as necessary to process payments.

Information means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C. 3502).

Safeguarding means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures. (1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract…

This is the start of the file's text. The full file is on GovTribe.

File details come from the government source that posted it.