S02 - 36C26320R0053.pdf

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Attached to: Q515--Referral Laboratory Testing Services Federal contract opportunity
Solicitation number: 36C26320R0053
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 23

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D.1 - Attachment 1 - QASP.pdf	PDF	Sep 14, 2020
36C26320R0053_3.docx	DOCX document	Sep 14, 2020
D.2 - Attachment 2 - Organizational Conflict of Interest.pdf	PDF	Sep 14, 2020
36C26320R0053_2.docx	DOCX document	Sep 11, 2020

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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 127

36C26320R0053 09-14-2020

Steven Porwoll 651-293-3049 10-14-2020

11:59AM ET

DEPARTMENT OF VETERANS AFFAIRS

NETWORK 23 CONTRACTING OFFICE

ATTENTION: Daniel Vagts

316 ROBERT ST N STE 506

SAINT PAUL MN 55101

621511

$35 Million

N/A

Department of Veterans Affairs Minneapolis VA Medical Center One Veterans Drive, Building 70

Minneapolis MN 55417

NETWORK 23 CONTRACTING OFFICE

ATTENTION: Steven Porwoll

316 ROBERT ST N. STE 506

SAINT PAUL MN 55101

Department of Veterans Affairs Financial Services Center PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

Requirement for Specialized Laboratory and Consultation Services for the Minneapolis VA Medical Center.

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

See Statement of Work - Section B.3, page 55.

See CONTINUATION Page

X ONE

Daniel Vagts Contract Officer

36C26320R0053

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 SCHEDULE OF ITEMS

B.3 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

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

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

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

2016)

C.4 52.216-18 ORDERING (OCT 1995)

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

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

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

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

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

C.10 SUPPLEMENTAL INSURANCE REQUIREMENTS

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

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

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

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

(DEC 2009)

C.15 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL

BUSINESS SET-ASIDE (JUL 2019) (DEVIATION)

C.16 VAAR 852.219-11 VA NOTICE OF TOTAL VETERAN-OWNED SMALL BUSINESS SET-ASIDE

(JUL 2019) (DEVIATION)

C.17 VAAR 852.219-71 VA MENTOR-PROTÉGÉ PROGRAM (DEC 2009)

C.18 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE

(JUL 2018)

C.19 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE (JUL 2018)

C.20 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

C.21 VAAR 852.237-7 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (JAN 2008)

C.22 VAAR 852.237-70 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE (OCT 2019)

C.23 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL ITEMS (JUN 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 List of Attachments

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

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

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

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

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

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

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

BUSINESS EVALUATION FACTORS (OCT 2019)

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

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

2008)

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

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

2020)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C263

NETWORK 23 CONTRACTING OFFICE

ATTENTION: Daniel Vagts

316 ROBERT ST N STE 506

SAINT PAUL MN 55101

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

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

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] MONTHLY

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

Department of Veterans Affairs

Financial Services Center

PO Box 149971

Austin TX 78714-9971

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

AMENDMENT NO DATE

B.2 SCHEDULE OF ITEMS

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

3.00 EA __________________ __________________

CPT: 88305 Gross and Microscopic, Level IV

Contract Period: Base POP Begin: 01-01-2021 POP End: 12-31-2021

CPT: 88305m26 Gross and Microscopic, Level IV-professional Fee

Contract Period: Base

12.00 EA __________________ __________________

CPT: 88313 Stain Group II (each stain)

Contract Period: Base

CPT: 88313m26 Stains Group II (each Stain)

Contract Period: Base

33.00 EA __________________ __________________

CPT: 88319 Histochemistry Stains (each)

Contract Period: Base

CPT: 88319m26 Histochemistry Stains (each)

Contract Period: Base

CPT: 88348 Electron Micoscopy Complete Interpretation and Report

Contract Period: Base

CPT: 88348m26 Electron Microscopy Complete Interpretation and

Report

Contract Period: Base

18.00 EA __________________ __________________

CPT: 88305 Gross and microscopic, level IV

Contract Period: Base

CPT: 88305m26 Gross and microscopic, Level IV

Contract Period: Base

90.00 EA __________________ __________________

CPT: 88313 Stains Group II (each Stain)

Contract Period: Base

162.00 EA __________________ __________________

CPT: 88346 Immunofluorescence study (each stain)

Contract Period: Base

CPT: 88346m26 Immunofluorescense study (each stain)

Contract Period: Base

CPT: 88348 Electron Microscopy, complete interpretation & Report

Contract Period: Base

CPT: 88348m26 Electron Microscopy, complete interpretation &

Report

6.00 EA __________________ __________________

CPT: 88342 Immunoperoxidase (each stain)

Contract Period: Base

CPT: 88342 m26 Immunoperoxidase (each stain)

Contract Period: Base

2.00 EA __________________ __________________

CPT: 88305 Gross and microscopic, Level IV

Contract Period: Base

Report

1.00 EA __________________ __________________

CPT: 88362 nerve Teasing

Contract Period: Base

Report Contract Period: Base

170.00 EA __________________ __________________

CPT: 88346 Immunofluorescense study (each stain)

Contract Period: Base

CPT: 88237 Tissue Culture/neoplastic disorders (TCCA), BM or Blood

Contract Period: Base

CPT: 88280 Additional karyotypes

Contract Period: Base

CPT: 88264 Metaphase Band (analyze 20-25 cells)

Contract Period: Base

CPT: 88239 Tissue Culture solid tumor (TCCA), solid tumor Contract Period: Base

Contract Period: Base

CPT: 88230 Tissue Culture, non-neoplastic lymphocytes

Contract Period: Base

CPT: 88262 Analysis: Count 15-20 cells, 2 karyotypes

Contract Period: Base

58.00 EA __________________ __________________

CPT: 88275 Oncology FISH analysis for Myeloid and Lymphoid

Disorders and solid tumors (100-300 cells) Contract Period: Base

124.00 EA __________________ __________________

CPT: 88271 Nucleic acid probe (FISH)

Contract Period: Base

16.00 EA __________________ __________________

CPT: 87901 HIV Genotype

Contract Period: Base

350.00 EA __________________ __________________

CPT: 87206 TC Lab AFB Smear Concentrated

Contract Period: Base

400.00 EA __________________ __________________

CPT: 87116 TC Lab AFB Culture

Contract Period: Base

36.00 EA __________________ __________________

CPT: 87118 TC Lab AFB Culture workup

Contract Period: Base

CPT: 87190 TC Lab AFB Susceptibility

Contract Period: Base

CPT: 87556 TCM Tuberculosis PCR amplificaion

Contract Period: Base

CPT: 87801 16s DNA Sequencing

Contract Period: Base

CPT: 374710 Trichomonas Vaginalis by Amplified Detection-Urine

Contract Period: Base

10.00 EA __________________ __________________

CPT: 82693 Ethylene Glycol, stat

Contract Period: Base

14.00 EA __________________ __________________

CPT: 84600 Volatile Screen, Alcohol, blood, stat

4.00 EA __________________ __________________

CPT: 82489 Basic Drugs of Abuse, Urine, Stat

Contract Period: Base

CPT: 84600 Methanol, Stat

Contract Period: Base

CPT: 84600 Isopropanol, Stat

Contract Period: Base

CPT: 82010 Acetone GC, Stat

Contract Period: Base

CPT: 82055 Ethanol, Stat

Contract Period: Base

CPT: 80329 Acetaminophen

Contract Period: Base

CPT: 80364 Opiate Quantitation

Contract Period: Base

5.00 EA __________________ __________________

CPT: 80307 Carboxy-THC (Cannabinoids Confirmation

CPT: 80301 Postmortem Forensic Blood Screen Testing

Contract Period: Base

50.00 EA __________________ __________________

CPT: 80301 Serum Drug Screen Testing - DA5

Contract Period: Base

CPT: 80320 Ethanol Confirmation

Contract Period: Base

CPT: 80304 Comprehensive Urine Drug Screen

Contract Period: Base

CPT: 80325 Amphetamine Confirmation, Blood

Contract Period: Base

CPT: 80353 Cocaine Metabolite, Blood Quantitation

Contract Period: Base

CPT: 80178 Lithium

Contract Period: Base

CPT: 85660 Hemoglobin S Screen

Contract Period: Base

CPT: 88321 Surgical Consultation & Report on Referred slides

Contract Period: Base

CPT: 88321m26 Surgical Consultation & Report on Referred slides-professional fee Contract Period: Base

Contract Period: Base

CPT: 88342m26 Immunoperoxidase (each stain)- Professional Fee

Contract Period: Base

CPT: 88313m26 Stain Group II (each stain)-Professional fee

Contract Period: Base

CPT: 88312 Stain Group I

Contract Period: Base

CPT: 88312m26 Stain Group I (each stain) -professional fee, CPT

Contract Period: Base

CPT: 83665 Postmortem Lead, Blood Contract Period: Base

CPT: 83825 Postmortem Mercury, Blood

Contract Period: Base

CPT: 82108 Postmortem Aluminum, Blood

Contract Period: Base

25.00 EA __________________ __________________

CPT: 87635 COIVD-19 testing

Contract Period: Base

CPT: 82565 Creatinine

Contract Period: Base

CPT: 84484 Troponin I

Contract Period: Base

Contract Period: Option 1 POP Begin: 01-01-2022 POP End: 12-31-2022

Contract Period: Option 1

Report Contract Period: Option 1

Contract Period: Option 1

Report Contract Period: Option 1

Contract Period: Option 1

Report Contract Period: Option 1

Contract Period: Option 1

Report Contract Period: Option 1

Contract Period: Option 1

Disorders and solid tumors (100-300 cells) Contract Period: Option 1

Contract Period: Option 1

0.00 EA __________________ __________________

Contract Period: Option 1

Contract Period: Option 1 professional fee Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 2 POP Begin: 01-01-2023 POP End: 12-31-2023

Contract Period: Option 2

Report Contract Period: Option 2

Contract Period: Option 2

Report Contract Period: Option 2

Contract Period: Option 2

Report Contract Period: Option 2

Contract Period: Option 2

Report Contract Period: Option 2

Contract Period: Option 2

Disorders and solid tumors (100-300 cells) Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2 professional fee Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 3 POP Begin: 01-01-2024 POP End: 12-31-2024

Contract Period: Option 3

Report Contract Period: Option 3

Contract Period: Option 3

Report Contract Period: Option 3

Contract Period: Option 3

Report Contract Period: Option 3

Contract Period: Option 3

Report Contract Period: Option 3

Contract Period: Option 3

Disorders and solid tumors (100-300 cells) Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3 professional fee

Contract Period: Option 3

Contract Period: Option 4 POP Begin: 01-01-2025 POP End: 12-31-2025

Contract Period: Option 4

Report Contract Period: Option 4

Contract Period: Option 4

Report Contract Period: Option 4

Contract Period: Option 4

Report Contract Period: Option 4

Contract Period: Option 4

Report Contract Period: Option 4

Contract Period: Option 4

Disorders and solid tumors (100-300 cells) Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4 professional fee Contract Period: Option 4

Contract Period: Option 4

GRAND TOTAL __________________

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

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

Minimum $2,000.00 Maximum $1,499,000.00

Ordering Procedures

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

B.3 STATEMENT OF WORK

The Minneapolis VA Health care system, hereinafter referred to as MVAHCS, requires the services of a contractor to provide specialized specific diagnostic testing needs (STAT and Routine) not provided by MVAHCS Laboratory Service.

The MVAHCS will award a firm, fixed-price, indefinite delivery indefinite quantity commercial services contract for all items listed in the Schedule of Items. The effective period of the contract shall be from date of award through twelve (12) months with the options to extend the contract for additional 12-month periods, at the discretion of MVAHCS, for up to four (4) additional years. Total contract will not exceed five years.

Testing needs consist of stat laboratory tests for drugs and toxins; comprehensive conventional and molecular cytogenetic (FISH) testing on blood, bone marrow, and solid tissue; histochemical testing, special stains, electron microscopy and interpretive reports on muscle biopsies; special stains, electron microscopy and interpretative reports on nerve biopsies; immunoflourescent testing, special stains, electron microscopy and interpretative reports on renal biopsies; immunofluorescent testing and interpretative reports on skin specimens; immunohistochemical breast markers including estrogen and progesterone receptor and electron microscopy and interpretive reports on diagnostic tissue specimens. A comprehensive list of tests with CPT codes can be found in the schedule of items.

To ensure proper oversight on the contract, quality of the testing and monitoring of the turnaround times, it is most advantageous the testing be consolidated into one source (laboratory).

These services require a Comprehensive Cytogenetics Laboratory with both conventional and molecular cytogenetic (FISH) testing. The contractor’s laboratory must be able to provide services Monday through Saturday.

For the Molecular Cytogenetics (FISH (fluorescent in situ hybridization)) testing, the following probes are required:

Myeloid Disorders (Blood/Bone Marrow)

AML:

o inv(3), t(3;3) EVI1 o t(8;21) AML1/ETO o 11q23 MLL o T(15;17) PML/RARA o inv(16) CBFB o CML: t(9;22) ABL1/BCR o Eosinophilia Panel: 4q/5q/8p

Eosinophilia Individual:

o 4q PDGFRA o 5q PDGFRB o 8p FGFR1 o MDS Panel: 5q/7q/+8/20q

MDS Individual:

o 5q,-5 o 7q,-7 o +8 o 20q

Leukemia/Lymphomas (Blood/Bone Marrow)

ALL:

o t(9,22) BCR/ABL o 11q23 MLL o t(12;21) ETV6/RUNX1 (TEL/AML1) o Anaplastic Large Cell: 2p23 ALK o Burkitt: 8q24 MYC o Burkitt: t(8;14) MYC/IGH o Dual hit lymphoma panel: 3q27(BCL6), MYC, IGH/BCL2 o CLL Panel: 11q,12cen,13q,17p o CLL & CCND1 Panel: 11q,12cen,13q,17p,t(11;14) o Cll limited panel: 11q, 17p o Diffuse Large B-Cell: 3q27BCL6 o Follicular: t(14;18) IGH/BCL2 o Mantle Cell: t(11;14) CCND1/IGH o MALT Panel: BCL6, 7q, 18q(MALT1), t(11;18) API2/MALT1, t(14;18) IGH/MALT1

MALT Individual:

o +18, 18121 MALT1 o t(11;18) API2/MALT1 o t(14;18) IGH/MALT1 o Nodal marginal zone panel: 3q27(BCL6), 7q, 18q(MALT1) o Splenic marginal zone: 7q o Myeloma Panel: 1pq, 13q, 17p, t(11;14), t(4:14), t(14;16) o Myeloma Limited Panel: t(4;14), t(14;16) o T-cell disorder: TCRA (14q11.2) o T-cell disorder: TCL1 (14q32.13)

Lymphoid tissue (Paraffin embedded) o Anaplastic Large Cell: 2p23 ALK o Burkitt: 8q24 MYC o Burkitt: t(8;14) MYC/IGH o Dual hit lymphoma panel: 3q27(BCL6), MYC, IGH/BCL2 o Diffuse Large B-Cell: 3q27 BCL6 o Follicular: t(14;18) IGH/BCL2 o Mantle Cell: t(11;14) CCND1/IGH o MALT: +18, 18q21 MALT1 o MALT: t(11;18) API2/MALT1 o MALT: t(14;18) IGH/MALT1 o Nodal marginal zone panel: 3q27(BCL6), 7q, 18q(MALT1)

Solid Tumors (Paraffin embedded) o Ewing Sarcoma: t(11;22) EWSR1 o Oligodendrogliomas: 1, 19 deletions o Synovial Sarcoma: t(X;18) SYT o ALK-EML4 2p23

Breast Cancer (Paraffin embedded) o HER2 FISH

Specimen origin:

Block Number:

Histologic type:

Cold ischemia time:

Time in formalin:

Contractor shall provide stat laboratory testing services for drugs and toxins to include: List of tests with reference ranges, specimen requirements, processing and analysis of the specimen; and reporting of specimen results through a phone call within 2 hours of carrier pickup (carrier pick up is expected with 30 minutes of requesting) and hard copy within 2 days to the MVAHCS. 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 the MVAHCS)

(2) Special instructions for handling of specimen

(b) Analyze samples.

(c) Contractor shall provide a detailed monthly billing for tests provided each month following the month in which the service was delivered. All invoices must be uploaded into the national VA electronic billing system.

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

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

(f) A Laboratory User’s Manual or similar documentation will be provided to the VA Laboratory. The manual shall include a list of all tests that the Contractor can provide along with the testing methodology used for each test, test reference ranges, length of time of testing, which days the test is run, and specimen requirements and any special handling required.

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

Contractor Qualification Requirements

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 but is not limited to Accreditation by the College of American Pathologists (CAP).

The VA Laboratory reserves the right to request the results of any proficiency testing that the contractor subscribes.

Personnel Qualifications

The qualification of the personnel described below shall be subject to review by MVAHCS laboratory Director. MVAHCS reserves the right to approve the assignment of individual personnel furnished by the contractor to perform the functions specified in the contract.

(a) The Pathologists for interpretive reports 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 directing the Comprehensive Cytogenetics Laboratory must be board-certified in Anatomic Pathology or Clinical Pathology. It is desired the Pathologist has at least 5 years’ experience in cytogenetics. It is also desired that The Director of the Comprehensive Cytogenetics Laboratory be certified in Clinical Cytogenetics by the Board of Medical Genetics or comparable certification. This laboratory must have highly skilled and trained personnel certified as Clinical Laboratory Specialists in Cytogenetics.

(c) It is desired that the Pathologist directing the electron microscopy lab be board-certified in Anatomic Pathology or Clinical Pathology and have at least 5 years’ experience in electron microscopy.

(d) Muscle and nerve biopsy testing requires an experienced MD with experience in interpretation of the specialized studies on muscle and/or nerve biopsies. It is desired that the MD has greater than 5 years’ experience in this specialty.

(e) Kidney biopsy testing requires an experienced Board-Certified Anatomic Pathologist or Clinical Pathologist with extensive training with kidney biopsies, preferably with nephropathologist fellowship training. It is desired that the Pathologist has at least 5 years’ experience in performing kidney biopsy testing.

Evidence of Insurance

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.

Contractor Responsibilities

Test Sample Preparation

A laboratory User’s manual or similar documentation will be provided to the MVAHCS laboratory. The manual shall include a list of all tests that the contractor can provide along with the testing methodology used for each test, test reference ranges, length of time of testing takes, which days the test is run, specimen requirements, special handling required and transportation instructions. A web-based copy will be accepted.

The MVAHCS laboratory shall be responsible to provide laboratory specimens prepared in accordance with the contractor’s user’s manual. Al specimens will be properly identified and labeled for testing.

Transport of Specimens

The contractor will provide the courier service for the transport of the specimens from MVAHCS to the contractor’s laboratory for testing.

Stat specimens:

The contractor will provide the courier service for the transportation of the specimen from MVAHCS directly to the contractor’s laboratory for testing within 30 minutes of notification of request.

Routine Specimens:

The contractor will provide the courier service for the transportation of the specimen from MVAHCS directly to the contractor’s laboratory for testing within 2 hours of notification of request.

Testing Requirements/ Turn Around Times:

(a) Gross & Microscopic Level IV, Electron Microscopy, Immunofluorescence Immunoperoxidase, stains

(i) Muscle Biopsy - A final report is required within 7 days of receipt of specimen

(ii) Renal/Kidney Biopsy

(a) Routine – The final report is required within 4 days of receipt of specimen

(b) Stat – The preliminary report is required within 24 hours of receipt of specimen. The final report is required within 4 days of receipt of specimen.

(iii) Nerve Biopsy - The final report is required within 7 days of receipt of specimen

(iv) Electron Microscopy - Other Tissues - The final report is required within 5 days of receipt of specimen

(v) Immunofluorescence – Skin - The final report is required within 2 days of receipt of specimen

(b) Cytogenetics – Chromosome Analysis

(i) Hematologic; Bone Marrow or Blood – The

(a) Routine – The final report is due within 5 days of receipt of specimen

(b) Stat – The preliminary report is required within 24 hours of receipt of specimen. The final report is required within 5 days of receipt of specimen.

(ii) Malignant Tissues

(a) Routine – The final report is due within 5 days of receipt of specimen

(b) Stat – The preliminary report is required within 24 hours of receipt of specimen. The final report is required within 5 days of receipt of specimen.

(iii) Blood – Metaphase Bands

(a) Routine – The final report is due within 5 days of receipt of specimen

(b) Stat – The preliminary report is required within 24 hours of receipt of specimen. The final report is required within 5 days of receipt of specimen.

(i) Routine – The final report is required within 2 days of receipt of specimen

(ii) Stat – The preliminary report is required within 24 hours of receipt of specimen. The final report is required within 2 days of receipt of specimen.

(d) Molecular – Microbiology

(i) Routine – The final report is required within 2 days of receipt of specimen

(ii) Stat – The preliminary report is required within 24 hours of receipt of specimen. The final report is required within 2 days of receipt of specimen.

(e) Toxicology

(i) Routine – The final report is required within 2 days of receipt of specimen

(ii) Stat – The preliminary report, via a telephone call (612-467-2400) to the VA laboratory personnel is required within 2 hours of courier pickup. The final report is required within 2 days of receipt of specimen.

(f) Breast Prognostic Markers/Immunohistochemistry

(i) Routine – The final report is required within 3 days of receipt of specimen

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 secure MVAHCS Laboratory FAX # 612-725-2079 located in the MVAHCS Pathology & Laboratory Medicine Service office. If results are telephoned (612-467-2400) prior to sending, the written report must include the name of the individual notified of the results, date and time of telephone report.

The contractor shall consult with the VA laboratory on test results by telephone as needed. Each consult report shall at a minimum indicate the following information:

(a) Patient’s name and identification code

(b) Physician’s name (if supplied)

(d) Patient’s location, e.g. clinic, ward (if supplied)

(e) Test ordered

(f) Date/time of specimen collection (when available)

(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 unsuitab

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File details come from the government source that posted it. Updated Sep 15, 2020.