36C25925Q0267 0001.docx

DOCX document 97 KB Posted Mar 28, 2025

Attached to: Q301--Unrestricted- Immunohistological Stains Reference Testing for Rocky Mountain Regional VA Medical Center
Solicitation number: 36C25925Q0267
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 19

About this file

Written by GovTribe AI · Mar 28, 2025

This document is an Amendment (0001) to a Blanket Purchase Agreement (BPA) for immunohistological and reference laboratory testing services for the Rocky Mountain Regional VA Medical Center. The solicitation (36C25925Q0267) seeks a contractor to provide comprehensive laboratory testing, including immunohistochemical stains, molecular testing, cancer profiling, and specialized diagnostic services across multiple cancer types. The contract period runs from July 1, 2025, to June 30, 2030, with an estimated ceiling limit of $675,000 and individual order limits up to $160,000.

Key amendments include incorporating a detailed spreadsheet of CPT codes for required tests, updating the Statement of Work, removing the Mammostrat test, and extending the quote submission deadline to April 10, 2025. The contractor must be CLIA and CAP certified, perform all tests in-house without subcontracting, maintain specific turnaround times (2-14 days depending on test type), and ensure testing accuracy. The contract covers an extensive range of tests, including over 250 individual immunostains, hematopathology tests, molecular genetic testing, and cancer-specific profiles across various cancer types like breast, prostate, lung, and brain cancer.

View the file

Other files

File	Type	Posted
36C25925Q0267 0002.docx	DOCX document	Apr 14, 2025
Attachment B - Amendment 0001 Questions and Answers.docx	DOCX document	Mar 28, 2025
Attachment A - CPT Codes.xlsx	XLSX spreadsheet	Mar 28, 2025
36C25925Q0267.docx	DOCX document	Mar 10, 2025

On GovTribe

Work with this file

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

Try for free Login

Text version

The file's text, extracted by GovTribe without its formatting.

36C25925Q0267 0001 36C25925Q0267 Amendment 0001 Q301--Unrestricted- Immunohistological Stains Reference Testing for Rocky Mountain Regional VA Medical Center

** HOUR & DATE for Receipt of Offers is EXTENDED to: 04-10-2025 16:30 MDT

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:

Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF

AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO

AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 03-28-2025

36C259-25-AP-0056

None 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

South Willow Drive, Suite 300 Greenwood Village CO 80111 To all Offerors/Bidders

36C25925Q0267

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 04-10-2025 16:30 MDT See CONTINUATION Page X Amendment 0001 Hereby Amends Solicitation 36C25925Q0267 as follows:

a. A spreadsheet with CPT codes for all required tests has been incorporated into Section D as Attachment A.

b. Questions and Answers have been incorporated into section D as Attachment B.

c. The Statement of Work has been amended to include the CPT codes reference in the test menu section and remove "Mammostrat" from the test menu as this test is no longer required.

d. The BPA Terms and Conditions has been amended in Section B.9 Authorized Limits to change "over $675,000.00 the period covered by the agreement" to "$675,000.00 over the period covered by the agreement."

e. Mammostrat was removed from the price schedule.

f. The deadline for quotes to be submitted has been extended until 04/10/2025, no later than 16:30 Mountain Time.

g. All other terms and conditions of this solicitation remain the same.

Lindsey Zwaagstra Contracting Officer

VA-VHA-RPOW-2025-0014

Continuation Pages

B.2 STATEMENT OF WORK

Rocky Mountain Regional VAMC Immunohistochemical, Special Stain, Hematopathology, Genetic, Molecular, & Solid Tumor Reference Laboratory Services Statement of Work

1. SCOPE:

The Contractor should be able to provide a wide range of testing services as well as specialized laboratory testing including but not limited to immunohistochemical stains, special stains, diagnostic and prognostic markers for breast cancer prognosis to include interpretation, IHC breast assays, HER2 Profiling, Micrometastasis analysis, gastric cancer profile, molecular PCR pathway testing, mismatch repair (MMR/microsatellite instability (MSI), diagnostic and prognostic molecular testing for all types of malignancy and other specialty testing, on a cost per test basis. See Test Schedule (Attachment A: Minimum Tests Required) for the minimum test list. This list is not all inclusive. Rocky Mountain Regional VA Medical Center (RMRVAMC) reserves the right to order any test provided by the Contractor.

2. GENERAL REQUIREMENTS:

A. In-house Testing

a. The Contractor shall have the ability to perform all testing listed without splitting the specimen and sending to subcontracted labs as these are irretrievable specimens from surgical/invasive procedures and cannot be recollected.

b. The Contractor shall perform all tests listed in house without sending tests out to a subcontractor as these are irretrievable specimens from surgical/invasive procedures and cannot be recollected in order to minimize loss, errors, and degradation of samples. Sample integrity shall be ensured by all tests being performed in house.

B. Turnaround Time

a. The Contractor shall have 2-5 days maximum from time of receipt to return stains to the Government for review by RMRVAMC pathologists.

b. The Contractor shall have 7-14 days maximum from time of receipt to return molecular testing, global testing, and specialized testing to the Government.

c. The Contractor shall have 2-3 days maximum from time of receipt to return a FAXED report of the diagnostic test results to RMRVAMC Pathology Department.

d. The Contractor shall have 2-5 days maximum from time of receipt of Government provided patient stains and specimens, to ship back/return patient stains/slides and molecular specimens (once testing is complete) to RMRVAMC Pathology Department.

C. Performance Measures

a. The Government will monitor the accuracy of invoices and quality of reports in relation to the clinical history for the patient.

b. The Contractor’s performance will be monitored on the following criteria:

i. No more than 5% of tests sent are falsely negative or falsely positive

ii. Contractor cannot request additional testing material in more than 10% of all cases sent

iii. Contractor cannot exceed defined Turnaround times in more than 10% of all cases sent D. Ordering Paper requisitions shall be provided by the Contractor. The Government will utilize the paper requisitions and check off tests needed for the specimen(s). The Government will send/ship the paper requisition/form along with the specimen(s) to the Contractor.

E. Prices and Terms The Contractor shall provide pricing for available in-house tests in accordance with Cost per Test (CPT) contained in the Test Schedule (Attachment A: Required Tests). RMRVAMC will provide an annual test volume. The values are estimated. Attachment A is not an all-inclusive list, but the minimal tests the Contractor provides. RMRVAMC reserves the right to order any test provided by the Contractor. Newly developed testing shall be added as required/needed. Any additional costs such as Industrial Funding Fees, special shipping and handling fees, or other usage fees must be clearly indicated in the price quote.

F. Resources

a. Government Furnished Resources

i. The Government shall package the specimens (tissue and cytology specimens) in packaging and shipping materials provided by the Government and ship the package to the Contractor.

ii. There will be no shipping costs to the Contractor for specimens shipped to the Contractor for testing.

b. Contractor Funded Resources

i. Contractor shall ship back the specimens (for stains and molecular tests) and slides (from the stains) in Contractor furnished packaging and shipping material.

ii. Shipping costs for sending specimens and slides back to the Government will be the sole responsibility of the Contractor.

3. TECHNICAL REQUIEMENTS

A. The Contractor must be Clinical Laboratory Improvement Act (CLIA) and College of American Pathologists (CAP) certified. The Contractor shall provide a copy of their CLIA number when sending their proposals to the solicitation.

B. The Contractor must have the required tests available with accompanying Current Procedural Terminology (CPT) codes. Each laboratory test must have defined turnaround times, defined specimen requirements, and defined specimen stability. These requirements should be available electronically.

C. The Contractor must have the ability to perform all testing listed without splitting the specimen.

D. These specimens are irretrievable as they are collected during invasive procedures.

E. The Contractor must have a system in place for the ordering of testing.

F. The Contractor shall have the ability to add new tests as they are developed/become available for the diagnosis of cancer.

G. The Contractor must perform the testing with sufficient quality of results as judged by the reviewing pathologist. Testing much correlate with clinical findings and other supportive diagnostic tests used to render a diagnosis.

H. The Contractor shall be HIPAA compliant.

Attachment A: Tests Required (See Attachment A for CPT Codes in SF30 Section D-Contract Documents, Exhibits, or Attachments)

· KRAS by PCR

· EGRF by PCR

· ALK FISH

· BRAF V600 Mutation

· BRAF by PCR

· EGRF by FISH

· MMR global

· Her 2 neu global

· Her 2 neu FISH

· ER global

· PR global

· MSI by PCR

· Kappa FISH (stain only)

· Lambda FISH (stain only) Immunostain:

· AACT

· AAT

· ACTH

· Actin (MSA)

· Actin (SMA)

· Adenovirus

· AE1/AE3 (pan-CK)

· AFP

· ALK-1

· Amyloid A

· AR

· ß-Amyloid P

· B72.3

· B-Amyloid

· BCA-225

· BCL1 (Cyclin D1)

· BCL6

· BCL2

· BerEP4

· Beta-Catenin

· BE-8, BOB1

· BRCA1

· Breast Triple Stain

· CA15.3

· CA19.9

· CA125

· Calcitonin

· Caldesmon

· Claponin

· Calretinin

· CAM 5.2

· Cathepsin D

· Cat Scratch

· Cyclin D1/BCL1

· CD1a

· CD2

· CD3

· CD4

· CD5

· CD7

· CD8

· CD10

· CD11c

· CD14

· CD15

· CD19

· CD20

· CD21

· CD22

· CD23

· CD25

· CD30

· CD31

· CD33

· CD34

· CD35

· CD38

· CD42b

· CD43

· CD45

· CD45RB

· CD45RO

· CD56

· CD57

· CD61

· CD68

· CD74

· CD75

· CD79a

· CD99

· CD117(C-KIT)

· CD123

· CD138

· CD163

· CDX2

· CDX2/CK7

· CEA monoclonal

· CEA polyclonal

· Chromogranin A

· CK5

· CK5/6

· CK7

· CK8

· CK14

· CK17

· CK18

· CK19

· CK20

· CK903(CK-HMW)

· CK-Double Stain (HMW/LMW)

· CK OSCAR (pan-CK)

· CMV

· Collagen IV

· COX2

· CXCR4

· Cyclin E

· D2-40

· DBA.44

· DCC

· Desmin

· DOG1

· DPC4 (SMADU)

· EBV(LMP-1)

· E-Cadherin

· eIFd4E

· EGFR

· EMA

· ER

· ERCC1

· Factor VIII

· Factor XIIIa

· Fascin

· Fli-1

· FOX P3

· FSH

· GCDFP-15

· GFAP

· GH

· Gastrin

· Glucagon

· GSTπ

· Glycophorin-A

· Glypican-3

· Granzyme

· H.Pylori

· HBVc

· HBVs

· HBME-1

· HER2(hercepTest)

· HCGβ

· Hemoglobin A

· HepPar-1

· HHV8

· HPV

· HLA-DR

· HMB-45

· HAFG2

· HPL

· HSV I

· HSV II

· IgA

· IgD

· IgG

· IgG4

· IgM

· Inhibin

· Insulin

· Kappa

· Ki-67

· Ki-67/Caspase-3

· LH

· Lambda

· Lysozyme

· Mammaglobin

· Melan A

· Mesothelin

· MGMT

· MITF

· MOC-31

· MSH2

· MSH6

· MDR

· MLH1

· M PO

· mTOR

· MUC-1

· MUC-2

· MUC-5

· MUC-6

· MUM1

· MyoD1

· Myogenin

· Myoglobin

· Napsin A

· NB

· NF

· NSE

· OCT 2

· OCT 4

· p16

· p21

· p27

· p53

· p57

· p63

· p120(caterin)

· p501S

· p504S

· Pakt

· Pan Melanoma

· Parvovirus

· PAX2

· PAX5

· PD1

· PDGFRA

· PDGFRB

· Perforin

· PHH3

· PLAB

· P.Carinii

· PMS2

· PP

· PR

· Prealbumin (TTR)

· Prolactin

· Prostate Triple Stain

· PSA

· PSAP/HPAP

· PTEN

· PTH

· RCC1

· S100

· Serotonin

· SMMHC

· Somatostatin

· Surfactant

· Spirochete

· Survivin

· Synaptophysin

· Tau

· TdT

· TM

· TGB

· TGF- α

· TRAP

· TS

· TSH

· TTF-1

· TIA-1

· Toxoplasma

· Tryptase

· Tuberculosis

· Tyrosinase

· Uroplakin III

· VEGF

· Villin

· Vimenti

· Wilm’s Tumor (WT-1)

· ZAP-70

Hematopathology:

· Flow Cytometry Panels

· FISH (Hematologic, Plasma Cell)

· Individual Probes

· Cytogenetics

· Molecular Genetic Testing

· Cancer Profiles

· Liquid Biopsy Testing Solid Tumor:

· Consultation

· Cancer Profiles

· Prostate Cancer Testing

· Breast Cancer Testing

· Colon Cancer

· Sarcoma

· Brain Cancer

· Bladder Cancer

· GI Cancer

· Melanoma

· Lung Cancer

Page 1 of

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

1.00

__________________

KRAS by PCR Contract Period: Base POP Begin: 07-01-2025 POP End: 06-30-2030 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing Not to exceed 50 tests annually

1.00

__________________

EGRF by PCR