36C26123Q0502 0001.docx

36C26123Q0502

5. PROJECT NUMBER (if applicable)

CODE

7.

ADMINISTERED BY

2. 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

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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 NUMBERE

D 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 amendmen t, 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)

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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) None

612MCP

Department of Veterans Affairs Network Contracting Office (NCO) 21 5342 Dudley Blvd, Bldg 209 McClellan CA 95652-2609

612MCP

Department of Veterans Affairs Network Contracting Office (NCO) 21 3230 Peacekeeper Way, Bldg. 209 McClellan CA 95652-1012 To all Offerors/Bidders

36C26123Q0502 04-17-2023

X

X

a. The purpose of this amendment is to answer questions from interested vendors.

IMPORTANT: Vendor shall sign and acknowledge the amendment and return the signed copy with quote.

Joleo Dianala Contracting Officer Solicitation Questions and Answers 36C26123Q0502 Histopathology Services for San Francisco VA Medical Center

1. PWS, item 1.1 – Please define the VA’s expectation for the Contractor to provide…“analysis and reporting of analytic results”.

0. Analysis pertains to histology and quality assurance, analysis does not pertain to any billable physician codes

1. PWS, item 1.1.3.4 – Can you provide a sample of the expected format for “statement of the total number of cassettes, blocks made and total number of slides sent”?

1. Statements can be submitted monthly listing the number of blocks processed (with H&E slide, number of recuts, number of specials stains, number of immunohistochemistry stains performed, number of unstained slides cut.

1. PWS, item 1.1.3.5 – With regards to “Check daily sheet for accuracy in case of discrepancy”, does this mean verification of a shipping manifest or something different? Please clarify.

2. Yes, this means checking the manifest and that statement of the total number of cassettes, blocks made and total number of slides sent.

1. PWS, item 1.1.5 – Is the Contractor’s lab representative expected to be present at each monthly pathology QA meeting?

3. No

1. PWS, item 1.1.7 – Please define “analyze” samples and provide accurate test results.

4. Analysis pertains to histology and quality assurance, analysis does not pertain to any billable physician codes

1. Would the Contractor ever complete the technical and professional components for a case?

5. No.

1. PWS, item 1.1.8 – Please clarify turnaround time expectations for slides to be returned to the SFVAMC. In addition, slides are not “reported”.

6. Turnaround expectations pertains to histology, immunohistochemistry, and special stains. The stains are interpreted at SFVAMC.

1. PWS, item 2.4 – Regarding “All work shall be performed at the Contractor’s facility”; are multiple facilities acceptable?

7. Yes, but specimen turn around time must be met.

1. PWS, item 3.1.1.3 – Regarding JCAHO accreditation; reference labs outside of a medical facility are often not inspected by JCAHO, as that organization is primarily focused on hospital accreditations. Please confirm this will not apply to the Contractor as an independent reference lab.

8. CAP certification without JCAHO accreditation is acceptable.

1. PWS, item 4.1.2 – What are the VA’s expectations with regard to “at least (minimum) daily controls” conducted by Contractor to determine procedure accuracy?

9. Regular stain controls are required for routine stains and regular positive and negative controls are required for special stains.

1. PWS, item 4.1.4 – Would the Contractor’s pathologist have to call the VA COR or designee before requesting add-on testing (e.g. breast markers)?

10. Yes

1. PWS, item 6.1 – Please clarify the turnaround time as the return of slides, special stains, and immunohistochemistry stains are not considered tests to be completed.

11. Routine specimen processing and staining are required to be received the following business day with earlier arrival preferable. Acceptable turn around time for Special stains and immunohistochemistry shall be 4 calendar days.

1. PWS, item 17.1 – Would there ever be medical-legal specimens used for evidence in legal proceedings that require chain of custody? Please clarify.

12. Rarely. Contractor’s duties are clearly specified in the contract.

1. Would SFVAMC request professional consults from the Contractor?

13. No.

1. Can you provide a list of the special stains and IHC antibodies required?

14. We currently require the following special and IPOX stains:

Required Special Stains:

AFB

Alcian Blue Alcian Blue/PAS Colloidal Iron Congo Red

EVG

IRON

FITE

Fontana

GIEMSA

GMS/PCP

GRAM

Jones Mucicarmine Oil Red O

PAS

PAS-Diastase PAS-Fungus Toluidine Blue Trichrome Uric Acid Von Kossa Warthin-Starry

Required Immunohistochemistry stains:

Actin (clone HHF35)

AFP

AMACR/p504s (clone 13H4) Amyloid A (clone mc1) Arginase-1 (clone EP261) BCL2 (clone 124) BCL6 (clone pg-b6p) BerEP4 (clone ber-ep4) β-Catenin (clone βcat1) C4d (clone A24-T) CA 19-9 (clone 1116-ns-19-9) CA 125 (clone m11) Calcitonin Caldesmon (clone h-cd) Calponin (clone calp) Calretinin (clone dak-calret1) Carbonic Anhydrase IX (clone MRQ-54) Caspase-3 CD1a (clone 010) CD2 (clone ab75)

CD3

CD4 (clone 4b12) CD5 (clone 4c7) CD7 (clone cbc.37) CD8 (clone c8/144b) CD10 (clone 56c6) CD15 (clone carb-3) CD19 (clone le-cd19) CD20cy (clone l26) CD21 (clone 1f8) CD23 (clone dak-cd23) CD30 (clone ber-h2) CD31 (clone jc70a) CD34 (clone qbend10) CD43 (clone df-t1) CD44 (clone df1485) CD45 (clone 2b11+pd7/26) CD45ro (clone uchl1) CD56 (clone 123c3) CD57 (clone tb01) CD68 (clone pg-m1) CD79a (clone jcb117) CD99 (clone 12E7) CD117/c-kit CD138 (clone mi15) CDX-2 (clone dak-cdx2) CEA mono (clone II-7) Chromogranin A (clone dAK-a3) CK 5/6 (clone d5/16b4) CK 7 (clone ov-tl12/30) CK 8/18 (clone EP17/30) CK17 (clone e3) CK 18 (clone dc10) CK 19 (clone rck108) CK 20 (clone kc20.8)

CK AE1/AE3

CK HMW (clone 34βe12) Pan-CK (wide spectrum) CMV (clone cch2+ddg9) Collagen IV (clone civ 22) Cyclin D1 (clone ep12) D2-40 (clone d2-40) Desmin (clone d33) DOG-1 (clone dog-1) EBV,LMP (clone cs.1-4) E-Cadherin (clone nch-38) EGFR (clone h11) EMA (clone E29) ERG (clone EP111) Factor XIIIa (clone e980.1) Gastrin GATA3 (clone L50-823) Galectin-3 (clone 9C4) GCDFP-15 (clone 23a3)

GFAP

Glycophorin A(clone dba44) Glypican-3 (clone 1G12) p40 (clone BC28) p53 (clone do-7) p63 (clone bc4a4) PAX5 (clone dak-pax5) PAX8 (clone MRQ-50) PLAP (clone 8a9)

PSA

PSAP (clone pase/4lj) Prostein(p501s) (clone 10e3) RCC (clone 8pm314) S100 SMA (clone 1a4) Smoothelin (clone r4a) SMM-HC (clone smms-1) Synaptophysin(clone DAK-SYNAP) TdT Thrombomodulin(clone 1009) Thyroglobulin TTF-1 (clone 8g7g3/1) Uroplakin ii/III (clone SP73) Villin (clone 1d2 c3) Vimentin (clone v9) vWF/Factor VIII WT-1 (clone 6f-h2) Hairy Cell Leukemia(clone DBA.44) HBME-1 (clone hbme-1) hCG Helicobacter pylori Hepatocyte (clone och1e5) HPV (clone k1h8)

HSV-1

HSV-2

Inhibin (clone R1) Insulin Kappa Ki-67 (clone mib-1) Lambda Lysozyme Mammaglobin (clone 304-1as) MOC-31 (clone moc-31) MUC2 (clone CCP58) MUC5 (clone CLH2) MUM1 (clone MUM1P) Myeloperoxidase Myogenin (clone F5D) Napsin A (clone tmu-ad02) NFP (clone 2f11) NSE (clone bbs/nc/vi-h14) OCT3/4 (clone N1NK) p16 (clone e6h4)

1. Can you provide a CPT code level utilization with annual volumes?

15. Our approximate annual volumes are as follows:

Blocks made with 1 H&E slide: 13,780 Recuts: 1936 Special stains: 428

IPOX: 4080

Unstained slides: 5748

1. When can we expect answers to bidders questions?

16. The time varies depending on the number of questions from interested vendors. As a reminder, the Government will post answers to questions on sam.gov. Please ensure the company regularly checks for amendments until the close date of the solicitation.

1. Because clarification questions will be accepted through May 8, which is only four days from the RFP due date, will you consider extending the RFP due date by two weeks? This will allow bidders enough time to respond appropriately based on the Q&A’s.

17. Thank you for your request. The Government will consider providing an extension. If approved, a solicitation amendment will be posted on sam.gov to specify a new due date and time. At this time, all quotes are due at the solicitation’s due date and time of May 12, 2023 11:59PM PDT.