Questions for Anatomic Pathology Updated.docx

Questions for Anatomic Pathology (Questions are in numerical order followed by a corresponding answer#)

1. We are performing independent research on the Combined Synopsis/Solicitation (36C24424Q0892). We would like to know if this is a brand new contract OR if there is (was) an incumbent performing these services. If not brand new, could you please provide the current / previous contract number?

Answer #1: The current contracts are as follows:

· 36C24424F0384 – Philadelphia

· 36C24424P0620 – Wilkes Barre

2. Pages 37 to 45 of the solicitation contain charts of each facility's historical annual volume for the tests subject to the solicitation. Could you please explain how the historical annual volumes were calculated? For example, are the figures provided an average of prior years? If so, how many prior years were included in that average, and what were the minimum and maximum number of orders during each one of those years?

Answer #2: The average of two years is provided to include a median.

3. The solicitation contemplates a base year and, at the election of the Government, up to three option years. May the Contractor condition its proposal on the Contractor's ability to decline an option year, and thus terminate the contract, if actual utilization is materially different than the historical utilization in the solicitation

Answer #3: This is for a Firm Fixed price BPA for a term of (4) four years. See updated price schedule. There are pricing periods not options. (See updated RFQ).

4. Requesting an extension for the due date.

Answer #4: See Block #11 of the amendment.

5. Request a 4-week extension to the RFP due date as well as a new open period for Q&A.

Answer #5: See Block #11 of the amendment.

Late Questions (6-11) were accepted as they provide clarification to the requirement

6. Given that this RFP includes two distinct VA facilities, would you consider aligning the turnaround requirements? The TAT used for Michael J Crescenz MC (CMCVAMC) tend to be more along industry standards for this type of testing. Having an award with different requirements and different geographical locations could be difficult to manage/measure under one award for both of the awardee and the CO.

Answer #6: The turnaround requirements shall remain. The 24 Hour TAT is needed. These are two different types of facilities and different sizes.

7. In reference to Factor 1 b. Unlike standard reference testing that provides a result (often times electronic), this RFP includes a portion of work needing to be physically returned (immunohistology prepared slides) to the client. This will of course add to the actual TAT. Considering these extenuating circumstances would you consider measuring TAT for both sites from receipt to the performing laboratory to the return of the result/sample? For immunohistology prepared slides a minimum of 12 hours would need to be added to the posted TAT used for the Michael J Crescenz MC (CMCVAMC ) for transportation back to the VA.?

Answer #7: Twelve (12) hours can be added but the definition of TAT must not change.

8. Would TAT outside of the requirements be considered for award?

Answer #8: It would be considered unfavorably.

9. Where can vendors present back to VISN 4 possible reflex testing and or associated testing based on the test list provided?

Answer #9: There needs to be a least a 99% match.

10. Will the proposing vendor be penalized or disqualified from the RFP if there is a “no match” to any tests in the test list?

Answer #10: All tests on the list shall be provided.

11. Can you please provide additional information for the tests below?

Answer #11: See Comments Section below for full answer.

Panel includes:

ABL, ASXL1, BCOR, BCORL1, BRAF, CALR, CBL, CDKN2A, CEBPA, CSF3R, CUX1, DNMT3A, ETV6, EZH2, FBXW7, FLT3, GATA1, GATA2, IDH1, IDH2, IKZF1, JAK2, JAK3, KDM6A, KIT, KMT2A, KRAS, MPL, NF1, NOTCH1, NPM1, NRAS, PDGFRA, PHF6, PML, PTEN, PTPN11, RAD21, RUNX1, SETBP1, SF3B1, SMC1A, SMC3, SRSF2, STAG2, TET2, TP53, U2AF1, WT1, ZRSR2.

Fluorescence in situ hybridization (FISH) for multiple myeloma (MM); IgH-CCDN1; FGFR3/IgH; CMAF/IgH; SNP microarray (Reveal®) Diagnostic test for multiple myeloma. Plasma cell enrichment diagnosis increased as much as 50% to 100%.

This test will detect chromosomal imbalance that may be present in neoplastic disorders and clonal evolution.

This test will detect chromosomal imbalance that may be present in neoplastic disorders and clonal evolution. It provides detection of copy-neutral loss of heterozygosity of any chromosome, and the percent and location of homozygosity, that may be associated with cancer gene mutations.

SNP microarray analysis is performed using the Cytoscan® HD Accel platform, which uses more than 743,130 SNP probes and 2,029,441 NPCN probes with a median spacing of 0.818 kb.