36C26326Q0727 Amd 0001.pdf

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

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)

1 12

0001 11-10-2026

None

36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

316 ROBERT STREET N, SUITE 506

SAINT PAUL MN 55101

36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

316 ROBERT STREET N, SUITE 506

SAINT PAUL MN 55101

To all Offerors/Bidders

36C26326Q0727

11-09-2026

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to:

See CONTINUATION Page Proposals due has been extended to: November 24, 2026 by 10:00am CST.

X -ONE-

NWI Offsite Pathology Services, Solicitation: 36C26326Q0727 Amendment 0001 incorporates the following:

(a) Post Responses to submitted RFI's

(b) IAW the attached RFI, the PWS has been revised.

(c) The Solicitation number in the SAM.gov announcement has been corrected from 36C26326R0063 to 36C26326Q0727.

(d) Proposals are due November 24, 2026 @ 10:00am CST.

Logan Gahring Contracting Officer

VA-VHA-RPOC-2026-0025

RFI Questions for 36C26326Q0727

NWI Pathology

1. Requesting confirmation: Participating VA facilities will furnish specific specimen collection and transport supplies as outlined in Attachment A (Table 1.1) and Sections 1.9 through 1.11.

Response: Table 1.11 identifies the Supplies that are to be provided by the contractor.

2. Ordering Authority and Communication Protocol Clarification / Confirmation Requested:

Requesting confirmation that a designated Pathologist from the participating VA facility(ies) will serve as the sole authorizing point of contact for requesting and receiving pathology laboratory services.

Additionally, confirm this designated authority will provide Contractor with the following compliance and credentialing information prior to contract award, or upon any proposed change of Key Personnel (per Section 2.1.9):

• 2.1.9.1: Provider Name, Title/Position, and Grade/Rank.

• 2.1.9.2: Curricula Vitae (not to exceed 2 pages per individual). Please clarify if this remains a mandatory requirement.

• 2.1.9.3: Technical Staff Competency Skills Assessment.

• 2.1.9.4: College of American Pathologists (CAP) or equivalent Proficiency Exam participation records for the past two (2) years.

• 2.1.9.5: Proficiency Examination Exception Reports for the past two (2) years.

Response: The information above is required information the contractor needs to provide. The POC’s at the each facility will be discussed after award. All contact will go through the Omaha Lab

POC.

3. Scope of Work & Workflow Clarifications

• Grossing Duties: Section 1.1 assigns grossing responsibility to the VA (excluding cytology). Please clarify if the Contractor will be required to perform any grossing tasks under this contract.

Response: Per 1.1 “VA will be responsible for specimen collection, preparation, grossing (with the exception of, cytology specimens); global surgical pathology cases would require grossing by the contractor. The VA will accession histology and cytology cases, VistA accessioning, preservation and storage of final slides and blocks.”

• Accessioning Protocol: Please confirm Contractor’s staff will also be required to accession both histology and cytology cases into the VA’s VistA or proprietary Laboratory Information System (LIS).

Response: The contractor would complete the work at their site, and then submit the report via fax

(402) 995-3353; the VA lab office staff will enter into Vista, or EHRM. The contractor will not have access to our systems.

4. Turnaround Time (TAT) Adjustments

• Process Dependencies: Requesting flexibility regarding contractual Turnaround Time (TAT) metrics. Any responsibilities or multi-step processing workflows introduce operational variables that directly impact overall diagnostic timelines.

Response: The contractual turnaround time is based on a metric based in the Path/Lab 1106 guidance and is not flexible.

5. Facility & Material Support

• Biohazard Disposal: Please clarify if the VA will provide or reimburse for biohazard waste removal services. Response: No.

• Control Materials: Please confirm if the VA will supply the necessary tissue blocks for positive laboratory controls. Response: No.

5. Attachment 5, Section 1.1.1 (Histology) – Request for Clarification & Technical Proposal Identified Discrepancy:

There is an operational contradiction regarding specimen retention and storage requirements between Sections

3.2.6.1 and 3.2.6.2: • Section 3.2.6.1 mandates a daily 9:00 a.m. physical slide return to the NWIHCS-Omaha Main Lab for assessment and permanent storage. • Section 3.2.6.2 shifts the responsibility of permanent block and slide storage to the contractor if the professional component is performed.

Response: 3.2.6.2 has been clarified to read “Permanent storage of blocks & slides will be the responsibility of the contractor if they perform the professional component.”

7. Clarification Requested:

Please clarify which entity retains permanent storage of slides and blocks when the contractor fulfills the professional component.

Response: 3.2.6.2 has been clarified to read “Permanent storage of blocks & slides will be the responsibility of the contractor if they perform the professional component.”

8. Proposed Operational Solution:

To eliminate transit delays and satisfy immediate assessment needs, the contractor will provide digital pathology results for review.

Response: The VA does not have the IT capabilities to allow for digital pathology. Submit the report via fax

(402) 995-3353; the VA lab office staff will enter into Vista, or EHRM. The contractor will not have access to our systems.

9. Regarding the physical specimens, we request flexibility on the 9:00 a.m. daily return mandate. We propose that the formal shipping logistics and transit process begin immediately following the successful completion of all initial and supplementary testing requests.

Response: The contractual turnaround time is based on a metric based in the Path/Lab 1106 guidance and is not flexible.

10. Section 3.2.6.3 Modifications Requested: • Turnaround Time (TAT): Requesting flexibility in TAT metrics when additional studies are ordered on tissue blocks.

Response: The contractual turnaround time is based on a metric based in the Path/Lab 1106 guidance and is not flexible.

• Specimen Return: Proposing a 24-hour turnaround time for returning tissue blocks to the VA upon formal request.

Response: The contractual turnaround time is based on a metric based in the Path/Lab 1106 guidance and is not flexible.

11. Reference: Attachment C (RFI + Sources Sought) indicates:

“The Nebraska-Western Iowa Health Care System (NWIHCS) intends to procure Medical Laboratory and Pathology Services, inclusive of autopsy services.” Please note the following clarification regarding our laboratory scope:

• We do not perform autopsies or receive intact bodies.

Response: This is a requirement of the PWS, which cannot be waived. Contractors are required to provide autopsy services. Should a contractor decide to provide the services through the use of subcontractors, the contractor must ensure that any subcontracting is done IAW the limitations on subcontracting.

12. Our technical staff only processes referred tissue sections and specimens.

Response: This alone does not fulfill the requirements of the PWS.

13. Is there any incumbent/recompete or is this a brand new project. If yes, could you provide us with their award number or even if the customer bought similar services in the past.

Response: This is a follow-on contract to: 36C26322D0064 with Physicians Laboratory, P.C.

A. Solicitation Document Clarifications

No. Solicitation Reference Question

1 Face page (SF 1449) Running page header Section E.2 (p. 56)

The solicitation number appears as 36C26326R0063 on the SF 1449 and as 36C26326Q0727 in the header of each page. The proposal file-naming conventions in Section E.2 reference 36C26324R0072 (Parts 1a, 1b and 2) and 36C26324R0063 (Part 1c).

Please confirm the correct solicitation number and the file-naming convention Offerors are to use for each proposal part. If the Section E.2 references were carried over from a prior solicitation, please issue a corrected Section E.2.

Response: The correct Solicitation Number is 36C26326Q0727 and has been updated throughout the document

2 Section B.2 (p. 4)

PWS 1.14 (p. 9) Section B.2 states the Period of Performance as April 1, 2027 – March 30, 2032.

The Year 5 line item (4/1/2031 – 3/31/2032) and PWS 1.14 end on March 31, 2032.

Please confirm the correct end date of the five-year ordering period.

Response: 4/1/2027 – 3/31/2032 3 Section B.2 (p. 4)

Section C (pp. 41–42) Section B.2 cites “C.6 FAR 52.216-22,” “C.4 FAR 52.216-18” and “C.5 FAR 52.216-19.” In Section C, these clauses are numbered C.4, C.2 and C.3, respectively (C.5 is FAR 52.217-8 and C.6 is FAR 52.222-90).

Please confirm the intended clause references.

Response: Corrected

4 Section B.1, item 5 (p.

3) PWS 5.2 (p. 29)

Section B.1 directs Offerors to “PWS Section 6.2” for billing instructions.

The billing instructions appear at PWS 5.2, and PWS Section 6 (Payment in Full/No Billing VA Beneficiaries) has no subsection 6.2.

Please confirm the correct reference.

Response: Corrected to 5.2 5 Section B.1, item 1 (p.

3) PWS 4.1 (p. 26)

Section B.1 identifies Megan Hollibaugh (402-995-3604) as the Contracting Officer’s Representative (COR). PWS 4.1 identifies the COR as Susan Dover (Susan.Dover@va.gov, 402-346-8800 Ext. 3358).

Please confirm the COR for this contract and issue a corrected reference if needed.

Response: Corrected mailto:(Susan.Dover@va.gov

6 PWS 3.2.7.4 (p. 15) PWS 3.9.6.3 (p. 21) Section D (p. 54)

PWS 3.2.7.4 refers to Internal Consults and Second Signature Consults “as requested – Attachment 13.”

Response: 3.2.7.4 has been removed, holdover from another document PWS 3.9.6.3 refers to the Medical Staff Bylaws and Regulations and the NWIHCS Collaborative Care Agreement, Version 14.0, as “(attached).”

Section D lists only Attachments 1 through 8 and does not identify any of these documents.

Response: 3.9.6 has been removed, holdover from another document

Please provide Attachment 13, the Medical Staff Bylaws and Regulations, and the Collaborative Care Agreement, or clarify whether Attachment 8 (ANP-RPT-6 Intradepartmental Consult Form) is the intended reference for

PWS 3.2.7.4.

Response: PWS has been revised to remove 3.2.7.4.

7 Attachment 5, Summary of Lab Information tab (cell B1) Section E.2 (p. 57)

The Instructions to Offerors on the Summary of Lab Information tab direct Offerors to indicate the performing laboratory in column “E” of the subsequent sheets. Section E.2 and the schedule tabs identify column G on the Profee_CMS tabs and column H on the CLIA tabs for this entry.

Please confirm the correct columns.

Response: This has been updated.

8 Section B.2 (p. 4)

Attachment 5 Section E.2 (p. 57)

Section B.2 provides one line item per ordering period (0001, 1001, 2001, 3001 and 4001). Attachment 5 numbers the Profee_CMS tabs in the 0001 series (e.g., 0001AA) and the CLIA tabs in a separate 0002 series (e.g., 0002AA), with corresponding 1002, 2002, 3002 and 4002 series in later periods.

Please clarify whether the combined Profee_CMS and CLIA totals for each ordering period are to be entered under the single Section B.2 line item, or whether Section B.2 will be amended to add the 0002, 1002, 2002, 3002 and 4002 line items.

Response: You will enter unit pricing within the spreadsheet. In Section B.2, you will enter the estimated total price for the year.

9 Attachment 5, Profee_CMS OP2 – OP5 tabs, rows 19–37 and 44–60

On the OP1 tab, the descriptions match their CPT codes. On the OP2 through OP5 tabs, the description in each of these 36 rows does not correspond to the CPT code on the same row. For example, CPT 88187 is described on OP1 as “Flowcytometry/read 2-8” but on OP2–OP5 as “Necropsy (Autopsy), gross & microscopic with Brain and Spinal Cord”; CPT 88104 is described on OP1 as “Cytopath fl nongyn smears” but on OP2–OP5 as “Cytopath fl nongyn filter.”

Please confirm whether the CPT code or the description controls, and issue a corrected Attachment 5 by amendment.

Response: This has been corrected.

B. Performance Work Statement – Autopsy Requirements

10 PWS 3.2.11.10 and

3.2.13 (p. 16) PWS 3.13.7 (p. 24) Contract Data Requirements List (p.

28)

The timeframe for submitting the final autopsy report is stated inconsistently.

PWS 3.2.11.10 requires the completed post-mortem exam, with final copy of succeeding pages, within 30 working days. PWS 3.2.13 requires final autopsy reports within 60 business days of completion of the autopsy. PWS

3.13.7 (Autopsy – Final Report, Acceptable Quality Level 100%) and the Contract Data Requirements List both state 60 working days.

Please confirm which timeframe applies and whether it is measured in working days or business days.

Response: The Directive has been updated to 60 calendar days

In addition, the Contract Data Requirements List cites PWS 3.2.9.2 and

3.2.9.3 for the provisional and post-mortem reports. These appear to correspond to PWS 3.2.11.9 and 3.2.11.10. Please confirm the references.

Response: These have been updated

11 PWS 3.2.9.1, 3.2.11.10,

3.2.13 and 3.13.7

An Offeror may be able to meet the final report timeframe in the large majority of cases but may be unable to guarantee that every case will be completed within it (for example, cases involving special studies).

Is meeting the timeframe in every case a condition of eligibility for award, or is it a performance standard administered under the QASP, subject to the “special studies” exception? Will the Government consider the 90-day timeframe referenced in NAME guidelines as an acceptable alternative?

Response: These are Performance Standards as reflected in the QASP, subject to the “special studies” exception.

12 PWS 3.2.10 (p. 15) PWS 3.2.11.8 (p. 15)

PWS 3.2.10 states, “The Government prefers to have autopsies performed within a 50-mile radius of each of the three locations identified in the PWS.”

(a) Is the 50-mile radius a requirement or a preference?

Response: This has been amended to remove the 50-mile radius. It is a preference due to cost and timely completion of autopsies.

) If an Offeror’s autopsy facility is outside this radius, is the Offeror ineligible for award, and how will the preference be considered in the evaluation?

Response: As with above, PWS 3.2.10 has been revised. Preference will not be considered as LPTA is a go/no-go evaluation based upon whether the Low-priced offeror meets the technical requirements.

) How does this preference relate to PWS 3.2.11.8, which requires transport of decedent remains directly to the contractor site within the “Omaha, Lincoln, or Grand Island Nebraska Metropolitan area”?

Response: As with above, PWS 3.2.10 has been revised. Preference will not be considered as LPTA is a go/no-go evaluation based upon whether the Low-priced offeror meets the technical requirements.

C. Schedule of Services (Attachment 5) – Pricing Clarifications

13 Attachment 5 (all tabs) Can the Government provide a utilization list that identifies the name of the test associated with each CPT code in Attachment 5? A single CPT code can describe more than one test, and laboratories report different CPT codes for the same test. Without the test name, Offerors cannot confirm that the unit price proposed corresponds to the test the Government intends to order.

Response: Some codes do not give a specific descriptor, and therefore might have to be discussed with the lab POC.

14 Attachment 5, Profee_CMS SLINs

0001AB (CPT 81479),

0001AJ (88099),

0001CB (88291),

0001EN (88399),

0001EP (89240) and

0001ER (TBD); CLIA

SLIN 0002LH (TBD)

These lines are unlisted or miscellaneous codes, or “TBD,” and do not identify a specific test. Please identify the tests, specimen types and expected scope the Government anticipates under each, or advise how Offerors should price these lines.

For lines with an estimated quantity of zero (e.g., CPT 88099), please confirm that the Contractor may invoice the Government at the proposed unit price if the service is ordered during performance.

Response: 81479 represents Tier 2 molecular Pathology Procedures.

This code should be used only when no other specific code exists, per CMS and payer policy. CPT 81479 functions as the universal fallback code for molecular pathology services lacking a defined CPT descriptor.

Laboratories (when ordering) must include documentation describing the specific test to be performed, and why it was ordered.

0001ER and 0002LH are miscellaneous line items. These do not need to be priced. The allows tests to be added to the schedule in the future.

15 Attachment 5, CLIA SLINs 0002DF (CPT

83516), 0002DG

(83520) and 0002KG –

0002KS (88230 –

88289)

These CPT codes apply to a wide range of assays and profiles (for example, immunoassays by analyte, and tissue culture and cytogenetic studies by specimen type). Please identify the specific test name the Government intends to order under each code and, for the cytogenetic codes, the specimen source.

Response: CPT 83516 is classified under chemistry procedures and is used to report immunoassays that detect or measure a non-infectious analyte using qualitative or semiqualitative multi-step method typically via ELISA or similar techniques. This code is only used for “not otherwise specified” or the analyte does not have its own CPT code.

Laboratories (when ordering) must include documentation describing the specific test to be performed, and why it was ordered.

16 Attachment 5, SLINs listed in Exhibit A for Question 16

Some CPT codes in Attachment 5 may not be reported by an Offeror’s laboratory for the tests the Government intends to order. These include CPT 0012M, 0013M, 0035U, 80305, 80306, 81170, 81246, 81345, 85347, 86849, 87140, 87143, 87149, 87169, 87250, 87327, 87531, 87623, 87906, 88120, 88121 and 88182 (including the TC lines).

For these lines, please provide the test names so Offerors can verify the applicable code, and advise whether an Offeror may (a) indicate that the code is not offered or not utilized, or (b) identify the alternate CPT code(s) under which the test would be billed. If neither is permitted, please advise how these lines should be completed.

Response: CPT code 81170 refers to the genetic analysis of variants in the kinase domain of the ABL1 gene, often used to assess resistance to tyrosine kinase inhibitors and to detect mutations associated with resistance to imatinib in leukemia patients.

17 Attachment 5, CLIA SLINs 0002AD (CPT

80047), 0002FN

(86359) and 0002FP (86360)

) CPT 80047 is a combined metabolic panel with ionized calcium. If the component tests are performed and reported under separate CPT codes (e.g., 80053 and 82330, both listed in Attachment 5), may the Contractor bill the component codes in lieu of CPT 80047?

Response: Per CLIA and Medicare you are not allowed break panels into components.

) CPT 86359 and 86360 are commonly performed together as part of a single profile. Will the Government order these as stand-alone tests or as a single profile, and may offerors allocate a profile price across two lines?

Response: Yes, they can allocate a profile price across the two lines

18 Attachment 5, CLIA SLINs 0002JM (CPT

87900), 0002JN

(87901), 0002JP

(87903) and 0002JQ (87904)

These codes are typically reported together for a single HIV genotype and phenotype susceptibility test, with CPT 87904 reported for each additional drug tested. Please identify the test(s) intended, confirm whether these four lines represent a single test, and confirm the number of CPT 87904 units (estimated quantity 89) anticipated per test. May this test be priced as a single line item?

Response: CPT code 87900 refers to infectious agent drug susceptibility phenotype prediction using genotype bioinformatics.

CPT 87901 is used for HIV-1 genotype analysis, specifically, examining the reverse transcriptase and protease regions to assess drug resistance.

CPT 87903 is used got infectious agent phenotype analysis by nucleic acid (DNA or RNA) with drug resistance tissue culture for HIV-1, testing the first through 10 drugs.

CPT 87904 is the code for HIV-1 drug resistance phenotype testing, billed for each additional drug tested beyond the primary set.

It can be ordered individually however is generally ordered as a panel.

19 Attachment 5, CLIA SLINs 0002JS (CPT 88142, est. qty 700) and 0002KF (CPT 88175, est. qty 1)

CPT 88142 (thin-layer preparation with manual screening) and CPT 88175 (thin-layer preparation with automated screening and manual rescreening or review) are reported according to the screening method used.

Pathology Services, P.C. offers only CPT 88175 for this testing and does not report CPT 88142. Because Attachment 5 estimates 700 units for CPT 88142 and 1 unit for CPT 88175, pricing these lines as listed would not reflect the testing that would actually be performed and billed.

Please confirm whether the Government will amend the estimated quantities in Attachment 5 to reflect the intended screening method (for example, by applying the estimated Pap test volume to CPT 88175), or advise how Offerors whose laboratories offer only CPT 88175 should complete these two lines so that contract pricing is accurate.

Response: CPT 88142 is the code currently used 95% of the time upon reviewing current contractors invoices. Very infrequently code 88175 is billed. We will not amend the current quantities as they are reflected accurately based on current billing practices. The offeror should input the price it would cost you to perform each code, either done by your lab, or sent out. Please note 88175 is approximately 8% higher Medicare cost than 88142 per test. Reminder to offerors: Estimated quantities are estimates.

20 Attachment 5, Profee_CMS SLIN

0001EQ (CPT 99001,

est. qty 2) Section B.2 (p. 4)

Section B.2 states that tests referred within the Contractor’s laboratory network or to subcontracted laboratories shall be at “no additional transfer charge or confirmation charge to the Government.” Please confirm whether specimen handling fees (CPT 99001) are billable under this contract and, if not, whether this line should be priced at zero or removed.

Response: If this question is pertaining to an autopsy, this code is not appropriate for that test, and the cost for an autopsy should be all inclusive of transportation and performance cost together.

If this question pertains to special testing then the contractor will get a receipt from the performing lab and the VA will only reimburse the cost that was charged to complete the test, with no additional fees charged to the Government.

Exhibit A – Attachment 5 Lines Referenced in Questions 14 – 21

Descriptions and estimated quantities are as shown on the Ordering Period 1 tabs of Attachment 5 (09/28/2026).

Response: The Government is not certain what is being inquired below. As a result, we are unable to respond, directly. However, If a potential offeror has questions regarding certain CPT Codes, they are officially published and maintained by the American Medical Association and can be accessed through the CPT Professional Edition, online databases, and CMS Resources.

CPT / Mod Tab SLIN Description (Attachment 5) Est. Qty

Question 14

81479 Profee 0001AB Unlisted molecular pathology 28

88099 Profee 0001AJ Unlisted necropsy (autopsy) 0

88291 Profee 0001CB Cyto/molecular report 1

88399 Profee 0001EN Unlisted surgical path px 3

89240 Profee 0001EP Unlisted misc path test 33 TBD Profee 0001ER Miscellaneous test varies depending on methodology/pathways Response: This line allows us to add tests to the schedule at a later time. No pricing is required..

TBD CLIA 0002LH Miscellaneous test varies depending on methodology/pathways Response: This line allows us to add tests to the schedule at a later time. No pricing required.

TBD

Response: Unlisted codes like 81479 should be used only when no specific code exists, per CMS and payer policy. CPT 81479 functions as the universal fallback code for molecular pathology services lacking a defined CPT descriptor.

0001ER and 0002LH are miscellaneous line items that allows tests to be added to the schedule. These do not require pricing to be entered.

Question 15

83516 CLIA 0002DF Immunoassay nonantibody 1

83520 CLIA 0002DG Immunoassay quant nos nonab 1 88230 CLIA 0002KG Tissue culture lymphocyte 20

88237 CLIA 0002KH Tissue culture bone marrow 366 88239 CLIA 0002KJ Tissue culture tumor 150

88261 CLIA 0002KK Chromosome analysis 5 16

88262 CLIA 0002KL Chromosome analysis 15-20 92

88271 CLIA 0002KM Cytogenetics dna probe 863 88272 CLIA 0002KN Cytogenetics 3-5 11

88275 CLIA 0002KP Cytogenetics 100-300 399

88280 CLIA 0002KQ Chromosome karyotype study 240

88285 CLIA 0002KR Chromosome count additional 4

88289 CLIA 0002KS Chromosome study additional 12

Response: CPT 83516 is classified under chemistry procedures and is used to report immunoassays for analytes other than infectious agent antibodies or antigens. The test can be qualitative (indicating presence or absence) or semiquantitative (measuring relative levels) and involves multiple steps to ensure accurate detection and measurement of the analyte Question 16

86849 Profee 0001AG Immunology procedure 2 88120 Profee 0001AU Cytp urne 3-5 probes ea spec 8

88120 TC Profee 0001AV Cytp urne 3-5 probes ea spec 0

88121 Profee 0001AW Cytp urine 3-5 probes cmptr 8

88121 TC Profee 0001AX Cytp urine 3-5 probes cmptr 0

88182 Profee 0001BR Cell marker study 2

88182 TC Profee 0001BS Cell marker study 0 0012M CLIA 0002AA Onc mrna 5 gen rsk urthl ca 1

CPT / Mod Tab SLIN Description (Attachment 5) Est. Qty

0013M CLIA 0002AB Onc mrna 5 gen recr urthl ca 1

0035U CLIA 0002AC Neuro csf prion prtn qual 1

80305 CLIA 0002AT Drug test prsmv dir opt obs 1

80306 CLIA 0002AU Drug test prsmv instrmnt 1

81170 CLIA 0002AY Abl1 gene 5

81246 CLIA 0002BE Flt3 gene analysis 7

81345 CLIA 0002BT Tert gene targeted seq alys 1

85347 CLIA 0002ER Coagulation time activated 12

87140 CLIA 0002GN Culture type immunofluoresc 2

87143 CLIA 0002GP Culture typing glc/hplc 1

87149 CLIA 0002GR Dna/rna direct probe 3

87169 CLIA 0002GU Macroscopic exam parasite 4

87250 CLIA 0002HF Virus inoculate eggs/animal 1

87327 CLIA 0002HL Cryptococcus neoform ag ia 13

87531 CLIA 0002JB Hhv-6 dna dir probe 1

87623 CLIA 0002JE Hpv low-risk types 1

87906 CLIA 0002JR Nfct agt gntyp alys hiv1 3

Response: CPT code 81170 refers to the genetic analysis of variants in the kinase domain of the ABL1 gene, often used to assess resistance to tyrosine kinase inhibitors.

Question 17

80047 CLIA 0002AD Metabolic panel ionized ca 1

80053 CLIA 0002AF Comprehen metabolic panel 13

82330 CLIA 0002CH Assay of calcium 5

86359 CLIA 0002FN T cells total count 2

86360 CLIA 0002FP T cell absolute count/ratio 1

(a) CPT 80047 is a combined metabolic panel with ionized calcium. If the component tests are performed and reported under separate CPT codes (e.g., 80053 and 82330, both listed in Attachment 5), may the Contractor bill the component codes in lieu of CPT 80047?

Response: Per CLIA and Medicare you are not allowed break panels into components.

(b) CPT 86359 and 86360 are commonly performed together as part of a single profile. Will the Government order these as stand-alone tests or as a single profile, and may offerors allocate a profile price across two lines?

Response: Yes, they can allocate a profile price across the two lines.

Question 18

87900 CLIA 0002JM Phenotype infect agent drug 5

87901 CLIA 0002JN Nfct agt gntyp alys hiv1 rev 6

87903 CLIA 0002JP Phenotype dna hiv w/culture 6

87904 CLIA 0002JQ Phenotype dna hiv w/clt add 89

Response: CPT code 87900 refers to infectious agent drug susceptibility phenotype prediction using genotype bioinformatics.

CPT 87901 is used for HIV-1 genotype analysis, specifically, examining the reverse transcriptase and protease regions to assess drug resistance.

CPT 87903 is used got infectious agenct phenotype analysis by nucleic acid (DNA or RNA) with drug resistance tissue culture for HIV-1, testing the first through 10 drugs.

CPT 87904 is the code for HIV-1 drug resistance phenotype testing, billed for each additional drug tested beyond the primary set.

It can be ordered individually, however is generally ordered as a panel.

Question 19

88142 CLIA 0002JS Cytopath c/v thin layer 700

88175 CLIA 0002KF Cytopath c/v auto fluid redo 1

Response: CPT 88142 is the code currently used 95% of the time upon reviewing current contractors invoices. Very infrequently code 88175 is billed. We will not amend the current quantities as they are reflected accurately based on current billing practices. The offeror should input the price it would cost you to perform each code, either done by your lab, or sent out. Please note 88175 is approximately 8% higher Medicare cost than 88142 per test.

Question 20

99001 Profee 0001EQ Specimen handling pt-lab 2

Response: If this question is pertaining to an autopsy, this code is not appropriate for that test, and the cost for an autopsy should be all inclusive of transportation and performance cost together. If this question pertains to special testing then the contractor will get a receipt from the performing lab and the

VA will only reimburse the cost that was charged to complete the test, with no additional fees charged to the Government.

Exhibit A – Attachment 5 Lines Referenced in Questions 14 – 21