36C24724R0031 0001.docx

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)

03-07-2025 None Department of veterans Affairs VISN 7 Network Contracting Activity CAVHCS-East Campus 2400 Hospital Ro.

Tuskegee AL 36083 Department of veterans Affairs VISN 7 Network Contracting Activity CAVHCS-East Campus 2400 Hospital Ro.

Tuskegee AL 36083 To all Offerors/Bidders

36C24724R0031

X X X This Amendment is to post the Questions and Answers to those that were submitted by interested parties.

See the attachment below for the Q&As, the RFP is being extended now till

MARCH 19,

BY 12 PM EST.

No other questions are being allowed at this time

Chelsea L. Smith Contracting Officer Q&A’s:

1. Please confirm that the address for the Birmingham VAHCS is 101 25th Street South, Birmingham, AL 35233 as listed on page 6.

ANSWER: Correction to be made in PWS 700 19th Street South, Birmingham, AL 35233

1. Please clarify that the Dublin VAMC is in Georgia and not South Carolina as listed in the chart on page 6.

ANSWER: Correct Dublin VAMC is in GA, and not SC. Correction to be made in PWS.

1. In Section 2.2: GENERAL REQUIREMENTS FOR REFERENCE LABORATORY SERVICES question 2.2.3 states that a duty of the onsite processor is “interpretation for clinical and anatomical pathological specimens sent to the contractor”. Question: Please elaborate on what is expected of an onsite processor with regard to this statement.

ANSWER: Meaning they need to be able to determine if the correct sample has been collected for the requested test. Ensure samples are sent at appropriate temperature and correctly labeled.

· Receive and process specimens: Receive specimens, enter orders into the laboratory information system, and process specimens based on testing requirements.

· Prepare samples: Prepare samples for testing, including centrifuging to separate plasma or serum from cellular elements.

· Maintain equipment and supplies: Ensure that equipment and supplies are properly maintained and that the work area is clean and safe.

· Enter data: Enter data into the laboratory information system.

· Maintain records: Maintain records of specimens and keep inventory of samples.

· Ensure quality: Perform quality assurance and ensure that specimens are handled and stored properly.

· Follow protocols: Follow hospital and departmental policies and procedures.

1. Please provide the total annual test volume for each facility.

ANSWER: I'm adding another Spreadsheet with each Station's Annual Test Volume from March 2024 to February 2025. Please note that all testing is subjective and will change monthly and annually based on needs alone.

1. The links appear to be broken on page 47 under D.3 for the wage rate determinations. Please provide. They are still active when I hit control and click. Here they are again.

Atlanta VA Health Care System (Decatur, GA)-SAM.gov

Birmingham VA Health Care System (Birmingham, AL)- SAM.gov

Carl Vinson VA Medical Center (Dublin, GA)- SAM.gov

Central Alabama Veterans Health Care System East Campus (Tuskegee, AL)- SAM.gov

Central Alabama Veterans Health Care System West Campus (Montgomery, AL)- SAM.gov

Charlie Norwood VA Medical Center (Augusta, GA)- SAM.gov

Ralph H. Johnson VA Medical Center (Charleston, SC)- SAM.gov

Tuscaloosa VA Medical Center (Tuscaloosa, AL)- SAM.gov

Columbia VA Health Care System (Columbia, SC)- SAM.gov

1. In Section 2.2: GENERAL REQUIREMENTS FOR REFERENCE LABORATORY SERVICES, question 2.2.13 states: For test results being returned to VA laboratories running Vista Lab, Referral laboratories are to include a VA ICN or EDIPI number with patient reports as an identifier. VA referring Vista laboratories are to supply the patients VA ICN or VA EDIPI with each lab order to enable the referral laboratory to include it with results returned to the VA.

Question: Is VA ICN or EDIPI also known as the Patient ID or MRN?

ANSWER: Yes, the VA ICN (Veteran Integrated Control Number) is a 17-character identifier assigned by the VA to each veteran—servers as a social security number. EDIPI (Electronic Data Interchange Personal Identifier) is a unique 10-digit number associated with personnel and common access cards.

1. Specifically for the tests described as “Misc Code” (1381, 1382, 1383 1874,) and “interpretation summary” (2061), please provide a more complete description and associated CPT code(s).

ANSWER: On occasion VISN 7 facilities order tests that do not have an existing vendor test code. These tests are processed as a courtesy to the facility and are billed using a generic miscellaneous/mail out test category. These tests cannot be priced at the individual level because the category covers various tests. In fairness to all vendors, we recommend all miscellaneous line items be removed from the bid. In reference to Item 2061 – Interpretation Summary Only; CPT code - 81162

1. Please provide the drugs in items 0630, 1546, and 1874.

ANSWER: Item 1546 could include any combination of 2 drug analytes. Item 1874 – includes the following analytes: Amphetamines, cocaine metabolites, marijuana, opiates, phencyclidine, benzodiazepines, methadone, propoxyphene, meperidine, tramadol, and ethanol – Item 0630 includes the following - Screen includes Amphetamines, Marijuana, Cocaine Metabolite, Opiates, and PCP (Phencyclidine)

1. For items 0614, 1576, and 2061, please provide more information on exactly what is being interpreted or what type of diagnostic consultation is being sought.

ANSWER: Items 0614 – Diagnostic consultation; CPT code 88323, Item 1576 – Physician Interpretation; CPT code 88141, Item 2061 – Interpretation Summary Only; CPT code 81162

1. Please provide the components of all the other tests listed or a more complete description.

ANSWER:

· Item 0076 – Accutype® IL28B - IL28B Genotype (CPT Code 81283)

· Item 0463 – CMT Advanced Evaluation – Includes Connexin32 Evaluation, ,DNM2 DNA Sequencing Test, EGR2 DNA Sequencing Test, FGD4 DNA Sequencing Test, FIG4 DNA Sequencing Test, GDAP1 DNA Sequencing Test, LITAF/SIMPLE DNA Sequencing Test, MTMR2 DNA - CPT Code 81448

· Item 0614 - Diagnostic consultation; CPT code 88323

· Item 0630 - includes the following - Screen includes Amphetamines, Marijuana, Cocaine Metabolite, Opiates, and PCP (Phencyclidine)

· Item 0929 Hereditary Erythrocytosis – CPT 81479 – performing lab Mayo Medical Laboratory – profile information – Reporting name: Molecular Interpretation; EPOR Gene, Mutation Analysis, B; HIF2A Gene, Mutation Analysis, B; PHD2 Gene, Mutation Analysis, B

· Item 1192 Interferon-Alpha – IFN alpha is mainly produced by monocytes/macrophages, lymphoblastic cells and fibroblasts, but different types of virus activated cells may produce the cytokine. CPT code 83520

· Items 1381, 1382 and 1383 - On occasion VISN 7 facilities order tests that do not have an existing vendor test code. These tests are processed as a courtesy to the facility and are billed using a generic miscellaneous/mail out test category. These tests cannot be priced at the individual level because the category covers various tests. In fairness to all vendors, we recommend all miscellaneous line items be removed from the bid.

· Item 1546 - could include any combination of 2 drug analytes

· Item 1566 Pharmacogenomics Panel – Individuals with particular genotypes may find their metabolism capabilities for certain prescription drugs range from extremely poor to extremely fast and may need to avoid or adjust to a higher or lower drug dosage in order to achieve a therapeutic effect. This test analyzes high-evidence markers for genes/loci of known pharmacogenomics value allowing clinicians to gain valuable insight into an individual's ability to metabolize drugs based on their genetic make-up. The pharmacogenomics panel reports genetic information only, currently we are not reporting medication information. CPT code – 81418

· Item 1576 – Physician Interpretation - CPT code 88141

· Item 1723 RMSF IGG Titer - Antigen specific IgG and IgM titers allow rapid diagnosis of infection by any of the spotted fever group of agents include R. rickettsii (rocky mountain spotted fever) and R. akari (rickettsial pox), both seen in the continental United States. CPT code 86757

· Item 1730 RPR Titer – Clinical significance for RPR - This is a nontreponemal screening test for syphilis. False positive results may occur, due to systemic lupus erythematosus, leprosy, brucellosis, atypical pneumonia, typhus, yaws, pinta, or pregnancy. Monitoring of RPR is helpful in assessing effectiveness of therapy. CPT code 86593

· Item 1785 Stage III – Includes Centromere B Antibody and Ribosomal P Antibody – CPT codes 83516 and 86235

· Item 1793 Sterile Hyphae – This is part of Fungal Identification, molds, CPT code 87999

· Item 1874 Tox 8 Profile, Urine – includes the following analytes Amphetamines, cocaine metabolites, marijuana, opiates, phencyclidine, benzodiazepines, methadone, propoxyphene, meperidine, tramadol, and ethanol

· Item 2011 LRP4 Autoantibody - Detects anti-LRP4 (low density lipoprotein receptor-related protein 4) in the sera of patients with Myasthenia Gravis (MG). The LRP4 protein activates MuSK kinase activity and promotes the clustering of AChR and their stabilization at the NMJ. Anti-LRP4 antibodies are found in approximately 9.2% (range 2% to 50%) of MG patients who are negative for both anti-AChR and anti-MuSK. CPT code - 86255

· Item 2017 CPT LC/MS/MS & IR SC – Components are: C-Peptide, LC/MS/MS; Insulin Resistance Score – CPT code 84681

· Item 2059 Juvenile Poly Pnl - Mutations in BMPR1A and SMAD4 are associated with Juvenile Polyposis syndrome (JPS). Individuals with JPS, have an increased risk for colorectal cancer (40-50%) and gastric cancer (up to 21%, if multiple polyps are identified in the stomach). The risk for small intestinal cancer and pancreatic cancer are also increased. This test detects pathogenic variants in the BMPR1A and SMAD4 genes. CPT codes – 81405, 81406, 81479

· Item 2061 Interpretation Summary - Interpretation Summary Only; CPT code 81162

· Item 2215 Autoimmune Cerebellar - Panel Includes – Yo Antibody Screen w/ Reflex to Titer and Western Blot, Voltage-Gated Calcium Channel (VGCC) Type P/Q Antibody, Tissue Transglutaminase (tTG) Antibody (IGA), IGA (Immunoglobulin A) – CPT Codes – 82784, 86255, 86364, 86596

1. Are we allowed to add columns to the right of the spreadsheet for the addition of our test codes and comments or may we add that information is existing columns and if so which ones?

ANSWER: Please provide a separate excel or PDF with your test codes mimicking this sheet for updates and confirm which test were updated.

1. If we are not allowed to add that information to the spreadsheet, may we add a second tab with that information?

ANSWER: Please submit a new excel or PDF with the information on it. The excel cant be modified per our system.

1. Please clarify which columns in the attachment are required to be completed. Clarify what information vendors should include in: Column H; Unit of Measure, Column M; UNSPSC, and Column N – SIC Code; and should vendors use column P, National Stock Number for our company specific test code?

ANSWER: Only thing I have to have is cost per test, and the amount so all should have the unit price, and extended amount with total of all test.

1. Where can vendors insert pertinent information such as test description, test code, and flag if testing is a send-out?

ANSWER: Test Descriptions, test codes, and flagging for send out can be modified in another Excel or PDF list; just make sure the line item is next to the updated information. You can also list out the color code or * all items that have to be sent out on another document.

1. In the event there is a test included in the price schedule that may have been discontinued industry wide, can vendors remove those items from the list (ex: Vitamin B12 Binding Capacity)? If not, how should vendors respond to tests that may no longer be available?

ANSWER: If a line item is discontinued, price it as 0.00. Then, on another form that you will supply and modify to descriptions, test codes, and flagging those to be sent out, you can either color code those that are discontinued or make a separate list to identify which line items are no longer available. Just make sure you have a key to let me know what color and symbols are. Test utilizations include historical ordering patterns which could have tests that have subsequently been discontinued and/or updated.

1. Are vendors able to remove tests that are described in the file as (“Mail Out Test, MISC Code, etc.), as they cannot be mapped or priced to a specific test? If not, please clarify how vendors should respond to these items.

ANSWER: DO NOT modify the price schedule. On occasion VISN 7 facilities order tests that do not have an existing vendor test code. These tests are processed as a courtesy to the facility and are billed using a generic miscellaneous/mail-out test category. These tests cannot be priced at the individual level because the category covers various tests. In fairness to all vendors, we recommend all miscellaneous line items be removed from the bid. These tests make up 0.1% (Line Items 1334 – 1337 “mail out tests”; 1381 – 1382 “misc. code”; 1383 “misc. Chantilly”) of the total volume of the RFP.

1. In the Statement of Work; Section 2.2 General Requirements for Reference Laboratory Services; Item 2.2.3; it states contractor shall provide personnel for a specimen processor for each participating facility. Please clarify if VISN 7 is specifically asking for one processor at each physical location or is VISN 7 requesting (8-9) onsite processors, but locations may vary depending upon the need/volumes of the location?

ANSWER: Processors are needed are dependent on need and volume of each location. Certain Locations have them now and those locations are currently:

Birmingham- 1

CAVHCS

Columbia-1 Charleston-1 Atlanta- 3 Tuscaloosa Dublin Augusta-1

1. Within the Statement of Work; Section 2.2 General Requirements for Reference Laboratory Services; Item 2.2.4; it lists an assay schedule. To ensure an all-inclusive file is provided to VISN 7, can vendors include their test set up schedule to the Price Schedule document? If so, which column can we use to populate this data.

ANSWER: Do not modify the Price Schedule, this is for our enteral system and any modifications besides descriptions, codes, unit price, and amount will cause our system to reject the file. You can provide a second documentation needed to show anything on your test set up schedule.

1. In the Statement of Work; Section 2.8 Quality Assurance; Item 2.8.3 (Quality Assurance Surveillance Plan); regarding the measure about turnaround time, please define what “high-volume tests by facility” means in this context.

ANSWER:

Monthly High-Volume test per Facility:

Birmingham-5,484

CAVHCS-1,968

Columbia- 1,960 Charleston-4,452 Atlanta- 6,885 Tuscaloosa-1449 Dublin-9,639 Augusta-3,209

We want to ensure that your company can perform at all volume levels, including high volumes, that would not delay results or patient care. Above is a monthly intake for each section.