36C25025Q0230.docx

36C25025Q0230

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

583-25-2-057-0002 36C25025Q0230 02-26-2025 Bryant, Jessica 03-13-2025

10:00AM

ET

36C250 Department of Veterans Affairs Network Contracting Office 10 24 Frank Lloyd Wright Drive Lobby M, Suite 2200 Ann Arbor MI 48105 X 621511 $41.5 Million N/A X 36C583 Department of Veterans Affairs Richard L. Roudebush VA Medical Center Pathology & Laboratory Services 1481 W. 10th St Indianapolis IN 46202 Y Department of Veterans Affairs Network Contracting Office 10 24 Frank Lloyd Wright Drive Lobby M, Suite 2200 Ann Arbor MI 48105

See website at:

https://www.fsc.va.gov/einvoice.asp for instructions & for invoicing website at:

https://www.tungsten-network.com/ customer-campaigns/ veteransaffairs

See CONTINUATION Page The Richard L. Roudebush VA Medical Center, Pathology and Laboratory Service, Request for Quote (RFQ) to provide Reference Laboratory Testing Services in accordance with the Performance Work Statement (PWS).

This solicitation is open market, unrestricted. Responses will be evaluated via comparative analysis utilizing FAR Parts 12 and 13. The resulting award will be an Indefinite Delivery Indefinite Quantity (IDIQ) Firm Fixed Price (FFP) contract.

Questions shall be emailed to Jessica.Bryant5@va.gov and are due by 01:00PM ET, 03/05/2025.

Responses shall be submitted no later than 10:00AM ET, 03/13/2025 via email to Jessica.Bryant5@va.gov.

See attached "Price Schedule" $0.00 See CONTINUATION Page 583-3650160-057-822300-2560-010022354 X X X One(1) Kristina L. Peart Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. CONTRACT ADMINISTRATION: All contract administration matters will be handled by the following individuals:

a. Contractor:

Contractor Name

Contractor Address

Contractor Main Phone

Contractor Primary POC

Contractor Primary POC Title

Contractor Primary POC Phone

Contractor Primary POC Email

SAM ID Number

Business Size

b. Government:

Veterans’ Health Administration Network Contracting Office (NCO) 10 24 Frank Lloyd Wright Drive, Lobby M, Suite 2200 Ann Arbor, MI 48105

Department of Veterans Affairs Veterans’ Health Administration Network Contracting Office (NCO) 10 24 Frank Lloyd Wright Drive, Lobby M, Suite 2200 Ann Arbor, MI 48105

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

c. Other: Monthly [X]

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Tungsten Network: https://www.tungsten-network.com/customer-campaigns/veteransaffairs.

5. LATE QUOTE SUBMISSION: Late submissions shall not be considered. Quotation shall be received by the date and time specified in Block 9 of the SF 1449 in order to be considered for award.

6. SUBMISSION OF QUOTE:

Offerors shall complete and submit all information designated below, failure to do so will result in an unacceptable/non-responsive quote submission and will no longer be considered for award.

Quotations shall include:

1. SF 1449 Blocks 17(a) and 30(a-c)

2. Section B.1 CONTRACT ADMINISTRATIVE DATA, section 1(a)

3. Completed Price Schedule – Excel Attachment and Section B.3 Aggregate Total

4. All information listed in Section E.12 EVALUATION – INSTRUCTION TO OFFERORS

5. Proof of active System for Award Management (SAM) registration;

By submission of a quote, the offeror acknowledges that the prospective awardee shall be registered in SAM at https://www.sam.gov at the time of quote submission and remains current during contract performance and through final payment. Registration in SAM is a requirement to conduct business with the Federal Government.

7. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PERFORMANCE WORK STATEMENT

Department of Veterans Affairs, Veterans Health Administration (VHA), VISN 10, Richard L. Roudebush VA Medical Center, requires the services of a contractor for reference laboratory testing services for a base year, and four (4), one-year option periods to be exercised at the Government’s discretion.

The contractor shall provide reference laboratory testing for the patients enrolled in the participating facilities. Contractor shall provide all necessary supplies to provide reference laboratory testing services for both the participating facilities below and all support facilities.

Reference Laboratory Services include at minimum specimen preparation and storage; transportation of clinical laboratory specimens; microbiology cultures and stocks; performance of analytical testing; reporting of analytical test results; consultative services; and reports as required by this document.

A. PARTICIPATING FACILITIES

Richard L. Roudebush VA Medical Center Pathology and Laboratory Service 1481 W. 10th St.

Indianapolis, IN 46202

B. SUPPORTING FACILITIES

a. Contractor shall ensure that supplies are provided as required by the Veterans Affairs Medical Center (VAMC).

b. A VA courier shall collect specimens from support facilities and those specimens shall be collected by the contractor courier from their assigned participating facility.

c. Government reserves the right to add or remove supporting facilities as necessary.

C. CONTRACTOR RESPONSIBILITIES

a. OVERVIEW

i. The Contractor shall provide at minimum:

1. All necessary supplies for specialized specimen collection, testing, transport, and packaging, shipping kits

a. Supplies shall be provided as the medical centers require additional supplies to support patient testing needs.

2. On-site Processing Personnel (See Section J “Customer Service”)

3. Centrifuge, label printer, computer, printer as needed for processing/sending samples.

4. Courier and flight services for the transportation of the specimens

a. Flights to be made out of an airport that provides the best efficiency in getting the specimens to the contractor while maintaining specimen integrity.

b. Courier service for pick-up of patient samples shall be provided 7 days per week and pick-up times required by the site are identified below:

· Monday – Friday at 2:00PM ET and at 6:00PM ET

· Saturday, Sunday, and Federal Holidays at 3:30PM ET

5. Dry ice (if required)

6. Chain of custody forms (if required)

7. Specimen transport request forms

8. Reference laboratory testing and reporting with current reference ranges

9. Secured web-based portal system, Intranet Laboratory Electronic Data Interchange (LEDI) system, and printer equipment

10. Contractor shall have interchange with the VA EHR computer system which will be installed during this contract at the time of award.

11. Contractor shall have a single national coding system.

a. Contractor shall utilize one test code per test nationally

b. Contractor shall utilize approved Patient Identifiers

12. Customer telephone service 24/7 365 days a year

13. Contractor shall have an electronic test menu submission system as the preferred test submission avenue with limited specialty tests to be submitted on paper test submission forms.

14. Shipping manifest

15. Monthly report to the VAMC to include, at a minimum, through an appropriate electronic format: (no PII/PHI can be included)

a. Tests ordered (including test code and test name)

b. Number of unsatisfactory specimens

c. Number of tests performed in current month; and

d. Calendar year-to-date with Current Procedural Terminology (CPT) code and cost. Reports to include all testing ordered for the calendar year.

e. This report shall include pricing per account number for each participating site.

16. Provide and maintain a user-friendly public website which allows easy reference for researching test information (test number/CPT coding, patient preparation, test utility, result interpretive guidelines. For tests not listed on public website Contractor shall provide access to their database for client research test information; and

17. Routine test results to the participating ordering facility within twenty-four (24) hours following test completion, except when specimens are picked up the day before a weekend or holiday (in which case the results shall be provided the following business day). The Contractor shall notify the facility within two (2) hours of any critical values or results. Lists of critical values requiring notification will be provided by the VA to the Contractor for this purpose.

18. Contractor’s billing and utilization reports shall run from the first day of each month through the last day of each month. For Example: January 1 – January 31, February 1 – 28 or 29(if leap year), and June 1 – June 30.

b. QUALIFICATIONS

i. Licensing and Accreditation

1. Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered. The Contractor/Subcontractor shall have all licenses, permits, accreditation and certificates required by law. The reference laboratory shall be licensed/accredited by the College of American Pathologists (CAP) or The Joint Commission (TJC), or any other licensing and/or Accreditation in order to perform the required testing listed in this PWS. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988.

2. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of all sanctions current or pending throughout the United States of America prior to contract award. In addition, the Contractor shall be responsible for providing written guarantee or evidence that all Subcontractors have appropriate licensure and accreditation to perform tests that the primary Contractor cannot perform prior to contract award and as requested by the Contracting Officer (CO). All proposed Subcontractor changes during the contract performance period must have prior approval by the CO. Changes to the requirements shall be addressed by bilateral modification.

3. Contractor Personnel assigned by the Contractor to perform the services covered by this contract shall be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this contract shall be licensed by the governing or cognizant licensing board.

4. Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPPA)

5. The Contractor shall notify the Contracting Officer in writing of all malpractice investigation or licensure or certification suspension that concerns the Contractor or Contractor personnel, or any discovery of any disciplinary action taken against laboratory(ies) performing under the contract within 24 hours of notification of an investigation or suspension

ii. Contractor Personnel:

1. The Contractor shall maintain current accreditation and notify the Contracting Officer of all lapses in state license, Clinical Laboratory Improvement Amendments (CLIA) certification, or clinical pathology certification. The Contractor shall provide access via website or email upon request a copy of the renewed licenses/certificates before expiration.

2. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or American Board of Bioanalysis, certified Bio-analyst.

3. The Contractor shall have at least three years of experience providing laboratory services and shall have at least one-year experience in transporting biomedical materials, similar to this requirement.

a. CLIA certifications shall include:

· Histocompatibility (010)

· Bacteriology (110)

· Mycobacteriology (115)

· Mycology (120)

· Parasitology

· Virology (140)

· Syphilis Serology (210)

· General Immunology (220)

· Routine Chemistry (310)

· Urinalysis (320)

· Endocrinology (330)

· Toxicology (340)

· Hematology (400)

· Immunohematology ABO Group & Rh type (510)

· Immunohematology Antibody Detection (transfusion) (520)

· Immunohematology Antibody Detection (non-transfusion) (530)

· Immunohematology Antibody Identification (540)

· Immunohematology Compatibility Testing (550)

· Histopathology (610)

· Oral Pathology (620)

· Surgical Pathology

· Molecular Biology

· Cytology (630)

· Radiobioassay (800)

· Cytogenetics (900)

4. The Contractor shall provide all technical advisory/recalls/alerts, prior to or simultaneously with field alerts, should be forwarded to the designated individuals determined at contract award.

5. The Government reserves the right to refuse the use of a subcontractor who fails to comply with evidence of accreditation(s) or licensures(s).

c. SPECIMEN PREPARATION

i. Contractor shall supply each Government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with Contractor’s requirements.

ii. Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory.

iii. If a medico legal specimen is submitted, the Contractor shall provide its own special forms and special handling procedures to maintain a valid “chain-of-custody possession” and develop the formal documentation necessary for that purpose. Contractor’s testing personnel who performed the analysis may be required to provide Court testimony. Contractor testimony shall be provided as required at no additional expense to the Government.

iv. Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen.

d. SPECIMEN TRANSPORATION

i. Contractor shall provide transportation of primarily biomedical materials that include patient specimens, cultures, and stocks, originating from Government facilities and destined to the contracted commercial reference laboratory.

ii. These specimens are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained.

iii. Contractor shall provide transportation/courier for pick-up of patient samples from the Government facilities listed in this document.

iv. Contractor's employee(s) shall report to the Laboratory Central Processing area, upon arrival at the VA for specimen pickup.

v. The Government reserves the right to adjust the courier pick-up days and times as necessary, provided a two-week notice has been provided and acknowledged by the Contractor at no additional charge to the Government.

vi. The Government reserves the right to add or remove courier pick-up locations provided a two-week notice has been provided and acknowledged by the Contractor at no additional charge to the Government.

vii. Processing shall begin immediately upon receipt at the testing site and results provided within the laboratory established turnaround times.

viii. Courier services shall be available seven (7) days a week, including Federal holidays as required. A list of Federal Holidays can be found in the following Link: Federal Holidays (opm.gov)

ix. Contractor shall provide all necessary supplies for biomedical materials to be transported from the VA medical facility to the performing laboratory. These supplies shall include at minimum:

1. Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor’s laboratory.

2. Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.

3. Test request forms, preprinted with the appropriate Shipping Section details and account information.

4. Test request forms for specialized testing (i.e., cytogenetics, tissue, etc.).

5. Printer and printer supplies including paper, labels, and toner/ ink cartridges, in sufficient quantities to perform work under this contract.

e. SPECIMEN TESTING

i. Contractor shall ensure test sample integrity is maintained at all times from the time they are picked up from the participating facility and delivered to the processing laboratory.

ii. Contractor shall provide the full range of laboratory testing capabilities to execute all required test orders as annotated in this agreement.

iii. All the testing shall be performed on the Contractors premises or within the Contractor’s network labs (as official or qualified subcontractor). Under no circumstance should the contractor allow any patient information to cross the US borders. Contractor referral to the secondary laboratory or subcontractor should be kept to a minimum for control and uniformity purpose. Subcontractor should be held to the same quality standard as specified in the contract.

iv. Contractor shall make available the following test information:

1. Requisition form requirements

2. Alphabetized test name list

3. Test order code

4. Specimen collection and preservation requirements

5. Test method employed (indicate if testing performed in duplicate) and interpretations

6. Test reference intervals adjusted for age, sex, or race, when required

7. Test specific sensitivity, specificity, and interferences, when required

8. Result code

9. Test critical values if any

10. Policy for critical value notification

11. CPT coding

12. Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between receipt of specimen by the Contractor and receipt of results by a government facility.

13. Schedule of test performance (specific days of week indicated)

14. Location of test performance by test name (i.e., name of primary laboratory, name of separate branch/division of primary lab, name, and address of secondary (sub-contracted) laboratory must be cited)

v. Contractor shall notify the Site Contracting Officer Representative (COR) for each participating facility of any test submitted to be processed that does not match this agreement prior to being tested so that the appropriate process can be followed to process the test.

vi. All reference laboratory testing is preferred to be tested using test methods that are FDA approved.

1. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan.

2. Upon request, the validation plan and validation results shall be made available to the COR or designee.

vii. Contractor shall ensure the accurate and timely performance of laboratory testing services on all tests within this agreement.

f. SPECIMEN RETENTION

i. All anatomic pathology materials (e.g., histology blocks, slides, or other diagnostic material) generated by the VA shall be returned within 7 days after final diagnosis is reported.

g. TEST RESULTS & REPORTS

i. Test Results

1. If the Contractor is unable to perform the test due to issues with the specimen integrity, the Contractor shall inform the VA as soon as possible with a maximum time of 24-hours of receipt of the specimen.

2. Once testing is completed, the laboratory results shall be transmitted via secured web-based portal system or the LEDI system to each participating facility via VAMC VISTA/CERNER computer system and printer equipment provided by the Contractor that will be located at each participating facility.

3. Alternate methods of reporting results in the event of electronic system failure shall include:

a. Electronic delivery of all reports is preferred.

b. Faxed, please verify fax number prior to sending patient results as fax numbers are subject to change.

4. All test results provided by the Contractor shall contain at minimum the following:

a. Two (2) full patient identifiers

b. Physician’s name

c. Facility name and address

d. Clinical Laboratory Improvement Amendments CLIA number (if requested)

e. Account number

f. Date/time specimen was collected

g. Date/time specimen was received

h. Date/time test was reported

i. Contractor generated Laboratory Accession Number

j. VA generated Laboratory Accession Number

k. Test ordered

l. Test result

m. Flagged abnormal results

n. Reference ranges

o. Name of testing laboratory

p. Type of specimen

q. Any additional comments related to test provided by submitting lab

r. Any other information the laboratory has that may indicate a questionable validity of test results; and

s. Unsatisfactory specimens shall be reported with regard to its unsuitability for testing.

5. The Contractor shall return representative slides, anatomic, hematologic, etc., for quality control review when requested. Quality control slides shall represent duplicate copies of original slides prepared by the Contractor from permanent tissue blocks. The Contractor shall provide quality control slides to the facility or clinics at the same time the Contractor submits the final reports. The Contractor shall prepare additional blocks and slides, in quantities specified by the facility for review by pathologists. For malignant cases, the Contractor shall call results to the submitting facility, and prepare paraffin blocks and slides for review by the Joint Pathology Center (JPC) or other Government Pathology Organization (GPO). For benign cases, the Contractor shall prepare slides for review by the facility. Upon provision of sample slides by the facility, the Contractor shall provide interpretation of sample slides. The sample shall include, at a minimum, breast biopsy, thyroid biopsy, mastectomy with nodes, colon resection, lymph node biopsy, and gynecology and non-gynecology cytology.

6. The Contractor shall store all blood and fluid specimens after all testing has been completed in the event repeat or add on testing for one (1) week at conditions that shall maintain sample viability. Upon request, samples shall be returned to the collecting VA facility via courier at conditions that shall maintain sample viability, at no additional charge to the VA. All anatomical pathology specimens (i.e., slides, blocks, etc.) shall be returned within two (2) weeks of test completion.

ii. Reports

1. All Reports shall run from the 1st day of each month through the last day of each month. For Example: January 1 – January 31, February 1 – 28 or 29 (if leap year), and June 1 – June 30.

2. Contractor shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.

3. Contractor shall provide a statistical analysis of the Government facilities’ workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities on mechanisms to reduce their costs.

4. Contractor shall provide a cumulative workload summary report of tests performed. The summary must include the facility account number, the test name, the test ordering code, monthly test volume, year-to-date test volume, unit test cost, monthly test expenditures and year-to date test expenditures, the VA and Test Lab generated accession numbers, and the name and address of the testing laboratory (contractor and subcontractor).

a. A copy of the report shall be delivered electronically to the Contracting Officer and COR by the 10th of the month following the close of the reporting month.

b. All reports shall be submitted in electronic spreadsheet format and have the capability to sort by four (4) different methods:

· Facility account number

· Test names listed alphabetically

· Test names listed in order of year-to-date test frequency (highest to lowest)

· Test names listed in order of year-to-date total test cost (highest to lowest)

iii. Additional Administration Requirements / Reports

1. The Contractor shall provide an updated copy of the Excel spreadsheet “Reference Lab Invoice Summary” to the Contracting Officer Representative, COR by the 10th of the month following the close of the reporting month. The Contractor shall update the quantities of tests invoiced during the prior month in this spreadsheet.

2. Contractor shall provide a monthly listing of any tests listed in Attachment 1 that 1) are no longer performed by contractor or 2) the test code or test name is updated. The Contractor shall highlight the rows RED in the Excel Spreadsheet “Declining Balances Monthly Test Tracker” for any test codes that are no longer performed by the Contractor or have updated test names and make a note in the “Notes” column. These tests will be either removed or updated via a supplemental agreement in accordance with 52.212-4. When invoicing, prior to the test code or test name being updated via contract modification, the Contractor shall reference the previous test code name and new test code name on the invoice.

3. The Contractor shall make all reasonable effort to notify the VA that a test ordered against the contract is not listed in the contract, in order to avoid an unauthorized commitment.

h. QUALITY REVIEW

i. Contractor shall provide the following:

1. In accordance with VHA Handbook 1106 a 10% retrospective quality management peer review shall be completed. This review shall be completed by a second pathologist on at least a quarterly basis for a minimum of 10% of all surgical pathology cases, fine needle aspirates, cytopathology cases and gynecologic cases.

2. This 10% review shall be performed by a pathologist certified in anatomic pathology. Reviews shall meet these review requirements:

a. Under no circumstances shall a resident physician act as a second reviewer for a staff pathologist.

b. Under no circumstances shall a staff pathologist review a resident physician’s diagnosis as this does not constitute a second review.

c. Individuals performing a second review in GYN cytology shall have achieved a current successful GYN cytology competency assessment.

d. The review process shall be random, shall include all types of specimens and shall include a review of the entire case.

e. At least 10% of the cytotechnologist’s gynecologic cases that have been interpreted as negative are routinely rescreened and are diagnosed and documented as being negative by a qualified pathologist.

f. Cases subjected for rescreening shall include some cases from high-risk patients, as well as random negative cases, based upon criteria established by the Chief or Director of Pathology and Laboratory Medical Services.

g. Ability to instantly generate reports like cost Management Report, turn-around-time report, Utilization Report and any other quality management report requested by the site.

i. CUSTOMER SERVICE

i. Contractor shall provide customer service that is accessible by toll-free telephone service 24 hours per day, 7 days per week to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this agreement.

ii. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address customer services throughout the agreement.

iii. On-Site Processing Staff

1. Contractor shall provide onsite reference laboratory processor(s) to interface directly with VA personnel to ensure maximum customer service, proper preparation and processing of specimens and completion of results. The contracted processor(s) will serve as the primary liaison between the reference laboratory and the VA. This individual will be responsible for fielding phone calls to/from the reference laboratory and addressing questions/issues with reference laboratory samples. This individual will process, aliquot, and otherwise prepare all samples to be sent to the contracted reference laboratory and will create shipping manifest and package samples according to all applicable requirements. This individual will be the primary individual responsible for procuring supplies required to send testing to the contracted testing facility.

a. Duties include but are not limited to:

· Centrifuging samples

· Aliquoting samples

· Labeling samples

· Packaging samples

· Specimen storage

· Filling out requisitions

· Cleaning work surfaces

· Filing testing paperwork

· Filling out required forms

· Creating shipping manifest

· Retention of shipping manifests

· Contacting the reference laboratory for test clarification or status updates

· Checking pending samples lists daily against vendor-stated turnaround times

· Troubleshooting and communicating resolution to VA staff

· Check, order and stock supplies for inventory

· Maintain and disinfect send-out centrifuge

· Complete all required VA training/compliance

2. The processor shall work in accordance with all Richard L. Roudebush VA Medical Center Pathology & Laboratory Medicine Service procedures and policies. The processor shall follow the contracting facility’s regulations for time off (sick, vacation, holidays, weekends). The vendor shall supply a replacement/backup processor for all instances in which the primary processor is unavailable. Notification to the Contracting Officer’s Representative is required for any unanticipated absences that may prevent or delay coverage. If the contractor’s processor is terminated or resigns, the contractor has 10 business days to provide a replacement processor.

3. The VA will supply adequate workspace, break and restroom facilities, personal protective equipment, office supplies necessary for basic processing and organization, as well as computer access.

iv. Parking

1. Contractors, including on-site staff and vendor personnel performing site visits, must obtain their own parking arrangements. The facility will not provide on-site parking. Parking is available in nearby parking facilities such as Eskenazi’s visitor garage. Temporary parking for courier pickups is available in the front of the building near the main entrance.

v. Environment of Care

1. All significant problems identified shall be reported verbally to the COR within 24 hours. A written corrective plan of action shall be submitted to the COR within five (5) working days. VA timeframes and priorities for completion of action plan items shall be mutually agreed upon by the Contractor and the VA Safety Officer. The Contractor shall successfully pass the participating Facility’ Safety and Infection Control inspections prior to the provision of patient care.

2. VA strives to ensure that the patients experience at each of the medical centers provides for convenience of obtaining all possible tests in one visit

vi. Personnel Security

1. Anyone with administrative or programmer access to a Federal computer system shall have a background investigation commensurate with the level of access granted to the VA computer system as determined by the Information Security Officer in concert with Human Resources Management Staff. These staff shall be operating within the borders of the U.S.A. and its territories.

vii. Continuing Education

1. The contractor shall provide ongoing continuing education material for Professional Acknowledgement for Continuing Education (PACE), Continuing Medical Education (CME) and Continuing Education (CE).

j. DATA MANAGEMENT & CONNECTIVITY REQUIREMENTS

i. Data Management System

1. Contractor shall provide to the Government all necessary laboratory test parameters (parameters are required for each test contained in a panel) to insure accurate test result transmission between the Government and the Contractor’s database. They shall provide all the IT support required for transition between reference labs, namely building existing and new test codes, test description, interface, troubleshooting and maintenance through the life of the contract. Required test parameters include:

a. Ordering code

b. LOINC code

c. CPT code

d. Interface code

e. Test cost

f. Reference ranges

g. Units of measurement

h. Test result interpretation or interpretive remarks, if appropriate

i. Testing site (if not performed at the vendor’s main laboratory facility

j. Test methodology

k. Specimen types

l. Specimen collection and handling requirements

m. Indication whether test is a panel/profile test, list of tests included

2. The parameters for all tests in the Contractor’s database shall be kept current and be available to the Government sites throughout the performance period of the contract. Updates to the test parameter information must be provided to Government sites no less than 2 weeks prior to the implementation of any changes. The Contractor shall provide telephone access to a Contractor’s technical representative to respond to any question(s) regarding the laboratory test parameter information.

3. The Contractor shall provide a data management system that meets the following requirements:

a. Test ordering shall be accomplished through a menu that is intuitive, has minimal options, and uses a mouse or touch screen. Upon selection of the test, the computer shall alert (flag) the user to the type of specimen required and the storage conditions. It must also alert the user to the location of the laboratory that will be performing the test.

b. Test definition, test information, and test requirements must be complete, available and easily accessible.

c. Shipping manifest shall be generated that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered.

d. The status and the results of testing shall be available within published timeframes and easily retrievable by the use of varying options. At a minimum the options must include:

· Sort by patient name

· sort by date; sort by test

· sort by incomplete test.

· Incomplete tests must have an indication of the pending time until completion. Alert messages, or other notification, must be generated when testing is delayed beyond published timeframes.

e. Reports of test results must be immediately available upon verification of the test result. Contractor’s computer located at the Government site must be able to print test results upon request and reprint retrospective test results.

ii. Equipment Security

1. Any equipment provided by the Contractor to VA which contains a storage device such that when the device is powered down, VA sensitive data remains on it shall be sanitized prior to removal from the VA premises, shall become the property of the Federal Government and remain on Federal property or shall be destroyed in accordance with Department of Veterans Affairs regulations at the time of removal (device decommissioning). Data required by the HIPAA to remain on equipment located on Contractor's property shall be safeguarded in accordance with HIPAA and this information shall be destroyed in accordance with VA requirements when no longer required by HIPAA to be held by the vendor.

iii. VA Connectivity Requirements

1. The Contractor shall provide each participating facility the capacity to order lab testing and receive results through a secure web-based portal. The Contractor shall show that this portal meets VA requirements for encryption of sensitive patient information. The requirements that VA utilizes for these types of transmission shall be the Federal Information Processing Standard (FIPS) Publication 140-2. The Contractor shall be responsible for transmission of orders, confirmation of orders, test results, and the preventive maintenance of the system. Contractor shall be available to train the Facility’s staff on the use of the system at each facility. An alternate method of sending orders and receiving results shall be in place in the event of system down time. A shipping manifest shall be generated that identifies the specimens sent to the reference laboratory, transportation conditions, and testing ordered.

2. CERNER is a new VA Computerized Electronic Health Record that the VA is in the process of transitioning to. The contractor shall ensure they have the ability to interface with CERNER and is operational and validation is complete with full menus complete at the time of contract award.

3. The Contractor shall have an electronic bi-directional interface system. The Contractor shall meet all Cyber Security requirements to establish an interconnection with the VA for transfer of test ordering details and laboratory test results directly from and into the VA computer system via the appropriate LEDI protocol. The interface shall be designed with a single data interface for the Facility which all sites shall utilize. The interface shall allow the generation of manifests to identify the specimens to be sent to the reference lab. Upon receipt of test results, the VA staff shall be able to review/validate test results before release. The Contractor shall be responsible for the purchase of any licenses for middleware products (e.g., Data Innovations) and hardware for any middleware or interface structure.

4. If the Contractor does not have a bi-directional electronic interface already in place, the Contractor shall have the following implemented within three (3) months of the contract award date. Contractor shall assist staff in the updating of the test database by providing all information required to create new test files for the required tests (i.e., sample requirements, shipping temperatures, reference ranges, CPT codes). Interface portal shall be connected and approved, including any required hardware, such as dedicated printers for labels and results. Interface validation shall be completed on the tests that have been updated in the database.

5. Due to the difficulties encountered with any major reference laboratory interfacing change or upgrade, Contractor shall temporarily provide a single knowledgeable point of contact for researching correct test information, point(s) of contact for developing, testing, and implementing a client/vendor interface, and then an ongoing point of contact for troubleshooting interface problems. Temporary service shall be in effect until interfacing change or upgrade has been completed.

6. The Contractor shall meet all Enterprise Cyber Security Infrastructure Project (ECSIP) requirements in order to establish an interconnection with the VA for transfer of laboratory test results directly into a VA computer system via the appropriate LEDI protocol. The ECSIP team shall have the ultimate decision on which connection type is appropriate.

7. The Contractor shall provide the following interfacing requirements: Laboratory Information Systems LIS physical connection and translation (drivers) and any required (additional) interface connection license(s) and the Interface shall transmit test results to the host computer via automatic upload. The interface connection shall be tested and verified before putting into use.

8. The reference laboratory shall meet VA information security and Health Insurance Portability and Accountability Account of 1996 (HIPAA) requirements and shall be able to interface with the current or any new interface partner of the Laboratory Information System. The Contractor shall have all users with VA access complete the VHA privacy training prior to starting services.

iv. Performance Improvement

1. The Contractor shall comply with the participating Facility Performance Improvement (PI) program as applicable to Pathology and Laboratory Medicine Service (PALMS). PALMS shall monitor the vendor’s Test Assay Turn Around Times (TATs) on a quarterly basis. Vendor shall provide a quarterly TAT report for all patient testing requests sent for analysis. Quality Assurance Technologists shall provide a quarterly report to participating facility management teams for review. Contractor PI activities may be directed by the VA facility, VISN or VHA, as well as accreditation or licensing bodies. The Contractor shall abstract, compile and report PI data as requested by the VA. VA Data collection methodology, report format, and reporting deadlines shall be defined by the participating facility. Examples of required PI activities include the VHA Performance Measures/Clinical Practice Guidelines program, and the Joint Commission ORYX or Core Measurement program. It is noted that PI activities are dynamic and subject to change, as driven by current priorities and resources. In all cases, the Contractor shall continually assess for, and act upon, clinical and administrative improvement opportunities. High priority shall be given by the Contractor to the prevention of risk for the patient. The Contractor shall implement process-related internal controls to prevent risk to the veteran. VA monitoring for continuous compliance with Joint Commission standards shall be directed by VA staff and communicated to the Contractor through the COR. VA aggregate and/or practitioner-specific data collected by the VA shall be provided to the Contractor in accordance with established reporting schedules. VA measures related to contract compliance shall be identified by the COR

v. Information and Records Management

1. The participating Facility’ Information Management plan shall be followed by the Contractor. Documentation and record keeping shall be in accordance with the Facility’ policies and procedures. Strict adherence to all documentation related to the performance of invasive procedures shall be maintained. Identified medical record delinquency data shall be forwarded to the Contractor by the participating facility

vi. Automated Data Processing (ADP) Security/HIPPA and Excluded Individuals

1. The VA shall provide access to the Veterans Health Information and Technology Architecture (VISTA) for Contractor employees. All Contractor employees accessing the VISTA system shall be required to sign and abide by all VAAAHS security policies and applicable VA confidentiality statutes, 38 U.S.C. §5701, 38 U.S.C. 7332, and the Privacy Act, 5 U.S.C. §552a. Background security investigations shall be completed before access to VISTA may be granted

2. Health and Human Service – Office of Inspector General (HHS/OIG): To Ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the Contractor is required to check the Health and Human Service – Office of Inspector General List of excluded individuals/entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. Further, the Contractor is required to certify in its proposal that all persons listed in the Contractor’s proposal have been compared against the OIG list and are not listed. During the performance of this contract the Contractor is prohibited from using any individual or business list on the List of Excluded Individuals/Entities

vii. Telecommunication Interface Requirements

1. In order for contract performance to begin within the shortest time possible after contract award, Contractor must already possess a current VA nationally approved Business Partner Gateway (BPG) Interconnection Security Agreement (ISA) and Memorandum of Understanding (ISd have an integrated system approach to facilitate and streamline all aspects of specimen ordering, testing, and reporting. As such, the Contractor shall develop and program an interface connection to electronically transmit orders, specimen status, and test results between the Contractor’s host computer system and the Government’s host computer system (VistA). (NOTE: A subcontractor may be utilized to outsource the connectivity solution.)

2. The VistA host computer system supports a Universal Interface (UI) and a Generic Instrument Manager (GIM). The GIM is a commercial hardware and software product that provides electronic connection between the Contractor’s…