36C25026Q0305

GENERAL INFORMATION

SET-ASIDE

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Dayton VA Medical Center 3140 Governor’s Place Blvd. Suite 210 Kettering OH 45409-1337

POINT OF CONTACT*

Contracting Officer Morgan Stein Morgan.Stein@va.gov

PLACE OF PERFORMANCE

ADDRESS

Department of Veterans Affairs

Battle Creek VA Medical Center

5500 Armstrong Road

Battle Creek MI

ADDITIONAL INFORMATION

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

DESCRIPTION

Combined Synopsis/Solicitation Notice

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with FAR part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

Solicitation number 36C25026Q0305 is issued as a request for quotation (RFQ) for all necessary labor, management, equipment, deliverables, and support to provide reference laboratory testing services for the Battle Creek VA Medical Center, Battle Creek and Wyoming, MI.

This acquisition is not set aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov.

The associated North American Industrial Classification System (NAICS) code for this procurement is 621511 – Medical Laboratories, with a small business size standard of $ 41.5 Million Dollars. The FSC/PSC is Q301 – Medical- Laboratory Testing.

The Network Contracting Office (NCO-10) is seeking to purchase Reference Laboratory Services for the Aleda E. Lutz VA Medical Center.

Responses will be evaluated via comparative analysis utilizing Indefinite Delivery Indefinite Quantity (IDIQ) Firm Fixed Price (FFP) contract.

Questions shall be emailed to Morgan.Stein@va.gov and are due by 12 PM April 15, 2026.

Responses shall be submitted no later than 4:30 PM May 15, 2026 via email to Morgan.Stein@va.gov.

36C25026Q0305 See attached "Price Schedule"

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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:

b. GOVERNMENT: Contracting Officer 36C250 Morgan Stein

Department of Veterans Affairs Network Contracting Office (NCO) 10 3140 Governor’s Place Blvd. Suite 210 Kettering OH 45409-1337

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:

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.

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

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

36C25026Q0305

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B.2 PRICE/COST SCHEDULE

Contractor shall provide all necessary labor, management, equipment, deliverables, and support to provide reference laboratory testing services in accordance with the Performance Work Statement (PWS).

Estimated Quantities: The Government has provided their best estimate as to the number of items/units that will be required over ordering period one. The need for services may change due to needs of the medical center.

Minimum Guarantee: The minimum guarantee for this contract is $2,000.00 over the life of the contract and only applies in the Federal Government Fiscal Year in which the contract is awarded. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

Maximum Contract Value: The maximum value of this contract shall be no more than $6,395,464.95.00 over the life of the contract.

Billing: While the contract is estimated, the contractor shall bill in arrears monthly. Contractor shall bill by Line-Item numbers equaling the total number for the month. Invoices submitted through Tungsten shall include all requirements of the Billing and Invoicing section of this solicitation and FAR 52.212-4(g) to have payments certified.

Aggregate Total Base Year Ordering Period One (1)

Ordering Period Two (2)

Ordering Period Three (3)

Ordering Period Four (4)

Ordering Period Five (5)

Aggregate Total for All Ordering Periods

See Attached Price Cost Schedule - BCVAMC and WCBOC Page 1 of Page 1 of

B.3 PERFORMANCE WORK STATEMENT

Department of Veterans Affairs, Veterans Health Administration (VHA), VISN 10, Battle Creek VA Medical Center, requires the services of a contractor for reference laboratory testing services for a five-year Indefinite-Delivery Indefinite-Quantity contract.

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; 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

Battle Creek VA Medical Center Pathology and Laboratory Service 5500 Armstrong Road Battle Creek, MI 49037

AND

Wyoming Community Based Outpatient Center (CBOC) 5838 Metro Way Southwest Wyoming, MI 49519-961

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. 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 5 days per week and pick-up times required by the site are identified below:

· BCVAME: Monday – Friday between 5:00PM ET and 6:00PM ET

· WCBOC: Monday – Friday between 2:00PM ET and 3:00PM ET

3. Dry ice (if required)

4. Chain of custody forms (if required)

5. Specimen transport request forms

6. Reference laboratory testing and reporting with current reference ranges

7. Secured web-based portal system, Intranet Laboratory Electronic Data Interchange (LEDI) system

8. Contractor shall have interchange with the VA EHR (Oracle/Cerner) computer system which will be installed during this contract at the time of award.

9. 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

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

11. 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.

12. Shipping manifest

13. 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.

14. 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

15. 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.

16. 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. 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.

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. 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.).

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 contract 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 contract.

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.

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 Price / Cost Schedule 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 Directive 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 contract.

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

iii. Parking

1. Contractors, and vendor personnel performing site visits, must obtain their own parking arrangements. The facility will not provide on-site parking. Temporary parking for courier pickups is available in the front of the building near the main entrance.

iv. 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.

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

v. Personnel Security

1. Anyone with administrative or programmer access to a Federal computer system shall have a background investigation (Tier 1) 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. The responsibility for the cost of background investigations is that of the contractor.

vi. 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 ensure 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. The Government site must be able to print test results upon request and reprint retrospective test results.

ii. Equipment Security

1. 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. 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. 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. 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 host computer and the Government’s host computer. The configuration must provide the required security of the Government host computer system. The actual electronic connection between the GIM and the Contractor’s host system is of the Contractor’s choosing. The initial and continual expense of the electronic message connectivity and maintenance shall be borne by the Contractor throughout the performance of the contract.

3. All electronic messaging between the two (Contractor and Government) host computer systems using the GIM shall utilize VistA Health Level Seven (HL7) V1.6 technical specifications. Health Level 7 (HL7) is a registered trademark of Health Level Seven, Inc, a Standards Developing Organization accredited by the American National Standards Institute to author consensus-based standards. Information regarding HL7 transmission protocols may be accessed through the Health Level Seven, Inc website, www.HL7.org.

4. VistA Laboratory Electronic Data Interchange (LEDI): identifies Government-specific content and encoding tables to be used with HL7 message protocol conventions. The LEDI specification follows very closely the HL7 V2.3.1 standard. LEDI identifies encoding tables and HL7 message protocol conventions.

5. LEDI also identifies to the commercial reference laboratory contractor shipping lists containing required specimen demographics and requested tests to be performed. This list will be provided in printed format during the implementation period. This information is also available in electronic HL7 format if required.

6. (LEDI) software will provide a HL7 acknowledgement for the receipt of tests results from the contractor. In the event that electronic communication is disrupted, the contractor shall provide hard copy of specimen results upon demand. The hard copy must contain Government’s assigned specimen identification where specimen identification is defined as a unique Government-assigned number that is associated with each specimen. This specimen identification number will appear on the test order form, on the specimen label and on the shipping manifest.

7. The Contractor shall provide the Government with specimen status in response to electronic and verbal query. Upon test completion, a formatted HL7 message containing specimen test results with Government’s assigned specimen identification shall be returned to the requesting medical center.

8. Contractor shall address within two hours of initial inquiry, interface connection questions where information is required to update, maintain, and support the services of the host-to-host linkage between the Government and the Contractor.

9. Contractor shall provide in-service training required for the routine loading and care of printers and other hardware located on-site. The training will ensure that Government staff is capable of performing routine servicing of hardware.

D. POLICIES, REGULATIONS, AND COMPLIANCE STANDARDS

a. POLICIES AND REGULATIONS

i. Policy/Handbooks:

1. VHA Handbook 1100.17: National Practitioner Data Bank Reports: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

2. VHA Directive 1100.21(1) Privileging: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=10179

3. VHA Directive 1100.20(2) Credentialing of Health Care Providers: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9444

4. Directive 1106 Pathology and Laboratory Medicine Service: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=11663

5. VHA Directive 1907.01(1) Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9235

6. Privacy Act of 1974 (5 U.S.C. 552a) as amended: http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

ii. Conformance Standards:

1. Contractor shall maintain full compliance with applicable Federal and State regulations. All services provided under this contract shall be performed in conformance with the National Fire Protection Agency (NFPA) 99- Health Care Facility Code, Occupational Safety and Health Administration (OSHA), HIPAA, and other applicable national, state, and local regulatory agencies. Contractor shall maintain Clinical Laboratory Improvement Act (CLIA) certificate of accreditation, and The Joint Commission (JC) and the College of American Pathology (CAP, if required) accreditations. A copy of the CLIA certificate shall be provided to the participating Facility when requested.

2. Contractor’s Laboratory Director shall be a licensed American Board of Pathology certified pathologist. The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. All contractor personnel shall meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI) and maintain required licenses. The Contractor shall maintain current licenses and certificates and provide copies of such to VA upon reasonable written request

iii. Joint Commission Compliance Standards

1. All applicable VA and VHA policies, procedures and directives shall be followed by the Contractor. The Contractor shall continuously meet or exceed all Joint Commission Hospital standards and provide oversight of care, treatment and services provided through contractual agreement standard LD.04.03.09. The patient population treated within the covered areas consists of veterans with varying physical, psychiatric, and psychological needs. Their conditions are in many cases, directly related to the individual’s service to this country. Contract personnel shall provide compassionate care with respect for the special needs of the veteran population served. Care delivered shall reflect the VA Medical Centers mission, vision, and values:

2. MISSION: Honor America’s veterans by providing exceptional health care that improves their health and well-being.

3. VISION: VHA shall continue to be the benchmark of excellence and value in health care and benefits by providing exemplary services that are both patients centered and evidenced based. This care shall be delivered by engaged, collaborative teams in an integrated environment that supports learning, discovery, and continuous improvement. It shall emphasize prevention and population health and contribute to the nation’s well-being through education, research, and service in National emergencies.

4. VALUES: VHA’s five core values are Integrity, Commitment, Advocacy, Respect, and Excellence. They define our culture and how we care for our Veterans.

E. SPECIAL CONTRACT REQUIREMENTS

a. AWARD SPECIFIC INFORMATION

i. Modifications

1. All modifications shall be given at minimum 60 days for any change to takes affect.

2. Modifications that change the terms and conditions of the contract shall be bi-lateral.

3. Modifications that are administrative in nature may be completed unilaterally by the Government to update attachments, points of contacts, etc.

ii. Pricing

1. Pricing shall be determined and established at the time of award for the all ordering periods. Pricing shall not change.

2. Variable Priced Tests shall not be included. They will either need to be provided an FFP or not orderable through this agreement.

iii. Tests and Reflex Tests

1. All tests and reflex tests shall be listed in the award with established test codes and pricing.

2. Only the tests and test codes listed in the award are authorized.

3. New tests may be added to the award without competition via bilateral modification.

4. New Tests:

a. New tests may be added to the award through a bi-lateral modification.

b. New Tests shall not be utilized until a bilateral modification is executed.

c. Pricing shall not change for any test replaced due to a test code/description change.

iv. Test Code/Description Changes

1. Test codes/descriptions listed as part of the award shall not change prior to the Contract being updated to reflect the change.

2. Contractor shall not change any Test codes/descriptions of any test on the award prior to a bi-lateral modification being executed.

a. This modification request shall include the updated list of tests to validate the Test Code/Description change for tests.

b. Modifications to change test codes/descriptions on the award shall not happen more than once per quarter via bilateral modification.

3. Pricing shall not change for any test code/description change that is replacing a test listed in the award regardless of whether they are FSS or open market.

v. Tests Not Listed in the Award

1. Tests not listed in this award with the assigned test…