36C24926Q0108_1.docx

SUBJECT*

Laboratory Courier Services for the Lexington VAMC

GENERAL INFORMATION

1101 Veterans Drive

Lexington KY

CONTACT INFORMATION

Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 204 Murfreesboro TN 37129

POINT OF CONTACT*

Elizabeth Trimm, Contracting Officer Elizabeth.Trimm@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Lexington VA Healthcare System (LVAHCS) requires lab specimen courier services. The Vendor shall provide all necessary management, labor, equipment, vehicles, transportation, information security (HIPAA), and insurance to provide courier services to and from the two (2) Lexington VA Medical Centers (Troy Bowling and Sousley Campuses), and to and from the Lexington VAMC CBOC to the Lexington VA Medical Center Main Campus (Troy Bowling).

The VHA Community Based Outpatient Clinics (CBOC) provide a variety of outpatient primary care and specialty care services in communities closer to where eligible veterans reside, thus improving convenience, equity of access in rural/underserved areas, efficiency and effectiveness of care, and access to care for all eligible veterans. These outpatient services may include primary care, preventive care, immunizations and vaccinations, prescription of medications, social work, dental, radiology, mental health counseling and group therapy, laboratory testing, women’s care, physical therapy, and referral to specialists. It should be noted that the type of medical services available at a CBOC can vary from clinic to clinic.

The Courier Service process must be in accordance with ANSI/AAMI Standard 79, appropriate Department of Transportation (DOT) regulations, Veteran Health Administration (VHA) Directive 1106, and LVAHCS Standard Operating Procedure (SOP) in the most current posting, in accordance with this Performance Work Statement (PWS).

All work is to be performed in accordance with applicable federal, state, and local regulations or ordinances, including any specified regulations for information security (HIPAA), dangerous goods, diagnostic specimens, and bio-hazardous materials.

This requirement will be awarded as a 5 – year firm-fixed priced contract consisting of one (1) Base Period Year and (4) one-year Option Periods. The anticipated start date is April 1, 2026. Pickup and delivery service must begin on the first day of the base periods.

Presolicitation Notice Presolicitation Notice

Presolicitation Notice

Performance Work Statement

1.0 Description of Requirement

The Vendor shall provide courier services to transport laboratory specimens to and from the Veteran Administration (VA) Community Based Outpatient Clinics (CBOCs) listed below to the designated services at the Lexington VA Healthcare System (LVAHCS) 1101 Veterans Drive, Lexington, KY 40502. The Courier Service process must be in accordance with ANSI/AAMI Standard 79, appropriate Department of Transportation (DOT) regulations, Veteran Health Administration (VHA) Directive 1106, and LVAHCS Standard Operating Procedure (SOP) in the most current posting, in accordance with this Performance Work Statement (PWS).

2.0 Scope of Work

Lexington VA Healthcare System (LVAHCS) requires lab specimen courier services. The Vendor shall provide all necessary management, labor, equipment, vehicles, transportation, information security (HIPAA), and insurance to provide courier services to and from the VA Medical Center, 1101 Veterans Dr, Lexington, KY 40502 and the VA Leestown Division (LD), 2250 Leestown Road, Lexington, KY 40511 and to and from the CBOC addresses cited under “Places of Performance.”

The VHA Community Based Outpatient Clinics (CBOC) provide a variety of outpatient primary care and specialty care services in communities closer to where eligible veterans reside, thus improving convenience, equity of access in rural/underserved areas, efficiency and effectiveness of care, and access to care for all eligible veterans. These outpatient services may include primary care, preventive care, immunizations and vaccinations, prescription of medications, social work, dental, radiology, mental health counseling and group therapy, laboratory testing, women’s care, physical therapy, and referral to specialists. It should be noted that the type of medical services available at a CBOC can vary from clinic to clinic.

All work is to be performed in accordance with applicable federal, state, and local regulations or ordinances, including any specified regulations for information security (HIPAA), dangerous goods, diagnostic specimens, and bio-hazardous materials.

3.0 Period of Performance

LVAHCS seeks a long-term Courier Service contract. The contract term will be broken down in the ordering periods in the price/cost schedule. This requirement will be awarded as a 5 – year firm-fixed priced contract consisting of one (1) Base Period Year and (4) one-year Option Periods. The anticipated start date is April 1, 2026. Pickup and delivery service must begin on the first day of the base periods.

4.0 Places of Performance

4.1 Main Campus/Main laboratory

VA Medical Center Bowling Campus Main laboratory B102 1101 Veterans Dr Lexington, KY 40502

4.2 Secondary Campus

Sousley Campus (Leestown Division) 2250 Leestown Road Lexington, KY 40511

4.3 Community Based Outpatient Clinics (CBOC)

Somerset VA Clinic 300 Medpark Dr.

Somerset, KY 42503

Morehead VA Clinic 333 Beacon Hill Drive #100 Morehead, KY 40351

Hazard VA Clinic 160 Nautilus Dr.

Hazard, KY 41701

Berea VA Clinic 209 Pauline Dr.

Berea, KY 40403

Additional sites may need to be added in the future. Sites may be added through mutual agreement and bilateral contract modifications.

5.0 Hours of Operations

Community Based Outpatient Clinic (CBOC) normal hours of operation are Monday through Friday, 8:00 AM to 4:30 PM Local Standard Time. The Lexington VA Medical Center Main and Secondary campuses are open 24/7.

All hours listed in this Performance Work Statement are listed as Local Standard Time.

5.1 Federal Holidays

Recognized Holidays: The following federal holidays set by law (5 U.S.C. §6103). The following are recognized United States (US) federal holidays:

When one of the holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When holiday falls on a Saturday, the preceding Friday is observed as a legal holiday by US Government agencies. Presidential holiday observances not listed will be treated as routine workdays unless VA notifies vendor at least 24hr beforehand.

6.0 Estimated Quantities

The quantities mentioned in the Price Schedule are estimated quantities based on VA historical needs. The estimated quantities are not guaranteed to the vendor but could be equal to, less than, or greater than the estimated quantities referenced.

7.0 Service Contract Requirement

Vendor shall provide hourly wages in accordance with U.S. Department of Labor Wage Determinations and FAR PART 22.10 (Service Contract Labor Standards) including Health and Welfare Benefits.

The following position is applicable: 31043 Driver Courier

8.0 Definitions and Acronyms:

CBOC: Community Based Outpatient Clinic CDC: Centers for Disease Control and Prevention CDR: Contract Discrepancy Report Contracting Officer (CO) – The person executing this contract on behalf of the Government with the authority to enter and administer contracts and make related determinations and findings.

Contracting Officer’s Representative (COR) – A person appointed by the CO to take necessary action to ensure the Vendor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

CPARS: Contractor Performance Assessment Reporting System, which is the official Government reporting system for Vendor past performance on awards.

DOT: U.S. Department of Transportation HIPAA: Health Insurance Portability and Accountability Act OSHA: U.S. Occupational Health and Safety Administration POP: Period of Performance QASP: Quality Assurance Surveillance Plan VA: Veteran Administration, Department of Veteran Affairs PWS: Performance Work Statement

9.0 Courier Services Specification

9.1 Scheduled Weekday CBOC Courier Service

Scheduled weekday CBOC courier services include the transportation of diagnostic specimens and all laboratory specimens (blood/body fluids). Items will be secured at-all-times while in the possession of the Vendor.

Scheduled Weekday CBOC courier services between each of the Lexington VA Medical Center CBOCs (listed in Section 4.3) to the Main laboratory Campus (Section 4.1) shall be provided once per day Monday through Friday, except for federal and federally observed holidays as described in Section 5.1.

9.101 Scheduled Weekday Pick-up Times:

Specimen transport container(s) must be picked up in person between the hours of 4:00pm – 4:30pm OR retrieved from secure outdoor lock boxes after 4:30pm at each of the locations below once per weekday:

(1) 300 Medpark Dr, Somerset, KY 42503

(2) 333 Beacon Hill Drive # 100, Morehead, KY 40351

(3) 160 Nautilus Dr., Hazard, KY 41701

(4) 209 Pauline Dr. Berea, KY 40403

Secure outdoor lock boxes may be used to facilitate courier pick up. Keys will be issued by the VA at onset of the contract. Lost or stolen keys must be notified to the VA immediately and replacement keys picked up from the main laboratory at 1101 Veterans Drive, Lexington, KY 40502 Room B102. If the lock boxes need to be re-keyed due to lost or stolen keys, the vendor will be responsible for cost of re-keying the locks and replacement keys. Replacement keys are $10 per key and will be deducted from the vendor submitted invoice. VA issued keys are government property on loan for the duration of the contract. Keys are expected to be returned to the COR at the main laboratory campus upon termination of contracted service.

Empty coolers may be returned in person during the CBOC hours of operation or left secured in the outdoor lock boxes at each CBOC location listed above.

9.102 Scheduled Weekday Delivery Times:

The delivered CBOC laboratory specimen containers should arrive at the VAMC Lexington, KY main laboratory room B-102 as soon as possible but no later than 9:30pm on the same day they are picked up from the CBOC.

Courier contactor personnel responsible for performing each pickup and delivery will signify completion of the task by legibly recording information required on the CBOC Pickup and main laboratory delivery logs.

The contractor will provide a single telephone number, providing coverage every day of the scheduled CBOC service, so CBOC and main laboratory personnel can inquire about the disposition/status of ALL pickup and delivery events. Courier must be able to relay to VA staff if specimens are picked up, delivered, or in route.

The courier must notify the VA main laboratory personnel within one (1) hour if there are delays or other issues regarding pick-up and delivery of specimen samples. Main laboratory phone number is 859-233-4511 x4529 or x5198.

Anticipated daily transport requirements for each CBOC are:

· Generally, 1 - 3 loaded specimen coolers or containers per CBOC.

· Coolers are 16"W x 10.5"D x 12.5"H

· Other containers may vary but are generally cooler-size or smaller.

CBOC Pickups cannot be completed earlier than scheduled time unless VA personnel or COR agree to a change in time for that specific date.

An equivalent number of empty coolers will be returned from the main campus back to each CBOC daily by the Vendor. Empty coolers will be given back to the Vendor staff at delivery to the Main Laboratory.

Laboratory specimens and any other hazardous materials will be properly packaged by the VA personnel for transportation. Vendor will not open or enter VA packaged coolers. Specimens are packaged by VA staff to protect PHI/PII and at specific storage temperatures. All specimens must be transported in accordance with all Department of Transportation (DOT) and OSHA Codes of Federal Regulations (CFR) 49 and 29.

The Vendor is responsible for any material handling equipment (dollies, carts) for any items being carried or transported.

9.2 Unscheduled Secondary Campus to Main campus specimen transport Service includes the transportation of diagnostic specimens and all laboratory specimens (blood/body fluids). Items will be secured at-all-times while in the possession of the Vendor.

Unscheduled evenings, weekend and Federal holiday consists of specimen transport covering weekdays Monday through Friday beginning at 4:30pm, continuing overnight to the following morning at 8:00 am, all day on Saturday and Sunday and all federal holidays as described in section 5.1. These deliveries will only be from the Secondary campus to the Main campus only. No unscheduled evening, after hours or holiday CBOC courier service is required.

This will be an on-call as needed service. VA staff will notify Vendor of pick-up need and specific building location with the VA secondary campus located at 2250 Leestown road. Lexington, KY 40511. Items picked up from the secondary campus will be delivered to the Main Laboratory campus at 1101 Veterans Drive, Laboratory room B102 Lexington, KY 40502.

9.201 For as-needed unscheduled service:

Pickup of laboratory specimen transport container(s) should be made within one (1) hour of order placed to Vendor from VA Leestown Division (LD), 2250 Leestown Road, Lexington, KY 40511. VA staff will direct courier to specific building and entrance for pick up. Delivery should be made within 30 minutes from pickup, regardless of the day or time order placed.

Vendor staff will deliver specimen transport containers to the main laboratory VA Medical Center, 1101 Veterans Drive, Lexington, Ky. (Fayette County) located on first floor, room B-102.

Vendor personnel responsible for performing pickup and delivery of laboratory containers will signify completion of each task by legibly recording information required on the VA pick-up and delivery logs.

The vendor will provide a single telephone number, providing coverage during the as-needed unscheduled service hours, so that Lexington VA HCS personnel can request specimen pick up, inquire about the disposition/status of pickup and delivery events, delays or inquire specimen location.

Vendor personnel will complete telephone calls as soon as possible, prior to pickup and delivery deadlines, to inform the VA main laboratory personnel of problems or delays that interfere with the pickup and/or delivery process. Main laboratory phone number is 859-233-4511 x4529 or x5198.

Anticipated trip transport requirements from the Secondary Campus are:

· 1 specimen cooler or specimen transport container.

9.3 Environmental Controls

The Vendor shall be responsible for maintaining a temperature-controlled environment between 65 to 80 degrees Fahrenheit in vehicle during transportation.

The Vendor drivers will not leave vehicles in extreme heat or cold while specimens are being transported without continuous temperature control in operation.

Items must be kept out of prolonged contact with environmental hazards such as dust, snow, and rain.

Should specimens and/or transported items be lost, broken, or otherwise damaged, the Vendor shall be required to submit a preliminary summary incident report to the COR within 24 hours of the incident. The Vendor shall provide a written incident report explaining the details of the incident; specifically, what caused the incident (who, what, where, when, and how) within 72 hours of the incident. The vendor shall be responsible for the replacement cost of any containers that are lost or damaged while in the Vendor’s custody.

9.4 Bloodborne Pathogens

The Vendor and the Vendor personnel shall comply with the effective VA Medical Center Policy (and Occupational Health requirements in accordance with OSHA Blood Borne Pathogens (BBP) Law and the OSHA Tuberculosis Compliance Directive, enforceable under OSHA’s General Duty Clause) governing healthcare workers infected with a blood borne pathogen. If the Vendor obtains information that a person providing services under this contract may be infected with a blood borne pathogen, the Vendor shall immediately advise the COR.

The vendor is responsible for training transport personnel in appropriate safety and transporting procedures suitable for biological specimen types and distance transport.

The vendor shall transport samples in such a manner as to ensure the integrity of the specimens.

All specimens must be transported in accordance with all local, state, and federal regulations, including specified regulations for bio-hazardous materials.

The vendor shall be responsible for complying with all regulations that define appropriate transportation of specimens and shall supply in writing that all drivers have been adequately trained on an annual basis. The vendor’s employees/couriers transporting test specimen must be trained in “Universal Precautions” in the handling of biohazard materials (specimens). Training must include utilizing clinical procedures in case of biohazard spills and accidents. The vendor must furnish a record of all required training to the COR before a contract employee begins work on this contract and annually thereafter.

9.5 HIPAA Compliance

The Vendor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). In addition, all VA security policies and applicable confidentiality statues such as 38 U.S.C. §5701 (VA Claims Confidentiality), 38 U.S.C. §5705 (Confidentiality of Healthcare Quality Assurance Review Records), 38 U.S.C. §7332 (Confidentiality of certain medical records), as well as 45 C.F.R. Parts 160, 162, and 164 (Health Insurance Portability and Accountability Act) should be followed.

As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities. The covered entity component of VA is the Veterans Health Administration (VHA).

9.6 Quality Control

The vendor shall develop and maintain a quality control program that ensures courier services are performed in accordance with these specifications. The vendor shall develop and implement procedures to track, identify, prevent, and remedy and ensure non-recurrence of defective services.

The vendor shall provide a method to accept and resolve customer complaints and notify the customer of the resolution.

The vendor shall immediately notify the COR upon receipt of a customer complaint in order that joint validation may be accomplished. The vendor is responsible for quality control and specification compliance.

9.7 Contingency Plan

The Vendor shall develop a contingency plan to address inclement weather and provision of services without interruption.

Inclement weather: The Vendor shall develop a contingency plan to address possible inclement weather conditions. The vendor is expected to make all deliveries on time during inclement weather if VA facilities are open for business. The COR will notify the Vendor of facility closures due to inclement weather as soon as they are aware, to allow Vendor to plan their staffing. In case a delivery cannot occur due to total road closures by Kentucky DOT, the Vendor shall notify all CBOCs, VA laboratory staff and the COR. This notification must occur as early as possible to allow VA to notify veteran patients that laboratory services or procedures need to be rescheduled.

Continuation of Services: The Vendor will develop a contingency plan to ensure timely, uninterrupted daily scheduled courier services for VA to all listed locations. This plan shall be reviewed annually by the Vendor, the COR, and other designated VA lab personnel. This includes backup personnel and vehicle(s), if needed, in case of vehicle breakdown.

Any changes to the original contingency plan shall be submitted to the COR and CO within three (3) business days of the changes.

9.8 Vendor Vehicle

The contractor is responsible for all travel costs.

Within five (5) business days after award, the vendor shall provide the following:

1) Number of vehicles, including make, model, and license plates.

Vendor vehicles used in the performance of this contract must be licensed and meet the minimum requirements as mandated by the State of Kentucky.

Vendor must own or lease every vehicle used in the performance of this contract. Under no circumstances are personally owned vehicles to be used nor are Vendor vehicles to be used for transport of any items other than VA property covered by this contract while in the performance of this contract. Large vehicles, trucks, or vans are not necessary for the performance of this contract.

Vehicles shall have the company name/logo prominently displayed.

Each vehicle used in the performance of this contract must be adequately stocked with at least one current/up-to-date complete “Spill Kit” for a bio-hazard clean-up in case of leakage or accidental discharge from container.

The Vendor shall provide comprehensive automobile liability insurance required by the State of Kentucky. Upon request, the Vendor shall provide certified proof of automobile liability insurance for all vehicles used by the Vendor in the performance of this contract.

Vendor vehicles must be maintained in a sanitary clean condition, absent from foreign debris and contaminants.

All vehicles must be in good working condition with all doors and trunks able to fully close and lock. Unattended vehicles with VA contents shall be locked at all times.

The following types of vehicles are prohibited from use under the contract:

· Bicycles

· Motorcycles

· Vehicles without a secure cargo area, such as convertibles

· Pickup trucks without fully enclosed and lockable bed cover unless cargo is secured in the driver’s cab.

9.9 Vendor and Vendor Personnel Responsibilities

The Vendor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure all proposed Vendor employee(s) are not listed.

A background investigation must be carried out by the Vendor, at the Vendor’s expense, to ensure Vendor staff are of good character, have no felony convictions and are able to gain access to all locations of the contract.

Vendor drivers must maintain a valid driver’s license for the type of vehicle operated as required by Kentucky.

The Vendor shall be licensed by the state and/or local health authority in those localities where licenses are required.

Vendor personnel must be able to communicate clearly in speech and writing in English. This is required to allow effective and efficient pass-down communication during normal transport and during emergent situations / delays.

Vendor personnel, while performing the services of this contract, shall conduct themselves in a professional business-like manner.

The Contracting Officer, upon discussion with the COR, reserves the right to exclude vendor staff members from providing services under the contract or task order based upon breaches of conduct, including conduct that jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction, or negligence in performing tasks, or other conduct resulting in formal complaints by Veterans or other staff members to designated government representatives. The vendor and COR shall address issues raised concerning vendor personnel conduct. The Contracting Officer shall be the final decision on questions of acceptability and in validating complaints.

Smoking is not permitted on any Federal property including any VA campus and CBOCs. Smoking is not allowed within vehicles at any time or by Vendor staff while transporting VA property.

The vendor’s drivers shall observe and abide by all signage, speed limits, pedestrian right-of-way, emergency vehicle right-of-way, and designated roadways.

The vendor shall supply his/her employees with uniforms that must be worn while performing the services of the contract and while vendor employees are on government property and in government buildings. These uniforms shall contain the vendor’s company name on the shirt.

Additionally, the vendor will provide employees with an identification card including company name, employee name and a recent picture of the employee which shall always be visibly above the waist. Recent picture is defined as a picture accurately reflecting the employee’s actual appearance. Consistency is necessary for identification purposes when the vendor or vendor’s personnel are on site at Lexington VA Health Care System or CBOC facilities.

The vendor’s drivers must maintain a record log of courier pick-ups and deliveries, indicating times and dates of pick-ups and deliveries, and number of containers.

The vendor’s drivers are required to notify the assigned COR during normal business hours of any unusual events that impede him/her in making delivery as required by the contract. After hour notifications will be to the main laboratory at the main campus 859-233-4511 x 4529 or 5198.

Under no circumstances shall any animal or person other than the qualified Vendor employee be in the vehicle or handle items being transported.

The Vendor must provide and maintain training for its employees in appropriate safety and transporting procedures suitable to specimen type and distances transported. This should include issues such as adherence to regulations for biohazards transport, use of rigid containers where appropriate, temperature control, notification, and immediate action procedures in case of accident or spills, etc. Upon request by the COR, the Vendor shall provide documentation certifying that training has been provided to Vendor’s personnel. Reference 49 CFR §173.199 Diagnostic Specimens and Used Health Care Products and § 172.700, Subpart H, Training, and International Air Transportation Association (IATA) Section 1.5.02 and ANSI/AAMI Standard 79.

The Government reserves the right to refuse acceptance of any Vendor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction, or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or VA staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The CO and COR shall deal with issues raised concerning vendor employee(s) conduct. The final arbiter on questions of acceptability is the CO.

Vendors must submit invoices within twenty (20) calendar days following the last day of the month in which services are rendered. The invoices must be electronically prepared and submitted in accordance with FAR 52.212-4(g). Invoices must include at least the current purchase order number, period of performance, the number of trips completed for each location and delivery type, and unit price for each line item (location).

9.10 Indemnification

The Vendor shall be liable for and shall indemnify and hold harmless the Government against all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Vendor, its agents, or employees.

9.11 Vendor Support for Employees

This is not a personal services contract. The vendor shall be responsible for supervision of its employees under this contract.

The Vendor shall be responsible for protecting vendor employee furnishing services. To carry out this responsibility, the vendor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

a. Workers’ compensation

b. Professional liability insurance

c. Health examinations

d. Income tax withholding

e. Wages in compliance with Service Contract Labor Standards (see Solicitation Attachments)

f. Social security payments.

9.12 Records Management Obligations

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

· includes Lexington VA Health Care System (LVAHCS) records.

· does not include personal materials.

· applies to records created, received, or maintained by Contractors pursuant to their LVAHCS contract may include deliverables and documentation associated with deliverables.

C. Requirements Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

LVAHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of LVAHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to LVAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to LVAHCS control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and LVAHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with LVAHCS policy.

The Contractor shall not create or maintain any records containing any non-public LVAHCS information that are not specifically tied to or authorized by the contract.

The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

The LVAHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which LVAHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take LVAHCS-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] D. Flow down of requirements to subcontractors The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

All correspondence relative to the Contract or any task order shall contain the contract number, task order number, facility name, and description of services performed.

10.0 GOVERNMENT RESPONSIBLILITES:

The government will work in concert with the Contractor to help enable completion of the work contract.

Adequate parking for loading and unloading items.

The government will issue an adequate number of medical grade coolers for the transport of specimens for each location. Vendor is responsible for lost, damaged or stolen coolers and must report these to the COR immediately. The government will issue the vendor replacement or loaner coolers so as not to disrupt services. However, the vendor is responsible for the order, cost, and replacement of exact medical grade coolers or an equivalent approved by the COR within 7 days of loss or the cost of government issued replacements will be deducted from vendor submitted invoices. Replacements coolers must be picked up or delivered to the Main laboratory address. Replacement medical grade cooler cost is approximately $200.

VA will issue initial lock box keys. If the lock boxes need to be re-keyed due to lost or stolen keys vendor will be responsible for cost of re-keying the locks and replacement keys. Replacement keys are $10 per key and will be deducted from the vendor submitted invoice. VA issued keys are government property on loan for the duration of the contract. Keys are expected to be returned to the COR at the main laboratory campus upon termination of contracted service.

All laboratory specimens will be secured by VA personnel in a specimen bag using a tamper evident opaque sealed packaging.

VA will provide pickup and delivery log sheets to be completed at each location. Information will include the date and time of pickup and delivery, courier initials and the number of packages transported.

11.0 Problem Resolution

The CO, upon discussion with COR and VA personnel, will resolve complaints concerning vendor relations with Government employees and/or patients. The CO is final authority on validating complaints. In the event the vendor is involved and named in a validated complaint, the Government reserves the right to refuse acceptance of the services being rendered. This does not preclude refusal in the event of incidents involving physical or verbal abuse by vendor personnel towards VA personnel, CBOC personnel, COR, and other vendor personnel while performing services as specified in this contract.

12.0 Reports and Deliverables

The Vendor shall be responsible for complying with all reporting and deliverable requirements established by the contract. Vendor shall be responsible for assuring the accuracy and completeness of all reports and other documents as well as the timely submission of each. Vendor shall comply with contract requirements regarding the appropriate reporting formats, instructions, submission timetables, and technical assistance as required. All reports and deliverables are to be sent by electronic mail unless otherwise specified by the CO or COR.

The following are brief descriptions of required documents that must be submitted by Vendor:

13.0 Quality Assurance Surveillance Plan (QASP)

The Vendor will be evaluated in accordance with the QASP.

The QASP provides a systematic method to evaluate performance for the stated contract.

This QASP explains the following:

· What will be monitored?

· How monitoring will take place.

· Who will conduct the monitoring?

· How monitoring efforts and results will be documented.

This QASP does not detail how the vendor accomplishes the work. Rather, the QASP is created with the premise that the vendor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the vendor through contract modification. Copies of the original QASP and revisions shall be provided to the vendor and Government officials implementing surveillance activities.

13.1 Government Roles and Responsibilities:

The following personnel shall oversee and coordinate surveillance activities.

Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the Vendor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the Vendor’s performance.

Contracting Officer’s Representative (COR) – The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the Vendor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

13.2 Performance Standards:

The Vendor is responsible for performance of ALL terms and conditions of the contract. CORs will provide QASP progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of vendor performance in the elements defined. Performance standards define desired services. The Government performs surveillance to determine the level of vendor performance to these standards.

13.3 Methods of QA Surveillance:

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

· Direct observation: 100% surveillance

· Periodic inspections: inspections scheduled and periodically) reported quarterly per COR delegation or as needed.

· Validated user/customer complaints: data will be collected from actual patient complaints. Complaints will be investigated and verified.

· Random sampling: random samples of specific documents will be required and reviewed by COR for compliance.

· Verification and/or documentation provided by vendor: vendor provided information on services provided to COR.

13.4 Performance Requirements:

The Performance Requirements are listed below. The Government shall use these standards to determine vendor performance and shall compare vendor performance to the standard and assign a rating. At the end of the performance period, these ratings will be used, in part, to establish the past performance of the vendor on the contract and for purposes of providing the CO with information for inclusion on CPARS:

Requirement

Method

If vendor performance does not meet the Acceptable Quality level, the CO shall inform the Vendor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the CO shall document the discussion and place it in the contract file. When the COR and the CO determine formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to CO. The CO will in turn review and will present to the vendor's program manager for corrective action.

The Vendor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Vendor is required to prepare a corrective action plan to document how the Vendor shall correct the unacceptable performance and avoid a recurrence.

The CDR will also state how long after receipt the Vendor is required to present this corrective action plan to the CO. The Government shall review the Vendor's corrective action plan to determine acceptability. The CO is ultimately responsible for the final determination of the adequacy of the vendor’s performance and the acceptability of the vendor’s corrective action plan. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO or for purposes of reporting vendor past performance on CPARS.

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