Attachment B-SOW.pdf

STATEMENT OF WORK

OBJECTIVE

The specific objective is to award a single contract to provide laboratory testing on samples with stat requirements due short specimen stability and viability, and urgent testing needs. The reference laboratory testing will be for all facilities within VISN22.

The Contractor shall provide the following services to each healthcare system:

A. Sample Processing: Provide specimen collection materials, appropriate transportation, and storage of specimens to ensure specimen integrity for all test orders. Safety Data Sheets will be provided to sites as appropriate for supplies containing hazardous chemicals.

B. Courier: Provide courier transportation with established pick-up times at VA Greater Los Angeles and other facilities identified within this document.

C. Monthly Reports and Business Review: Provide a statistical analysis of the VISN22 facilities’ workload test volumes and assist in the monitoring of ordering trends and utilization patterns.

SCOPE OF WORK

The Contractors shall provide in accordance with the specifications outlined below a full range of reference laboratory services.

VISN 22 is comprised of VA Medical Centers, VA Outpatient Clinics (OPC), and VA Community-Based Outpatient Clinics (CBOC). Services provided to VISN 22 under the resultant contract shall include the transportation of clinical laboratory specimens to the Contractor’s laboratory(s), the performance of analytical testing as defined by the Contractor's reference test manual, the reporting of analytical test results and business review services VISN 22 laboratory operation.

All requirements and provisions defined in the specifications of this solicitation apply to any laboratory (i.e.

branch, division, sub-contractor, etc.) performing reference testing on behalf of the Contractor.

It is possible that during the life of this contract that VISN 22 might add additional facilities within the California, Arizona, or New Mexico geographic areas that will require the services specified in the Statement of Work. The prices charged for services provided to any new facilities shall adhere to the prices shown in the Price Schedule.

When additions occur, a modification to the contract will be executed notifying the Contractor of the new facility to be serviced.

PARTICIPATING HEALTHCARE SYSTEMS

VISN 22 WEST HEALTHCARE SYSTEM

VA LONG BEACH HEALTHCARE SYSTEM

5901 E. Seventh St Long Beach, CA 90822

VA LOMA LINDA HEALTHCARE SYSTEM

11201 Benton Street Loma Linda, CA 92357

VA SAN DIEGO HEALTHCARE SYSTEM

3350 La Jolla Village Drive San Diego, CA 92161

VA GREATER LOS ANGELES HEALTHCARE SYSTEM

11301 Wilshire Blvd.

Los Angeles, CA 90073

LOS ANGELES AMBULATORY CARE CENTER

351 E Temple St.

Los Angeles, CA 90012

DESCRIPTION OF SERVICES

D. SAMPLE PROCESSING: Each facility will provide properly prepared laboratory specimens, identified and labeled for testing. The Contractor shall provide an adequate supply of specimen collection materials for such testing, including all materials required for specialized handling as dictated by the Contractor’s reference laboratory's specimen collection requirements, (e.g. dry ice, stabilizing tablets, ice packets, etc). The Contractor shall transport and store specimens in such a manner as to ensure the integrity of the specimen. The Contractor shall provide additives required for collection of specimens in unit packages to facilitate collection at Community Based Outpatient Clinic’s (CBOC) and Outpatient Clinics (OPC) if indicated per specimen collection requirements. Material Safety Data Sheets will be provided by the Contractor to sites as appropriate for supplies containing hazardous chemicals (e.g. boric acid tablets, acids).

E. SPECIMEN TESTING: The Contractor shall provide testing of patient specimens as requested by VISN

22 facilities.

F. SPECIMEN STORAGE: The Contractor shall store the specimens a minimum of seven (7) days after the test is reported to allow for subsequent action (e.g. problem solving and/or repeat testing).

G. FAR 52.212-4(c) CHANGES: SOW: Services determined by the Contracting Officer to be within the general scope of the contract or PRODUCT ADD-ON: The VA may have a need for additional testing over the life of the contract that are not currently on the Price Schedule or FACILITY: The VA may add any new location incorporated into VISN 22. Any of these changes shall be made in accordance with FAR 52.212-4(c) Changes.

H. STAT Testing:

1. The contractor shall be able to provide stat testing for samples with a turnaround time of less than 24 hours.

2. Technical Only stains: CPT code 88341, 88342, 88344, 88360 shall be returned to the VA Greater

Los Angeles in one business day.

PATIENT TEST REPORT

A patient test report is defined as a printed final copy of laboratory testing results or host-to-host VPN electronic transmission of test results. This report will be received by VPN computer interfaced to the VistA Laboratory Package. Contractor shall make all results retrievable via Secure Web Portal; in addition to providing the Web Portal, Contractor may send also send results via fax to a secure facsimile. Specifications outlining the requirements of the computer interface to the VistA Laboratory Package, including computer hardware, maintenance and supply requirements are defined in Technical Data Requirements – Interface Telecommunication Requirements.

I. PATIENT TEST REPORT: At a minimum, the Contractor shall provide the following information on each laboratory test report/result:

1. Patient's name and/or identification number

2. VA accession number

3. Physician's name

4. VA medical record number

5. The submitting facility name

6. Patient's location, if provided to include clinic/ward

7. Test ordered

8. Date/time of specimen collection

9. Date/time test completed

10. Test result

11. Reference intervals

12. If applicable, toxic and therapeutic ranges

13. Flagged abnormal,

14. Critical Value

15. Reference laboratory specimen number

16. Name and address of testing laboratory

17. Any other information that may indicate a questionable validity of test results

18. Unsatisfactory specimen shall be reported with documentation supporting its unsuitability for testing

The Contractor shall provide test results, either by hard copy or electronic report transmission, within 4-8 hours following specimen pick-up for stat ordered tests.

The Contractor shall immediately provide notification of a test result that has been identified in the Contractor’s laboratory as a critical value by telephone and fax to the submitting VISN 22 laboratory upon verification of the critical test result. Critical values are test results that indicate a dire/serious situation with a patient where intervention is required imminently. The hard copy result must follow any critical value notification and it will be documented to show who provided the notification, who received the notification and the time and date of the notification.

Upon request contractor shall provide a daily report listing all incomplete tests and their processing status.

CLIENT SERVICES: Contractor shall provide Client Services 24 hours per day, 7 days per week to address inquires such as test availability, specimen collection, storage, transport requirements, addition or cancellation of testing, and the ordering of supplies. During normal business hours, the Contractor shall provide access to medical experts to address laboratory test interpretation, testing recommendations, and education regarding new testing options.

BUSINESS REVIEW REPORT:

J. BUSINESS REVIEW: The Contractor shall provide a annual business review in downloadable MS

Excel format. Each healthcare system shall receive a facility specific report and VISN22 Leadership shall receive a single cumulative document to include all VISN22 healthcare system.

In the Business Review Report, the Contractor shall provide actionable recommendations for improvement along with the following information:

1. Test ordering trends

2. TAT overview and test that exceeds the TAT

3. Exception overview

4. Number of support calls

5. Per facility, a test utilization comparison from the previous Business Review Report

6. List of test code changes

7. Per site, list of tests ordered not listed on test menu and cost associated with those tests

8. Per site, listing of reflex testing and cost associated

9. Test cancellation due to specimen integrity

REQUIREMENT FOR COURIER SERVICES

K. GENERAL

The Contractor shall provide courier services for the participating facilities for which Contractor provides laboratory services.

1. The Contractor shall provide specimen pickup and transport services with clearly defined special handling procedures.

2. All requirements and provisions defined in the specifications of this solicitation shall apply to any entity, i.e. branch, division, sub-contractor, etc. performing courier services on behalf of the Contractor.

3. Courier transportation time is inclusive to the required TAT of test result.

4. All report data the Contractor exports and submits to the facility shall be Health

Information Portability and Accountability Act (HIPAA) compliant.

L. DESCRIPTION OF SERVICES

1. Transported items shall be primarily biological substances (patient specimens). These items 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. The Contractor shall transport microbiology cultures, stocks and regulated medical waste that are also in Division 6.2. Other incidental items (not included in Division 6.2) that may be transported include laboratory testing reagents (of limited size and quantity), patient reports or other paperwork.

2. VISN 22 facilities shall be responsible for the processing of biological substances in preparation for transportation. Each VISN 22 facility will provide a shipping manifest minimally detailing the dates and times of receipt and delivery of specimen and the number of specimens transported by temperature category.

3. Contractor shall provide point to point specimen tracking and specimen reconciliation for each individual specimen, such as, barcoding or any other pre-approve method.

M. REQUIREMENTS

1. The Contractor shall provide safe transport of all biological substances. This shall include the proper receipt, distribution, storage and security of patient specimens in accordance with all federal regulations governing the safe transport of these materials including the following, which are incorporated herein by reference:

a. Department of Transportation 49 CFR Parts 171-180 – Hazardous Materials:

Infectious Substances; Harmonization with the United Nations Recommendations, Final Rule.

b. Department of Health and Human Services 42 CFR Parts 72 and 73 – Interstate Shipment of Etiologic Agents and Select Agents and Toxins

c. Department of Labor/OSHA 29 CFR, Section 1910.1030-Bloodborne Pathogens

d. HIPAA Privacy Rule 45 CFR Parts 160 1nd 164.

2. Contractor shall comply with all state and local regulations that are applicable to the services it provides.

3. The Contractor shall implement procedures that ensure the accountability and integrity of all biological substances from the point of possession to the point of delivery.

4. The Contractor shall ensure that all transport personnel are properly trained and that their competency is regularly assessed in the appropriate safety, packaging and environmental control procedures suitable to specimen type and distances transported.

5. The Contractor shall have personnel that adheres to the regulations for the transport of hazardous materials as cited in 49 CFR 172 Subpart H, which are incorporated herein by reference, and shall minimally include:

a. Education on the types of biological materials transported including definitions of an infectious substance and a biological product.

b. Education on appropriate hazardous material packaging and labeling to recognize non-compliance.

c. Requirements for the appropriate receipt of the packages including the availability of shipping manifest.

d. The use of appropriate containers to transport specimens between the point of origin to the transport motor vehicle and, likewise, from the transport motor vehicle to the destination point.

e. Appropriate installation, use and security of environmental temperature control devices that maintain ambient, refrigerated, frozen or incubated conditions that insure the integrity of the specimens and avoid loss or breakage of the containers.

f. Identification of specimens requiring environmental temperature control storage.

g. Certified education (hazmat training) on appropriate decontamination and notification procedures in case of accident or spills. This includes the identification and appropriate use of personal protective equipment and the use of mitigation and disinfection products.

h. Education on procedures for hazardous spill communication, i.e. contact telephone numbers.

i. Education on the protection of the privacy and confidentiality of the personally-identifiable information

6. The Contractor shall provide an adequate supply of materials necessary for the efficient, organized and coordinated receipt, transport, and delivery of specimens (e.g. bags, temperature condition stickers, transportation receipt forms, rigid-sided containers, dry ice, coolers, incubators, etc.). Upon request, the Contractor shall provide temperature integrity tracking data.

SPECIFICATIONS

N. LICENSURES: Contractor shall perform specimen testing only in fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing described in this document. The reference laboratory must be licensed/accredited by the College of American Pathologists (CAP) as well as any other state regulatory agencies as mandated by federal and state law. In addition, the Laboratory must be certified as meeting the requirements of the Clinical Laboratory Improvement Act (CLIA) of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information in accordance with Health Insurance Portability and Accountability Account of 1996 (HIPAA) and VA Directives 1106, 1106.01 and 1106.2

For each laboratory used, Contractor shall provide copies of all relevant permits/licenses and certification inclusive of any sanctions current or pending throughout the United States of America as requested.

As these documents are reissued or reworded, the Contractor shall supply a copy to the Contracting Officer and each VISN 22 facilities. The above documents must also be supplied for each reference laboratory that is a subcontractor of the Contractor.

SECURITY

O. DATA SECURITY REQUIREMENTS

The Contractor shall be responsible for the security and integrity of specimens and for the compliance of all Health Insurance Portability and Accountability Act (HIPAA) provisions. Additionally, the Contractor shall be afforded access to the VISN 22 VistA and shall be responsible for ensuring the proper credentialing of employees interacting with VISN 22 personnel. Contractor shall adhere to all Information Technology Security requirements as set forth in VA Handbook 6500.6, which is incorporated herein by reference;

vendor shall adhere to Appendix C and Appendix D and submit proper documentation as required.

P. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Contractor shall adhere to the security requirements in the approved MOU/ISA established between the Contractor and VA.

GENERAL INFORMATION

Q. CONTRACTOR’S PROGRAM MANAGER: The Contractor shall provide a Program Manager who shall be responsible for managing the performance of work. The name of this person shall be designated in writing to the Contracting Officer. The Contractor’s program manager shall have full authority to act for the Contractor on all matters relating to daily operations of this contract.

Name:

Address:

Phone No.:

Fax No.:

Email:

R. CONTRACTOR EMPLOYEES: The Contractor shall not employ any person for work on this contract if such employee is identified to the Contractor as a potential threat to the health, safety, security, and general well-being of the public.

S. INVOICING & PAYMENT

The Contractor shall submit a monthly invoice per account number for services rendered following the close of the month in which the test result was reported. The invoice shall be accurate and shall display chronologically by date of receipt by the Contractor the name of the patient, the date of specimen was picked up by the Contractor from the VISN 22 facility, detailed list of the test performed on each patient, and the unit and total testing costs.

The Contractor shall not charge VISN 22 for repetitive testing performed on a specimen to verify questionable initial results.

The Contractor shall submit in arrears a properly completed itemized invoice in accordance with FAR clauses 52.212-4(g) Contract Terms and Conditions – Commercial Items via Tungsten Network:

http://www.tungsten-network.com/customer-campaigns/veterans-affairs/

No advance payments shall be authorized. Payment shall be made monthly for services provided during the billing month in arrears in accordance with FAR 52.212-4, para. (i). Upon submission of a properly prepared invoice for prices stipulated in this contract for services delivered and accepted in accordance with the terms and conditions of the contract, less any deductions stipulated in this contract.

Payment of invoices may be delayed if the appropriate invoices as specified in the contract are not completed and submitted as required.

T. REQUIRED REGISTRATIONS: Contractor shall be registered and maintain an active account for the following sites during the duration of the contract.

1. SYSTEM FOR AWARD MANAGEMENT: WWW.SAM.GOV

2. DATA UNIVERSAL NUMBERING SYSTEM (DUNS): In accordance with FAR Provision 52.212-1 paragraph (j), the Contractor shall provide the Dun and Bradstreet number assigned to his/her firm in the space provided below:

DUNS#: 05-635-4640