Technical Requirements - Drive-Thru Testing Services.pdf

Technical Requirements 36C25721Q0710 Page 1 of 3

Technical Requirements

The contractor’s laboratory must provide the following estimated number of testing and requirements listed in the SOW:

• Estimated quantity 32,374 Inhouse COVID-19 & FLU A&B RT-PCR Testing

• 24-48 hours TAT from time of collection.

• Must be a local laboratory in Bexar County for patient access.

• Must provide drive through collection site for social distancing safety and specimen transportation.

• Must be able to perform Inhouse RT-PCR for SARS-CoV-2 and FLU A&B testing and be an approved testing site by the CDC.

• Must have EUA (Emergency Use Authorization) from FDA for RT-PCR SARS CoV-2 testing.

• Vendor must provide Turn Around Times, pricing and whether testing is done inhouse or is sent out for all testing listed in Attachment A.

1. The reference laboratory selected is required to be fully licensed, accredited and inspected by the Laboratory Accreditation of an accrediting agency to include; College of American Pathologists (CAP) with deemed status from the Center for Medicare and Medicaid Services, Center for Disease Control and any other state regulatory agencies as mandated by Federal and State Statutes. The Laboratory is required to be certified by the Joint Commission, American Associates of Blood Banks (AABB). The Clinical Laboratory shall meet all requirements set forth by the Clinical Laboratory Improvement Act (CLIA) of 1988, be accredited for High Complexity Testing and comply with the National Standards to Protect the Privacy of Personal Health Information (HIPPA) and VHA Handbook 1106.1. These above listed requirements must be met upon the date of Solicitation.

2. The following documentation must be submitted with the vendors offer:

A. Professional Staff Curricula Vitae B. Technical Staff Competency Skills Assessment C. Technical and Courier Staff Shipping and Handling of Laboratory

Specimens/Hazardous Materials Training and Assessment D. CAP and/or any other Proficiency Exam Participation for the past two (2) years E. Proficiency Examination Exception Reports for the past two (2) years F. Policy, list of tests and associated results for critical and alert value notification G. Description of Performance Improvement (Quality Assurance) Program/Plan H. Current year performance improvement monitors that include and not limited to demonstration of number of lost/damaged specimens, number of cancelled specimens, delays in turnaround times (including but not limited to: due to lack of staffing, lack of availability of reagents, instrumentation issues, etc.), resolution of complaints, errors in reporting patient results, and courier route delays/cancellations

I. Other Quality Assurance Monitors.

36C25721Q0710 Page 2 of 3

J. Implementation Plan: The Contractor shall furnish a schedule to show a customizable implementation plan of the required services (telecommunications, interface connectivity and validation, client service support, courier/logistics, ordering, supplies, specimen processing services, reporting, quality assurance, billing, etc.)

3. In addition, all Contractors must meet the following background investigation requirements: All users with access to the data received from Department of Veterans Affairs (VA) are U.S. Citizens with a valid Contractor's license and current background Investigation or a mutually agreed upon VA level background clearance verified at the National Agency Check with Inquiries, level for laboratory technical staff and business operations staff. Anyone with administrative or programmer access to a Federal computer system will have a background investigation commensurate with the level of access granted to the VA computer system as determined by the Information Security Officer in concert with Human Resources Management Staff and/or the Department of Veterans Affairs Security & Investigations Center. These staff must be operating within the borders of the U.S.A. and its territories.

4. The contractor must be able to meet all Enterprise Cyber Security Infrastructure Project (ECSIP) requirements to establish interconnection with the VA Vista and CPRS systems via the appropriate Laboratory Electronic Data Interchange Protocol.

5. The reference laboratory shall meet VA information security and HIPPA 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 and HIPAA Training and the VA Privacy and Information Security Awareness and Rules prior to starting services.

The Contractor shall provide the following interfacing requirements:

A. LIS physical connection and translation (drivers) B. Any required (additional) interface connection license(s) C. Web-based electronic ordering and resulting D. Provide documentation of successful interfacing with a minimum of 2 VA references

(not within VISN 17) and 2 private sector, other federal agency, state or local government agencies/ institutions. References to include the facility address, telephone number, email address, and contact person’s name which can validate experience within the last three (3) years.

E. Interface shall transmit test results to the host computer via automatic upload.

F. Automatic printing of laboratory results to a dedicated reference lab printer.

6. The Contractor shall provide timely (defined by the minimum and maximum turnaround times detailed in the description of requirements) and appropriate testing of patient specimens as requested by STVHCS facilities.

7. Each STVHCS facility will provide laboratory specimens properly collected identified with both the Patient’s Identification (as utilized by each facility) and requested tests. For those specimens that require special handling, the Contractor shall provide at no additional

36C25721Q0710 Page 3 of 3 charge an adequate supply of specimen collection materials for such testing that is destined to the commercial reference laboratory for analysis (i.e. dry ice, stabilizing tablets, ice packets, 24-hour collection container with preservatives, special collection tubes, etc.).