Industry Day Questions - Attachment 1.pdf

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Primary Reference Laboratory/Phlebotomy/Courier Services
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36C24125Q0414
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This document is an Industry Day Questions attachment containing a comprehensive list of technical and quality-related questions for potential reference laboratory service providers for the VA VISN 1 region. The questions are organized into two main sections: Technical Capabilities and Quality and Accreditation, covering critical aspects such as test menu capabilities, specimen collection and transportation processes, laboratory interfaces, emergency services, quality management systems, staffing, and regulatory compliance.

The questionnaire seeks detailed information from potential contractors, including their test menu for CPT codes 80000-90000, experience with VA EMR systems, specimen tracking procedures, temperature monitoring during transport, subcontractor utilization, CLIA subspecialty certifications, and accreditation status. Key requirements include point-to-point specimen tracking, 24/7 emergency transportation services, adequate staffing for VISN 1 VA Medical Centers, and demonstrable quality management systems. These questions are part of a Request for Information (RFI) for a primary reference laboratory, phlebotomy, and courier services contract, with the industry day scheduled virtually for May 5-9, 2025.

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Reference Laboratory Requirements Questions for Business Concerns:

Technical Capabilities

1. The VA is seeking services for Cost Per Test (CPT) codes 80000-90000 and generic codes. What tests are included in your test menu.

2. Can you provide a list of affiliated reference labs that your laboratory utilizes for esoteric testing?

3. The majority of testing must be completed at your lab. Do you use any subcontractors for testing? If so, can you provide a list of subcontracted laboratories?

4. How do you ensure that subcontracted labs maintain all the necessary licenses and accreditation?

5. Do you have any experience interfacing with VA EMR systems such as VISTA?

6. Do you have successful performance experience with contracts of the same size and scope as the requirement for VISN 1?

7. What specimen collection options do you currently provide? Can you provide a list of specimen collection locations located in New England?

8. How do you currently handle specimen collection appointments and patient walk-ins?

9. Do you provide any specialty collection tubes/containers for esoteric testing?

10. Routine transportation services are needed daily, including Federal Holidays upon request. This transport is for all VISN 1 sites in New England. What are your plans for specimen transport? What courier services do you have in place?

11. VA requires emergency transportation services which need to be available 24 hours per day, seven days per week including Government holidays. What are your anticipated response times to emergency transport requests?

12. What are your internal QA metric goals for successful transport of specimens? Do you have a written SOP for routine transportation of various specimen types?

13. Do you have any special protocols for irreplaceable specimens?

14. Point to point specimen tracking and specimen reconciliation for each individual specimen is required. What is your procedure for specimen tracking from time of collection to result?

15. Temperature monitoring is required during transport. What is your procedure for temperature monitoring of specimens?

Quality and Accreditation

1. Describe your quality management system.

2. Have you had any loss of testing capability due to regulatory deficiencies and/or proficiency testing performance in the last 2 years?

3. In what CLIA subspecialties do you have certification?

4. Which CMS-deemed status laboratory accreditation program, such as CAP or TJC, are you accredited by?

5. What type of consultative services can you offer our Anatomic and Clinical

Pathology laboratory staff?

6. Do you currently have adequate staffing to support the needs of all VISN 1 VA Medical Centers? If not, what is your plan to ensure adequate staffing by the start of the contract?

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