Attachment 6 - Questions and Answers - Lab Testing.pdf

FA670324Q0015 – Laboratory Testing Services Questions and Answers

Question

I wanted to confirm that the contractor is drawing the labs at an offsite location and ensuring results are systematically available? I wasn't certain as to the need for the Exhibit A Supply list given this.

Answer

The awarded contractor will not ever come to the base and do testing. Dobbins will collect and send out for testing via their courier. Members are sometimes sent to the contractor’s collection site to be drawn and have their tests completed but that is not very often. Most of the tests are simply specimens collected and ordered by Dobbins and just handed off to take and complete required tests. They do not ever draw on the base or run tests here.

Question

What qualifications are required for the medical staff?

Answer

All laboratory testing staff shall comply with minimum Federal, State, and local law qualifications/requirements. The laboratory shall hold all legally-required license(s), certification(s), and accreditation(s) in accordance with Federal statutes and implementing regulations as well as those of the state in which the laboratory is located. Any subcontractors performing services hereunder shall meet the same requirements as the prime contractor. Proof of the above required certification(s), accreditation(s), license(s), etc., shall be furnished to the Government.

The Contractor shall operate a successful quality control program as required by CLIA and CAP. Current CLIA requirements are located at the Health Care Financing Administration’s website : http://wwwn.cdc.gov/clia/. Upon request of the Contracting Officer, the Contractor shall provide documentation of quality control policies, quality control results for assays, on-going calculations of quality control performance (coefficient of variation, mean and standard deviation), monthly Levy-Jennings graphs, documentation of appropriate analyzer maintenance. Upon request, the Contractor shall provide verification results for assays of non-regulated analytes, and analytes for which proficiency testing does not currently exist.

Question

Do I understand correctly that there will be 209 test for the entire year and the patient could be scheduled for transport to receive one of them or more?

Answer

The approximate total test required per year is 235. 209 is what we project for UTA weekends. Occasionally a patient would need to go to their facility to be drawn at their facility and that test processed and tested rather than being drawn by us and picked up by the courier.

We do not ever require patient transport by the contractor.

http://wwwn.cdc.gov/clia/

Question

How many patients total would be needing services per week?

Answer

Most of our tests are collected by us and would just need the specimens picked up by their courier. The majority of our collection and tests are collected once per month on a Saturday.

Patients needing to be able to go to their facility will drive their themselves. They must have a facility within 25 miles of DARB that can offer collection/testing.

Question

Once the call is made with the information for scheduling would that call be once a week or daily?

Answer

The Contractor shall provide routine local courier pick-up, between 9:00 a.m. and 3:00 p.m., local time, unless a different time is mutually agreed upon by the point-of-contact (POC) and the Contractor, Monday-Friday, excluding Federal holidays.

The Contractor shall accommodate additional specimen pick-ups for unscheduled testing, Monday-Friday between 9:00 a.m. and 3:00 p.m., local time, for each facility. Courier response time shall be within three (3) hours after notification. Unscheduled specimen transport costs are a separate contract line item and shall be the only additional charge for unscheduled testing.

The contractor shall provide pick-up service daily upon notification of the contractor by the Medical Squadron by 1200 of the day service is requested. Pick-up will be no later than 1600 on the date of pick-up. For pick-up services on Saturday/Sunday of drill weekends, the medical unit will notify the contractor of this requirement in advance. Advance notification is sending out the UTA weekend schedule once a year and then calling on the Saturday to ensure pick-up will be properly handled.

Question

Does the contractor need to have the different modes of travel setup, including air for the patient?

Answer

The contractor shall provide all personnel, services, transportation, materials, equipment and supplies to perform laboratory testing services. All services will be for military and DoD civilian personnel located on Dobbins ARB, Georgia. The contractor shall perform all work in accordance with the Performance Work Statement (PWS) and contract.

Laboratory testing will not be performed on government-owned property. All services shall be executed at the contractor’s premises or within the contractor’s network of facilities (affiliate or qualified subcontractor) which must be located within a 25-mile radius of Dobbins ARB, GA (zip code 30069). The contractor will never transport a patient for testing.