Amendment_01_Questions_and_Government_Responses.pdf

W91YTZ24Q0121 Analyzer Questions from Contractors with Government Responses

All questions pertain to the Statement of Need (SON), Paragraph 3. Minimum Requirements/ Specifications/ Salient Characteristics:

Question 1. Item 3 states, “Analyzer shall require small aspiration volumes, less than 100 µl to perform full hematology reportable test profile. Can the “less than 100ul” be eliminated?

Government Response: No: The analyzer must possess the capability of performing full hematology reportable test profiles on less than 100 uL of whole blood patient samples. The analyzer qualification is required due to frequent short samples that are collected and received from the neonate nursery and the Emergency center, and multiple published patient safety reports due to specimen rejection for quantity not sufficient samples. Setting a minimum sample volume of 100 uL or less will prevent harmful recollections from the patients and improved turn-around times for laboratory results. The Government has revised the statement of need item accordingly.

Question 2. Item 5 states, “System shall use state of the art technology, such as fluorescent flow cytometry for WBC, WBC differential, NRBC, reticulocyte and platelet identification and enumeration.” Can “such as fluorescent flow cytometry” be eliminated.

Government Response: no: The system shall possess fluorescent flow cytometry for differentiation and numeration of WBC, NRBC, Platelet and NRBC parameters including a 6-part differential that includes immature granulocyte populations. Fluorescent flow cytometry is the gold standard in the laboratory. It provides a greater clinical picture of what in happening with the patient in-vivo. This also aids in eliminating erroneous errors that cause extra hands-on manual testing and improves result turn-around time. The Government has revised the statement of need item accordingly.

Question 3. Item 6 states, “System shall offer fully reportable, FDA approved extended 6-part differential, including Immature Granulocytes, to reduce the need for manual differentials.” Can you change the above to: “System shall offer fully reportable Immature Granulocytes or Monocyte Distribution Width.”?

Government Response: No: Monocyte distribution width is not a parameter this hospital is interested in reporting any longer. The only department that is the MDW (monocyte distribution width) is reportable to is the emergency center. The physicians have rejected the training on it. The government has revised the statement of need item accordingly.

Question 4. Item 7 states, “System shall offer fully reportable, FDA approved reticulocyte hemoglobin measurement, as recommended in the DoD Guidelines for the Management of Chronic Kidney Disease. A reticulocyte panel that includes quantitative and qualitative information may greatly improve patient outcomes.” Can you add to the above “or FDA approved Monocyte Distribution Width to help better detect severe infection including Sepsis.”?

Government Response: No: Monocyte distribution width is not a parameter this hospital is interested in reporting any longer. The only department that is the MDW (monocyte distribution width) is reportable to is the emergency center. The physicians have rejected the training on it. Also, monocyte distribution width is not the same thing as hemoglobin reticulocyte measurement. MDW is an early sepsis indicator, a reticulocyte panel gives an indication of bone marrow function and is used by urology for management of kidney disease.

The Government has revised the statement of need item accordingly.

Question 5 Item 9. States, “System shall offer fully reportable, secondary on-board platelet methodology to reduce the need for manual platelet reviews. Dual platelet methodologies are preferable in order to reduce manual confirmations. Reduction of manual tests would greatly increase the work force utilization and enhance workflow, resulting in quicker results to the clinicians.” Can you delete the entire requirement as this appears to be taken from another competitor’s website?

Government Response: The system is required to offer a secondary on-board platelet measurement methodology which will reduce the need for manual platelet reviews for confirmations. Platelet clump suspect flags cause extended turnaround times for laboratory results. The secondary method will assist in reducing unnecessary patient recollects especially with neonate specimens, improve patient turn-around times, and eliminate manual work by the hematology staff. RBC fragments may also produce erroneous platelet counts on analyzers in which a secondary platelet measurement is needed. The Government has revised the statement of need item accordingly.

Question 6. Item 11 states, “Body Fluid shall provide an FDA Approved WBC, RBC and Total nucleated count with a 2-part WBC differential with every body fluid analysis.” Can you delete “2-part WBC differential with every body fluid analysis” since the urinalyses analyzer in your lab is able to go down to zero and is the gold standard for body fluid testing.

Government Response: No, we will not have that urinalysis analyzer in the next 5-year cycle, and body fluids have never been supported by the urinalysis section. Having a hematology analyzer that is capable of this criterion will reduce manual body fluid counts that require 1+ manual hours of a technician’s time and will eliminate variability between technicians. The Government has revised the statement of need item accordingly.

Question 7. Item 14 states, “QC peer group data shall have real time, automatic electronic data upload capability to analyzer quality control.” Can the Government change “QC user group data is preferred to be real time”? Every vendor has peer review data.

Government Response: Modified: It is preferred QC peer group data shall have real time, automatic electronic data upload capability to analyzer quality control. This is a best practice to monitor your QC information in real time. If you can recognize QC peer group deficiencies, then you can have an overview on the functionality of the analyzer without waiting until the end of the month for comparison. The Government has revised the statement of need item accordingly.