Request_for_Clarification_Questions.pdf

Request for Clarification – RFP #2024-RFP-095-PR – Forensic Toxicology Services

1. Question 17 asked how would a proposer “prove the capability to handle at least 2000 cases every month”, and was answered that “The proposer will know, based on their current workload and turnaround time, if they can take on 2000 cases a month and deliver the expected turnaround.” Our takeaway is that we simply need to assert that we have the capability. If we simply make a statement that "yes, we can handle 2000 cases per month with expected turnaround", will we be scored the same as a submitter that says “yes, and we can accommodate 30% more”?

Please note that proposals are evaluated based solely on the information provided by the proposer. To support your claim that your laboratory can accommodate 2,000 samples per month with the expected turnaround time, it is important to provide sufficient details and documentation, such as data on current capacity, workload, and performance metrics. All proposals will be evaluated equally based on the criteria outlined in the RFP.

Assertions without supporting details may not be as informative as proposals that include details and verifiable information (i.e., data on current capacity, workload, forecast models).

2. The response to question 18 says that “A laboratory can be accredited but have a yearlong turnaround time or inadequate instrumentation.” This is not the case. ISO17025 requirement 6.1 explicitly evaluates “Does the laboratory have available the personnel, facilities, equipment, systems and support services necessary to manage and perform its laboratory activities?” and requirement 6.4 evaluates “Does the laboratory have access to equipment (including, but not limited to, measuring instruments, software, measurement standards, reference materials, reference data, reagents, consumables or auxiliary apparatus) that is required for the correct performance of laboratory activities and that can influence the results?” For the record, it also evaluates in 8.6.2 “Does the laboratory seek feedback, both positive and negative, from its customers? Is the feedback analyzed and used to improve the management system, laboratory activities and customer service? While the ISO standard does not explicitly state an acceptable turnaround time, no client would be satisfied with a yearlong turnaround time. In light of the above, and the response to question 17, which appears to say that a simple statement of capacity is sufficient proof, would you please confirm that statement will be evaluated equally to any other statement of capacity?

As previously stated on question 1, proposals are evaluated based solely on the information provided by the proposer. Assertions without supporting details may not may not be as informative as proposals that include details and verifiable information (i.e., data on current capacity, workload, forecast models).

3. The response to question 19 contradicts our statement that a QA manual is more than one document and is reviewed by the accrediting organization.

In fact, the review of the QA documents, plural, is inseparable from the accreditation process as it is reviewed in nearly every one of the requirements. Given that the stated purpose for the request is “to ensure the appropriate quality controls and standards are applied to the testing.

For example, a lab can be accredited and have a cutoff for fentanyl at 5 ng/mL (which is too high, should be 1 or less). We want to make sure the laboratories testing methods are compatible with what we need.”, would be it acceptable to provide a list of analytes, cutoffs, and methods of testing?

Yes, it would be acceptable to provide a list of analytes, cutoffs, and methods of testing; however, the QA manual is still a requirement for this

RFP.

4. Given that instrumentation is reviewed during accreditation as described above and in section 7.2.1 and 7.2.2 of the standards, wouldn’t that be sufficient to ensure our methods and instrumentation are properly selected and methods validated? Different technologies can do the same things and some of what is listed has been supplanted by better instruments. Should a respondent be penalized for not holding onto older, less effective equipment?

We are seeking laboratories that not only utilize the latest technology but also demonstrate the capability to achieve greater sensitivity. It is critical that the proposer/laboratory can meet the specific requirements for our office, which often involve the ability to accurately detect and analyze low concentrations. While adherence to accreditation standards is essential, the proposal should also highlight how your laboratory’s technology and methods are specifically suited to meet the demands of our office, ensuring both precision and reliability.

5. The response to question 21 assumes that the only way to know whether a respondent can test for something is to review the testing methods. Given that the validation processes are evaluated during accreditation and that methods are proprietary information to a laboratory, would it be acceptable to provide the list of analytes, cutoffs and instruments?

Yes, that is acceptable.

6. The response to question 26 seems to miss the point of the question. We assume NMS is the incumbent laboratory. Is Evaluation Criteria 6.C a typographical error or is there some expectation that an awardee will obtain some kind of information from the former lab if chosen?

Yes, that is a typographical error.

7. Otherwise, how would a lab be competitive on this? If that is not the point of Evaluation Criteria 6.C, please clarify the intent of the criteria. If it is to ensure that reports can be received via a secured portal, please say so.

Yes, reports should be received via secure portal.