Amendment - QandA.pdf

84-21-Q-DPR020

Amendment 3/1/2021

Solicitation Questions and Answers

Provided below are questions sent by vendors for Solicitation 84-21-Q-DPR020, USCG Hair

Sample Collection Kits and Testing.

The cost of shipping Hair Sample Collection Kits to the Coast Guard shall be at no cost to the

Coast Guard. At the Coast Guard’s request, the Contractor will provide overnight shipment of

Hair Sample Collection Kits to the Coast Guard. The Coast Guard will ship hair samples to the

Contractor at the Coast Guard’s expense.

Q: What would be the approx. number of kits requested at any given time? Varies, could be as many as 200-300 per facility or as few as 2.

Q: Would these be sent to one central location or multiple Coast guard facilities, and how many facilities? Multiple CG facilities worldwide, including but not limited to, California, Oregon, Washington, Alaska, Hawaii, Guam, Ohio, Mississippi, Massachusetts, Virginia and Florida.

The Coast Guard requires guidance from the Contractor regarding the collection of hair samples as necessary to ensure the collection of testable samples by the agency.

Q: Collection requirements will be provided, typically need 600 mg (9 panel drugs of abuse).

This panel includes barbiturates. Could customize the panel. This requirement is in terms of collection training, guidance, process, certification.

Q: Would a customized panel to include only listed drugs be preferable, or would a list of all possible hair testing that is available be desirable? For listed drugs and may consider other options.

The Coast Guard requires drug testing for 2,500 hair samples collected by the agency. The

Contractor will analyze and subsequently report the results of the hair test for at least the following drugs: amphetamines, Adderall, benzodiazepines, cocaine, fentanyl; opioids, phencyclidine, and marijuana.

Q: Is THC required? Yes, testing for marijuana is part of our listed requirements. This is not currently part of NMS Labs panel, but could potentially be added for a contract of this size.

The Coast Guard requires application of extensive wash criteria and procedures to eliminate or account for potential external contamination on the hair. All assay cutoff levels must be cleared by the Food and Drug Administration (FDA). The tests shall occur upon receipt by the

Contractor following intended collection, and within sufficient time to report results to the Coast

Guard within seven business days.

Q: How many samples would be shipped for testing at any one time? Varies, could be as many as 100 or more, or as few as 1 or 2.

Q: TAT would be dependent on volume received at any one time. Would 9 days for negatives and 17 days for positives by acceptable? No, requirement is as stated.

Q: Can the FDA cut off levels be provided, or can a link of where these are published be provided? Lab must have 510(k) FDA approval for each assay cut off level for the drugs it screens.

The Coast Guard requires that the results of such drug testing be securely delivered to a U. S.

Government designated program coordinator within seven business days of hair sample receipt by the Contractor, and all personal identifiable information about sampled members will be held confidential to all other inquires.

Q: Is a secure web portal allowed to be used to disseminate results? YES Individuals would have separate log in for access. YES

The Coast Guard requires that the results of all tests conducted be of sufficient quality for introduction and acceptance by military, Federal, and state courts, as well as by the Coast Guard for appropriate criminal and administrative purposes. In addition, the Coast Guard requires that the Contractor provide support for any such criminal or administrative actions.

Q: Are results expected to be quantitative or is qualitative results acceptable? Both. We require quantitative results with qualitative explanations of the results. Wash and testing criteria, standards and procedures must be proven to be consistently reliable, with positive results indicating “ingestion” or “systemic” presence rather than inadvertent exposure to the drug.

Q: Are testimony events expected to be in person or can they be via video? Primarily in-person.

Our criminal justice system requires in-person testimony. For certain administrative hearings, trial preparation, and pre-trial litigation, use of remote support may be possible but not for criminal trials.

Q: Are additional fees for testimony allowed to be invoiced? Yes, will be billed to separate account (charged to individual cases)

The Coast Guard requires multiple client “sub-accounts” under this contract, each with designated representatives who are authorized to order supplies or receive results.

Q: Would sub accounts be invoiced separately, or would the invoice for all sub accounts be sent to one central account? One central account.

Approximately how many locations will the contractor be expected to ship hair testing kits to?

Up to 160.

What are the addresses of the locations that the bidder will need to ship the hair test kits to?

Addresses will be provided when kits are ordered. Contractor will ship kits to multiple CG facilities worldwide, including but not limited to, locations in California, Oregon, Washington, Alaska, Hawaii, Guam, Ohio, Mississippi, Massachusetts, Virginia and Florida.

How many samples should we expect to receive and test at our laboratory, monthly? Varies, from 0 to more than 100.

Please confirm all hair test kits will be sent to the contractor’s laboratory for laboratory testing?

Hair samples will be sent to contractor’s laboratory for testing.

The agency has requested FDA approved cut offs. Please describe this expectation. The FDA does not regulate drug testing cut off levels. Would the agency accept industry standard cutoffs that are approved and reviewed by our accrediting and governing agencies? Lab must have

510(k) FDA approval for each assay cut off level for the drugs it screens. Wash and testing criteria, standards and procedures must be proven to be consistently reliable, with positive results indicating “ingestion” or “systemic” presence rather than inadvertent exposure to the drug.

What is the historic positivity rate of hair testing kits for the Coast Guard? More than 1%.

Please confirm the Coast Guard is looking for samples to be initially screened and then confirmations performed automatically on presumptive positives. Correct.

What company is currently providing these services to the Coast Guard? Psychemedics

Corporation

What prices is the Coast Guard currently paying for laboratory testing services? $135,000

Please confirm the 7 day turnaround time expectation is from the time the sample is received at the laboratory. Correct.

How often does the agency typically require contractor support for criminal or administrative action? Criminal and administrative actions can take up to 18-months and require regular expert support both remotely and in-person. Agency also requires documentary and educational literature to inform decisions.

Is the agency expecting to be billed separately for litigation support? Yes, will be billed to a separate account. (Charged to individual cases, as needed)

During these times of required physical distancing, would telephonic and/or video testimony be acceptable? No. Our criminal justice system requires in-person testimony. For certain administrative hearings, trial preparation, and pre-trial litigation, use of remote support may be possible but not for criminal trials.