FR 2020-29059

The document released by the Department of Health and Human Services (HHS) is a notice informing federal agencies about laboratories and Instrumented Initial Testing Facilities (IITFs) certified to conduct drug testing using urine and oral fluid samples. It highlights the standards these laboratories must meet under the Mandatory Guidelines for Federal Workplace Drug Testing Programs. Despite numerous laboratories being listed as certified for urine drug testing, the notice indicates that currently, no laboratories are approved for oral fluid sample testing. This aspect stands out as a significant point needing clarification.

General Summary

The notice from HHS is a formal announcement detailing the certification status of various labs across North America that conduct federal workplace drug testing specifically using urine samples. It also outlines the historical context of the Mandatory Guidelines for such programs, dating back to 1988 and includes updates to those guidelines over the years. The comprehensive list of certified laboratories provided helps ensure transparency and accountability in workplace drug testing.

Significant Issues and Concerns

Several issues emerge from the notice. Notably, there is an absence of certified laboratories for oral fluid drug testing, despite guidelines being published. The document does not explain why no certifications exist for oral fluid samples, which leaves a gap in understanding that could benefit from further details for federal agencies and the general public. Additionally, the list includes previous names of the laboratories, potentially creating confusion unless clarified.

The certification process is outlined, involving performance testing and inspections, but the criteria and procedures are not elaborated. This lack of detailed insight into the standards and inspection protocols might be pertinent for stakeholders to understand how laboratories maintain compliance.

Impact on the Public

Broadly, this document impacts the public by maintaining the integrity and credibility of federal drug testing procedures. Knowing which laboratories are certified assures government workers and employers of the reliability and accuracy of drug testing results. However, the lack of certified oral fluid testing labs might limit the scope and flexibility of drug testing methods available for federal agencies.

Impact on Specific Stakeholders

For laboratories themselves, this notice sets a benchmark for standard compliance that they must strive to complete certification and remain listed. Certification requirements mean ongoing efforts to meet stringent standards, which can be beneficial in enhancing quality and trustworthiness, yet also imposing in terms of resources required for compliance.

Federal agencies engaging these laboratories get a verified directory of reliable service providers, ensuring their drug testing is completed accurately and according to federal protections for employees. However, they might face challenges due to unavailability of certified options for oral fluid testing generally known for less invasive sampling, thus limiting methodology tailored to specific workplace requirements.

Conclusion

The document provides vital information on the status of lab certifications for workplace drug testing, ensuring consistent adherence to federal standards. While the document serves as a guidepost for compliance and lists certified entities, it poses challenges through its lack of elaboration on certain crucial aspects such as the certification process for oral fluid testing, potential rationales behind current restrictions, and what steps laboratories should follow in case of suspension or revocation of their certification. These areas, if clarified, could significantly enhance the transparency and operability necessary for all involved stakeholders.