10/14/2015 Proposed Guidelines | October 14, 2015 1
10/14/2015 Understanding the Public Comments Submitted Regarding SAMHSA’s Proposed Guidelines for Lab-Based Oral Fluid Testing 2
10/14/2015 Sponsored by OraSure Technologies OraSure Technologies is the maker of the Intercept Oral Fluid Drug Test, a lab-based oral fluid testing system that was ranked as the #1 recognized brand name in oral fluid testing in a 2015 national drug testing industry survey. For More Information go to: www.chooseintercept.com Or Call: 800-ORASURE 3
10/14/2015 Bill Current • Founded the WFC & Associates in 1998 • Nina French became a partner in 2014 and the company changed its name to the Current Consulting Group, LLC • Publisher of the On-Line Ultimate Guide to State Drug Testing Laws at StateDrugTestingLaws.com • Director of the Annual Survey of Drug Testing Industry Trends (now in its 17 th year) • Former Executive Director of the American Council for Drug Education, Director of the Institute for a Drug-Free Workplace, and Vice President of Consulting for Employee Information Services • Author of 10 books, including Why Drug Testing? 4
10/14/2015 Available to DATIA Members at a Special Rate 5
10/14/2015 Overview SAMHSA’s proposed guidelines for lab -based oral fluid testing have generated a lot of debate among employers and providers of drug testing. A 60-day public comment period produced responses from many companies regarding collection and testing procedures, including everything from when oral fluid testing should be permitted to how split specimens would best be conducted. These are all important issues because the final guidelines will establish “best practice” standards that are likely to reshape how drug testing is conducted in the future. They will also impact state laws that are silent on how to conduct oral fluid testing. While final decisions from SAMHSA are months away, this presentation will help drug testing providers and employers better understand the key issues in preparation for selling and/or implementing a lab-based oral fluid testing program, including merging drug testing technologies such as adding lab-based oral fluid to a urine testing program to get the best of both methods. 6
10/14/2015 Background: May 12, 2015 7
10/14/2015 Federal Register • On May 12, 2015, the Federal Register published proposed guidelines from the Substance Abuse and Mental Health Services Administration (SAMHSA) for the inclusion of oral fluid specimens in the Mandatory Guidelines for Federal Workplace Drug Testing Programs. • The proposed guidelines were subject to public comment for a 60-day period from the date they were published in the Federal Register . SAMHSA is reviewing the comments and determining if additional changes to the guidelines are needed. 8
10/14/2015 Federal Register These proposed guidelines will: 1. Establish standards and technical requirements for oral fluid collection devices, 2. Initial oral fluid drug test analytes and methods, 3. Confirmatory oral fluid drug test analytes and methods, 4. Processes for review by a Medical Review Officer (MRO), and 5. Requirements for federal agency actions. 9
10/14/2015 Federal Register • These Guidelines provide flexibility for federal agency workplace drug testing programs to address testing needs and remove the requirement to collect only a urine specimen, which has existed since the Guidelines were first published in 1988. • Federal agencies, MROs, and regulated industries using these Guidelines will continue to adhere to all other federal standards established for workplace drug testing programs. • “These proposed OFMG provide the same scientific and forensic supportability of drug test results as the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (URMG).” 10
10/14/2015 Federal Register • Clearly, the proposed guidelines as currently constituted will initially apply to federal workplaces only. • However, “some agencies such as the Department of Transportation (DOT), are required to follow these guidelines in developing drug testing programs for their regulated industries, whereas others, such as the Nuclear Regulatory Commission (NRC), use the guidelines as part of the regulatory basis for their federal drug testing programs.” 11
10/14/2015 Some Major Provisions • The collection process for oral fluids provides that the specimen collection will be under observation. • The OFMG enable split specimen testing by requiring two specimens to be obtained from the donor, either concurrently or serially, using separate collection devices or a single collection device that can be split into two separate specimens. • The Department is proposing that all specimens be tested for either albumin or Immunoglobulin G (IgG) to determine whether the specimen is valid. • In the event that an individual is unable to provide an oral fluid specimen, the federal agency may authorize the collection of a urine specimen. 12
10/14/2015 Public Comments • SAMHSA is in the process of reviewing the comments and determining if additional changes to the guidelines are needed. • Hundreds of public comments were submitted from major providers and manufacturers of drug testing, as well as federal agencies and trade associations. 13
10/14/2015 Who Submitted Public Comments According to SAMHSA, there were 117 commenters broken down as follows: • 85 individuals (most of these were the urine paruresis “can’t pee” folks) • 11 professional organizations (includes DATIA, SAPAA, NSC, Pipeline consortium, etc.) • 5 HHS certified labs • 7 manufacturers • 6 MRO’s/TPAs • 1 Lab (non certified) • 1 employer • 1 law firm 14
10/14/2015 Who Submitted Public Comments The comments were categorized this way*: • Specimen validity testing – 19 comments • Proposed cutoffs – 39 comments • THC/THCA – 14 comments • Other drug analytes – 4 comments • Collection device performance requirements – 16 comments • HHS cost/benefit analysis – 4 comments • Initial test analytical requirements – 9 comments • MRO requalification/training – 16 comments (combines OF and urine comments) *note – 168 of the 240 comments for both OF and urine were from individuals with a social anxiety order (paruresis) and are excluded from the total above 15
10/14/2015 Public Comments: Adulteration/Specimen Validity 16
10/14/2015 Collection Basics • Two basic types of collection devices currently exist: – one is designed to collect undiluted (neat) oral fluid by expectoration; – the second type makes use of an absorbent pad that is inserted into the oral cavity for specimen collection and then placed in a tube containing a diluent. • The Department is recommending that all collection devices maintain the integrity of the specimen during collection, storage and transport to the laboratory for testing. 17
10/14/2015 Collection Specifics All devices must have: • An indicator that demonstrates the adequacy of the volume of collected specimen; • A sealable, non-leaking container; and • Components that ensure pre-analytical drug and drug metabolite stability. • The device components must not substantially affect the composition of drugs and drug metabolites in the oral fluid specimen. 18
10/14/2015 Collection Specifics The proposed guidelines specify that a collection device should collect either a minimum of 1 mL of undiluted (neat) oral fluid OR, for those collection devices containing a diluent (or other component, process, or method that modifies the volume of the specimen), that the volume of oral fluid collected should be within 0.1 mL of the target volume and the volume of diluent in the device should be within 0.05 mL of the diluent target volume. 19
10/14/2015 Proposed for Validity Testing SAMHSA is proposing that all specimens be tested for either albumin or Immunoglobulin G (IgG) to identify invalid specimens. Section 3.1 Which tests are conducted on an oral fluid specimen? (c) Must ensure that the following specimen validity tests are conducted on each oral fluid specimen: (1) Determine the albumin concentration on every specimen; or (2) Determine the immunoglobulin G (IgG) concentration on every specimen. 20
10/14/2015 Decrease Invalid Tests • Generally, those in favor of testing for albumin or IgG were first and foremost in favor of validity testing… though some were specific. • “ First Advantage would therefore prefer that IgG be required as a validity test rather than albumin, since the general availability of albumin is much greater than human IgG.” • However, many commenters were opposed to testing for albumin or IgG. • Opposition centered on two key points: 1) oral fluid collections being fully observable, and 2) the proposed guidelines already require the collection of a specific volume of saliva and devices must have built-in volume indicators. 21
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