Proposed Guidelines | October 14, 2015 1 10/14/2015 Understanding - - PDF document

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Proposed Guidelines | October 14, 2015

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Understanding the Public Comments Submitted Regarding SAMHSA’s Proposed Guidelines for Lab-Based Oral Fluid Testing

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• ral fluid testing in a 2015 national drug testing

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• 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 17th 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?

Bill Current

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Available to DATIA Members at a Special Rate

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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

• ral fluid to a urine testing program to get the best of both methods.

Overview

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Background: May 12, 2015

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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.

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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.

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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).”

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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.”

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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.

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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.

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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

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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

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Public Comments: Adulteration/Specimen Validity

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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.

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Collection Specifics

All devices must have:

• An indicator that demonstrates the adequacy of the volume
• f 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.

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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.

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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.

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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

• f saliva and devices must have built-in volume indicators.

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Decrease Invalid Tests

• OraSure: “Regarding specimen validity tests for albumin or IgG,

OraSure considers this unnecessary and Section 3.1.c should be

• removed. Since all sample collections are directly observed by a

collector and the oral fluid collection device is required to have a sample adequacy indicator, which is also observed during the collection process, OraSure believes this negates the need for an additional laboratory test that will increase costs of oral fluid testing and waste oral fluid sample that could be utilized for the additional drug tests being required in these guidelines.”

• Thermo Fisher: “Unlike urine samples, the volume collected for
• ral fluid specimens is limited. We need to have sufficient sample

volume to meet Department’s requirement for testing additional analytes in the initial screen and confirmation.”

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Decrease Invalid Tests

• Redwood Toxicology: “… believes that since the oral fluid

collection process requires a visual inspection of the mouth cavity, a 10 minute wait period, observed collection, and a specimen volume adequacy indicator, the requirement to determine either albumin or immunoglobulin G to verify specimen validity is unnecessary. Additional specimen validity testing wastes valuable specimen possibly needed for multiple confirmations.

• Alere: “… believes Specimen Validity testing should not be
• required. Remove section 3.1 (c).”

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Public Comments: Split Specimen

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Split Specimen

The Department is recommending that a split specimen be collected either: – 1) as two specimens collected simultaneously or serially with two separate collection devices, or – 2) collected with a collection device that subdivides the specimen into two separate collection tubes. “If collected serially, collection of the second specimen must begin within two minutes after the completion of the first collection. “The Department believes this allows sufficient time for the collector to begin the second specimen collection in a timely manner, to minimize differences in oral fluid collected using two separate collection devices.”

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Split Specimen Comments

• “The ACOEM recommends that the final rule only allow true

split testing and disallow collection systems that work only with sequential testing.”

• “CannAmm believes that two specimens collected

simultaneously using a single collection device that directs the oral fluid into two separate collection tubes is most preferred by our organization and industry stakeholders; and aligns to the retest procedures defined in the Canadian Model for Providing a Safe Workplace - Alcohol and Drug Guidelines and Work Rule.”

• DATIA “… does not believe that serial collection of

specimens, with the second specimen collected within two minutes of the first specimen, constitutes a split specimen or should be allowed.”

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Split Specimen Comments

• OraSure “… supports the guidelines to allow for both

simultaneous and serial collection of two oral fluid samples.”

• Quest “… supports simultaneous or serial collection using

two different collection devices is acceptable. If a serial collection is performed, there should be no more than a 2 minute interval between the end of the first collection and the start of the second.”

• SAPAA “… believes that serial or simultaneous collection

using two collection devices constitutes a split collection in the spirit of the Omnibus Employee Transportation Testing Act of 1991 (OTETA).”

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Public Comments: FDA Clearance—Devices & Assays

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FDA Cleared Device: Comments

• “DATIA supports having HHS publish a list of allowable (FDA-

cleared) oral fluid collection devices.”

• “OraSure supports a published list and recommends this not

be limited to the collection device, but include the FDA cleared system consisting of the collection device and immunoassay screens as described further in our comments under section 11.9. This will provide an independent source to employers, third party administrations, laboratories, and

• thers to easily identify FDA cleared products for workplace

testing.”

• “SAPAA agrees that that the collection and testing system

used in oral fluid drug testing should be cleared or otherwise recognized by the FDA.”

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FDA Cleared Device: Comments

• “Drager agrees that FDA-cleared oral fluid collection devices must

be utilized by applications used by the general public. However, we see the use of workplace-drug-testing equipment in a similar manner to the use of workplace-alcohol-testing equipment. Since

• ral fluid drug tests would be performed only by specifically-

trained and certified operators similar to BATs for workplace alcohol testing, we propose that FDA-cleared devices not be required for workplace oral fluid drug testing applications.”

• Alison Stockdale “… whenever possible, oral fluid collections

should mirror those already established for urine collections. Because HHS does not publish a list of FDA-cleared urine specimen collection containers but does provide regulation on what a specimen collection container parameters are, it is suggested that this information not be published by HHS.”

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FDA Cleared Assays: Comments

• LabCorp “Section 11.9 (a)(1) indicates the initial drug test may be

an immunoassay, without qualification as an FDA-cleared

• immunoassay. LabCorp requests that the Department clarify the

intent; for example, if an immunoassay can be utilized as a laboratory-developed test (LDT) or FDA-modified test, what are the additional requirements, if any, to use these formats?”

• “Immunalysis requests a clarification on Section 11.9 (a) (2) which

allows an initial test to use a technology (e.g. spectrometry, spectroscopy). Therefore does such a test have to be FDA cleared? What performance claims would be necessary? Previously initial and confirmatory testing were to be performed using two separate techniques based on different chemical principles - has that requirement been eliminated? Is it possible to screen and confirm with the same technique? Would this not cause any error in the first assay to be repeated in the second?”

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FDA Cleared Assays: Comments

• “OraSure understands that the FDA will not clear an oral fluid

collector without an associated assay. OraSure agrees with the FDA that when an immunoassay screening drug test is utilized in the testing process, the immunoassay and oral fluid collection device needs to be FDA cleared together as a system. This approach will eliminate off label uses of various immunoassays and devices that have not undergone the proper research, development, and clinical testing necessary to assure accurate and reliable performance of the system in the workplace drug testing

• market. OraSure recommends that SAMHSA require that all

immunoassays used to screen oral fluid samples must be FDA cleared with the oral fluid collection device as a total system.”

• Quest “Based on current FDA Guidance, Quest recommends that

both the collection and testing system used in workplace oral fluid drug testing be cleared or otherwise recognized by the FDA.”

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Public Comments: Other Collection-Related Issues

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Waiting Time to Collect 2nd Specimen Comments

• “Drager suggests this requirement may not be realistic. We

would propose the time interval be extended to ten minutes. By then a result of the initial test is usually developed, and based on this result the operator can decide if a second sample should be collected. If the two minutes remain in the guidelines, this would mean that a second sample has to be collected in every instance, independent of the initial result. This would result in doubling the cost due to the permanent use of two collectors.”

• “LabCorp believes the requirement for a serial collection to

begin within 2 minutes of the first collection may be difficult to monitor and may lead to qualitative/quantitative differences in the specimens. How will this be monitored?

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Rinsing Mouth Comments

• Drager believes that in order to effectively collect oral cavity

contents even with dry mouth conditions, oral fluid collection devices exist which are designed with rigid, porous capillary

• material. Training procedures for these collectors state that valid

test results are obtained when the volume adequacy indicator is activated or after a maximum of four minutes of sample collection

• activity. These procedures specifically instruct against offering the

subject water to rinse or drink. We propose that Section 8.3.d.2 be modified to make the offering of water conditionally-allowed depending on the collection device manufacturer’s instructions.”

• LabCorp believes this section mirrors the UrMG with regard to

permitting the donor to hydrate if unable to provide a specimen. This section raises several questions: Is there evidence that hydration improves the ability to provide an oral fluid specimen? Does hydration contribute to sample dilution? Will hydration be allowed between serial split collections?

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1 Hour Allowed to Provide Sample

• OraSure “OraSure considers this amount of time to be excessive

and it may lead to employees missing additional time out of work costing the employer both time and money. A donor with dry mouth should be provided up to 8 ounces of water and the collection should be conducted after 10 minutes from consumption of this water with no additional time allowed for this process as it negates one of the benefits of performing oral fluid collections.”

• Quest “For donors unable to provide the volume required by the

collection device being utilized, Quest suggests the Department consider an immediate collection of a urine specimen.”

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Standardized Collection Device: Comments

• ACOEM “Currently, there are different devices on the market that

are used for oral fluid collection. In discussions with our MRO members and also with a wide variety of collection personnel that we oversee, it is ACOEM's strong suggestion that a consistent device be used for oral collection.”

• “First Advantage believes that more than one device should be

approved by the FDA to ensure competitive and fair pricing as well as ongoing product availability.”

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Public Comments: THCA Testing

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THCA Testing: Comments

• “Immunalysis states the references provided in the guidance

further show that THCA (THC-COOH) detection eliminates the possibility of a passive exposure defense; therefore its inclusion in the program should be mandatory to determine marijuana use. Laboratory instrumentation required for the analysis of THCA in

• ral fluid is widely available (2dGC/MS; GC/MSMS, LC/MS-MS etc.)

and can be added to routine laboratory testing. A cut-off of 50pg/mL for confirmatory analysis will allow laboratories to reach the 20pg/mL (40%) confirmation requirement.”

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THCA Testing: Comments

• “The First Advantage Medical Review Officer Team believes that

the experimental evidence presented casts significant doubt on the capability of the laboratories to consistently test for THCA with accuracy, sensitivity and validity. A suggested and preferable approach would be to lower the cutoffs for THC, which, in effect, lengthens the window of detection.”

• CannAmm's chief MRO Dr. B Demers would be reluctant to test for

THCA as solely testing for the active parent drug is one of the defining characteristics of oral fluid testing.

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THCA Testing: Comments

• OraSure “… since the risk of detecting passive exposure to marijuana is

extremely low, there is no need for a confirmation assay for ∆-9- tetrahydrocannabinol-9-carboxylic acid (THCA). Very few laboratories are able, at this time, to test for THCA. In Occasion 38 of the 2015 NLCP Oral Fluid Pilot PT Proficiency Program2, only 2 out of 18 participating laboratories reported results for THCA.”

• Thermo Fisher recommends NOT including THCA testing for the

following reasons:

• The majority of the time, THCA exists in combination with THC. No

significant THC positives were reported for samples containing THCA

• alone. The THCA levels reported in the oral fluid specimens were at

low pg/mL

• For the THCA alone (in the absence of THC) to be detected as

positive in the immunoassay, the levels must be at least ≥1000 pg/mL

• The oral fluid sample volume is limited and it should not be wasted

for unnecessary tests

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THCA Testing: Comments

• LabCorp “With regard to the inclusion of THC-COOH, while LabCorp

believes it adds value by expanding detection windows and assists in interpretation of results, we agree with the Department’s concern regarding the challenges for laboratories in accurately and reliably detecting the metabolite in low picogram concentrations. Additional requirements for more sophisticated and expensive instrumentation may be a barrier limiting the number of laboratories that can perform the

• testing. However, permitting the MRO to request this additional testing

to assist in interpretation of results as permitted in section 3.5 is an important provision. We suggest permitting the MRO to request analysis

• f THC-COOH when considered relevant to result interpretation; this

would facilitate referral if the primary laboratory does not have the capability to detect THC metabolite.”

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Public Comments: THC Testing/Cut-Off Levels

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THC Testing: Comments

• “Immunalysis believes the recommended cut-off is appropriate, in fact

any revision should be upward rather than lower. Published literature utilizes collection devices with poor extraction efficiency for THC (<50%) so higher cutoff concentrations would be more appropriate to account for recovery.”

• “LabCorp believes that the current proposed cutoffs are

appropriate for this purpose. A 4 ng/ml initial test cutoff has gained fairly widespread use; it is unclear from the cited studies whether there is data that specifically demonstrates a meaningful difference in detectability in specimens screened at 3 vs. 4 ng/ml.”

• Redwood Toxicology “… believes increased THC initial and

confirmation cutoff levels, in addition to the inclusion of THC- COOH to minimize claims of passive exposure is justified.”

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THC Testing: Comments

• “The ACOEM recommends that the cut off and confirmation

concentration levels for THC detection in oral fluid be dropped to 2 ng/ml for the initial test and 1 ng/ml for the confirmation test.”

• “CannAmm's chief MRO Dr. B Demers is in favor of reducing the

cutoff concentration for delta 9 THC to extend the window of detection.”

• “SAPAA supports a lower initial test cut‐off than the proposed 4

ng/mL. We recommend an initial screening cutoff of 3 ng/mL and a confirmation cutoff of 1.5 ng/mL.”

• “Drager proposes that the OFMG Initial Test Cutoffs be presented

in an acceptable range format rather than a single value. Therefore, we propose that Marijuana (Δ-9-Tetrahydrocannabinol) Initial Test Cutoff Concentrations could be presented in a range of 3-5 ng/mL, which would include the 3 ng/mL cutoff, to extend the detection window and to increase the number of specimens that are identified as containing THC…”

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THC Testing: Comments

• OraSure proposes 3ng/mL THC. The majority of THC positives are near

the cutoff and by increasing the cutoff to 4ng/mL, there will be a reduction in the THC positivity rate. In addition, the data sited in the Executive Summary on page 32 that urine and oral fluid cutoffs for THC are comparable was determined from Quest who uses a 3ng/mL screening cutoff.

• Thermo Fishers recommendation is to lower the THC cutoff

concentration to 3 ng/mL for the following reasons: The positivity rate for THC in oral fluid specimens was increased from 4.0% in 2012 to 5.1% in 2013 as reported in 2013 Drug Testing Index (DTI) by Quest Diagnostics. This increase in positivity rate is partially attributed to the cutoff of 3.0 ng/mL and the new oral fluid collection device. Quest introduced the new Oral fluid assay with a cutoff of 3.0 ng/mL using the Oral-Eze Collection Device in 2011. Lower cutoff concentration will increase the positivity rate for THC and the window of detection will be longer.

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Public Comments: Expanded Opiates

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Expanded Opiates: Comments

• “LabCorp understands that the expansion of the test panel to include

additional opiates is consistent with the proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG); however, in our experience the incidence of Hydromorphone and Oxymorphone is extremely low in oral fluid. Other metabolites of hydrocodone and oxycodone are much more prevalent and should be considered for inclusion in lieu of the current proposed compounds.”

• “ACOEM is in strong support for the inclusion of testing for oxycodone,

hydrocodone and its metabolites.”

• “First Advantage believes that the additions to the opiate panel are most

appropriate in view of the epidemic of prescription opiates in the general population.”

• “The National Safety Council (NSC) is very pleased that hydrocodone,

hydromorphone, oxycodone and oxymorphone are included in the proposed oral fluid drug testing panel.”

• “SAPAA supports testing for the proposed new analytes (Oxycodone,

Oxymorphone, Hydrocodone, Hydromorphone).”

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Public Comments: MRO Issues

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MRO Issues: Comments

• This section requires requalification training and re-examination

every 5 years. As in the UrMG, there is currently no requirement for continuing education (CE) credits. LabCorp agrees that periodic requalification of an MRO’s certification to perform result review and interpretation under the Federal Guidelines should be a

• requirement. However, use of CE credits is more commonly used

to ensure ongoing competence by accrediting bodies than a full re-examination. Requiring annual CE credits (e.g. 12 – 15 hours/year) including credits from mandatory training/courses specific to the workplace drug testing rules would be beneficial to the program as a whole and should be sufficient to ensure that MROs are able to fulfill the role as defined in the Guidelines.

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MRO Issues: Comments

• “First Advantage is strongly opposed to inserting federal

requirements for Medical Review Officer continuing education units.”

• “SAPAA supports the proposed MRO requalification training and

examination requirements (every 5 years) administered by a SAMHSA approved MRO certification organization. However, SAPAA does not believe that the CMEUs need to be specified or required as part of ongoing MRO qualification standards.”

• “DATIA does not support requiring recertification CEUs

within the OFMG.”

• “First Advantage is strongly opposed to inserting federal

requirements for Medical Review Officer continuing education units.”

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Conclusion

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Where Do We Go From Here?

During a recent DTAB meeting, next steps regarding the guidelines were discussed. High level summary:

• DTAB review of comments – 90 days (mid August to mid

October)

• SAMHSA routing and review – 30 days beginning Oct 27
• Review throughout various agencies (30 days each, total of

165 days)

• Publish in Federal Register – estimated April 2016
• Implementation period AFTER publication in Federal Register

– 12 to 24 months

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