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  • ACOEM Responds to SAMHSA Proposal to Include Oral Fluid Testing in Mandatory Guidelines for Federal Workplace Drug Testing Programs

    July 14, 2015

    SAMHSA
    Attention: Division of Workplace Programs
    1 Choke Cherry Rd.
    Room 7 — 1045
    Rockville, MD 20850

    RE: Docket SAMHSA — 2015 — 0002 and SAMHSA — 2015-2

    Dear Sir or Madam:

    The American College of Occupational and Environmental Medicine (ACOEM) welcomes the opportunity to provide comments to the Department of Health and Human Services (DHHS) proposed revisions to the scientific and technical guidelines to include oral fluid testing and the revisions to similar guidelines regarding urine testing. As our organizational membership consists of a number of physicians who are medical review officers (MRO), we are keenly aware of the issues that have been brought forth in these proposed revisions.

    Within the notices, DHHS has asked for specific comments regarding issues of special interest as well as overall comments regarding the proposed changes. We offer our comments on the following areas indicated topically below.

    1. The Addition and Acceptance of Oral Fluid Testing (OFMG)
    We are in agreement that the “time has come” for alternative specimen testing and the advancements in science regarding oral fluid testing at currently at a level on par with urine testing. We note that there was concern earlier regarding the sensitivity of oral fluid testing regarding THC, but this issue has now been resolved as laboratories have improved the detection assays. MROs are concerned about what will likely be an increase in positive rates for OFMG due to the fact that all collections for oral fluid will, at least theoretically, be observed collections. Although there is some concern expressed by our MRO members regarding architectural considerations for collection facilities, the fact that urine collection will remain as a valid specimen to be collected and also as a back-up specimen collection option in the scenario where not enough oral fluid can be collected has led most MROs to the conclusion that collection facilities will need to maintain their configuration for urine collection and add designated areas for oral fluid collection. Granted, these added areas should be small, but according to the proposed rule, they do have to maintain a degree of privacy. We are of the belief that these adjustments to collection facilities will be small and manageable.

    We would point out that the estimates regarding the number of OFMG collections that will occur after the final rule is published may be low. It is our opinion that there will be a monumental shift towards oral testing from urine testing because of the fact that it is a much more efficient and direct process for the collector. Most MROs and others who manage collection facilities understand that it is much less likely to be able to adulterate oral fluid than urine. Additionally, there is a favorable viewpoint toward a move to oral fluid collection in that the process is quicker for most collections as time is involved with having the donor go into a restroom style facility to provide the sample. Thirdly, it is our opinion that oral fluid collection in comparison to urine is looked upon favorably from a hygienic perspective by both donors and collectors.

    2. Split Sample Testing for OFMG?
    The proposed rule gives the option for OFMG split testing to collect the sample either concurrently, or sequentially. We would recommend that the final rule only allow true split testing and disallow collection systems that work only with sequential testing. Obviously, the nomenclature of “split specimen testing” implies that a split of a singly collected specimen has occurred and technically a sequentially collected specimen, cannot therefore, by definition be called a “split.” There is concern from a legal standpoint from our members that a “split” test performed upon a sequentially collected sample does not, in actuality, confirm the same specimen’s results, and we wonder if legal challenges to this proposed option might render it unfavorable. Additionally, all be it small, there may be a risk of non-reconfirmation with sequential testing because of the time frames involved with collecting a second specimen.

    3. OFMG Testing for THC versus THCA
    DHHS specifically asks for comments about testing OFMG for THCA instead of THC. This is an issue that “held up” oral fluid testing being promulgated for wider use for a number of years because the fact is that THCA testing of oral fluid alone misses a substantial number of specimens that contained the parent product THC. While we note that the science regarding improved sensitivities for OFMG and marijuana metabolites have improved, we believe this is still an issue that raises concern. We are therefore suggesting that THC is what should be tested for OFMG and that THCA is not a reliable metabolite for such purposes.

    4. OMFG Cut-Off Levels
    DHHS has asked specifically for comments regarding proper cut-off levels for THC testing for oral fluid. In the proposed rule, DHHS has pointed out accurately that the detection time for THC in oral fluid is relatively short. For this reason, we would recommend 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 as opposed to the 2014 Guidelines that proposed a value of 4 ng/ml and 2 ng/ml respectively.

    5. Addition of Synthetic Opioid Testing
    ACOEM is in strong support for the inclusion of testing for oxycodone, hydrocodone and its metabolites. Our organization has been calling for this addition for many years as our physicians are keenly aware of the problem of synthetic opioid abuse and misuse and its subsequent concerns with the safety of workers who are inappropriately using these drugs. Our MROs are of the belief that the inclusion of synthetic opioids to the urine drug panel will increase MRO workload as there will be a significant number of these positive laboratory tests that will require the MRO to seek out explanations for legitimate medical use. Given that, we would ask the agency for guidance on MRO issues in determining what is “legitimate use” in the areas of spousal use, use of medications that have been sitting idle and are used episodically, etc. MROs significantly struggle with situations, for example, where a donor indicates that they used a previously prescribed synthetic opioid in the past, hold onto the bottle, and use it 9-12 months later for a painful yet different condition. There is wide and varied MRO practice on these types of situations and some MROs determine these positive tests while others determine them as negative. Consistency, we believe, in how MROs should interpret these laboratory positive tests is important and we would look to the agency to provide more specific guidance in this regard.

    Concern has also been expressed by our MRO members that the number of reported safety sensitive concerns issued by MROs will increase substantially in cases where synthetic opioid use exists but downgrade them because the donor has a legitimate medical prescription. When an MRO indicates to a DER that a safety sensitive concern is present because of these medications in a situation where the test is reported out as negative, we want to be clear that our concern is taken seriously by the DER and that appropriate fitness for duty considerations are implemented as these medications can create considerable impairment.

    6. MRO Training and Certification
    Regarding the issue of MRO training and certification, ACOEM supports universal time frames regarding these issues. All certification bodies should be consistent in that a 5-year certification interval is appropriate. Re-training and re-certification should occur at 5-year intervals as the science of drug testing and the pharmacology of new medications is an ever-evolving process.

    We would point out that the terminology used in the proposed rule is a bit confusing for MRO physicians in that we do not refer to our continuing education credits as CEUs, but rather CME (Continuing Medical Education) credit hours. We would suggest that the terminology CME credit hours be used in any future correspondence as that is what MDs and DOs are used to. Regarding the question of the number of CME credit hours that are suggested to be obtained by MROs prior to the recertification process, we believe that most MROs do a good job of self-monitoring their need for increased education. Within ACOEM, we offer a variety of CME opportunities throughout the year that also includes our Annual Meeting. While it might be debated as to what an acceptable number of CME credit hours might be, it is our belief that 15 CME credit hours per certification period (3 CME credit hours per year) is consistent with what most physicians are required to do in similar areas where additional certification beyond what their licensing board requires.

    7. MRO Requirements for Substance Abuse Donor Discussions and Referral Sources
    We are opposed to the new proposed requirement that MROs, during their interviews with donors should provide information “to include information about how to discuss substance misuse and abuse and how to access those services.” Our MROs want to keep their role forensic. There is a concern that this added requirement spills over into a doctor-patient relationship because they are (a) making a diagnosis (substance abuse has specific diagnostic criteria - how can you make that determination over the phone?) and (b) offering medical advice. Previous information from the agency has made it clear that the MRO/Donor interaction does not imply a physician-patient relationship and this new proposed rule likely will obscure this. Additionally, many MROs are concerned about a slippery slope trend towards their roles spilling over into the fitness-for-duty arena. We do not believe MROs should be required to determine fitness for duty unless more drastic changes are made within the agency rules, and we do not believe for example, that in the DOT Drug Testing Program, that this is even practical. Lastly, many MRO services are provided on a national level and to expect MROs who review drug tests from donors across the country to have knowledge about each local service area is impractical and onerous.

    8. Morphine/Codeine Cut-Off Levels for OFMG Clinical Evidence Determination
    The proposed rule stipulates that OFMG level of 150 ng/mL is the cut off where the MRO would need to consider clinical evidence of illegal drug use when the donor does not have a legitimate medical explanation for a laboratory positive. The rule states this is a “conservative” estimate as it is 10 times the confirmatory cutoff level (15 ng/ml). It is ACOEM’s belief that consistency with this cutoff level should occur with the levels that are used for urine testing. Since the urine level that we use to consider this is 15,000 ng/ml, that falls short of the 10 times confirmatory cut off of 2,000 ng/ml. Using an appropriate ratio, we would suggest that this level be 120 ng/ml in order to adequately take into consideration the issue of poppy seed ingestion.

    9. Validity Testing for OFMG
    The proposed rule asks for input regarding appropriate validity testing for oral fluid. It is our belief that testing for IgG and albumin are sufficient.

    10. OMFG Collection Devices
    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 our strong suggestion that a consistent device be used for oral collection. We believe that the devices that required a swab technique provide the most consistent and hygienic method of oral fluid collection and would recommend that the final rule not allow for collection devices that require the collection of spit.

    11. Adulteration of OFMG
    Interestingly, there is not much in this proposed rule regarding adulteration issues and oral fluid testing. Similar to urine testing, we would suggest that the final rule provide instructions to collectors in a situation where there is an obvious attempt to adulterate an oral fluid collection. We are aware of examples that have been communicated to us that include the chewing of dye capsules, the use of dissolvable pouches that contain non-human oral fluid, etc. There can be no doubt that the subversion industry will attempt the creation of materials in an attempt to produce a clean specimen in an otherwise drug-using donor, similar to what has been experienced in the urine drug testing world (urinator, artificial urine containers, etc.). It is our suggestion that the final rule contain a statement that directs collection personnel to document a refusal to test when there is an obvious attempt at oral fluid adulteration.

    Thank you for the opportunity to comment upon these proposed rules. We are available to discuss this issue further at your request. Please contact Patrick O’Connor, ACOEM’s Director of Government Affairs, if you have additional questions or need additional information. He can be reached at 202-223-6222, or by e-mail at patoconnor@kentoconnor.com.

    Sincerely,

    Mark A Roberts, MD, PhD, MPH, FACOEM
    ACOEM President

    Douglas W. Martin, MD, FACOEM
    Chair, ACOEM Medical Review Officers Section