Okay, the final thing that you should be sure that you have worked out with your employers are the things that are listed on the final bullet on this slide. Reviewing procedures for dealing with internet prescriptions, for example, particularly obviously for those that are controlled substances. Admission of the use of someone else's prescribed medication. This is often referred to as spousal use or familial use. The DOT regulation is actually silent on that issue. It says that the medical review officer should only accept authorized use of a controlled medical use of a controlled substance or authorized medical use of a drug as a reason for overturning it to a negative result, but many medical review officers feel that that definition of authorized use, if you will, may include, in some circumstances, the use of someone else's medication, particularly a family member's. If that is going to be your policy, you need to make sure that your employers know how you are going to treat that, how you're going to validate or document that. Again, over 20 years, it has been my experience that the majority, the majority of medical review officers for DOT-regulated testing, because this involves safety-sensitive positions and employees, do not accept an explanation or an allegation by a donor that they have used someone else's medication, that they are only going to accept documentation of use of a medication prescribed to that individual. In New York State, is it illegal to use somebody else's medicine? Yeah, I think, yeah, right, her comment is that in New York State, there is a specific state law that backs up a medical review officer in terms of not accepting use of someone else's prescribed medication as legitimate or legal use of a substance. Current versus outdated prescriptions, that's another thing that the medical review officer needs to determine. Again, there is no specific guidance in the DOT regulation for what is a current prescription. If a person is positive, for example, for codeine or for morphine, and the script that they present is for Tylenol-3 or Tylenol-4, which is Tylenol with codeine, that was dated or dispensed two years ago, is that, is the medical review officer going to accept that as a legitimate medical explanation for the positive test result? And again, MROs vary some in that. It may also depend on what the script is. If it is for, for example, a codeine containing cough syrup that the person may have gotten two years ago, and it is cold weather, and the person has a cold, then they may say that I'm going to accept that. Oftentimes people say, well, don't medications have an expiration date? And not technically. Again, there may be some state laws about use of medications after a certain dispensing date, but in general, there's not necessarily a hard and fast thing of this medication can only be used for, you know, six months or for one year or whatever. So that's something, again, that has to be part of your procedures and communicated to your employer clients. And then the other issue, of course, has to do with clinical examinations for opiate use, for example. Does the medical review officer do those automatically? Is it a case-by-case basis? Will the employer be told when a clinical examination is going to be required as part of the verification process, et cetera? So those are the kinds of things that you have to make sure that you have talked about. MRO employer protocols for non-federal testing, and I want to cover this today because many of you, while you deal with DOT results a lot, may also deal with non-DOT or non-federal results, and there are certain things, then, that you have to make sure that you have established with the employer client because they are not covered by DOT regulation. Probably the best example of this is the one toward the bottom of the list, medical marijuana policy. For a DOT test result, the rule specifically says a medical review officer cannot accept a prescription or recommendation for the use of medical marijuana, even in a state where it has been voted and determined as legal to do so. They have to treat marijuana as a Schedule I substance for which, under the federal classification system, for which there is no legitimate medical use. But for non-regulated testing, this becomes an issue. Now again, our MRO practice strongly recommends to our non-regulated clients that if they are doing drug testing for marijuana in a state where marijuana is medically authorized, they have to include in their policy that that will not be accepted as a reason for a positive test. So if they need to use medical marijuana, then they can't be working for that employer in those positions that require drug testing. Now this is going to get further complicated for all of us, as the states that have most recently enacted medical marijuana legislation have included language that says an employer may not discriminate in either hiring or in any other employment action for those employees who have medical marijuana duly authorized and signed off under the state legislation. The two that I know of right now that that applies to are the states of Rhode Island and Arizona, beginning in April of 2011. So those become issues again that you have to, this is part of that consultative role that the medical review officer and his or her staff have with employers. Okay, the other thing I want to talk about on this employer relationship section has to do with the DER again. You see that the DER is defined under DOT rules as the employee who is authorized by the employer to take immediate actions to remove employees from safety sensitive duties or cause employees to be removed from these duties and to make required decisions. Phone contact with a DER when an immediate employer action is necessary is essential part of this. So therefore, you as MRO staff members have to have primary and secondary phone contact information as we mentioned earlier. And the second major thing that you're going to be using the DER in your relationships with is for assistance in contacting a donor when the MRO's attempts to do so have been unsuccessful. Okay, let's move to collectors and remember we're going to try to cover in this segment the relationships with the employers which we've done, the relationship with the collectors and finally your relationships with the laboratories, the drug testing laboratories. Probably of the three, collectors, that's the greatest range of various kinds of contacts and relationships that you are going to have. I have listed on this slide the major issues that will require MRO staff and collector interaction. Getting that MRO copy of the CCF, that copy 2 or another suitable copy that has the donor signature in order to release a result or in order to work a case, a verification case. Questions about the conduct of a specific collection. For example, the specimen temperature box was not checked or as we talked about before, the direct observation. Is this a 1 of 2, a 2 of 2? Was direct observation done on a DOT follow-up or return to duty or a second collection? Was it directly observed? Sometimes the CCFs that you receive are not legible. I mean, facts or whatever, they're just not legible and so you have to contact the collector to try to kind of fill in the blanks before you can review and release a test result. The memos of correction, notification of error correction training that is required of a collector when the MRO has canceled a test due to a collector's error, whether that was a fatal error in CCF documentation or a correctable error that could not be corrected. You often will have questions from a collector during a collection process. Shy bladder is probably one of the things that it just seems that collectors can't quite get right yet and need some guidance on. Sometimes while the person is still there, certainly in terms of once they have sent a CCF and there's just not enough documentation about was there three hours, were fluids offered, you know, were there any partial specimens or specimen attempts made during that three hour time period, for instance. DOT versus non-DOT testing protocols oftentimes may be the circumstance where the collector did a, used a custody and control form that was a non-federal form and yet the employer intended and wanted this to be a DOT test. And so then you need to talk with the collector, perhaps get a signed statement from them that why was a non-DOT, a non-federal form used, were the DOT procedures followed, and that kind of thing. And in some instances you're dealing with a lost specimen, your result is not in, you've got an MRO CCF copy, you've got a result, excuse me, you do not have a result and you've contacted the laboratory, they don't seem to have accession to the specimen, so you may be going back to the collector based on the information you have on the CCF to see when the specimen was shipped, was it shipped or is it sitting in the back of a refrigerator somewhere and what you can do to assist in trying to locate the specimen. Generally speaking, the contact information to get the collector is on the CCF, if you can read it, and if it is in fact current for that particular collector. Many of the laboratories now, if the collector phone number or fax number is on the CCF, will in fact transmit that information along with other information that they report relative to the test result. Many MRO companies, third party administrators, even employers may maintain a database or a list of collection sites or collectors that they most frequently use for given locations and that may be something that you can refer to to get information to contact a particular collector. You should identify contact information for nationwide collection site networks. For example, both Quest Diagnostics Laboratory and LabCorp Incorporated have nationwide networks of collection sites normally associated with what are called patient service centers or PSCs. And so it does help oftentimes for you as an MROA to have a regional supervisor or manager for those PSCs that you can contact when you're having difficulty getting information or getting in contact or getting issues resolved with a particular PSC location. There are other national, nationwide groups or entities that typically do urine specimen collections ranging from Concentra to U.S. Health Works to EMSI, et cetera, and again there where you do have those national networks that you may be using for various employers that can become a valuable resource. How do you get the CCF copy from collectors? It's extremely difficult, I think, to continue to try to impress upon collectors that they should be faxing or scanning the MRO copy of the CCF to you, the medical review officer office, as soon as possible after the completion of the collection. Now the regulation, much to my dismay, says only that they must send it within two days and they're allowed to send it by snail mail. And so consequently, if it's been put in the USPS, in an envelope, coming to your office, the chances of it getting there as soon as the test result is reported from the laboratory is often slim to none. Now the DOT regulation does encourage the collection site or the collector to fax or to transmit that CCF as quickly as possible and preferably on the same day as the collection by scanning or facsimile, but it is not mandated. Follow-up calls to collectors to get the MRO copy, we have put in place in the last couple of years an automated notice to collectors. When we get a laboratory result and if we have the collector information, particularly a fax or an email, we will send an automated fax or email that says, you know, we are looking for the MRO copy of the CCF or specimen, ID number such and such, collected on such and such a date, and again, we have that information, obviously, from the laboratory report of the negative result or if it's a non-negative from the copy one that we have obtained from the laboratory. If the collector says they don't have the MRO copy, that they did in fact fax it and they put it in the mail, then you can obviously request them to give you the collector copy, which is copy three, which they should still have for how many days? At least 30 days after the collection was accomplished. You need to establish an internal SOP for how long you wait for the MRO CCF or an equivalent copy before canceling a test. We have basically identified that as two weeks, and if they haven't gotten it within two weeks and we've made numerous follow-up attempts to get a copy of it, we then figure that we're probably never going to really be able to get a copy. We will try the employer, but chances are, if the collector doesn't have their copy, they do not have the MRO copy, then our chances of getting it after two weeks are greatly diminished. Remember that the MRO CCF copy is not required on non-federal results, although some MROs still require it for non-negative tests. So it's not as crucial on the non-federal CCFs, and part of the reason it's not is because many non-federal custody and control forms have the donor information on the copy that goes to the lab, the donor name at least, and usually a contact number. Donor allegations of collector errors. This is a kind of a sticky wicket, if you will, or it can be a slippery slope. I do want to reiterate that for DOT tests, it is not the role of the medical review officer and this language is taken directly from the rule, to make decisions about factual disputes between the donor and the collector concerning matters occurring at the collection site that are not reflected on the CCF. The MRO cannot cancel a test, a DOT test, based on an error that does not have a significant adverse effect on the right of the donor to have a fair and accurate test. So for example, if the donor alleges that the collector did not have them wash their hands or did not put blueing in the toilet, or the collector, you know, did in fact handle two donors at the same time, but yet the chain of custody, okay, is complete and intact on its face, the MRO cannot cancel that test because of those admissions or those allegations of errors in the process. The MRO or the MRO staff member may contact the collector to inquire about allegations that are made by the donor concerning errors in the collection process. However, if the collector disputes the donor's allegations and the CCF is complete and adequate, the MRO cannot cancel the test based on what the donor has said. If the collector supports the donor's statements that there were errors in the process, that if in the MRO's opinion compromised the donor's right to a fair and accurate test, then the MRO may cancel the test. An example of this is a shy bladder collection. And the donor, and you look at the form and there is no indication, for example, that the donor was there for three hours. And when you call, the collector says, well, yeah, the donor came in at 3 o'clock and we closed at 4.30. So that was it, it was over by 4.30. Under DOT rules, you see the donor was not afforded, right, the rights that they have under the regulation for providing a specimen. So that's going to be a canceled test, that's not going to go to shy bladder exam, etc. And the collector then would have an error correction memo, right, because they failed to follow the rule. That once they started that collection, they were obligated to complete that collection. And in this case that meant, you know, affording them the full three hours. Whether that was calling the DER at closing time and saying your guy still has not urinated, come pick him up and take him over to, you know, the hospital collection site or whatever to continue this. Or whether that means calling the DER and saying we're going to keep a collector here but you're going to be charged overtime. Fine, doesn't matter. But the point is, the donor's right to that cannot be compromised, okay? If the donor has signed the certification statement that the specimen was processed, labeled and sealed in his or her presence, later allegations that this did not occur are essentially unsupportable. So again, if the donor tells the MRO in the interview, well, you know what, I never saw that specimen being sealed. I mean, I came out and put a cup on the table and walked out and there were three cups of urine sitting there. That wasn't my urine specimen. But the point is, if they have signed the certification statement, right, with the date on it, that certification statement says, you know, I attest to the fact that this was the urine collected for me, I presented it to the collector, it was labeled and sealed in my presence, I have not adulterated or manipulated the specimen in any way. And so why did you sign that? Well, I didn't read it, I just signed it. Too bad. Because you have now lost the supportability to your claim that the specimen is not yours and is not properly identified. Specimen temperature issues, the MRO assistant may need to get involved where the specimen temperature was incorrectly documented on the CCF or where the correct collection procedures for a temperature out of range specimen were not followed, meaning that it was to be sent to the laboratory and then a second CCF initiated and a second collection under direct observation was to follow. Now remember that the laboratory, if they receive a specimen where the temperature box is not checked at all, it's not checked yes or no, the laboratory is supposed to request a memo of correction from the collector before reporting the result. However, and this kind of does not pass the logic test, if they don't get a statement of correction that says oh yes it was in range because I just forgot to check the box, if it had been out of range I would have made a remark, okay, they go ahead and test it anyway and report the result to you. So there you are maybe with a negative, right, no temperature box was checked and there's no statement from the collector as to whether they simply forgot to take the temperature or they forgot to mark the temperature that it was in range or no it wasn't in range but that's all I did, okay. So those then become issues for you as an MRO staff member in terms of presenting this case to the medical review officer for final disposition. You cancel the test because it was an incomplete collection. Do you report the negative test result but verbally inform the employer of the collection process error? You cancel the test and order an immediate recollection under direct observation. So what would you do? What would be your response here? You do what? The third one, you cancel the test and order an immediate recollection under direct observation. That's what we do but there is nothing in the regulation that says that's what we have to do. And so again that becomes a matter of your standard operating procedure and how you proceed. We do this because by canceling the test we're going to force the collector to undergo error correction training and we're hoping that eventually they'll get the message that they have to do the second collection when the first specimen is marked temp out of range. Okay shy bladder collections, again I talked about this throughout the session today that the MRO should assist the employer in setting up the medical examination of the donor as soon as possible. The MRO certainly may perform this examination if that is feasible. There is no special certification or requirement other than the person is a licensed physician to be an examining physician. They don't have to be a urologist, they don't have to be a nephrologist, they don't have to be a certified shy bladder doctor, okay, if there is such a thing, which I don't think there is, for conducting the examination. Of course the MRO then is going to receive the written report from the examining physician that will often come in to you as the staff member. You then put that together with this case so that the MRO then is going to make his or her final determination. Cancelled if there is a medical explanation for the inability to produce an adequate urine specimen or refusal to test if there is no medical condition or explanation. In order for a shy bladder collection to result in a cancelled test, there must be one or more of the following, and these are identified here. The documentation of a medical or pre-existing psychological condition, evidence that the collector did not follow the shy bladder protocol and the donor did not have access to fluids or did not have enough time, or three, evidence that the collector committed another serious error such as sending the donor away or not completing the shy bladder procedure on the same day the donor first appeared. So those are all circumstances under which it would be a cancelled test. And the alternative, of course, you only have two options there, cancelled or refusal to test. Illegible CCFs. The illegible CCFs require judgment calls again by you. Generally speaking, it is going to be you as the MRO staff member because you are the one that is most likely to be reviewing the custody and control form in terms of making sure that it's available for the MRO for the donor interview on non-negative. And also, of course, you can't release a negative result on your own without having a legible copy of the MRO, the copy to the MRO CCF. Legibility of donor ID number. That really should not be an issue. The really key thing on the CCF is not the donor ID number, but it is the what? The specimen ID number. That's the critical thing. And of course, the other important thing about the CCF from an MRO staff member's perspective is that you can see that the donor's signature and you can see the collector's signature. Generally, many signatures are not legible and there's no requirement that you as an MRO staff member confirm that the signatures match or represent the printed name. I mean, you do not have to have a signature card on file from every collector to make sure that that is the collector's signature. I mean, the scrawls that you see all the time, I mean, again, who knows whether that was the same person that signed it or not, but that is not your responsibility. If the fax copy quality is the issue, try to get an image via email or scanned, the document scanned somehow, or request a statement from the collector as to the data contained on the CCF, or you can also try to get just the mailed copy. Collector errors are generally categorized into three groups. There's the fatal flaws, which we can't do much about. It's going to be an automatic cancellation of the test and an automatic requirement for error correction training. The correctable flaws, they're significant enough to cause the MRO to cancel the test under the provisions of Part 40 unless they are corrected. The laboratory generally requests a memo of correction and tests the specimen and reports the result if the correction memo is received for most of those correctable flaws. The other correctable flaw, of course, that the laboratory has nothing to do with, but that you do, is the donor signature. De minimis flaws are flaws that demonstrate perhaps poor collector technique or inattention to detail, but they are not serious enough to affect the outcome of the result. Okay, three of the five correctable flaws that are defined by DOT are errors that will be identified by the MRO, not the laboratory, and we have covered those. Donor signature, certifying signature missing on what? Only non-negative results, right? We don't need a certifying scientist's signature on negatives or negative dilutes, right? Collector used a non-federal form for what is supposed to be a federal drug test. The MRO, MRO staff will usually only know this, quite frankly, when the DER has indicated that hey, you reported this result to me as a non-DOT and it should have been a DOT test. Sometimes they will know it before you get the result, hopefully, like let's say it was a post-accident test and we sent the person there, but you know what, I know right now that the hospital or the 24-hour urgent care only had a non-federal form, but it should be a DOT post-accident. Those are the kinds of things that you get, again, with employer input. Here are the corrective actions for a missing donor signature. It can be a memo from the collector. It does not have to be a memo from the donor. There is no provision in the rule to have the donor return to the collection site to sign a copy or for the MRO to fax them a copy of the CCF and have the donor sign it some days after the collection has been done. Only the collector who conducted the collection can provide the memo explaining why the donor signature is missing. The donor left before they signed the form. The collector inadvertently didn't turn to page two and just looked over page one and thought everything was done and sent the specimen off to the laboratory. If the collector does not provide a memo that states that, in fact, the donor was there and on this date and that they simply did not sign the form because they refused to do so, but the collector didn't put that remark in because they left prior to it being done or because the collector may have failed to request them to sign it, then the MRO has to cancel the test. When a DOT test is canceled because of a fatal flaw or an uncorrected flaw that was due to the collector's error or oversight, of course, the collector has to undergo error correction training. Frequently, it is you as the MRO staff member who must notify the collector of this requirement because it is the MRO who cancels the test, not the DER, not the laboratory, et cetera. It is the MRO who cancels the test. The laboratory may report a fatal flaw as rejected for testing, but the test result that goes to the employer is from, not the lab, but from you, right, as the medical review officer of the MRO office or MRO staff. Notification of the requirement for error correction training should always be in writing. We use a standard form, tell them what the error was, tell them the date that they have to have the error correction training completed by in order to continue to serve as a DOT qualified collector, and you need to have follow-up, ways of a tickler file or some other way to make sure that you have procedures to follow up on the completion of error correction training. We require on the form that tells them they have to undergo the correction training, a thing at the bottom that they have to fax back or send back to us that says that collector Donna Smith has completed her error correction training on such and such a date, and then that is signed by the supervisor, the facilitator, or the instructor who gave the error correction training, including the mock collections that are a part of DOT required training. We do provide in our notice to them what error correction training has to consist of under the rule. We just take that paragraph out of Part 40 so that they know that they have to do three mock collections and that they have to reiterate the error, you know, the training in the area of the error that was made. DOT versus non-DOT tests. I think we've talked about that, the key things that you need to know if you are going to redesignate a test from non-DOT to DOT where a non-federal CCF was used, you need a statement from the collector as to why the incorrect CCF was used and that the DOT collection protocol was followed, including the collection of a split specimen. You need a reissued laboratory result or a statement from the laboratory that they have tested the specimen using the cutoff levels and for the panel and under the protocol necessary for federal testing. If a federal CCF is used and it should have been a non-DOT test, there is no requirement for memos from collectors or reissuance of any laboratory result or any statement from the laboratory. The employer, however, should document the circumstances and retain their documentation for a DOT audit. Okay, relationships with laboratories, finishing up here on this particular segment. The laboratory personnel in general are identified on this slide, customer service folks or call center personnel for the laboratory. They are the ones that will help you track down a result, reassign results for tests, test on an incorrect CCF, for example, get this business of having the laboratory reported out as a DOT test, for example. They will help you address billing issues between the laboratory and the medical review officer if you are getting billed from the laboratory for analytical or other services and they can provide you with general information on specimen status. The accessioners are the ones that unpack specimens, log them into the laboratory system, check the CCF and the specimen for fatal and correctable flaws. You probably will have not very much direct involvement with the accessioning staff. They're inside the laboratory in a secure area. Most of your information about the accessioning process, if a specimen was dropped or lost in the accessioning process, will come to you from your contact with the customer service person. And then there's the certifying scientist who actually reviews the CCF, the internal chain of custody document, reviews either the immunoassay and, in the case of a confirmed result, the confirmation analytical data, and will sign the document, which is the laboratory copy one of the CCF. You may have some contact with the CCF, most contact, excuse me, with the certifying scientist. Most contact with the certifying scientist to discuss, for example, an invalid result or why a different specimen validity test was done or wasn't done. Most of that will be between the medical review officer, himself or herself, and the certifying scientist. But there's nothing in the regulation that prohibits you from discussing that directly with the certifying scientist. Responsible person is the lab director or other senior toxicologist. And they, in general, again, will not be people that you will be interfacing with. Laboratory process, remember, and you'll have another part of this particular presentation today will include details about the laboratory analytical process, the internal chain of custody. This slide simply presents to you what is done in the accessioning phase and then in the screening or initial testing phase, which is done by an immunoassay analysis and using cutoff levels. And you know that the DOT rule in all federal testing identifies a cutoff level for the screening assay and then, in many cases, a different cutoff level for the confirmation assay, which is generally done by some form of mass spectrometry. And you see the two types of approved methodologies listed on this slide and in Dr. Peet's segment of this course, he will discuss with you the specifics of that process. The specimen validity testing, we talked about before that that is required for all DOT and HH testing now. And the possible outcomes of specimen validity testing, SVT, we did discuss. Alterated, substituted, invalid, or dilute. And then the issue of what types of interference we may get that would lead to an invalid result. And again, in the laboratory analysis segment of this course, we'll go into a lot more detail about the causes, the reasons, and the possible explanations. One of the other things in terms of laboratory that you as MROAs may be involved with is the blind proficiency testing. DOT-regulated employers or third-party administrators, TPAs, that have testing programs for more than 2,000 regulated employers, so this is kind of the big operations, whether that's a big company or a big consortium or third-party administrator, have to submit a blind proficiency specimen either that is purchased from a reference laboratory that is known to contain drugs above cutoff level or known to be negative or known to have an adulterant or other specimen validity irregularity in it. Seventy-five percent of those are negatives, 15 are positive, and 10 percent are either adulterated or substituted. They are sent to the laboratory by the employer, by a service that you would contract with, or by the third-party administrator. They are disguised or they look exactly to the laboratory like an employee specimen. In other words, they have an employer name or fake location on it. They have the MRO listed. They would have a donor ID number, a made-up number, etc. It would be a split specimen, and the results would come to the medical review officer just like they would if they are an employee specimen. So you as the MRO staff member would match the laboratory result with the expected finding on the proficiency specimen that you have from the reference laboratory. In other words, CCF number 1, 2, 3, 6, 4 should be negative. And so then you check that against what the laboratory reports. Generally speaking, the service or the employer or whoever has put those specimens into the system will provide you the MRO copy, but instead of it having a donor signature, a name, it will say that it is a proficiency specimen. So that's how you know in terms of when these results come reported by the laboratory. Okay, so we talked about all of the additional analytical procedures. The two things that we haven't mentioned today are the 6M or heroin metabolite. This became mandatory for all tests. I know that this slide says that it's only on morphine positives, but effective in October of last year, October the 1st, the laboratories must now do the analysis for the heroin-specific metabolite referred to as 6-acetylmorphine or 6M on every specimen, not just on the positive morphine specimens. So I want you to make sure that you understand that it is possible for you to get a result that is going to be positive for 6-acetylmorphine, heroin, but negative for morphine or negative for codeine. Now that will require, if that happens, that the medical review officer, you're going to have to prompt the medical review officer that he needs to contact the certifying scientist to see if there was any detectable morphine below the cutoff. What is the cutoff for morphine today in the DOT panel? Anybody remember? 2,000 nanograms. That's correct. Okay, so the additional circumstances we have talked about in terms of that the medical review officer staff member would interact with the laboratories, and we talked about which areas of the laboratory personnel those would involve. So this completes our initial segment, if you will, on the MRO staff member and MRO assistance duties, particularly in terms of the operations of the office and the relationships that you as MRO staff members have with employers, collectors, and laboratories. Thank you.

MRO staff members

internet prescriptions

someone else's prescribed medication

controlled substances

DOT regulation

outdated prescriptions

positive test result

medical marijuana policies