I'm Donna Smith and we'll be starting today's training with a session on the Medical Review Office and the operations. We will then continue through the basics and the introduction to MRO staff functions, roles, and tasks, particularly as it relates to Department of Transportation regulated testing. So taking a look at the MRO office or the MRO setup, there's really certain basic core functions that any MRO office, whether it's a part of a clinic, a standalone third party administrator with MRO role, or as part of a private medical practice, has to have. And the first of those is to receive the laboratory test results. For Department of Transportation regulated testing and all federally regulated testing, that's a core principle of how the program was set up. That test results from the laboratory have to come to the medical review officer. They can't go to the employer first or they can't go to the employer's medical department if that person is not serving as the medical review officer. So they do have to go to the person that has been designated or identified as that employer's medical review officer. The second major task for MRO staff and the physician medical review officers is to review the test documentation. And probably this is a function that falls more to the MRO staff members than it does to the physician MRO himself or herself in terms of the review of various documentation, principally of course the custody and control form and the laboratory result in whatever format that may have been received. And then of course the MRO office is also interpreting test results. And the interpretation of test results is almost certainly at the end of the process is the physician MRO's responsibility by interpreting that result and making a final test result determination. And then there is the reporting function, to report the test result after the medical review officer has made the verification decision to the employer. And again, this is a task that in real life falls mostly to the MRO assistants or MRO staff in terms of the actual reporting of the results, whether that is by telephone and then followed up in some form of electronic or hard copy notification, or whether that is again through various applications that may be web-based or password-protected email or other kinds of ways of transmitting test results. And then of course what would be a federal program without the requirement to maintain records? And even though the federal government is I think trying to go paperless, I don't know that it's going to exist in my lifetime. So there is the retention of records. So we're going to talk about all of these functions and what the MRO staff members' role and tasks are related to those requirements. So we know by just going around in the class this morning what type of practices there are in terms of how MROs are set up. There are freestanding medical review officer practices where that is entirely all that is done, is workplace drug testing or other things that are related to drug testing. It's possible that the MRO functions may be in a department that is part of a third-party administrator or consortium as a service agent. The Department of Transportation allows in its regulations that a third-party administrator or a consortium of activities can serve as a service agent and have medical review officer and medical review officer staff as a part of that organization. It does not allow the same kind of arrangement for a drug testing laboratory, for example. So there cannot be an MRO section or an MRO department that is part of a drug testing laboratory. Medical review officers can be a part of a medical practice or a medical clinic and that's actually quite common. Looking at these five types or ways in which medical review officer functions are practiced, that's probably the most common as we look across the U.S. today. There are also a number of medical review officer practices that are part of a hospital department and sometimes that's part of an occupational health department or it may be part of various other sections, if you will, of the hospital that principally usually deal in outpatient services of some kind. And of course, and we have all of these types represented with our group today, that it may be an employer-based in a medical department, in a wellness, occupational health, health and safety, and so that the medical review office can be a part of the employer. And of course, the distinction there is, in terms of receiving test results under DOT rules, is that those test results can come to the physician that is a member of that company or that is a staff member as a medical director or other physician that works directly for a Lockheed Martin or a Sunoco oil, etc. But again, the results have to go specifically to that MRO and the other individuals who have access to those results have to be MRO staff members who are under the direct supervision. They can't be HR people, for example, that don't report to or are not supervised by the medical review officer. Okay, so that's kind of the overview of how medical review officers may be set up in what types of settings and in what type of practice. Federal drug testing requirements, of course, state that all laboratory results must be reported to the MRO office and the MRO office then, in turn, is responsible for reporting those test results to the employer. Consider that for DOT, all test results are ordered or originate with the employer. Even a pre-employment test is being conducted, you know, by the employer that has made a job offer or that is considering a candidate or applicant for a safety-sensitive position. That's different from some other testing in drug testing, for example, that may not be employer-based. In child welfare services, custody, probation, parole, you know, there's a number of things where the test may be actually the individual's responsibility to go and get tested. It may be testing, like, for example, in professional health or professional licensing monitoring programs where it is the state board of nursing or the state medical board that is requiring a test of an individual who may be on probationary or other status with regard to their professional license. But in federal testing, and federal testing is a term I'll use throughout our session today, I'm referring principally to Department of Transportation-mandated testing. But also included in that is testing that is mandated by the Department of Health and Human Services regulation, if you will, called the Mandatory Guidelines for Federal Workplace Testing. So the federal government, employees who work for the federal government, whether they work in the Department of Defense, the Department of Interior, or the Department of Commerce, many of them are subject to drug testing under the DHHS guidelines or rules because they are federal employees who are in safety-sensitive or security-critical positions. And then the third group, if you will, of federal testing is the testing that occurs under the Nuclear Regulatory Commission's fitness-for-duty regulations. And that testing, drug testing as well as alcohol testing, does require a medical review officer just like DOT testing and federal employee testing is done at all nuclear energy facilities throughout the U.S. In all cases, those that are licensed by the Nuclear Regulatory Commission for the production and distribution of nuclear power. So federal testing then takes in that whole gamut. How many people are we talking about in the U.S. today? Well, the DOT estimates that there are close to probably between 9 and 11 million people that are tested under DOT drug testing regulations. The federal employees that are in testing-designated positions such as the Transportation Safety Administration, the TSA security people at the airports, as well as, as I mentioned, other federal employees probably account to close to 2 million employees. And then the Nuclear Regulatory Commission, the number of employees that are subject to federal drug testing there is in the, probably in the 40,000 range nationwide. So you can see the DOT, of course, is by far the kind of the elephant in that room of federal testing. And so what we'll be talking about today for MRO staff are what the DOT standards are for the MRO process and the MRO staff processes. The MRO office of non-physician staff must be under the direct personal supervision of an MRO. Now that doesn't necessarily mean that the MRO has to be sitting, you know, next to or in the office adjoining a, an MRO assistant or MRO staff member on a daily basis. But in terms of the supervision and responsible for, ultimately responsible for the work that the MRO staff member does, that is the MRO physician's responsibility. The course, as you know, is called the MRO assistant course. I want to stress, because it has been drilled into me in my discussions over the past three years with members of the Department of Transportation's Office of Drug and Alcohol Policy and Compliance, that nowhere in Part 40, if you do a word search for MRO assistant, will you find that term. The Part 40 regulation doesn't identify an MRO assistant role as they identify, for example, a certifying scientist in the context of, of a drug testing laboratory. It talks about non-physician, if you will, MRO staff. And so the term, and I'll use them interchangeably today, when I'm using the term MRO staff, what I'm meaning is MRO assistants, people that are non-physicians that assist or, or perform MRO tasks, you know, under the supervision of the physician MRO. Now what about the staffing? Well, we've heard some, again, in, in looking at MRO practices across the country. We have heard that staffing levels vary. In many instances, there is only one MRO staff member, and it may even be a person who is a half-time FTE who does other tasks related to that medical practice or to that clinic or whatever, and maybe a half of their hours are spent in MRO staff functions, et cetera. It can be full-time or multiple physicians. In the MRO company that I currently am associated with, for example, we have four physician medical review officers, and we have seven MRO staff. That MRO staff within that group is also divided in terms of their, their primary function. So we have three of those individuals on MRO staff who really do entirely the negative result tasks, and other MRO staff members are there specifically to assist the physician MROs with the non-negative result tasks, and we'll talk about those kinds of divisions and those kinds of functions as we go through this, this session. So in many ways, the, the MRO staffing is test volume driven. So I mentioned four MRO physicians, three of whom are full-time, one who is part-time, and the seven MRO staff members, but that represents a test volume per month of close to 50,000 total tests that are coming through. So it is very much usually test volume driven. Automation in receiving test results also plays a big part in what your staffing needs are. Custody and control form, review, documentation, seeking errors of correction, memos of errors of correction, et cetera. Those kinds of things are, also drive what the staffing pattern looks like. Review and reporting of dress test results is not generally limited in many instances to an eight-hour day Monday through Friday. And so oftentimes the MRO's office staffing has to include some provision, for example, for either reporting test results out, or for some of you like, that work for a company that provides national service, you often have to have coverage beyond 5 p.m. or prior to 8 a.m. in your particular time zone because you are servicing clients on the West Coast, for example, if you are located on the East Coast, and that makes a difference again in terms of the responsibilities. Job descriptions and workflow documents are an essential part, I think, of a good MRO staff to really identify specifically what the MRO staff member roles and responsibilities are, the task, what the division of labor is, how they review and quality assurance, because there is a quality assurance component, certainly, to MRO functions. In-service training, staff meetings, quality control, as I mentioned, are really essential. And it has been my experience over a number of years of working with MRO staff members and conducting training for them, that no matter how long you are doing this, there is always changes to the process. There are changes to the federal regulations. There are changes in terms of how test results, in fact, may be reported by the laboratories. We recently, in the DOT regulatory environment, had significant changes about cutoff levels. We had even changes about drugs that are being tested for and, therefore, that will be reported out. And all of that impacts, certainly, on the MRO staff member's ability to prepare cases for the physician MRO, as well as to release and report results. Probably the most essential contact information that the MRO staff needs to have is how to get in touch with employers and other service agents that are involved in the drug-free workplace process, the testing process. And the term that we all learn at the very beginning of getting involved, certainly, in DOT testing is that acronym called the DER, or the DER. That's the Designated Employer Representative, and that's the central person, if you will, contact between the medical review officer office and the employer. Now many employers have multiple DERs. In terms of your role in setting up or in interfacing with a new client account or a new customer account for the MRO practice, one of the central things you need to try to see is to make sure that you don't have just one DER name, but you have an alternate. Because there is going to come the time when you have a positive result that has been verified that needs to be reported out immediately because the employer under DOT regulations has an immediate duty to remove that person from driving the school bus, working on the gas line, or flying an airplane, or whatever it may be in the transportation industry. And if you only have one contact to report that to, and that contact is not available, then you as a medical review officer department are kind of in limbo as to what to do. Because you have a responsibility for public safety, right, and for carrying out the requirements of the regulation, but you also have a requirement of confidentiality and the fact that you can only report these things to authorized people at the company. Many employers do have multiple DERs and in some instances it gets even more complicated. We have several clients that we serve, customers we serve, who has one DER for pre-employment test results, and oftentimes that's in a staffing office or an HR office. And then another DER that may be in a safety office or in a medical department within the company, et cetera, where random test results and post-accident and test results on incumbent or active employees are reported. We also know that there are some companies, again multi-leveled oftentimes, that non-negative results may have to go to a regional safety coordinator or a regional director, whereas negative results can be reported to identify contact people at a given location. So there can be a distinction in terms of DERs for the type of test, if you will, of test reason, as well as sometimes they are divided in terms of negative or non-negative reporting. You need to make sure that, again, as you're putting together your office or your departmental procedures and processes, that you do have an understanding of what your after-hours reporting protocols are for non-negative results. And oftentimes this is not something that is set up with the employer or not set up for the office in general, the MRO office in general, and then you have a circumstance where you do have a test result that is verified as a positive, for example, or a refusal to test after-hours. It was a random test, it is a person in a safety-sensitive function, and again there is the dilemma then, what do we do with this? Now we'll talk about what the regulation requires of you as an MRO office or department, and then also in terms of what are your options for how you as an office, how you as an MRO staff may meet the regulatory obligations. There are some DOT agencies that require an MRO DER identification system. The FTA, in particular, has always emphasized this particular kind of requirement that's been buried in one of the sentences in Part 40 for a number of years. And that is that because a lot of the interaction between the MRO office, including the physician and or the staff member, is telephonic, that there needs to be a way that when you contact the DER, that the DER knows for sure that it is you contacting them. And so that this is not just a crank call or somebody else calling to report a test result, but that in fact it is you making that call. Likewise, even though you may have a telephone number or whatever, you need to be certain that the person you are talking to on the phone is the DER, is the authorized person. The FTA recommends that you do that by establishing some type of a password or some other identification, if you will, for you as the MRO staff member, as well as for the DER. Now the MRO office communications, let's talk about, we've talked about employer contacts, meaning your contacts with employers, with the DERs, with those that are authorized to receive information on federal test results from you. Let's talk about the contacts you will have with other service agents. And I've listed those service agents on this slide. Collection sites, collectors, specimen collectors. Laboratories, you will have contact with laboratories, with drug testing laboratories. And in many instances you will have some contact with what the rule or the Part 40 regulation refers to as referral physicians. These are other physicians that will be involved in some way in a drug testing case prior to the medical review officer making his or her final test result determination. You will have perhaps a lot of contact with third party administrators because in many instances you will be reporting results to a third party administrator rather than directly to an employer, which it doesn't seem like with all of the other strictures that the Department of Transportation regulation puts on test result reporting that you would be able to do that. But in fact, the rule does allow a medical review officer to report an employer's test results to a third party, to a TPA or to a consortium. Now again, the employer who has ordered the test or whose name appears on the custody and control form as the employer of record for that test has to have agreed that my test results will be reported to a third party administrator as a service agent. But that's one of the more confusing parts, I think, of how the test result parameters, reporting parameters are set up under the DOT rules. And to a lesser extent, you as an MRO staff member may have some involvement with a substance abuse professional, a SAP as the DOT rule calls it. Generally speaking, your contact or your interaction with them is based perhaps on a follow-up testing program in terms of the duration and or the frequency of testing. Or if any of you are involved with U.S. Coast Guard drug testing, then you know that the medical review officer prior to signing a return to work letter for that individual to be eligible to get his Coast Guard license or document reinstated must have communicated with the substance abuse professional to see that the individual has successfully complied with the treatment requirements. I wanted to stress this. This is probably one of the things that for those of you that have taken medical review officer assistant or staff courses before, or even your supervising physician who may have attended MRO training courses under the qualification training requirements of the Department of Transportation, there was a recent ODAPSE, and ODAPSE, remember, is that acronym that stands for the Department of Transportation's Office of Drug and Alcohol Policy and Compliance. And so they are the proponent office for the Part 40 rule or regulation and therefore issue interpretations of that rule and opinions, if you will, about that regulation's implementation or compliance with it. And they recently issued an opinion concerning MRO staff communications with pharmacy, prescribing physicians, medical treatment facilities, et cetera. And I'm going to go ahead and read this quote because I think it's important for us to fully understand it. Under Part 40, the MRO, which they mean the physician MRO, must not delegate to staff the responsibilities for contacting and conferring with the pharmacy, contacting and discussing an employee's result and medications with the prescribing physician, and verifying the authenticity of all medical records the employee provides. Again, says the Office of Drug and Alcohol Policy and Compliance, these are MRO duties that are required by Part 40 and must not be delegated to any staff. Now I can tell you as a person that's been involved in this for a number of years, I was frankly quite surprised by this opinion. Because it had been the practice of many MRO offices that I know to have the MRO staff member validate, for example, a pharmacy printout that it did come from a pharmacy, you know, when there were medications that were being used to provide a legitimate medical explanation for a positive test result. I know that in many instances there were circumstances where the MRO staff member may have contacted a prescribing physician, again, to validate that a script that was received or a bottle label was in fact prescribed for that individual. But in this past year, in 2010, ODEPSI has taken the impression, has taken the stand that because these are tasks that are central to this verification process involving the employee's private or protected medical information, right, that that has to be done physician to pharmacist, physician to physician, et cetera. So that's something that, again, just in looking at your processes that you, now that doesn't mean that you may not have contact with physicians or you may not have contact with a hospital or a clinic or you may not have some contact, for example, with a pharmacy. However, the discussion concerning an employee's medications or medical treatment with those service agents or with those entities is the purview of the physician medical review officer. Okay, let's talk a minute about lab negative or negative dilute test results in terms of what your responsibilities as an MRO staff may be, what the regulation says about that, and what you would be required to do. An electronic laboratory result report can be used as the basis, if you will, for a laboratory negative or a laboratory negative dilute result, test result. The copy 1 of the CCF, and remember the custody and control form is a 5-ply form, right, under federal rules. Copy 1 goes where? To the laboratory. Copy 2 is the copy that is sent to whom? The medical review officer, the MRO. Copy 3, the collector retains in his or her records, just to make sure when you're chasing down, it may have to chase down a collector copy for some purpose, how long does the regulation require a collector to keep a custody and control form when he or she has done a DOT urine drug collection? Do you know? It's 30 days. Now many people keep it longer than that, many collectors, but I'll tell you with today's filing and storage and paper kind of stuff, collection sites that do any volume probably aren't keeping them much longer than that, just because they can't be put in a patient medical record. So it's a separate storage kind of requirement for a clinic, a busy clinic, or a busy hospital-based facility. Okay, and then copy 4 is whose copy? That's the employer's copy, and oftentimes copy 4 of the CCF is sent to the employer's third-party administrator who's responsible for administering, keeping the statistics and keeping all the records for the employer, and then of course copy 5 is the one that has been given by the donor when they have completed the specimen collection process. No regulatory requirement for how long the donor has to keep his or her copy, and my experience is that most of them don't have it 24 hours later. It's not a piece of paper that they keep in their wallet or hang on their wall waiting for their test result to come back. Okay, so the hard copy of the MRO copy of the CCF is required by the Department of Transportation and by the Department of Health and Human Services guidelines for any negative results. So you as an MRO staff member who can review and release and report negative test results and negative dilute test results cannot release that to the employer or to the third-party administrator until you have received and reviewed the MRO copy of the CCF. What if you can't get the MRO copy of the CCF? It hasn't come in the mail, it hasn't come to you via fax, it hasn't come to you via some type of scanning program through a fax server or whatever, and you've got a test result there that needs to be released to the employer. What option do you have if you do not have the MRO copy? Anybody know? You can use the collector's copy or the employer's copy of the form in place of the MRO copy. For federal testing and DOT testing, which is all done using the same federal custody and control form, the employer copy and the collector copy contain the same information that is on the MRO copy and is therefore needed, if you will, for the review and release of a negative result. The principal thing, of course, there is that it has that donor information section. Why can't you go to the laboratory to get their copy of the CCF to replace a lost or an unobtainable MRO copy? Right, because the laboratory copy, copy one, does not have the donor information on it. The only piece of donor information that's generally on the laboratory copy is the donor ID number, which can be an employer number, used to be almost always a social security number, but we increasingly are getting away from the use of social security numbers on these kind of documents for identity theft and privacy reasons. But there is no donor name, there's no donor signature, no donor certification statement, date of birth or contact information on the copy that goes to the laboratory. The Department of Transportation, in terms of when you as an MRO staff release and report a laboratory negative to an employer or a negative dilute, there is now a requirement that you have to include on that test result report or on that MRO copy of the CCF that you provide to the employer as a document of this is a reported negative test result, you have to include the date on which you got that MRO copy. And the reason that the DOT requires that is to make sure that you have not reported the negative result, right, before you obtained the MRO copy of the CCF. Memos of correction for correctable flaws must also be received prior to reporting out a negative or negative dilute. So if there was a correctable flaw, we'll go over those at various times in other segments of this course, you must have the memo of correction from, generally speaking it is from the collector before you can release the result. Now for laboratory non-negative test results, of course, and non-negative test results is the category that we take everything other than a negative and a negative dilute. So those are laboratory positive tests, adulterated specimens, substituted specimens, and invalid specimens. For federal tests, again, DOT, HHS, or NRC mandated, you must have in this case the laboratory's copy of the CCF and it must have the signature of a certifying scientist. And it must be recorded in addition to any electronic data feed that you get from the laboratory that gives you the test results. You must also have an image of this CCF, laboratory CCF, where the certifying scientist has signed it, has a printed name, and has checked the appropriate box for what the non-negative result is. Larger laboratory systems do provide that CCF copy one on a secure website where you as an MRO assistant or MRO staff member can access and download that image. It used to be that most of the laboratories that our MRO practice works with would fax those to us. You know, whenever they had signed out a non-negative result, increasingly we are finding that the larger laboratories are saying, we're not going to fax those to you. We're going to post them on our website and you have to go on, again, through a password protected system when you need a test result CCF and download it from there. Okay, and of course then on the non-negative test results you also need the MRO copy of the CCF and again it is extremely important here because that may be your only route for the medical review officer to initiate the contact for the donor interview. All right, what about MRO records in the MRO office? Let's take a look at this list here, which unfortunately hasn't shrunk a lot over the past several years, if anything it has increased. Certainly the paper documents and while all of us try, I think, in many ways to go as paperless as we can, that's happening in general in medical records and in office and other types of record keeping systems, but for federal drug testing requirements there is still, no matter how paperless you go, you have to be able to produce a printable image, okay, of those documents. You can store them electronically, but ultimately they can't just be in code or whatever. You have to be able to produce the image that is readable and can certainly be identified with all the core components, for example, by a DOT auditor. So what do you have to keep? You have to keep those copies of the CCF, laboratory copy for non-negatives and MRO copy or an equivalent copy, if you will, for all test results. You do have to be able to have a printed copy of the laboratory results. So if the laboratory result is provided to you, not just with the laboratory CCF, but an actual laboratory report via fax, via download, via some other type of electronic transmission, you have to be able to print that out into a readable form. Now if I go into, for example, the laboratory import engines, as we call them in our office, and were to push the button and say I want to look at the raw data from the laboratory on specimen number 1, 2, 5, 6, 4, I wouldn't have a clue what that says because that's all in code, if you will. But there has to be a mechanism that that code can be translated so I can press a print button and in fact it says for specimen 1, 2, 5, 6, 4, these were all of the drugs that were tested for, these five were negative, this one was positive, what the quantitative value was for that drug, which is now a mandatory part of DOT and other federal testing, the laboratory has to report to the MRO. Donor consent forms for release of information, again, in DOT testing these are relatively rare to be honest with you, but if there is a circumstance where you do have to obtain a consent form or release of information form to provide results or to provide drug testing information then you must retain a copy of that and in general if that is a consent or release of information for non-negative results you have to keep that for the life of your non-negative result file which is under DOT rules, what, how many years? For non-negative case file, MRO case file, you have to keep it how many years? Five years, that's correct. Requests for memos of correction, if you are the one that has initiated the request to a collection site or to a laboratory for a memo of correction you have to maintain that documentation with the record and again if it was for a non-negative result that should be part of that five year record, whether it's an electronic or a hard copy file that is kept. If you had a memorandum of correction for a negative result, let's say that the collector's signature was missing and you have a memo of correction received and then you could report that on out as negative. You only have to maintain that memo of correction for one year because that's your only requirement for hard copy record retention for an MRO reported negative result. As for information, reconfirmation often referred to as split specimen testing under DOT rules. You need to keep those kinds of documents again with the file. Remember reconfirmation testing is only going to occur or split specimen testing on verified positives, adulterated or substituted specimens. So again that information needs to be retained for that five-year period. You can't do a reconfirmation or a split specimen on a negative, who would want that? And you can't do it on an invalid. So therefore it falls under the five-year record retention. Subpoenas, employer requests for information for administrative hearings, for arbitrations, that kind of thing, those type of documentation should be retained. Prescriptions, medical records and pharmacy records that the MRO used in making a final test result determination, even if it was taking a laboratory positive and overturning it we often say to a negative, right? Because there is a legitimate medical explanation. The documentation of how the, what the physician used to arrive at the conclusion that this was a legitimate medical explanation must be kept with the file. And you know when we talk about this five and one year retention requirements in the MRO office I want to make sure that you understand that the Department of Transportation has essentially said that you have a five-year retention requirement on any non-negative result that has come in to the medical review officer. So if you had a positive for morphine and codeine that was overturned by the medical review officer to a negative because there was a script or because there was no clinical evidence of opiate abuse, etc. and the report to the employer was what? Negative. That doesn't mean that you only have to keep that file and documentation though for one year. So it doesn't go by the end result, is that making sense? It goes by the, what came in to the MRO's office in terms of non-negative laboratory reports for five years and negatives for one. Okay. Medical records, MRO records, excuse me, organization and storage. We organize or file your records using a system that works for your office environment and I can't really give you any specific guidance on that nor does the regulation address that. You may want to assign MRO case file numbers to each non-negative result. You may want to do it through some type of a verification log system. You may do it by specimen ID number. You may do it by employer. You may decide to do it by donor ID. Some people do it by month and date and keep their MRO case files chronologically by a date system. You do need to develop a system to cross-reference donor IDs, specimen IDs, and employer IDs and that oftentimes becomes really crazy because it is not, it's not beyond the realm of possibility that for some reason you need to look at other test results that have come in for a particular donor or individual over time. You may need to, for example, be able to identify the number of follow-up tests, okay, that have been done for a certain person in terms of, again, meeting the requirement. So there's a number of ways that you need to be able to cross-reference your record retention information, either, again, electronically or in hard copy. If your organization is also maintaining personnel or medical files, like this might apply to someone, for example, that is working in an employer's medical department, occupational health department, or wellness department, the drug test, the MRO record, so if you have a medical director who is also serving as the medical review officer for DOT test results, the DOT test results and the MROs records associated with that test should not be a part of that employee's health record, you know, the health record that's maintained by that. And the same thing would be true in a hospital setting or a clinic setting. You may have an individual who comes or to the MROs practice, private practice, who sees the physician in the context of being an internist or a general practitioner or whatever, and also, however, comes there for a drug test for an employer. And the collection is done there, and the physician is also the medical review officer for that company. Well, those drug test results and those MRO records should not be with that employee's medical record, says the DOT. Those should be separate kinds of things, and it's because to some extent they are certainly protected by different privacy laws. All the medical records are protected by HIPAA, believe it or not. Federal drug tests do not fall under HIPAA. Release of a record under HIPAA for insurance purposes cannot release DOT drug test results, so that's the main reason why they cannot be with the employee's medical file. All right, phone calls, information release, etc. You need to always document as an MRO staff member who is calling the date and time of the call and certainly a brief synopsis of the conversation. If the call is relevant to a case that is currently under review, meaning that the medical review officer has, it was a non-negative case, non-negative result from the laboratory, you need to include that phone call documentation in that MRO case file so that the MRO is aware of any and all communication that has been received concerning this particular test result. You need to be careful, of course, that you are speaking to an authorized DER on any call from an employer, and probably this next bullet here, this sub-bullet, is one of the most frustrating parts of any MRO assistant or staff member's daily work. There are DERs out there who absolutely think that they should be able to get the information immediately, that if they didn't get a negative, they had three people who went for a test on Tuesday, and on Wednesday they have two negatives while they're on the phone wanting to know what's the status of that third test. Well was it positive? Well is it going to the MRO? Well should I get the employee in here? And what do you have to say on a DOT test result? That unless the employer has a stand-down waiver. Now how many employers in the U.S. have successfully applied for and been granted a stand-down waiver by the DOT agencies? At last count there were a total of nine, nine in all of the U.S. So the likelihood that your employer is one of those nine and you don't know about it, it's pretty slim, right? So you need to tell them that you cannot tell them anything about that test. Well is it going to be positive? Is it going to be negative? Do you have it from the laboratory? And your answer is, I'm sorry, right, but I cannot give you any information about this result. It has not been released as a negative result, right? Now does that mean that it might not be a negative tomorrow? It may very well be because it may have been that it was a batch behind at the laboratory, right? It may, it could be any number of reasons. It wasn't, there was an error in the accessioning process at the lab with that particular specimen. So it's going to come out negative the same as the other two, but a day or two later. It may have had a positive screen and had to go for confirmation, but it's going to be negative on the confirmation. And it will be therefore negative to you and then on to the employer. So that's the reason that the Department of Transportation does not allow you to give any information to the DER until the test result has been officially released or reported by the Medical Review Officer Department. In the case of a negative, that you have the paperwork that is necessary. In the case of a non-negative, that the MRO has completed the verification process. How do you handle, as an MRO staff member, the calls from physicians, pharmacists, medical treatment providers? Again, you should always authenticate and validate who is calling to ensure that that caller is legitimate. In many instances, if that individual is returning a call from the Medical Review Officer, again according to this most recent ODAPSI information or opinion, you should pass that call on to the physician MRO for any dialogue between the pharmacist or prescribing physician, etc. And again, the bottom one, do not release any information to lawyers without either a signed release from the donor or the employer. Lawyer calls and says that I am representing Joe Jones and I need a litigation package, I need the MRO's notes, I need whatever, whatever. You have to indicate to that individual that you need a signed release from the employee. And it's not good enough that the lawyer sends you on his fancy letterhead, I am representing Joe Jones in reference to his drug test done on the 10th of October, right? Because you have no idea. Now how do you know you have a signed release that's from Joe Jones? Without Joe Jones' case, well you have Joe Jones' signature on file, don't you? And so that's the reason that you need a signed release in terms of, and again, it's the same thing if the employer, if somebody calls you and says I'm representing the employer in an arbitration hearing, well you don't take that at face value, right, from that employer. You would have to have, again, something in writing from the DER that says yes, so and so law firm or attorney is representing us in an arbitration hearing, unemployment hearing, please release to him the information to which we as an employer are entitled, okay? If you get a subpoena with regard to a DOT drug test result, the Office of Drug and Alcohol Policy and Compliance recommends, A, that you inform the DER that records related to a drug test that the employer has ordered, paid for, et cetera, has been received. And for a DOT test, the ODAPC strongly recommends that you or the medical review officer contact their office here in Washington, D.C. to get advice as to whether the subpoena can be quashed or whether you must comply. Remember a DOT test is really not your property or my property, it really is because it was done under a federal rule, it is the purview in terms of how it can be used and what can be done with it of the Department of Transportation. Very different from a non-regulated test, where they're all bets are off in terms of, you know, sometimes it depends on who paid for that test. If the employee himself or the applicant himself paid for that test, then there's at least some case law that would say that test result and everything about it, it goes to that person. If the employer paid for that test, then the employer really is the custodian of that information and has the right to what can be done and cannot be done with the information. But for DOT, that really is still controlled by the Department of Transportation. Okay, test result reporting, let's talk about this. We've kind of gone through in today's session thus far, those critical functions or tasks of the MRO office. So now we want to look at test result reporting. Non-negative test results that require an immediate action by the employer, by the DER, such as removal from duty or the immediate recollection of a specimen, should be communed verbally via telephone, etc., to the DER as soon as possible following the MRO verification determination. That's what the rule says, essentially. That's a paragraph of it, a paraphrase of it. So verbal reporting is really only encouraged or required, if you will, when it is a non-negative verified result that requires an immediate action, okay? Pre-employment, does that require an immediate action? Not really, right? Because the person isn't in a safety-sensitive function. But a positive result on a safety-sensitive employee that's a random post-accident, reasonable suspicion, etc., does require immediate reaction or immediate action by the employer in terms of removing that individual from duty. A test that has been canceled by the MRO, where the MRO's further determination is that the individual must undergo an immediate recollection of a specimen, oftentimes under direct observation, then again there is a sense of immediacy and urgency that the DOT rules put on that particular context. Now the DOT rule does specify that non-negative test results should always be reported on the same business day that the MRO verifies the test. Verbal notification, if it is done, should be followed up by a hard copy, meaning again some type of an electronic test result that the person can go on to a password-protected website or through fax or through fax server, password-protected email, PDF, etc. That must be done within two business days of the initial report to the DER or the TPA. Use of a voicemail, which is a fact of all of our lives today, it seems, in telephone communications today, to leave a message is generally not considered sufficient since you really have no way of knowing or ensuring that the DER will pick up that message in a timely fashion, particularly as it relates to the same business day that the verification has taken place. Again that's probably the reason why you need to make sure you have an alternate DER. I know all of us are supposed to put on our telephone messages when we're going to be gone for a day or when we're not going to be able to receive or take calls or listen to our messages, but I can tell you that I'm as guilty as the next person that oftentimes I don't do that or, the reverse is true, I will put a message on that I'm going to be out of the office Thursday and Friday and Monday, March 23rd through the 27th, but then I tend to leave that message on even when I'm back on Tuesday, Wednesday, Thursday or Friday, right? So a person calling me, for example, as a DER with a test result might get that message and have no idea whether I'm in fact in the office on Tuesday, because I still have that kind of out of office recording on my voicemail, but it's not necessarily accurate in terms of dates that I would be available. Okay, recording of phone calls, and by that I mean voice recording, such as you've all done this with various service providers or, for example, trying to obtain customer service from your bank or from the airline or from whomever, and the first thing that you will hear is, this phone call may be what, recorded for what, is it a quality control or quality assurance purposes, something, which is kind of a euphemism for, you know, who knows what, okay? They do that, they tell you that it may be recorded because why? They have to, by law. In general, if you record any incoming call or any call in which you are conversing with another party and you are going to record it, now again, unless you have a court order for a wiretap or, you know, those other kinds of things, but you have to let the person know that it's happening. Again, I can tell you over 20 years of being involved in MRO practice and talking with probably at this point literally thousands of MROs and their staff members, that in general the recording, the telephonic recording of phone calls with donors or with DERs as a way to, what, to prove or to validate what was said or that a notification was made is probably not a good idea. It's not worth the trouble that it involves. That in general, again, a good record keeping system of so and so call at such and such a time, you know, is as helpful down the road in court as playing back a recording. So in general, I don't find that the telephonic recording of either donor or DER conversations with MROs or with MRO staff members is something that has been found to be helpful or is a standard of practice. Okay, one of the trickiest things I think for MRO staff members over the past couple of years has been dealing with the scenario where there are more than one specimen collected and test result for a single collection event. And this happens most often when a donor goes to a collection site and provides a specimen and that first specimen is either temperature out of range, it smells like bleach or is cloudy or foamy, right, or the collector has observed some attempt to adulterate or manipulate the specimen, or the specimen color, for example, may be blue or green, which would indicate, again, that there has been an active attempt to manipulate the collection process by using water that was, that had a blueing agent in it to dilute or to add to a specimen volume. So in those instances, the DOT regulation requires that a collector inform the individual that this specimen is suspect because of its temperature range, because of its properties, etc., and that under DOT regulations, the individual must remain there and provide a second specimen under direct observation. And there's a variety of steps that go into that process. What the DOT rule also says, and collectors, I think, are beginning to get that into their heads, is that you must send the first specimen as well as the specimen that is collected under direct observation to the laboratory. So there are going to be two specimens, two custody and control forms, right? Two specimen ID numbers that go to the laboratory for testing. Now, that means that you, as the MRO staff member who's got all these results coming in from the laboratory, are going to get, have the potential to get multiple results for a given unemployment test or pre-employment test, okay, or for a given collection event. So here's the DOT rule on what you are to do as the MRO staff member in supporting the reporting, if you will, to the employer. If the specimen is, a single specimen, is verified positive for multiple drugs, such as, this is a specimen that is positive for marijuana and cocaine, right? You report it as positive and you list all the drugs that were verified. If the specimen is verified as adulterated or substituted and positive for drugs, you report as both a refusal to test specimen adulterated or refusal to test specimen substituted and you report that the specimen was also positive for THC, for example, or positive for marijuana. If an invalid result is reported in conjunction with a positive adulterated or substituted result for a single specimen, you do not report the invalid result. In the old days of this program, it was possible to get positive for cocaine, all right, but invalid because there was GCMS interference. What does that mean? It probably means that there was some type of an adulterant added to the specimen that was designed specifically to interfere with the mass spectrometry for marijuana, for example. And so the adulterant worked, okay, in terms of the laboratory not being able to confirm the marijuana, but the cocaine was still able to be confirmed by mass spectrometry. So that's a case where it would be positive for cocaine and invalid. Used to report both of those to the employer. That confused employers a lot. So now you don't report the invalid if you have a verified positive or a verified adulterated or substituted. Now let's say that the laboratory report was positive for codeine and also invalid. The medical review officer is going to have a legitimate explanation for the codeine, for example, as a valid script. Then you see it doesn't become just a straight negative, then the invalid, he would also explore why was it invalid? What else did the laboratory find? And so that result, in fact, then might be reported out, okay, as a canceled invalid with a requirement for a recollection. So it's really the invalid designation in combination with an adulterated or a substituted or a positive finding that you have to look at in terms of what are you actually going to report to the employer. Okay, so now let's go back to that circumstance where there was a testing event and there were two separate specimens. And again, this is the trickier thing, I believe, for the MRO staff member in terms of making sure that what it is that you report to an employer in this circumstance. If both tests were negative, both the suspect one, specimen number one, and the observed one, number two, you report the result as negative. Does the employer get two negative results reported? No. It is the second test that becomes the, quote, test of record, the observed test. And that one is reported as negative. In your system, if you have a system that has to have some type of deposition, if you will, for each test result that's been entered, the first test would be a no result. Is that making sense? Or no test. Or a do not report. It doesn't matter what you designate that. The DOT rule doesn't give you a specific category that you have to call that. Would you report the first one as a canceled test? No. Because see, a canceled test has to be reported by the employer on their MIS report, and there has to be an outcome or a follow-up to that canceled test. And if this was a pre-employment, you have a negative on the observed specimen, so the person is eligible to be hired. By confusing it with the canceled, which means that they aren't eligible to be hired under DOT rules, that makes that problematic. Okay, if either test was negative, whether it is the suspect specimen or the directly observed specimen, and the other was verified as one or more non-negatives, in other words, you have a negative on the suspect specimen, right? The observed specimen gives you a positive for marijuana, right? Then you are going to report only what? Only the positive for marijuana. And it could be the opposite. We've had these occur, although you kind of think, how could that be? But we've had the suspect specimen, okay, that is actually positive for an adulterant, or maybe it is substituted, and then the direct observation one is negative. Guess what? It is still the substituted or adulterated specimen that is the result for that collection. You say, well, how did that happen? Well, the person probably thought they were going to be positive, so they substituted their urine specimen, or they used an adulterant, when in fact, right, in the specimen collected 20 or 30 minutes later, it was actually negative. Well, too bad, you guessed wrong, right? Because the adulterated or substituted finding is still the test result that prevails. I have a question. Yes. What if it is negative, or whatever the case is, do you still send the employer to get a copy of each of the chain of custody? Her question is, if it is two negatives, and you're only going to report one, do you still send the employer two chain of custodies? Now, if you're talking about the employer copy of the CCF from the collection site, or that has come to you from the collection site as the MRO, the answer is yes, but you do not send them both MRO copies, if that's how you report the test result on the copy to the MRO section. You would only send them the MRO section with the stamped signature, or the MRO signature, for the one that counts, okay? You would not, so they would not get two MRO results, is that making sense? For a negative and a negative, or for a negative and a non-negative. Now, again, interestingly enough, if the first specimen was substituted, right, and the next one, and the observed specimen was positive for marijuana, in that case you are going to give them two separate MRO results, alright? First specimen substituted, creatinine less than, you know, two, and specific gravity less than 1.001, for example, and then a second result that is positive for marijuana. The reason for that, again, has to do with the statistics. What the employer has to do in that regard is no different. He has to remove that person from safety-sensitive functions. You know, he doesn't have to remove them twice, I mean, obviously he has to remove them once, but for statistical purposes, he must identify that he's had both a substituted specimen and he has had a positive specimen, okay? Alright, if the first specimen is verified as non-negative, report the result immediately and do not wait to receive the result of the second, because it doesn't matter, does it? Whatever the second one is, if it's negative, you're not going to report it, right? Because only the non-negative is going to count. If it is also non-negative, that second specimen, because it has drugs in it or it is also adulterated, then you're going to report that result too, alright? If the second specimen is reported as negative, remember, we do not report the result if both were verified as non-negative, report all of the non-negative results. Again, I can share with you from our experience on a day-to-day basis with this kind of thing, the problem is that oftentimes we don't know that a result we get in as a negative is specimen one of two. It's not marked on the form. It may not even be marked on the form anywhere we can read it, okay, that a direct observation was to follow or that a second specimen was done or that this was a suspect specimen. And so that comes in as a negative and it goes right through our system. We've error checked the custody and control form and we have the lab report as a negative and we report it right out to the employer. And then guess what? Two days later, okay, we get the result on the directly observed specimen. Same collection date, the time, same donor, same employer, and now that one is positive. So then what do we have to do if we have had that happen? We have to contact the DER and tell them that the negative that we reported to them is either a canceled test in that case or that it is a no result, that the result of this test will be coming to you, okay? We use a no result rather than a canceled. And so we say that that first specimen, that specimen ID number 1, 2, 3, 4, 5, 6 is a no result. And then we report the result on specimen 1, 2, 3, 5, 1, 2, 3, 4, 5, 7, which is the observed specimen. More questions about that? Another requirement that was placed unfortunately on the MRO and consequently ROLS 2 in many instances, the MRO staff member, is a requirement for reviewing return to duty follow-up direct observation collections. All DOT return to duty and follow-up tests beginning in 2010 must be direct observation collections. If you receive a negative result and the direct observation box is not checked, but the box that says this is a return to duty or a follow-up drug test and there is no note indicating that the collection was directly observed, you have some tasks to do before you can report that as a negative result to the employer. You must contact the collector to find out if the test was properly marked as return to duty and follow-up. In other words, was this a true return to duty and follow-up test? And then if so, why was it not done as a direct observation? Oh, it was, where you didn't mark the direct observation box or you didn't, you know, indicate that in the remarks section. So then you would obtain a memo of correction from the collector that yes, it was a follow-up DOT drug test and yes, it was directly observed by a person of the same gender as the donor, but I failed to mark the observed box on the form. Okay, so that is, and then you can report, once you get that memo of correction, you can report that out as a negative follow-up test, right? Let's say the opposite is true, that the person says yeah, it was a follow-up test and we didn't do direct observation because we didn't have a male observer here, we only had female collector and females in the office and it was a male donor. Then you do not report that negative result, okay? And you must then inform the DER, and there's no MRO interview or anything that's done in this process, you as the staff member must inform the DER that they have to send the person back for another follow-up test, and it has to be directly observed. Now here's the flip side though, let's say that that test result on a follow-up test comes back positive, but it's not marked that it was observed, and in fact you contact the person and they say no, we didn't observe them, do you throw out a positive result? No. The DOT is always going to again error, if you will, conservatively on the side of protecting public safety, so even though it wasn't directly observed, the individual still is in violation of DOT rules by having used a prohibited substance and therefore that positive or non-negative verified result will stand, okay? The control elements for the MRO office, you do need to have some standing operating procedures or at least work instructions for all of the MRO office processes, how you handle dilutes, how you handle two specimen events, how you handle the checking of the custody and control form, how you control for things like making sure that directly observed specimen collections are done when they're mandated by the rule. The audits and case reviews should be conducted on a selected sample of MRO office cases on a regular basis, whether that's ones that the MRO reviews to see that, make sure that U.S. staff members are doing them correctly and appropriately, or whether it's from someone outside of the MRO department or function that would be reviewing these for consistency and for full documentation, etc. The DOT requires that the physician medical review officer review 5% of all negatives that have been reviewed by the MRO staff. Now this 5% number is capped at 500 cases per quarter for large volume offices such as ours and probably Washington Occupational Health, for example, would also have a cap on the number of negative tests that the MRO physicians would have to personally review. The MRO review of those negatives that have been administratively reviewed and released and reported by MRO staff members must include every test where a memo of correction was needed. And I got to tell you, we in our office now get to that 500 cap per quarter because there just seem to be so many test results anymore that there's some type of a memo of correction. And so those do have to be reviewed each and every one by the medical review officer and that can count toward, again, the 5% of total reviews. Information of this quality control review by the MRO must be maintained separately and easily retrievable for DOT audit and inspection. And therefore, in your SOP that you may be required to produce upon a DOT agency audit, you should have the procedure for this administrative review. Do you pull cases at the end of each month? Do you pull a certain number each week? Do you set aside those that have memos of correction? And then the medical review officer does that review at the end of each week or month or at the end of each quarter. In other words, you should have that all written out by how this is done. And then there should be a way that the auditor, if he comes in and says, okay, the MRO does their administrative review or their personal review of cases at the end of every quarter. Let me see the cases that Dr. Chase or Dr. Hartenbaum or Dr. Ferguson, right, did for the first quarter of 2011. And so then you would have to pull all of those and be able to show that to the auditor that there was a way of telling that this release, this result was originally reviewed and released by Chris, but Dr. Chase, by initialing it and checking off on either a form or somewhere on the result, personally reviewed that result on March 28th. So there has to be an identifiable way. You can't just hope that, you know, an auditor is coming in that you just, you know, pull a bunch of cases and say these are the ones that he reviewed. There has to either be a log that shows that or some way of showing that the MRO has reviewed those cases. Okay, so that brings us to the end of that particular module that we just discussed, which was the MRO office and the operations.

Medical Review Office

MRO

Department of Transportation

DOT

regulated testing

test documentation

interpretation of results

reporting to employer

record keeping

physician MRO

negative test results

non-negative test results