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1 Case-in-Point Investigating and Making a Case for Drug Diversion Donna H. Mooney, MBA, RN One of the biggest challenges facing boards of nursing (BONs) is ensuring that a fair disciplinary process occurs in a timely manner. Allegations of drug diversion raise the bar for a BON to act quickly and efficiently in determining the truth while ensuring the process is fair. This article presents a case of an uncooperative nurse suspected of diverting drugs and explores the legal, evidentiary, and reporting requirements needed for a BON to present a defensible drug diversion case. On September 4, 2012, the evening shift supervisor called the vice president of nursing to report that Jane Smith was found on duty not acting right. The supervisor reported that she went to the unit after being called by the charge nurse, and she observed Ms. Smith standing in front of the medication station staring. When the supervisor asked her what was going on, Ms. Smith gave an incomprehensible response. Ms. Smith was taken to the supervisor s office and asked to wait. The supervisor went back to the unit, ran a medication dispensing report and found that four oxycodone doses were removed for two of Ms. Smith s patients, but the doses were not documented in the patients records. The supervisor invoked the hospital s for cause drug testing policy and took Ms. Smith to the lab for a urine drug screen. Once there, Ms. Smith said she was unable to produce a specimen. She was given water to drink and asked to wait and try again. After 15 minutes, Ms. Smith said she was leaving. When the supervisor asked if she felt well, Ms. Smith said she did. Then, she went back to the unit, gathered her belongings, and left the facility. The vice president of nursing reported the incident to the board of nursing (BON). Proving drug diversion, legally defined as diverting drugs from their original purposes (U.S. Department of Justice, 2013), can be fairly easy. A simple audit of the patient records and the controlled substance log frequently provides the evidence to prove diversion. But what complicates these cases is that investigators may try to prove a medication diverter is also a substance abuser, rather than focusing on the more easily proven case of diversion. This case illustrates the value of pursuing the charge of drug diversion rather than substance abuser, particularly in the case of the uncooperative nurse, although some evidence of impairment (substance abuse) existed in this case, proving it would be difficult. Ms. Smith did not cooperate with the hospital drug screening policy, making it unlikely that she would cooperate with the BON s investigation. If the BON failed to make the case against Ms. Smith, she could practice elsewhere, raising a significant patient safety concern. However, the BON believed that a careful investigation could support a case of drug diversion; once proven, the nurse would likely be prevented from practicing and public safety would be protected. This article reviews the legal, evidentiary, and reporting requirements the BON applied to present a defensible drug diversion case. Making the Case The first step in conducting a defensible investigation is understanding the legal and regulatory requirements that the BON and possibly the courts will consider as conclusive evidence when deciding the case. One needs to consider which laws, rules, or regulations were violated. In a case of drug diversion, violations of the nurse practice act, Controlled Substances Act, and other policies or standards set by the profession will be evaluated. Nurse Practice Act To establish jurisdiction, the investigator must look to the nursing practice act (NPA) and decide whether proof of the allegations would constitute a violation. In this case, the North Carolina rules and NPA explicitly direct the nurse regarding what the BON can or will do in cases of misuse of drugs (North Carolina [NC] Nursing Practice Act, 2009). In G.S of the North Carolina NPA, the BON may initiate an investigation on receipt of information about any practice that might violate a provision of the NPA (NC Nursing Practice Act, 2009). On the subject of drug-related cases, provisions 3, 4, and 5 apply: (3) Has a mental or physical disability or used any drug to a degree that interferes with his or her fitness to practice (4) Engages in conduct that endangers the public health (5) Is unfit or incompetent to practice nursing by reason of deliberate acts, negligent acts or omissions regardless of whether actual injury to the patient is established (NC Nursing Practice Act, 2009). Possible rules violations include Regulation 21 NCAC (c ) (1) Drug or alcohol abuse 9

2 Table 1 Regulation and Scheduling of Controlled Substances The Controlled Substances Act of 1970 regulates the production and distribution of stimulants, narcotics, depressants, hallucinogens, and anabolic steroids. The Drug Enforcement Administration has categorized these drugs into five schedules, based on their abuse potential, medicinal value, and harmfulness. Schedule I drugs are the most hazardous; schedule V drugs, the least hazardous. Schedule I: High potential for abuse; no currently accepted medical use in the United States. Using the drug even under medical supervision is thought to be unsafe. Heroin, cocaine, methamphetamines, and usually, marijuana.* Schedule II: High potential for abuse; currently accepted medical use in the United States (or currently accepted medical use with severe restrictions). Abuse may lead to severe psychological or physical dependence. Morphine, Demerol, fentanyl, Oxycodone, Adderall, Ritalin, and Percocet. Schedule III: Lower abuse potential than schedule I and II drugs; currently accepted medical use in the United States. Abuse may lead to a moderate or low degree of physical dependence or high psychological dependence. Hydrocodone, Vicodin, Lortab, and Lorcet. Schedule IV: Lower abuse potential than schedule I, II, or III drugs; currently accepted medical use in the United States. Abuse may lead to limited physical dependence or psychological dependence. Alprazolam, diazepam, lorazepam, phentermine, Stadol, Halcion, and Ambien. Schedule V: Low abuse potential compared with drugs in other schedules; currently accepted medical use in the United States. Abuse may lead to limited physical dependence or to psychological dependence.some schedule V drugs may be available in limited quantities without a prescription (if state law permits). Codeine preparations. * In at least one state, North Carolina, marijuana is in a schedule by itself: Schedule VI. (2) Illegally obtaining, possessing, or distributing drugs or alcohol for personal or other use, or other violations of the Controlled Substances Act (21) Accepting responsibility for client care while impaired by alcohol or other pharmacological agents (North Carolina Administrative Code, n.d.). The Controlled Substances Act Although the Controlled Substances Act that defines controlled substances as substances (or drugs) having high potential for abuse may vary slightly from state to state, the intent of this law is the same. If one signs out a controlled substance, there must be documentation in the records to substantiate administration of the drug to the patient or appropriate records to account for any waste. (See Table 1). The Controlled Substance Act does not require the BON or the investigator to know or be able to prove what the person did with the drug (U.S. Department of Justice, 1970), although BONs spend a lot of time trying to answer this question. BONs need to show only that there is a lack of accountability for the drug as evidenced by the documentation or the lack of documentation. Discrepancies in Documentation The Controlled Substances Act is not specific about which documents should be used when signing out a controlled substance; rather, the law relies on facility policy to determine the appropriate documents for demonstrating compliance (U.S. Department of Justice, 1970). Any discrepancy in documentation compliance is a potential violation of the NPA, which calls for nurses to maintain an accurate record regarding the care they provide and, depending on the extent of the discrepancies, could also constitute a felony as defined in the Controlled Substances Act. What constitutes a discrepancy? A discrepancy would be any link in the chain (lack of documentation) that does not accurately account for the entire dose of the controlled substance signed out. Examples of discrepancies include, but may not be limited to: signing out a controlled substance for which there is no practitioner s order signing out a controlled substance for which there is a physician s order but failing to provide follow-up documentation to account for the drug signing out a controlled substance for which there is a physician s order but failing to account for a missing portion. These practice discrepancies are problematic and may cause suspicion but they are not actionable without more objective information. Although they allow a BON to proceed with charges, they may only address the issue of poor documentation. But BONs need to determine the underlying cause of the discrepancies to collect the evidence that meets the burden of proof. The burden of proof for an administrative action in North Carolina is clear and convincing evidence: the BON must show that it is substantially more probable the alleged acts are true, and the trier of fact must have a firm belief and strong conviction in the facts as presented. This is not the standard in all jurisdictions. Approximatley half of all jurisdictions continue to use the preponderance of the evidence standard. From a regulatory approach, an assessment of other practice-related markers may suggest or clarify the extent of the problem. Though there may be no concrete evidence that drug diversion has occurred, the following signs or behaviors can be objective evidence of increased narcotic retrieval or discrepancies in the records: Excessive sign outs of controlled substances Sign outs to a patient only when a specific nurse is on duty Lack of waste or excessive amounts of waste Excessive amounts of wastage 10 Journal of Nursing Regulation

3 Patients reporting they did not receive the medication signed out to them A nurse documenting more pain medication sign outs than other staff members document Documentation of administering pain medication when the pain assessment scale indicates no need for the medication A nurse always signing out the maximum dose of medication, though other staff members find lower doses effective The investigator also must know what the facility requires for accurate documentation. If facility policy states that documentation must occur on the medication record, in the dispensing system, and in the nurse/progress notes, failing to document in all three places is a practice discrepancy. What about signing out a drug at 0930 but not documenting it until 1030? Depending on facility policy and cultural norms, this may be a practice discrepancy. Most would say that an hour is too long to hold on to the drug, but does the facility have something in writing that disallows this practice? The more of these behaviors, the more likely a problem exists. Sloppy documentation and poor practice are not proof of diversion, but they go a long way in helping to meet the burden of proof to proceed with charges. Investigating the Case After receiving the report on Ms. Smith, the investigator began an inquiry. First, the investigator established jurisdiction to proceed with the investigation. If the allegation were true, jurisdiction would be established because it represented a violation of the NPA. The investigator called the vice president of nursing for verification of the information. Although the vice president submitted the information, the investigator also needed to talk to the supervisor who saw and interacted with Ms. Smith. What does the investigator need to know? Dates of employment. The investigator should determine if Ms. Smith is a long-term employee or a new hire. The answer will help determine if additional background information may need to be gathered from other sources. Current job status. After Ms. Smith left the facility, was she suspended? Was she terminated? Was she placed on probation? Was she sent to an employee assistance program? Normal work hours. If Ms. Smith typically works the night shift and is the only licensed person on the unit, these circumstances might explain why she has a large number of oxycodone sign outs. Type of unit. The type of unit could also explain why she is the high user of a certain drug. For example, one would expect to have a higher use of controlled substances on an orthopedic floor as compared to a pediatric floor. Previous issues. Has Ms. Smith been counseled or disciplined about discrepancies in her documentation of controlled substances? Description of behavior. Can the supervisor describe in behavioral terms what she meant by not acting right, such as slurred speech, staggering gait, illegible handwriting, and inability to focus and respond to simple questions? The investigator should obtain a copy of the following: the hospital policy for documentation of controlled substances; the policy for the use of the medication-dispensing system; the waste policy; the policy for obtaining for cause drug screens; a copy of the termination notice resulting from the failure to take the drug screen; the audit conducted by the facility with the corresponding dispensing system accountability (sign out) record; the corresponding patient medication administration record (MAR); and the corresponding progress note (to show the medication was documented to the patient). In this case, the investigator also interviewed the charge nurse and a coworker on the unit, but until that night, there had been no concerns about this nurse. Writing the Report Writing the report may be the most important step in the discipline process. A thorough investigation can be rendered useless if the investigator cannot document the findings in a report that is readable, objective, accurate, concise, and factual (Council on Licensure, Enforcement and Regulation, n.d.). In the first one or two paragraphs, the report should address the Five Ws (who, what, when, where, and why), so the reader is immediately focused on what is being alleged and what the investigator thinks has been proven. If the report is not readable and concise, it may be dismissed as not understandable. It needs to be objective, not filled with the investigator s opinion. Below are excerpts of the report from this investigation along with explanations on how and why the investigator presented certain information. On December 15, 2012, a complaint was received in the office of the board of nursing from ABC Medical Center in Anytown, NC, reporting Ms. Jane Smith was terminated after being found to have diverted controlled substances as evidenced by numerous discrepancies in her documentation and handling of controlled substances. On September 4, 2012, at approximately 10:30 p.m., the vice president of nursing received a call from the evening shift supervisor, reporting that she had been called to the orthopedic unit by the charge nurse to observe Ms. Smith. When the supervisor arrived on the unit, she observed Ms. Smith standing at the medication station appearing to stare at the screen. When later questioned by this investigator, the supervisor stated that Ms. Smith seemed to be dazed, and when the supervisor spoke to Ms. Smith, she was not able to respond. The introductory paragraph lets the reader know that the report focuses on discrepancies in the documentation of controlled substances, even though the initial concern may have been impairment on duty. The more specific behavioral information on Ms. Smith s condition, including her inability to respond, clarifies the original vague statement that Ms. Smith was not 11

4 acting right, which is too subjective for a BON to make a determination of the cause. Ms. Smith was taken to the supervisor s office and asked to wait. The supervisor went back to the unit, ran a medication-dispensing report, and noted that four oxycodone doses were removed for two of Ms. Smith s patients, but the doses were not documented in the patients records. The supervisor invoked the hospital s for cause drug testing policy and took Ms. Smith to the lab for a urine drug screen. Once there, the forms were filled out, but Ms. Smith stated that she was unable to produce a specimen. She was given water to drink and asked to wait and try again. The longer she sat, the more anxious she became. After another 15 minutes, Ms. Smith said she had enough and was leaving. The supervisor asked if she felt well; Ms. Smith said she felt fine. She went back to the unit, gathered her things, and left the facility. This paragraph addresses discrepancies in documentation that give the supervisor the ability to invoke the for cause drug testing policy. Facility Policy The facility policy supported the supervisor s request that Ms. Smith submit to a for cause urine drug screen. A chain of custody form was filled out, and the employee health nurse was contacted to ensure the policy was followed. At the direction of the employee health nurse, the supervisor had Ms. Smith fill out a form declaring any medication that she was currently taking and listing all food she had consumed in the last 36 hours. The policy required that Ms. Smith not be left alone between the time the specimen was requested and the time it was obtained. The policy also indicated that leaving the facility before the specimen was obtained would be grounds for termination. The policy also stated that if the subject was thought to be impaired, the hospital was to arrange for transportation to get the employee home. Policies about the steps to be taken when diversion is suspected can differ from hospital to hospital. It is important to identify the applicable hospital policies and ensure that the facility adhered to the policies during the course of their investigation. This will aid the BONs case in providing evidence that will be defensable should the case result in an administrative hearing. The investigator did not emphasize Ms. Smith s alleged impairment because the emphasis needed to be on the charge that could be proved diversion versus the charge that was difficult to prove impairment. Accountability Audit This investigator conducted an accountability audit of the sign outs of oxycodone by Ms. Smith between July 1, 2012, and August 31, 2012, and found she was the highest user on the unit. The next highest user signed out less than half as many doses. The audit revealed Ms. Smith was responsible for 135 transactions and had a 72% discrepancy rate: On 17 occasions, she signed out oxycodone without a physician s order. On 21 occasions, she signed out oxycodone without accounting for waste. On 59 occasions, she signed out oxycodone without documenting that the patient received the medication. Ms. Smith also failed to follow the facility policy by not having a witness for the waste of oxycodone, and after signing out oxycodone, she failed to appropriately document it in the MAR and the progress notes. This part of the report gets to the undisputable aspects of the case: the substantive documentation discrepancies with the lack of accountability. The 72% discrepancy rate speaks for itself and certainly takes away the argument for an oversight in charting. Employee History Ms. Smith was employed in the facility from May 15, 2012, until her termination. A review of her recent employment history showed that she was terminated from two other facilities in the previous year. When contacted for additional information about the terminations, each of the human resources directors would give only the dates of employment and state that Ms. Smith was in her probationary period. When asked if Ms. Smith would be eligible for rehire in a position that would require the handling of controlled substances, both responded, No. A check of Nursys did not reveal previous discipline actions against Ms. Smith. The employment history lets the reviewers know that there have been issues in the past. The history suggests a pattern and a practice of problems with handling controlled substances. Case Outcome The evidence found in this case supports by clear, convincing evidence that Ms. Smith failed to appropriately document controlled substances, a clear violation of the NPA and the Controlled Substances Act. By definition, this also proves diversion, but some BONs are not comfortable using this term unless the person admits to injection or ingestion or someone saw them use the drug. Despite the reports that Ms. Smith appeared impaired on duty, there was insufficient evidence to substantiate impairment. Because Ms. Smith refused to be interviewed and the staff was unable to meet with her to discuss possible resolution of the case, a letter of charges was issued charging her with the documentation discrepancies. She was offered the option of having her license suspended until she could have an evaluation by an addictionologist. If the addictionologist diagnosed chemical dependency, she would be required to go into the BON s alternative program. If she was not required to enter the alternative program, she would be offered a license with probationary conditions for 1 year. Ms. Smith did not accept delivery of the letter of charges, and a hearing was held. After hearing the evidence, the BON suspended Ms. Smith s license for 1 year, ordered an ethical/legal decision-making course with an emphasis on documentation, and ordered her to appear before the licensure committee to request reinstatement of her license. Before reinstatement, Ms. Smith will have to be evaluated by an addictionologist and provide 4 months of clean drug screens immediately preceding her appearance before the licensure committee. 12 Journal of Nursing Regulation

5 Conclusion This case was sound (meeting the clear and convincing evidentiary standard) because the investigator emphasized the elements of the case that were provable and legally required and did not attempt to overreach by suggesting charges for something that could not be proven impairment. The result was that Ms. Smith will be unable to practice nursing in the immediate future, thus protecting the public. References Council on Licensure, Enforcement and Regulation. (n.d.). NCIT report writing module. Retrieved from aspx?pageid= North Carolina Administrative Code. (n.d.). Title 21, Chapter 36. Retrieved from Title%2021%20-%20Occupational%20Licensing%20Boards%20 and%20commissions North Carolina Nursing Practice Act. (2009). Retrieved from U.S. Department of Justice, Office of Diversion Control. (2013). Code of Federal Regulations 21 Part Retrieved from U.S. Department of Justice, Office of Diversion Control. (1970). Controlled Substances Act. Retrieved from gov/21cfr/21usc/index.html Donna H. Mooney, MBA, RN, is Manager of Discipline Proceedings for the North Carolina Board of Nursing. She was a former inspector with the North Carolina Drug Commission assigned to the North Carolina State Bureau of Investigation, Diversion Investigations Unit. She is a senior instructor with the National Certified Investigator/Inspector Training program for the Council on Licensure, Enforcement and Regulation (CLEAR) in both the Basic and Advanced levels, and she teaches on the topic of drug diversion investigation. She has served on the Discipline Committee for the National Council of State Boards of Nursing and served two terms as president of CLEAR. 13

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