Drug Screening in the ED: Medical Legal Concerns and Applicability
Drug Screening in the ED: Medical Legal Concerns and Applicability
By Daniel E. Brooks, MD, Banner Poison Center, Department of Medical Toxicology, Banner Good Samaritan Medical Center; Frank LoVecchio, DO, Banner Poison Center, Department of Medical Toxicology, Banner Good Samaritan Medical Center; and Preethy Kaibara, MD, LLB, Shufeldt Law Firm; Phoenix, Arizona.
Patients often present to the ED with unknown medical conditions that require an interview, physical exam, and laboratory testing to identify and treat any underlying etiologies. In many instances, the patient's history is limited (or unobtainable) and the examination may only be suggestive, both of which increase the importance of laboratory testing. One test commonly used in this scenario is a drug screen (i.e., "urine drug test" or simply "drug testing").1-4 However, this is sometimes a controversial decision. Some studies suggest that drug screens rarely influence clinical interventions or disposition,3,5-8 but other authors support the use of routine drug screening in the ED.2,4,8 In addition to this dispute, the test itself is associated with problems that restrict its ability to provide real-time, clinically-relevant information and is often misunderstood by the ordering physician.9 These limitations include issues related to sensitivity and specificity, qualitative versus quantitative results, sampling requirements, providers' interpretations of the results, and legal implications. This article will provide information assisting clinicians in the ED to avoid legal pitfalls while best utilizing drug screens.
Drug Screens Do Not Determine Levels, Only Presence of Drugs. Drug screens are biochemical assays that determine the presence of a drug class and should not be confused with more elaborate comprehensive drug tests. For example, gas chromatography with mass spectroscopy (GC-MS) is much more reliable (in terms of sensitivity and specificity) than a drug screen but is not available at most hospitals. GC-MS also typically is a "send out" test only used in specific scenarios. Drug screen assays are developed to achieve high sensitivity; however, this affects the specificity and may lead to positive results in patients with no clinical evidence of intoxication. Likewise, drugs with a large volume of distribution (high fat solubility) may be detected for long periods of time after the last dose was actually consumed, but may not be responsible for the patient's current symptoms. In this sense, the test's sensitivity may be too high for routine clinical purposes. For example, a patient may present to the ED with altered sensorium secondary to uremia, but have a positive THC screen from a single marijuana use three days prior. Irrelevant results may affect medical management as well as patient disposition, resulting in suboptimal care. One study found that 43.4% of patients presenting to a psychiatric ED (a specific subset of all ED patients) had a positive drug screen; no data concerning clinical intoxication or effect on disposition was offered.10
On the other hand, some drugs such as g-hydroxybutyrate (GHB) have very short detection periods. This mandates that samples be collected shortly after exposure and that drug-specific testing be ordered. The issue of drug screen specificity and "false-negative" results is more complicated. (See Table 1.) Drug screens, such as the commonly used EMIT II, typically test for the presence of a shared structural component (or metabolite) of a drug class. For example, when testing for benzodiazepines the assay uses an antibody that interacts with oxazepam, a shared intermediate metabolite of most, but not all, benzodiazepines. (See Figure 1.) This allows for false-negative results following some exposures. Many institutions have adapted point-of-care toxicology assays for drugs of abuse such as Triage Panel for Drugs of Abuse plus TCA that often are used at the bedside. These assays also are affected by similar sensitivity and specificity limitations.
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Drug screen results are qualitative (sometimes semi-qualitative), and are typically reported as positive or negative without including a concentration. Several substances commonly tested for in drug screens (such as ethanol, acetaminophen, and salicylate) require concentrations to make optimal treatment decisions. Although some institutions have implemented automatic "reflex testing" (i.e., positive screening results automatically trigger a quantitative test), physicians often have to order the second, quantitative serum test. This disconnect may lead to delays in results, treatment, or disposition.
Prior Medical Legal Cases
Patients presenting to the ED are typically approached without legal considerations unless information (e.g., "date-rape") suggests otherwise. Although it is beyond the scope of this article to cover all of the legal ramifications of an ED evaluation regarding a drug screen, some basic points are mentioned. Studies have shown a wide variation in the accuracy of patient self-reporting of substance use compared to subsequent drug screen results.11-15 It should be noted that neither documenting reported substance use nor actual drug screen results are sufficient to establish intoxication.
Breach of Confidentiality. In Ballensky v. Flattum-Riemers, a physician provided positive drug screen results from a driver involved in a motor vehicle crash to a policeman with the intent of getting the results to the deceased passenger's family.16 The court upheld that the patient could sue the physician for breach of confidentiality because there was no clinical basis for the disclosure. In discovery, the physician testified that the patient wasn't clinically intoxicated in the ED. This case demonstrates the importance of correlating clinical suspicion with the patient's presentation. Staff should focus on gathering objective evidence of drug effects and document clinical findings (e.g., slurred speech, nystagmus, ataxia, and somnolence) and functional variables (e.g., agitation or impaired insight). Performing re-examinations also is important, particularly at discharge, and it is best if these are documented by more than one source.
Although there is little litigation pertaining to drug screening in the ED, available case law highlights areas of potential liability. These areas include ordering drug screens, informed consent, and disclosure of results. As discussed previously, issues of chain of custody and validity of results are generally outside of physician control. As a result, litigation related to those areas generally focuses on the laboratory's liability rather than the ED's.17
Order Drug Screens for Clinical Purposes Only. Requests for drug screens for non-clinical purposes (e.g., by police) may confound clinical decision making. However, it should not be presumed that the patient will refuse because there may be repercussions. In many instances, individuals can be sanctioned for refusing testing as well as for positive test results. In Fergeson v. Charleston S.C., a hospital required physicians to test all pregnant mothers for cocaine, regardless of clinical presentation.18 The physicians were instructed to forward positive results to local law enforcement. Although the policy was instated benevolently (to reduce crack addicted babies), the Supreme Court held it to be unconstitutional.19 This case emphasizes that ordering tests without medical necessity is legally unfavorable.
Informed Consent and Drug Use in the Workplace. In terms of informed consent, many employers investigate whether drug use was involved in work place accidents. Such "post-event" testing may involve ED-based evaluations. Documentation of informed consent is essential in these cases as the patient may seek compensation for the outcome of unfavorable results. If the patient does not consent to testing, you should abide by this and document the informed refusal. However, do not refrain from advising safety precautions (driving or working restrictions, for example) if you feel they are clinically indicated. Most importantly, use a witnessed approach that avoids coercion.
In Sharp v. Cleveland Clinic, an on-duty nurse was suspected of drug intoxication.20 A consent for urine drug testing in the ED was obtained and she was informed that she could leave at any time but could not operate an automobile. She provided the sample after a police officer had chaperoned her to her car to obtain some items. She later sued the hospital for false imprisonment; her claim was denied because she had consented to testing and at no time was coerced to stay in the ED. For the ED provider, this case highlights the importance of chain of custody and following hospital policies.
Who Should be Privy to Results Once the Screen Has Been Ordered? Once the specimen is obtained, HIPAA and corresponding state privacy legislation affect who is entitled to the results. Legal requests for test results can be complicated because patient confidentiality is paramount. A clinician's default rule should be not to disclose the result without clear authorization from the patient. Related forms signed by the patient at a different time or letters from the employer should not be substituted for express written consent without review with hospital counsel. In Shioleno Industries Inc. v. Columbia Medical Center of Arlington Subsidiary LP, an employee was injured at work and his employer later faxed forms to the hospital requesting drug screen results.21 The hospital, however, did not share these results (which were positive) because the patient did not authorize it; the worker, therefore, was granted worker's compensation. The employer subsequently sued the hospital for increased worker's compensation liability premiums as a result of the hospital's non-disclosure, citing their employee handbook and other documents as evidence of implied consent. The Texas Court of Appeal decided in favor of the hospital, stating that workers must provide express release of information.
Similarly, police officers may request drug or alcohol testing. Without a valid warrant or voluntary patient consent, drug tests should be performed based on clinical judgment and the test results should not be shared with law enforcement. Generally, the State can obtain the result for criminal prosecution if the test was done in response to a medical necessity,22 though this does not entitle an officer to a copy of the result at the moment the test was done without a warrant or the patient's informed consent.23
Nevertheless, there may be situations when you feel test results should be reported for reasons concerning public safety. Although most states have legislation requiring medical information not to be disclosed without express patient authorization, there are many statutory exceptions to the rule. Such exceptions provide statutory immunity for a good faith disclosure by physicians. The risks of improper disclosure include: claims of breach of physician-patient privilege, invasion of privacy, breach of physician-patient confidentiality, violation of statute, and breach of fiduciary relationship between a physician and patient. The patient plaintiff in Ballensky, noted previously, sued the doctor for such a breach.16 The court agreed that the physician did not have statutory immunity for the claim and that the disclosure to police was not done with "reasonable cause to suspect an injury was inflicted in violation of any criminal law of the state," as was required by the North Dakota law at issue.16
In Shaddox v. Bertani, a dentist reported a patient who had repeatedly requested narcotics despite receiving no invasive treatment to that patient's employer, the San Francisco Police Department.24 The police officer sued the dentist for violation of the California Confidentiality of Medical Information Act. Here, the court found that the dentist's disclosure fit one of the exceptions in the Act and was, thus, immune from liability.
Determining whether a disclosure is in good faith can be complicated. Each state has different laws protecting confidentiality and different exceptions can be found in both civil and criminal statutes. Further, Federal laws also may apply. Clinicians should involve hospital counsel whenever possible to determine if there is statutory protection for disclosure. Examples of jobs for which reporting may be considered are positions involved with public safety, health, or security concerns, or those in federal and state departments of transportation when there is a concern for drug intoxication. For example, the FAA has well developed protocols for drug testing and investigational procedures.25
Pitfalls in ED Drug Testing
Mandated vs. Nonmandated Testing. Historically, drug testing (including alcohol) has been divided into two main categories: mandated and nonmandated tests. Mandated testing has its roots in Executive Order 12564, which in 1986 directed each federal agency to establish a program to test its employees who were in safety-sensitive positions for illicit drugs.26 Then, in April 1988, the National Institute on Drug Abuse (NIDA) guidelines were published.27
In 1989, the Department of Transportation (DOT) adopted the NIDA guidelines for its drug testing procedures as part of the government's "war on drugs" campaign. The adoption resulted in mandated testing for millions of employees within six different agencies. The DOT guidelines ensure that: 1) DOT procedures are followed for collection and analysis of the specimen as well as resultant reporting; 2) the five drugs tested for are marijuana, cocaine, amphetamines, opiates, and phencyclidine; 3) the types of testing include post-accident, pre-placement, reasonable cause, random, and periodic; and 4) NIDA-certified laboratories are used for specimen analysis.28 These guidelines highlight why ED drug screening alone is not valid for legal purposes. For example, two key elements are lacking: established "chain of custody" for sample collection and standards for techniques.
Required Samples/Specimens. Another issue related to drug screens involves everyone involved understanding and obtaining any required specimens as quickly as possible.9 The required sample (i.e., urine, blood, or both) depends on which assay your laboratory utilizes and what order sets your hospital has developed. For example, some hospitals utilize the BEDS (basic emergency department screen) order set that requires both urine and blood (serum) to run. It is important that ED staff (including whoever orders the tests) completely understand what is required to prevent delays. Additionally, this knowledge allows staff to take advantage of samples (i.e., urine) spontaneously offered; yet if missed may require an invasive procedure (bladder catheter).
Once the results are obtained, it is paramount to correlate lab data with available patient history and physical findings. ED staff should remember that a positive drug screen does not imply intoxication. Likewise, a negative drug screen result does not rule out an exposure. For example, if a person takes a large amount of temazepam (which is not metabolized to oxazepam) and presents to an ED with coma and respiratory failure, his/her drug screen will be reported as a (false) negative for benzodiazepines. Although these results should not change the patient's management, if the staff are unaware of the test's limitations, resources may be wasted in an effort to otherwise establish the diagnosis.
Summary
ED drug screens may offer important information for optimal patient care, including disposition. It is important that ED staff are educated about the following in terms of ordering a drug screen at a specific institution: what specific assay is used, what biological specimen(s) are required, the expected turn-around time, and the different available tests or "order sets." The laboratory personnel may be a useful resource to help educate the entire ED staff and we strongly suggest contacting your laboratory for further, site-specific discussion. Finally, use your regional poison center as a resource in terms of drug testing and result interpretation by calling 800-222-1222.
Current law suggests that great care must be taken to drug screen appropriately, document clinical findings, obtain informed consent (or refusal) and disclose results in confidence. Always document objectively and seek advice from counsel when necessary. In summary, drugs of abuse screens rarely change clinical management in the ED. Having a better understanding of these issues will assist practitioners in understanding limitations and how best to utilize results.
References
1. Kellermann AL, Fihn SD, LoGerfo JP, et al. Utilization and yield of drug screening in the emergency department. Am J Emerg Med 1988;6:14-20.
2. Fabbri A, Marchesini G, Morselli-Labate AM, et al. Comprehensive drug screening in decision making of patients attending the emergency department for suspected drug overdose. Emerg Med J 2003;20:25-28.
3. Olshaker JS, Browne B, Jerrard DA, et al. Medical clearance and screening of psychiatric patients in the emergency department. Acad Emerg Med 1997;4:124-128.
4. Skelton H, Dann LM, Ong RT, et al. Drug screening of patients who deliberately harm themselves admitted to the emergency department. Ther Drug Monit 1998;20:98-103.
5. Mahoney JD, Gross PL, Stern TA, et al. Quantitative serum toxic screening in the management of suspected drug overdose. Am J Emerg Med 1990;8:16-22.
6. Montague RE, Grace RF, Lewis JH, et al. Urine drug screens in overdose patients do not contribute to immediate clinical management. Ther Drug Monit 2001;23:47-50.
7. Brett AS. Implications of discordance between clinical impression and toxicology analysis in drug overdose. Arch Intern Med 1988;148:437-441.
8. Henneman PL, Mendoza E, Lewis RJ. Prospective evaluation of emergency department medical clearance. Ann Emerg Med 1994;24:672-677.
9. Durback LF, Scharman EJ, Brown BS. Emergency physicians perceptions of drug screens at their own hospitals. Vet Hum Toxicol 1998;40:234-237.
10. Shiller MJ, Shumway M, Batki SL. Patterns of substance use among patients in an urban psychiatric emergency service. Psychiatr Serv 2000;51:113-115.
11. Perrone J, De Roos F, Jayaraman S, et al. Drug screening versus history in detection of substance use in ED psychiatric patients. Am J Emerg Med 2001;19:49-51.
12. Chen WJ, Fang CC, Shyu RS, et al. Underreporting of illicit drug use by patients at emergency departments as revealed by two-tiered urinalysis. Addict Behav 2006;31:2304-2308.
13. Rockett IR, Putnam SL, Jia H, et al. Declared and undeclared substance use among emergency department patients: a population-based study. Addiction 2006;101:706-712.
14. Hser YI, Maglione M, Boyle K. Validity of self-report of drug use among STD patients, ER patients, and arrestees. Am J Drug Alcohol Abuse 1999;25:81-91.
15. Rouse BA. Epidemiology of illicit and abused drugs in the general population, emergency department drug-related episodes, and arrestees. Clin Chem 1996;42(8 Pt 2):1330-1336.
16. N.D., no. 2006 ND 127, 6/5/06.
17. See for discussion, Newman A, Feinman JM. Liability of a laboratory for negligent employment or pre-employment drug testing. Rutgers Law Journal Winter 1999:473-488.
18. 532 U.S. 67 (2001); 10 HLR 480, 3/22/01.
19. Fourth Amendment: Freedom from unreasonable search and seizure.
20. Ohio Ct. App., No 2007-T-1022, 4/11/08.
21. Sahioleno Industries, Inc. v. Columbia Medical Center of Arlington, No. 2-06-016-CV (2d. District, Tex. Ct. App. March 15, 2007.
22. Ex parte Radford, 557 So. 2d 1288, Ala., 1990 Feb 02/1990.
23. Com v. Shaw, 564 PA. 617, 770 A. 2d. 295, Pa. 2001, April 16, 2001.
24. Cal Ct. App., No. A097480, 7/30/03.
25. 14 C.F.R Part 121 Appx I, Part 121.
26. Reagan R: Executive Order 12564: Drug-free federal workplace. Federal Register 1986;51(September 27):32:889.
27. Department of Health and Human Services: Mandatory guidelines for federal workplace drug testing programs. Federal Register 1988;53(April 11):11:970.
28. U.S. Department of Transportation: Procedures for transportation workplace drug testing programs. Federal Register 1989;54(December 1):49:854.
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Some studies suggest that drug screens rarely influence clinical interventions or disposition, but other authors support the use of routine drug screening in the ED. In addition to this dispute, the test itself is associated with problems that restrict its ability to provide real-time, clinically-relevant information and is often misunderstood by the ordering physician.Subscribe Now for Access
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