Patient safety and modesty: A risk management approach Insight Article - June 11, 2020 Compliance Regulations Policies & Procedures Sign in to save Elizabeth Cameron MBA, JD Tom Ealey CPA Primum non nocere — first, do no harm. The Hippocratic Oath helps provide an ethical foundation for the practice of medicine, and patients expect that medical services will make them no worse and probably better. The patient-physician relationship The patient-physician relationship is direct; the patient has the rights and the physician has the responsibilities. Physicians, allied clinicians and staff are responsible for the safety and modesty of every patient during every encounter. Most medical providers and provider organizations are well attuned to these responsibilities, but 99% quality and compliance will never be good enough. Every physician, allied clinician and their provider organizations has potential financial, reputational and legal risks during every encounter with every patient. Every physician, clinician and provider organization has a duty to create safety and modesty policies for patients and to ensure compliance with those policies. Risk management Benjamin Franklin’s philosophy of “an ounce of prevention is worth a pound of cure” fits well with modern risk management practices. The first and primary rule of risk management is prevention. The incident that never occurs is the least costly. Addressing issues is financially expensive and time consuming and damages reputations. Prevention resides in sound management practices: proper policies and procedures, training for everyone, supervision and enforcement. A duty of care Healthcare services by necessity involve personal and intimate contact with patients. Providers receive extremely sensitive information from patients. Most of us understand this through our professional work and our own personal experiences. Providers and their employing organization have an ethical, legal and risk management duty to protect the privacy, modesty and physical security of patients, thereby protecting themselves and the organization. The practice also has an obligation to protect the providers from sexual misconduct and workplace violence.1 Physical safety All business and professional organizations have a duty to protect the physical safety of their customers and guests. In healthcare, it is the safety and comfort of patients and families, as well as vendors, salespeople, etc. This starts with the design of the office and the purchase of furniture and equipment. It encompasses such matters as clearing snow and ice and providing adequate handicapped parking. Renters in a multi-office building may have to depend on the landlord for the safety of outdoor space and common areas, and these matters should be discussed thoroughly when the lease is signed or renewed and monitored constantly. Compliance with the Americans with Disabilities Act 1990 (ADA) is a minimum standard, and the design and operation of the office should go well beyond the minimum. Medical facilities and practices must also comply with state disability acts. Some offices have special concerns. For example, an orthopedic office will have many patients with ambulation problems and many senior and elderly patients. A busy sports medicine practice should have exam and therapy tables designed for 300-pound athletes and powered exam tables that move up and down. All office personnel should be cognizant of the special needs of obese and morbidly obese patients, and staff should be trained in safety practices for those patients. Unnecessary treatments There have been media reports and government action claiming physicians, dentists and other clinicians are providing unnecessary treatments to patients as a way of generating more revenue. This is a very small minority of providers, but the resulting billing may be considered criminal. In the cases we follow there is a common thread: Others knew and did not speak up. Medical necessity is not an issue just for individual physicians, it is an issue for the group practice as well. Physician-executives and practice administrators must monitor clinical activity and outcomes for any possible signs of unnecessary treatment. Modesty Many of us know the queasy feeling one has when shuffling down the hospital hallway in a hospital gown. We tolerate the embarrassment because we want to help those who are trying to fix our medical problems. Medical exams, treatments, surgery, procedures and daily care often involve disrobing and very intimate viewing and touching. Clinicians have been trained to avoid lascivious thoughts and actions. However, this is not routine for patients, even when the activity is appropriate. Every exam and treatment performed should be thought through, procedures developed and communicated through training, and appropriate supplies provided and used. Some patients will assist the process by wearing appropriate clothing, others will not have that foresight. Appropriate gowns that fit every size of patient and draping materials should be available in the clinical environment (an orthopedic office would have different needs than an OB/GYN office). Curtains must be installed, and doors should be closed in all appropriate areas. Sexual harassment Sexual harassment law applies not only to employees but also to patients, family members, contractors, vendors and anyone else on the practice premises or interacting with practice members. Title VII of the Civil Rights Act (CRA) and resulting guidelines from the Equal Employment Opportunity Commission make clear the responsibilities of organizations for everyone working for or visiting your facilities.2 Organizations tied to educational institutions are also subject to CRA Title IX regulations. Protecting providers Title VII requires practices to protect providers and employees from sexual misconduct by patients, families, visitors and vendors and contractors. The Occupational Safety and Health Administration (OSHA) requires protections from workplace violence.3 Anticipating every scenario is impossible, but policies and practices to protect providers require forethought on possible problems. Dating patients Dating patients by anyone in the practice should be prohibited. Treating spouses and children has its own issues, so clear policies should be established before problems arise. Sexual assault For the past four years, sexual assault has been in the news, driven largely by assault on elite athletes. Much of this was triggered by a major newspaper reporting effort by the Atlanta Journal Constitution, followed by the Indianapolis Star and then a national media effort.4 To be very clear, only a very small minority of physicians and other clinicians are caught sexually assaulting patients. However, the resulting damages are immense. Chaperone policies Physicians and their teams — nurses, technicians, front desk personnel, surgery team members, hospital staffers, etc. — all have a duty to protect and ensure patient modesty and safety. Protecting modesty is often very difficult; many medical exams and treatments are by necessity intimate and invasive. The practice also has an obligation to protect providers and staff from patients. A physician or other professional should never view or touch a patient with any real or perceived improper motives. These issues cut through all provider-patient contact, regardless of gender identity or sexual orientation. Historically, a substantial number of the reported problems are male providers with female patients, followed by male providers abusing male patients. (There is no reliable national data source, but journalists have aided us with compilations of data.)5 Chaperone policies protect physicians from false accusations just as the chaperone protects the patient from physician misconduct. Some patients have gender preferences for providers, some for reasons of modesty and some for religious or cultural reasons. Every effort should be made to accommodate patients within the resources available. Those of us who have spent considerable time in physician offices know nurses and medical assistants run in and out of exam rooms as they are required to multitask throughout the day. This creates a chaperone policy problem and risky situations. The most frequent excuses we have heard for noncompliance — “the physician was in a hurry,” “the office was understaffed,” “the chaperone stuff is silly,” “patients aren’t concerned,” “this patient knows me,” “efficiency is important” — do not justify creating major risks for the patient or organization. There should be a chaperone — a spouse, parent, friend or clinical staffer — in the room every minute of the encounter. Chaperones are especially critical when intimate areas are exposed or examined. The gender of the patient and physician is irrelevant. If sensitive conversations must take place, the chaperone should be a nurse or medical assistant (MA), or the conversation can be moved to a consultation room or the physician’s office. Sound policies ensure compliance through training and help with floor supervision. Specific practices The most sensitive specialty is OB/GYN. This is not to diminish intimate exams and procedures for males, but OB/GYN is often more invasive and can require more visits and exams. Although there are no reliable national statistics for inappropriate conduct by physicians, reviewing available information makes it clear that the biggest issue is male physicians being inappropriate with female patients, followed by male physicians being inappropriate with male patients. These problems are not limited to gynecology; the Larry Nassar scandal (Michigan State University) involved sexual assault on girls and young women cloaked in sports medicine procedures. The Richard Strauss scandal (Ohio State University) and the Robert Anderson scandal (University of Michigan) involved males, most over the age of 18. Physicians should never be alone with any patient in any stage of undress. Physicians engaged in psychology and counseling practices must be sensitive to protecting patients as well as therapists. Much of this work is done one-on-one without a third-person chaperone. Therapists also may be concerned about protecting third parties from the patient. The proper professional associations offer advice and information on protecting patients and providers. Best practices should be adopted by all clinicians in this space.6 These standards for sensitive practices also apply to primary care, internal medicine and dermatology physicians who deal with clinical issues. Sports medicine and athletic training Much of sports medicine contact does not occur in the office environment, but rather in the locker room, on the field or in a training room. This group or public treatment provides some protection for athletes, but care should be taken to avoid one-on-one time with the athletes. Chaperone policies still apply. Informed consent No patient should ever be touched, examined or treated without informed consent, excluding emergencies.7 As with all safety procedures, proper practice protects the patient and the provider. In healthcare, “informed” is a term of art as much as a term of law — for example, how much does the patient need to know, how much can the patient understand, how much risk information is enough or is too much, what are the intellectual and cognitive abilities of the patient (and the family chaperone), how much must parents and guardians be told? Only patients with legal “capacity” (ability to make their own decisions) can give informed consent to medical treatment. This may require “proxy consent” by a power of attorney, spouse, guardian, etc. Generally, minors do not have capacity, but review the discussion below and consult your legal counsel when setting policy. Consent and treatment of minors For most minors, informed consent can only come from parents or guardians, emergent situations excepted. Obtaining proper consent before examining or treating a minor is critical, even more so if the exam involves any undressing or examination of intimate areas. Clear policies and rigid enforcement are essential during the treatment of minors. Providers should check state statutes, because there could be one or more special categories of minors. A process to verify age is essential, because some minors may look like adults (requesting a driver’s license or other ID at check-in is one approach). Some states have legal provisions for “emancipated minors” and/or “mature minors” and the practice should have very clear guidelines matching the specific state’s statutes and regulations. Practices dealing with reproductive health should be very clear on current state statutes, which tend to change often. Young people away from home Every year millions of minors attend summer youth camps, band camps and sports camps, some operated by youth organizations, others by colleges and universities. Typical registration policies require a physical exam and/or a health history, parental contact information and a broad consent focused on emergency services. Sponsoring organizations and providers — paid or volunteer — need to set and adhere to policies designed to protect the health, modesty and safety of the youth participants. An enforced chaperone rule is very critical to protecting minors and providers. When a practice allows or contracts clinicians to work with camps or to serve as team physicians, liability may follow. At the very least, malpractice insurance policies should be reviewed for coverage or lack of coverage. Clinicians should be required to obtain permission before volunteering. If a practice is formally involved (orthopedic groups providing team physicians, for example), there should be clear policies on the arrangement with the school or camp and regulations for treatment and follow up. Duty to supervise within the practice All employers have a duty to supervise employees; risk management requires us to always be aware of vicarious liability. Employers of clinicians have a major duty to supervise, due to the nature of the contact and the potential liability from malpractice or other negligence. This duty cannot be discharged sitting in an office waiting for complaints. Practice administrators and supervisors must be in clinical areas watching and observing patient flow and observant of protocols. The management term for this is “management by wandering around” or “MBWA,” but the wandering must be intentional and monitoring details of operational performance.8 Also, there are human resources advantages to supervisors being present and visible on a regular basis. Can physicians be supervised? Anyone who has worked extensively with physicians knows the profile: smart, highly educated, ambitious, and driven. This makes for a confident physician but does not make for someone who accepts supervision easily or at all. Some physicians will accept supervision from physician executives, some even chafe at that. Physicians tend toward compliance when there is a culture of compliance, such as when the staff is trained to protect patient safety and modesty. A culture of compliance is reinforced when other physicians and physician leaders insist on compliance with clinical safety and modesty procedures. With physicians who don’t work in an independent practice, compliance risks fall more heavily on the hospital, network, or university, necessitating a strong culture of compliance. Physicians cannot be allowed to override or ignore safety, privacy and modesty policies, and must not be permitted to pressure staff members to disregard policies and procedures. Supervising other providers All providers and clinical staff members who contact patients in clinical settings must be subject to the same policies, trained to follow those policies, supervised for compliance, and must have a safe whistleblower outlet. This includes physician assistants, nurse practitioners, therapists (physical, occupational, speech), therapy aides, athletic trainers and assistants, imaging technicians, nurses, nurse aides, office medical assistants, lab techs and anyone else who sees patients face-to-face, places patients in exam rooms, are involved with patients who are in any state of undress or staff who lay hands on patients in any way. Pandemic preparedness As this was written, the COVID-19 pandemic was spreading and causing major damage to the economy and great stress on the healthcare system. As a result, there will be a great deal of after-action analysis and rethinking of disaster preparedness. Although it is too early to determine, one obvious change will be to expand inventories, especially personal protective equipment (PPE). For an overwhelming majority of providers and staff there is nothing untoward about their work with patients; professionalism trumps curiosity or discomfort. But for a small minority of providers, rules are not a concern, and those providers create a safety and liability nightmare. Notes: OSHA. “Workplace Violence.” Available from: bit.ly/3cG8dDM. Munsey C. “Stay safe in practice.” Monitor on Psychology. April 208, p. 36. Available from: bit.ly/2yVAEiv. OSHA. Teegardin C, Robbins D. “An AJC national investigation: Still forgiven.” Atlanta Journal-Constitution. Available from: doctors.ajc.com. Ibid. Munsey. U.S. Equal Employment Opportunity Commission. “Policy Guidance Documents Related to Sexual Harassment.” Available from: bit.ly/2ZcYctW. Cameron E, Ealey T. “Primer on Informed Consent,” Compliance Today, March 2020, p. 46-50.