POCT 2 Legal, Regulatory, and Ethical Issues PDF

3 Legal, Regulatory, and Ethical Issues C H A P T E R O U TLINE Legal Issues, 35 Documentation of Perioperative Patient Care, 44 Liability, 36 Legal Aspects of Drugs and Medical Devices,...

3 Legal, Regulatory, and Ethical Issues C H A P T E R O U TLINE Legal Issues, 35 Documentation of Perioperative Patient Care, 44 Liability, 36 Legal Aspects of Drugs and Medical Devices, 47 The Joint Commission and Sentinel Events, 39 Ethical Issues, 48 Consent, 42 C H A P T E R O B JEC TIVES After studying this chapter, the learner will be able to: Define negligence as it applies to caregivers. Identify three potential events that could lead to litigation. Discuss informed consent. Describe the role of The Joint Commission in the promotion of Describe the importance of patient care documentation. patient safety. List several methods of documentation of patient care. K E Y T E R M S A ND DEFINITIONS Advance directive Document that indicates wishes concerning Near miss An event or situation that just by chance did not cause health care and usually designates someone to make decisions patient injury. A very close call. if the patient is unable to do so for self. Negligence Careless performance of duty. Autonomy Self-government or independence. Plaintiff Person who initiates a lawsuit. Causation Action directly or indirectly causing an injury. Proximate cause An act of commission or omission by one or Consent Voluntary, autonomous permission to proceed with an more persons that caused a consequence to another. agreed-on course of action. Root cause analysis The baseline reason for the occurrence of Damages Compensation awarded to make restitution for an injury failure in a process or system. or a wrong. Sentinel event An unexpected occurrence that involves physio- Defendant Person named as the object of a lawsuit. logic or psychologic injury or death. This occurrence signals the Deposition Statement given under oath that is a documentation need for appropriate reporting and documentation, immediate of fact used in a court of law. investigation, and response. Iatrogenic Injury or illness caused by professional intervention of a Systems approach A global attitude of improvement and safety health care provider. that encompasses involvement of individuals and the organi- Indicator A measured increment of performance, process, system, zation at all levels. Adverse events are attributed not only to or outcome. individuals but also failure of the interaction of the individual Liability Legally responsible for personal actions. and the organization. Malpractice Substandard delivery of care that results in harm. Tort Wrong committed by one person against another; civil action. Competent patient care is the best way to avoid a malpractice or Performing in a particular manner merely to avoid being sued is negligence claim. Unfortunately, even under the best of circum- not an ethical practice. stances, a patient may be injured and recover monetary damages as compensation. Understanding how a liability action starts and Legal Issues how it proceeds is important in the effort to avoid the many pitfalls that can lead to being named and successfully sued in a lawsuit. Inherent in professional practice is the duty to safeguard the safety Caregivers should consider that liability is not the only ratio- and rights of patients. The patient is at risk for harm during any nale behind competent care. The main focus should be the desired surgical procedure. These factors also may present health care outcome for the patient and the exemplary delivery of care. providers with ethical dilemmas complicated by legal issues. 35 36 SECTION 1 Fundamentals of Theory and Practice Respect for the patient’s autonomy and the patient’s right to make synonymous with malpractice in a tort action. The following fac- informed decisions about his or her own health care should be tors contributing to a successful lawsuit on behalf of the plaintiff considered and balanced by the professional obligations of benefi- have been called the “four Ds of malpractice”: cence (the duty to benefit) and nonmaleficence (not to harm). 1. Duty to deliver a standard of care directly proportional to the Any caregiver can be named in a lawsuit. Being named in a suit degree of specialty training received does not mean that you have been successfully sued and does not 2. Deviation from that duty by omission or commission always mean you are liable for anything. Attorneys frequently 3. Direct causation of a personal injury or damage because of name everyone involved with the patient in the suit as part of the deviation of duty fact-finding process for building the lawsuit. When in doubt 4. Damages to a patient or personal property caused by the about personal competency for a new or unfamiliar procedure or deviation from the standard of care piece of equipment, seek guidance from the clinical educator or Statutory laws (laws by legislation) and common laws (laws immediate supervisor. based on court decisions) differ from state to state. Courts differ Regardless of who is in charge of the team, each team member at times in their interpretation of laws. Any caregiver who is in is responsible for his or her own actions. When performing duties some way thought to be responsible for injury to a patient may be within the scope of practice and according to facility policy and sued. The nurse manager or clinical educator responsible for procedure, the risk for being successfully sued in a malpractice or assigning duties to this individual may be included in the suit negligence suit is very limited. Honest mistakes can result in pa- if delegation and supervision are in question. tient injury. If a suit is brought to court, a jury can evaluate a Caregivers, such as nurses, technologists, and technicians, are reasonable set of circumstances, facts, and testimony to render a considered employees of the health care facility. The facility is almost verdict in favor of the caregiver. The plaintiff does not always always named in the suit as ultimately responsible for hiring, moni- win. If the verdict is found in favor of the plaintiff, the damages toring credentials, evaluating, and disciplining their employees. awarded may be for compensatory award. Many states have set The court may rule that a learner or an experienced practitio- limits on the amount of money that can be awarded by the court. ner is liable for his or her own acts. A learner may be held respon- The quality of health care is assessed through the outcome of sible for independent actions in proportion to the amount and services rendered. If the outcome is unacceptable, patients tend to type of instruction received and judged by the standard of other take grievances to court. The severity of an injury usually deter- learners in training. An instructor can be named with the learner mines whether a claim of merit will arise, but other contributing as partially liable. factors include a breakdown of rapport between the patient and Medical care and professional liability have become institu- the health care team members and unrealistic expectations about tional problems. The primary cause of professional liability claims the outcome of care. is iatrogenic medical injury—an injury or other adverse outcome Causes for litigation lie in patients’ and their families’ belief sustained by a patient as a result of treatment. Many incidents in that physicians and/or health care organizations have not pro- the perioperative environment have been causes for a lawsuit. vided appropriate diagnosis, treatment, or results. Although the physician is professionally responsible for patient care, other pa- Liability Prevention for the Facility and the Team tient care personnel act as part of the health care team, carrying responsibility for their own actions. Medical and surgical sales Complex technologies, acuity of hospitalized patients’ conditions, personnel and suppliers of equipment and drugs also are indi- short-stay procedures, diverse roles of providers, inadequacy of rectly involved in treatment and may be held responsible for staffing numbers, and other factors present challenges in manag- product liability. ing risks for liability. Many surgeons restrict their practices to avoid patients who have complex diseases or who are at high risk Liability for uncertain outcomes. Others practice defensive medicine, or- dering tests principally to protect themselves against possible liti- To be liable is to be legally bound and responsible for personal gation. Because lawyers have become increasingly sophisticated in actions that adversely affect another person. Every patient care representing injured patients, all health care providers need to provider should always perform duties in accordance with stan- take measures to protect themselves from litigation. A preventive dards and practice guidelines established by federal statutes, state strategy includes the following: practice acts, professional organizations, and regulatory agencies Become active within the professional organizations associated and those that are common practice throughout the community. with setting the standards for practice. Most organizations pro- Deviation from these standards and practices that cause injury to vide up-to-date education and resources for improvement of a patient can result in liability for negligence or malpractice. For practice. Have a voice in shaping the future of the profession. this type of civil suit to be successful for the plaintiff, he or she has Remain current with continuing education. Become certified, to prove that negligent care or malpractice caused the injury. and maintain the credential. Negligence is the failure to use the care or skills that any care- Establish positive rapport with patients. Patients are less likely giver in the same or a similar situation would be expected to use. to sue if they perceive that they were treated with respect, dig- These acts of omission or commission that cause damage to a nity, and sincere concern. Patients have the right to accurate patient may give rise to tort action, which is a civil lawsuit. information and good communication. Malpractice is any professional misconduct, unreasonable lack Comply with the legal statutes of the state and standards of of skill or judgment, or illegal or immoral conduct. Malpractice accrediting agencies, professional associations, and the health and negligence claims usually are settled in a civil court; however, care facility policies. depending on the severity of the injury and the extent of the Adhere to the policies and procedures of the facility. Seek a misconduct, they may be taken to criminal court. From the legal position on the policy and procedure committee to have a say point of view of damages or fault, professional negligence is often in the formation and revision of facility practices.  CHAPTER 3 Legal, Regulatory, and Ethical Issues 37 Document assessments, interventions, and evaluations of pa- rule, the surgeon is liable for acts of team members only when he tient care outcomes. Each patient care activity is an indicator or she has the right to control and supervise the way in which a of competent care and should be documented. Leave a paper perioperative caregiver performs the specific task. A good example trail that is easy to follow for the reconstruction of the event in of this is counting sponges, sharps, and instruments. The facility, question. not the surgeon, establishes the mechanism by which the employee Prevent injuries by adhering to policies and procedures. Short- team accounts for items used during a procedure. The surgeon does cuts can be hazardous to the patient and team members. share some liability if he or she prohibits or prevents the team from If an injury occurs, control further injury or damage by report- accomplishing this task. If this is the case, the circulating nurse ing problems and taking corrective action immediately. should clearly document the surgeon’s refusal to permit counting in Maintain good communications with other team members. the medical record and report to the immediate supervisor. In addition to these strategies, the facility as the employer and the caregiver as the employee should take steps to avoid liabil- Independent Contractor ity. The facility protects the patient, its personnel, and itself by maintaining safe and well-defined policies and procedures The employer may be held responsible for employees under the based on national standards and recommended practices. master–servant rule. However, the current trend is to hold an in- dividual responsible for his or her own acts under the principle of Liability Insurance the independent contractor. For example, a private scrub person, biomedical technologist, or first assistant may contract with sev- Formerly it was thought that patients did not sue nurses and other eral surgeons to provide services on a fee-for-service basis. These patient care providers because they had no large assets. Unfortu- individuals are not directly employed by the facility but are usu- nately, this is no longer true. Increased autonomy increases the ally credentialed and given permission to work with the surgeon risk for liability. Perioperative nurses make independent nursing by the medical staff department. Some questions may arise con- decisions based on their assessments, and they can perform and/ cerning the level of responsibility of the facility for credentialing or delegate certain patient care interventions without a physician’s someone who is accused of substandard practice. The facility will order. No matter how careful the caregiver is, mistakes can hap- be named in the suit initially but may be dropped at a later date. pen. An unintentional wrong may cause injury to a patient. A detailed contract explaining all responsibilities and duties Most facilities carry insurance that covers incidents that result should be written and signed by all contracting personnel. in harm to a patient when policies and procedures are followed; The Joint Commission (TJC) determined that the facility that however, they may not cover the employee who fails to follow the permits independent contractors, such as private first assistants, established protocol. In some instances the facility’s insurance interns, residents, or other privately engaged personnel, is respon- may not adequately cover all of the expenses associated with a sible for specific standards associated with accountability. Current lawsuit, such as a private attorney, time in deposition, and lost standards are as follows: wages during suspensions and trial. The contractor must be appropriately credentialed for the role. The caregiver who accidentally caused the injury may be The contractor must be competent. named in the suit as an individual or as a codefendant. Carrying The contractor must be providing care under the direct super- personal liability insurance protects against a possible discrepancy vision of a licensed practitioner. with the facility’s insurance coverage and provides the employee The contractor may perform duties only within the scope of with the opportunity for representation by a personal attorney. his or her intended role. A professional liability policy can be individualized to meet the The contractor must adhere to the policies and procedures of practice of the insured. The policy costs are tax deductible, and the facility. the protection of personal assets and wages may well be worth the The contractor must be oriented to the facility’s emergency price of the coverage. Professional associations recommend indi- evacuation procedures. vidual professional liability insurance and frequently offer dis- The contractor must be current in immunizations and health counts to members. screenings. The contractor must display appropriate identification at all times. Borrowed Servant Rule The contractor must comply with all background checks, pos- In the past the surgeon was considered the captain of the ship in sibly including fingerprinting and drug testing. the perioperative environment and was liable for the negligent acts of servants. In the early 1940s and 1950s, courts held that Doctrine of the Reasonable Man this doctrine, based on the master–borrowed servant relationship, was applicable by the mere presence of the surgeon. Once having A patient has the right to expect that all patient care personnel entered the operating room (OR), the surgeon was considered to will use knowledge, skill, and judgment in performing duties that have complete control over other team members. But courts now meet standards exercised by other reasonably prudent profession- recognize that the surgeon does not have complete control over als involved in similar circumstances. the acts of the perioperative patient care team at all times. Whenever a mishap occurs in patient care, the cause of the Each member of the team has significant performance auton- event is compared with local and national standards of care. Ex- omy. The surgeon usually is not held responsible when a periopera- perts are consulted by attorneys, and the mishap is studied. The tive caregiver fails to carry out a routine procedure as expected. results should show whether the same event performed by some- Courts have decided that certain procedures do not need to be one else of the same or similar education and role would have had personally performed by the surgeon, such as counts or mixing the same result under the same or similar circumstances. This is medications on the sterile field. According to the borrowed servant how the courts determine the reasonableness of a caregiver’s 38 SECTION 1 Fundamentals of Theory and Practice actions. An example of this might be how drugs are administered. Maintaining a competent staff of physicians and other caregivers The average nurse in average circumstances would check and re- Revoking practice privileges of a physician and other caregivers check to be sure the right patient gets the right drug. A careless when the administrators know or should have known that the nurse might omit checking the patient’s identification and admin- individual is incompetent or impaired ister the wrong drug. This would be considered unreasonable and Corporate negligence includes the use of personnel who are would be a source of liability. inadequately trained for the position they hold. The Alabama Supreme Court found HealthTrust, Inc. liable for permitting a Doctrine of Res Ipsa Loquitur surgical technologist to perform in the role of first assistant at Crestwood Hospital in 1997 (Cantrell v. Crestwood). The surgical Translated from Latin, res ipsa loquitur means “the thing speaks technologist was holding a retractor during an open hip proce- for itself.” Under this doctrine, the courts allow the patient’s in- dure on a pediatric patient and permanently injured the sciatic jury to stand as inference of negligence. The defendant has to nerve. Her leg is disfigured, and she has undergone multiple failed prove that he or she did not act negligently. Before this doctrine surgeries to restore function. The surgeon was not found liable for can be applied, three conditions must exist: the acts of the facility’s employee. 1. The type of injury would not ordinarily occur without a neg- ligent act. 2. The injury was caused by the conduct or instrumentality within Extension Doctrine the exclusive control of the person or persons being sued. If the surgeon goes beyond the limits to which the patient con- 3. The injured person could not have contributed to negligence sented, liability for assault and battery may be charged. This or voluntarily assumed risk. doctrine implies that the patient’s explicit consent for a surgical This doctrine applies to injuries sustained by the patient while procedure serves as an implicit consent for any or all procedures in the perioperative environment, such as a retained foreign object deemed necessary to cope with unpredictable situations that jeop- (e.g., sponge, towel, needle, or other instrument/item), a fall, or a ardize the patient’s health. By medical necessity and sound judg- burn. The defendant must prove that a breach did not occur and ment, the surgeon may perform a different or an additional surgi- that he or she was not negligent. cal procedure when unexpected conditions are encountered during the course of an authorized surgical procedure (e.g., find- Doctrine of Respondeat Superior ing an abscess near the target organ or finding a tumor extended into adjacent structures). An employer may be liable for an employee’s negligent conduct The surgeon may extend the surgical procedure to correct or under the respondeat superior master–servant employment rela- remove any abnormal or pathologic condition under the exten- tionship. This implies that the master will answer for the acts of a sion doctrine. The court will determine whether the patient con- servant. If a patient is injured as a result of an employee’s negligent sented to a specific procedure or generally to surgical treatment of act within the scope of that employment, the employer is respon- a health problem. The surgeon may not routinely remove the ap- sible to the injured patient. The patient may name both the facil- pendix or gallbladder during a tubal ligation. ity and the employee in a civil suit, but the employee may be dropped from the suit if he or she was following facility policy and Assault and Battery procedure and acting within the appropriate scope of practice. A facility may have outdated practices or unsafe procedures. In legal terms, assault is an unlawful threat to harm another One example might be the labeling of drugs on the sterile field. physically. Battery is the carrying out of bodily harm, as by touch- Instead of requiring the name and dose of the drug to be written ing without authorization or consent. Lack of informed consent on the sterile container and the syringe, the facility may permit to perform a procedure is an important aspect of an assault-and- the scrub person to place the cap of the syringe into the medicine battery charge. Informed consent must be obtained by the physi- cup containing local anesthetic to signify the contents of both the cian and consent to perform a procedure must be given volun- syringe and cup. This is a practice that was in effect in some fa- tarily with full understanding of implications by the patient. The cilities up to a few years ago. It is clearly an unsafe practice to re- purposes of a written, signed, and witnessed consent are to protect quire a scrub person to manage drugs on the sterile field in this the surgeon, anesthesia provider, perioperative team members, manner. The facility would be found liable for this action if it and facility from claims of unauthorized procedures and to pro- required the employee to perform at this unacceptable level. tect the patient from unsanctioned procedures. Consents are dis- cussed in detail later in this chapter. Doctrine of Corporate Negligence Invasion of Privacy Under the corporate negligence doctrine, the facility may be liable not for the negligence of employees but for its own negligence in The patient’s right to privacy exists by statutory or common law. failing to ensure that an acceptable level of care is provided. The The patient’s chart, medical record, DVD, videotapes, x-rays, and facility has a duty to provide services and is responsible for the photographs are considered confidential information for use by following: physicians and other health care personnel directly concerned Screening and verifying qualifications of all staff members, with that patient’s care. The patient should give written consent including medical staff, according to standards established by for videotaping or photographing his or her surgical procedure for TJC medical education or research. The patient has the right to refuse Monitoring and reviewing performance and competency of photographic consent. staff members through established personnel appraisal and The patient has the right to expect that all communications peer review procedures and records pertaining to individualized care will be treated as  CHAPTER 3 Legal, Regulatory, and Ethical Issues 39 confidential and will not be misused. This includes the right to cardiac arrest. The only team members on hand were the anesthe- privacy during interview, examination, and treatment. The sur- sia provider and the surgical technologist. At the trial, the circulat- gery schedule bearing the names of the patients should not be ing nurse admitted to knowing that it was wrong to leave the posted in a location where the public or other patients can read it. patient because of his condition but left because of the surgeon’s Some patients, such as celebrities, may request to be admitted insistence. The expert witness testified that the circulating nurse with an alias. Care is taken when identifying these patients so they should not have been ordered away from the patient to work in will not be confused with other patients and receive the wrong another room. The court decided that if adequate help for resus- procedure. Community hospitals may be admitting people from citation had been available in the OR during the patient’s crisis he the surrounding neighborhood. The caregiver may be in a posi- would not have suffered permanent brain damage, which oc- tion to learn private information about a neighbor. Maintaining curred because of this breach of duty. According to the court, the the confidentiality of patient information is imperative. Every circulating nurse had a duty to remain with the patient. health care worker has a moral obligation to hold in confidence If an event necessitates leaving a patient, it is important to any personal or family affairs learned from patients. Many facili- transfer care to another caregiver of equal status and function. In ties have implemented confidentiality agreements with all health uncontrollable circumstances, the perioperative manager should care personnel on the premises. Health care personnel must sign be consulted immediately. The patient must not be left unat- and date the agreement and understand that it is a legal binding tended. No one, not even a physician, may release a caregiver document. Violations can lead to punishment or termination of from a responsibility to a patient. A child or disoriented patient employment. Schools for surgical personnel require students to left alone or unguarded in a holding area, for example, may sus- sign confidentiality agreements before going to a clinical site. tain injury by an electric shock from a nearby outlet or by some other hazard within reach. The circulating nurse may be consid- Health Insurance Portability and Accountability ered negligent by reason of abandonment for failure to monitor a patient in the OR. The circulating nurse should be in attendance Act during induction of and emergence from anesthesia and through- The Health Insurance Portability and Accountability Act (HIPAA) out the surgical procedure to assist as needed. was originally published in the Federal Register in 2003 and was updated in 2009 and 2013. This act provides for confidentiality The Joint Commission and Sentinel Events of health data involved in research or transmitted and stored by electronic or any other means. The release or disclosure of this Professional accountability requires professionals to monitor per- protected health information (PHI) requires patient authoriza- formance as it applies to patient outcomes. The identification of tion. HIPAA covers far more than PHI—it covers fingerprints, an undesired outcome may be the result of direct or indirect ac- voice prints, and photographic images. Specific information can tions of the caregiver. Such an outcome is referred to as a sentinel be found at www.hhs.gov/hipaa. event—an unexpected event that involves a risk for or the occur- In 2009, HIPAA added the Health Information Technology rence of death or serious physical or psychologic injury. Serious for Economic and Clinical Health Act (HITECH). With in- injury specifically includes loss of limb or function. The term creased electronic health record (EHR) sharing of medical infor- sentinel was selected to represent the concept because the serious- mation between health care providers and facilities, security and ness of the event requires immediate investigation and response. privacy measures needed strengthening and are enforced through These events have a significant effect on patient outcomes; they the HITECH Act. The Omnibus Act of 2013 added four new should be evaluated for root cause and a plan to prevent its occur- additional rules to HIPAA that strengthened privacy laws to pro- rence should be prepared. tect health information from unauthorized use or sale. When a victim of crime or a perpetrator is in a health care fa- Root Cause Analysis cility, both have the right to privacy. Caregivers may not speak to news media or any other person concerning either individual. If a TJC developed and approved a list of sentinel events that should crime is discovered by a caregiver, the information must be re- be voluntarily reported and other events that need not be reported ported to an appropriate supervisor. At no time is a caregiver to (Box 3.1). The TJC publication Framework for Root Cause Analysis make a promise of secrecy to a suspected perpetrator. and Corrective Actions has been made available to institutions as a The use of social media, such as Twitter, Facebook, and Insta- guideline for investigating the causes of sentinel events. The ob- gram to discuss patient information is a violation of patient con- jective is to improve the system that has permitted the error to fidentiality.1 Accessing patient records without authorization is occur. The guidelines include a fill-in-the-blank questionnaire to grounds for dismissal from employment. Both of these activities help track the cause of the event. are violations of HIPAA and are punishable by law. The guidelines suggested by TJC allow each facility flexibility in determining the root causes for events specific to the environ- Abandonment ment. Using flowcharts, the facility can identify one or more of these root causes in identification of the problem or proximate Abandonment consists of leaving the patient for any reason when cause of the error. Each facility is encouraged but not required to the patient’s condition is contingent on the presence of the care- report sentinel events to TJC. Other sources, such as the patient, giver. If the caregiver leaves the room knowing there is a potential a family member, or the media, may generate a report and can need for care during his or her absence, even under the order of a find the forms on-line on TJC’s website. If TJC becomes aware of physician, the caregiver is liable for his or her own actions. an event, the facility is required to perform a root cause analysis In Czubinsky v. Doctor’s Hospital, the surgeon ordered the cir- and action plan or other approved protocol within 45 days of the culating nurse to leave the room to help him start another proce- occurrence. A TJC glossary of sentinel event terminology is avail- dure. During the circulating nurse’s absence, the patient had a able at www.jointcommission.org. 40 SECTION 1 Fundamentals of Theory and Practice BOX 3.1 Reportable and Nonreportable Sentinel In 2004, Minnesota was the first state to adopt the adverse Events Identified by The Joint Commission events list as mandatory to report. In the first year of mandatory reporting, surgical adverse events were the highest reported of all the Reportable categories by early 2006. Other states have followed by implement- Any event that results in the loss of life or limb (e.g., death, paralysis, ing reporting systems and including additional categories of adverse coma) associated with a medication error events that are mandatory to report. For additional information Suicide of a patient within 72 hours of being in an around-the-clock care setting about the NQF adverse event list, go to www.qualityforum.org. Elopement or unauthorized departure of an individual from an around-the-clock care facility that results in suicide or homicide or permanent loss of function Abduction from a care facility National Patient Safety Goals Rape Discharge of an infant to the wrong family Universal Protocol is incorporated into the National Patient Safety Hemolytic transfusion reaction involving the administration of blood or Goals (NPSGs) implemented in July 2010 by TJC (Fig. 3.1). The blood products having major blood group incompatibilities up-dated TJC accreditation statements incorporate NPSGs’ lan- Surgery on the wrong patient or the wrong body part guage to prevent wrong patient, wrong site, and wrong surgery Intrapartum maternal death related to the birth process events as part of Universal Protocol. The complete list of 2019 A perinatal death unrelated to a congenital condition in an infant weighing NPSGs can be viewed at www.jointcommission.org. more than 2500 g Universal Protocol adherence is expected wherever patient care Assault, homicide, or other crime resulting in patient death or a major is provided. Examples of accredited facilities accountable for permanent loss of function meeting the NPSGs include the following: A fall that results in death or major permanent loss of function as a direct Ambulatory health care facilities result of the injuries sustained Hemolytic transfusion reaction involving incompatible blood Critical access hospitals A retained foreign object from surgery Hospital systems Office-based surgeries Nonreportable Patient safety is a serious concern when the patient’s protective Any near miss reflexes and cognition are impaired by preoperative medications Full return of limb or bodily function by discharge or within 2 weeks of the and/or anesthetics. The focus of the applicable patient safety goals initial loss of function includes but is not limited to the following points: Medication errors that do not result in death or the permanent loss of function Adequate patient identification Any sentinel event that has not affected the recipient of care Accurate marking for surgical procedures A death or injury that follows discharge against medical advice (AMA) Eliminating medication errors Unsuccessful suicide attempts Unintentionally retained foreign body without permanent loss of function Improving communication between caregivers Minor hemolysis with no clinical sequelae Preventing health care–associated infections Preventing injury from falls and pressure points Adapted from The Joint Commission: Accreditation Committee examples of voluntary reportable Safe and appropriate use of machinery alarms (e.g., electrosur- sentinel events, 2019. gery, cardiac monitors) Identification of patient safety risks Institutional Reporting of Sentinel Events “Never Events” and Reimbursement for The Patient Safety and Quality Improvement Act of 2005 a Hospitals and Health Care Facilities encourages a culture of safety in the health care system. TJC The Centers for Medicare & Medicaid Services (CMS) took indicates that mistakes are minimized by designing a systems action in 2009 to improve patient care and decrease errors and approach that anticipate and possibly prevent human error.b Each injury by denying payment for medical errors that result in seri- procedure has inherent safety risks that are not always apparent. ous harm or death for patients. The CMS no longer reimburses These tend to surface when procedural guidelines are not estab- for care rendered to patients to remedy the consequences of lished or not effective. errors. The CMS generated a list of nonreimbursable conditions, The 2005 act references data that show the incidence of report- or a “No Pay List,” for the following injuries acquired during care: ing to be more accurate when done on a voluntary basis rather Air embolism than when reporting is mandatory. Health care facilities have re- Blood incompatibility quested protection for reporting information because to rework Catheter-associated urinary tract infection the system the faults need to be known. This is the main way of Poor control of blood sugar studying problems and finding solutions for improved perfor- Deep vein thrombosis or pulmonary emboli after total knee or mance. Many states have adopted the National Quality Forum’s total hip surgery (NQF) list of adverse events as the foundation for mandatory Falls or trauma while in care adverse event reporting.c Removal of a retained object from surgery Pressure injury a Surgical site infection after certain orthopedic or bariatric This act is an amendment to Title IX of the Public Health Service Act. b Institute of Medicine: To err is human: building a safer health system, surgery Washington, DC, 1999, National Academy Press, pp 86–87. Surgical site infection after coronary artery bypass surgery c The full list of adverse events as defined by the NQF is located on the Catheter-associated vascular (bloodborne) infection Minnesota Department of Health’s website: health.state.mn.us. Accessed Details concerning statistics and trends in CMS programs and December 2018. rulings can be found at www.cms.gov.  CHAPTER 3 Legal, Regulatory, and Ethical Issues 41 Conduct a pre-procedure verification process SpeakUP TM Address missing information or discrepancies before starting the procedure. Verify the correct procedure, for the correct patient, at the correct site. When possible, involve the patient in the verification process. Identify the items that must be available for the procedure. Use a standardized list to verify the availability of items for the procedure. (It is not necessary to document that the list was used for each patient.) At a minimum, these items include: relevant documentation Examples: history and physical, signed consent form, preanesthesia assessment labeled diagnostic and radiology test results that are properly displayed Examples: radiology images and scans, pathology reports, biopsy reports any required blood products, implants, devices, special equipment Match the items that are to be available in the procedure area to the patient. Mark the procedure site At a minimum, mark the site when there is more than one possible location for the procedure and when performing the procedure in a different location could harm the patient. The site does not need to be marked for bilateral structures. Examples: tonsils, ovaries For spinal procedures: Mark the general spinal region on the skin. Special intraoperative imaging techniques may be used to locate and mark the exact vertebral level. Mark the site before the procedure is performed. If possible, involve the patient in the site marking process. The site is marked by a licensed independent practitioner who is ultimately accountable for the procedure and will be present when the procedure is performed.* Ultimately, the licensed independent practitioner is accountable for the procedure – even when delegating site marking. * In limited circumstances, site marking may be delegated to some medical residents, physician assistants (P.A.), or advanced practice registered nurses (A.P.R.N.). The mark is unambiguous and is used consistently throughout the organization. The mark is made at or near the procedure site. The mark is sufficiently permanent to be visible after skin preparation and draping. Adhesive markers are not the sole means of marking the site. For patients who refuse site marking or when it is technically or anatomically impossible or impractical to mark the site (see examples below): Use your organization’s written, alternative process to ensure that the correct site is operated on. Examples of situations that involve alternative processes: mucosal surfaces or perineum minimal access procedures treating a lateralized internal organ, whether percutaneous or through a natural orifice interventional procedure cases for which the catheter or instrument insertion site is not predetermined Examples: cardiac catheterization, pacemaker insertion teeth premature infants, for whom the mark may cause a permanent tattoo Perform a time-out The procedure is not started until all questions or concerns are resolved. Conduct a time-out immediately before starting the invasive procedure or making the incision. The A designated member of the team starts the time-out. The time-out is standardized. Universal The time-out involves the immediate members of the procedure team: the individual performing the procedure, anesthesia providers, circulating nurse, operating room technician, and other active participants who will be participating in the procedure from the beginning. Protocol All relevant members of the procedure team actively communicate during the time-out. During the time-out, the team members agree, at a minimum, on the following: correct patient identity for Preventing Wrong Site, correct site Wrong Procedure, and procedure to be done Wrong Person Surgery™ When the same patient has two or more procedures: If the person performing the procedure changes, another time-out needs to be performed before starting each procedure. Guidance for health care professionals Document the completion of the time-out. The organization determines the amount and type of documentation. This document has been adapted from the full Universal Protocol. For specific requirements of the Universal Protocol, see The Joint Commission standards. Fig. 3.1 The Joint Commission poster for the Universal Protocol. (From The Joint Commission: Speak up initiatives, available at www.jointcommission.org.) 42 SECTION 1 Fundamentals of Theory and Practice Consent act for the patient and the treating physician and should be docu- mented appropriately. The circulating nurse, as patient advocate, General Consent should ensure that an accurate and complete informed consent process has taken place before permitting the patient to be trans- Most facilities require the patient or his or her legal guardian to ferred to the OR.2 sign a general consent form on admission. This form authorizes The anesthesia provider also has a responsibility to inform the the attending physician and the staff to render standard day-to- patient of any potential for unfavorable reactions to any medica- day treatment or to perform generalized treatments and care as tion or anesthetic agent that may be given during the surgical the physician deems advisable. This general consent is relied on procedure. The risks of anesthesia should be explained without only for activities performed in routine care. Physicians and causing the patient undue stress. If the surgeon intends or wants nurses should be knowledgeable about the statements on the form to perform a procedure not specified on the consent form, the used in their facility. circulating nurse has the responsibility to inform the surgeon and/ Each facility should have policies and procedures in place or proper administrative authority of the discrepancy. about the authorization of general consent. Many facilities require The surgeon may be approved by the U.S. Food and Drug the patient or appropriate guardian to sign the general consent Administration (FDA) as a clinical investigator or by the Depart- document in the admission department before admission to the ment of Health and Human Services (HHS) as a researcher for facility. This is facilitated by the admissions clerk, who is a non- the controlled experimental use of new drugs, chemical agents, or medical person. This in no way equals informed consent. Box 3.2 medical devices. Written consent based on an informed decision compares content examples of general consent to treat versus in- to participate in the research should be obtained from the patient formed consent. before any investigational item, drug, or procedure begins. The surgeon completes an investigator’s report that is returned to the supplier of the drug or device and eventually filed with the FDA Informed Consent (www.fda.gov). The patient is free to refuse or withdraw at any State statutes differ in their interpretation of the doctrine of in- time from research performed under the auspices of the HHS. All formed consent, but all recognize the physician’s duty to inform parties involved with the procedure are bound by HIPAA and the the patient of the risks, benefits, and alternatives of a procedure confidentiality implied therein. More information can be found and to obtain consent before treatment. Failure to do so may be on the HHS website (www.hhs.gov). considered a breach of duty. Informed consent is a process—not a paper document that is signed. Explanations of the procedure, risks, Informed Consent for a Surgical Procedure benefits, and alternative therapy are made verbally to the patient’s According to the American College of Surgeons, a reasonable level of understanding.2 Some facilities have a special form that is approach to informed consent should involve answering the fol- used during this process. A surgeon or anesthesia provider may be lowing patient questions: held liable for negligence if the patient can prove failure to dis- What do you plan to do to me? close significant information that would have influenced a reason- Why do you want to do this procedure? able person’s decision to consent. Informed consent is a protective Are there any alternatives to this plan? What things should I worry about? What are the greatest risks or the worst thing that could happen? BOX 3.2 Examples and Comparison of Consent The patient has the right to waive an explanation of the nature Form Contents and consequences of the procedure and has the right to refuse treatment. When a patient signs a consent agreement, consent is General Consent to Treat given only for the specific procedure indicated on the form. Ad- Admission to facility ditional procedures should be listed and signed separately—not Time and date admitted added after the patient has already signed the form. Contents Admissions clerk name documented about informed consent should include but are not Mode of admission limited to the following: Treating/admitting physician Who will be performing the procedure, including any resi- Person responsible for payment Contact persons for emergency dents, interns, or first assistants Basic care assumptions (such as dietary orders, activity orders, testing, Each surgical procedure to be performed, including secondary examination by physician) procedures Any procedure for which an anesthetic is administered Informed Consent Procedures involving entrance into the body via an incision, Name of patient and legal guardian as appropriate puncture, or natural orifice Name of facility Any hazardous therapy, such as irradiation or chemotherapy Specific procedures and who explained them Other persons attending the performance of the procedure, Specific practitioners and their roles such as students, sales personnel, or other observers Risks of the procedure Video recording or photography and the disposition of the Alternatives to treatment Signatures: patient or legal guardian, surgeon(s), and the witness to the recorded/photographed images signatures Date and time the process took place Responsibility for Informed Consent before a Surgical Procedure Data from Centers for Medicare & Medicaid Services, 2018, available at www.cms.gov. The surgeon is responsible for obtaining informed consent from the patient, which should include the risks, benefits, and possible  CHAPTER 3 Legal, Regulatory, and Ethical Issues 43 complications of all proposed surgical procedures. The explana- Consent documents vary. Policies related to informed consent tion should include a discussion of the removal and disposition of are developed by the medical staff and governing body in accor- body parts, the potential for disfigurement or disability, and what dance with legal requirements. All personnel involved in the care the patient may expect in the postoperative period. The preopera- of patients should be familiar with these policies. tive discussion also should include advice to the patient regarding medications, diet, bathing, smoking, and other factors that might Witnessing a Consent affect outcome and rehabilitation. A witness verifies that the consent was signed without coercion The surgeon has the ultimate responsibility for obtaining in- after the surgeon explained the details of the procedure. The pa- formed consent for the procedure and should document this ac- tient’s or guardian’s signature should be witnessed by one or more tivity in the patient’s permanent record according to facility policy authorized people. The witnesses may be physicians, nurses, other and procedure. The patient or appropriate guardian may be re- facility employees, or family members as established by policy. quired to sign this record in the presence of a witness. All consent Checking or witnessing the signature of the patient or other au- documents become a permanent part of the patient’s medical re- thorized person does not constitute validation of informed con- cord and accompany him or her throughout the perioperative sent. The witness assumes no liability or responsibility for the environment. When checking the patient’s identity and chart on patient’s understanding. The witness signing a consent document arrival in the OR, it is the duty of the circulating nurse and the attests only to the following: anesthesia provider to be certain of the following: Identification of the patient or legal substitute The appropriate consents are on the chart and are properly Voluntary signature, without coercion completed, dated, and signed. Mental state of signatory (i.e., not coerced, sedated, or The information on the form is correct concerning the patient, confused) at the time of signing procedure, and personnel performing the procedure. Consent in Emergency Situations Validation of Consent In a life-threatening emergency, the consent to treat and stabilize is not essential. Although every effort should be made to obtain The patient should personally sign the consent unless he or she is consent, the patient’s physical condition takes precedence over a a minor, is unconscious or mentally incompetent, or is in a life- procedure permit. The patient’s state of consciousness may pre- threatening situation. The next of kin, legal guardian, or other vent him or her from verbalizing or signing a permit for treat- authorized person should sign for these patients. The physician ment. Permission for a lifesaving procedure, especially for a gives explanations to the parent of a minor or to the legal guardian minor, may be accepted from a legal guardian or responsible rela- of an incompetent adult. tive by telephone, fax, or other written communication. If it is A consent document should contain the patient’s name in full, obtained by telephone, two nurses should monitor the call and the surgeon’s name, the specific procedure to be performed, the sign the form, which is signed later by the parent or legal guardian signatures of the patient and authorized witness(es), and the date on arrival at the facility. of signatures. A signed consent is regarded as legally valid for as long as the patient still consents to the same procedure. Institu- Right to Refuse a Surgical Procedure tional policy may vary. The patient should reconcile the advantages and disadvantages of The patient giving consent for treatment should be of legal age the surgical intervention. Each patient is entitled to receive suffi- and mentally competent. Except in life-threatening emergency cient information from which to intelligently base a decision re- situations, the patient should sign the consent form before pre- garding whether to proceed. The patient has the right to decide medication is given and before going to the OR or other proce- what will or will not be done to him or her. Only after making dural/interventional area. This may be done in the surgeon’s of- this decision is the patient asked to sign a written consent for a fice, in the facility’s admitting office, or on the patient care unit; surgical procedure. it is done freely without coercion. If the patient is the following: The patient has a right to withdraw written consent at any A minor, a parent or legal guardian should sign. time before the surgical procedure. The surgeon is notified, and An emancipated minor, married, or independently earning a the patient is not taken into the OR. The circulating nurse docu- living, he or she may sign. ments the situation in the patient’s record. The surgeon should A minor who is the parent of an infant or child who is having explain the medical consequences of refusing the surgical proce- a procedure, he or she may sign for his or her own child. dure. If therapeutically valid, alternative methods of medical Illiterate, he or she may sign with an X, after which the witness management should be offered. The surgical procedure is post- writes, “Patient’s mark.” Because illiteracy implies the inability poned until the patient makes a final decision. The procedure may to read and write, the patient should indicate an understand- be canceled. ing of a verbal explanation. The surgeon should document the patient’s refusal for surgical Unconscious, a responsible relative or guardian should sign. treatment. For legal protection, the surgeon should also obtain Mentally incompetent, the legal guardian—who may be either from the patient, parent, or legal guardian a written refusal for the an individual or an agency—should sign. A court order may be procedure or other treatment. The physician is required to inform necessary to legalize the procedure in the absence of the legal the patient of the consequences of refusing diagnostic tests or guardian. therapeutic procedures. An adult or an emancipated minor who is mentally incapaci- tated by alcohol or other chemical substance, the spouse or Second Opinion responsible relative of legal age may sign when the urgency of If the surgeon or patient has doubts about the necessity of a the procedure does not allow time for the patient to regain procedure, another opinion should be sought from a qualified mental competence. specialist in the appropriate field of surgery. Consultation is a 44 SECTION 1 Fundamentals of Theory and Practice common and desirable part of good surgical practice. A second serves as a means of communication among providers for conti- opinion may be required by third-party payers (i.e., insurance nuity of care. Policies and procedures should be in place for carriers) or managed care services. This is particularly indicated if documentation. Each patient care facility is responsible for the the surgical procedure involves extended disability. Policy may following: require special consultation or consent for procedures resulting Establishing, evaluating, and enforcing policies and procedures in reproductive sterilization or a pregnancy termination. for patient care documentation Interpreting and outlining standards for care documentation Advance Directives in accordance with accreditation guidelines Protecting the privacy of patients by preventing unauthorized The Patient Self-Determination Act enacted by the U.S. Congress access and use of documented patient care data and reports in December 1991 ensures the patient the opportunity to partici- Creating forms and charting formats for personnel to use in pate in decision making before a procedure.d The law requires that hard copy documentation patients be informed of their rights to make their own decisions Selecting protocol for computerized archives of patient care regarding their health care. This act applies to hospitals, nursing records and reports homes, home health care agencies, hospice programs, and health Providing a timely mechanism for retrieval of archived patient maintenance organizations. It does not apply to freestanding am- care records and reports for reference in a timely manner for bulatory or office settings. In 2016 CMS issued a final rule allow- routine or emergency care ing advanced care planning conversations and counseling to be All interactions with patients should be documented in the reimbursed under the physician fee schedule. patient’s medical record in the appropriate format. Regardless of Each patient has the right to determine the care received and the format or the media used for the patient’s record, all entries participate in the selection of delivery methods. The caregiver has should be: the obligation to respect the patient’s wishes regarding that care. Documented on the appropriate form (e.g., code sheet, peri- This right extends to the issue of refusing treatment. Policies operative record, medication sheet, progress note). should be in place to provide for making patients aware of their Written legibly in ink without erasures. The charting proce- right of self-determination. dure may be specific (e.g., all entries are to be made in black The term advance directive encompasses durable power of ink if paper charting is used). attorney and living wills. The living will concept allows the pa- Stated factually. Documentation of objective data and services tient to refuse treatment or nonessential measures to prolong life rendered should be very specific. Observations and actions in a hopeless situation. A durable power of attorney document should be stated definitively, objectively, and concisely. Record designates the person authorized to make decisions in the event what is seen, heard, felt, or smelled (i.e., the facts without that the patient is incapacitated. It allows the wishes of patients judgment or opinion). Write quotes of the patient’s subjective concerning their care needs to be met if they become impaired expression. and cannot make decisions. The durable power of attorney does Stated in understandable terminology. Abbreviations may be not apply to pediatric patients or to incompetent adults who are permissible only for very commonly accepted medical terms already under legal guardianship. These patients already have deci- (e.g., T&A, D&C, TUR). Most institutions provide a stan- sion makers available to decide treatment options. dard list of their accepted medical abbreviations for charting On admission to the facility, the patient is asked whether he purposes. or she has an advance directive or durable power of attorney. A Dated (month, day, year), including the time (am/pm) the note federal regulation requires that the institution be aware of is written and the time action was performed as appropriate for whether such a document exists and enact it in the event of significant events or changes in the patient’s condition. Late impaired cognitive function of the patient. The perioperative entries are documented as per facility policy. Computerized team should be made aware of its existence. A copy, not the entries are date stamped. original, is placed in the patient’s record. Advance directives may Signed with the full legal signature, title, and status of the also indicate the patient’s preferences concerning organ dona- writer, either in permanent ink or electronically. tion. The family is still asked for consent before any procure- Corrected if an error is made. The date, time, and initials of ment occurs after the patient’s death. In some states, the family the person making a correction should be noted next to the has the right to refuse procurement regardless of the patient’s correction. A single line should be drawn through incorrect last wishes. information on a paper document without obliterating it (the mistake should not be scribbled out or erased), and the correct Documentation of Perioperative Patient Care information should then be entered. Correction fluid is not acceptable. If an entire page must be recopied, the original is Verbal communication between patients and health care provid- attached to the new copy and not destroyed. ers does not constitute legal documentation of care. Entries in Additional documentation in the patient’s record should the record by nurses and physicians provide a history of the include the following: patient’s clinical course and responses to treatment. The record Execution of the physician’s orders and the patient’s responses serves to identify what was done. The broad assumption is that Any teaching of the patient or family, including how he, she, if something is not documented, it was not done. The record or they indicated understanding Any unusual event, such as a fall, spontaneous change in condition, or injury d Patient Self-Determination Act, Public Law 101-508, Fed Reg 57, March 6, All visitors, especially physicians 1992. Any notification of physicians or supervisors  CHAPTER 3 Legal, Regulatory, and Ethical Issues 45 The perioperative nurse should be alert to signs that a patient according to cues given by a patient with a specific set of signs does not clearly understand what is going to happen as a result of and symptoms. This approach uses direct quotes and assess- surgical intervention. This should be documented and brought to ment data. the attention of the surgeon. Significant observations should be Problem-oriented charting (problem-oriented medical record recorded in the chart. For example, if a patient verbally withdraws [POMR]). Approach using a problem list as the working consent for a surgical procedure or expresses a fear of death in the element from which care is planned. Working from the list, OR, the perioperative nurse is responsible for communicating this patient priorities are investigated, diagnosed, treated, mini- information to the surgeon and anesthesia provider and for mized, solved, or remain ongoing. As problems are solved, they recording the patient’s statement. are stricken from the list. Computer-generated charting. Use of standardized care plans Benefits of Documentation to the Facility formulated in the computer and modified for the individual patient. The computer time and date stamps the plan as it is There are many reasons for accurate documentation other than printed for the hard copy record. This form of charting re- those for legal application. Some facilities use the data for strategic quires the caregiver’s signature. planning and growth of the organization. Benefits of accurate Computer information systems, check-off forms, and flow sheets. documentation to the facility include but are not limited to the Commonly used as shortcuts for record keeping. Unfortu- following: nately, it is easy to rely on the standardized data on these pre- Legal permanent record printed records and inadvertently omit potentially important Billing and reimbursement individualized information. Most computerized patient re- Performance improvement cords have secondary documentation fields to complete for Measurement of clinical pathways individualized data capture. Budget and financial planning Staffing ratios Computerized Documentation Research protocol Many facilities have been using computers for patient admit- Utilization review ting, billing, scheduling, and human resource information for Risk management several decades. Within the past decade, patient data have been Patient acuity and census recorded and stored electronically at the patient care unit level. Referred to as electronic health records (EHRs) or electronic Standards and Methods for Documentation of medical records (EMRs), the documentation is transmitted elec- tronically to multiple sites, including the OR, surgeon’s offices, Patient Care patient care areas, and other health care facilities around the The standards for patient care documentation are established by world. Only select personnel are permitted to access this infor- the American Nurses Association (ANA) and TJC. The standard mation and must log on using employee identification and of care requires that patient care documentation reflect the ap- passwords to enter the computer system.3 Documenting under plication of the nursing process (assessment, nursing diagnosis, another individual’s name and password is against facility pol- outcome identification, planning, intervention, and evaluation) icy. Passwords are changed at routine intervals. Retrievable data during the entire length of stay, according to the ANA and TJC. recorded and accumulated in these electronic files include The use of the perioperative nursing data set (PNDS) is the patient care information, laboratory results, surgical reports, method of choice for perioperative patient care documentation. admission and discharge summaries, and many highly sensitive The PNDS provides a standardized universal language for patient details about a patient’s financial status. Many larger multihos- care documentation and is used by many surgical computer infor- pital systems, such as the Cleveland Clinic, have used the Inter- mation system manufacturers. net to permit multiple record access points for office-based physicians, surgeons, and the patient. All authorized users have Charting Modalities access to reports and health data as soon as they are entered into Many ways of recording patient care information have been used the system. over the years. Changes in technology have created more methods Nurses charged with the responsibility of accessing and con- of recording patient care. Examples of documentation methods tributing to computerized patient data should be aware that secu- include the following rity and confidentiality must be protected. Failing to maintain the Narrative charting. Expository writing about significant secrecy of passwords and failing to log off after use are common events using third-person commentary, quotes, and standard problems identified with unauthorized access. Some systems have abbreviations. Entries are sequential, timed, dated, and a built-in log-off feature if the workstation is left idle for a pro- signed. longed period. If this happens, the user has to reenter the system Block charting. Short commentary on activity that resembles by logging back on. narrative charting covering a longer period of several hours or days. Entries are sequential, timed, dated, and signed. Some Perioperative Documentation facilities use a checklist format. Specific care given in the perioperative environment should be Focus charting. Specific documentation directed at a documented on the patient’s chart. Most facilities use a preprinted designated aspect of the patient’s needs, status, or health form with a standardized plan of care. Space is provided to add considerations. individualized patient needs and to document additional inter- Subjective-objective charting (subjective-objective assessment plan ventions. Data included in the record come from several patient [SOAP]). Multidisciplinary approach to documenting care care areas. 46 SECTION 1 Fundamentals of Theory and Practice PROS/CONS chart per policy. Any area on the patient’s body with redness or injury before hands-on care begins must be documented as Computerized Documentation “present on admission.” Patient identification and verification of the surgical site, in- Pros tended surgical procedure, allergies, and nothing-by-mouth Terminology is standardized. (NPO) status. Abbreviations are standardized. Significant intraoperative times, such as arrival in and departure Useful for accumulation of data from many sources. from the OR, anesthesia start and finish, and incision and closure. Data retrieval is easier and efficient. Patient’s condition on transfer to and from the OR, as well as Information is legible and in standard terminology. the method of transport to and from the OR, and by whom. Uses standardized formats, flowcharts, and graphs. Any change in the patient’s skin integrity, such as redness or All entries and printing are time and date stamped. injury should be documented as “not present on admission.” Can minimize errors if orders are entered online instead of handwritten. Level of consciousness or anxiety manifested by objective Data can be transferred electronically between physician’s office observation. and care facility. Patient position, and types of restraints and supports used for Record updating is more timely and ongoing. maintaining the patient’s position on the OR bed and for pro- Can save time, space, and resources. tecting pressure areas, and by whom. Easier to retrieve archived charts from previous admissions. Personal property disposition, such as religious articles, hear- Health care organizations with multiple remote sites can transfer ing aid, spectacles, and dentures. patient data online. Skin condition and antimicrobials used for skin preparation, and by whom. Cons Intravenous (IV) site, time started, type of needle or cannula, Can be confusing for inexperienced users. Failure to log off can leave the system available to unauthorized use. solutions administered IV (including blood products), and by Can be out of service for undetermined periods. whom. Needs periodic maintenance and software updates. Medication types and amounts (including local anesthetic agents), Backups of files are needed in case of failure. irrigating solutions used and amounts, and given by whom. Paper records must be kept when the system is down. Tourniquet cuff location, pressure, inflation duration, identifi- Impersonal interaction between patient and caregivers. cation of unit, and applied by whom. Preoutlined care plans are less individualized. Estimated blood loss and urinary output, as appropriate. Hardware and software can be costly to install. Sponge, sharps, and instrument counts as correct or incorrect. Potential for breach of security if files are transferred online. If inconclusive, state steps taken in remedy of the situation and Charting can be easily recorded under the wrong patient. notification steps taken. Detailed information may be left out because the user only clicks on items from a checklist that applies to the patient. Surgical procedure performed, location of the incision. Specific equipment used (e.g., laser), electrosurgical unit, dis- persive and monitoring electrode(s), and prosthetic devices implanted, if applicable, including the manufacturer and lot/ A comprehensive checklist is included with the chart to assist the serial number. circulating nurse to determine whether all of the data initiating Specimens and cultures sent to the laboratory. Universal Protocol are included on the chart (see Fig. 3.1). Expected Site and types of drains, catheters, and packing as applicable. outcomes should be specified (e.g., the patient is free from injury). Wound classification is documented at the end of the proce- The circulating nurse should document specific activities performed dure when all risks for infection have been identified. to achieve the expected outcomes. The permanent perioperative Type of dressing applied. record should include but not be limited to the following: Any unusual event or complication, and action performed. Preoperative history and physical (H&P) examination, labora- All personnel in the room and their roles, including physicians, tory reports, consent form(s), and other documents in the visitors, sales personnel, students, and others as applicable. PROS/CONS Patient Hand-over Pros Every facility should establish a format for standardized hand-off/ A hand-over is defined as a linear transmission of information and hand-over protocols and policies. Standardized protocols provide responsibility from one qualified caregiver to another. critical patient information necessary for safe patient transfer and TJC recommends a standardized hand-over in their National Patient reduction in communication breakdown. Safety Goals. It is called the Targeted Solutions Tool for Hand-off Many standardized communication and documentation models Communications. exist. Examples of standardized documentation formats include the AORN also has recommendations for transferring patient care information. following: Standardized protocols are recommended because the hand-over of 1. SBAR (Situation, Background, Assessment, and Recommendation). patients to another health care provider is reported as a high-risk time 2. I PASS THE BATON (Introduction, Patient, Assessment, Situation, Safety) associated with sentinel events. 3. Concerns, Background, Actions, Timing, Ownership, Next  CHAPTER 3 Legal, Regulatory, and Ethical Issues 47 4. SHARED (Situation, History, Assessment, Request, Evaluate, and Cons Document) Communication breakdown has been documented as the root cause 5. SURPASS (SURgical Patient Safety System) of many sentinel events. Hand-over reporting improved when health care facilities established Problems and errors related to poor hand-over include room noise, a format of standardized tools, checklists, and protocols. These rushing, errors on record, distractions, multitasking, change of staff, protocols can be written, verbal, and or electronic methods of accurate lack of information, personnel physiologic problems, relationship documentation and communication. barriers, lack of experience, and number of personnel involved in the Hand-over communication improved when personnel were educated hand-over process. about the standardized protocols and policies. Positive education More research is needed to identify an error-free transfer of information methods include role playing, competency training, case studies, to improve patient outcomes. The current standardization protocols still anticipated patient needs, and simulation. have breakdowns in communication putting patients at risk for injury. Professional attributes that improve receiving hand-over reports include completing all necessary physiologic tasks before report References begins (attaching monitors, securing the patient), reducing noise and 1. Burns S, Parikh R, Schuller K: Utilization of a checklist to standardize the distractions, improving listening skills, using standard vocabulary, operating room to post-anesthesia care unit patient handoff process, asking questions, taking notes, and reading back information to verify. Periop Care OR Manage 2018;13:1–5, 2018. The person taking report signs the document and records the names 2. AORN: Transfer of patient care information: guidelines for perioperative of the personnel giving the report. practice, Denver, CO, 2019, AORN, Inc. Incident Report BOX 3.3 Unusual Situations That Require an When an accident or unusual incident occurs involving a Incident Report patient, employee, or property in the facility, the factual details Falls or unexpectedly finding a patient, visitor, or other personnel lying on should be reported to the nurse manager and documented the floor according to institutional policy. Details should be objective, Injury to patient, visitor, or other personnel complete, and accurate. They should be written as statements of Needlesticks facts without interpretation or opinion. For example, it should Any fire or smoke event be stated that the area of the patient’s skin under the inactive Possible theft or loss of an item dispersive electrode of the electrosurgical unit was mottled and Malfunctioning equipment red when the electrode was removed, rather than that the Intruder or unauthorized personnel Medication error patient’s skin appeared burned by the dispersive electrode. The Medication reaction details of equipment used, including the serial number or asset Lost sponge or instrument during a procedure (incorrect and unresolved tag identification of the generator and the lot number of the count) electrode, should be included. Object retained within patient The action performed as a result of any adverse event should be described in detail. Any equipment in question should be re- moved from service and tagged as “out of order” for repair by the biomedical personnel of the facility. Any suspect device should be inspected and reapproved for use according to institutional policy became the enforcing agency with authority to implement a bef