Week 9 Handout PDF

MA - 156 - Phlebotomy WEEK 9 Quality Phlebotomy and Legal Issues 01 QUALITY PHLEBOTOMY Quality phlebotomy is a set of policies and procedures designed to ensure the highest-quality patient care and consistent specimen analysis. Continual, gradual improvement in the standard of care delivered is the...

MA - 156 - Phlebotomy WEEK 9 Quality Phlebotomy and Legal Issues 01 QUALITY PHLEBOTOMY Quality phlebotomy is a set of policies and procedures designed to ensure the highest-quality patient care and consistent specimen analysis. Continual, gradual improvement in the standard of care delivered is the goal of quality phlebotomy. The phlebotomist is best able to control preanalytic variables, which are those that influence patient care and sample integrity before analysis in the laboratory. Patient preparation, specimen collection, and transport and processing are critical areas for quality phlebotomy. Throughout this term, you have learned important precautions and techniques designed to maintain both the comfort and safety of the patient and the quality of the sample collected. We review those items here and discuss the laboratory procedures that have an impact on the quality of test results. Features of Quality Phlebotomy Quality phlebotomy refers to a set of policies and procedures designed to ensure the delivery of the highest-quality patient care and consistent specimen analysis. Quality phlebotomy ensures better patient care by reducing errors and increasing efficiency, making the delivery of care more cost efficient. There are several components to quality phlebotomy. Quality control (QC) refers to the quantitative methods used to monitor the quality of procedures, such as regular inspection and calibration of equipment, to ensure accurate test results. QC is part of quality assurance (QA), the larger set of methods used to guarantee quality patient care, including the methods used for patient preparation and collection and transportation protocols. Both QC and QA are included in total quality management (TQM), the entire set of approaches used by the institution to provide patient satisfaction. Continuous quality improvement (CQI) is the major goal of TQM programs. QA programs are mandated by the Joint Commission. Joint Commission standards require that a systematic process be in place to monitor and evaluate the quality of patient care. The direct involvement of workers is a requirement of TQM programs. The team approach improves production by reducing errors and waste, thereby resulting in a reduction in healthcare cost. The Joint Commission publishes yearly National Patient Safety Goals, which outlines goals and how to meet them with regard to patient safety in every area of healthcare delivery, including the clinical laboratory. National Patient Safety Goals 2024 National Patient Safety Goals The purpose of the National Patient Safety Goals is to improve patient safety. The goals focus on problems in healthcare safety and how to solve them. Patient Identification - Improve the accuracy of patient identification. Use at least two patient identifiers when providing care, treatment and services. Improve Communication - Improve the effectiveness of communication among caregivers. Report critical results of tests and diagnostic procedures on a timely basis. Medication Safety - Improve the safety of using medications. Label all medications, medication containers, and other solutions on and off the sterile field in perioperative and other procedural settings. Note: Medication containers include syringes, medicine cups and basins. Reduce the likelihood of patient harm associated with the use of anticoagulant therapy. Maintain and communicate accurate patient medication information. Clinical Alarm Safety - Reduce patient harm associated with clinical alarm systems. Improve the safety of clinical alarm systems. Health Care-Associated Infections - Reduce the risk of health care-associated infections. Comply with either the current Centers for Disease Control and Prevention (CDC) hand hygiene guidelines or the current World Health Organization (WHO) hand hygiene guidelines. Reduce Falls - Reduce the risk of patient harm resulting from falls. Reduce the risk of falls Pressure Ulcers - Prevent health care-associated pressure ulcers (decubitus ulcers). Assess and periodically reassess each patient’s and resident’s risk for either developing a pressure injury or worsening of their existing pressure injury. Take action to any identified risks. Risk Assessment - The organization identifies safety risks inherent in its patient population. Reduce the risk for suicide. Note: Apply to patients in psychiatric hospitals or patients being evaluated or treated for behavioral health conditions as their primary reason for care. In addition, apply to all patients who express suicidal ideation during the course of care. Identify risks associated with home oxygen therapy, such as home fires. Health Care Equity - Improve health care equity. Improving health care equity for the organization’s patients is a quality and safety priority. Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery Conduct a preprocedure verification process. Mark the procedure site. A time-out is performed before the procedure. Different healthcare organizations will have different programs in place to promote quality improvement. The Joint Commission stresses the collection and analysis of data to understand where the organization is weakest, and where to focus on improvements. Important aspects of any quality improvement program that you may be responsible for include: patient wait time accurate patient identification duplicate test orders technical proficiency multiple attempts for a single collection complication caused by phlebotomy procedures specimen re-collection caused by collection errors postcollection specimen handling Total Quality Management TQM focuses on gradual, continual improvements in the quality of services provided by the laboratory. Rather than merely setting a minimum standard to be met, the TQM philosophy sees the potential for improvement in every area, no matter how high the current performance level, to improve the services provided to “customers.” For the clinical laboratory, the customers are the patients, the physicians and other healthcare providers who order tests, and the personnel who use test results to provide treatment. The phlebotomist is the member of the laboratory team with the most patient contact and is therefore most directly responsible for customer satisfaction in this area. Quality Assurance and Quality Control QA guarantees quality patient care through a specific program, including both technical and nontechnical procedures. QA programs use written documentation to set standards for the performance of procedures, monitor compliance with written procedures, and track patient outcomes with scheduled evaluations of all laboratory activities. Documentation provides written policies and procedures covering all services and provides evidence that standards have been met and that work is being performed efficiently. In the event of a problem, documentation provides a means of monitoring the actions taken to resolve the problem. Documentation includes a procedure manual for laboratory procedures, a floor book distributed to nursing departments detailing schedules and other information, the identification of variables that may affect patient care and test results, re-collection lists, hemolysis data, and continuing education for all members of the laboratory staff. QC is part of QA. QC is the set of quantitative methods used to monitor the quality of procedures to ensure accuracy of test results. Its focus is on identifying the problems that may be preventing the delivery of quality phlebotomy. QC requires documenting equipment inspections, calibrating instruments, and monitoring the protocols used in each step of phlebotomy, from patient preparation and identification, through collection procedures and equipment, to transportation of specimens and distribution in the laboratory. Together, QC and QA help to ensure quality patient care. Procedure Manual The procedure manual is present in the department at all times. It contains protocols and other information about all the tests performed in the laboratory, including the principle behind the test, the purpose of performing it, the specimen type the test requires, the collection method, and the equipment and supplies required. QA procedures relevant to the procedure manual include updating the standards and protocols to comply with advances in the field, training for laboratory members in the proper performance of procedures, scheduled testing of standard samples, and monitoring of results. Directory of Services The directory of services contains a variety of information pertinent to the smooth coordination of nursing staff and laboratory personnel. It may be available in hard copy or online at the laboratory website. It includes laboratory test schedules, early morning collection schedules, and written notification of any changes, plus information on patient preparation, specimen types and handling, and normal values. QA procedures relevant to the information in the directory of services include monitoring the numbers of incomplete or duplicate requisitions received, collecting statistics on the number of missed or delayed collections, and recording the time between a test request and a results report. Monitoring of Variables A variable is any factor that can be measured or counted that affects the outcome of test results and therefore patient care. Once identified, a variable is controlled through the institution of a set of written procedures. Monitoring of the variable is performed and documented to ensure that its impact on test results is minimized. There are three types of variables: preanalytic, analytic, and postanalytic, each of which can affect test results. The phlebotomist is most responsible for controlling preanalytic variables, those that occur before analysis of the specimen. Venous blood specimen collection accounts for more than half of the errors in preanalytic variables. Analytic variables, those that occur during specimen analysis, can be affected by preanalytic variables, such as collection time or transport conditions. Postanalytic variables, such as delays in reporting results or improper entry of results in the data bank, also may be part of the phlebotomist’s responsibilities. Preanalytic Variables Requisition Handling Preanalytic variables occur in each area of the phlebotomist’s duties, beginning with test ordering and requisition handling. Requisitions must be accurately and completely filled out with the patient number, tests ordered, and priority. Variables to be controlled include duplicate or missing requisitions, tests left off the requisition, missing patient identification number, missing doctor name, or priority not indicated. When demographic, diagnostic, and insurance information is omitted or is inaccurate, there is a delay in collection of the specimen and reporting results, introducing both a preanalytic and a postanalytic variable. QA procedures for these variables include recording and counting the numbers of each type of requisition error. Equipment Phlebotomy equipment is designed and manufactured to be free of defects and minimize variability. Nonetheless, errors do occur, and it is up to the phlebotomist to identify and eliminate them before they interfere with patient care. QA procedures include the following: Tubes should be checked for lot number and expiration date. Never use an expired tube. Inventory control and tracking lot numbers of all phlebotomy supplies are used to document that the process is being monitored. Stoppers should be checked for cracks or improper seating. Reject any tube with a defective stopper. Tubes may lose vacuum without any visible sign of defect. When filling a tube, be aware of incomplete filling because of loss of vacuum. Clinical and Laboratory Standards Institute (CLSI) guidelines indicate that the volume should be ± 10% of the stated draw. Needles should always be inspected for defects, including blunted points or burrs. Never use a defective needle or one from a package with a broken seal. Syringe plungers must move freely in the barrel. Reject a syringe with a sticky plunger. Patient Identification It cannot be emphasized too strongly that proper patient identification is the most important procedure in phlebotomy. Improper identification can lead to injury or death. Proper identification is made when the patient number on the requisition matches the number on the patient’s identification band and that band is attached to the patient. A further check on correct identification is to ask the patient to state his or her name and date of birth and to match that to the identification band and the requisition. The Joint Commission requires two patient identifiers on the patient ID band, such as name, hospital number, and date of birth. CLSI requires three identifiers. The patient must verbally verify all required identifiers by stating name, DOB, and a third identifier. A delta check is a QA procedure that helps spot identification errors. This check compares previous patient results with current results. If the difference (“delta”) between the two sets of results is outside the limit of expected variation, it alerts laboratory personnel to the possibility of an error. Patient Preparation and Specimen Collection Patient Preparation The patient’s physical condition at the time of the collection has a significant effect on the sample quality. The phlebotomist has little or no control over most of these variables but may note their presence to aid in the interpretation of test results. Factors include the following: Posture. A sample collected from an erect patient has higher concentrations of large molecules such as enzymes and albumin, as well as white blood cells (WBCs) and red blood cells (RBCs), compared with a sample collected from a supine patient. This is caused by a gravity-induced shift in fluids upon standing. Short-term exercise. Exercise increases levels of muscle enzymes, such as creatine kinase, as well as WBCs, creatinine, and fatty acids. Long-term exercise. A prolonged exercise regimen increases sex hormones, as well as many of the values increased by short-term exercise. Medications and medical treatments. Certain medications affect test results directly. Aspirin is the most common one, prolonging bleeding times. Other treatments to be aware of include the administration of radiographic dyes, blood transfusions, or intravenous (IV) fluids, as these can affect test results. Anticoagulants (warfarin and heparin) cause prolonged bleeding after the puncture. It is important to know this, since it requires extra time after the puncture to apply pressure at the site and thus avoid compartment syndrome. Alcohol consumption. Although moderate amounts of alcohol do not affect test results (except, of course, for the alcohol test), glucose is slightly elevated, and chronic consumption can lead to increased values on liver function tests, as well as interfering with platelet aggregation studies. Smoking. Smoking increases catecholamines, cortisol, WBCs, mean corpuscular volume, and hemoglobin, and it decreases eosinophils. Smoking also affects arterial blood gases (ABGs). Stress. Anxiety, crying, or hyperventilating may affect test results, including the stress hormones produced by the adrenal cortex. Prolonged crying or hyperventilating alters ABGs, and crying can increase WBCs. Diurnal variation. Certain specimens must be collected at specific times of day because of significant changes throughout the day. Such specimens include cortisol and iron. Fasting. Prolonged fasting increases bilirubin and fatty acids. Overnight fasting concentrates most analytes. A fasting specimen should be taken 8 to 12 hours after the last intake of food. It is the phlebotomist’s responsibility to ascertain that the patient has had no food during that time. Caffeinated beverages, such as coffee, tea, and soda, must be avoided as well. Caffeine causes a transient rise in blood sugar levels. A patient not in the fasting state may produce a lipemic sample, in which the serum or plasma appears turbid. This turbidity, which is caused by an increase in blood triglycerides, interferes with many tests that rely on photometry, or the passage of light through the sample. A lipemic sample may cause clinically significant variances in results for phosphorus, creatinine, total protein and calcium. High-speed centrifugation may be used to pretreat lipemic specimens to overcome interference, but in cases of gross lipemia, the sample may have to be recollected. Age. Many laboratory values vary with age. For instance, because organ function declines with advancing age, values affected by kidney or liver function are different for the elderly than for younger patients. Cholesterol and triglyceride values increase with age, whereas the sex hormones may rise and then fall. Both RBC and WBC values are higher in infants than in adults. For all these reasons, it is important that the patient’s date of birth be documented on the requisition form. Altitude. Patients living at higher altitudes have less oxygen available to breathe, so the body compensates by producing a higher RBC mass. Therefore patients living in mountainous regions have higher counts of RBCs, hemoglobins, and hematocrits. Dehydration. Prolonged diarrhea or vomiting causes loss of fluid from the intravascular circulation. This results in hemoconcentration because of loss of water from plasma. Hemoconcentration produces a false increase in many analytes, including RBCs, enzymes, calcium, and sodium. Sex. The normal ranges of some analytes differ for males and females. Males, for example, have higher hemoglobin, hematocrit, and RBC counts than do females. Pregnancy. The changes that occur in pregnancy affect laboratory values. The presence of the fetus and increased water retention cause a dilution effect that is reflected in falsely lower hemoglobin and RBC counts, as well as other analytes. Specimen Collection The phlebotomist has almost complete control over the variables that arise during specimen collection. These include the following: Site selection. Sites that can cause specimen contamination include hematomas or areas with edema and the side of the body that has undergone mastectomy or is currently receiving IV fluids. Sites that can cause pain or injury to the patient include burns or scars, previous puncture sites, the arm near a mastectomy, sites near fistulas or shunts, and the back of the heel or other regions close to the bone. Damage to nerves is the most common phlebotomy injury. In addition, accidental puncture of an artery during a venous procedure, or use of an artery for routine collection, carries a significant risk of infection. When a patient complains of stinging, pain, or tingling at or near the puncture site, immediately stop the procedure and find a more appropriate site. Tourniquet application. Tourniquets should be left on no longer than 1 minute to reduce hemoconcentration. Hemoconcentration causes the false increase of large molecules, such as proteins and cholesterol and the false decrease of electrolytes like chloride and potassium. Once blood flow is established, the tourniquet must be released. Tourniquets applied too tightly can cause petechiae. Site cleansing. Proper cleansing reduces the risk of infection. Blood culture collections require special care to prevent contamination of the sample with skin flora. As part of its QA program, the microbiology department keeps records of blood cultures contaminated with normal skin flora. Iodine must be removed from the site after collection, because it can irritate the skin. Iodine should not be used for dermal puncture, because it is virtually impossible to keep it out of the sample. Iodine interferes with bilirubin, uric acid, and phosphorus tests. Specimen collection. Specimens must be collected in the right tube for the test ordered and in the right order. The sample volume must be matched to the quantity of additives in the tube, and the tube size should be chosen to provide adequate volume for the test required. The specimen must be mixed gently and thoroughly by inversion immediately after being drawn. Labeling. Incorrect or incomplete labeling makes a specimen useless and requires redrawing the specimen at a later date. Label tubes immediately after they are drawn, before leaving the patient’s room. Be sure that the labeling is complete, and note any special patient conditions on the requisition. Patient’s Perception The patient’s perception of the level of care he or she receives is directly affected by the skill, professionalism, and care you show as a phlebotomist. This perception reflects not only on you but on the entire laboratory as well. You should strive to avoid painful probing, unsuccessful punctures, and repeated draws and be scrupulously careful regarding site selection, accidental arterial puncture, and nerve injury. In addition, infection control procedures must always be followed. Break the chain of infection by performing hand hygiene upon entering and leaving the room, and by wearing gloves during the procedure. Accidental Puncture Accidental puncture with a used needle must be reported immediately to a supervisor. Immediate and follow-up testing for bloodborne pathogens, plus counseling, is standard protocol for accidental needle sticks. QA procedures include monitoring the number of accidental punctures and instituting additional training or equipment modifications in the event of frequent accidents. Transportation Specimen transportation variables include the method of delivery, the treatment of the sample during transportation, and the timing of delivery. Samples requiring either cold or warm temperatures during transport must be placed in the appropriate container and must be handled so that the appropriate temperature is maintained throughout the transport process. A heel-warmer packet gradually loses its heat, for instance, and if the sample is not delivered before heat loss, the sample will be compromised. Short turnaround time (stat) specimens require prompt delivery and analysis, and the on-time record of the phlebotomist and the laboratory is analyzed in QA programs to determine whether changes must be made in transportation procedures. Pneumatic tube systems require special monitoring to ensure that the sample is not overly agitated during transport, causing hemolysis. Some samples cannot travel by pneumatic tube, and it is the phlebotomist’s responsibility to ensure their proper handling. The directory of services contains precisely this type of information. Processing Specimen processing is another area in which the phlebotomist and other laboratory staff have almost complete control over the variables that arise. These include the time between collection and processing, the centrifugation process, the possibility of contamination and evaporation, the proper storage conditions, and the processing of aliquots. Separation Times No more than 2 hours should elapse between the time a specimen is collected and the time serum or plasma is separated from formed elements. After this time, the sample will begin to show falsely lowered glucose and falsely elevated potassium and lactate dehydrogenase. Even less time should be allowed for determinations of potassium, adrenocorticotropic hormone, or cortisol. Ammonia samples must be separated within 15 minutes of collection. The exception is for samples collected in serum separator tubes, which are stable once they are spun and a good gel seal is in place. Centrifuge Maintenance Centrifuges must be calibrated every 3 months with a tachometer to ensure that they are running at the reported speed. Variation may indicate the need to replace worn parts. Spinning samples below the required speed may result in incomplete separation of liquid from formed elements, affecting test results. Evaporation and Contamination Specimens should not be left uncovered any longer than necessary during processing. Evaporation of liquid, especially from small samples, can affect ABGs, alcohol, and ammonia, among other tests. Contamination may occur while the sample is uncovered, arising from airborne dust or talc from gloves. Contamination may also occur from incomplete separation, such as when RBCs are left in the sample after incomplete centrifugation. Refrigerators and Freezers Fluctuations in cold storage units can degrade sample quality. Temperatures of refrigerators and freezers must be monitored daily, with temperatures recorded either automatically or manually at specified times of day. Temperature readings that are too high or low indicate that the unit needs maintenance or replacement. Aliquot Handling and Labeling Multiple aliquots prepared from a single specimen allow different departments to share a single sample for multiple tests. Each aliquot must be properly labeled as to the source and additives present. Specimens with different additives should never be combined in a single aliquot. Analytic Variables An analytic variable is any variable that affects the testing process. Although most samples are tested by medical laboratory scientist (MLS), medical technologist (MT), and medical laboratory technologist (MLT) laboratory personnel, the phlebotomist may be trained to perform CLIAwaived testing. It is important to understand the analytic variables that can have a negative impact on test results. Point-of-care testing instruments require calibration and controls to be performed before testing patient samples. If the instrument is malfunctioning or the reagents are bad, calibration and control values will fall outside the predetermined range of acceptance. If pipetting of reagents is required for a test, improper pipetting technique may yield results that fall outside the expected range or falsely fall inside the expected range. No tests should be run until the instrument is working properly. Always follow the manufacturer’s guidelines and any facility guidelines for ensuring that a point-of-care (POCT) instrument is functioning properly before testing a patient sample. Postanalytic Variables A postanalytic variable is any variable in the reporting and follow-up of test results. The phlebotomist may be responsible for reporting POCT results that he or she performed. Before a result is reported, it must be interpreted as being valid. A delta check, discussed earlier in this chapter, helps ensure that results generated are correct. If the result is outside the expected range, it may be necessary to perform the test again. If the phlebotomist is unsure, a MLS, MT, or MLT should be consulted. Once the result has been verified, the result is delivered to the physician ordering the test. The method of delivery is determined by the facility, and may include telephone, fax, computer, or hand delivery. 02 LEGAL CONSIDERATIONS In other courses in the Medical Assisting program you have covered legal considerations. This will be mostly a review of those concepts but from a phlebotomy perspective. Legal and ethical considerations form an important underpinning to the practice of medicine, and phlebotomy is no exception. An increasingly complex and litigious healthcare environment has made familiarity with legal issues an important part of the phlebotomist’s training. Medical malpractice is the most common legal claim in the healthcare field. Injuries that arise from failure to follow the standard of care may be grounds for a finding of malpractice. Careful observance of the standard of care, and documentation of that practice, is the best defense against malpractice. Comprehensive federal regulations governing the privacy of medical information have affected every sector of healthcare delivery. In addition to the legal requirement to protect patient confidentiality, there is an ethical duty to do so. Although full consideration of all the relevant legal issues is beyond the scope of this chapter, we introduce some important legal and ethical concepts that have an impact on the profession. The healthcare system has become increasingly complex in the past 2 decades. This complexity stems from the interplay of technologic advances, associated increased costs of delivering care, and fear of litigation. Several factors have led to the dramatic rise in healthcare costs in recent decades. First is the gradual inflation in the price of all goods and services. More important has been the growing sophistication of medical technology, with consequent higher costs for equipment purchase and maintenance, plus the need for highly trained operators at all levels of healthcare delivery. For instance, the cost of drawing a blood sample has risen significantly since the development of safety needles and other systems designed to protect the phlebotomist. The simple compound microscope that was used to do a differential blood count in the 1940s cost perhaps a few hundred dollars and required only occasional adjustment and cleaning. In contrast, today’s automated cell counters cost thousands of dollars and require frequent calibration and regular maintenance, as well as a higher level of training to operate. Similarly, the fast pace of drug discovery and development has increased the cost of medical treatment for the typical patient. All these advances have enhanced the quality of patient care, but at a significant price. In addition to these sources of cost increase, more stringent regulations designed to safeguard healthcare providers have led to higher costs for service delivery. Even more significantly, the availability of sophisticated technology has meant that more doctors order more tests on more patients, and that more patients expect them to order the tests. As the standard of care has risen, multiple sophisticated and expensive tests have been prescribed to supplement (and sometimes substitute for) a physician’s clinical judgment. Increased fear of litigation has also fueled the rise in the use of multiple tests, often as much to protect against future lawsuits as to provide crucial medical information. Such “defensive medicine” is understandable, given the very high cost of malpractice insurance and the potential for a ruinous liability judgment in the event of an oversight or mistake. The rising cost of healthcare has led to efforts to keep costs under control, including reimbursement restrictions on diagnostic tests and limitations on prescription drugs. Meanwhile, the rights of patients have been increasingly recognized and expanded, and the level of care expected by patients has grown. The American Hospital Association has created the Patient Care Partnership, a statement of what patients should expect during a hospital stay with regard to rights and responsibilities. It emphasizes the patient’s right to quality care, a clean and safe environment, and protection of privacy, among other rights. Because of the conflicts arising from the interplay of these factors, along with the general rise in litigation in our society, the healthcare professions have been subjected to more and more lawsuits. Understanding your legal obligations and rights in this complex system is an important part of your professional training. The Legal System To understand your rights and obligations under the law, it is helpful to know a little bit about how the legal system operates. Laws Laws are created in a variety of ways. Statutory law is created by a legislative body. At the federal level, this is Congress, made up of the Senate and the House of Representatives. These laws are called statutes. State legislative bodies vary from state to state but usually follow the federal model. Case law is law determined by court decisions, usually as an interpretation of existing statutory law. State courts rule on state laws, and federal courts rule on federal laws. The U.S. Supreme Court has ultimate jurisdiction over all laws, both federal and state. Administrative law is created by administrative agencies, such as the Internal Revenue Service (IRS) or the Occupational Safety and Health Administration (OSHA). The regulations promulgated by these agencies are given the force of law by the statutory laws that created the agencies. Laws are also classified as either public or private. When a public law is violated, the offense leads to a criminal action, and the violator is prosecuted by the public in the person of the government’s attorney (the district attorney). The offense may be either a felony or a misdemeanor, depending on the seriousness of the crime. Phlebotomists can be charged with violations of public law. Failing to obtain informed consent from a patient before any procedure is example of this. Therefore blood must never be drawn without first obtaining the patient’s consent. A patient can give consent either in writing or verbally. If a patient refuses to have his or her blood drawn, the phlebotomist must not attempt to force the patient to comply. To persist can lead to criminal charges of assault and battery. Assault is an unjustifiable attempt to touch another person, or the threat to do so. Battery is the intentional touching of another person without consent. There are only a few situations in which the person whose blood is being drawn is not the person whose consent must be obtained. Parents have the right to give consent for a child to have his or her blood drawn, even though the child may refuse and may even be combative. Legally appointed guardians give consent for patients who are incapacitated. If there is any doubt about who is entitled to give consent, always ask the nurse or physician before proceeding with the draw. In contrast to public law, when a private law is violated, the offense may lead to a civil action, in which the defendant is sued in civil court by the plaintiff, the person claiming to have been harmed by the defendant. Civil wrongs include torts. A tort is defined as any wrongful act that causes harm or injury to another person. Torts can be either intentional or unintentional. Unintentional torts are the basis for most medical malpractice suits. A malpractice suit may be brought against the individual causing the harm, or the institution employing the individual, or both. Supervisors may be held liable for the harms caused by an individual under their supervision. A patient may choose to bring a civil action in a case for which a criminal action was also brought, whether or not the defendant was found guilty in the criminal action. For instance, a patient with a damaged nerve may sue for malpractice even if the case was not strong enough to sustain a criminal action. Other causes of action could include reusing needles, careless probing for a vein, accidental artery stick resulting in injury to patient, drawing samples not requested by the physician, or releasing test results to someone not authorized to receive them. A patient must file a civil action within a specific time period after the damaged occurred, often within 2 years. This time period is called the statute of limitations. Settlement and Judgment Almost all civil and criminal actions are settled out of court. In an out-of-court settlement, the two parties reach an agreement without the intervention of a judge or jury. When a civil case is settled out of court, the settlement often includes a condition stating that neither party may discuss the amount of the settlement. When the parties cannot reach agreement, the case goes to court for trial and judgment. A judgment against the defendant in a civil case usually results in a fine (known as damages), which may be only compensatory (to pay for costs incurred because of the injury, such as further medical care) or punitive. Headline-making damage awards are most often for punitive damages. Judgments in either civil or criminal actions can be appealed if the losing party feels that some part of the court proceeding was in error. Judgments may be upheld, reversed, or modified on appeal. Professional Liability To be liable for an action means that you are legally responsible for it and can be held accountable for its consequences. As a medical professional, you are liable for both your actions (called an act of commission) and, in some cases, your failure to act (called an act of omission). For instance, if you damage a nerve while performing routine venipuncture, you may be held liable for an act of commission (i.e., something you did that you should not have). If a physician orders a test that you fail to perform and, as a result, the patient suffers harm, you may be held liable for an act of omission (i.e., something you did not do that you should have). You are legally responsible for any action you perform as a medical professional, whether or not it is a duty assigned to you or you have received training for it. For instance, if you perform an arterial puncture, you are liable for any injuries that may result from it, whether or not you have been properly trained to perform it. Therefore a professional should not attempt to perform duties for which he or she is not trained. As a phlebotomist, you must perform only those procedures that you have been properly trained to perform and that fall within your scope of practice as a phlebotomist. Your scope of practice is the set of procedures and responsibilities for which your training has prepared you and for which you have demonstrated competency. By performing a duty normally assigned to someone with a higher level of training and expertise, you are legally liable for that higher level of care. Your institution has policies and procedures regarding the duties you are expected to perform. Judgments regarding medical liability revolve around the concept of the accepted standard of care, which represents the consensus of medical opinion on patient care in a particular situation. The failure to perform an action consistent with the accepted standard of care is negligence. For example, phlebotomists violate the standard of care if a dirty needle is not properly disposed of and is used on another patient, or if the phlebotomist probes during the venipuncture to find the vein and damages nerves with improper drawing techniques. Cases have been prosecuted in which the phlebotomist did not correctly identify the patient and, as a result, the patient received incorrect test results and improper care. If the patient dies as a consequence, the phlebotomist could be charged with murder or manslaughter. When the standard of care is not followed, those professionals who were responsible for decision-making in that situation are liable for injuries incurred by the patient. For instance, most institutions allow a phlebotomist to make only two unsuccessful attempts at routine venipuncture before seeking the assistance of a more senior phlebotomist. If this is the accepted standard of care in your institution and you violate that policy, a patient who experiences harm or suffering as a result may have grounds to sue you and your hospital. The doctrine of respondeat superior means “Let the master answer.” Under this doctrine, employers are held liable for the actions of their employees who are performing their responsibilities as delineated in the employee’s scope of practice. As such, your actions as a phlebotomist can either protect the hospital against litigation or put it at risk. In a trial, the jury decides exactly what constitutes the accepted standard of care, whether that standard was followed, and whether the medical professionals were negligent. These decisions are usually made after listening to a variety of expert witnesses. Medical Malpractice Malpractice is the delivery of substandard care that results in harm to a patient. It is the most common liability in medicine and is sometimes called medical professional liability. A malpractice suit is brought by the plaintiff and usually names one or more professionals, as well as the institution, as the defendants. The suit alleges professional negligence as the cause of specific harms, which may include both physical and emotional distress, as well as lost income or potential income, as the result of specific actions. In a civil suit, the plaintiff asks for damages, or monetary compensation. Damages may be awarded to cover only the actual costs of the injury, such as lost wages or further medical care. Damages can also be awarded to compensate for legal costs or pain and suffering. Punitive damages may be awarded to punish the defendant, usually for gross violations of accepted standards of care. In a malpractice case, the burden of proof is on the plaintiff to show the four elements of negligence: duty, dereliction, injury, and direct cause. Duty The plaintiff must prove that the defendant owed the plaintiff a duty of care. For example, if a phlebotomist had a requisition for a patient and was expected by his or her supervisors to draw blood, the phlebotomist owed the patient a duty of care. Dereliction The plaintiff must prove that the defendant breached the duty of care to the plaintiff. This determination revolves around the accepted standard of care and the specific action or inaction of the plaintiff. For example, if a phlebotomist mislabeled the sample specified on the requisition, this may constitute dereliction or breach of duty. Injury The plaintiff must prove that a legally recognizable injury to the patient actually occurred. For instance, if mislabeling led to improper care that harmed the patient, injury occurred. If the time of draw for a therapeutic drug monitoring sample was written incorrectly, and the patient received too much medication as a result, the patient may be able to prove injury. Direct Cause The plaintiff must prove that the injury was sustained as a direct result of the defendant’s actions or inactions. For example, if overmedication can be shown to be a direct result of mislabeling, direct cause is demonstrated. Other Examples of Potential Malpractice in Phlebotomy The standard of care when drawing blood from a patient is to perform no more than two unsuccessful punctures before calling for assistance. A phlebotomist who continues to attempt venipuncture without calling for assistance at this point is derelict in his or her duty. A patient who subsequently experiences pain and swelling in the arm may have a cause of action, if it can be shown that the injury resulted from the excess number of attempts. The standard of care when drawing at a patient’s bedside is not to place the phlebotomy tray on the bed. A phlebotomist who does so is derelict in his or her duty. If a patient’s movements subsequently cause the tray to spill and filled tubes to break, the patient may be exposed to bloodborne pathogens (assuming the samples were from a different patient who was infected). To establish injury, the patient would then have to become infected. To establish direct cause, the patient would need to show that the infection was the result of the exposure (and not the result of exposure from some other source). The standard of care when leaving a patient’s bedside is to raise the bed rail if it was lowered for the draw. Therefore the phlebotomist has a duty to perform this action. If he or she fails to do so, this is a dereliction of duty. If the patient subsequently falls from bed and is injured, the question becomes whether the phlebotomist’s failure to raise the bed rail was the direct cause of the injury. Mitigating factors might include whether the patient had been visited by a nurse in the meantime and whether the fall was the actual cause of the injury. Other standards of care include proper patient identification, following the protocols for blood collection processes in all procedures, and the relevant protocols for all nonblood collection procedures. For example, proper site cleaning is part of the standard of care, and performing venipuncture without proper cleaning of the site is a violation. Once the site is cleaned, it cannot be touched even if the gloved finger is cleaned with alcohol. Phlebotomists must also follow all institutional policies and procedures as they apply to their scope of practice. Phlebotomists must also comply with all HIPAA regulations and safeguard the privacy of their patients. Defense Against Malpractice As the preceding examples illustrate, deviation from the standard of care leaves the phlebotomist exposed to charges of malpractice. Conversely, the principal defense against a malpractice suit is to show that the standard of care was followed. This requires not only the actual practice of good care but the documentation of it as well. Clear, complete medical records are the cornerstone of the defense, because they show exactly what was done, when, by who, date, time, and witness if any. If good care is delivered and good medical records document this, a malpractice suit has little chance of succeeding. Similarly, if a situation arises in which observation of the standard of care is called into question, all parties should carefully document exactly what happened—who did what when. For instance, if a patient complains of a shooting pain during a draw, you have a responsibility to follow institutional protocol to deal with the injury or the complaint; you should not try to avoid reporting it. Each institution has a set of protocols for reporting such incidents, which usually involve prompt and complete documentation of the circumstances of the incident in an event report. Patient communication is also an important aspect of preventing malpractice claims. For instance, clear communication with the patient is essential for obtaining informed consent for medical procedures. Procedures must be explained in a way that the patient can understand, and the patient must give positive consent (“Yes,” or “I understand”), not merely a nod of the head or a look of agreement. If you and the patient do not speak the same language, an interpreter must be present to explain the procedure. As another example, you must remember to ask specifically whether the patient is taking blood-thinning medications, such as heparin. Without this information, you may not apply pressure long enough after the draw, possibly leading to compartment syndrome, a potentially serious complication. The only time nonverbal consent is acceptable is in cases in which immediate action must be taken to save a patient’s life. This is called implied consent. A medical emergency removes the need for informed consent. If a patient rolls up his or her sleeve and extends the arm after being told by the phlebotomist that he or she is there to draw the patient’s blood, this too indicates implied consent. Liability Insurance Liability insurance covers monetary damages that must be paid if the defendant loses a liability suit. Most hospitals require a doctor to show proof of insurance before receiving admitting privileges. Phlebotomists are usually covered by their institution’s liability insurance, although some phlebotomists also obtain their own. Confidentiality In addition to your legal obligations, as a phlebotomist you are bound by both legal and ethical responsibilities, especially in the area of confidentiality. With the passage of the Health Insurance Portability and Accountability Act (HIPAA), the privacy of medical information has taken on legal ramifications as well. Health Insurance Portability and Accountability Act HIPAA defines a set of standards and procedures for protection of privacy of health information. Protected health information (PHI) is any part of a patient’s health information that is linked to information that identifies the patient, such as date of birth, name, Social Security number, or address. PHI includes all medical and billing information in the patient’s medical record, including diagnosis of all medical diseases, the results of tests, provider notes, insurance filings, patient payments, and other related information, in all forms include written, oral, and electronic. Violations include errors in the transmission of PHI, such as transmission to the wrong provider. Under HIPAA, patients have the right to control their PHI, and disclosing PHI to anyone without the patient’s consent is illegal. Upon intake, patients are informed of their rights under HIPAA. Your institution should have defined procedures for protecting private health information while allowing that information to be disclosed to those who need to know it and have a right to know it. Entities that require access to a patient’s PHI for the purpose of medical treatment and billing for services are covered by HIPAA, including: Health insurance companies Healthcare clearing houses, such as medical billing companies Healthcare providers: doctors, nurses, hospitals, laboratories, radiology, and pharmacy Business associates: entities that perform services on behalf of the covered entity Safeguarding a patient’s privacy requires several precautions: Never discuss a patient’s condition, tests, or financial information in a public place, such as a hallway, elevator, or eating area. Be careful to keep phone conversations private. Avoid using the patient’s name if possible. Never discuss information concerning a patient with someone not directly involved in that patient’s care. Never release medical information concerning a patient to anyone not specifically authorized to acquire it. Disclosure of information to a third party (such as an employer, the news media, or a relative other than the parent or legal guardian of a minor) requires written authorization from the patient. Never leave patient records out where patients or visitors can glance at them. Always log off computers when tasks are completed. When HIPAA is violated, penalties may be enforced against covered entities and any employee working for a covered entity who had responsibility for the violation. Penalties may include fines and prison terms. The severity of the penalty depends on, among other factors, whether the violation was intentional and whether a profit was made with the violation. In addition to protecting the patient’s right to privacy, you have an obligation to maintain the integrity of the doctor–patient relationship. This means that you should not reveal test results to the patient but should leave this to the physician. A patient is also entitled to privacy out of ethical considerations alone. As noted earlier, the Patient Care Partnership was developed by the American Hospital Association to encompass not only the right to confidentiality but also other important aspects of ethical patient care. While it does not carry the force of law, it represents an ideal that healthcare institutions may use to evaluate their own practices. SOURCE: Warekois, Robin, S. et al. Phlebotomy. Available from: Pageburstls, (5th Edition). Elsevier Health Sciences (US), 2020.