Chapter 2: Quality Assurance and legal Issues in Healthcare
A 12-year-old inpatient who refused to have his blood collected was restrained by a healthcare worker while the phlebotomist collected the specimen. This could be considered an example of a. assault and battery. b. implied consent. c. malpractice. d. negligence.
Answer: a WHY: A 12-year-old is not old enough to give consent for a medical procedure such as phlebotomy. A phlebotomist who collects a blood specimen from a minor without permission from a parent risks being charged with assault and battery. If no harm to the patient was involved, this would not be considered negligence or malpractice. The patient refused blood collection, so this is not considered implied consent.
Which of the following would violate a patient's right to confidentiality? a. Discussing the nature of a patient's test results with the family b. Giving the patient a physician's name that you know and trust c. Sharing information on a "difficult draw" with a coworker d. Showing a patient his or her lab results when requested
Answer: a WHY: As a professional, the phlebotomist should recognize that all patient information is private or confidential. A recent ruling by the Department of Health and Human Services states that patients may request to see their laboratory test results, but it is not a phlebotomist's duty to give them out unless that is the institution's policy. However, letting other phlebotomists know where the best site is to obtain a blood sample on a patient who is a "difficult draw" is part of proper patient care and not considered a violation of patient confidentiality.
A patient is told that she must remain still during blood collection or she will be restrained. Which tort is involved in this example? a. Assault b. Battery c. Fraud d. Malpractice
Answer: a WHY: Assault involves the act or threat of causing an individual to be in fear of harm. Threatening to restrain the patient can be considered assault. Restraining an unwilling patient and collecting a blood specimen without permission can be considered assault and battery.
Drawing a patient's blood without his or her permission can result in a charge of a. assault and battery. b. breach of confidentiality. c. malpractice. d. negligence.
Answer: a WHY: Attempting to collect a person's blood without permission can be perceived as assault, which is the act or threat of intentionally causing a person to be in fear of harm to his or her person. If the act or threat is carried out, then it can also be perceived as battery. Battery is defined as the intentional harmful or offensive touching of a person without consent or legal justification. Breach of confidentiality involves failure to keep medical information private or confidential. Negligence requires doing something that a reasonable person would not do or not doing something a reasonable person would do. Malpractice is negligence by a professional.
Civil actions involve a. legal proceedings between private parties. b. offenses that can lead to imprisonment. c. regulations established by governments. d. violent crimes against the state or nation.
Answer: a WHY: Civil actions involve legal proceedings between private parties. The most common civil actions involve tort. For example, a claim of malpractice because of harm or injury to a patient by a phlebotomist is a civil wrong or tort. Crimes against the state or that violate laws established by governments are criminal actions for which a guilty individual may be imprisoned.
Legal actions in which the alleged injured party sues for monetary damages are a. civil actions. b. criminal actions. c. malpractice. d. vicarious liability.
Answer: a WHY: Civil lawsuits are concerned with actions between private parties, such as individuals or organizations, and constitute the bulk of the legal actions dealt with in healthcare. Almost all legal actions against healthcare workers are civil actions in which the alleged injured party sues for monetary damages. Criminal action deals with felonies and misdemeanors. Malpractice, a type of negligence, would constitute a civil action. Vicarious liability is a liability imposed by law on one person for acts committed by another.
A laboratory technician asked a phlebotomist to recollect a specimen on a patient. When the phlebotomist asked what was wrong with the specimen, the technician replied, "The specimen was OK, but the results were inconsistent." How might the laboratory technician have decided that the results were questionable? The results did not a. compare with previous results after a delta check. b. match results of patients with the same diagnosis. c. measure up to the results on the control specimens. d. relate well to other patients tested at the same time.
Answer: a WHY: Delta checks compare current results of a test with previous results for the same test on the same patient. Although some variation is to be expected, a major difference in results could indicate error and require investigation.
The level of care that a person of ordinary intelligence and good sense would exercise under the given circumstances is the definition of a. due care. b. quality care. c. critical care. d. standard of care.
Answer: a WHY: Due care is a level of care that is expected to be exercised by a person of ordinary intelligence and good sense under the given circumstances. The standard of care is the level of skill and care that is expected to be performed to provide due care. Quality care and critical care are phrases that might be used in healthcare to describe types of assistance or supervision given to a patient.
Why would a physician order a test for bismuth in the urine? a. An abnormal quantity of this substance may cause renal damage. b. Mineral supplements and bismuth preparations cause diarrhea. c. Pepto-Bismol can become addictive and cause stomach ulcers. d. Too much bismuth causes inflammation of the digestive track.
Answer: a WHY: Elevated levels of bismuth in the body can cause renal damage and neurologic problems, such as dementia. Any medications and mineral supplements containing bismuth should be stopped one week prior to the test so the results will not be affected.
How do QA and QC differ? a. QA aims to prevent future problems. b. QA is a component of a QC program. c. QC attempts to prevent future problems. d. All the above.
Answer: a WHY: Even though QA and QC are often mistakenly used interchangeably the terms have different meanings. QA is a program or process that is designed to prevent problems in the future by evaluating present and past performance. QC is a component of a QA program and is used to prevent problems before results are released.
An example of a person-specific identification is the a. assigned medical record number. b. information shown on an IV pole. c. patient's private room number. d. All of the above.
Answer: a WHY: Examples of person-specific identification include full name, date of birth, and medical record number. The patient's room number or patient information on the IV pole cannot be used as an identifier.
When the threshold value of a QA clinical indicator is exceeded and a problem is identified, a. an action plan is implemented. b. an incident report must be filed. c. patient specimens must be redrawn. d. the patient's physician is notified.
Answer: a WHY: If the threshold of an indicator is exceeded (see Fig. 2-1), data are collected and organized to see if there is a problem. If a problem is identified, an action plan called a corrective action preventative action (CAPA) plan is established and implemented.
In the central processing area of a large clinical laboratory, a. computers monitor refrigerator and freezer temperatures. b. periodic reports on equipment are required by the CDC and OSHA. c. QC checks on the centrifuges are done by phlebotomists. d. refrigerator temperatures are monitored by the lab manager.
Answer: a WHY: In a large laboratory, items such as refrigerators, freezers, and centrifuges are monitored by computers, and reports are sent to the facilities department. Inspections on the reliability and consistency of these items are done by TJC or CAP.
An example of negligence is when the phlebotomist a. fails to report significant changes in a patient's condition. b. forgets to sign off the patient draw at the nurses' station. c. is unable to obtain a specimen from a combative patient. d. misses the vein and redirects the needle to complete the draw.
Answer: a WHY: Not reporting an obvious problem with a patient's condition (such as severe breathing difficulties or inability to awaken) could lead to serious consequences and is an example of negligence or failure to exercise reasonable care. Inability to obtain a specimen from a patient is not negligence, especially if the patient is combative and not willing to cooperate. It is not a major issue if the patient is not signed out as the phlebotomist leaves the nursing area. A quick call can inform the nursing staff of the patient's phlebotomy status.
Which of the following is a phlebotomy QA procedure? a. Checking needles for blunt tips and barbs b. Keeping a record of employee sick leave c. Recording any instrument maintenance d. Tracking all laboratory OSHA violations
Answer: a WHY: QA procedures include checking for needle defects before use. It is not part of the phlebotomy QA to track all laboratory OSHA violations or to record any of the chemistry instrument maintenance. Keeping a record of employee paid sick leave is an important personnel issue but is not a part of laboratory QA.
An example of a QC measure in phlebotomy is a. checking the expiration dates of evacuated tubes. b. documenting every missed venipuncture. c. logging hours worked on the timesheet daily. d. recording patient census daily in the computer.
Answer: a WHY: QC procedures involve checking all operational procedures to make certain they are performed correctly. This includes checking expiration dates of evacuated tubes. Phlebotomy QC does not mean documenting every missed venipuncture or recording patient census daily. Filling out the timesheet is important but is not considered a QC procedure.
CLIAC's role in assisting CMS to administer CLIA is to a. advise. b. educate. c. inspect. d. manage.
Answer: a WHY: The Clinical Laboratory Improvement Advisory Committee (CLIAC) was formed to assist in administering Clinical Laboratory Improvement Amendments (CLIA) regulations. Its purpose is to provide technical and scientific guidance or advice to the appropriate people at the Centers for Medicare and Medicare Services (CMS) who are administering the regulations. CLIAC's advice centers on the need for revisions to the standards.
The Joint Commission a. accredits healthcare organizations. b. approves phlebotomy programs. c. certifies laboratory personnel. d. develops phlebotomy standards.
Answer: a WHY: The Joint Commission is a nongovernmental agency that establishes standards and provides accreditation for healthcare organizations. Their standards focus on improving the quality and safety of care provided and stress performance improvement by requiring healthcare facilities to be directly accountable to their customers. The Clinical and Laboratory Standards Institute (CLSI) develops standards for laboratory procedures, including phlebotomy. NAACLS develops phlebotomy competencies and has an approval process for phlebotomy programs. Laboratory personnel are certified by organizations such as ASCP, AMT, and NCA.
TJC's National Patient Safety Goals address a. healthcare-associated infections. b. proficiency testing in the laboratory. c. tracking methods for complaints. d. waived testing practices and protocol.
Answer: a WHY: The Joint Commission's National Patient Safety Goals address several areas of healthcare. A safety expert panel as well as physician, nurse, and risk managers review and update the CQI-required safety goals. Examples of areas addressed are patient identification, staff communication, and healthcare-associated infections (HAIs).
The purpose of The Joint Commission's Office of Quality Monitoring is to a. evaluate and track complaints related to care. b. implement immediate response to safety issues. c. inspect healthcare facilities for accreditation. d. set specific patient safety goals to improve care.
Answer: a WHY: The Joint Commission's Office of Quality Monitoring was created to evaluate and track complaints about healthcare organizations relating to quality of care. The office has a toll-free line that can help people register their complaints. Information and concerns often come from patients, their families, and healthcare employees.
Which hospital department's blood culture collections exceeded the threshold for each month of the quarter? a. Emergency room b. Laboratory c. Outpatient services d. Radiology
Answer: a WHY: The report on the form in Figure 2-1 clearly states that the emergency room (ER) is over threshold for each month of the quarter. The percentage of contaminated draws for the ER went as high as 11.5% in May. The report shows the comparison between laboratory draws and those in the ER. This QA indicator tool is an objective measurement of phlebotomist technique.
Which one of the following actions points to negligence? a. Causing harm as a result of a violation of duty b. Documenting an unusual happening during a draw c. Informing the patient of a scheduled lab procedure d. Watching for implied consent from the patient
Answer: a WHY: To claim negligence, the following elements must be present: a legal obligation or duty owed by one person to another, a breaking of that duty or obligation, and harm resulting from that breach of duty. Informing the patient of a scheduled lab procedure is the responsibility of the person who ordered the test. Watching for implied consent from a patient is necessary in some cases. Documenting an unusual happening during venipuncture is a good habit to get into in case there are future complaints.
CLIA laboratories that perform high-complexity testing a. are funded by the federal government. b. are subjected to routine inspections. c. must hire PhDs as supervisors. d. must renew their certificates annually.
Answer: b WHY: CLIA requirements are stringent for laboratories that perform moderate- and high-complexity testing. These laboratories are subject to routine inspections and must have written protocols for all procedures used. The laboratories are not federally funded. Personnel standards do not dictate that PhDs be hired as supervisors. The certificates do not need to be renewed annually.
Continuous quality improvement means a. accepting unionization by the hourly employees. b. being committed to ongoing process monitoring. c. overseeing employees' investments and retirement. d. providing annual salary increases and bonuses.
Answer: b WHY: Continuous quality improvement means the institution is committed to an ongoing effort to improve all necessary processes so as to provide better service to their customers, the patients. Normally, unionization, employee investments, and financial issues do not fall under the institution's CQI plans.
A process in which one party to a lawsuit or a witness for that party is questioned under oath while a court reporter records every word is a a. civil action. b. deposition. c. discovery. d. tort.
Answer: b WHY: Giving a deposition is a process in which a party or witness for one party is questioned under oath by a lawyer from the other party with both defense and prosecuting attorneys present. A court reporter records every word. Discovery is the process in which both sides exchange information about witnesses and evidence that will be presented at trial. It involves both sides taking depositions and submitting questions called interrogatories that must be answered in writing. Civil actions are procedures in which the alleged injured party sues for monetary damages, and the tort is the most common civil action in healthcare.
Significant gaps in the quality of waived testing practices in physicians' offices, for example, resulted in the recent development of a. behavioral competencies. b. good laboratory practices. c. quality indicators. d. test threshold values.
Answer: b WHY: Good Laboratory Practices (GLPs), as seen in Box 2-1, are 10 QA recommendations developed by the Clinical Laboratory Improvement Advisory Committee (CLIAC) for Certificate of Waiver (CoW) labs because of problems with the quality of their testing practices. These GLPs emphasize QA when collecting and performing blood work using waived testing kits.
The abbreviation ISO stands for an entity that a. accredits national standards-setting bodies. b. develops voluntary international standards. c. identifies safety violations by U.S. industries. d. promotes international safety organizations.
Answer: b WHY: ISO stands for the International Organization for Standardization, which is a nongovernmental international organization of 162 national standards bodies from all over the world, whose members share knowledge and develop voluntary international standards that cover many industries, including healthcare.
A patient agrees to undergo treatment after the method, risks, and consequences are explained to him. This is an example of a. implied consent. b. informed consent. c. c.respondeat superior. d. standard of care.
Answer: b WHY: Informed consent implies voluntary and competent permission for a medical procedure, test, or medication and requires that the patient be given adequate information as to the method, risks, and consequences involved before consent is given. In implied consent, the patient's actions or condition (as in an emergency in which the patient is unconscious) indicate consent rather than a verbal or written statement.
Malpractice is a claim of a. breach of confidentiality. b. improper treatment. c. invasion of privacy. d. res ipsa loquitur.
Answer: b WHY: Malpractice can be described as improper or negligent treatment by a professional resulting in injury, loss, or damage. Breach of confidentiality involves failure to keep medical information private or confidential, as opposed to invasion of privacy, which involves physical intrusion or the unauthorized publishing or releasing of private information. Res ipsa loquitur is a Latin phrase meaning "the thing speaks for itself" and applies to the rule of evidence in cases of negligence in which a breach of duty is obvious.
All of the following are subject to quality-control (QC) procedures by a phlebotomist EXCEPT a. patient identification. b. patient IV adjustment. c. phlebotomy technique. d. specimen labeling.
Answer: b WHY: Patient identification, phlebotomy technique, and specimen handling are all areas of phlebotomy that are subject to QC procedures. Adjusting a patient's IV is not in the scope of practice for a phlebotomist.
Which preanalytical factor that can affect validity of test results is not always under the phlebotomist's control? a. Patient identification b. Patient preparation c. Specimen collection d. Specimen handling
Answer: b WHY: Preparing a patient for testing is not generally under the control of the phlebotomist. However, it is up to the phlebotomist to determine that preparation procedures have been followed. For example, if a test is ordered fasting, the phlebotomist must check to see that the patient is indeed fasting. The phlebotomist is responsible for obtaining proper patient identification, collecting the specimen, and handling the specimen properly after collection until turning it over to the laboratory for testing.
One of the steps in the risk management process is a. approving rule variations. b. educating employees. c. sharing issues with patients. d. validating new treatments.
Answer: b WHY: Risk management is a process that focuses on identifying and minimizing situations that pose a risk to patients and employees. Generic steps in risk management involve ID of the risk, treatment of the risk using policies and procedures already in place, education of employees and patients, and evaluation of what should be done in the future. Sharing issues and information with patients is unauthorized, can lead to the issues with personnel, and is not one of the designated steps in the process. Approving rule variations and validating new treatments is not part of the risk management process.
The abbreviation for the federal regulations that established quality standards for all laboratories that test human specimens is a. BBP standard. b. CLIA '88. c. HazCom. d. OSHA.
Answer: b WHY: The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) are federal regulations aimed at ensuring the accuracy, reliability, and timeliness of patient test results regardless of the size, type, or location of the laboratory. CLIA regulations pertain to all laboratories in the United States that perform laboratory testing used for the assessment of human health or the diagnosis, treatment, or prevention of disease. The Occupational Safety and Health Act (OSHA) mandates safe working conditions for employees and is enforced by the OSHA. The Bloodborne Pathogens (BBP) standard was instituted by OSHA to protect employees from exposure to bloodborne pathogens. The Hazard Communication standard (HazCom) was developed by OSHA to protect employees from exposure to hazardous chemicals.
The standard of care used in phlebotomy malpractice cases is often based on standards from which organization? a. CAP b. CLSI c. OSHA d. NAACLS
Answer: b WHY: The Clinical and Laboratory Standards Institute (CLSI) is a global, nonprofit organization that publishes standards for phlebotomy procedures. These standards are recognized as the legal standard of care for phlebotomy procedures. CAP sets standards for laboratories, but not specifically for phlebotomy procedures. OSHA sets and enforces standards regarding the safety of employees. NAACLS approves phlebotomy programs.
The guidelines and standards from which organization are the basis for national certification exam questions and the standards of care for the laboratory? a. ACO b. CLSI c. HIPAA d. PHS
Answer: b WHY: The Clinical and Laboratory Standards Institute (CLSI) is a global, nonprofit standards-developing organization with representatives from the profession, industry, and government. CLSI uses a widespread agreement process to develop voluntary guidelines and standards for all areas of the laboratory.
The abbreviation for a national agency that sets standards for phlebotomy procedures is the a. ASCP. b. CLSI. c. NAACLS. d. NCCT.
Answer: b WHY: The Clinical and Laboratory Standards Institute (CLSI) is a global, nonprofit, standards-developing organization with representatives from the profession, industry, and government who use a consensus process to develop guidelines and standards for all areas of the laboratory. The American Society for Clinical Pathology (ASCP), NCCT, and NAACLS are organizations that contribute to the standards of phlebotomy practices by offering continuing education, certification exams, and phlebotomy program approval, respectively.
Which organization provides voluntary laboratory inspections and proficiency testing? a. ASCP b. CAP c. CLSI d. OSHA
Answer: b WHY: The College of American Pathologists (CAP) is a national organization of board-certified pathologists that offers laboratory inspection and proficiency testing. OSHA inspections involve safety violations. The American Society for Clinical Pathology is an organization that certifies laboratory personnel. The Clinical and Laboratory Standards Institute (CLSI) develops standards and guidelines for laboratory procedures, including phlebotomy. OSHA mandates and enforces safe working conditions for employees.
The Joint Commission a. accredits or approves schools of phlebotomy. b. has a toll-free line for customer complaints. c. offers proficiency testing for the laboratory. d. writes guidelines for purchasing equipment.
Answer: b WHY: The Joint Commission created an Office of Quality Monitoring to track and evaluate complaints about healthcare organizations and their quality of care. The office has a toll-free line that can help people register their complaints.
The Joint Commission's Sentinel Event program's purpose is to a. demonstrate flexibility in setting QC measures. b. prevent unfavorable events from happening again. c. research healthcare organizations' collection of data. d. standardize measurements of quality performance.
Answer: b WHY: The Joint Commission is committed to improving the safety of patients. The Joint Commission's quality improvement sentinel event policy is intended to identify unfavorable occurrences, initiate an immediate response, and take steps to prevent it from happening again. It stresses early identification of serious physical or psychological injury or any deviation from practice that increases the chance that an undesirable outcome might recur. Because the intent of this policy is to protect the patients and residents, it can never be considered flexible. Researching healthcare organizations' (HCOs') data collection and working to standardize QA is not the goal of the sentinel event QI program.
A deficiency rated moderate by the SAFER Matrix could happen a. at any time. b. occasionally. c. only rarely. d. within a year.
Answer: b WHY: The Joint Commission's SAFER Matrix rates the likelihood of harm associated with a deficiency as either low (rare, but could happen); moderate (occasionally happens); or high (could happen at any time). The scope of the deficiency is identified as limited, a pattern, or widespread.
The use of the microbiology quality assessment form for tracking and evaluating blood cultures began in which year? a. 1985 b. 1990 c. 2000 d. 2004
Answer: b WHY: The date this QA monitoring began was in 1990 (see Fig. 2-1). This long-term tracking serves to point out valuable patterns in collection and gives insight into corrective actions that can be taken.
The definition of a minor is anyone a. who is not self-supporting. b. who is not the age of majority. c. younger than 18 years of age. d. younger than 21 years of age.
Answer: b WHY: The definition of a minor is anyone who has not reached the age of majority. The age of majority is determined by state law and normally ranges from 18 to 21 years of age regardless of whether the individual is self-supporting.
This quality assessment and tracking tool shows the number of contaminated blood cultures to be highest in which month? a. April b. May c. June d. September
Answer: b WHY: The number of contaminated blood culture draws was highest in May (see Fig. 2-1).
A lawsuit is filed against the phlebotomist after a patient claimed an injury occurred during a venipuncture. In litigation proceedings, the phlebotomist is the a. client. b. defendant. c. plaintiff. d. prosecutor.
Answer: b WHY: The person against whom a complaint has been filed is the defendant. The person who complains of injury is the plaintiff and will become the prosecuting attorney's client.
A phlebotomist explains to an inpatient that he has come to collect a blood specimen. The patient extends his arm and pushes up his sleeve. This is an example of a. expressed consent. b. implied consent. c. informed consent. d. refusal of consent.
Answer: b WHY: With implied consent, the patient's actions or condition (e.g., emergency situations in which the patient is unconscious) indicate consent, rather than a verbal or written statement. A patient who extends his or her arm and pushes up his or her sleeve after being told that the phlebotomist is there to collect a blood specimen is implying consent with his or her actions. The patient is obviously not refusing consent or he or she might have pulled his or her arm away and kept the sleeve down. To give expressed consent, the patient would have to provide a written or verbal statement of consent. Implied consent can be informed consent; however, implied consent is the best choice because it is a more specific answer to the situation.
Deceitful practice or false portrayal of facts either by words or conduct is the definition of a. battery. b. discovery. c. fraud. d. negligence.
Answer: c WHY: Fraud is a deliberate deception carried out for unlawful gain and is in the form of a deceitful practice or false portrayal of facts, either by words or by conduct. Battery is defined as intentional harmful or offensive touching of or use of force on a person without consent or legal justification. Negligence is failure to exercise due care. If any of these torts make it to court, a formal discovery will occur, which involves taking depositions and interrogating parties involved.
After a failed venipuncture attempt and before deciding to switch to the patient's other arm, the phlebotomist moves the needle around several times in search of the vein without knowing exactly where the needle is in relationship to the desired vein. No blood was obtained. At the new site, blood easily flows and the venipuncture is completed. The patient later complains of pain in the antecubital area where the phlebotomist was unsuccessful. What claim can be made against the phlebotomist? a. Assault b. Fraud c. Negligence d. Res ipsa loquitur
Answer: c WHY: Negligence is failure to exercise due care or perform duties according to the standards of the profession. If a medical procedure such as phlebotomy results in injury, a claim of negligence can be made by the injured party. Redirecting the needle multiple times in an attempt to locate a vein without knowing where the vein and needle are currently located in the arm is called probing and is not considered due care because it can result in damage to nerves, arteries, and other tissues. Pain in the area where the venipuncture attempt was unsuccessful is an indication that the patient may have been physically harmed by the probing.
CLIA categorizes certificates for laboratories according to a. personnel qualifications. b. quality-control standards. c. the complexity of testing. d. the size of the laboratory.
Answer: c WHY: Not all laboratories perform the same level of testing. All laboratories subject to CLIA '88 regulations are required to obtain a CLIA certificate according to the complexity of testing performed there. Complexity of testing is based on the level of difficulty involved in performing a test and the degree of risk of harm to the patient if the test is performed incorrectly. The higher the complexity of testing performed, the more stringent the CLIA requirements are. Personnel qualifications are spelled out in the regulations but do not determine the type of certificate the laboratory will be awarded. In addition, QC standards and the size of the laboratory do not play a part in determining CLIA certification.
If a specimen label was not completely filled out, which category does that fall under on the occurrence form? a. Disposition b. Patient order information c. Specimen identification d. Specimen integrity
Answer: c WHY: On the near-miss/occurrence report form, the error in the collection process is listed under "Specimen Identification" because the patient name and other required identifying information on the specimen label must be complete for it to be accepted for testing. An incompletely labeled specimen must be redrawn. The phlebotomist and the error are documented and corrective action is noted.
One of The Joint Commission's screening criteria used to determine accreditation of the clinical laboratory is the category "Immediate Threat to Health and Safety." An example of failing to meet this criterion would be a. absence of a QC program for each area of the laboratory. b. lack of documentation of ongoing education for the staff. c. recurrent problems with proper patient identification. d. use of unlicensed personnel in a state that requires it.
Answer: c WHY: One of the four scoring categories used to screen pre- and postanalytical processes in the laboratory is "immediate threat to health and safety." If patient identification is not carefully and methodically performed, it is a critical threat to the health and safety of patients. Because of the severity of this category, preliminary denial of accreditation (PDA) would be issued until corrective action is validated.
Guides used to monitor all aspects of patient care are called a. IQCP tools. b. PI standards. c. QA indicators. d. QC deficiencies.
Answer: c WHY: QA indicators are measurements or values that provide information on the effectiveness or quality of processes. For example, they can be used to monitor adequacy, accuracy, timeliness, and customer satisfaction. QA indicators are designed to look at all areas of care and are used in conjunction with process improvement tools, such as Lean or Six Sigma, to monitor workflow and outcomes. Individual quality control plans (IQCP) are the latest addition to the CLIA quality system and allow laboratories to customize their QA programs.
An internal process focused on identifying and minimizing situations throughout the healthcare organization that pose danger to patients and employees is a. a performance improvement plan. b. decision criteria for accreditation. c. facility-wide risk management. d. the delta check procedure.
Answer: c WHY: Risk is managed in two ways: controlling risk to avoid incidents and paying for occurrences after they have happened. Risk management focuses on minimizing the situations that could lead to occurrences for patients and employees. Sentinel event policies signal the need for immediate investigation and response to an occurrence that had unexpected results. Performance improvement plans and delta checks in an institution deal with QA rather than risk management.
One of the responsibilities of the Centers for Medicare and Medicaid Services (CMS) is to a. accredit all educational facilities. b. operate risk management programs. c. oversee administration of CLIA '88. d. provide healthcare worker insurance.
Answer: c WHY: The Centers for Medicare and Medicaid Services (CMS) is an agency of the U.S. government that administers or manages federal healthcare programs for Medicare and Medicaid. The supervision of federal regulations passed by Congress such as the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) also falls under its scope of authority. Although the CMS manages federal healthcare programs, it is not in the business of insuring medical personnel, operating risk management programs, or accrediting educational programs.
The standard of care in the practice of phlebotomy is influenced by which of the following organizations? a. The Environmental Protection Agency b. The Health Insurance Privacy Agency c. The Joint Commission and CAP d. The U.S. Food and Drug Administration
Answer: c WHY: The Joint Commission and CAP are standards-setting bodies. All departments of a healthcare facility, including the laboratory, must comply with TJC standards to receive accreditation. A CAP-certified laboratory must have documentation in an employee's file that the employee is qualified and trained to perform the responsibilities for which he or she is assigned. The Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) are agencies of the federal government that are designed to protect the public in their respective areas.
What is the abbreviation for an agency that has an approval process for phlebotomy programs? a. CLIAC b. CLSI c. NAACLS d. NCCT
Answer: c WHY: The National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) is an agency that approves phlebotomy programs. The Clinical Laboratory Improvement Advisory Committee (CLIAC) was formed to advise CMS regarding CLIA '88. The Clinical and Laboratory Standards Institute (CLSI) develops standards for laboratory procedures, including phlebotomy. The National Center for Competency Testing (NCCT) is one of the several organizations that certify laboratory personnel, including phlebotomists.
One of the NPSGs specified in 2018 is for the laboratory to a. decrease the number of sick days. b. identify and report safety issues. c. improve staff communication. d. increase proficiency testing.
Answer: c WHY: The annually updated goals address several critical areas of concern that contribute to patient safety and describe expert-based solutions. For 2018, the National Safety Patient Goals for the clinical laboratory are (a) identify patients correctly, (b) improve staff communication, and (c) prevent infections by complying with current hand hygiene guidelines from the CDC or WHO.
If a sentinel event occurs, the healthcare organization is required to a. develop new personnel guidelines and standards. b. incorporate a complaint procedure into the process. c. monitor improvements to see if they are effective. d. send a complete report to The Joint Commission.
Answer: c WHY: The intent of this policy is to help healthcare organizations identify sentinel events and take steps to prevent them from happening again. The steps involve conducting a thorough analysis of the cause, initiating improvements to reduce the risk, and monitoring improvements for effectiveness. HCOs are not expected to develop new personnel standards or create a complaint procedure. After an event, the HCO is not required to report these incidents to The Joint Commission.
Which laboratory document describes in detail the steps to follow for specimen collection? a. OSHA safety manual b. Policy guidelines c. Procedure manual d. Safety manual
Answer: c WHY: The laboratory procedure manual is a reference book that describes in detail the step-by-step processes for specimen collection and other procedures performed in the laboratory. An example of a page from a procedure manual is shown in Figure 2-4. Other manuals may contain information on safety, details on administrative duties, or data for the QC program.
Which of the following contains a chronologic record of a patient's care? a. Delta check b. Internal report c. Medical record d. Test catalog
Answer: c WHY: The medical record is a chronologic record of a patient's care and serves as a valuable tool in evaluating medical treatment and communicating with all the patient's caregivers. A delta check compares current results of a lab test with previous results for the same test on the same patient. A major difference in results could indicate an error and requires investigation. An internal report is used for specific incidents, and the test catalog gives specimen requirements and collection information.
Which one of the following is found in a procedure manual? a. Description of QC checks for equipment used b. Instruction for reporting errors in specimen handling c. Listing of all revision dates for the procedure d. References to the applicable CLIA regulations
Answer: c WHY: The procedure manual states the policies and procedures that apply to each test or practice performed in the laboratory. It is a QA document that must be made available to all employees of the laboratory for standardization purposes. Among other things, it contains actions taken, purpose of the procedure, and all revision dates (Fig. 2-4).
The process in which both parties exchange information by taking depositions and submitting interrogatories to the other party involved in a lawsuit is called a. collaboration. b. deposition. c. discovery. d. litigation.
Answer: c WHY: The process in which both sides in a lawsuit exchange information about witnesses and evidence that will be presented at trial is called discovery. It typically involves each party taking depositions and submitting questions called interrogatories that must be answered in writing by the other party involved. Some collaboration may be involved but it is not the term used to describe this process. Litigation is the process used to settle disputes, and discovery is part of this process.
Performing one's duties in the same manner as any other reasonable and prudent person with the same experience and training is referred to as a. required care. b. res ipsa loquitur. c. standard of care. d. vicarious liability.
Answer: c WHY: The standard of care is defined as a level of care that protects clients from harm because it follows established standards of the profession and expectations of society. It requires that duties be performed the same way any other reasonable and prudent person with the same experience and training would perform those duties.
Unauthorized release of confidential patient information is called a. a type of negligence. b. failure to use due care. c. invasion of privacy. d. violation of discovery.
Answer: c WHY: Unauthorized release of confidential patient information is called invasion of privacy and can result in a civil lawsuit. It may also be considered breach of confidentiality if medical information is involved. It is not considered a type of negligence or failure to use due care, nor is it called a violation of discovery.
A specimen was mislabeled on the floor by the same phlebotomist for the second time. The phlebotomist's supervisor is required to fill out a performance improvement plan. Which of the following is the only information that would not be included? a. Explanation of the deficiency b. Description of the consequence c. Detailed corrective action plan d. Suggestion for new guidelines
Answer: d WHY: A document called a performance improvement plan (Fig. 2-5) is used in counseling a person or when suspension is necessary. The document states the deficiency, describes a specific action plan for improvement, or indicates consequences such as termination or suspension. New guidelines are sometimes implemented because of an incident but are not included on the incident report form.
The period within which an injured party may file a lawsuit is known as a. binding arbitration. b. a discovery period. c. a litigation process. d. a statute of limitations.
Answer: d WHY: A statute of limitations is a law setting the length of time after an alleged injury in which the injured person is permitted to file a lawsuit. The time limit is specified in each state's medical malpractice law. Binding arbitration is a way that equitable settlements over a controversy are made outside the courts. It is one of the pathways used in the litigation process, which is defined as a course of action used to settle legal disputes. One of the steps in the litigation process is the discovery period.
The term "tort" means a a. criminal action. b. felony charge. c. personal injury. d. wrongful act.
Answer: d WHY: A tort is a wrongful act resulting in injury for which a civil, rather than criminal, action can be brought. A tort is committed against one's property, reputation, or other legally protected right, for which an individual is entitled to damages awarded by the court. Damages are generally in the form of monetary awards. See Table 2-1 for information about criminal and civil actions.
Which test specimen must be collected in a metal-free plastic container? a. Direct bilirubin b. Indirect bilirubin c. Total bilirubin d. Urine bismuth
Answer: d WHY: A urine sample for bismuth must be collected in a metal-free plastic container to avoid interfering substances from the container when tested.
In which month did the laboratory blood culture collections exceed 3% contamination? a. April b. May c. June d. None of the above
Answer: d WHY: As shown in the report (see Fig. 2-1), during the three months being monitored, the laboratory staff did not exceed the allowable contamination rate of 3% during blood culture collection.
A busy phlebotomist misidentifies the patient when collecting a specimen for transfusion preparation. The possible misdiagnosis of blood type could cause the patient's death. If the phlebotomist's action results in injury, this wrongful act is called a. assault. b. battery. c. fraud. d. negligence.
Answer: d WHY: Failure to exercise the level of care that a person of ordinary intelligence and good sense would exercise under the given circumstances is called negligence. If a medical procedure results in injury, the injured person has the right to sue for damages. Because the phlebotomist did not threaten or intend to harm the patient, there are no assault and battery charges. The phlebotomist did not commit fraud because there was not a willful plan to deceive the patient.
Which of the following is an example of a QA indicator? a. All phlebotomists' absences will be reviewed and recorded. b. Laboratory personnel will not wear lab coats when on break. c. No eating, drinking, or smoking is allowed in lab work areas. d. The contamination rate for BCs will not exceed the national rate.
Answer: d WHY: Following standard precaution guidelines, not wearing lab coats outside of work areas, and not eating, drinking, or smoking in lab work areas are all safety rules. QA indicators are not considered rules but are statements that serve as monitors of patient care. By setting a limit or threshold value, they serve as initiators of action plans, as shown in Figure 2-1.
Doing something that a reasonable and prudent person would not do or failing to do something that a reasonable and prudent person would do is a. battery. b. discovery. c. fraud. d. negligence.
Answer: d WHY: Negligence involves doing something that a reasonable and prudent person would not do or not doing something that a reasonable and prudent person would do. Battery is the intentional harmful or offensive touching of another person without consent or legal justification. Discovery is the process in which both sides in a lawsuit exchange information about witnesses and evidence that will be presented at trial. It typically involves both sides taking depositions and submitting written questions called interrogatories that must be answered by the other party in writing. Fraud is deceitful practice or false portrayal of facts by word or conduct.
If a glucose specimen is collected above an IV, under what category would this error be listed on the occurrence form? a. Disposition b. Patient order information c. Specimen identification d. Specimen integrity
Answer: d WHY: On the near-miss/occurrence report form, the error in the collection process is listed under "Specimen Integrity." The test results for a glucose specimen drawn above an IV containing glucose will most likely be completely out of normal range. The specimen has no integrity or reliability, and therefore the results cannot be trusted because the process used to obtain it did not follow the collection standard regarding IVs.
QC protocols prohibit use of outdated evacuated tubes because a. additives that speed up clotting become crystallized in the tube. b. bacteria begin to grow in these tubes, yielding erroneous results. c. stoppers may shrink, allowing specimen leakage if the tube is inverted. d. tubes may not fill completely, changing additive-to-sample ratios.
Answer: d WHY: Outdated tubes should never be used. The tube vacuum and the integrity of any additive that might be in the tube are guaranteed by the manufacturer but only if the tube is used before the expiration date. After that date, the additive may break down and no longer function as intended. In addition, outdated tubes may lose some of the vacuum and no longer fill completely, changing the additive-to-sample ratio. In either situation, the results may be incorrect or erroneous. It has not been shown that the tube stoppers shrink when held past the expiration date or that bacteria start to grow in outdated tubes. It is important to note that some additives can be seen on the sides of tubes before blood is added because they are made this way at the factory.
SAFER is a(an) a. CLIA safety program. b. NAACLS accreditation tool. c. ISO's latest safety standard. d. TJC site survey approach.
Answer: d WHY: SAFER stands for "survey analysis for evaluating risk." It is the name of a method used by TJC to communicate risk levels of deficiencies cited during site surveys. The method uses a tool called the SAFER Matrix to visually present the likelihood of harm to a patient, staff, or visitor that is associated with a deficiency that was identified in the site survey.
Special handling of specimens for bilirubin testing normally means to a. collect them in a metal-free container. b. refrigerate the sample one hour after collection. c. ship the specimen in refrigerated container. d. wrap them in foil to protect them from the light.
Answer: d WHY: The bilirubin sample is most often ordered by the physician to check liver function. For the most accurate results, the tube of blood should be protected from sunlight and artificial light to stop the breakdown of bilirubin in the sample. If not protected, the test results could be flawed. By carefully placing a foil around the specimen after collection, light cannot get to the specimen.
