Phlebotomy Simplified Third Edition Chapter 2 Ethical, Legal, and Reguatory Issues Copyright © 2019, 2013, 2008 Pearson Education, Inc. All Rights Reserved

Chapter Learning Objectives (1 of 3) 2.1 Explain how ethics and laws differ and describe their importance to health care providers. 2.2 Describe the basic functions of the medical record. 2.3 Define informed consent and implied consent and how they differ. 2.4 Describe how to avoid blood collection lawsuits.

Chapter Learning Objectives (2 of 3) 2.5 Identify key components of the Health Insurance Portability and Accountability Act (HIPAA) and Clinical Laboratory Improvement Amendments (CLIA). 2.6 Identify methods to maintain confidentiality of privileged information on patients.

Chapter Learning Objectives (3 of 3) 2.7 Define the medicolegal terms related to phlebotomy procedures, policies, and protocols designed to avoid medicolegal problems. 2.8 Discuss the legal risks of computer entries on patients’ data.

Ethics and Laws (1 of 2) Ethics are a set of principles or values on religious and moral teachings. Laws are a collection of rules to enforce order in a community, state, or group. Laws have been developed for the community and society. An action can be moral but not legal, and vice versa.

Ethics and Laws (2 of 2) Ethics Check Is this action legal? Does it foster a “win-win” situation with the patient and my supervisor? How would I feel about myself if I read about this decision in the newspaper? Can I live with myself after making this decision, and is it right?

Basic Legal Issues (1 of 10) Patients know more about health care these days because of the Internet, the newspaper, and other sources. They are much more willing to sue anyone who their lawyer believes has caused them harm in providing health care.

Basic Legal Issues (2 of 10) Legal Terminology Because the legal system is becoming more involved in health care, the health care worker should have some knowledge of basic legal terminology.

Basic Legal Issues (3 of 10) Negligence Failure to provide proper care, resulting in injury to others

Basic Legal Issues (4 of 10) Malpractice (Professional Negligence) Improper care of a patient by a health care professional, resulting in injury to the patient.

Basic Legal Issues (5 of 10) Patient’s Confidentiality Confidential materials include: Communications between the physician and the patient. Patient’s verbal statements and medical computer entries on patients. Nonverbal communications, such as laboratory test results.

Basic Legal Issues (6 of 10) Confidentiality and HIV Exposure State law regarding confidentiality and HIV status varies from state to state.

Basic Legal Issues (7 of 10) Confidentiality and HIV Exposure If exposure to the blood occurs through a needlestick, lancet, or another means, the home health care worker needs to obtain patient’s HIV status and information about other potential infectious diseases, to ensure proper immediate and long-term self- protective procedural steps can be taken.

Basic Legal Issues (8 of 10) Confidentiality and HIV Exposure If employed by a health care facility, the health care worker should follow the guidelines established by the facility. If self-employed, it is important to see a health care provider for a postexposure protocol and follow-up. Counseling should be sought.

Basic Legal Issues (9 of 10) Informed Consent Voluntary permission given by a patient to allow touching, examination, and/or treatment by health care providers. Signed by the patient to approve the medical treatment(s).

For long description, see slides 37-43: Appendix A Figure 2-1 Example of an Informed Consent Form For long description, see slides 37-43: Appendix A

Basic Legal Issues (10 of 10) Implied Consent If patient agrees to allow blood collection by the phlebotomist, the patient is giving the phlebotomist implied consent for the procedure. Patient does have the right to refuse the blood collection or any procedure.

Figure 2-2 Giving Testimony in a Lawsuit Being involved in a lawsuit can be very unsettling for both the plaintiff and defendant.

Medical Records (1 of 3) Purpose of Medical Records To monitor for continuous patient care To provide a record of the patient’s illness and treatment To provide a method of communication between the physician and the health care team

Medical Records (2 of 3) Purpose of Medical Records To provide a legal document that can be used by patients and by hospital or health care workers to protect them in a possible lawsuit and for regulatory agency compliance

Medical Records (3 of 3) Used for nonmedical reasons such as billing, utilization review, quality improvement, and so on Legal duty to keep records, documentation, and laboratory test results confidential

HIPAA (1 of 2) The federal Health Insurance Portability and Accountability Act (HIPAA) was created in 1996 to protect the privacy and confidentiality of every patient’s medical information.

Figure 2-3 Proper Documentation Proper documentation of laboratory test results into medical records is extremely important. Dmitry Kalinovsky/Shutterstock

HIPAA (2 of 2) Patient’s written consent Health care worker’s confidentiality and nondisclosure agreement Keep the confidentiality of all patients’ information. Keep computer password secure from others’ knowledge.

Legal Cases Related to Clinical Laboratory Activities Delmetrea Salter v. Deaconess Family Medical Center et al Lazernick v. General Hospital of Monroe County Hellmann v. Sacred Heart Hospital

Cases Resulting from Improper Technique and Negligence (1 of 2) Wristband or identification error Hematoma Abscess at the puncture site Patient falls Patient fainting before, during, or after blood collection procedure

Cases Resulting from Improper Technique and Negligence (2 of 2) Mislabeled blood gas specimen leading to delay in result and mismanagement of a patient Nerve damage Emotional distress Complications from collecting blood from the arm on same side as a mastectomy

HIV-Related Issues (1 of 2) Health care worker must demonstrate a causal connection between his/her HIV infection and his/her employment. There must be a documented incident report at health care facility involving a needlestick injury, a puncture wound, or other exposure to HIV-contaminated blood or body fluids.

HIV-Related Issues (2 of 2) Health care worker’s lifestyle will be investigated to determine whether the exposure occurred elsewhere. Pre-employment health evaluations are used. Employers legally responsible for monitoring postexposure management and treatment.

Malpractice Insurance (1 of 4) Focus on medical errors and patient safety in the health care facilities has affected the need for health care workers to have malpractice insurance.

Malpractice Insurance (2 of 4) Often, health care staff in the hospital or clinical laboratory is covered by a blanket malpractice insurance policy. Increased legal exposure for allied health and nursing professionals

Malpractice Insurance (3 of 4) Examine need for personal malpractice insurance Does the employer carry liability insurance? Is adequate dollar value coverage provided? Are there coverage limitations?

Malpractice Insurance (4 of 4) Examine need for personal malpractice insurance Are there procedures that must be followed for policy coverage? Is a job change expected soon? Specimen collecting provided off-site or in patients’ homes?

Clinical Laboratory Improvement Amendments (CLIA) (1 of 2) Regulations ensure the quality and accuracy of laboratory testing. Essentially applies to every clinical laboratory testing facility in the United States and requires laboratory certification by the federal government

Clinical Laboratory Improvement Amendments (CLIA) (2 of 2) The blood collection procedures area is a major part of CLIA inspections, because it has been found that most laboratory errors occur during the preanalytical (specimen collection and handling) phase of testing.

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Appendix A (1 of 7) Long Description for Figure 2-1 The top of the form provides the name of the organization, Memorial Health. The form gives the instructions, complete original in ink for hospital chart, and patient must be awake, alert and oriented when signing. Next, the form asks for the date and time, followed by I authorize the performance upon, with a space for an answer, then the words of the following operation, state nature and extent, followed by another space for an answer. Then, to be performed under the direction of doctor, followed by a space for a name.

Appendix A (2 of 7) Part 1. I have been advised that there is a favorable likelihood of success, but I understand that a completely successful outcome may not be achievable, and there are no guarantees regarding the outcome. I also understand that certain adverse events could occur as a result of the performance of the procedure of treatment, including pair, infection, laceration or puncture of internal organs, bleeding, nerve damage or even in rare cases, death.

Appendix A (3 of 7) Part 1. I understand that hospitalization or other institutional care, home care or care by health professionals may be needed following the procedure or treatment, related to full recovery, recuperation or convalescence. I understand the alternatives to this procedure, including my right to refuse to consent to it, and I nevertheless have decided to consent to performance of the procedure or treatment.

Appendix A (4 of 7) Part 2. I consent to the performance of operations and procedures in addition to or different from those now contemplated, whether or not arising from presently unforeseen conditions which the above named doctor or his or her associates or assistants may consider necessary or advisable in the course of the operation. Part 3. I consent to the disposal by hospital authorities of any tissues or parts which may be removed.

Appendix A (5 of 7) Part 4. The nature and purpose of the operation or procedure, possible alternative methods of treatment, the risk and benefits involved and the course of recuperation have been fully explained to me. No guarantee or assurance has been given by anyone as to the results that may be obtained. Part 5. I understand and agree with the above information. I have no questions which have not been answered to my full satisfaction.

Appendix A (6 of 7) Part 5. I understand that I have the right to ask for further information before signing this consent. I have crossed out any paragraph above which does not apply or to which I do not give consent. Next, comes the patient signature, followed by a blank line for a signature, with the instructions, or parent or guardian if patient is under 18 years of age.

Appendix A (7 of 7) Part 5. Then relationship and witness signature appears with a blank space for a written answer. The signatures may come from patient, parent or guardian. A second witness needed for telephone consent. Return to presentation