MLS LAB FINALS LEGAL AND ETHICAL ISSUES

compliance

formalized monitoring of an organization's adherence to laws and regulations; required in the health care industry to prevent fraud, abuse and waste in the clinical laboratory industry while providing quality service to the customer.

Fraud and abuse laws

laws governing relationships between provider and referral sources; ensures that the customer is not being overcharged for testing or charged for testing that was not ordered and that unnecessary testing is not being conducted.

Chief Compliance Officer

a person within the laboratory tasked to develop the laboratory compliance plan and sees to its adherence; should be advised by compliance committee formed to assist in the implementation of the compliance program.

compliance

is essential to prevent overcharging.

- This can be overcharging of the patient, Medicare, Medicaid, or the insurance carrier

Antikickback Law (bribe)

Prohibits the knowing and willfull payment or offer of any remuneration directly or indirectly in return for inducing, referring, or soliciting services, including laboratory testing paid for by a federal health program

prohibits payment in money or services to a physician in order to solicit business from that physician

Stark Law (or Physician Self-Referral Law) , sila ra maka kwrta

Forbids physician from referring sample to laboratory in which physician or immediate family member has financial interest

False Claims Act

Prohibits knowingly presenting false claim to government; specific intent to defraud is not required. • Knowingly - reckless disregard for the truth

Prohibits changing billing code (upcoding) to increase reimbursement

Civil Monetary Penalties Law

Prohibits claims for services that are not provided as claimed

state laws

• Many states have their own set of laws that prohibit the payment of referral fees as well as the referral of the laboratory tests to a laboratory in which the physician has a financial interest

• Not limited to the Medicare and Medicaid programs

• Penalties vary depending on state

Clinical Laboratory Improvement Act (CLIA)

• Includes specifications for quality control, quality assurance, patient test management, and personnel and proficiency testing

• Includes some of the regulations that direct the laboratories in how the phlebotomist is proven to be competent in his or her job performance

Protected Health Information (PHI)

When a patient's personal information is connected to his or her medical information, it is referred to as protected health information (PHI).

• Phlebotomist has responsibility to patient to keep patient's PHI confidential

Health Insurance Portability and Accountability Act (HIPAA)

Protects health insurance coverage for workers and their families when they change or lose their jobs

Portion of this act that affects most phlebotomists: - Restricts dissemination of health information on patient

- provides the guidelines to keep PHI private and secure

compliance plan

Laboratory should have this plan to ensure they are not outside the law in any policies

Standards of conduct

A standard for all employees that details the policies of the laboratory in relation to fraud, waste, and abuse, and adherence to all government regulations (includes instructions on what to do when a government inspector comes to a location and how to respond to unqualified requests for patient information).

Medical necessity

Ability to order only those tests that are appropriate for treatment of the patient.

Billing

Assurance that all claims submitted to Medicare or other federal health programs are correctly identified as services or tests that were performed before the patient is billed

Reliance on standing orders

- Use of a recurring or standing order on a patient is discouraged but not denied.

Compliance with applicable HHS fraud alerts

- Could be notifications that certain physicians are no longer able to order laboratory tests.

Marketing

cannot offer one test or service and then give the patient something else

Prices charged to physicians

Laboratory prices must not provide any inducements to gain a physician's business.

Compliance as an element of a performance plan

Adherence to compliance must be a part of the evaluation of all employees.

Requisition design

Requisition slip used by the laboratory should have a standardized listing of tests for the most commonly ordered tests (to encourage physician to order only those tests that are medically necessary and appropriate for each patient); all requisitions should include a patient diagnosis to determine the medical necessity of the tests ordered to avoid civil penalties (physician)

Client supplies and equipment

» Laboratory may provide laboratory-related supplies and equipment if these supplies and equipment are used solely for the purpose of collecting and preparing samples for the laboratory to do the testing.

Courier services (paid by laboratory)

» Courier could transport additional items, but the physician must be charged a fair market value for the transportation of items

Hazardous and infectious wastes

Laboratory may dispose of only those hazardous wastes and sharps containers that were generated during the collection of samples and nothing generated by the physician's office use.

In-office phlebotomist

Laboratory may provide physician's office with phlebotomist to provide convenience to patient for the sole purpose of collecting samples for the laboratory.

Questionable test requests

Documentation needed when physician is called to question an order: time and date of confirmation of the question; any diagnosis information obtained; name of the individual with whom the phlebotomist spoke; initials of the phlebotomist; and any instructions given by the physician

• Release of test information

Results can be released only to the person who ordered the tests.

» CLIA 88 and HIPAA state that results can be released only to authorized persons or the individual responsible for using patient results.

Malpractice

failure of a professional person to offer a standard of care, resulting in injury or harm to the patient.

Best practices

Most efficient and effective way of accomplishing a task, process, or activity based on repeatable procedures that have proven themselves over time for large numbers of people.

best defense

to follow standard procedures and best practices and not deviate from these

Consent to perform venipuncture

» Legal implied consent - patient goes to the facility and presents his/her arm to have blood drawn.

» Drawing from the refusing patient can result in assault and battery charges

Negligence

occurs when actions are not taken to watch the patient or to prevent injury during fainting.

lower patient's head towards his/her knees or lap while holding the patient in the chair

If patient is displaying signs of possible fainting, what do you do?

if patient is conscious

tell the patient to breathe slowly to avoid hyperventilation

If patient has gone into convulsions

do not try to restrain him/her, but move objects or furniture out of the way to prevent injury

patient is fully recovered

let him/her lie down with the head lower than the feet; cold/ wet towels on patient's forehead/neck

hematoma

leakage of blood out of a vein during or after venipuncture that causes a bruise; as blood migrates in the tissue toward the skin, the characteristic discoloration or ecchymosis (the black and blue) will appear.

20 mins

how many minutes do you apply an ice pack sa hematoma in the first 24 hours

warm moist clothes for 20 mins four or five times a day

. If the arm is still tender after the first day, the patient may apply?

non-aspirin-containing pain medication

If the arm is still tender after the first day, the patient may take/drink?

Accidental arterial puncture

Can cause hemorrhage --> major bruising and compression of the nerve

arm down to the fingertips, nerve damage

If nerve is touched, patient will have a sharp shooting pain in the?

REJECT

Mislabeled/unlabeled sample

15 degrees

angle of syringe to avoid deep, probing venipunctures, and nerve damage

basilic

avoid draws from what vein

bedside

we should label all tubes in this location to avoid mislabeled or unlabeled samples

all filled tubes should be placed here to prevent breakage and accidental blood-borne pathogen exposure

Ethics

Moral philosophy of acting responsibly - Varies by individual, religion, social status, or heritage

be treated themselves.

In performing their jobs, phlebotomists must treat patients as they would like to?

death

is an event

grief

is a response of death

denial

anger

bargaining

depression

acceptance

5 stages of emotions

Denial

- when the family and patient deny reality ("I will be OK, just let me go home")

Anger

- when persons express their anger and rage ("I don't want you to draw my blood! I'm going to die anyway")

Bargaining

- when persons are willing to do anything to change what has happened or is happening to them ("Let me live. I'll change my ways")

Depression

- when the process is recognized, and there is deep sorrow over the thought of dying ("I will do whatever you want me to do, I don't care")

Acceptance

- the realistic acknowledgement of the fact that one is going to die ("God's will be done, I am ready")