CMT Regulatory Standards & Ethics 3 — Questions and Answers
Question 1: What is the primary purpose of a chain of custody in specimen collection?
- To speed up laboratory processing time
- To document the handling of a specimen from collection to final result (Correct answer)
- To ensure the patient is billed correctly
- To assign technician responsibility for errors
Correct answer: To document the handling of a specimen from collection to final result
Chain of custody documents every person who handles a specimen and every transfer, ensuring integrity especially in legal or forensic cases.
Question 2: Under HIPAA, a 'covered entity' includes which of the following?
- A patient's family member
- A health insurance plan (Correct answer)
- A medical equipment manufacturer
- A hospital visitor
Correct answer: A health insurance plan
HIPAA defines covered entities as health plans, healthcare clearinghouses, and healthcare providers that transmit health information electronically.
Question 3: Which ethical principle supports a patient's right to make their own healthcare decisions?
- Beneficence
- Non-maleficence
- Justice
- Autonomy (Correct answer)
Correct answer: Autonomy
Autonomy is the ethical principle that respects an individual's right to make informed decisions about their own medical care.
Question 4: A laboratory is required to report a confirmed case of tuberculosis to which authority?
- The hospital's billing department
- The patient's insurance company
- The local or state public health department (Correct answer)
- The FDA
Correct answer: The local or state public health department
Tuberculosis is a notifiable disease, and laboratories are legally required to report confirmed cases to the local or state health department.
Question 5: What is the consequence of performing high-complexity testing without proper CLIA certification?
- A warning letter from the CDC
- Civil and/or criminal penalties and loss of Medicare/Medicaid reimbursement (Correct answer)
- Mandatory staff retraining only
- Temporary suspension of one employee's license
Correct answer: Civil and/or criminal penalties and loss of Medicare/Medicaid reimbursement
Performing testing beyond a lab's CLIA certification can result in civil penalties, criminal charges, and exclusion from federal reimbursement programs.
Question 6: Which document must a laboratory maintain to demonstrate ongoing compliance with CLIA quality control requirements?
- Patient satisfaction surveys
- Quality control logs and records (Correct answer)
- Employee time sheets
- Insurance claim forms
Correct answer: Quality control logs and records
CLIA requires laboratories to maintain quality control records that document daily checks ensuring test accuracy and reliability.
Question 7: A patient asks the medical technician to explain the risk of a procedure. The technician is unsure. What is BEST practice?
- Give a general explanation based on memory
- Tell the patient risks are not the technician's responsibility
- Refer the question to the supervising clinician or physician (Correct answer)
- Advise the patient to search the internet for information
Correct answer: Refer the question to the supervising clinician or physician
Explaining procedural risks is within the scope of the licensed physician or supervising clinician, not the medical technician.
What is the primary purpose of a chain of custody in specimen collection?