PAM Regulatory Compliance & Standards 2 — Questions and Answers
Question 1: Under OSHA's bloodborne pathogen standard, which action is required before reusing electrode pads on a different patient?
- Wipe with alcohol and air dry
- Discard and use new pads (Correct answer)
- Autoclave at 134°C
- Soak in saline for 10 minutes
Correct answer: Discard and use new pads
Single-use electrode pads must be discarded after each patient to prevent cross-contamination under OSHA bloodborne pathogen standards.
Question 2: Which federal agency classifies therapeutic ultrasound devices and sets performance standards for their manufacture?
- OSHA
- CMS
- FDA (Correct answer)
- CDC
Correct answer: FDA
The FDA regulates and classifies therapeutic ultrasound devices under the Federal Food, Drug, and Cosmetic Act.
Question 3: A state practice act requires that a physical therapist assistant (PTA) apply PAMs only under 'general supervision.' This means the supervising PT must be:
- In the same room during treatment
- On-site and immediately available
- Available by phone or electronic means (Correct answer)
- Present at the start and end of each session
Correct answer: Available by phone or electronic means
General supervision requires the supervising PT to be available for consultation but does not require physical presence on-site.
Question 4: Which document outlines the scope of practice for physical therapists administering PAMs in the United States?
- CMS Conditions of Participation
- APTA Guide to Physical Therapist Practice (Correct answer)
- OSHA Hazard Communication Standard
- FDA 510(k) Premarket Notification
Correct answer: APTA Guide to Physical Therapist Practice
The APTA Guide to Physical Therapist Practice defines the scope, processes, and preferred outcomes for physical therapy interventions including PAMs.
Question 5: When documenting a diathermy treatment in a hospital setting, Joint Commission standards require the record to include all EXCEPT:
- Treatment parameters used
- Patient's response to treatment
- The therapist's personal opinion of prognosis (Correct answer)
- Goals addressed during the session
Correct answer: The therapist's personal opinion of prognosis
Joint Commission documentation standards require objective findings, parameters, and patient response—not subjective personal opinions unsupported by clinical data.
Question 6: A clinic purchases a used Class IV therapeutic laser. What regulatory step is required before clinical use?
- Notify the local health department within 30 days
- Register the device with the FDA and comply with laser safety standards (Correct answer)
- Obtain OSHA approval for laser use in a clinical setting
- Submit a 510(k) application as the new owner
Correct answer: Register the device with the FDA and comply with laser safety standards
Class IV lasers must be registered with the FDA and the facility must comply with ANSI Z136.1 laser safety standards before clinical use.
Question 7: Under Medicare Part B billing guidelines, which condition must be met for electrical stimulation to be a covered service?
- It must be performed by a physician only
- It must be part of a plan of care and medically necessary (Correct answer)
- It requires prior authorization regardless of diagnosis
- It must be combined with ultrasound to qualify for reimbursement
Correct answer: It must be part of a plan of care and medically necessary
Medicare Part B covers electrical stimulation when it is medically necessary and included in a certified plan of care established by a physician or qualified practitioner.
PAM Regulatory Compliance & Standards 2
Under OSHA's bloodborne pathogen standard, which action is required before reusing electrode pads on a different patient?