Regulatory Standards & Compliance Flashcards

Which ISO standard specifies quality management system requirements for manufacturers of medical devices, including PCR IVD kits?

Answer: ISO 13485

ISO 13485 defines QMS requirements for medical device manufacturers, and the FDA QMSR now incorporates it.

Under the HIPAA Privacy Rule, which item counts as protected health information in a PCR lab report?

Answer: A patient's name linked to their test result

PHI is individually identifiable health information, such as a patient's name tied to their diagnostic result.

Which FDA premarket pathway is used for most moderate-risk (Class II) infectious disease nucleic acid tests that have a predicate device?

Answer: 510(k) premarket notification

Most Class II NAATs reach market through 510(k) clearance by showing substantial equivalence to a predicate.

Which OSHA standard requires a lab to keep Safety Data Sheets for hazardous chemicals such as PCR reagents and gel stains?

Answer: Hazard Communication Standard (29 CFR 1910.1200)

The Hazard Communication Standard requires SDSs, labeling, and training for hazardous chemicals.

How many unique patient identifiers do accrediting bodies generally require on a specimen sent for PCR testing?

Answer: At least two

Accreditation standards and patient safety goals require at least two identifiers, such as full name and date of birth.

Which practice is the main regulatory and accreditation expectation for preventing amplicon carryover contamination in a clinical PCR lab?

Answer: Physically separated pre- and post-amplification areas with unidirectional workflow

Accreditation checklists expect separate pre- and post-PCR areas and a one-way workflow to prevent amplicon contamination.

Under CLIA, who must approve, sign, and date a new PCR test procedure before it is used for patient testing?

Answer: The laboratory director

CLIA requires the laboratory director to approve, sign, and date procedures before use and when they change.