Regulatory Compliance & Safety Standards Flashcards

Under The Joint Commission's laboratory standards, what is the required frequency of temperature monitoring documentation for a blood bank refrigerator?

Answer: Every 4 hours (continuous monitoring with alarm verification)

TJC and AABB standards require continuous temperature monitoring with alarms for blood storage units, with alarm checks documented at least every 4 hours to ensure blood component integrity.

Which federal act requires laboratories that handle select agents (e.g., Bacillus anthracis, Francisella tularensis) to register with the CDC or USDA?

Answer: Public Health Security and Bioterrorism Preparedness and Response Act of 2002

The 2002 Bioterrorism Act established the Select Agent Program, requiring facilities possessing, using, or transferring select agents to register and comply with CDC/USDA regulations (42 CFR Part 73).

A laboratory consultant is reviewing a facility's QC program and finds that the lab uses a single-rule Westgard rule (1₃s) only. What is the primary limitation of relying solely on this rule?

Answer: It has high false rejection rates when used alone without multi-rule context

The 1₃s rule alone has a relatively high false rejection rate (~1% with stable processes), which wastes resources; Westgard multi-rules are designed to balance error detection with false rejection rates.

Under CLIA, laboratories performing moderate-complexity testing must have a quality assessment (QA) program that includes monitoring of which element?

Answer: Turnaround time, specimen rejection rates, and corrected report rates

CLIA's quality systems requirements mandate that labs monitor indicators of pre-analytic, analytic, and post-analytic quality, including TAT, specimen problems, and report corrections.

An employee in a clinical laboratory reports a needlestick injury from a patient known to be HIV-positive. Under OSHA's Bloodborne Pathogens Standard, what is the employer's immediate obligation?

Answer: Provide confidential medical evaluation and follow-up, including testing and post-exposure prophylaxis counseling, at no cost to the employee

29 CFR 1910.1030 requires employers to immediately provide a confidential medical evaluation and follow-up at no cost, including source patient testing (with consent) and PEP counseling.

Which ISO standard provides the specific requirements for quality and competence in medical laboratory testing?

Answer: ISO 15189

ISO 15189 is the international standard specifically designed for medical laboratories, covering both quality management system requirements and technical competence requirements.

Under CLIA regulations, what action is required when a laboratory identifies a reportable critical value that cannot be communicated to the ordering provider?

Answer: Document all attempts to notify and escalate through an alternative authorized healthcare provider per the laboratory's established policy

Labs must have a documented policy for critical value notification that includes escalation procedures when the ordering provider is unreachable, and all notification attempts must be recorded.