Clinical Regulatory Compliance

Compliance

• act/process of complying with demands or official requirement

• goal: ensure conformity to regulations to avoid legal issues

Practical Areas in a Clinical Lab

• human resources

• Title IX

• Clery Officer

• Occupational/Environmental Safety

• Export Control

Roles of a regulatory officer

• staff qualifications and training

• competency and proficiency testing

• laboratory tests (LDT) and validations

• instrument and maintenance and calibration

• facility standards and paper work

Roles and Education

• Lab Director: MD/DO/PhD + certifications & experience.

• Technical Supervisor: PhD + certifications & experience.

• Medical Lab Scientist: Master’s* + certification.

• Medical Lab Technologist: Bachelor’s* + certification.

• Specialized certifications (e.g., Microbiology, Histotechnician, Hematology)

Safety/Regulatory Training

Bloodborne Pathogens, Hazardous Waste, Emergency Readiness, Fire Extinguisher use, HIPAA, Instrument Protocols.

Competency Testing

• purpose: ensure staff can safely and accurately perform tasks

• includes: graded protocol execution, result accuracy

• scheduling:

Proficiency Testing

• Evaluates lab assay performance

• Lab purchase kits, uploading results, external evaluation (API, CAP, TJC, etc.)

Labratory-Developed Tests (LDTs)

• defintion: test designed and validated within a single lab

• validation: cross-verify with approved method; (~25 samples per assay)

• specificity: validation is unique to each labs instruments, reagents and processes

Instrument Maintenance and Calibration

• Rule of 2: calibrate most instruments twice annually

• can be manufactured or external expert peformed

• document all cleaning and maintenance; follow daily/weekly/monthly schedules 

Facility Standards and Quality Assurance includes:

• protocol maintenance/review

• corrective action logs

• regular staff meetings and incident reports

• ongoing data/report

post inspection

produce a report of issues: conditions/violations, response plan, timelines and internal review implementation

What is the primary goal of compliance in a clinical lab?

To limit liability by enforcing legal and regualtory standards

Name three areas of compliance outside the lab

• human resources

• title IX

• export control

Key inspector checklist item

• staff qualifications/training

• competency and proficiency testing

• LDT

• validations

• instrument maintenance/calibration

• facility standards

Minimum education for a Medical Laboratory Scientist

Masters degree (preferred) and certification

Competency testing schedule

• prior to self sufficiency

• 6 months

• 1 year

• annually thereafter

Purpose of proficiency testing

external evaluation of lab assay performance

What defines a labraotry developed test (LDT)

a test designed and validated by a single lab, with lab specific protocol

Standard number of samples for LDT validation

15-30 (25 typical)

Instrument Rule of 2

Calibrate instruments twice annually

Elements of a quality assurance plan

• protocol review

• corrective action logs

• staff meetings, incident reports

• regular data review

Post Inspection First Step

• create a report detailing issues

• violations

• response plan with timelines