Miami Dade Laboratory Qa Audit Checklist

These Miami Dade laboratory quality audit checklist forms are used by inspectors during on-site assessments of laboratories, or used internally as guides to conduct audits.

Are the quality standards at your testing lab easily available to staff and inspectors?

Does the laboratory offer procedures for handling complaints regarding its testing or reporting policies and procedures?

1. Review the Quality Assurance Manual
Are the lab’s staff easily accessing a quality assurance manual that clearly outlines organizational charts and generic position descriptions illustrating relationships among management, technical operations, and support services?

Doee the Quality Control Plan include written procedures for equipment inspection, identification (labeling), usage, storage and maintenance to ensure only current equipment is used by lab personnel? Does it include an effective document management system to record calibrations, preventive maintenance, cleanings and document them?

Do your QC plans include a process to ensure all testing discrepancies and deviations from established laboratory policies are investigated, addressed and documented? Do they include feedback mechanisms for corrective actions to help avoid repeat nonconformities or undesirable situations?

2. Review the Test Methods
Are records maintained in your laboratory that provide accurate, readily available records (including archived SOPs ) documenting all testing activities? All corrections or additions made to test reports must be communicated via an additional documented transmission, clearly marked as such?

Does the laboratory employ appropriate formulas to convert raw data to final results, and perform regular tests that validate method detection limits, applicability range, linearity and other parameters?

Miami Dade Approved Testing Laboratories are labs that have met certain criteria and been certified to test building materials and products to meet county regulations. This page includes forms and checklists to assist laboratories during product control application procedures as well as help prepare for Miami Dade product control audits.

3. Review the Sample Preparation
Does the laboratory implement procedures and controls to prepare samples and evaluate sample quality, including using blanks, spikes, reference toxicants and proficiency test samples?

Are corrections to laboratory analytical records legibly made without altering original entries and initialed and dated? Is the laboratory prepared to provide an audit trail version of its test report with chain of custody?

Are the current accreditation certificates visible and accurately represent their accreditation status in reports, catalogs, advertising campaigns, business solicitations proposals and proposals submitted by laboratories? In addition, any changes that affect analytis would need to be reported immediately as they could impact analysis for which they have accreditation status.

4. Review the Test Results
Miami-Dade laboratories offer laboratory services and tests for STDs (HIV/AIDS, chlamydia, gonorrhea and bacterial vaginosis), Tuberculosis (TB), Refugee Health Assessments and Women’s Health and Family Planning clinics in their county. Services include rapid HIV and chlamydia testing as well as in-house screenings for syphilis, gonorrhea trichomoniasis bacterial vaginosis along with pregnancy/urinalysis blood glucose triglyceride/TTC screens.

Does the laboratory document raw data observations, calculations and derived data, calibration records, final test reports and their respective chains of custody in such a way as to ensure continuity and integrity of its analytical process?

5. Review the Calibration Records
Miami-Dade Crime Lab scientists conduct criminal case examinations using cutting-edge science. As members of this entity known as CSIs (Crime Scene Investigators), these scientists wear suits and carry guns when conducting investigations of crimes in Miami-Dade. If needed for break or nap time they have access to their Break Room as well as an Armory to store all their weapons.

Laboratories must ensure their equipment is calibrated on an ongoing basis to maintain peak performance. Calibration involves testing temperature and pressure. Laboratories should keep records detailing any calibration done on their equipment as well as maintenance performed.