CLS 301 - Quality Assurance and Regulatory Compliance

Quality Assurance (QA)

process by which the lab ensures quality results by quality control, documentation, proficiency testing programs, laboratory instrumentation, standard operating procedures (SOPs), and produce reliable and accurate laboratory results

QA Guidelines

program designed to deliver optimal patient care, evaluate the adequacy, suitability, and timelines of care, all testing and reporting processes must be listed in the the SOPs, includes pre-analytical, analytical, and post-analytical phases, includes corrective action to prevent recurrence

Corrective action to precent recurrence

root cause analysis (RCA), revised SOPs, and retrain personnel

QA Mandates

through the Joint Commission, Federal mandates, state mandates, and laboratory accreditation

The Joint Commission

requires hospitals to have a QA program - subset of a Total Quality Management Plan (TQM) and hospital accreditation

Federal Mandate

clinical laboratory improvement amendments (CLIA)

State Mandate

California Department of Public Health (CDPH)

Laboratory accreditation

College of American Pathologist (CAP) - checklists and biannual inspections

QA Goals

continuous evaluation to identify and correct problems, minimize errors in all 3 phases of testing, continuous improvement, customer satisfaction, and accurate and timely results

Pre-Analytical phase

patient identification, phlebotomy and specimen collection

Analytical phase

analysis of collected samples - accurate and error free

Post-Analytical phase

outcome of the analysis and reporting of results

Quality Control (QC)

statistical process control that ensures test results’ accuracy and precision while detecting and eliminating error

Accuracy

how close the tested value is to the real “true” value

Precision

reproducibility of a testing procedure

QC guidelines cover all lab activities

specimen collection and processing, clinical testing, and result reporting

Quality checks include

actual test performance, lab supplies, reagents (parallel testing: new lot, new shipment, daily/day of use), instrumentation, personnel

QC sample controls

samples chemically and physically similar to patient samples and tested in the exact same manner - tested daily along with patient samples (results must be within the established ranges)

Proper documentation of QC performance is required

consistent QC results ensure testing is reliable - when out of range, patient results cannot be reported

Quantitative tests

CLIA mandates two levels of QC must be performed each usage day - low level and high level

Qualitative test

CLIA mandates a positive and negative control must be performed each usage day

QC Documentation

accurate record keeping is critical for QC, can be hard copy or electronic, record of QC performed whenever patient testing occurs

Documentation includes

results of calibration, date shipment is received, date new reagents or controls are put into sue, lot numbers and expiration dates

Calibration

standardization of clinical lab instruments that involves testing samples with known values which may include instrument adjustments - must be performed at least every 6 months to ensure lab equipment is functioning properly

Decontamination and Maintenance

instruments should be cleaned and maintained properly and recorded in appropriate logs

Preventative maintenance (PM)

schedule of maintenance to keep equipment in peak operating condition, vendors perform instrument adjustments, and replacement of certain parts

QC Statistics

parameters describing spread of data around the mean

Range

difference between highest and lowest values in set S

Standard deviation (SD)

statistical expression of dispersion of values around the mean

Coefficient of Variation (CV)

expresses the SD as a percentage - (SD/mean) x 100 - the lower the CV the higher the precision

Control limits

range within which control values must fall for assay to be considered valid - based on standard bell curve - reference range

Levey-Jennings Chart

plot of daily control specimen values used to evaluate deviation (shifts or trends - ± 2 SD is warning, ± 3 SD action)

Shift

data point shifts from one side of the mean to the other

Trend

values on the same side of the mean for more than 6 consecutive data points

True positive

positive result in a patient who does have the disease

False positive

positive result in a patient who does not have the disease

True negative

negative result in a patient who does not have the disease

False negative

negative result in a patient who does have the disease

Analytical sensitivity

smallest quantity of an analyte that can be detected by a test method - reduces false negatives

Analytical specificity

the ability of a method to detect only the analyte it is designed to detect - reduces false positives

Proficiency Testing Program

required by labs who perform moderate/high complexity tests - CAP unknown samples - treated like all other patient samples - must pass to keep accreditation

Personnel Competency Assessment - CLIA mandates each individual be evaluated

direct observation of routine patient test performed, monitor the recording and reporting of test results, review of quality control and proficiency testing results, direct observations of performance of instrument and maintenance, assessment of previously analyze specimens, internal blind testing samples or external proficiency testing samples, assessment of problem-solving skills

Regulatory Compliance

formal monitoring of how an organization follows laws and regulations - helps prevent fraud, abuse, and waste in clinical lab, ensures correct testing and fair billing

Office of the Inspector General (OIG)

recognizes that physicians or other authorized providers must be able to order tests they believe are appropriate for the diagnosis and treatment of their patients

American Medical Association (AMA) created

basic test panels to help determine information about a patient’s health status - CBC, CMP, electrolyte panel, hepatic function panel, lipid panel

Anti-Kickback Law

prohibits payment for soliciting testing paid for by federal program

False Claims Act

prohibits knowingly presenting a false claim to the governmentC

CLIA

covers QC, competency, and proficiency

Stark Law

prevents MDs from having financial interest in lab selectionH

HIPPA

protection of confidentiality of patient healthcare information (PHI)

Laboratory Compliance Plan

written SOPs promoting commitment to compliance, designation of Chief Compliance Officer, process to receive anonymous complaints without retaliation, regular training programs for all employees, audit and evaluations to monitor compliance and reduce identified problems, actions to investigate and remediate systemic problems and develop policies to address them, develop system to respond to illegal activities including disciplinary action

CDPH license

must document at least 12 continuing education units annually/ 24 every two year for licenses renewal

ASCP

must document at least 12 continuing education units annually or 36 every 3 years for license renewal