CLS 301: Quality Assurance and Regulatory Compliance

• Quality control (QC)

• Documentation

• Proficiency testing programs

• Laboratory instrumentation

• Standard operating procedures (SOPs)

• Produce reliable and accurate laboratory results

Quality assurance ensures quality lab results through… (6)

Root cause analysis (RCA)

Corrective action to prevent recurrence; leads to revised SOPs and retraining of personnel

Subset of Total Quality Management Plan (TQM)

The Joint Commission requires QA programs in hospitals which is…

Hospital accreditation

QA programs in hospitals are required for…

Clinical Laboratory Improvement Amendments (CLIA)

QA federal mandates are enforced by…

California Department of Public Health (CDPH)

State QA mandates are enforced by…

College of American Pathologist (CAP)

Laboratory QA mandates are enforced by…

• Continuous evaluation to identify and correct problems

• Minimize errors in all three phases of testing

• Continuous improvement

• “Customer” satisfaction

• Accurate and timely results → quality patient care

QA goals (5)

• Pre-Analytical

• Analytical

• Post-Analytical

3 phases of testing

• Patient identification

• Phlebotomy and specimen collection

Pre-analytical phase includes… (2)

Analysis of collected samples (accurate and error free)

Analytical phase of testing includes…

• Outcome of the analysis

• Reporting of results

Post-analytical phase of testing includes… (2)

QC guidelines

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

Quality Assurance

Helps achieve the highest degree of excellence in patient care

• Specimen collection

• Specimen processing

• Clinical testing

• Result reporting

QC guidelines cover all lab activities such as… (4)

• Actual test performance

• Lab supplies

• Reagents (parallel testing/daily)

• Instrumentation

• Personnel

Quality checks include…

Controls

Samples chemically and physically similar to patient samples and tested in exactly same manner

Proper documentation

(——-) of QC performance is required

Quantitative and Qualitative tests

CLIA mandates these two types of QC tests

High and low levels of QC performed each usage day

QC test for quantitative tests

Positive and negative control must be performed each usage day

QC test for qualitative tests

• Results of calibration

• Date shipment is received

• Dates new reagents or controls are put into use

• Lot numbers and expiration dates

QC documentation includes… (4)

Every 6 months; maintenance or changing instrument parts calls for calibration as needed before patient testing

How often is calibration of clinical lab instruments done? What is the exception?

Preventative maintenance

Schedule of maintenance to keep equipment in peak operating condition; vendors perform instrument adjustments; may include replacement of parts

CV% = (SD / mean) * 100

Coefficient of variation is found by… (equation)

Precision

The lower the coefficient of variation, the higher the…

Mean ± 2SD

Reference Range

Levey-Jennings Chart

Plot of dailt control specimen values; used to evaluate deviation

• ± 2SD (warning limit)

• ± 3SD (action limit)

When is the warning limit and when is the action limit

Shift

Data points move from one side of the mean to the other

Trend

Values on the same side of the mean for more than 6 consecutive 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

Manufacturer

Who determines sensitivity and specificity

Analytical sensitivity

The smallest quantity of an analyte that can be detected by a test method; same as “limit of detection”

False negative

What does sensitivity reduce?

Analytical specificity

The ability of a method to detect only the analyte it is designed to detect

False negative

Sensitivity reduces…

False positive

Specificity reduces…

Proficiency Testing Program

CLIA requires all labs performing moderate or high complexity tests to participate in (———); verifies that the laboratory as a whole can provide accurate results

Accreditation

Labs must pass proficiency testing to keep…

Personnel Competency Assessment

Verification that individuals can accurately perform skills required to perform lab testing properly and accurately

• 1. Direct observation of routine patient test performed

• 2. Monitor the recording and reporting of test results

• 3. Review of quality control and proficiency testing results

• 4. Direct observations of performance of instrument maintenance

• 5. Assessment of previously analyzed specimens, internal blind testing samples or external proficiency testing samples

• 6. Assessment of problem-solving skills

CLIA mandates 6 areas to be evaluated for each individual, for each test performed per year:

Regulatory Compliance

Formal monitoring of how an organization follows laws and regulations; prevents fraud, abuse, and waste in clinical lab; ensures correct testing and fair billing

Office of the Inspector General (OIG)

Regulatory Compliance inspections are conducted by the (————); is part of the Health and Human services (HIS); 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

Medicare coverage criteria

Center for Medicare and Medicaid Services (CMS) will only pay for tests which meet…

CPD code (diagnosis code)

All orders must have a (——) that supports the test ordered in order to be a covered service

American Medical Association

Created basic test panels to help determine information about a patient’s health status (CBC, CMP, electrolytes panel, Hepatic function panel, Lipid panel)

Anti-Kickback Law (1972)

Prohibits payment for soliciting testing paid for by federal program

False Claim Act (1986)

Prohibits knowingly presenting a false claim to the government

CLIA (1988)

Covers QC, competency, and proficiency

Stark Law (1989)

Prevents MDs from having financial interest in lab selection

HIPPA (1996)

Protection of confidentiality of patient healthcare information (PHI)

1. Written SOPs promoting commitment to compliance

2. Designation of Chief Compliance Officer

3. Process to receive anonymous complaints without retaliation

4. Regular training programs for all employees

5. Audits and evaluations to monitor compliance and reduce identified problems

6. Actions to investigate and remediate systemic problems and develop policies to address them

7. Develop system to respond to illegal activities including disciplinary action

Laboratory Compliance Plan

California Department of Public Health (CDPH)

Personnel must report to (——-) within 30 days any change of name or address

• 12 continuing educational units (CEUs) annually

OR

• 24 CEUs every two years

Must document at least (——2——) to the California Department of Public Health for license renewal

• 12 continuing education units (CEUs) annually

OR

• 36 CEUs every three years

Must document at least (——2——) to the American Society for Clinical Pathology for license renewal