1. Introduction to Clinical Laboratory (Operations & Administration)

Section A: Clinical Lab Organizations. Section B: Organizational structure/setting of laboratories. Section C: Patient Safety

What is the HHS & what departments fall under it?

Human Health Services. FDA (Blood & Biologics Division, CMS & CDC)

What does CMS stand for and what is their primary role?

Centers for Medicare/Medicaid Services. Primary role is to administer & enforce CLIA. Grant “deemed status” to accreditation agencies such as COLA, CAP, TJC to act as its proxy

How do clinicals labs get reimbursement through medicare or medicaid?

By obtaining a CLIA certificate from CMS

What does OSHA stand for?

Occupational Safety & Health Administration

What does TJC stand for and what are they responsible for?

The Joint Commission
Inspect & accredit both the lab & the hospital as an institution. Focus on a continuum of quality initiatives throughout healthcare facility

What does CAP stand for and what are they responsible for?

College of American Pathology
Accredits laboratories by performing inspections in accordance with ISO-15189/90001
Known for peer to peer inspection

premier service for proficiency testing

When does CLIA apply to a facility or health institute?

When
1. Patient results are reported from the lab to another entity
2. Results are made available for “diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings

What are the four aspects in which CLIA is applied to a facility? (more specific)

1. when test results are returned to patient or patient’s health care provider

2. when test result is used to identify potential study subjects

3. when test result is used to determine treatment or procedure

4. when test result is used by research group that will either report results or use them for screening

What are the three organizations that implement CLIA? And how do they implement it?

1. FDA. Categorizes tests based on complexity & more

2. CMS. Issues laboratory certificates & more

3. CDC. Develops technical standards & lab practice guidelines & more

What are the four aspects of a clinical lab that CLIA defines?

1. laboratory personnel hierarchy, education background, & assigned duties

2. requirements for a lab’s QA program

3. Categories of testing (waived, moderate, PPM, complex)

4. analytes that are mandated to be monitored & reported through recognized proficiency testing services

When is CLIA not applicable?

1. For simple waived test (at home/self testing)

2. When CLIA compliance obstructs medical research

3. When test is non-orderable & will not be in their medical record

4. If a facility is granted an IRB research waiver

What are the 3 CLIA tests based on complexity?

1. Waived. Low risk even with an incorrect result. “home use”

2. Moderate complexity. proficiency testing required. Six elements of personnel competency assessment.

3. High complexity. Require higher level technical training, interpretation, and judgement. I.E. micro cultures

What are the seven criteria in which lab tests or categorized by the FDA?

1. knowledge

2. training & experience

3. reagents & material prep

4. characteristics of operational steps

5. calibration, QC, & proficiency testing

6. Test system troubleshooting & equipment maintenance

7. Interpretation & judgement

What are the 4 settings of lab testing?

Central lab, POC, reference lab, physician office laboratories

What are some tests that are done in the physician office labs?

urine pregnancy, urine dipstick, rapid strep A swabs, KOH preps, pinworm exam, wet mount

Who are the 6 personnel that work in a clinical lab?

Pathologist, supervisors/managers, CLS, MLT, Lab assistant

What did the US Institute of Medicine (IOM) conclude after a 1999 study?

53% of medical errors caused by failures in the diagnostic stage of care (13% failure of appropriate testing, 32% failure to act on test findings, 55% failure due to avoidable delays)

What is the definition of a diagnostic error & what can it include?

The failure to establish an accurate & timely explanation of a patients health problems or to communicate that explanation to the patient.
Can include delayed, wrong, or missed diagnoses

What are the 6 IOM healthcare quality goals?

1. safety

2. timeliness

3. effectiveness

4. efficiency

5. equity

6. patient centered

What is the quality management system (QMS)?

a formalized system to ensure compliance with regulatory requirements regarding healthcare services & patient outcomes
includes policies, processes, procedures, & resources involved in the lab

What is the primary responsibility of quality assurance?

Guides ALL aspects of the laboratory in producing accurate & timely results
Implements quality indicators & continuous quality improvement

What are the 5 CLIA elements for quality assurance?

1. pre, analytical, and post-analytical systems

2. personnel competency

3. proficiency tests

4. inspections (internal + external)

5. documentation

6. retention of records

What is the definition of lab quality control?

Discipline of routinely testing reference control materials and manufacturer procedural controls alongside real patient samples to verify accurate & precise test results

What are some variables that could lead to errors in the pre-analytical phase? (5)

Proper test order, patient ID, proper specimen labeling, patient preparation specimen collection, handling, storage, & documented policies for sample rejection

What are some variables that affect testing in the analytical phase?

Reagents (proper preparation/labelling), instrument calibration, internal/external QC, corrective action for failed QC, preventative maintenance, method evaluation, sensitivity, specificity, accuracy, precision

What are some variables that affect reporting of results in post-analytical phase?

review of results, reference ranges to guide interpretation of results, notification of critical results, correction, routing of sample for follow up testing, TAT

What are the 5 principles of a high reliability laboratory?

1. Preoccupation w/ failure (every small error could → bigger issue. near misses shouldn’t be ignored)

2. sensitivity to operations (in-tune to frontline concerns & possible barriers to quality by promoting an environment where everyone contributes to insight)

3. Reluctance to simplify interpretations

4. Resilience (detect, contain, recover from errors)

5. Deference to expertise

What aspects help nurture a “just culture” in a lab environment?

Transparency

open reporting

creating a learning environment

What questions should be asked in the just culture process?

What happened, what usually happens, why did it happen, what is the procedure, what deviation from procedure occurred, and what system is set to prevent these events?

What are the three things to evaluate in respect to human error?

1. substitution test (would someone w/ equal training make the same mistake?)

2. test of intention

3. Impaired practice

What are some secondary effects of an error made in the lab?

Loss of reputation, customers, income, negative effect on staff retention, and increased costs (litigations or insurance)