Lab Management/QA/QC Flashcards
CLIA ‘88
clinical laboratory improvement amendments of 1988
2 primary goals of a laboratory
to produce reliable results and a safe working environment for all employees
why federal regulations and standards were developed
to protect employees and ensure quality for physicians and patients
2 organizations that require CLIA compliance to distribute funds
Medicare and medicaid
who is responsible for ensuring all employees are compliant
lab managers and leaders
organization that regulates how work is done in the lab
CLIA to ensure consistent and high quality performance
3 primary concerns of regulatory agencies
setting standards, conducting inspections, and imposing sanctions
what is a waived test?
a simple routine test that has little to no risk of error, usually cleared for home use by the FDA
what are the lab activities that must be performed to be CLIA compliant when performing moderate or high complexity testing
Personnel standards, proficiency testing, and quality assurance programs
5 criteria for determining the complexity of a testing procedure
risk of harm to the patient, likelihood of erroneous results, type of testing methodology used, degree of interpretation required, specialty or difficult of testing
HCFA
Health care financing administration
JCAHO
joint commission on accreditation of health care organizations
COLA
commission of office laboratory accreditation
NCCLS
national committee for clinical laboratory standards
2 certifying agencies that act on behalf of the federal government
CAP, college of American pathologists and JCAHO, joint commission on accreditation of health care organizations
other regulatory agencies for labs
OSHA, occupational safety and health administration, CDC, centers for disease control, FDA, food and drug administration, COLA, commission of office laboratory accreditation, and NCCLS, national committee for clinical laboratory standards
what is proficiency testing?
a means to maintain quality control, must be CLIA approved, histology proficiency testing is voluntary and established through the pathologist
purpose of a Quality Assurance Program
mandatory for a lab to maintain its certification and/or licensure, assures quality resulting
components of success for a Quality Assurance Program
active quality control, quality assurance, and proficiency test programs
what a pathologist reviews when assessing a histology lab and technicians
dissection quality, fixation, processing, embedding, quality of sectioning, staining quality, coverslipping
define and calculate FTEs
full-time equivalents: total number of hours of all employees/2080. 2080 is one full time employee working 40 hours per week for 52 weeks a year
2 responsibilities a lab must guarantee to a physician and a patient
guarantee reliable results, and give the physician an estimate of what is normal
how does JCAHO measure the quality of a facility’s health care?
determining that the highest quality and appropriate care is delivered to patients, using ongoing quality assurance programs
3 components of a good quality assurance plan
commitment, facilities and resources, and technical competancy
why do we need quality control, employee orientation, continuing education, and performance evaluation
to ensure quality care for patients and results for doctors
test requesting procedures
requires 2 identifiers; patient name, social security #, date of birth, medical records number, date and time of specimen collection, source of specimen, test required, and clinicians name
patient identification
proper labeling is essential, how to collect and transport the specimen to the lab,
transport and processing
special instructions for transport of unusual specimens such as: testicular biopsies, muscle and nerve biopsies, products of conception POC for genetic studies, cervix specimens
TAT relevance to the lab, physician, and patient
time the specimen arrives in lab to the time it leaves the lab/result is reported
patient identification
proper labeling is essential, lab can only accept properly labeled specimens
transport and processing
special instructions for transport of unusual specimens such as: testicular biopsies, muscle and nerve biopsies, products of conception POC for genetic studies, cervix specimens; delivery to the correct area and proper technician in a timely manner
quality control
must be documented; preventative maintenance records, temperature charts, quality control checks and documentation, how the lab will take corrective action in response to problems
procedure/lab manual
written policies and procedures available to all employees, must include: specimen collection requirements, test requesting information, processing details, complete written procedure, reagents and controls used, end results that are desired. Should be updated and reviewed regularly, each employee signs off for review
3 quality control measures for instruments
preventative maintenance records, temperature charts, , reagent records for quantity and expiration
