Lab Management/QA/QC

Question 1

CLIA ‘88

Answer 1

clinical laboratory improvement amendments of 1988

Question 2

2 primary goals of a laboratory

Answer 2

to produce reliable results and a safe working environment for all employees

Question 3

why federal regulations and standards were developed

Answer 3

to protect employees and ensure quality for physicians and patients

Question 4

2 organizations that require CLIA compliance to distribute funds

Answer 4

Medicare and medicaid

Question 5

who is responsible for ensuring all employees are compliant

Answer 5

lab managers and leaders

Question 6

organization that regulates how work is done in the lab

Answer 6

CLIA to ensure consistent and high quality performance

Question 7

3 primary concerns of regulatory agencies

Answer 7

setting standards, conducting inspections, and imposing sanctions

Question 8

what is a waived test?

Answer 8

a simple routine test that has little to no risk of error, usually cleared for home use by the FDA

Question 9

what are the lab activities that must be performed to be CLIA compliant when performing moderate or high complexity testing

Answer 9

Personnel standards, proficiency testing, and quality assurance programs

Question 10

5 criteria for determining the complexity of a testing procedure

Answer 10

risk of harm to the patient, likelihood of erroneous results, type of testing methodology used, degree of interpretation required, specialty or difficult of testing

Question 11

HCFA

Answer 11

Health care financing administration

Question 12

JCAHO

Answer 12

joint commission on accreditation of health care organizations

Question 13

COLA

Answer 13

commission of office laboratory accreditation

Question 14

NCCLS

Answer 14

national committee for clinical laboratory standards

Question 15

2 certifying agencies that act on behalf of the federal government

Answer 15

CAP, college of American pathologists and JCAHO, joint commission on accreditation of health care organizations

Question 16

other regulatory agencies for labs

Answer 16

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

Question 17

what is proficiency testing?

Answer 17

a means to maintain quality control, must be CLIA approved, histology proficiency testing is voluntary and established through the pathologist

Question 18

purpose of a Quality Assurance Program

Answer 18

mandatory for a lab to maintain its certification and/or licensure, assures quality resulting

Question 19

components of success for a Quality Assurance Program

Answer 19

active quality control, quality assurance, and proficiency test programs

Question 20

what a pathologist reviews when assessing a histology lab and technicians

Answer 20

dissection quality, fixation, processing, embedding, quality of sectioning, staining quality, coverslipping

Question 21

define and calculate FTEs

Answer 21

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

Question 22

2 responsibilities a lab must guarantee to a physician and a patient

Answer 22

guarantee reliable results, and give the physician an estimate of what is normal

Question 23

how does JCAHO measure the quality of a facility’s health care?

Answer 23

determining that the highest quality and appropriate care is delivered to patients, using ongoing quality assurance programs

Question 24

3 components of a good quality assurance plan

Answer 24

commitment, facilities and resources, and technical competancy

Question 25

why do we need quality control, employee orientation, continuing education, and performance evaluation

Answer 25

to ensure quality care for patients and results for doctors

Question 26

test requesting procedures

Answer 26

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

Question 27

patient identification

Answer 27

proper labeling is essential, how to collect and transport the specimen to the lab,

Question 28

transport and processing

Answer 28

special instructions for transport of unusual specimens such as: testicular biopsies, muscle and nerve biopsies, products of conception POC for genetic studies, cervix specimens

Question 29

TAT relevance to the lab, physician, and patient

Answer 29

time the specimen arrives in lab to the time it leaves the lab/result is reported

Question 30

patient identification

Answer 30

proper labeling is essential, lab can only accept properly labeled specimens

Question 31

transport and processing

Answer 31

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

Question 32

quality control

Answer 32

must be documented; preventative maintenance records, temperature charts, quality control checks and documentation, how the lab will take corrective action in response to problems

Question 33

procedure/lab manual

Answer 33

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

Question 34

3 quality control measures for instruments

Answer 34

preventative maintenance records, temperature charts, , reagent records for quantity and expiration