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What agency approves new test methodologies, instruments, and reagents before they are available for purchase by consumers? - correct answer ✅FDA How often should biological safety hoods be inspected? - correct answer ✅Annually A chain of custody is required for all of the following: - correct answer ✅Legal blood alcohol, pre-employment drug screen, and paternity testing A chain of custody is required for all of the following, EXCEPT: - correct answer ✅Fetal fibronectin What federal legislation regulates most clinical laboratories? - correct answer ✅Clinical Laboratory Improvement Amendments (CLIA) What is the level of complexity of most testing performed in clinical laboratories? - correct answer ✅Moderately complex
How often does CLIA require clinical laboratories to have inspections? - correct answer ✅Every 2 years Which laboratories are NOT required to participate in proficiency testing? - correct answer ✅Laboratories performing waived testing only. Which proficiency testing (PT) results do not meet the CLIA performance criteria? - correct answer ✅Failed the same analyte in two consecutive PT events Which one of the following is an example of alternate proficiency testing? - correct answer ✅Split samples sent to another facility using the same test method. All of the following are pre-analytical errors except which one? - correct answer ✅Transcription error entering a manual result
Following equipment maintenance, when is quality control suggested? - correct answer ✅After any preventative maintenance What is the most common reason for a control value to be outside of 3SD? - correct answer ✅Random error If one control is outside the 95% confidence limits, then what is the most appropriate remedial action to take initially? - correct answer ✅Repeat the same control Where should an unopened container of methanol be stored? - correct answer ✅Flammable safety cabinet After preventative maintenance by field service, which one of the following is recommended? - correct answer ✅Verification of QC results According to CLIA, who is responsible for specimen processing, test performance, and reporting test results? - correct answer ✅Testing personnel
Which one of the following is NOT a job duty of the testing personnel? - correct answer ✅Interpretation of highly complex testing All of the following are job duties of testing personnel: - correct answer ✅Inventory control, equipment maintenance, and accuracy of reported results Which one of the following is not required to be kept in the employee's personnel records? - correct answer ✅Continuing education documents? All of the following are required to be kept in the employee's personnel records: - correct answer ✅Job competency training checklist, remedial action documentation, and annual performance appraisal. Which one of the following statements concerning CEUs is false? - correct answer ✅CEUs are mandated by the College of American Pathologists
OSHA Hazard Communication Standard requires original container labels to contain all of the following information: - correct answer ✅Product name, warning label, and manufacturer's name and address Which federal agency requires safety training during new employee orientation and annually thereafter? - correct answer ✅OSHA Which plan minimizes personnel exposure to hazardous chemicals?
correct answer ✅Chemical hygiene plan Which bloodborne pathogens are of greatest risk to laboratorians?
correct answer ✅Hepatitis B and HIV All of the following are components of the OSHA Tuberculosis plan:
correct answer ✅All employees with patient contact must be fit for respirators, all laboratory employees are required to have PPD skin tests, employees who have had a positive PPD must have an annual chest x-ray exam.
All of the following are components of the OSHA Tuberculosis plan EXCEPT: - correct answer ✅All lab employees are exempt from having fit testing for respirators. When a fire occurs, when should the hospital operator be notified of the fire? - correct answer ✅After pulling the alarm Which federal agency regulates disposal of biohazardous waste? - correct answer ✅Environmental protection agency (EPA) Which federal agency regulates facilities that use radioisotopes? - correct answer ✅Nuclear Regulatory Commission (NRC) Which federal agency regulates the disposal of hazardous chemicals and biohazardous wastes? - correct answer ✅EPA
Which federal agency regulates packaging, labeling, and transportation of biological products? - correct answer ✅Department of Transportation (DOT) Which law required the Department of Health and Human Services to establish standards for protected health information? - correct answer ✅Health Insurance Portability and Accountability Act (HIPAA) Quality control should be performed and monitored to ensure which one of the following? - correct answer ✅Reliability What is the term used to describe material with physical and chemical properties closely resembling the test specimen and containing concentrations of the substance being measured? - correct answer ✅Control A procedure has a 2SD variation from a mean value. How many values from a normal population will 2SD include? - correct answer ✅95.45%
To produce reliable results, how long should a patient fast before having blood drawn for lipid studies? - correct answer ✅12-16 hours Reactivity is what color diamond using the National Fire Protection Agency code? - correct answer ✅Yellow Who are the testing personnel for proficiency samples? - correct answer ✅Any personnel who perform the test(s) Title 17 of CCR conveys what exactly? - correct answer ✅The administrative and regulatory powers to public health departments What does Title 17, section 2505 convey? - correct answer ✅It requires laboratories to report all test results suggestive of certain diseases of public health importances to local health department of county where the healthcare provider who submitted the specimen is located What are the typical Role of local Public Health Department laboratories? -
1-2 years clinical training (this is the area we fall under :)) Are CLIA waived tests cleared by the FDA? - correct answer ✅Yes, for home use PPM stands for..... - correct answer ✅provider performed microscopy Are PPM CLIA waived? - correct answer ✅no it is actually considered moderate Examples of PPM? - correct answer ✅Wet preps, WBC of nasal/fecal, and Fern tests Types of high complexity testing - correct answer ✅Broth cultures, any identification, and any susceptibility What time is permited to report E 1 pathogens? - correct answer ✅1 hour
What time is permitted to report E 2 pathogens? - correct answer ✅1 working day CLIA reg. requirements specify using at least _________ level(s) of controls each day of testing - correct answer ✅2 levels Scoring complexity - correct answer ✅Scored based on total points from 7 subjects of criteria(1-0). <12= moderate; >12 high PPM is limited to what types of microscopy? - correct answer ✅bright-field and phase-contrast Health and Human Services (HHS) - correct answer ✅The United States Department of Health and Human Services (HHS) is the part of the federal government that's responsible for administrating programs that deal with health and welfare. According the official HHS website, the department works with almost one fourth of all federal government expenditures and administers more grant dollars than all other federal agencies combined. The Department's programs are administered by 11
immunohematology test results must be kept at least - correct answer ✅5 years Pathology tests must be retained : - correct answer ✅for at least 10 years A run cannot be greater than________ or __________. - correct answer ✅24 hrs/ less than the frequency recommended by the maunfacturer Who qualified to perform a PPM? - correct answer ✅Physician, midlevel practioner, and a dentist A lab director may not direct more than_____ _ labs - correct answer ✅5` Personell could perform high complexity testing without supervision T/F - correct answer ✅False. The general supervisor needs to watch
When should the Hep B vaccine be given to employees? - correct answer ✅10 days of initial employment OSHA requires individuals who were exposed to be tested in what intervals? - correct answer ✅3, 6, and 12 months Family and Medical Leave Act (FMLA) - correct answer ✅Federal law requiring organizations with 50 or more employees to provide up to 12 weeks of unpaid leave after childbirth or adoption; to care for a seriously ill family member or for an employee's own serious illness; or to take care of urgent needs that arise when a spouse, child, or parent in the National Guard or Reserve is called to active duty Consolidated Omnibus Budget Reconciliation Act (COBRA) - correct answer ✅employees w/group health plans and > employees in prior yr must offer continued health & dental insurance coverage to terminated employees for limited periods of time
