Exam 43: Quality Assessment in the Hematology Laboratory

While running a CBC on the hematology analyzer, the platelet count is flagged for thrombocytopenia and possible interference. On reviewing the peripheral smear, many grapelike clusters are noted on the smear. What is your next step?

Which federal agency introduced the Blood-borne Pathogens Standards that require educating and training laboratory employees, implementing an exposure control plan, and using a record-keeping mechanism?

A CBC is received from the ICU and assayed STAT on the hematology analyzer. The CBC results show an MCHC of 42 g/dl. What is your next step?

Drawing blood from an IV site is classified as:

The TAT is being monitored for CBC reporting on samples from the critical care units. This monitor fits into which patient safety goal?

Control values for the PT reagent have been established as: Level 1: mean - 10.4, 1sd - 0.6; Level 3: mean - 24.6, 1 sd - 1.8. Control values for the morning QC were Level 1: 11.7; Level 3: 28.9. What is the next step?

Describe necessary components of a laboratory's response to unsatisfactory performance on proficiency testing challenges.

When evaluating a new method or instrument, linear regression analysis is used to detect systematic and random errors. The observation of a constant systematic error usually indicates what?

List the three components that make up a comprehensive Quality Assurance program and list four sub-components under each major heading.

Which federal agency originally introduced and continues to oversee the universal precautions guidelines?

The daily QC protocol for the hematology analyzer includes 2 levels of assayed commercial control for every 8 hours of patient testing plus a normal patient control every 4 hours. What does the normal patient control monitor?

Differentiate between Quality Assessment and Quality Control and explain why they are necessary.

Proficiency testing is a type of:

A new lot of APTT reagent is being evaluated and the following data points have been gathered to validate the reference range. Values: 32.6, 30.4, 33.7, 29.8, 30.7, 30.4, 32.5, 31.8, 29.6, 33.4, 31.9, 30.7, 32.6, 29.9, 30.9, 31.2, 33.1, 32.9, 28.6, 29.9. Given this information, what is the new reference range?

What parameter(s) is(are) used to assess an instrument's analytical reliability?

Under the CLIA '88 regulations, documentation of instrument maintenance must be:

Your hematology laboratory is installing a new analyzer and you are responsible for validating the instrument reportable range. The manufacturer has supplied you with a linearity kit which spans the entire stated reportable range but after assaying the kit, you are getting unacceptable values for the upper end of the WBC reportable range. The manufacturer states the WBC range is 0-100.0 × 10⁹/L but your results become non-linear at an upper value of 91.0 × 10⁹/L. What are your next steps? What will you set for your lab's reportable range for WBC on the new analyzer?

The most likely cause of a delta check alarm is due to either random error or:

A CBC is performed on a patient with a strong cold agglutinin. The MCHC is >40 g/dl and warming the sample does not correct the MCHC. The laboratory professional performs a manual hematocrit (mHCT) on the sample. What values can be reported on the CBC?

The SDS will must contain all of the following information except: