Clinical Informatics for Pathology and Lab Medicine Flashcards
Which of the following is NOT required on laboratory reports that adhere to the requirements of CLIA 1988?
Select one:
a.
Abnormal flags
b.
Test performed
c.
Test report date
d.
Reference ranges
Abnormal flags
CLIA‘88 requires all of the other answer options except for abnormal flags (coded flags for high/low/critical results). This doesn’t seem intuitive, but these are not incorporated into the CLIA’88 regulation.
All of the following represent big data sources EXCEPT:
Select one:
a.
Collections of whole slide images
b.
Online genomic databases
c.
Laboratory information systems
d.
Electronic health records
a.
Collections of whole slide images
Collections of whole slide images represent volume, but they do not include velocity or variety of data input since they are not acquired quickly at the current time and since the file types are highly standardized for a given instrument. Laboratory information systems, online genomic databases and electronic health records all satisfy volume, velocity and variety requirements for big data.
Which is the following best defines a bioinformatics pipeline?
a. Multiple sets of one or more computational algorithms performed in series which transform raw genetic sequence data into interpretable variants
b.
Software embedded in a next-generation sequencing instrument that converts raw sequence data to interpretable variants
c.
Multiple sets of one or more computational algorithms performed in series to analyze biological data
d.
Software that converts a FASTQ file into a VCF file
Multiple sets of one or more computational algorithms performed in series to analyze biological data
A bioinformatics pipeline is composed of multiple sets of one or more computational algorithms performed in series to analyze biological data. While the term bioinformatics pipeline is often used in conjunction with next-generation sequencing in the fields of pathology and genomics, bioinformatics pipelines can be used in all types of biological analysis. Bioinformatics pipelines may have a component algorithms running within as well as outside of the next-generation sequencing instrument. While some pipelines may stop with the construction of the VCF file, post-VCF modification can be included in some bioinformatics pipelines.
Two-dimensional (2D) barcodes are superior to linear (one-dimensional or 1D) barcodes because:
a.
Barcode readers know what data is encoded in a 2D barcode automatically but they don’t with 1D barcodes.
b.
2D barcodes are easier to set up and install than 1D barcodes.
c.
2D barcodes can contain multiple data elements where 1D barcodes can usually only just contain one data element.
d.
2D barcodes never require special software in the laboratory information system to read them (unlike 1D barcodes).
2D barcodes can contain multiple data elements where 1D barcodes can usually only just contain one data element.
Correct. Because of their significantly greater data density, two-dimensional barcodes may contain multiple data elements where one-dimensional barcodes, in most cases in healthcare, only contain one data element such as an accession number for a laboratory specimen or medical record number on a patient’s armband. Similar to one-dimensional barcodes, two-dimensional barcodes by themselves do not indicate what type of data is encoded. Because two-dimensional barcodes have significantly higher data density, descriptors can be included in the encoded content, but these descriptors still require software to interpret them. Both one-dimensional and two-dimensional barcodes may require special software in order to read them, particularly if they encode more than one data element. Outside of ISBT 128 barcodes, linear barcodes rarely contain more than one data element, whereas it is more common to find multiple data elements encoded in two-dimensional barcodes. Therefore, the need for additional software to interpret multi-element data can make set up of two-dimensional barcodes more difficult than non-ISBT 128 linear barcodes.
According to the Patient Access Rule, which of the following is correct:
Select one:
a.
Patients can request only verified results directly from the laboratory
b.
Patients are entitled to their laboratory results immediately after requesting them
c.
Patients must go to medical records to obtain a copy of their laboratory data
d.
Patients have to get permission from their physician to request a copy of their lab results
Patients can request only verified results directly from the laboratory
Patients may request laboratory results directly from a laboratory. This rule supersedes all state laws regarding release of laboratory results directly to patients from laboratories. Laboratories have up to 30 days to comply with the patient’s request, and patients do not have to get permission from their ordering provider to make this request from the laboratory.
The currently accepted CLSI standard for barcode symbology in the laboratory is:
Code 128
The Clinical and Laboratory Standards Institute (CLSI) AUTO-02A standard states that only code 128 linear barcodes are acceptable for use. Code 39 was deprecated years ago by CLSI because the check character is optional and not required. No other linear symbology has a check character component.
All of the following are advantages of RFID over barcodes EXCEPT:
Select one:
a.
Can be used to locate missing items
b.
Has no chance of interference or mis-scan
c.
Does not require “line of sight”
d.
Can scan items in bulk
b.
Has no chance of interference or mis-scan
Unlike barcodes, RFID tags which are placed close to each other may not be picked up by an RFID scanner due to interference of the signals. Interference is an important element of RFID technology which must be validated prior to putting into clinical use. Many hospitals use RFID tags on large pieces of equipment such as beds, IV poles, monitors, etc. When implementing RFID tags on laboratory/pathology specimens, testing for possible interference should take place.
Which of the following pairs of laboratory systems are regulated by the FDA?
Select one:
a.
Blood Bank and Whole Slide Imaging Systems
b.
Laboratory Information Systems and Automation Lines
c.
Autoverification Servers and Middleware
d.
HL7 Interfaces and Automation Lines
Blood Bank and Whole Slide Imaging Systems
Of the options offered, only laboratory information systems involved in the selection and transfusion of blood and tissue products and whole slide imaging systems used in primary diagnosis are regulated by the FDA.
information system architecture
In the EHR (Integrated) vs
(Interfaced) separate and communicate via HL7 interface
Patient access rule
all labs (CLIA or no) must send labs directly
blood bank system is regulated by FDA (Class III medical device)
Interfaces between databases
Bidirectional
asysmmetric vs symmetric (ADT)
vs unidirectional (printing labels)
class I vs Class III (High risk–require 510k clearance)
I and II may need 510 k clearance
pre-market approval for fda- 3 years
SaMD
software used with device developed by third part
software performing functions more than necessary to cotnrol hardware
UDI
unique device identifier (Device identifier + production identifier)
