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Quality Control and Assurance
Sterile products Chapter 9
28
Other
Not Applicable
06/15/2008
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Term
Quality improvement assumes that             .
 Definition
While proccesses are performed over time, integrity is not lost. 
Term
Essential quality improvement tasks include           .
 Definition
  • maintaining trends
  • taking corrective measures
  • making suggestive measures for change
Term
Medication errors usually happen, as a result of              .
 Definition
system failures
Term
Various agencies have issued guidlines to help establish            .
 Definition
Standard practices
Term
The appropriate temperature range for a product placed under refrigeration is             .
 Definition
2 - 8  degrees C
Term
Sterile products should be properly labeled with             
Definition
  • Patient name
  • prescribed regimen
  • ingredients
  • expiration datep
  • patient nam
  • auxiliary labels
  • patient i.d., lot number, concentration
Term
Record or documentation that illustrates how product is made is reffered to as a
 Definition

SOP
Term
qUALITY ASSURANCE INCLUDES                 
Definition
  • personnel training and assessment
  • enviromental control and monitoring
  • SOPs and P&Ps
Term
Random checks can be describe as a quality assurance procedures known as                                   
Definition
Validation Proccess
Term
When unsure of which risk level a specific product falls under, it is best to              .
 Definition
choose the most stringent level
Term
Batch testing can be desribed under the quality assurance function known as                 .
 Definition
end- product evaluation
Term
Suggestions as to how a proccess can be more effective can best be described under which QA function?
 Definition
improvement
Term
The way medications are packaged, prepared, and delivered can be best described as part of which QA function?
 Definition
Storage and handling
Term
Proper documentation includes patient information and a                  that records specific information regarding the preparation and final product.
 Definition
worksheet
Term
5 rights
 Definition
  • patient
  • time
  • route
  • dose
  • drug
Term
products stored at room temperature and administered within 28 hours of preparation are categorized as risk level            .
 Definition
1
Term
Risk level                   requires controlled areas held to 100,000 clean room standards.
 Definition
3
Term
Risk level            includes products with the least potential risk of product integrity and patient safety, while risk level            includes products with the greatest risk.
 Definition
1, 3
Term
A process of evaluating personnel in their competency or skills is known as an              .
 Definition
Assessment
Term
P&P stands for              and             .
 Definition
POLICIES AND PROCEDURES
Term
JCAHO stands for                          .
 Definition
The Joint Commission on Accreditations of Healthcare Organizations. 
Term
Alum Bladder irrigation is an example of a product made in risk level                .
 Definition
3
Term
Room temperature indicates a temperature of                    
Definition
15 to 30 degrees C
Term
Evaluations and revisions to guidlines, policies and procedures, and SOPs ahould be done             .
 Definition
Constantly or all the time
Term
Quality Assurance is a sole responsibility of a QA manager. ( true or false)
 Definition
False
Term
The temperature of freezers in which medications are stored should be documented ( true or false)
 Definition
true
Term
Risk level 3 products are those that require refrigeration to extend experation dates ( true or false)
 Definition
false
Term
All personnel who perform aseptic compounding should read and understand USP 797 ( true or false)
 Definition
True
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