Difference between revisions of "Template:LIMSpec/Laboratory scheduling and capacity planning"

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(Created as needed.)
 
(Updated for 2022.)
 
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   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
   ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25 (c)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-14-1]
   | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25 (c)]<br />[https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories B2]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-14-1]
   | style="background-color:white;" |'''28.1''' The system should be able to accurately gauge and report test-based work capacity or throughput.
   | style="background-color:white;" |'''28.1''' The system should be able to accurately gauge and report test-based work capacity or throughput.
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-14-2]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-14-2]
   | style="background-color:white;" |'''28.2''' The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.
   | style="background-color:white;" |'''28.2''' The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.
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   | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-14-3]
   | style="padding:5px; width:500px;" |[https://www.astm.org/e1578-18.html ASTM E1578-18 E-14-3]
   | style="background-color:white;" |'''28.3''' The system should provide a means for tasks to be scheduled and allocated against available resources.
   | style="background-color:white;" |'''28.3''' The system should provide a means for tasks to be scheduled and allocated against available resources.
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Latest revision as of 20:42, 5 May 2022

Regulation, Specification, or Guidance Requirement
21 CFR Part 211.25 (c)
ACMG Technical Standards for Clinical Genetics Laboratories B2
ASTM E1578-18 E-14-1 		28.1 The system should be able to accurately gauge and report test-based work capacity or throughput.
ASTM E1578-18 E-14-2 28.2 The system should provide scheduling tools for allocating personnel and instruments to laboratory tasks.
ASTM E1578-18 E-14-3 28.3 The system should provide a means for tasks to be scheduled and allocated against available resources.
42 CFR Part 493.1274 (d) 28.4 The system should be able to track and limit the quantity of samples or hours worked on a type of sample by personnel, e.g., number of cytology slides or hours worked on them.
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