Checklist Phase 2 - Process Management
Has the laboratory formulated clear and specific sample acceptation/rejection criteria for each type of sample used by the laboratory, leaving no room for interpretation? |
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Does the laboratory have an SOP for Sample Collection to ensure correct collection of good quality samples for each test, protecting the safety of both the sample collector and patient as well as the privacy of the patient? |
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Does the SOP for Sample Collection include at least the following element? [tick-off]
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Does the laboratory have an SOP for Sample Reception and Processing? |
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Does the SOP for Sample Reception and Processing cover the following procedures:
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Has the laboratory authorized staff members for reviewing requests and deciding which examinations must be performed? |
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Has the SOP for Sample Reception and Processing been read by all relevant staff members? |
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Does the laboratory use a Sample Reception Register? |
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Does the Sample Reception Register leave room for including the following information:
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Does the SOP for Sample Reception and Processing have an appendix with a Sample Rejection Form? |
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Does the Sample Rejection Form include the following elements?
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Are copies of completed forms stored at the laboratory? |
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Has the laboratory made flowcharts of all the procedures routinely being performed in the laboratory? |
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Has the laboratory formulated quality controls to guard the quality of each process step in each procedure? |
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Are internal quality control results recorded in a register? |
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Are internal quality control protocols included in all relevant SOPs? |
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Does the laboratory have an SOP for Internal Quality Control that contains:
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Does the laboratory monitor internal quality control results and act on quality control failures? |
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Are internal quality control results continuously monitored? |
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Does the laboratory undertake action as soon as possible to solve internal quality control failures/deviations from trends? |
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Is reporting of results halted when internal quality controls deviate/fail? |
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Has the laboratory developed a list of all SOPs needed to standardize the entire primary process? |
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Are all routinely performed procedures in the laboratory standardized in SOPs? Take a sample by asking for several SOPs indicated in the flow charts and check the document control log of the laboratory. |
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Are all SOPs complete and in line with the Master SOP, covering all required elements such as quality control, safety, tasks, authorizations and responsibilities, references, appendixes, etc.? |
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