Checklist Phase 2 - Process Management

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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?

 Activity

Does the SOP for Sample Collection include at least the following element? [tick-off]

  • Pre-collection:
    • Instructions for identification of the patient
    • Instructions to verify that the patient meets examination requirements (e.g. verification that the patient is sober when this is needed for laboratory testing)
    • Instructions for protecting patient safety
    • Instructions for protecting safety of the laboratory staff member
    • Instructions for protecting the privacy of the patient
    • Instructions for correct treatment of the patient (with respect, friendly, and polite)
    • Instructions for information provision to the patient (what is going to happen, when can the patient expect the results and where can the patient get the results)
    • Instructions for preparation of the patient (including provision of information to the patient on sample collection and laboratory testing)
    • Guideline for completion of the Request Form, including identification of the person collecting the sample and the patient
  • Collection:
    • Instructions for correct collection of the sample, including reference to sample acceptance criteria to ensure collection of a good quality sample
  • Post-collection:
    • Procedure of labeling of the sample
    • Requirements for correct and safe packing of the sample
    • Instructions on sample transport (including time frame and temperature interval) and proper storage conditions if the sample is not transported directly after collection
    • Instructions for safe disposal of materials used for collection of the sample

 Activity

Is reporting of results halted when internal quality controls deviate/fail?

 Activity

Does the laboratory undertake action as soon as possible to solve internal quality control failures/deviations from trends?

 Activity

Are internal quality control results continuously monitored?

 Activity

Has the laboratory made flowcharts of all the procedures routinely being performed in the laboratory?

 Activity

Does the laboratory monitor internal quality control results and act on quality control failures?

 Activity

Does the laboratory have an SOP for Internal Quality Control that contains:

  • An explanation on the concept of internal quality control
  • The general procedure for performing an internal quality control
  • Procedure for developing internal quality control materials
  • The procedure for periodic review of internal quality controls
  • The procedure to follow when an internal quality control fails

 Activity

Are internal quality control protocols included in all relevant SOPs?

 Activity

Are internal quality control results recorded in a register?

 Activity

Has the laboratory formulated quality controls to guard the quality of each process step in each procedure?

 Activity

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.?

 Activity

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.

 Activity

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?

 Activity

Does the Sample Reception Register leave room for including the following information:

  • Patient name + label
  • Details of requester
  • Type of primary sample
  • Date of sample collection
  • Date of sample reception
  • Date of sample acceptance
  • Examination(s) requested
  • Results of examinations + name of the laboratory technologists performing the examinations
  • Date of reporting
  • Signature and initials of person sending the report

 Activity

Has the laboratory authorized staff members for reviewing requests and deciding which examinations must be performed?

 Activity

Does the SOP for Sample Reception and Processing cover the following procedures:

  • Checking sample integrity and deciding if the sample is accepted or rejected
  • Introduction of the sample into the laboratory register
  • Sample labeling
  • Sample processing
  • Procedure for processing urgent samples
  • Procedure for dealing with verbal requests
  • Periodical review of required sample volumes

 Activity

Does the laboratory have an SOP for Sample Reception and Processing?

 Activity

Does the laboratory use a Sample Reception Register?

 Activity

Has the SOP for Sample Reception and Processing been read by all relevant staff members?

 Activity

Are copies of completed forms stored at the laboratory?

 Activity

Does the Sample Rejection Form include the following elements?

  • Identification of the patient
  • Identification of the person collecting the sample
  • Identification of the clinician (if different than the person collecting the sample)
  • Identification of the sample
  • Reasons for sample rejection
  • Action to be taken (does the sample requester have to send in a new sample? Does the sample collector have to change the procedure?)

 Activity

Does the SOP for Sample Reception and Processing have an appendix with a Sample Rejection Form?

 Activity

Has the laboratory developed a list of all SOPs needed to standardize the entire primary process?

 Activity

LQSI tool version: 1.0

LQSI tool version: 1.0