Checklist Process Management

Does the laboratory have a Request Form that includes at least the following details (tick off):

  • Patient details (name, address, telephone number, birth date, gender, etc.)
  • Requester details
  • Type of primary sample
  • Examination(s) requested
  • Clinical information relevant to the laboratory (HIV status, CD4 count, etc)
  • Date, time and place of sample collection
  • Date and time of receipt of the sample at the laboratory

Activity

Is the Request Form for Laboratory Testing clear?

Activity

Does the Request Form for Laboratory Testing provide clear guidance on how it should be filled-out?

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

Has the maximum allowed turnaround time been determined for each examination performed in the laboratory?

Activity

Is a table with the maximum allowed turnaround times for each examination included in the quality manual of the laboratory?

Activity

Is a table with the maximum allowed turnaround times for each examination included in the SOP on Reporting and Archiving of Results?

Activity

Does the SOP on Reporting and Archiving of Results include the procedure that the requester is immediately informed if the TAT of an examination is exceeded and this can compromise patient care?

Activity

Are staff members aware of the procedure for immediately informing the requester if an examination is exceeding the turnaround time when this can compromise patient care?

Activity

Is there an SOP that covers all the more simple procedures for which it is too laborious/inefficient to make separate SOPs but that are critical for proper functioning of the laboratory?

Activity

Has the laboratory identified and listed all the tests performed to determine which SOPs need to be written?

Activity

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
    • 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 the turnaround time monitored on a continuous basis for each examinations?

Activity

Is the result of turnaround time assessment included in the Quarterly Reports?

Activity

Are corrective and preventive actions implemented in an attempt to decrease the percentage of samples exceeding the turnaround time to a minimum?

Activity

When sudden increases are seen in the percentage of samples exceeding turnaround time, is an analysis performed to identify the cause and implement corrective and preventive actions?

Activity

Is the efficacy of corrective and preventive actions to minimize/counteract increase of samples exceeding turnaround time determined in subsequent turnaround time assessments?

Activity

Is correct transportation of samples monitored on a continuous basis by the laboratory by checking whether the transportation requirements in the SOP for Sample Collection are met?

Activity

If problems arise in transportation of samples, does the laboratory investigate these problems to find the cause?

Activity

If problems arise in transportation of samples, is a nonconformity form always completed?

Activity

Are corrective and preventive actions undertaken to solve problems in sample transportation?

Activity

Is the effect of the preventive/corrective actions to solve problems regarding sample transport evaluated to see if they worked?

Activity

Have SOPs been written for all the tests routinely performed at the laboratory?

Activity

Have all SOPs been written according to the procedures described in the Master SOP?

Activity

Do all SOPs have the same structure and lay-out, complying with the guidelines of the Master SOP?

Activity

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

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

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

Activity

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

Activity

Does the laboratory use a Sample Reception Register?

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 standardized the procedure of validation of examination methods and equipment in an SOP?

Activity

Does the laboratory monitor correct performance of all its processes using quality indicators?

Activity

Is action undertaken upon detection of a sudden change in the value of a quality indictors to identify and solve the problem and prevent it from reoccurring?

Activity

Have limits of acceptability been set for each quality indicator?

Activity

Are actions undertaken to optimize the laboratory processes such that the limits of acceptability for each quality indicator aren’t exceeded any longer?

Activity

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

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

Are copies of completed forms stored at the laboratory?

Activity

Has the laboratory validated all the examination methods performed in the laboratory?

Find evidence by asking for the validation reports.

Activity

When the laboratory, through validation, identified the need to change an examination method, was this change made (including adaption of the SOP for that method)?

Activity

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

Activity

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

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

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