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
	Have 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 (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 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 of 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 formulated quality controls to guard the quality of each process step in each procedure?	Activity
	Are internal quality control results recorded in a register?	Activity
	Are internal quality control protocols included in all relevant SOPs?	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
	Does the laboratory monitor internal quality control results and act on quality control failures?	Activity
	Are internal quality control results continuously monitored?	Activity
	Does the laboratory undertake action as soon as possible to solve internal quality control failures/deviations from trends?	Activity
	Is reporting of results halted when internal quality controls deviate/fail?	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

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Checklist Process Management

Is the Request Form for Laboratory Testing clear?

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

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?

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

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

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

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?

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?

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?

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

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?

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

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

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

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?

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

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

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

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

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

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

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

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

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

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

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

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

Does the laboratory use a Sample Reception Register?

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

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

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?

Have limits of acceptability been set for each quality indicator?

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

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

Are copies of completed forms stored at the laboratory?

Has the laboratory validated all the examination methods performed in the laboratory? Find evidence by asking for the validation reports.

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)?

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

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

Are internal quality control results recorded in a register?

Are internal quality control protocols included in all relevant SOPs?

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

Are internal quality control results continuously monitored?

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

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

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

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.

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.?

Questions on how it works?

LQSI tool version: 1.0

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

Find evidence by asking for the validation reports.

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.