Activities related to Phase 4 - Process Control

  • Make an SOP covering the various smaller activities that are carried out such as cleaning of the laboratory and organization of work discussions.

    In each laboratory there are many small activities that need to be documented in a procedure, but it would be too inefficient to describe everything in separate SOPs (making a separate SOP for every small procedure would consume too much time compared to what it yields). Hence, make one SOP compiling all these small activities in the laboratory, titled “SOP for General Activities”.

    Construct this SOP just like any other SOP but make new (sub) paragraphs for every procedure.

    Examples of procedures that can be captured in this SOP are:

    • Stock management
    • Ordering supplies with unusual ordering procedures.
    • Producing bacterial stocks.
    • Temperature monitoring and cleaning of refrigerators, freezers, incubators and inspissators.
    • Cleaning of the laboratory building (offices, stockroom, toilets, etc).
    • Cleaning of the containment laboratory.
    • Internal communication.

    A template SOP is not provided as this SOP is highly specific to the local situation, making a template SOP not useful. Make sure that this SOP is read by all relevant personnel members.
  • Inform the clients of the laboratory when changes in an examination procedure or in available test procedures are made.

    When an examination procedure is changed or when an examination procedure is added to the range of available laboratory tests, the service manual must be revised/updated and sent to the clients of the laboratory accompanied by a letter explaining what has changed. Make sure that all aspects of new examinations are included in the service manual (i.e. required sample type; criteria for acceptance/rejection of primary samples; required volumes of primary samples etc.).

    In such cases the relevant SOPs and quality manual also need to be changed.
  • Systematically review requests and samples to decide which examinations will be performed and which methods will be used to performing them.

    On the request form the requester needs to indicate the reason for the request and the test requested. An authorized staff member should review each request at sample reception to determine if the reason for the request is consistent with the sample and the examination requested. In case of discrepancies the requester must be consulted.

    The process of this review and handling of discrepancies is included in the SOP describing sample reception, written in phase 2.
  • Identify and start monitoring critical parameters.

    A part of the responsibility of a reference laboratory is disease surveillance. Besides that, critical parameters can also give a good insight in quality performance of the laboratory. To be able to monitor critical parameters the laboratory should first identify which parameters should be monitored and how it is going to do that. Therefore you have to ask the question: "what information do I want to get and where am I going to use it for?" Examples of parameters that can be monitored:

    • Number of samples received
      Information that can be retreived from this parameter is:
      • Increase/descrease in number of patient: can this be related to something that has changed in the laboratory or outside the laboratory? (Less patient were referred to the laboratory due to decrease in trust in the laboratory services; patient feel not valued; etc.). A root cause analysis should point out the root cause and helps in formulating potentially necessary preventive/corrective actions.
      • The number of patients divided over the number of laboratory technicians analyzing the samples yields an indication of the workload. If this is too high corrective measures should be taken. If this is low (technicians have less than approximately 10 slides per day to examine) this could lead to a decrease in proficiency of staff.
    • The smear positivity rate.
      Giving an indication of increase and decrease of incidence of TB. It may also show seasonal influences.
    • The culture positivity rate.
      This can also be a good quality indicator: if the positivity rate is normally low, and in two months of the past year it was suddenly high, this could indicate contamination of culture. A root-cause analysis should further point out what the cause was and if corrective and preventive actions are necessary. This parameter can also be used to track the conformance of culture positivity with smear positivity.
    • DST results
      Providing an insight in decrease or increase of MDR TB.
    • Results of external quality assessments over time.
      This is not necesarily a disease surveillance parameter but it can be used to monitor the proficiency of laboratory personnel.
    • Results of rereading
      Giving an indication of the competence of personnel members.
    • Et cetera...

    Data from monitoring of critical parameters can be input into management review leading to introduction of changes in the laboratory policy and planning. When for example the number of patients has increased (and it looks like this is not going to decrease again) the hiring of more staff could be necessary.

    When the laboratory has established the critical parameters to be monitored and has tested the system of monitoring the parameters (e.g. investigated if the parameters provide the laboratory with useful information and are thus really usefull for monitoring), the complete procedure should be recorded in an SOP.
  • Monitor adherence to the turnaround time.

    The adherence to the turnaround time set for all examinations will be reported in the quarterly reports. At least 10% of the samples should be assessed randomly to determine their turnaround times.

    If deviations from the set turnaround time are detected, identify the root causes and fill out a Notification Form to initiate the corrective action procedure.
  • Write and implement an SOP on Assurance of Continuity of the Laboratory Process.

    It is important that requested examinations can be performed at all times. When employees are unexpectedly ill, the turnaround time of examinations should not increase. Therefore, an SOP is necessary that describes the preventive procedures in place to prevent loss of continuity in the laboratory process. Part of this SOP is a personnel substitution matrix that was already made in phase 3 (Personnel) which should be added as annex. Also the procedures in place to prevent unacceptable delay of laboratory results in case of stock outs should be described. To get a good grip on what is expected in this activity have a look at the example SOP on Assurance of Continuity of Examinations.

    Make sure that this SOP is read by all relevant personnel members.

    * SOP on Assurance of Continuity of Examinations
  • Appoint deputies for key positions.

    Appoint deputies for all the supervisory positions to ensure that work can continue at all times. If, for example, a piece of equipment breaks down in absence of the equipment supervisor to solve it, a deputy equipment officer should be present to solve the problem.

    Update the personnel substitution matrix (developed in phase 3), the personnel files and the authorization matrix based upon these appointments.