Checklist Phase 2

Is access to the laboratory facility controlled against unauthorized persons?

Activity

Can the access control system, protecting the laboratory from unauthorized access, be overridden for evacuation in case of an emergency such as fire?

Activity

Are primary sample collection facilities separated from the laboratory rooms?

Activity

Is the sample processing room separated from the room where PCR is performed?

Activity

Are laboratory rooms where incompatible procedures are being undertaken separated from each other?

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Are rooms for cleaning of laboratory glassware and tools separated from the laboratory rooms?

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Are the rooms designed and furnished in a logical way enabling a unidirectional workflow and preventing unnecessary movements of people through the rooms?

Activity

Is office space separated from laboratory rooms?

Activity

Is there a dedicated area for breaks/lunches?

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Is communication from the laboratory room to outside possible without leaving the room?

Activity

Are emergency numbers available near telephones and clearly visible?

Activity

Is the use of mobile phones forbidden inside all laboratory rooms?

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Is continuous delivery of electricity guaranteed through a working generator and/or Uninterrupted Power Supply (UPS) system in case of a power failure?

Activity

Is all the essential/critical equipment locked onto the generator?

Activity

Is an indicator placed in relevant rooms for monitoring the air flow and preventing that pathogens are blown towards the staff working in the laboratory?

Activity

Are all hazardous materials in the laboratory registered?

Take a sample by identifying some hazardous materials and looking them up in the register.

Activity

Is the Hazardous Material Register up to date?

Take a sample by comparing the amount of several materials as noted in the register and in reality.

Activity

Are MSDS Sheets present for all hazardous materials in the laboratory?

Take a sample and check.

Activity

Have critical environmental/equipment parameters been identified?

Activity

Are all critical environmental/equipment parameters monitored adequately?

Activity

Are all Critical Parameter Log Sheets filled out completely and up-to-date?

Activity

Are all Critical Parameter Log Sheets placed at a logical location?

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Has a Quality Officer been appointed?

Activity

Is the position of Quality Officer visible, at the right place, in the Organizational Chart?

Activity

Does the laboratory have a job description of the position of Quality Officer?

Activity

Is the position of Quality Officer included in the Authorization Matrix?

Activity

Do the Quality Officer and Laboratory Manager have regular bilateral meetings to discuss proceedings?

Ask the Quality Officer.

Activity

If a staff member was appointed as Quality Officer, has his former position been filled by a new/another staff member if necessary?

Activity

Implementing a quality management system is a process of change. By reacting correctly to critical remarks and resistance towards implementing the quality management system the Laboratory Manager can prevent that staff stops cooperating. This is called change management. Change management is necessary to keep all the staff as possible involved in this process.

Activity

Does the laboratory have an up-to-date routine work schedule?

Activity

Is this Daily Routine Work Schedule placed at a visible location accessible to all staff?

Activity

Do all staff members know where to find the Daily Routine Work Schedule?

Take a sample by asking this question to several staff members.

Activity

Is the laboratory legally identifiable?

Activity

Is the laboratory and its status recognized by the appropriate authorities?

Activity

Are the Organizational Charts up-to-date?

Activity

Are the Organizational Charts signed and dated by the appropriate management?

Activity

Has an SOP for Competency Assessment been developed?

Activity

Does this SOP contain one or more standardized form(s) that must be used to record the findings of the assessment?

Activity

Are competency assessments done annually for each staff member?

Activity

Is a report made of each competency assessment?

Activity

Are the points for improvement described in the report of a competency assessment, including with a description of the strategy on how to improve these points?

Activity

Are the reports of the competency assessments stored in the personnel files?

Activity

If training needs are identified during competency assessment, is the staff member send to the appropriate training?

Activity

Is the competency of the Laboratory Manager annually assessed?

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Does the laboratory have an induction program for new staff?

Activity

Is the procedure of the induction program documented in an SOP?

Activity

Does the SOP for Induction of New Personnel include a checklist for verifying correct completion of the program?

Activity

Are completed checklists stored at a logical location (e.g. in the personnel file of the new staff member)?

Activity

Are performance appraisals performed for all staff members at least once per two years?

Activity

Are findings of performance appraisals discussed with staff members that were assessed to find the root cause and come to a good approach on eliminating this root cause and improving performance?

Activity

Are findings of performance appraisals recorded, including the identification of root causes behind poor performance and the approach chosen to eliminate these and improve performance?

Activity

Is a personnel file present of each staff member?

Activity

Are all the records described in ISO 15189:2012 article 5.1.9 (ISO 15189:2007 5.1.2) present in the personnel file of each staff member?

Activity

Are the personnel files structured in an orderly fashion?

Activity

Is the Personnel Files folder stored in a locked cabinet that is only accessible to the Laboratory Manager and the secretary?

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Does the laboratory have a standardized, documented procedure for procurement and reception of new equipment?

Activity

Does the laboratory have a standardized, documented procedure for acceptance or rejection of donated equipment?

Activity

Is the SOP for Procurement and Reception of Equipment stored at a logical location, accessible to all staff members?

Activity

Is the SOP for Procurement and Reception of Equipment demonstrably reviewed and verified by fellow staff members?

Activity

Is the SOP for Procurement and Reception of Equipment demonstrably authorized by laboratory management?

Activity

Are all technical and managerial staff members aware of the existence of the SOP for Procurement and Reception of Equipment and do they know when to use it?

Activity

Has all equipment in the laboratory been labeled?

Activity

Do the equipment labels include the following data:

  • Equipment code
  • Date of last service/calibration
  • Date of next service/calibration

Activity

Are the equipment labels resistant to fluids, chemicals, light, and other daily factors causing wear and tear of the labels?

Activity

Is it documented who is responsible for each piece of equipment and who is authorized to use the equipment?

Activity

Do staff members who are responsible for a piece of equipment know their responsibilities?

Take a sample by asking such a staff member.

Activity

Are staff members authorized for use of a piece of equipment properly instructed/trained?

Activity

Does the laboratory have a Maintenance Log Sheet for each piece of equipment that shows what maintenance has been performed at which moment to which piece of equipment?

Activity

Does the laboratory use log sheets to record usage of specific pieces of equipment where necessary?

Activity

Do staff members know how and when to fill out Usage Log Sheets/log books for each piece of equipment?

Activity

Are the Usage Log Sheets placed near the piece of equipment they have been developed for?

Activity

Are Maintenance Log Sheets of equipment stored orderly in the Equipment Archive?

Activity

Does the laboratory have an Equipment Archive that contains all the documents and records needed for each piece of equipment as listed in ISO 15189:2007 article 5.3.4 or ISO 15189:2012 article 5.3.1.7?

Activity

Does the laboratory have a documented procedure that describes the following:

  • Activities that need to be undertaken when new equipment is introduced in the laboratory
  • The required measures for ensuring maintenance and calibration of the piece of equipment
  • Ensuring presence of the SOP for maintenance and use of the piece of equipment

Activity

Are Bench Aids used for various pieces of equipment?

Activity

Are these Bench Aids in accordance with the currently authorized versions of SOPs for equipment?

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Is the method of maintenance and calibration of equipment documented?

Activity

Is the budget needed for the maintenance and calibration of equipment calculated and documented?

Activity

Have funds been identified for annual maintenance and calibration of equipment?

Activity

Have funds been identified for training of a staff member for internal maintenance and calibration of equipment?

Activity

Is a preventive maintenance program in place for all pieces of equipment?

Activity

Does the laboratory demonstrably adhere to this program?

Compare maintenance records for a piece of equipment from the equipment file with the dates this maintenance was planned in the Equipment Maintenance Schedule.

Activity

Is the procedure for ensuring equipment maintenance standardized in an SOP?

Activity

Does the laboratory have an SOP for Equipment Repair, including a clear procedure for disinfection and clear labeling the equipment as “defect”?

Activity

Does the laboratory have an SOP explaining the procedure to be followed for ensuring validation of equipment when it is returned into service after repair?

Activity

Does the laboratory have an overview of all the items in stock?

Activity

Has the laboratory formulated key specification for each item in stock?

Activity

Does the laboratory have an Inventory Control Register that contains the following details:

  • Names of all the items in stock
  • The number of units of each item currently in stock
  • The average number of units used per day of each item
  • The minimum stock level of each item for which a new order must be made
  • Of each item the average number of days before orders arrive at the laboratory
  • The supplier details of each item
  • The key specifications of each item

Activity

Is the Inventory Control Register kept up to date by counting the items in stock and comparing this with the number of items shown in the register?

Activity

Does the laboratory routinely perform acceptance tests on newly delivered products before they are taken into service?

Ask for evidence.

Activity

Does the laboratory have a documented procedure on selecting, ordering, acceptance testing and storing of new reagents and consumables?

Activity

Does the laboratory have a documented procedure on maintenance of the inventory?

Activity

Are all supplies stored under the right conditions in the laboratory?

Activity

Are records of supplies kept with the following details? [tick off]

  • Name of the supply
  • Preparation date/date of receipt
  • Whether or not acceptance criteria were met and any follow-up actions
  • Opening date (to be filled out when first opened)
  • Expiry date (can often be found on internet if not visible on supply package)
  • Possible safety warnings (Risk (R-) and Safety (S-) phrases or Health (H-) and Precaution (P-) phrases) if not indicated already on the supply package

Activity

Are all supplies stored such that they cannot fall from shelves or suffer damage in other ways?

Activity

In regions where earthquakes are a real risk: are supplies stored in such a way that they cannot be damaged due to an earthquake?

Activity

Are all supplies stored according to the first-in-first-out (FIFO) system?

Activity

Are all storage areas complying with the safety requirements related to the supplies stored in them?

Activity

Do storage areas protect the supplies from external influences such as humidity, light, insects, etc.?

Activity

Are all storage areas lockable to prevent unauthorized access?

Activity

Are all storage areas labeled with hazard symbols related to the supplies stored in them?

Activity

Is a list with R- and S-phrases/H- and P-statements provided on each storage area where this is relevant?

Activity

Do staff members know what R- and S-phrases and H- and P-statements are and how to find them?

Take a sample by asking some staff members.

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 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

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

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 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

Does the laboratory have a fixed format for the Result Report?

Activity

Does the Result Report include at least the following elements: [tick off]

  • Name of the laboratory
  • Personal details of the patient, including clinical information as received by the laboratory from the requester
  • Details of the requester
  • List of examinations performed
  • Date of the primary sample collection
  • Primary sample type
  • Comments on the quality of the sample (either adequate for the examinations performed or inadequate, which could influence reliability of results)
  • Examination results
  • Biological reference intervals/decision values, including the “alert/critical” intervals for all examinations performed, with interpretive comments on results, if applicable.
  • Details of the laboratory staff member reviewing the results and authorizing the report for release
  • Date and time of release of the report

Activity

Was the format of the Result Report discussed with regular clients of the laboratory during development?

Activity

Is a procedure in place that ensures verification of correct transcription of results on reports?

Activity

Is a procedure in place for authorizing Result Reports for release only if review of results has taken place and correct transcription of correct results and other important information to the report has been confirmed?

Activity

Does the laboratory have a procedure to ensure immediate notification of the requester in case results fall within critical intervals?

Activity

Does the laboratory record the occurrences in which results fall within critical intervals and requesters have to be notified directly (for verification purposes)?

Activity

Does the laboratory use a method for sending the Result Reports to the requesters with a minimum risk for losing reports?

Activity

Does the laboratory use a method for sending the Result Reports to the requester that ensures that reports are delivered as soon as possible?

Activity

Are patient data (such as Request Forms, work forms, registers, copies of Result Reports, revised Result Reports, Immediate Notification Forms, etc.) stored securely, protected from unauthorized access?

Activity

Are patient data (such as Request Forms, work forms, registers, copies of Result Reports, revised Result Reports, Immediate Notification Forms, etc.) stored in a logical way enabling quick and easy retrieval of data?

Activity

Does the laboratory have an SOP for Recording, Reporting and Archiving of Results, describing at least the following procedures:

  • Recording of results
  • Reviewing and authorizing results for release
  • Normal procedure for reporting of results
  • Immediate reporting of results from urgent samples
  • Immediate reporting of results in critical intervals
  • Notification of clinician if turnaround time is exceeded
  • Reporting via telephone or other electronic means
  • Reporting of results of samples of inadequate quality but that were still tested
  • Alteration of reports
  • Archiving of results

Activity

Are the procedures in the SOP for Recording, Reporting and Archiving of Results routinely and correctly implemented in practice?

Activity

Are all staff members that are involved in any way in recording, reporting and archiving of results aware of the contents of the SOP for Recording, Reporting and Archiving of Results?

Activity

Is the laboratory able to trace back the staff members who signed documents based on signatures or initials?

Activity

Have all laboratory staff members signed a confidentiality agreement?

Activity

If the laboratory stores information digitally: are weekly backups being made?

Activity

Are backups of the computerized system stored behind lock and key in another building than the laboratory building where the computerized system is?

Activity

Does the laboratory have an overview of the time each type of record should be archived?

Activity

Does the laboratory have an overview of where each type of record should be archived?

Activity

Are SOPs available at logical locations, at least:

  • Near the place where the procedures the SOPs describe are routinely performed
  • In the office areas
  • In the dedicated quality documents archive

Activity

Are inconsistencies and errors found in documents recorded in a Document Revision Form?

Activity

Do staff members know where to find the Document Revision Form?

Activity

Do staff members know what the Document Revision Form is for and do they know how to use it?

Activity

Is a Document Control Log available that shows all the quality documents of the laboratory with at least the following details:

  • The document code
  • The document title
  • The name of the author
  • The names of the reviewers
  • The name of the authorizer
  • The current version number
  • The date on which it was released for use
  • The date before which the document must be reviewed
  • Distribution list
  • Remarks
  • The title of the previous version
  • The name of the author of the previous version
  • The names of the reviewers of the previous version
  • The name of the authorizer of the previous version
  • The date on which the previous version was released for use
  • The date on which the previous version was replaced

Activity

Is each quality document (SOP, quality manual chapter, Biosafety Manual chapter) supplied with a front page that contains the following information: [tick off]

  • Document code
  • The document title
  • The name of the author
  • The names of the reviewers
  • The name of the authorizer
  • The current version number
  • The date on which it was released for use
  • The date before the document must be reviewed
  • Distribution list
  • Description of changes compared to previous version

Activity

Does the laboratory have a document control system that ensures that all its quality documents are reviewed, and, when necessary, revised on an annual (or, after maturation of the quality management system, biannual) basis?

Activity

Are the Bench Aids used in the laboratory based on current versions of SOPs?

Activity

Have all quality documents currently in use been reviewed by at least one reviewer?

Activity

Are all the quality documents used in the laboratory authorized for release?

Activity

Are copies of replaced quality documents in the quality documentation archive clearly marked as “replaced” with the date on which they were replaced?

Activity

Are all the references in quality documents to other documents, locations and equipment correct?

Activity

Does the laboratory have a dedicated archive in which it stores all its current and replaced quality documents for a period of five years?

Activity

Are all the procedures related to the document control system standardized in an SOP?

Activity

Is staff aware of what they have to do when they detect an error in a quality document?

Take a sample by asking several staff members.

Activity

Are the Equipment SOPs complete, i.e. do they include the procedures that were developed in phase 2 such as calibration, preventive maintenance and corrective maintenance?

Activity

Does the laboratory have a database/register with regular customers?

Activity

Are correct biological reference intervals/decision values and alert/critical interval values included for all the examinations performed by the laboratory in the Laboratory Result Reports?

Activity

Is the correctness of the biological reference intervals/diagnostic decision values and alert/critical interval values regularly verified for all the examinations performed by the laboratory?

Activity

If the methodology of an examination is changed, does the laboratory verify if the biological reference interval/diagnostic decision value and alert/critical interval value is still correct for that examination?

Activity

Does the laboratory have a service manual that includes the following: [tick-off]

  • Description of which tests are available at the laboratory, including information on which the clinical situations require this test to be performed.
  • What sample is needed for each test, the volume/amount needed and, if applicable, special timing of collection.
  • How this sample must be collected, including:
    • Identification of the patient and verification that the patient meets possible pre-examination requirements.
    • How to prepare the patient.
    • How to label the patient specimen.
    • The type of container in which the sample must be collected.
  • How and under which conditions it must be packed and sent to the laboratory, including:
    • Time frame within which the sample must be sent to the laboratory.
    • Temperature interval in which it must be transported.
    • The method of packing the sample container to prevent leakage.
  • If applicable, requirements regarding patient consent.
  • The procedure for requesting routine laboratory testing, including how to complete the Request Form.
  • The procedure for requesting urgent laboratory testing if applicable.
  • The normal turnaround time for each test.
  • The biological reference intervals and, if applicable, the critical/alert values for specific tests.
  • A list of factors known to affect the performance of the examination or the interpretation of results of each examination.
  • The routine method of reporting.
  • A guideline to interpreting the Result Report.
  • The procedure for reporting urgent testing results.
  • Requesting additional testing, including the time-frame in which this is possible.
  • The laboratory’s policy on protection of patient information.
  • The laboratory’s complaint procedure (this will not yet be included in phase 2 as this will be developed in phase 4).

Activity

Has the Laboratory Service Manual been sent to all the clients of the laboratory?

Activity

When changes are made to the service manual, is the new version directly printed and sent to the clients of the laboratory, with the note that they have to destroy the previous version?

Activity

Are correct biological reference intervals/decision values and, if applicable, alert/critical interval values included for all the examinations performed by the laboratory in the Laboratory Service Manual?

Activity

If the biological reference interval/diagnostic decision value and/or alert/critical interval values turn out to be incorrect after changing the methodology of an examination, is this value directly adapted in both the Laboratory Service Manual and the Laboratory Result Report format and is the new version of the Laboratory Service Manual sent directly to the clients of 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

Does the laboratory participate in proficiency testing/inter-laboratory comparison schemes for all the examinations performed?

Activity

If participation in a proficiency testing scheme or organization of an inter-laboratory comparison for a certain test is not possible: does the laboratory have a rechecking/retesting system to compare results?

Activity

If results of proficiency testing/inter-laboratory comparisons are deviating/incorrect, does the laboratory act with performing an analysis to identify the causes of the problem and does it implement corrective actions, and, if possible, preventive actions?

Activity

Does the laboratory have an SOP for participation in a proficiency testing scheme and/or an inter-laboratory comparison scheme?

Activity

If the laboratory is the organizer of an inter-laboratory comparison scheme, does the SOP for External Quality Assessment include the procedure for organizing this?

Activity

If the laboratory rechecks/retests samples for a certain test (in case no PT or inter-laboratory comparison was possible), does the SOP for External Quality Assessment include the procedure for organizing this?

Activity