Checklist

Has a Biosafety Officer been appointed?

Do all the staff members know who the Biosafety Officer is?

Has a Quality Officer been appointed?

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

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

Ask the Quality Officer.

Is the implementation of the quality management system coordinated through a Quality Project Team?

Are Quality Project Team meetings held on a regular basis?

The presence of minutes serve as prove for this.

Does the laboratory have a designated person who is responsible for monitoring stocks and ordering supplies and reagents (called a “Stock Officer”)?

Do all laboratory staff members know who the Stock Officer is?

Has an Equipment Officer been appointed?

Is the Equipment Officer protected against overburdening of work by allocating tasks of his/her former work to other staff members (if necessary)?

Are all reagents and supplies stored under the proper conditions, protected from unauthorized access and easily retrievable?

Is defective equipment demonstrably contaminated and stored outside the laboratory protected from use?

Are documents and records protected from unauthorized access?

Is an SOP present describing how to clean the laboratory building?

Is a cleaning schedule present?

Is the laboratory cleaned on a regular basis?

Is the Quality Officer appointed as Internal Auditor?

Is a Position Job Description present for the position of Internal Auditor?

Does the Authorization Matrix include the tasks and responsibilities pertaining to the position of Internal Auditor?

Is staff safeguarded from overburdening?

Are educational needs consistently assessed in competency assessments and performance appraisals?

Have specific staff members been authorized to communicate with clients so that proper communication and information provision to clients is ensured?

Has a Baseline Assessment of the laboratory been conducted to gain information on where some elements of a quality management system may be already in place and functioning, or where there are gaps that need to be addressed?

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

Is a backup staff member defined for each staff member in the laboratory?

Is the laboratory staff aware of the existence of the personnel replacement matrix and which purpose it serves?

Take a sample by interviewing some staff members.

Are patients in the waiting area and primary sample collection facility protected against rain and direct sunlight?

Are there enough chairs in the waiting area and primary sample collection facility so that every patient can sit?

Does the laboratory have a standardized procedure for hiring new permanent and temporary staff, and having guests?

Does the procedure for hiring new permanent and temporary staff cover all the following elements:

• Regarding permanent and temporary staff:
  • Criteria to which all applicants must comply
  • Procedure for defining specific criteria for the vacancy
  • Procedure of drafting and publishing the vacancy
  • Procedure of selecting suitable applicants based on application letters
  • Procedure of inviting applicants and organizing the application interview
  • Procedure of selecting applicants based on the application interview
  • Procedure of hiring suitable applicant, including:
    • Determining salary
    • Writing Personal Job Description
    • Adapting Authorization Matrix
    • Creating a personnel file
    • Ensuring that staff member is properly induced according to the SOP for Induction of New Personnel
    • Providing training to new staff (e.g. training into quality management to ensure that the staff member understands and works via the quality management system).
• Regarding guests:
  • Procedure of identification and recording of guest details
  • Procedure of recording details of the visit
  • Procedure of allowing access of the staff member to the laboratory (including a health check to determine if the guest’s health allows for accessing the testing areas).

Has commitment to implement a quality management system been created among laboratory staff?

Interview various staff members to find out if a meeting was held and if this was successful.

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

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

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

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

Does the retention schedule for storing different types of materials include the storage durations for samples and slides?

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

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?)

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

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

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

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?

Has the Risk Group for each laboratory room been determined?

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

Take a sample by asking such a staff member.

Is the quality management system appropriately documented in a quality manual, i.e. does it include information on each of the 12 quality system essentials and how these are implemented in the laboratory?

Have all staff members read the quality manual?

Does the Quality Year Plan take into account the Quality Policy, Long Term Goals, Core Values, Mission and Vision of the laboratory?

Has the Quality Year Plan and the action plan based on the Quality Year Plan been presented to the laboratory staff?

See minutes of that meeting.

Is the Request Form for Laboratory Testing clear?

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

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

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

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

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

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

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?

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

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

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?

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

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.

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

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?

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?

Is the folder Personnel Files up-to-date; i.e. have all certificates and diplomas been collected for all staff members and been stored in the personnel files?

Have all laboratory staff members signed a confidentiality agreement?

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

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

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

Is budget available for the Continuous Education Program?

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

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

Does the laboratory have an archive for laboratory records that is constructed in a logical way allowing for quick and easy access to information?

Does the laboratory archive protect records from deteriorating influences such as fire, humidity, insects, sunlight, etc.?

Has the effectiveness of control steps and preventive/corrective actions implemented in the laboratory routine procedures following the Failure-Mode-Effect-Analysis been evaluated?

Has the effectiveness and feasibility of the control steps and preventive/corrective actions that were optimized based on the first audit been evaluated in subsequent audits?

Is timely implementation of the action plans following internal audit monitored?

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

Are internal quality control protocols included in all relevant SOPs?

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

Is the Quality Year Plan complete (does it cover all the aspects of the quality management system)?

Is the Quality Year Plan appropriately stored and easily retrievable?

Did the laboratory formulate goals for the coming year prior to drafting the Quality Year Plan?

Are the long-term goals of the laboratory covering all the core-activities?

Are the long-term goals of the laboratory documented and stored?

Is the Mission of the laboratory documented and stored?

Does the Quality Policy describe clearly the scope of the laboratory services?

Does the Quality Policy contain a statement of the management’s commitment to implement and maintain the quality management system?

Does the Quality Policy contain a requirement that all staff members of the laboratory must be familiar with the policies and procedures of the laboratory and implement these?

Are staff familiar with the contents of the Quality Policy?

Take a sample by randomly asking staff members.

Does the laboratory have a clear Vision?

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

Have limits of acceptability been set for each quality indicator?

Has the laboratory investigated if there are potential conflicts of interest among laboratory staff?

Has the laboratory procedures in place on how to act in specific emergency situations?

Is an evacuation plan in place?

Are there organizational emergency arrangements in place including a division of roles and responsibilities for specific emergency situations?

Is a documented contingency plan present in the laboratory that should be followed in case of downtime of the computerized information system, to ensure access to laboratory information at all times?

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?

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

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

Has the laboratory manager been trained in principles of change management?

Do the equipment labels include the following data:

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

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

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

Does the laboratory have a job description for each position in the laboratory?

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

Are all job descriptions (both Position Job Descriptions and Personal Job Descriptions) up to date?

Has the laboratory formulated the procedure for selecting referral laboratories? If the laboratory does not refer samples to other laboratories: is a statement included in the quality manual explaining that no samples are referred to other laboratories?

Is a folder present containing documents with appointments between the referral laboratories and this laboratory and monitoring data?

Is the computerized system properly protected by a firewall?

Are specific staff members authorized to either I) access digital laboratory information, or II) access and enter digital laboratory information, or III) access, enter and change digital laboratory information, and is the Authorization Matrix adapted to indicate who is authorized to perform these activities?

Are action plans made to solve/correct the nonconformities identified in the external mock audit with corrective actions and control steps and preventive actions when necessary and applicable?

Is the audit report of the external mock audit with the action plan archived when all action points have been completed?

Is the Authorization Matrix signed and dated by the Laboratory Manager?

Do staff members know what the Authorization Matrix is?

Are staff members able to explain how the Authorization Matrix works?

Does the equipment register contain the following details for each piece of equipment? (tick off)

• Identity
• Label
• Serial number
• Manufacturer name
• Manufacturer’s contact person and contact details
• Service provider name
• Service provider’s contact person and contact details
• Date of purchase
• Date of putting into service
• Location
• Condition
• Frequency of maintenance
• Date of previous maintenance
• Date of next scheduled maintenance
• Remarks

Has the laboratory identified critical needs for specific pieces of equipment that must be present in order for the piece of equipment to function?

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

Are all hazardous materials in the laboratory registered?

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

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

Take a sample and check.

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

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?

Are action plans all stored together in one folder, with a logical structure (e.g. completed action plans in the back, open action plans in the front, sorted on date, etc.)?

If the laboratory is part of a bigger organization: does the laboratory have an Organizational Chart that clearly shows the position of the laboratory within the bigger organization?

Does the laboratory have an Organizational Chart showing the organization of all positions within the laboratory?

Are the Organizational Chart(s) stored in a folder that is accessible to all the staff members of the laboratory?

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

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

In laboratories where the presence of first aid providers is necessary: have enough staff members been appointed as first aid provider such that continuous presence of at least one first aid provider is ensured?

Does the Biosafety Manual contain an explanation of the tasks and responsibilities of first aid providers?

Have the Personal Job Descrptions of the first aid providers been adapted to reflect the authorizations of their position as first aid provider?

Is a report drafted of the client satisfaction survey that shows the main findings and points for improvement that were identified?

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

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

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

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

Have critical environmental/equipment parameters been identified?

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

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, is a nonconformity form always completed?

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

Are emergency numbers available near telephones and clearly visible?

Has an external audit been performed to verify complete and correct implementation of the quality management system in compliance with ISO 15189 before the laboratory applies for accreditation?

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?

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

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

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, controls and, if possible, preventive actions?

Do laboratory staff members participate in clinical rounds at least 4 times per year?

Are minutes made of meetings between laboratory staff and clinical staff?

Has a Facilities & Safety Assessment been performed?

Are the action points in this action plan from the Facility & Safety Assessment formulated according to the SMART method?

Have completed action points from the Facility & Safety Assessment been signed and dated for completion?

Is the functioning of the quality management system reviewed annually by laboratory management?

Do Management Review Reports include action points if applicable?

Are Management Review Reports securely and orderly stored?

Have preventive actions, control steps and corrective actions appropriately been implement to prevent and control nonconformities?

Look into the reports of failure mode effect analyses and see if failure modes have reasonably been prevented and controlled by preventive actions, control steps and corrective actions in practice. With reasonable is meant that the implementation of preventive actions, control steps and corrective actions weighs up against the probability of failure modes in combination with the severity of the consequences.

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

Is a report made of each competency assessment?

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

Is the competency of the Laboratory Manager annually assessed?

Is purchasing of new equipment taken into account in making the laboratory budget for the next year?

Are Bench Aids used for various pieces of equipment?

Are all items available in the laboratory stock recorded in a Stock Inventory Register?

Take a sample by checking for two or three supplies in the stock if their Stock Cards are in the Stock Inventory Register and check if the Stock Cards are up-to-date.

Do staff members know the correct procedure of taking items from the stock?

Take a sample by asking random staff members.

Have certificates of the introductory course in quality management been stored in the Personnel Files folder?

Is the certificate of the laboratory biosafety training of the Biosafety Officer stored in a folder called "Personnel Files"?

Are first aid kits present and placed at accessible locations?

Is there an SOP that provides procedures for dealing with the different types of spills?

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

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

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

Has a laboratory staff member appropriately been trained in performing failure-mode-effect-analyses?

Are primary sample collection facilities separated from the laboratory rooms?

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

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

Is there a dedicated area for breaks/lunches?

Does the laboratory have an SOP for Selection and Evaluation of Suppliers?

Does the laboratory develop contracts for reception of services in a standardized way?

If contracts are amended/changed, does the laboratory have records/minutes explaining the amendments/changes and why they were made?

Does the laboratory maintain minutes of meetings to discuss the contents of the contracts for service delivery?

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

Are staff meetings held regularly (weekly)?

Do the minutes of weekly staff meetings include a summary of discussions, SMART action points and the agenda for next week?

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

Ask for evidence.

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?

Are observations made during internal audits reported and are nonconformities identified and scored according to severity?

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

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

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

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

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

Do staff members know what R- and S-sentences are and how to find them?

Take a sample by asking some staff members.

Is there a written procedure on how to act in case of a suspected laboratory associated infection/laboratory accident whereby a staff-member has potentially become infected?

Is this action plan of the Quality Year Plan signed and dated by the Laboratory Manager for approval?

Are staff members aware of action points assigned to them?

Take a sample by asking staff members about action points assigned to them.

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

Find evidence by asking for the validation reports.

Have all pieces of equipment that have a direct influence on the outcome of examinations been validated?

Is there an standardized procedure in place assuring that the laboratory determines and corrects the negative influence of defective equipment on laboratory testing?

Has procedure for determining and correcting the negative influence of defective equipment routinely been performed in the past when equipment appeared to be defective?

Ask the interviewee to show an example.

Is the pressure of the biosafety level III regularly monitored and recorded?

Is the negative pressure system included in the preventive maintenance program of the laboratory?

Is an up-to-date Biosafety Manual present in the laboratory?

Does the Biosafety Manual contain general safety rules for working in the laboratory with human material?

Does the Biosafety Manual contain procedures for emergency situations?

Is the Biosafety Manual easily accessible for all staff members at a logical location?

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 the pre-examination requirements (e.g. for some examinations the patient must be sober; the sample collector must verify that the patient is indeed sober).
  • How to prepare the patient.
  • How to label the patient.
  • 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 leaks.
• 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.
• 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).

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?

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?

Does the Master SOP have different sections on how to write Analysis SOPs, Equipment SOPs and Procedure SOPs?

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

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

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?

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

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

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

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

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?

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

Are complaints handled in a standardized way?

Has the laboratory standardized the procedures for information management in an SOP?

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

Does the laboratory demonstrably adhere to procedures for processing and disposal of different types of waste produced?

Does lab staff adhere to guidelines on safe disposal of waste?

Is potentially infectious material properly incinerated?

Is the area around the fire pit/incinerator free from clutter?

Are separate, clearly distinguishable containers present for different types of chemical waste?

Are trashcans for (bio)hazardous waste clearly distinguishable to prevent confusion with the bins for normal waste?

Are SOPs present for all pieces of equipment?

Are Equipment SOPs stored at a logical location (near the equipment they have been written for), accessible to all staff members?