Checklist Phase 2

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

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

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

Is office space separated from laboratory rooms?

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

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

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

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.

Are all critical environmental/equipment parameters monitored adequately?

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

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

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

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

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

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

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

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

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

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 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)?

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?

Is a personnel file present of each staff member?

Are the personnel files structured in an orderly fashion?

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?

Has all equipment in the laboratory been labeled?

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

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

Take a sample by asking such a staff member.

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?

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

Are these Bench Aids in accordance with the SOPs for equipment?

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 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.

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

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

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

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

Ask for evidence.

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

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-) sentence numbers) if not indicated already on the supply package

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

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

Are all storage areas lockable to prevent unauthorized access?

Is a list with R- and S-sentences provided on each storage area where this is relevant?

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?

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

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 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?)

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

Are internal quality control results recorded in a register?

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

Are internal quality control results continuously monitored?

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

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 have a fixed format for the Result Report?

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

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?

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

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

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

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

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

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

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

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

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 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?

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

Are all the quality documents used in the laboratory the current versions?

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

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

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?

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?

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

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

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?

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?