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How to write Standard Operating Procedures (SOPs) for clinical laboratories - 1 of 4

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Tamer Soliman

The document provides guidance on writing standard operating procedures (SOPs) for clinical laboratories. It discusses the importance of SOPs for ensuring consistency, accuracy, and quality in laboratory testing. The document outlines different types of SOPs that could be written for various areas of the clinical laboratory, including procedures for sample handling, equipment use, reagents, and safety. It emphasizes that SOPs should be concise, detailed, clear, and easily understood. The document also provides a roadmap for writing, revising, approving, and implementing SOPs in the clinical laboratory.

Health & Medicine
Related topics:
Operating Procedures • Quality Assurance
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Dr. Tamer Soliman Lecturer of Clinical Pathology Sohag University Hospital EGYPT ‫اءات‬‫ر‬‫إج‬‫التشغيل‬‫القياسية‬‫لمعامل‬‫التحاليل‬‫ـبية‬‫ط‬‫ال‬ Standard Operating Procedures Clinical Laboratories Based on WHO Laboratory Quality Stepwise Implementation Tool for the Episode
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Good morning Sir Omar, The New Technologist has just assigned to the job recently He doesn’t know what his tasks are ! Sorry Sir, Mrs Nadia is on Vacation and No one could do her Job Sorry Doc, The new chemistry machine is troubleshooting How to manage? Sorry Sir, Tarek is very sick and No one could perform his work Doctor, The blood cell counter always gives Low hemoglobin values Sorry Doctor I can’t remember… in that Centrifugation step 3000 rpm for 5 minutes OR 5000 rpm for 3 minutes
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Why there are No SOPs? Sorry … Sir
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPS
Documents that include a set of step–by–step instructions that laboratory staff should meticulously follow when performing a procedure These SOPs are complied to laboratory management system to help lab staff to carry out complex routine operations A set of written instructions that document a routine or repetitive activity Followed by an organization ‫اءات‬‫ر‬‫ـ‬‫ـ‬‫ـ‬‫ـ‬‫ج‬‫إ‬ ‫ـية‬‫س‬‫القيا‬ ‫ـيل‬‫ـ‬‫ـ‬‫غ‬‫التش‬ Standard Operating Procedures General definition Laboratory definition By US Environmental Protection Agency Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Following well-written SOPs would ensure : Consistency ‫تطابق‬ Accuracy 1 2 • Everyone should perform the tests exactly the same way • So that the same result can be expected from all staff. • Consistency enables people who use laboratory results to observe changes in a particular patient’s results over time. • Following written procedures helps laboratory staff produce more accurate results. • They not relying on memory alone so they will not forget steps in the process.
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Consistent (reliable) + Accurate results are primary goals of the laboratory Following well-written SOPs would ensure : Consistency ‫تطابق‬ Accuracy Quality 1 2 3 and could be considered as the definition of quality in the laboratory.
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman A GOOD SOP should be : Concise, Detailed and Clear So that staff not normally performing the procedure will be able to do so by following the SOP All necessary details should be included (e.g. ambient temperature requirements and precise timing instructions) Easily understood by new personnel or students in training Reviewed and Approved by the laboratory management Approval is indicated by a signature and a date (this is important to ensure that the procedures being used for testing in the laboratory are those that are up to date and appropriate) Updated on a regular basis
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Test Samples Method Receiving and Describing Quality Assurance Master SOPs Analysis and Template Prepare Reagents Archiving Complaints Registration SOPs inside the Clinical laboratory? A number of SOPs could be written:
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Laboratory Method Describing Dealing with Safety Precautions Equipment Instruments and Machines Test Samples Receiving and Quality Assurance Master SOPs Analysis and Template Prepare Reagents Archiving Complaints Registration
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Samples Receiving and Registration Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Test Method Describing Quality Assurance Master SOPs Analysis and Template Prepare Reagents Archiving Complaints
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Prepare Reagents Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Test Samples Method Receiving and Describing Quality Assurance Master SOPs Analysis and Template Archiving Complaints Registration
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Equipment Instruments and Machines Dealing with Laboratory Safety Precautions Test Samples Method Receiving and Describing Quality Assurance Master SOPs Analysis and Template Prepare Reagents Archiving Complaints Registration
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Test Analysis Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Samples Method Receiving and Describing Quality Assurance Master SOPs and Template Prepare Reagents Archiving Complaints Registration
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Dealing with Laboratory Equipment Instruments and Machines Test Samples Method Receiving and Describing Quality Assurance Master SOPs Analysis and Template Prepare Reagents Archiving Complaints Registration Safety Precautions
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Master SOPs and Template Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Test Samples Method Receiving and Describing Quality Assurance SOPs Analysis Prepare Reagents Archiving Complaints Registration
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Quality Assurance Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Test Samples Method Receiving and Describing Master SOPs Analysis and Template Prepare Reagents Archiving Complaints Registration
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Archiving Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Test Samples Method Receiving and Describing Quality Assurance Master SOPs Analysis and Template Prepare Reagents Complaints Registration
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Dealing with Complaints s Laboratory Safety Precautions Equipment Instruments and Machines Test Samples Method Receiving and Describing Quality Assurance Master SOPs Analysis and Template Prepare Reagents Archiving Registration
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Policies Standards Procedures Guidelines Term ‫سياسات‬ ‫معايي‬ ‫اءات‬‫ر‬‫إج‬ ‫إرشادات‬ = Advise Me ! = What Is Required? = Why I Do This? = How I Do This?
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Policies Standards Procedures Guidelines Term Teacher Director Manager Quality Operator Who ‫سياسات‬ ‫معايي‬ ‫اءات‬‫ر‬‫إج‬ ‫إرشادات‬ 1 2 3 4 Advice on how to act in a given situation Recommended but Not Mandatory Quantifiable measures to achieve acceptable level of quality A set of ideas or plans that is used as a basis for making decisions A series of detailed steps to accomplish an end Meaning Example Company Policy Life Standard Licensing Procedures Diagnosis Guidelines Level Makes Them
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman ProcessProcedure ‫عملية‬‫اء‬‫ر‬‫إج‬ Working to accomplish a task Using inputs to create an output People work through a process to achieve an objective A Broad conceptA Limited concept People use procedure to carry out a task Actions Decisions + Actions The Procedure is a part of the Process The Process includes many Procedures
Be careful when using Generic SOP template to prepare your own SOP Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Attention • These generic SOPs always need to be checked and adapted to the situation in your laboratory. • Otherwise, the procedures performed in your laboratory are still not standardized and quality is not assured. • Your SOPs should be appropriate for your department. SOPs should take into account the conditions in your locale and the capabilities and limitations of your department.
Package inserts are NOT SOP’s Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Attention • Package inserts do NOT include specific information that pertains to your laboratory. • Do NOT rely solely on manufacturer’s package inserts for SOP’s. • DO use information from the package insert to include in the SOP. • DO use illustrations from package inserts. ‫يتناسب‬
Spreading the tasks of writing SOPs over different staff members 1. Prevents the overloading of one staff member with a huge amount of work. 2. Increases the involvement and commitment of all staff members. Writing SOPs is a Team Mission Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Attention
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Attention SOP may not work well if the work is related to Creativity
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPRoadmap
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap 2.1 Title Page 2.2 TOC 2.3 Text INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP General FORMAT PROCESS SOP 1 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System? 2.1 Title Page 2.2 TOC 2.3 Text INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP General FORMAT PROCESS SOP 1 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP 1 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP PROCESS SOP 1 4 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT 2 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap 2.1 Title Page 2.2 TOC 2.3 Text INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP General FORMAT PROCESS SOP 1 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap 2.1 Title Page 2.2 TOC 2.3 Text INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP General FORMAT 1 2 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 PROCESS SOP 4 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP General FORMAT PROCESS SOP 1 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP 1 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
1. SOP Intro Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 1.1 SOP OVERVIEW SOPs are documents that include: A set of step–by–step instructions that laboratory staff should meticulously follow when performing a procedure Laboratory Management System Complex Routine Operations These SOPs are complied to To help lab staff to carry out Definition
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman • In quality management it is important that You do what you say and say what you do • By recording all the major processes in the laboratory in SOPs You assure that these processes are carried out In exactly the same way every time Which means that you have standardized the process • As the SOPs need to be reviewed and authorized by different persons You also assure the quality of the procedures.
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman WHO Laboratory Quality Stepwise Implementation Tool 3.1 Develop a Request Form for Laboratory Testing 3.2 Write a master SOP 3.3 Make a list of all tests performed in the laboratory 3.4 Make SOPs for all tests performed by the laboratory https://extranet.who.int/lqsi/content/write-master-sop https://extranet.who.int/lqsi/content/make-sops-all-tests-performed-laboratory Phase I Phase II Phase III Phase IV 1. Create commitment for Quality Implementation 2. Ensure adequate and competent personnel 3. Make Procedures for all tests 4. Make procedures for all equipment 5. Start organizing an inventory system 6. Start organizing the biosafety The 1st step in standardizing the primary process is : The documentation of the procedures of all the tests currently performed in the laboratory in SOPs SOPs is one of the components of the Laboratory Quality System
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman WHO Laboratory Quality Stepwise Implementation Tool Phase I Phase II Phase III Phase IV SOPs is one of the components of the Laboratory Quality System
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman WHO Laboratory Quality Stepwise Implementation Tool Phase I Phase II Phase III Phase IV Also, in quality management : SOPs are subject to regular review and revision by setting up a document control system. 14. Set up a document control system [ will be discussed later ] SOPs is one of the components of the Laboratory Quality System
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Communications1 SOPs facilitate Well-written SOPs clearly communicate responsibilities to Laboratory Staff ‫بالمسئوليات‬‫التعريف‬ Lab Staff Written Responsibility
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Communications1 SOPs facilitate They don’t have to rely on their memories
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Total Quality System2 SOPs provide a Quality Item How SOPs provide this item Quality Policy Mission Statements Quality Plan Implementation of Policies Quality Manual Application of Standards
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Total Quality System2 SOPs provide a Procedure Implementation of SOPs Training Using SOPs for self-training Auditing Documenting Errors and Failures Quality Improvement Corrective Actions Quality Item How SOPs provide this item
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Productivity3 SOPs Help to Increase More likely to achieve Peak Performance Also  Manager by saving their time Not have to remind them of what needs to be done Productivity Not have to re-train Lab staff
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Cross-training4 SOPs Facilitate SOPs allow other lab staff To fill in and complete tasks they don’t normally perform if those key players are on vacation or out sick.
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons The Lab Staff5 SOPs are essential to EvaluationProcess Performance How can you hold laboratory staff responsible for tasks and processes that aren’t documented?
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons The Lab Staff5 SOPs are essential to EvaluationProcess Performance Without SOPs, job performance often becomes a matterof opinion
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons The Lab Staff5 SOPs are essential to EvaluationProcess Performance With SOPs, Manager can: Clearly identify Successes
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons The Lab Staff5 SOPs are essential to EvaluationProcess Performance With SOPs, Manager can: Communicate Deficiencies
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons The Lab Staff5 SOPs are essential to EvaluationProcess Performance With SOPs, Manager can be able to justify his: Disciplinary Termination actions Get OUT !! actions ‫عقاب‬ ‫الخدمة‬‫إنهاء‬
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Support Each Other6 SOPs help Lab Staff to When learning new processes, Lab staff can help and train each other, rather than relying on a manager to do so.
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Support Each Other6 SOPs help Lab Staff to Also, lab staff have theopportunity to correct / redirect each other when tasks are not being performed correctly.
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Safer Work Environment7 SOPs help to Create a Clearly written SOPs … Along with proper training  Reduce the odds of Accidentsor Injuries
1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Safer Work Environment7 SOPs help to Create a Clearly written SOPs … Along with proper training  Reduce legal liability when an incident occur
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 4.1 Preparation 4.2 Review and Approval 4.3 Frequency of Revisions and Reviews 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap
1. SOP Intro 1.2 SOP Purpose (Types of SOP) Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Administrative SOPs ‫إداري‬ Technical SOPs ‫تقن‬A B
1. SOP Intro 1.2 SOP Purpose (Types of SOP) Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Administrative SOPs ‫إداري‬ Technical SOPs ‫تقن‬A B Can be written for a wide variety of activities: • Reviewing documentation such as contracts • Quality Assurance and Management Plans • Inspecting (auditing) the work of others • Determining organizational training needs • Developing information on records and maintenance • Validating data packages • Describing office correspondence procedures. ‫عقود‬ ‫اقبة‬‫ر‬‫م‬ ‫المكتبية‬ ‫اسالت‬‫ر‬‫الم‬
1. SOP Intro 1.2 SOP Purpose (Types of SOP) Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Administrative SOPs ‫إداري‬ Technical SOPs ‫تقن‬A B SOPs for Equipment • Calibration • Operation • Maintenance SOPs for Analysis (Tests) SOPs for Procedures Written for any procedure inside the Lab • Range from collecting the patient sample and cleaning of laboratory rooms • Prepare Reagents • Prepare Sample • Perform Test analysis • Perform Quality controls 2 3 [ The majority of Lab SOPs ] Measurement of certain AnalyteFor Work on Lab Machines 1
1. SOP Intro 1.2 SOP Purpose (Types of SOP) Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Administrative SOPs ‫إداري‬ Technical SOPs ‫تقن‬A B Master SOPs [ SOP of SOPs ] C • Used to explain exactly HOW an SOP must be written • To make sure that all the SOPs in the laboratory are written in the same way and written complete
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman safety checklists for Reduce workSaving Provide Effort minimize Variations address concernsQuality promote Time Requirements Governmental Allow Following Health and miscommunication minimize Project activities valuable for used as auditing detailed instructions Self–Training as they provide 1 2 3 4 5 6 Legal defensibility 7 8 9 10 11 1. SOP Intro 1.3 Benefits of using SOPs
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
1. SOP Intro 1.4 Writing Style Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Easy-To-ReadSimple+ Concise 2 Abbreviated Step-by-step Instructions 3 Available in 1 4 Information Clear (Unambiguous) Explicit Detailed Not complicated The active voice Use Present verb tense (Add … Mix … Incubate … etc.) The Term “you” should Not be used, but implied 6 5 Local language You should now add 1.0 ml and then you should vortex Examples Add 1.0 ml and vortex
1. SOP Intro 1.4 Writing Style Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Easy-To-ReadSimple+ Concise 2 Abbreviated Step-by-step Instructions 3 Available in 1 4 Information Clear (Unambiguous) Explicit Detailed Not complicated The active voice Use Present verb tense (Add … Mix … Incubate … etc.) The Term “you” should Not be used, but implied Concern using illustrations e.g. flowcharts Following the style guide used by the laboratory e.g. Font size and margins 6 5 7 Local language 8
Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman To be Continued … Episode 2

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How to write Standard Operating Procedures (SOPs) for clinical laboratories - 1 of 4

  • 1. Dr. Tamer Soliman Lecturer of Clinical Pathology Sohag University Hospital EGYPT ‫اءات‬‫ر‬‫إج‬‫التشغيل‬‫القياسية‬‫لمعامل‬‫التحاليل‬‫ـبية‬‫ط‬‫ال‬ Standard Operating Procedures Clinical Laboratories Based on WHO Laboratory Quality Stepwise Implementation Tool for the Episode
  • 2. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Good morning Sir Omar, The New Technologist has just assigned to the job recently He doesn’t know what his tasks are ! Sorry Sir, Mrs Nadia is on Vacation and No one could do her Job Sorry Doc, The new chemistry machine is troubleshooting How to manage? Sorry Sir, Tarek is very sick and No one could perform his work Doctor, The blood cell counter always gives Low hemoglobin values Sorry Doctor I can’t remember… in that Centrifugation step 3000 rpm for 5 minutes OR 5000 rpm for 3 minutes
  • 3. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Why there are No SOPs? Sorry … Sir
  • 4. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPS
  • 5. Documents that include a set of step–by–step instructions that laboratory staff should meticulously follow when performing a procedure These SOPs are complied to laboratory management system to help lab staff to carry out complex routine operations A set of written instructions that document a routine or repetitive activity Followed by an organization ‫اءات‬‫ر‬‫ـ‬‫ـ‬‫ـ‬‫ـ‬‫ج‬‫إ‬ ‫ـية‬‫س‬‫القيا‬ ‫ـيل‬‫ـ‬‫ـ‬‫غ‬‫التش‬ Standard Operating Procedures General definition Laboratory definition By US Environmental Protection Agency Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman
  • 6. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Following well-written SOPs would ensure : Consistency ‫تطابق‬ Accuracy 1 2 • Everyone should perform the tests exactly the same way • So that the same result can be expected from all staff. • Consistency enables people who use laboratory results to observe changes in a particular patient’s results over time. • Following written procedures helps laboratory staff produce more accurate results. • They not relying on memory alone so they will not forget steps in the process.
  • 7. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Consistent (reliable) + Accurate results are primary goals of the laboratory Following well-written SOPs would ensure : Consistency ‫تطابق‬ Accuracy Quality 1 2 3 and could be considered as the definition of quality in the laboratory.
  • 8. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman A GOOD SOP should be : Concise, Detailed and Clear So that staff not normally performing the procedure will be able to do so by following the SOP All necessary details should be included (e.g. ambient temperature requirements and precise timing instructions) Easily understood by new personnel or students in training Reviewed and Approved by the laboratory management Approval is indicated by a signature and a date (this is important to ensure that the procedures being used for testing in the laboratory are those that are up to date and appropriate) Updated on a regular basis
  • 9. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Test Samples Method Receiving and Describing Quality Assurance Master SOPs Analysis and Template Prepare Reagents Archiving Complaints Registration SOPs inside the Clinical laboratory? A number of SOPs could be written:
  • 10. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Laboratory Method Describing Dealing with Safety Precautions Equipment Instruments and Machines Test Samples Receiving and Quality Assurance Master SOPs Analysis and Template Prepare Reagents Archiving Complaints Registration
  • 11. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Samples Receiving and Registration Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Test Method Describing Quality Assurance Master SOPs Analysis and Template Prepare Reagents Archiving Complaints
  • 12. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Prepare Reagents Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Test Samples Method Receiving and Describing Quality Assurance Master SOPs Analysis and Template Archiving Complaints Registration
  • 13. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Equipment Instruments and Machines Dealing with Laboratory Safety Precautions Test Samples Method Receiving and Describing Quality Assurance Master SOPs Analysis and Template Prepare Reagents Archiving Complaints Registration
  • 14. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Test Analysis Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Samples Method Receiving and Describing Quality Assurance Master SOPs and Template Prepare Reagents Archiving Complaints Registration
  • 15. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Dealing with Laboratory Equipment Instruments and Machines Test Samples Method Receiving and Describing Quality Assurance Master SOPs Analysis and Template Prepare Reagents Archiving Complaints Registration Safety Precautions
  • 16. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Master SOPs and Template Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Test Samples Method Receiving and Describing Quality Assurance SOPs Analysis Prepare Reagents Archiving Complaints Registration
  • 17. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Quality Assurance Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Test Samples Method Receiving and Describing Master SOPs Analysis and Template Prepare Reagents Archiving Complaints Registration
  • 18. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Archiving Dealing with Laboratory Safety Precautions Equipment Instruments and Machines Test Samples Method Receiving and Describing Quality Assurance Master SOPs Analysis and Template Prepare Reagents Complaints Registration
  • 19. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPs inside the Clinical laboratory? A number of SOPs could be written: Dealing with Complaints s Laboratory Safety Precautions Equipment Instruments and Machines Test Samples Method Receiving and Describing Quality Assurance Master SOPs Analysis and Template Prepare Reagents Archiving Registration
  • 20. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Policies Standards Procedures Guidelines Term ‫سياسات‬ ‫معايي‬ ‫اءات‬‫ر‬‫إج‬ ‫إرشادات‬ = Advise Me ! = What Is Required? = Why I Do This? = How I Do This?
  • 21. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Policies Standards Procedures Guidelines Term Teacher Director Manager Quality Operator Who ‫سياسات‬ ‫معايي‬ ‫اءات‬‫ر‬‫إج‬ ‫إرشادات‬ 1 2 3 4 Advice on how to act in a given situation Recommended but Not Mandatory Quantifiable measures to achieve acceptable level of quality A set of ideas or plans that is used as a basis for making decisions A series of detailed steps to accomplish an end Meaning Example Company Policy Life Standard Licensing Procedures Diagnosis Guidelines Level Makes Them
  • 22. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman ProcessProcedure ‫عملية‬‫اء‬‫ر‬‫إج‬ Working to accomplish a task Using inputs to create an output People work through a process to achieve an objective A Broad conceptA Limited concept People use procedure to carry out a task Actions Decisions + Actions The Procedure is a part of the Process The Process includes many Procedures
  • 23. Be careful when using Generic SOP template to prepare your own SOP Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Attention • These generic SOPs always need to be checked and adapted to the situation in your laboratory. • Otherwise, the procedures performed in your laboratory are still not standardized and quality is not assured. • Your SOPs should be appropriate for your department. SOPs should take into account the conditions in your locale and the capabilities and limitations of your department.
  • 24. Package inserts are NOT SOP’s Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Attention • Package inserts do NOT include specific information that pertains to your laboratory. • Do NOT rely solely on manufacturer’s package inserts for SOP’s. • DO use information from the package insert to include in the SOP. • DO use illustrations from package inserts. ‫يتناسب‬
  • 25. Spreading the tasks of writing SOPs over different staff members 1. Prevents the overloading of one staff member with a huge amount of work. 2. Increases the involvement and commitment of all staff members. Writing SOPs is a Team Mission Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Attention
  • 26. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Attention SOP may not work well if the work is related to Creativity
  • 27. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOPRoadmap
  • 28. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap 2.1 Title Page 2.2 TOC 2.3 Text INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP General FORMAT PROCESS SOP 1 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
  • 29. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System? 2.1 Title Page 2.2 TOC 2.3 Text INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP General FORMAT PROCESS SOP 1 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3
  • 30. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP 1 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
  • 31. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP PROCESS SOP 1 4 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT 2 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
  • 32. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap 2.1 Title Page 2.2 TOC 2.3 Text INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP General FORMAT PROCESS SOP 1 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
  • 33. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap 2.1 Title Page 2.2 TOC 2.3 Text INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP General FORMAT 1 2 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 PROCESS SOP 4 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
  • 34. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP General FORMAT PROCESS SOP 1 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
  • 35. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman SOP Roadmap 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP 1 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
  • 36. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
  • 37. 1. SOP Intro Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 1.1 SOP OVERVIEW SOPs are documents that include: A set of step–by–step instructions that laboratory staff should meticulously follow when performing a procedure Laboratory Management System Complex Routine Operations These SOPs are complied to To help lab staff to carry out Definition
  • 38. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman • In quality management it is important that You do what you say and say what you do • By recording all the major processes in the laboratory in SOPs You assure that these processes are carried out In exactly the same way every time Which means that you have standardized the process • As the SOPs need to be reviewed and authorized by different persons You also assure the quality of the procedures.
  • 39. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman WHO Laboratory Quality Stepwise Implementation Tool 3.1 Develop a Request Form for Laboratory Testing 3.2 Write a master SOP 3.3 Make a list of all tests performed in the laboratory 3.4 Make SOPs for all tests performed by the laboratory https://extranet.who.int/lqsi/content/write-master-sop https://extranet.who.int/lqsi/content/make-sops-all-tests-performed-laboratory Phase I Phase II Phase III Phase IV 1. Create commitment for Quality Implementation 2. Ensure adequate and competent personnel 3. Make Procedures for all tests 4. Make procedures for all equipment 5. Start organizing an inventory system 6. Start organizing the biosafety The 1st step in standardizing the primary process is : The documentation of the procedures of all the tests currently performed in the laboratory in SOPs SOPs is one of the components of the Laboratory Quality System
  • 40. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman WHO Laboratory Quality Stepwise Implementation Tool Phase I Phase II Phase III Phase IV SOPs is one of the components of the Laboratory Quality System
  • 41. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman WHO Laboratory Quality Stepwise Implementation Tool Phase I Phase II Phase III Phase IV Also, in quality management : SOPs are subject to regular review and revision by setting up a document control system. 14. Set up a document control system [ will be discussed later ] SOPs is one of the components of the Laboratory Quality System
  • 42. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons
  • 43. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Communications1 SOPs facilitate Well-written SOPs clearly communicate responsibilities to Laboratory Staff ‫بالمسئوليات‬‫التعريف‬ Lab Staff Written Responsibility
  • 44. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Communications1 SOPs facilitate They don’t have to rely on their memories
  • 45. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Total Quality System2 SOPs provide a Quality Item How SOPs provide this item Quality Policy Mission Statements Quality Plan Implementation of Policies Quality Manual Application of Standards
  • 46. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Total Quality System2 SOPs provide a Procedure Implementation of SOPs Training Using SOPs for self-training Auditing Documenting Errors and Failures Quality Improvement Corrective Actions Quality Item How SOPs provide this item
  • 47. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Productivity3 SOPs Help to Increase More likely to achieve Peak Performance Also  Manager by saving their time Not have to remind them of what needs to be done Productivity Not have to re-train Lab staff
  • 48. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Cross-training4 SOPs Facilitate SOPs allow other lab staff To fill in and complete tasks they don’t normally perform if those key players are on vacation or out sick.
  • 49. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons The Lab Staff5 SOPs are essential to EvaluationProcess Performance How can you hold laboratory staff responsible for tasks and processes that aren’t documented?
  • 50. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons The Lab Staff5 SOPs are essential to EvaluationProcess Performance Without SOPs, job performance often becomes a matterof opinion
  • 51. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons The Lab Staff5 SOPs are essential to EvaluationProcess Performance With SOPs, Manager can: Clearly identify Successes
  • 52. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons The Lab Staff5 SOPs are essential to EvaluationProcess Performance With SOPs, Manager can: Communicate Deficiencies
  • 53. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons The Lab Staff5 SOPs are essential to EvaluationProcess Performance With SOPs, Manager can be able to justify his: Disciplinary Termination actions Get OUT !! actions ‫عقاب‬ ‫الخدمة‬‫إنهاء‬
  • 54. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Support Each Other6 SOPs help Lab Staff to When learning new processes, Lab staff can help and train each other, rather than relying on a manager to do so.
  • 55. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Support Each Other6 SOPs help Lab Staff to Also, lab staff have theopportunity to correct / redirect each other when tasks are not being performed correctly.
  • 56. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Safer Work Environment7 SOPs help to Create a Clearly written SOPs … Along with proper training  Reduce the odds of Accidentsor Injuries
  • 57. 1. SOP Intro 1.1 SOP OVERVIEW Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 7 SOPs for NEED WE Reasons Safer Work Environment7 SOPs help to Create a Clearly written SOPs … Along with proper training  Reduce legal liability when an incident occur
  • 58. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
  • 59. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 4.1 Preparation 4.2 Review and Approval 4.3 Frequency of Revisions and Reviews 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap
  • 60. 1. SOP Intro 1.2 SOP Purpose (Types of SOP) Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Administrative SOPs ‫إداري‬ Technical SOPs ‫تقن‬A B
  • 61. 1. SOP Intro 1.2 SOP Purpose (Types of SOP) Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Administrative SOPs ‫إداري‬ Technical SOPs ‫تقن‬A B Can be written for a wide variety of activities: • Reviewing documentation such as contracts • Quality Assurance and Management Plans • Inspecting (auditing) the work of others • Determining organizational training needs • Developing information on records and maintenance • Validating data packages • Describing office correspondence procedures. ‫عقود‬ ‫اقبة‬‫ر‬‫م‬ ‫المكتبية‬ ‫اسالت‬‫ر‬‫الم‬
  • 62. 1. SOP Intro 1.2 SOP Purpose (Types of SOP) Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Administrative SOPs ‫إداري‬ Technical SOPs ‫تقن‬A B SOPs for Equipment • Calibration • Operation • Maintenance SOPs for Analysis (Tests) SOPs for Procedures Written for any procedure inside the Lab • Range from collecting the patient sample and cleaning of laboratory rooms • Prepare Reagents • Prepare Sample • Perform Test analysis • Perform Quality controls 2 3 [ The majority of Lab SOPs ] Measurement of certain AnalyteFor Work on Lab Machines 1
  • 63. 1. SOP Intro 1.2 SOP Purpose (Types of SOP) Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Administrative SOPs ‫إداري‬ Technical SOPs ‫تقن‬A B Master SOPs [ SOP of SOPs ] C • Used to explain exactly HOW an SOP must be written • To make sure that all the SOPs in the laboratory are written in the same way and written complete
  • 64. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
  • 65. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
  • 66. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman safety checklists for Reduce workSaving Provide Effort minimize Variations address concernsQuality promote Time Requirements Governmental Allow Following Health and miscommunication minimize Project activities valuable for used as auditing detailed instructions Self–Training as they provide 1 2 3 4 5 6 Legal defensibility 7 8 9 10 11 1. SOP Intro 1.3 Benefits of using SOPs
  • 67. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
  • 68. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman 2.1 Title Page 2.2 TOC 2.3 Text General FORMAT PROCESS SOP 42 TYPES SOP 3.1 Master SOP 3.2 Administrative 3.3 Technical SOPs 3.3.1 Procedure 3.3.2 Equipment 3.3.3 Analysis 3 INTRO SOP 1 1.1 Overview 1.2 Purpose 1.3 Benefits 1.4 Writing Styles SOP Roadmap 4.1 Preparation 4.2 Revision and Approval 4.3 Frequency of Reviewing 4.4 Checklists 4.5 Document Control 4.6 Document Tracking and Archival 4.7 How to Apply a SOP System?
  • 69. 1. SOP Intro 1.4 Writing Style Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Easy-To-ReadSimple+ Concise 2 Abbreviated Step-by-step Instructions 3 Available in 1 4 Information Clear (Unambiguous) Explicit Detailed Not complicated The active voice Use Present verb tense (Add … Mix … Incubate … etc.) The Term “you” should Not be used, but implied 6 5 Local language You should now add 1.0 ml and then you should vortex Examples Add 1.0 ml and vortex
  • 70. 1. SOP Intro 1.4 Writing Style Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman Easy-To-ReadSimple+ Concise 2 Abbreviated Step-by-step Instructions 3 Available in 1 4 Information Clear (Unambiguous) Explicit Detailed Not complicated The active voice Use Present verb tense (Add … Mix … Incubate … etc.) The Term “you” should Not be used, but implied Concern using illustrations e.g. flowcharts Following the style guide used by the laboratory e.g. Font size and margins 6 5 7 Local language 8
  • 71. Writing SOPs for ClinicalLaboratories – Dr. Tamer Soliman To be Continued … Episode 2