hivdr mod 10 sops
DESCRIPTION
SOPTRANSCRIPT
Standard Operating Procedures (SOPs)
*
*
Organization
*
*
Organization
*
Present: SOPs and other documentation are "behind the scenes" in many other aspects of quality, such as:
Personnel
Equipment
Managing Documents
Present an overview of the topics in this module:
First, we’ll define the differences between processes and procedures, and why we need both.
Then, we’ll look at how to write processes and procedures that enhance lab quality.
We’ll look at other types of documents that support SOPs.
*
*
Identify components of SOPs.
Identify the SOPs that are needed to ensure the quality of testing.
Given a procedure, demonstrate how to write an SOP.
*
*
Why do we need to document both?
*
*
Present:
Laboratory work is a sequence of key processes in which the laboratory uses resources such as people, instruments, methods, and materials, to transform orders for laboratory tests into results and reports.
Key processes for the laboratory are shown as part of the quality assurance cycle, and are also referred to as the “Path of Workflow.”
Documenting key processes provides a means to identify problematic activities that can be improved to help prevent medical errors.
The main information in a process document depicts or describes “how something happens.”
Flowcharts or tables are usually used to present process information.
*
Each Process Has Procedures
*
*
Standard Operating Procedures (SOPs)
Present:
The laboratory needs to provide carefully documented instructions, in the form of procedures, for all activities that support genotyping.
These instructions provide essential information for both new and experienced employees about how to perform all their job tasks.
*
*
Flow of work
One task
What the operator needs to do and how
*
*
Can be used for training and competence assessment programs
Personnel can become competent more quickly
Way to identify, label, and correct process problems
*
*
Purpose: to ensure reproducible and correct performance of laboratory tests
Reduce inter-operator and inter-run variation
Made specific for each laboratory
Controlled document: need a regulated system for
Preparation
Approval
Distribution
Revision
Training
Brainstorm:
Ask participants, “What do you think should be included in every SOP? That is, what are some standard components of SOPs?
Record their answers on a flipchart.
*
*
Why do we need to document both?
*
*
What SOPs does a genotyping lab need?
How can each lab write SOPs that work for it?
*
*
Genotyping process
*
*
Include the word “process”
Process: Flowchart or Table
Main part of document
Supporting Documents
Related procedures (SOPs)
Present the components of process documents, referring to the sample process document as you do so.
Provide a simple example: The hiring process for lab technicians includes procedures for recruiting, screening, interviewing, and negotiating procedures that need to be completed.
Distribute blank paper.
Ask participants to work in small groups.
Assign each small group to one of the three processes below and ask them to develop a process document that contains all the items on the slide, with special attention to the process flow itself.
Document approval process
New assay validation process
New employee training process
Allow about 30 minutes.
Ask each group to present its work. Discuss similarities and differences among process flows when there are different small groups that have worked on the same process. Also, talk about how discussing and documenting lab processes improves shared understanding of what those processes include.
*
*
Present:
Whereas process documents depict or describe how related activities are sequenced across time, procedure documents present step-by-step instructions that a single individual needs to take to successfully complete one activity in the process.
Therefore, one process document refers to a number of supporting procedure documents.
Each procedure includes several components, as shown here.
Refer participants to handout 11, which is the SOP template.
Explain:
This template provides a format as well as instructions for completing an SOP.
*
*
Customer Service
Ask participants: What are some procedures that may need to be documented that relate to the processes during the pre-testing phase?
Note participant responses on a chart. Possible responses include:
Test requesting: Instructions for entering laboratory orders into a computer system or completing paper requisitions, including provision of necessary clinical information.
Sample Collection and Labeling: Instructions for identifying patients, collecting blood and labeling collected samples.
Sample Transport: Instructions for transporting samples to the laboratory.
*
*
Specimen management: collection, labelling, receipt, assessment, storage and shipping
Criteria for unacceptable samples and follow up action
Any storage or processing before the test
Any preparations for samples transported to other laboratories for testing
Equipment maintenance
Sample transport
Present: These are our recommendations for procedures that you should develop for pre-testing.
Refer participants to handouts 12, 13, and 14, which are:
The specimen management SOP
The specimen clarification form
The specimen log-in form
Discuss: Allowing for differences among labs in formatting, does this SOP meet the guidelines you were just given?
*
*
*
Ask participants: What are some procedures that may need to be documented that relate to the processes during the testing phase?
Note participant responses on a chart. Possible responses include:
RNA extraction
Operation of the sequencer
Data colelction and analysis
*
Unidirectional Laboratory workflow
Properly Handling and manipulation of infectious human material and biohazardous waste disposal
All steps of sequencing procedure, including editing and interpretation
Internal quality control
For commercial tests, can use manufacturer’s manuals or write own procedures Copied from previous slide.
If manufacturer’s procedures are modified:
Document changes
Verify adapted procedure
Present: These are our recommendations for procedures that you should develop for testing.
Present: If you are using commercial tests such as TruGene or ViroSeq, you have a head start, because these manufacturers generally provide some procedural documentation and other support documents. Here are some points to keep in mind as you develop your testing procedures:
Refer participants to handouts 15, 16, and 17, which are:
The ViroSeq SOP
The ViroSeq Log
The ViroSeq Sequence Editing QC form
*
*
*
Ask participants: What are some procedures that may need to be documented that relate to the processes during the post-testing testing phase?
Note participant responses on a chart.
Possible responses include:
Examination procedures cover the activities from the time the sample reaches the examination area to the time results are reviewed and preliminary interpretations are determined.
Procedures for manual examinations differ from procedures for automated examinations. Manual examination procedures are usually method-specific.
*
Detection of containments
Negative controls and what to do if they are positive
Phylogenetic testing for cross-contamination (SQUAT)
Decontamination procedures
Data management
Data storage and retrieval procedures
From WHO list of required SOPs.
Refer participants to handouts 18, 19, and 20, which are:
The Occurrence Management SOP
The Occurrence Management Log
The Occurrence Management Form
*
*
Other Helpful Procedures (Data Management):
Electronic transfer of data from an instrument into a computer system
Manual entry of data into a computer system
Manually reporting results on paper report forms
Entering test results into the laboratory’s information system (include each prompt in the computer program sequence)
Correcting results: how to change results that have been erroneously entered into the reporting system and are thus available for review and use by clinicians and caregivers.
Supervisory and/or medical review of examination results, where such review is required.
*
*
Sample retention:
Post-examination procedures for sample retention need to include step-by-step instructions for archiving sample materials in such a way as to be readily retrievable when needed.
Schedule for the duration of sample retention as defined by regulatory or accreditation requirements, and organizational needs.
Disposal of samples after they have exceeded their established retention times.
(continued)
Special Safety Precautions
Refer to the SOP template (handout 11).
Discuss: How well would this template work for you? What adjustments would you want to make? Why? What process would you use for creating SOPs for your lab?
Discuss: Sometimes, it is hard to decide if information should be part of an existing procedure or in its own procedure. For example, if you wanted to put in some special guidelines for cleaning a piece of equipment, would you include them in a procedure on “cleaning” or in the equipment testing procedure? (Note: Encourage participants to conclude that if there are cleaning steps that are completed each time you do the testing procedure, then those steps should be part of the testing procedure. If not, then they should be in a separate procedure.)
*
*
What SOPs does a genotyping lab need?
How can each lab write SOPs that work for it?
*
*
What other types of documents help with process control?
*
*
Record results of a given procedure
Forms include:
Facility name and location
Form ABC-100-F01 is with Procedure ABC-100-P01)
Guidelines:
Note needed forms in Appendices section of SOPs
Present:
Forms are the blank documents (or computer screens) onto which the results generated from the performance of a given procedure are recorded.
Form documents need to include:
A title that describes the form’s purpose
Facility name and Location.
Effective Date
Fields in which to record information generated from performing the procedure (ex. Results, interpretations, date, time, initials)
A means to link the form to its respective procedure document (The document numbering system ex. Form ABC-100-F01 is associated with Procedure ABC-100-P01)
Examples of properly completed forms, labels, and tags should be included with their respective procedures in the procedures manual. These examples can be placed in the Appendices section of their respective procedures.
Refer to the forms included with the SOP handouts.
Note the numbering system.
Note the clarity of the titles.
*
*
QC form(s) for genotyping
Document approval request form
Lab reagent inventory form
Flowchart for sample management
*
*
Procedure Manuals
Procedure manuals should be organized in a way that can be easily followed by laboratory personnel and should contain the following elements:
Table of contents
Process descriptions (optional)
Present the information on the slide.
Trainer’s Note: If possible, show an example of a well-organized procedure manual as a model.
*
*
3 C’s: Current, complete, and correct
Traceable to the “parent” document
Effective date is listed.
If some of the above qualities are missing, start the document change process.
Present information on job aids, emphasizing that they must be kept out of date.
Ask participants to provide some examples of job aids already in their labs. How are they kept up to date?
*
*
Discussion
Besides SOPs, what other types of documents help with process control?
*
*
managing documents
Why is it important to control how documents are created, updated, copied, and stored?
What are some general guidelines for document management?
*
*
Approved format
Current, approved version
Quality Assurance Manager is responsible for the assignment and tracking of all documentation
System may be
Paper-based
Electronic-based
Present:
The laboratory needs a document management system to ensure that all documents are written in the approved formats, are current version, and are reviewed and approved by the appropriate individual(s) in a timely manner.
The Quality Assurance Manager is responsible for the assignment and tracking of all documentation.
*
*
Get rid of old, outdated information
Standardize procedures
Maintain quality of laboratory services and results
Present: A document management process is vital for ensuring that staff access and use only the most current versions of documents and that everyone is following the same process sequence and procedure instructions. In so doing, performance variations that can affect the quality of laboratory services and results are greatly reduced or actually eliminated.
*
*
Numbers for type of procedure
100 = General Laboratory
F = Form
P = Procedure
T = Table (process)
C = Flowchart (process)
Present:
A standard system of documentation is used to identify document types. This helps with grouping related documents.
Explain how the ID, with nine letters/numbers and two dashes, is derived.
Ask: What ID would be appropriate for your lab for a form related to genotyping quality control (procedure 4)?
*
*
Requestor completes approval request form
Lab supervisor(s) reviews document
Lab Director approves all new procedures and any major modifications.
The Quality Assurance Manager maintains review and approval documentation in the master file hard copy binder
Present:
It is important to establish a process for the timely review and approval of new documents before they are placed into use.
There should be a document approval request form that is always used for new document and document revisions. This form should specify:
The need for revision or new documentation.
Any related documents that are affected.
If validation is necessary.
Name, date, and signature of Quality Assurance Manager
Effective date for use of the new or revised document.
If rejected, reason why document was rejected as well as the signature and date of the rejector.
Annual review signatures and dates.
The lab supervisor is responsible for review of documents specific to that laboratory.
The Laboratory Director is responsible for approval of all new procedures as well as any major modifications to current procedures.
Lab documents used across different labs should be reviewed by all laboratory supervisors. If this is not possible, at minimum one Laboratory Supervisor must review the document.
*
*
Master file:
Electronic
All previous versions , clearly identified
RETIRED in bold on the upper right hand corner of the header OR
Watermarked diagonally across the page in order
Hard copy
Present:
The master file serves as the original electronic source from which working copies of the current version are generated.
The current version and all previous versions of a laboratory document are stored in the master file.
When a document is changed, the new version becomes the new master document, and the previous version is retired and archived in the master file.
Retired documents will indicate RETIRED in bold on the upper right hand corner of the header or watermarked diagonally across the page in order to identify the document as obsolete and prevent its unintended use.
The documents are stored properly.
*
*
Discussion
Why is it important to control how documents are created, updated, copied, and stored?
What are some general guidelines for document management?
*
*
Reflection
What are the strengths and weaknesses of our current processes and procedures?
Where are we vulnerable to errors?
How can we improve our documentation to reduce errors?
Discuss these questions in the large group.
*
*
Managing Documents
*
*
Practice: Create an SOP for Making Coffee
Ask participants to work in groups of three to four people to complete the following steps:
Draft an SOP for making a cup of coffee, using the SOP template.
Ask another group to review the SOP.
Note: As with genotyping, there may be different procedures, depending on what equipment you use and other choices you must make. There is no single correct answer, but each SOP should be thorough and complete.
Facilitate exercise. Make sure that groups stay focused on creating an SOP and what to include in each section.
*
*
Summary
Ask participants to work in pairs (two people from same lab) to complete the following steps:
Create a process for identify, creating, validating, and approving SOPs in their labs.
Create a list of SOPs they’ll need
Decide the “who, what, when” for completing the SOPs
Summarize the module.
*
*
Organization
*
*
Organization
*
Present: SOPs and other documentation are "behind the scenes" in many other aspects of quality, such as:
Personnel
Equipment
Managing Documents
Present an overview of the topics in this module:
First, we’ll define the differences between processes and procedures, and why we need both.
Then, we’ll look at how to write processes and procedures that enhance lab quality.
We’ll look at other types of documents that support SOPs.
*
*
Identify components of SOPs.
Identify the SOPs that are needed to ensure the quality of testing.
Given a procedure, demonstrate how to write an SOP.
*
*
Why do we need to document both?
*
*
Present:
Laboratory work is a sequence of key processes in which the laboratory uses resources such as people, instruments, methods, and materials, to transform orders for laboratory tests into results and reports.
Key processes for the laboratory are shown as part of the quality assurance cycle, and are also referred to as the “Path of Workflow.”
Documenting key processes provides a means to identify problematic activities that can be improved to help prevent medical errors.
The main information in a process document depicts or describes “how something happens.”
Flowcharts or tables are usually used to present process information.
*
Each Process Has Procedures
*
*
Standard Operating Procedures (SOPs)
Present:
The laboratory needs to provide carefully documented instructions, in the form of procedures, for all activities that support genotyping.
These instructions provide essential information for both new and experienced employees about how to perform all their job tasks.
*
*
Flow of work
One task
What the operator needs to do and how
*
*
Can be used for training and competence assessment programs
Personnel can become competent more quickly
Way to identify, label, and correct process problems
*
*
Purpose: to ensure reproducible and correct performance of laboratory tests
Reduce inter-operator and inter-run variation
Made specific for each laboratory
Controlled document: need a regulated system for
Preparation
Approval
Distribution
Revision
Training
Brainstorm:
Ask participants, “What do you think should be included in every SOP? That is, what are some standard components of SOPs?
Record their answers on a flipchart.
*
*
Why do we need to document both?
*
*
What SOPs does a genotyping lab need?
How can each lab write SOPs that work for it?
*
*
Genotyping process
*
*
Include the word “process”
Process: Flowchart or Table
Main part of document
Supporting Documents
Related procedures (SOPs)
Present the components of process documents, referring to the sample process document as you do so.
Provide a simple example: The hiring process for lab technicians includes procedures for recruiting, screening, interviewing, and negotiating procedures that need to be completed.
Distribute blank paper.
Ask participants to work in small groups.
Assign each small group to one of the three processes below and ask them to develop a process document that contains all the items on the slide, with special attention to the process flow itself.
Document approval process
New assay validation process
New employee training process
Allow about 30 minutes.
Ask each group to present its work. Discuss similarities and differences among process flows when there are different small groups that have worked on the same process. Also, talk about how discussing and documenting lab processes improves shared understanding of what those processes include.
*
*
Present:
Whereas process documents depict or describe how related activities are sequenced across time, procedure documents present step-by-step instructions that a single individual needs to take to successfully complete one activity in the process.
Therefore, one process document refers to a number of supporting procedure documents.
Each procedure includes several components, as shown here.
Refer participants to handout 11, which is the SOP template.
Explain:
This template provides a format as well as instructions for completing an SOP.
*
*
Customer Service
Ask participants: What are some procedures that may need to be documented that relate to the processes during the pre-testing phase?
Note participant responses on a chart. Possible responses include:
Test requesting: Instructions for entering laboratory orders into a computer system or completing paper requisitions, including provision of necessary clinical information.
Sample Collection and Labeling: Instructions for identifying patients, collecting blood and labeling collected samples.
Sample Transport: Instructions for transporting samples to the laboratory.
*
*
Specimen management: collection, labelling, receipt, assessment, storage and shipping
Criteria for unacceptable samples and follow up action
Any storage or processing before the test
Any preparations for samples transported to other laboratories for testing
Equipment maintenance
Sample transport
Present: These are our recommendations for procedures that you should develop for pre-testing.
Refer participants to handouts 12, 13, and 14, which are:
The specimen management SOP
The specimen clarification form
The specimen log-in form
Discuss: Allowing for differences among labs in formatting, does this SOP meet the guidelines you were just given?
*
*
*
Ask participants: What are some procedures that may need to be documented that relate to the processes during the testing phase?
Note participant responses on a chart. Possible responses include:
RNA extraction
Operation of the sequencer
Data colelction and analysis
*
Unidirectional Laboratory workflow
Properly Handling and manipulation of infectious human material and biohazardous waste disposal
All steps of sequencing procedure, including editing and interpretation
Internal quality control
For commercial tests, can use manufacturer’s manuals or write own procedures Copied from previous slide.
If manufacturer’s procedures are modified:
Document changes
Verify adapted procedure
Present: These are our recommendations for procedures that you should develop for testing.
Present: If you are using commercial tests such as TruGene or ViroSeq, you have a head start, because these manufacturers generally provide some procedural documentation and other support documents. Here are some points to keep in mind as you develop your testing procedures:
Refer participants to handouts 15, 16, and 17, which are:
The ViroSeq SOP
The ViroSeq Log
The ViroSeq Sequence Editing QC form
*
*
*
Ask participants: What are some procedures that may need to be documented that relate to the processes during the post-testing testing phase?
Note participant responses on a chart.
Possible responses include:
Examination procedures cover the activities from the time the sample reaches the examination area to the time results are reviewed and preliminary interpretations are determined.
Procedures for manual examinations differ from procedures for automated examinations. Manual examination procedures are usually method-specific.
*
Detection of containments
Negative controls and what to do if they are positive
Phylogenetic testing for cross-contamination (SQUAT)
Decontamination procedures
Data management
Data storage and retrieval procedures
From WHO list of required SOPs.
Refer participants to handouts 18, 19, and 20, which are:
The Occurrence Management SOP
The Occurrence Management Log
The Occurrence Management Form
*
*
Other Helpful Procedures (Data Management):
Electronic transfer of data from an instrument into a computer system
Manual entry of data into a computer system
Manually reporting results on paper report forms
Entering test results into the laboratory’s information system (include each prompt in the computer program sequence)
Correcting results: how to change results that have been erroneously entered into the reporting system and are thus available for review and use by clinicians and caregivers.
Supervisory and/or medical review of examination results, where such review is required.
*
*
Sample retention:
Post-examination procedures for sample retention need to include step-by-step instructions for archiving sample materials in such a way as to be readily retrievable when needed.
Schedule for the duration of sample retention as defined by regulatory or accreditation requirements, and organizational needs.
Disposal of samples after they have exceeded their established retention times.
(continued)
Special Safety Precautions
Refer to the SOP template (handout 11).
Discuss: How well would this template work for you? What adjustments would you want to make? Why? What process would you use for creating SOPs for your lab?
Discuss: Sometimes, it is hard to decide if information should be part of an existing procedure or in its own procedure. For example, if you wanted to put in some special guidelines for cleaning a piece of equipment, would you include them in a procedure on “cleaning” or in the equipment testing procedure? (Note: Encourage participants to conclude that if there are cleaning steps that are completed each time you do the testing procedure, then those steps should be part of the testing procedure. If not, then they should be in a separate procedure.)
*
*
What SOPs does a genotyping lab need?
How can each lab write SOPs that work for it?
*
*
What other types of documents help with process control?
*
*
Record results of a given procedure
Forms include:
Facility name and location
Form ABC-100-F01 is with Procedure ABC-100-P01)
Guidelines:
Note needed forms in Appendices section of SOPs
Present:
Forms are the blank documents (or computer screens) onto which the results generated from the performance of a given procedure are recorded.
Form documents need to include:
A title that describes the form’s purpose
Facility name and Location.
Effective Date
Fields in which to record information generated from performing the procedure (ex. Results, interpretations, date, time, initials)
A means to link the form to its respective procedure document (The document numbering system ex. Form ABC-100-F01 is associated with Procedure ABC-100-P01)
Examples of properly completed forms, labels, and tags should be included with their respective procedures in the procedures manual. These examples can be placed in the Appendices section of their respective procedures.
Refer to the forms included with the SOP handouts.
Note the numbering system.
Note the clarity of the titles.
*
*
QC form(s) for genotyping
Document approval request form
Lab reagent inventory form
Flowchart for sample management
*
*
Procedure Manuals
Procedure manuals should be organized in a way that can be easily followed by laboratory personnel and should contain the following elements:
Table of contents
Process descriptions (optional)
Present the information on the slide.
Trainer’s Note: If possible, show an example of a well-organized procedure manual as a model.
*
*
3 C’s: Current, complete, and correct
Traceable to the “parent” document
Effective date is listed.
If some of the above qualities are missing, start the document change process.
Present information on job aids, emphasizing that they must be kept out of date.
Ask participants to provide some examples of job aids already in their labs. How are they kept up to date?
*
*
Discussion
Besides SOPs, what other types of documents help with process control?
*
*
managing documents
Why is it important to control how documents are created, updated, copied, and stored?
What are some general guidelines for document management?
*
*
Approved format
Current, approved version
Quality Assurance Manager is responsible for the assignment and tracking of all documentation
System may be
Paper-based
Electronic-based
Present:
The laboratory needs a document management system to ensure that all documents are written in the approved formats, are current version, and are reviewed and approved by the appropriate individual(s) in a timely manner.
The Quality Assurance Manager is responsible for the assignment and tracking of all documentation.
*
*
Get rid of old, outdated information
Standardize procedures
Maintain quality of laboratory services and results
Present: A document management process is vital for ensuring that staff access and use only the most current versions of documents and that everyone is following the same process sequence and procedure instructions. In so doing, performance variations that can affect the quality of laboratory services and results are greatly reduced or actually eliminated.
*
*
Numbers for type of procedure
100 = General Laboratory
F = Form
P = Procedure
T = Table (process)
C = Flowchart (process)
Present:
A standard system of documentation is used to identify document types. This helps with grouping related documents.
Explain how the ID, with nine letters/numbers and two dashes, is derived.
Ask: What ID would be appropriate for your lab for a form related to genotyping quality control (procedure 4)?
*
*
Requestor completes approval request form
Lab supervisor(s) reviews document
Lab Director approves all new procedures and any major modifications.
The Quality Assurance Manager maintains review and approval documentation in the master file hard copy binder
Present:
It is important to establish a process for the timely review and approval of new documents before they are placed into use.
There should be a document approval request form that is always used for new document and document revisions. This form should specify:
The need for revision or new documentation.
Any related documents that are affected.
If validation is necessary.
Name, date, and signature of Quality Assurance Manager
Effective date for use of the new or revised document.
If rejected, reason why document was rejected as well as the signature and date of the rejector.
Annual review signatures and dates.
The lab supervisor is responsible for review of documents specific to that laboratory.
The Laboratory Director is responsible for approval of all new procedures as well as any major modifications to current procedures.
Lab documents used across different labs should be reviewed by all laboratory supervisors. If this is not possible, at minimum one Laboratory Supervisor must review the document.
*
*
Master file:
Electronic
All previous versions , clearly identified
RETIRED in bold on the upper right hand corner of the header OR
Watermarked diagonally across the page in order
Hard copy
Present:
The master file serves as the original electronic source from which working copies of the current version are generated.
The current version and all previous versions of a laboratory document are stored in the master file.
When a document is changed, the new version becomes the new master document, and the previous version is retired and archived in the master file.
Retired documents will indicate RETIRED in bold on the upper right hand corner of the header or watermarked diagonally across the page in order to identify the document as obsolete and prevent its unintended use.
The documents are stored properly.
*
*
Discussion
Why is it important to control how documents are created, updated, copied, and stored?
What are some general guidelines for document management?
*
*
Reflection
What are the strengths and weaknesses of our current processes and procedures?
Where are we vulnerable to errors?
How can we improve our documentation to reduce errors?
Discuss these questions in the large group.
*
*
Managing Documents
*
*
Practice: Create an SOP for Making Coffee
Ask participants to work in groups of three to four people to complete the following steps:
Draft an SOP for making a cup of coffee, using the SOP template.
Ask another group to review the SOP.
Note: As with genotyping, there may be different procedures, depending on what equipment you use and other choices you must make. There is no single correct answer, but each SOP should be thorough and complete.
Facilitate exercise. Make sure that groups stay focused on creating an SOP and what to include in each section.
*
*
Summary
Ask participants to work in pairs (two people from same lab) to complete the following steps:
Create a process for identify, creating, validating, and approving SOPs in their labs.
Create a list of SOPs they’ll need
Decide the “who, what, when” for completing the SOPs
Summarize the module.