MLS 407 | Laboratory Procedure Format

Why follow SOPs?

to ensure accuracy and reliability of patient test results, regardless of who performs the activity

What is an SOP?

Provides detailed, step-by-step instructions for performing a specific task/process/maintenance/QC/QA/employee competency documentation

Can be electronic or on paper

Who requires written procedures for all laboratory tests and activities?

the CLIA, CAP, and AABB

• must be available to and followed by all testing personnel

• readily accessible, reviewed at least every two years, and approved by laboratory director/designee

• AABB requires all critical processes with annual reviews, controlled documentation, and traceable revisions

What are the different types of sources that inform the development of SOPs?

• Manufacturer manuals

• Regulatory and accreditation guidelines

• Technical manuals, textbooks, peer-reviewed literature

• Professional organization resources

• Practice guidelines from organizations (CDC, IDSA, WHO)

T/F: You can use a textbook in place of a laboratory-specific SOP

False

The Clinical and Laboratory Standards Institute (CLSI)

• Organization that publishes consensus-based standards including guidance on SOP structure and required elements: QMS02 Quality Management System: Development and Management of Laboratory Documents

• Not REQUIRED to follow, but highly encouraged

What is the standardized format for SOPs?

1. Procedure title (include analyte, specimen type, method/instrument used, laboratory name and location in header/footer)

2. Procedure sections

3. Visual aids

4. Document control, versions, approval

   1. Each SOP assigned a unique document control number (version number, date of revision/approval)

What components are required by the CLIA in an SOP?

• Significance of measurement/purpose

• Microscopic examination (If applicable)

• Specimen collection and handling requirements

• Reagents/media

• Supplies and equipment

• Calibration procedures (If applicable)

• Safety precautions

• QC

• Procedure

• Calculations (If applicable)

• Expected results/reference values (If applicable)

• Critical values/panic values (If applicable)

• Reporting results

• Method performance specifications/limitations

• References

• Authors

• Approval signatures and dates

• Unique control number/version control

What is the difference between SOP, protocol, and policy?

SOP: provides detailed, step-by-step directions for a task/process.

• Explains how exactly how to complete the task

Protocol: a collection of interrelated instructions that describes the flow of a work process, including who is responsible for each part of the process sand decision-making points (if/then statements)

• often refer user back to specific SOPs

• guide to as “what should happen” within a process

• explains when and under what circumstances actions are taken

Policy: states an overall goal an organization intends to accomplish but does not provide detailed steps for accomplishing that goal

• directs what an institution “wants to do”

How do procedures, protocols, and policies relate?

1. Policies (what do i do?)

2. Processes (how does it happen?)

3. Procedures (how do i do it?)

4. Supporting documents (worksheets, forms, QC records, templates)

What are ways to organize a procedure manual?

1. By laboratory department or department section

2. By phase of testing

3. By procedure type

Access to procedures

1. Electronic

   1. Easy to update, can be integrated with the intranet, version control and audits build in, access limited by login/pass, supports keyword search

2. Paper

   1. Requires manual updates and distributions, stored in binders, must track approvals and versions manually, always accessible, slower to locate content

SOP numbering system

• Unique identifier assigned to each procedure

• Easy retrieval

• Supports version control

• Enhances compliance

• Streamlines training and audits

• Common numbering formats:

  • Department-based

  • Function-based

  • Sequential by date or manual section

How can procedures be organized within manuals

• Alphabetic

• Frequency of use

• Similarity

Each SOP must include

• Effective date

• Revision number

• Approval/signature of laboratory director

• Maintain a revision history log to track changes over time

• Outdated versions should be removed from use but archived for reference

All clinical laboratories performing patient testing must follow:

CLIA regulations

Procedures must include the following (CLIA requirements 1-14)

1. Requirements for patient prep, specimen collection, labeling, storage, preservation, transportation, processing, referral, criteria for specimen acceptability and rejection

2. Microscopic examination, including detection of inadequately prepared slides

3. Step-by-step procedure, including calculations and interpretations

4. Preparation of slides, solutions, calibrators, controls, reagents, stains, other materials

5. Calibration and calibration verification procedures

6. Reportable range for test results

7. Control procedures

8. Corrective action to take when calibration or control results fail to meet laboratory’s criteria for acceptability

9. Limitations in test methodology, including interfering substances

10. Reference intervals (normal values)

11. Imminently life-threatening test results, or panic/alert values

12. Pertinent literature references

13. Laboratory’s system for entering results in patient record and reporting patient results including, when appropriate, the protocol for reporting imminently life-threatening results, or panic/alert values

14. Description of course of action to take if test system becomes inoperable

CLIA vs CLSI

CLIA

• Legal requirements

• Procedure requirements

CLSI

• Best practice guidelines

  • QMS02 describes how to write and organize high-quality procedures

• Supplemental to CLIA

  • Helps labs meet and exceed CLIA requirements

• Widely adopted, not required

What are other requirements per CLIA section?

• Package inserts

• Procedure approval and change tracking

• Recordkeeping

What are sections that may not be included in all procedures

• Critical values

• Calculations

• Calibration/Calibration verification

• Reference/expected values

Principle section

• Analyte being measured

• Scientific method the test is based on

• How the measurement is made

• The analyte being measured

• Expected outcome or what the procedure aims to accomplish

Significance of Measurement/Purpose Section

• Medical usefulness of the test (clinical relevance)

• Utility (how do the results influence care)

• Interpretative values (what the results might indicate)

Scope Section

• Who can perform the procedure

• Situations when the procedure is performed

Specimen Collection and Handling Requirements Section

• Instructions for patient preparation

• List of specimen types which can be used to perform the test

• Acceptable collection methods

• List of anticoagulants/preservatives allowed

• Minimum volume required for conducting the test

• Specimen labeling instructions

• Specimen handling

• Criteria for rejection of a specimen

• Stability and specimen storage instructions

Reagents/Media Section

List of all required reagents ormedia, including:

• Storage conditions

• Handling

• Composition

• Stability

• Preparation instructions, if not supplied ready to use

• Any safety precautions

• Directions for preparing in-house reagents

Calibration and Calibration Verification Procedures Section

• How the test is calibrated, including the number of calibrators/standards and their concentrations

• How calibration is verified

• Corrective action suggestions when calibration fails

• Calibration is the process of setting the instrument or test system to produce correct results by comparing it to known reference standards.

• Use of calibrators/standards of known concentration

• Establish calibration curve (standard curve)

• Calibration verification is the process of confirming that the test system remains accurate after calibration. It checks whether the system can produce correct results across the reportable range without adjustment.

Safety Precautions Section

• Required personnel protective equipment (PPE)

Any additional safety precautions

• Chemical hazards

• Biological hazards

• Safe handling and disposal

• Emergency procedures

Quality Control Section

• Type of quality control (QC) performed, including levels of controls tested and frequency of testing

• Criteria for accepting/rejecting patient results and steps for troubleshooting if QC fails

• Direction for QC material prepared in-house, if applicable

What can be added to help clarify steps in a procedure?

Diagrams

In what section of a procedure would you find: If lipemic or hemolyzed specimens interfere with testing

Method Performance Specifications/Limitations Section

In what section of a procedure would you find: Minimum volume of specimen required to conduct a test

Specimen Collection and Handling Requirements

In what section of a procedure would you find: Who can perform the laboratory test and under what situations?

Scope

Is the Scope section required by the CLIA?

No

In what section of a procedure would you find: What the acceptable specimen containers or tubes are

Specimen Collection and Handling Requirements

In what section of a procedure would you find: How to store the testing reagents

Reagents and Media

In what section of a procedure would you find: Proper storage and handling of patient specimens

Specimen Collection and Handling Requirements

In what section of a procedure would you find: how frequently QC samples should be tested

Quality Control

In what section of a procedure would you find: the steps listed to perform patient specimen testing

Procedure

In what section of a procedure would you find: any necessary patient preparation

Specimen Collection and Handling Requirements

In what section of a procedure would you find: how to prepare the testing reagents

Reagents and Media

In what section of a procedure would you find: how to document patient results

Reporting Results

In what section of a procedure would you find: if an incubator is required to perform testing

Equipment (usually combined with Supplies section)

In what section of a procedure would you find: criteria used to determine acceptability of quality control results

Quality Control

In what section of a procedure would you find: how to perform calibration

Calibration and Calibration Verification Procedures

In what section of a procedure would you find: the methodology of the test

Principle (states what analyte is being measured, the scientific method the test is based on, how the measurement is made, and the expected outcome)

In what section of a procedure would you find: PPE requirements

Safety Precautions

In what section of a procedure would you find: specific supplies required to perform the test

Supplies

In what section of a procedure would you find: follow-up action if a critical value is obtained

Critical Values

In what section of a procedure would you find: information about the sensitivity and specificity of the test

Method Performance Specifications/Limitations

What is the best resource to start with when you have a question regarding a laboratory test?

The procedure