Process Control: Sample Management

Process Control: Sample Management

• Sample management is essential for accurate laboratory results
• Errors in sample collection can lead to inaccurate lab results
• A sample management handbook should include: sample collection instructions, acceptable sample types, rejection criteria, handling procedures including collection, transport, storage, and disposal.
• Sample integrity must be maintained during transportation to ensure all regulations and requirements are met.
• The quality of a lab analysis is only as good as the sample collected
• Good sample management directly affects patient care and outcomes.

Learning Objectives

• Participants will be able to identify sample collection errors that produce incorrect lab results;
• Identify the contents of a handbook for off-site sample collectors;
• Justify the rationale behind rejecting unsatisfactory samples
• Outline a sample handling system including collection, transport, storage, and disposal.
• Explain the importance of sample integrity and adherence to regulations when transporting samples.

Scenario

• Laboratory PCR tests for influenza virus on patient samples from Clinic A are mostly negative. Clinic A's medical staff report their patients have all the clinical signs of influenza.
• The lab needs to determine why the results are negative, even with clinical signs of influenza
• The lab will have to review samples and processes to identify the cause of the discrepancies.

The Quality Management System

• The quality management system covers many aspects of sample management.
• Essential elements like personnel, equipment, purchasing and inventory, documents and records, process control, information management, occurrence management, assessment, process improvement, customer service, and facilities and safety are all important for the smooth operation of a laboratory.

The Result of Any Laboratory Examination

• The result of any lab examination is only as good as the sample received.

Good Sample Management

• Good sample management is essential for accurate laboratory diagnosis and influences lab efficiency and therapeutic decisions.

Components of a Laboratory Handbook

• Information needed for all personnel.
• Sample collection, preservation, and labeling instructions.
• Sample transport guidelines.
• Sample retention, storage, and disposal procedures.
• Policies and procedures.
• Contact information.

The Laboratory Handbook

• The laboratory handbook is used by all personnel, and is understood by all lab staff.
• It contains information crucial for the accuracy and consistency of operations.

Laboratory Handbook Contents

• Information on the laboratory's address and contact information.
• Lab operating hours and contact personnel.
• A list of all available tests.
• Sample collection procedures.
• Sample transport procedures, and an estimated TAT (Turnaround Time).
• How urgent requests are handled.

Laboratory Responsibilities

• Provide sample collection information (What, When, How).
• Provide sufficient containers and supplies.
• Evaluate all samples before examination.
• Implement a clear system for labeling samples.

Test Requisition

• Necessary information on the requisition form includes: patient ID, tests requested, date and time of sample collection, sample source, clinical data, contact information.

Field Data Collection Form

• Information on general patient information, date of onset of illness, clinical specimens, unique ID, type of collection, clinical diagnoses, health status, and remarks.

Collection Requirements

• Proper patient preparation for sampling.
• Correct patient identification.
• Correct selection of the required sample type and appropriate containers.
• Accurate labeling of all samples.

Finger Prick Procedure

• A step-by-step procedure on how to perform a finger prick.

Labeling

• Each sample must have the following information: patient's name, unique patient identifier, test ordered, date and time of collection, initials of the collector.
• Computer-generated bar codes are preferred whenever possible.

Sample Labeling Error Example

• Problems in sample labeling can lead to inaccurate results, major complications, or a transfusion reaction

Outcomes of Improper Collection

• Delays in reporting test results.
• Unnecessary re-draws/re-tests
• Decreased customer satisfaction.
• Increased costs.
• Incorrect diagnosis and treatment.
• Injury.
• Death.

Preexamination Steps

• Verify completeness of the test request form, sample appropriateness, label information.
• Record sample information in a register.
• Apply sample rejection criteria.

Labeled Samples

• Properly labeled samples with complete information and completed requisitions..

Actions for Rejected Samples

• Inform the authorized personnel.
• Request another sample.
• Record rejected samples.
• Retain rejected samples based on preset criteria.
• Extraordinary situations may require testing suboptimal samples.

Sample Register or Log

• A sample register or log should include the date and time of collection, receipt date and time, sample type, name of the patient, all required demographics, and assigned lab identifiers, and tests to be performed.

Sample Tracking-Manual

• Confirm receipt of samples including date and time.
• Label samples correctly and store with requisition until lab ID is assigned.
• Track all aliquots.

Sample Tracking-Computer

• A database system for sample tracking should include patient ID, collection date and time, sample type, laboratory tests, health care provider name, and location of the sample.

Sample Handling

• Treat all samples as if they are infectious. Follow Universal precautions.

Sample Storage - Written Policy

• Describe the samples to be stored.
• Determine retention time.
• Define the proper storage location.
• Describe proper storage conditions.
• Establish sample organizing procedures.

Sample Retention

• Establish a retention policy.
• Monitor stored samples, including freeze/thaw cycles.
• Maintain an organized, accessible system.

Sample Referral

• Record information on the referring samples (samples referred). include date and who referred the samples.
• Monitor/track, record turnaround time, results delivery, referral laboratory, and problems with the referral.

Sample Disposal

• Implement sample disposal policy.
• Adhere to local and national regulations.
• Implement disinfection procedures.

Sample Transport

• Maintain sample integrity: temperature, preservation, appropriate containers, and time limitations.
• Assure all safety regulations are met.

Transport Regulations

• Understand regulations from national, international (ICAO/IATA), rail, road, sea traffic, postal, and courier services.

Transport Regulations Mandatory Compliance

• Comply with regulations by addressing: violation, accidents/spills, and reduce biohazards and safety of couriers, lab staff, passengers, and carriers.

Classification of Infectious Substances

• Categorize infectious substances (Category A and B).
• Category A Substances are very dangerous, and the packages need to meet high standards and the process of handling and shipping them needs extra precautions.
• Category B Infectious Substances do not need as detailed packaging or shipping procedures.

Exemptions

• List of exemptions, such as substances that do not contain infectious substances, environmental samples, or decontaminated medical waste.

Triple Packaging (UN 2007)

• Detail the types of packaging that should be used for Category A and B infectious substances. Include aspects like leakproofness, pressure test, absorbent material, drop test, and required marks/labels.

Managing Sample Transport

• Fulfil all required regulations and train personnel for proper procedures.
• Maintain the integrity of samples by monitoring temperature, transportation time, preservation, and packaging measures.

Summary

• Provide a laboratory handbook with sample collection information.
• Create a system for tracking samples throughout the lab.
• Implement sample storage and disposal policies.
• Maintain sample integrity.
• Follow all transportation regulations.
• Always follow universal precautions

Key Messages

• Good sample management ensures accurate and reliable lab results.
• Proper sample management improves patient care and outcomes.

Comments/Questions

• General commenting/question section for ongoing communication about samples.

This quiz focuses on the essential aspects of sample management in laboratory settings. Participants will learn about the importance of accurate sample collection, handling procedures, and maintaining sample integrity during transportation. Test your knowledge on the guidelines that ensure quality laboratory results and their impact on patient care.