Laboratory Sample Examination Management
1.0 Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide structured guidelines for conducting examinations on patient samples by formulating necessary methods, techniques, and management practices.
2.0 Scope
This SOP covers Surgical Pathology, Molecular Pathology, Flow Cytometry, Hematology, Cytogenetics, and Cytopathology sections. It aims to establish guidelines for:
Preparation of Reagents
Examination Procedures
Reporting of Results
3.0 Reference
This SOP aligns with the Quality System Manual.
4.0 Details
4.1 Clause Activities
4.1.1 Sample Pre-examination Management
ResearchNeeds Laboratory operates in a controlled manner, receiving samples through contracted agencies or in-house from walk-in patients. Specific procedures are followed for:
Collection Process
Requisition Form
Sample Documentation and Traceability
4.1.4 Sample Receipt and Accessioning Process
Upon sample receipt at the laboratory, activities include documenting sample details, managing transport and storage, and generating unique Accession Numbers using a defined breakdown.
4.1.5 Specimen Collection and Handling Manual Guidelines
Guidelines for patient and user instructions regarding sample collection, transportation, rejection criteria, and storage are detailed in the Specimen Collection and Handling Manual (SCHM).
4.1.6 Authorization of Uncertain Primary Samples
Uncertain primary samples undergo authorization before processing, either from contracted agencies or through approval by section heads.
4.1.7 Quality Control Plan for Sample Receipt
Verification of sample transit conditions, labeling, and identifying discrepancies are part of the Quality Control Plan for Office (Receiving).
4.1.8 Acceptance Criteria and Resampling
Samples are verified for acceptance based on established criteria. Uncertainties lead to resampling and subsequent processing as per specified procedures.
4.1.9 Volume Verification and Collection Management
Phlebotomists monitor and verify the volume of collected test samples, ensuring efficiency and adherence to Turn Around Times (TATs).
4.1.10 Authorization for Test Type and Methodology
Section In-charges are authorized to determine test types, extent, and methodologies.
4.1.11 Handling of Urgent Samples
'URGENT' labeled samples undergo special handling based on designated procedures and authorized Turn Around Times (TATs).
4.1.12 Sample Traceability and Record Maintenance
Traceability of samples back to the original and comprehensive record maintenance ensure accountability and reference.
4.2 Sample Examination Management
4.2.1 Procedure Manual and SOP Structure
Each section has a detailed Procedure Manual encompassing essential aspects of examination procedures, ensuring standardized processes across all sections.
4.2.2 In-house Procedure Documentation and Review
In-house procedures are documented and regularly revised to accommodate necessary changes, subject to biennial reviews and intermittent need-based assessments.
4.1.4 - Sample Receipt and Accessioning Process
Upon receipt of samples at the laboratory, especially from outstation collections, the following activities occur:
Recording the date and time of sample receipt
Managing primary sample transport and storage procedures
Customer Care Executive/Sample Reception Staff: Responsible
for handling sample reception and ensuring proper documentation of sample
details.
Document Reference: Refers to the specific guidelines or
documents outlining conditions, including temperature requirements, client
codes, and modes of payment.
The details of the (TRF) are captured crucial details within
the Laboratory Information Software. This system generates a unique patient
Accession Number (e.g., 101266588-1) with the following breakdown:
First 2 Digits: Center number from where the booking is
initiated
Next 2 Digits: Year
Following digits: Running serial number of samples received
from that center
Digits after Hyphen: Sample Number (e.g., 01 for the 1st
sample, 02 for the 2nd sample, and so on)
Once the accession number is generated, multiple copies of
barcodes containing specific sample details are printed. These barcodes are
affixed to the Test Requisition Form (TRF) and respective specimen containers
to ensure sample integrity and traceability. The barcode includes:
Accession number
Type of sample (e.g., Blood/FFPE, etc.)
Date and time of registration
Patient's name and age
Referring Customer/Clinician/Hospital/Centre
4.1.5 - Specimen Collection and Handling Manual Guidelines
Guidelines and instructions for patients, users, and
phlebotomists regarding the collection of primary samples are disseminated
through an approved Specimen Collection and Handling Manual (SCHM).
The SCHM contains comprehensive information and broad guidelines covering the following areas:
Instructions for patient preparation and identification of
primary samples
Sample collection methods, including the use of vacutainers
and necessary additives, ensure proper sample collection techniques are
followed according to approved protocols.
Guidelines for Sample Collection Requirements
Rejection Criteria and Repeated Examination Protocol
Sample Transportation Instructions
Specimen Storage Instructions
Reference to Laboratory Test Offerings and User Information
4.1.6 Authorization of Uncertain Primary Samples
To ensure traceability and avoid ambiguity, ResearchNeeds mandates authorization for uncertain primary samples before processing. Authorization is either obtained from the contracted agency on behalf of the referral doctor or approved by section heads in the case of direct verbal requests. Additionally, all verbal requests are corroborated via email, an additional Test Requisition Form (TRF), or a written prescription.
4.1.7 Quality Control Plan for Sample Receipt
Upon sample receipt at Researchneeds, the Customer Care Executive performs a thorough verification of transit conditions, specifically ambient temperatures (with or without cool packs) for outstation collections. Each sample box undergoes scrutiny to ensure proper transit conditions before test examination. Records of these activities are meticulously maintained in the Specimen Collection Register.
4.1.8 Acceptance Criteria and Resampling
Samples are verified for acceptance based on established criteria. Uncertainties lead to resampling and subsequent processing as per specified procedures.
4.1.9 Volume Verification and Collection Management
Phlebotomists monitor and verify the volume of test samples collected to ensure adequacy for testing. Proper sample collection and packaging protocols are followed for transportation to the laboratory as per established Work Instructions (WI).
4.1.10 Authorization for Test Type and Methodology
Section In-charges within the ResearchNeeds Management System have the authority to determine the type, extent of testing, and methodological approaches for their respective sections.
4.1.11 Handling of Urgent Samples
Samples labeled as 'URGENT' are given priority and handled accordingly. These samples are processed expeditiously under the supervision of the section head. Turn Around Time (TAT) for urgent samples is set by the responsible section head.
4.1.12 Sample Traceability and Record Maintenance
Every sample is identifiable and traceable back to the original sample through accession numbers or patient details. Comprehensive records are maintained to ensure traceability.
4.2 Sample Examination Management
4.2.1 Procedure Manual and SOP Structure
Each section maintains a comprehensive Procedure Manual governing examination protocols. SOPs within this manual cover various aspects related to the examination process.
4.2.2 Documentation and Revision of In-house Procedures
In-house developed procedures undergo documentation and regular revision to accommodate necessary changes. Biennial reviews and intermittent need-based assessments ensure updated manuals.
4.2.3 Test Registers and Worksheets Maintenance
Specific registers or worksheets, downloaded from the Laboratory Information System (LIS), are diligently maintained within each section. These documents record various test information and results using defined formats.
4.2.4 Section In-charge Approval of SOPs/Work Instructions
SOPs/Work Instructions for test examinations are approved by Section In-charges to ensure appropriate methods and techniques are used during sample examination.
4.2.5 Availability and Control of Approved SOPs/Work
Instructions
Approved SOPs/Work Instructions for conducting test examinations are readily accessible at each section's workbench. The Quality Manager and Section In-charges oversee revision control and ensure timely updates in documents undergoing modification.
4.2.6 Specification of Examination Performance
Work Instructions include examination performance specifications, aiding in identifying performance criteria and measuring test accuracy attributes, thereby setting desired test result benchmarks.
4.2.7 Definition of Biological Reference Intervals
Test procedures' Work Instructions define biological reference intervals where applicable and outline the frequency for such intervals.
4.2.8 Revision of SOPs in Case of Examination Procedure
Changes
Revisions in laboratory examination procedures prompt revision and authorization of relevant SOPs. Communication of significant changes affecting interpretations is made to laboratory users.
4.2.9 Completion of Daily Analysis and Handover Protocols
Technical staff complete their assigned analyses daily and provide comprehensive explanations during task handovers. Respective Section In-Charges are informed, and all staff sign in the respective Lab register/Worksheet to maintain accountability.
4.3 Assuring Quality of Results
4.3.1 Validated Procedures and Quality Control Plans
ResearchNeeds follows validated procedures as per manufacturer manuals for kits or through standardized and validated in-house procedures. Quality control plans are established for each section, providing step-by-step instructions from sample receipt to final reporting. Discrepancies and corrective actions are documented in non-conformance handling registers maintained within each section. A comprehensive quality assurance and control procedure is outlined in the lab SOP.
4.4 Post-Examination Procedures
4.4.1 Review and Release of Examination Results
Authorized In-Charges across sections review interim and final examination results against available patient clinical information. They approve the release of results upon verification.
4.4.2 Handling Unsatisfactory Results and Report Generation
If analysis results are unsatisfactory, technical staff are instructed to repeat the procedure or specific steps until satisfactory results are obtained. Unsatisfactory results are either removed from the system or marked 'Obsolete/Not for Reference' in hard copies to prevent confusion or discrepancies during report generation. Final reports are generated solely based on authorized analytical results.
4.5 Sample Review, Storage, and Referral Laboratories
4.5.1 Review of Previous Reports and Sample Storage
Previous reports or samples of the patient are reviewed alongside the current sample, ensuring a comprehensive understanding of the patient's medical history. Safe storage and disposal of samples are managed by section heads, following designated Waste Disposal Instructions.
4.5 Referral Laboratories and Consultants
4.5.1 Sending Samples to Referral Laboratories
Samples may be sent to another NABL & CAP accredited laboratory due to breakdowns or uncontrollable situations. It is ensured that samples sent comply with the referral laboratory's requirements and procedures. In case of discrepancies, a fresh sample is requested following the referral laboratory's procedure.
4.5.2 Evaluation of Arrangements with Referral Laboratories
Agreements with referral laboratories undergo biennial reviews to ensure alignment with NABL and CAP requirements.
4.5.3 Evaluation and Resolution with Referral Laboratories
Referral laboratories and consultants are evaluated according to prescribed formats. Any identified gaps are discussed with their authorized representatives, and records of corrective actions taken toward the closure of these gaps are maintained.
4.5.4 Outsourced Sample Records
Records of any outsourced samples are diligently maintained within respective sections, retaining them for defined periods in accordance with the retention guidelines for test reports.
4.6 Reporting and Release of Examination Results
4.6.1 Details in Examination Reports
All examination reports shall encompass essential details such as identification of the examination and procedure, laboratory information, patient identification details, specimen type, date of receiving the primary sample, measurement procedures used, examination results, reference range (where applicable), interpretation/judgment of the approving authority, comments, identification of any examination under the R&D program, signature of the authorized section in-charge, date of reporting, test report status, and number of pages.
4.6.2 Work Instruction for Result Reporting
A comprehensive Work Instruction (WI) is established to address instructions and special guidance, if any, for reporting results within each section. Test reports are delivered well within the committed time period, with preliminary reports, when necessary, clearly marked as preliminary.
4.6.3 Investigating Discrepancies and Documentation
Any discrepancies between preliminary and final reports or clinical findings are thoroughly investigated and documented in the Non-Conformance (NC) register.
4.6.4 Ensuring Legible and Accurate Reports
The Section In-Charge, authorizing each Test Result Report, ensures that the report is legible, free from transcription errors, and adheres to recommended medical terminology.
4.6.5 Intra-Departmental Consultations and Reviews
Intra-departmental consultations are included in patients' reports when necessary. Any insignificant observations are recorded and retained, and an annual retrospective review is conducted for applicable cases.
4.6.6 Verbal Communication of Reports
Details of any verbal report communication to referring clinicians are recorded in the respective format. Verbal communication is utilized in cases of critical findings or clinician requests, following defined critical value protocols.
4.6.7 Retention of Materials
Materials post-analysis and reporting are retained as per the Work Instruction for Retention of Materials.
4.6.8 Return and Loan of Blocks/Slides in Surgical Pathology
All blocks and slides received in the Surgical Pathology
sections are returned to the patient/clinician upon request. In cases of loaned
materials for specific programs, acknowledgments are taken for receipt of the
material.
5.0 List of Work Instructions:
Work Instruction for Waste Disposal
Work Instruction for Retention of Materials
Issue of Blocks/Slides
Procedure Manual - Molecular Biology
Procedure Manual - Flow Cytometry
Procedure Manual - Hematology
Procedure Manual - Surgical Pathology (Includes
Histopathology and IHC)
6.0 List of Formats:
Procedure Manual - Cytopathology
Procedure Manual - Cytogenetics
Accession Register (revoked)
Laboratory Test Register (Histopathology)
Laboratory Test Register (IHC)
Laboratory Test Register (Cytopathology)
Laboratory Register - SPP Decalcification Register
Laboratory Register - SPP Daily Instruction Register
Laboratory Register - SPP Daily IHC Processing Register
Laboratory Register - SPP Daily Biopsy Block Entry Register
Laboratory Register - SPP Dispatch Register
Laboratory Register - SPP HC Marker Monthly Summary
Registers
Laboratory Test Register (Hematology) (revoked)
Laboratory Register - SPP Intra Laboratory Cases
Laboratory Register - SPP IHC Control Block Register
Laboratory Test Register (Flow Cytometry) (revoked)
Laboratory Test Register (DNA Ploidy) (revoked)
Laboratory Test Register (PCR Qualitative) (revoked)
Laboratory Test Register (PCR Quantitative/ Gene
Amplification)
Laboratory Test Register (Infectious) (revoked)
RNA Isolation Record
DNA Isolation Record
Laboratory Test Register (FISH)
Laboratory Test Register (Karyotyping)
Log of Verbal Communications of Results
Acknowledgment Receipt
Referral Laboratory/Consultant Evaluation
7.0 List of Records:
Laboratory Test Register (Histopathology)
Laboratory Test Register (IHC)
Laboratory Test Register (Cytopathology)
Laboratory Register - Decalcification Register
Laboratory Register - Daily Instruction Register
Laboratory Register - Daily IHC Processing Register
Laboratory Register - Daily Biopsy Block Entry Register
Laboratory Register - Dispatch Register
Laboratory Register - HC Marker Monthly Summary Register
Laboratory Register - Intra Laboratory Cases
Laboratory Register - IHC Control Block Register
RNA Isolation Record
DNA Isolation Record
Laboratory Test Register (FISH)
Laboratory Test Register (Karyotyping)
Log of Verbal Communications of Results
Acknowledgment Receipt
Referral Laboratory/Consultant Evaluation
END OF THE DOCUMENT
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