Collection and Handling . If a patient produces more than 3 non-formed stools within a 24 hour period (unless ilius obstruction is suspected), they should be tested for C. Difficile. VHA Hbk 1106.01, Pathology and Laboratory Medicine Service Procedures Upon receipt of container, label specimen container with patient full name, date of birth, name of test ordered, date & time collection started and date & time collection ended. Part 493, Subpart M (493.1407), Standard; Laboratory director responsibilities. The laboratory must also include a correction factor for each test to account for systematic errors that occur between tests. Before reporting study-participant results, each laboratory that introduces a non-waived (a CLIA designation) test such as an ELISA test, must demonstrate performance specifications comparable to those established by the manufacturer (as found in manufacturers publications such as user manuals or package inserts) to ensure the assay is performing optimally within the proposed testing environment [36]. HEMATOLOGY SPECIMEN COLLECTION AND HANDLING Inspector Instructions: Sampling of hematology specimen collection and handling policies and procedures Sampling of patient CBC specimens (anticoagulant, labeling, storage) How do you know if the CBC specimen is clotted, lipemic, or hemolyzed? The nurse should then flush the line with about 10ml of saline or per facility flushing policy, and any infusing fluids resumed. All specimens (including glass slides) must be labeled with the patient name and at least one of the following second identifiers which are unique to the patient: Date of Birth Facility/Hospital Patient Number Requisition Number The result is vastly enhanced data management and data sharing-within the laboratory and across laboratories. Guidance for Industry: Bioanalytical Methods Validation. All electronic orders must be accompanied by an appropriate manifest or packing list that indicates the patient, specimen, and testing to be performed. A key component of the QM Program is the Quality Assurance Unit (QAU). All specimens (including glass slides) must be labeled with the patient name and at least one of the following second identifiers which are unique to the patient: The primary container that holds the specimen should have these two identifiers. Call (630) 986 1005 or Schedule Online, 616 South Route 31 Suite H All specimens submitted to ACL for testing must be appropriately labeled. Using a new syringe, collect blood for culture through the hub. Laboratories must be appropriately licensed to perform testing when required by law. DAIDS Guidelines for Good Clinical Laboratory Practice Standards-Training 2007. Q2(R1): Validation of Analytical Procedures: Text and Methodology. This laboratory policy is based on the requirements for the College of American Pathologists (CAP), our accrediting body. Walk-ins accepted or make an appointment to avoid a wait. The College of American Pathologists (CAP) has issued instructions for patient sample identification. Leave a visible window on the side of the tube so the contents can be seen. Signature logs should be archived so that those individuals who performed trial testing throughout the length of a trial are identifiable. ), Different names on requisitions vs. patient demographic or billing information, Patient name on the requisition and specimen. Safety training must be completed before any employee begins working in the laboratory and on a regular basis thereafter. Note: The fields utilized for these data elements will vary by LIS, as described in the next . Label each tube with the patient full name, date of birth, date & time of collection, and collection site. The use of the term "patient" within checklist requirements when referring to specimens, records, testing, All floors, walls, ceilings, and bench tops of the laboratory must be clean and well maintained [48]. Part 493, Subpart M (493.1423), Standard; Testing personnel qualifications. Bull M, Lee D, Stucky J, Chiu YL, Rubin A, Horton H, McElrath MJ. The laboratory must have an established documented inventory system to maintain an appropriate amount of working supplies and reagents and to prevent delays in testing of specimens due to lack of required reagents [20,33]. Call (815) 578 1547 or Schedule Online, Specimen Collection & Handling Requirements, Copyright - NICL Laboratories - All Rights Reserved. These include accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference intervals, and any other parameter required for test performance. PDF Guideline Statement INACTIVE* - CAP All specimens submitted to laboratory for testing must be appropriately labeled. A 10ml syringe is appropriate for specimen collection. All QC materials and reagents must be properly labeled for content and include storage requirements, date opened, prepared, or reconstituted by the laboratory, and the initials of personnel who prepared/reconstituted the QC material and reagents, and expiration date [23]. Validation of all laboratory software used for collection, processing, recording, reporting, storage, or retrieval of examination data. The " Collection and Handling of Thoracic Small Biopsy and Cytology Specimens for Ancillary Studies " guideline divides the recommendations into six main categories: Endobronchial Ultrasound Guided Transbronchial Procedures, Transthoracic Procedures, Bronchoscopic Procedures, Pleural Effusions, Considerations for Ancillary Studies During Maligna. Please contact the laboratory with questions about specimen stability. Due to these guidelines, a specimen will be rejected within 7 days of a previous test, unless special arrangements are made in advance of the ordering process. GEN.60000, College of American Pathologists. Additional specimen collection/labeling requirements apply to specimens collected for immunohematology testing (blood bank). If you are ready to apply, submit our accreditation program request form to initiate the accreditation process. Open towelette. Specimen Collection & Handling Requirements - NICL Laboratories College of American Pathologists. The Collection and Handling of Thoracic Small Biopsy and Cytology Specimens for Ancillary Studies guideline divides the recommendations into six main categories: Endobronchial Ultrasound Guided Transbronchial Procedures, Transthoracic Procedures, Bronchoscopic Procedures, Pleural Effusions, Considerations for Ancillary Studies During Malignant Investigations, and Considerations for Ancillary Studies During Non-malignant Investigations. The site is secure. NICL Laboratories specimen collection supplies and procedures support sample viability for a minimum or 48 hours except where indicated. Patient Insurance billing (must include patient insurance billing information). Annual updates of the Reproductive Laboratory Medicine checklist incorporate the latest best practices and advances in technology based on input from experts in the field. PDF Specimen Labeling and Handling - TriHealth A client service representative will notify your office concerning 2) The following production systems and services may experience intermittent issues due to scheduled system maintenance and improvement. 2015;139 (12):1515-24. (The specimen should take the shape of the collection container). For example, required data element tumor size must be indicated followed by the response (tumor size: 7.5 cm). In cases where the appropriate specimens are difficult to obtain and the manufacturer has not provided reference ranges appropriate for the laboratorys study participant population, the laboratory may use published reference range(s). List specific labeling requirements for reagents/controls/solutions. body fluid in a syringe). All QC samples must be tested in the same manner as study-participant specimens and by the personnel who routinely perform study-participant testing [28]. There are several tests which require 24-hour urines and a preservative may need to be added by the laboratory based on which test has been ordered. Reference the SRL Test Collection Manual for information on the appropriate shipping conditions for the testing to be performed. Control activities must be well defined and managed through an ongoing quality control (QC) program to capture immediate performance issues, as well as assay problems that can occur over time. The laboratory director or designee must review, sign, and date the Result Modifications/Corrective Action Logs at least monthly [44]. It is important to replicate all of the previous information (test results, interpretations, reference intervals) for comparison with the revised information and to clearly indicate that the result has been corrected [43]. To ensure interchangeability of the data from any assay used, a correction factor must be incorporated into the relevant test procedure and reflected in the appropriate SOPs if the laboratory has determined the need for correction factors based on the validation exercises. Ask the patient not to urinate into the bedpan and not to put toilet paper into the bedpan. There must be evidence of a system which highlights the need to place supply orders, tracks orders (once placed), and defines alternate plans for delayed deliveries of supplies and recovery procedures for out-of-stock conditions (a system that details steps to ensure minimal lapse in ability to perform testing). Additionally, competency assessments must be conducted every six months during the first year of employment, and annually thereafter. For diarrhea, a second specimen container may be used as a scoop. Ensure that the appropriate source and tube type have been identified prior to specimen collection. Laboratories are not required to verify or establish performance specifications for any analytical test system used by the laboratory before April 24, 2003 [36]. The toolkit includes: The CAP strongly recommends you review this toolkit with your team members. The laboratory must provide evidence of implementation of the QM Program (i.e., minutes of committee meetings, results of ongoing measurement, and documentation-related complaint investigations) [64]. The patient's name (full last name, then full first name) is The second patient identifier may be one of the following: always required. PDF CAP Accreditation Checklists 2022 Edition All laboratory staff signatures, initials, or codes used as staff identifiers on any laboratory documentation must be linked to a printed name list. The laboratory must promptly notify the appropriate clinician and/or clinic staff member if an erroneous result is reported and then corrected as decisions about the clinical trial product and patient/study participant management depend on these data. Retention time periods established by the laboratory must meet or exceed the requirements set forth by the product sponsor and/or any applicable regulatory bodies such as the FDA [31]. The laboratory must maintain and document acceptance criteria to test specimens and must follow site-specific instructions defined in the QC plan to routinely monitor analytic performance and to identify, document and resolve QC analytical problems. Remove blue cap from the specimen cup place on a clean surface with the inside of the cup facing up. This is so as to be able to detect immediate errors as well as changes that occur over time and hence assure the accuracy and reliability of test results, particularly if the data are used for patient management or product advancement decisions. A laboratory can only ensure specimen integrity when following appropriate specimen management and transportation procedures. Proper identification helps to insure that each patient receives the correct laboratory results and diagnosis. Molecular amplification procedures within the laboratory that are not contained in closed systems must have a uni-directional workflow. Uniform Labeling of Blocks and | College of American Pathologists Specimens are to be shipped per published Department of Transportation (DOT) and International Air Transport Association (IATA) requirements. The laboratory must maintain a written current document control plan that addresses and ensures the following vital elements of SOPs: A master list of SOPs currently used in the laboratory [25]; an authorization process that is standard and consistent, limiting SOP approvals to laboratory management [24]; assurance that all SOPs are procedurally accurate and relevant, as well as review of each SOP at appropriate time intervals [27]; removal of retired or obsolete SOPs from circulation and identification of them as retired or obsolete; and an archival system that allows for maintenance of retired or obsolete SOPs for a period defined by the laboratory that meets or exceeds the requirements of applicable regulatory bodies, such as the U.S. FDA [24]. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. View Map, Mon-Fri 9am 1pm The QM Program is a systematic approach to plan the achievement of quality objectives, comply with approved procedures, and assign specific functional responsibilities to laboratory staff. The optimal Urinalysis specimen is the first morning void or urine that has been in the bladder for at least four hours. CHM.12600, College of American Pathologists. As a follow-up step, the laboratory director or designee must consistently review, sign, and date all documentation at least monthly to establish an audit trail [11,12]. The specimen cannot be collected on a swab. The expectation is that compliance with the GCLP standards, monitored annually by external audits, will allow research and development laboratories to maintain data integrity and to provide immunogenicity, safety, and product efficacy data that is repeatable, reliable, auditable and that can be easily reconstructed in a research setting. The test will continue until the next day at the same time. TWO IDENTIFIERS are required for patient and specimen identification. PDF Universal Labeling of Specimens - d2xk4h2me8pjt2.cloudfront.net Handle specimen containers carefully touch only the outside of container to avoid contamination. CAP inspection | definition of CAP inspection by Medical dictionary The patients identifying information is one of the most crucial aspects of the report. When the laboratory cannot report study-participant test results within the time frames established by the laboratory, the laboratory must notify the appropriate individual(s) of the delays [43].