Associated Records and Forms: Any related SOPs, standardized forms, benchmarks, and other source documents must be enlisted. WHAT IS RECORDS MANAGEMENT? stream FTEs, full-time employees; N/A, not applicable; TAT, turnaround time. [1]. Annual Update. Audits shall be conducted in a manner to ensure objectivity and impartiality. A document control system is one of the most critical tools for ensuring compliance in highly regulated laboratories or industries. Problems encountered with the referral laboratory should be well documented for tracking purposes. Any change to a validated test procedure shall be documented with version controls and approved before implementation. The particular option is chosen according to the current status of the SOP. associate the identity of each author and/or witness with each record automatically, create and store records randomly on disks, desktops, or hard drives, store records on media that have limited shelf-life, allow access to the electronic records by unauthorized personnel, rely on methods of dating your entries that can be altered, alter any portion of an electronic document. Implementation of these GMPs requires detailed maintenance and records of calibrations of standards and service to laboratory equipment. If applicable, the susceptibility results should follow the protocol for cascade reporting. Requests for testing shall have the appropriate documentation accompanying the specimens. A procedure or set of procedures intended to ensure that a product or service adheres to a defined set of quality criteria. The Ohio State University General Records Retention Schedule as of March 15 2013. An SOP should be a well-focused and concise document. Pertinent clinical information should also be provided, such as unique travel history or immunocompromised status. INTRODUCTION. Clearly state the revised wording. AMIA Annu Symp Proc. The laboratory shall have a process for identifying potential NCEs (near misses) that require preventive action. Cabinet Coding: It is also necessary to provide a number to the cabinets in the room(R1, R2, R3, etc.). Pharmaceutical Quality Control Labs (7/93) | FDA The first step is documentation of what occurred in the process that led to the event, including the identification of all involved parties and actions and the date, time, and location, if the occurrence is outside the laboratory. 2. Perspect Clin Res. For the maintenance, safety, and integrity of the data archiving is an essential element of the Quality Management system. https://doi.org/10.1007/978-981-16-3074-3_10, DOI: https://doi.org/10.1007/978-981-16-3074-3_10. The procedure may be a hard copy or electronic and shall be available to personnel who perform the test. CDC and the Association of Public Health Laboratories. Before In addition to serving the needs of the laboratory, the LIS should meet requirements of internal and external customers, such as a bidirectional interface with other electronic systems. Inclusion in an NLM database does not imply endorsement of, or agreement with, The equipment performance and maintenance records should be reviewed annually, maintained, and . Each primary sample and its aliquots shall be traceable within the microbiology laboratory and throughout the total testing process. Laboratory personnel shall follow guidelines for biosafety laboratory compliance (20), and management shall provide the resources to protect staff from occupationally acquired infections (21). Laboratories shall follow the manufacturer's recommendations on storage and shelf-life. 5 for an example of appropriate signage for a laboratory door. QA rules should be applied to test results and can be applied automatically within a LIS to enhance the recognition of potential problems. This final overarching section contains the QSEs that complete the building of the QMS. Gupta SK. A systematic, stepwise review process should verify that demographics, calculations, congruity of results, and notifications or disclaimers appear correctly on the report. Purchasing and Inventory 6. In addition to this, the world is becoming digitalized. aCenters for Disease Control and Prevention, Atlanta, Georgia, USA, bCity of Milwaukee Health Department Laboratory, Milwaukee, Wisconsin, USA, cChildren's Hospital of Wisconsin, Milwaukee, Wisconsin, USA, dDepartment of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada, eDepartment of Epidemiology, University of Iowa, Iowa City, Iowa, USA, fNational Jewish Health, Denver, Colorado, USA, gDivision of Clinical Microbiology, Mayo Clinic, Rochester, Minnesota, USA. The laboratory director and laboratory management shall approve the installation and validation of new computer systems as well as changes to existing validated systems. Despite the fact that most of the preanalytical activities occur outside the walls of the microbiology laboratory, and they are the greatest source of errors, the laboratory remains responsible for the total testing process. The reviewers should check if test results are accurately calculated and transcribed from raw data and if dilutions and other correction factors have been applied appropriately. Laboratory quality management. Optional information may include the initials or name of the person who unpacked and received the product into the inventory. The number and frequency of internal audits may be dictated by an accrediting body or determined by the organization. The laboratory personnel who will perform the testing going forward are the ones responsible for performing PQ testing. Environmental Health and Safety Department University of Washington . The laboratory is responsible for processes and procedures for their methods, operational controls, and resources. See Fig. Coding plays an important role in archiving the paper data. Patient confidentiality shall be maintained throughout the disposal process. The chief aim of the SOP should be mentioned briefly and clearly. from Basel University. Guidance for industry: part 11, electronic records; electronic signaturesscope and application. Examples of critical results include positive CSF Gram stain results and positive blood culture results. All documents shall be approved by the appropriate person who has the authority, as defined in a written procedure, before they are put into use. Similarly, to maintain high standards of care, the expertise of microbiologists is a great resource to inform policies and decisions regarding emerging infectious diseases, biosafety and biosecurity in all laboratories, infection prevention and control across the organization, antimicrobial stewardship programs, and other institutional programs. A customer can be internal or external to the organization. All PT results should be reviewed by the laboratory director, or designee, and the QA officer and discussed with relevant staff. In other words, document control should be system oriented and not person oriented. Introduction of new staff to the laboratory environment: . The laboratory should develop and maintain an up-to-date storage/freezer inventory log and adequate labeling to locate samples or isolates for future testing. A laboratory quality management system is a systematic, integrated set of activities to establish and control the work processes from preanalytical through postanalytical processes, manage resources, conduct evaluations, and make continual improvements to ensure consistent quality results. Choi B, Drozdetski S, Hackett M, Lu C, Rottenberg C, Yu L, et al. Failure to participate in a quality assessment program for each test method or multiple unsuccessful PT results may result in the revocation of authorization to perform a specific test or to test a specific specialty by the laboratory. In order to contact the laboratory for advice, key information should include the hours of operation of the microbiology laboratory and contact information during and after normal hours of operation. Roles and responsibilities for advisory services and consultation. Data stored on paper can be damaged or lost easily. Paper Documents: Paper documents include study plans, SOPs, DRSs, document files, ledger, letters, approvals, and notes on paper. The temperature must be maintained under the required conditions 24 h per day and not altered for energy savings during off-peak hours. An example of general laboratory information and the specimen collection and handling guidance that may be provided by a laboratory is shown in Table 17. If the nonconformity involves patient testing, the process shall also include reporting of the event as part of institutional event management when there is potential for patient harm. The Introduction to the standard states the following: . Communication is a critical component of the CI process. This ensures that all tasks in the laboratory are completed by the appropriate personnel (10). Adoption of lean principles in a high-volume molecular diagnostic microbiology laboratory, http://www.cdc.gov/tb/programs/genotyping/Chap3/3_CDCLab.htm, http://www.who.int/ihr/training/laboratory_quality/quality_manual/en/, https://www.canada.ca/en/public-health/services/canadian-biosafety-standards-guidelines/second-edition.html, http://www.selectagents.gov/Regulations.html, https://grants.nih.gov/grants/policy/select_agent/42CFR_Additional_Requirements.pdf, https://www.youtube.com/watch?v=8RlA0D6cjDc, Ensure that QMS elements are considered in all work practices, Communication of quality policy and objectives, Provide timely and transparent communications regarding quality, Read the quality manual and adhere to QMS policies, Create a quality team to accomplish quality objectives, Perform duties as assigned to ensure quality, Participate as a leader of a quality team, Participate as a member of a quality team, Work closely with the quality manager to achieve the laboratory's quality objectives, Develop, approve, distribute, and periodically review, e.g., every 13 yr, Read and ensure that laboratory staff are aware of content, Establish, communicate, and periodically review, e.g., every 13 yr, Establish or contribute to development of quality policy and standards, Read, adhere to, and openly endorse policy and standards, Establish specific, measurable, achievable, realistic, and time-bound quality objectives, Work to achieve objectives as applicable for the level of responsibility, Laboratory procedures, forms, and records, Write and approve procedures and related forms, Review documents annually and revise if needed, Retain documents and records for the prescribed period of time, Comply with federal, state, local, and other regulatory requirements, Adhere to all regulatory policies and procedures, Educate staff on all regulations that apply to the science and operation of the microbiology laboratory, Changes in technical or procedural process, New regulatory requirements for technical procedures, Problems with suppliers of critical materials, Equipment failures or need for preventive maintenance contracts, Analysis of nonconformities and near misses, Performance in proficiency testing events, Follow-up actions from previous management reviews, Results of continuous improvement efforts, including the status of corrective and preventive actions, Determine quality topics and timeline for management review, Senior management decides what topics and level of detail should be presented, Suggest key areas important for management review, Provide suggestions to laboratory management, Responsible for scheduling planned meetings to review reports, Decide presentation format that would be most beneficial to capture data, Collate monthly data into comprehensive data that can be presented graphically over time, Assist in the completion of records that will be used to document quality issues, Understand what process improvements are in progress, Record minutes of the meeting, including recommendations made and follow-up actions, Share outcome of management review meeting with laboratory staff, Advising on selection of tests and services, May provide resource support for the creation and accessibility of advisory services, Create the test menu and counsel on choice and use of services, Follow and enforce the policies and procedures that govern the criteria for appropriate choice and use of microbiology services, Write, promote, and enforce the policies and procedures that govern the criteria for appropriate choice and use of microbiology services, Advising on clinical cases for treatment or infection control, Provide initial advice on testing based on policies and procedures, Facilitate contacting the appropriate personnel to respond to request for advice, Professional judgments on the interpretation of results, Provide initial interpretations based on policies and procedures, Promoting effective utilization of laboratory services, Support and promote the effective utilization of laboratory services across the institution, Select, create, promote, and enforce policies and procedures that govern effective utilization of laboratory services, Identify, follow, and enforce laboratory utilization policies and procedures, Consulting on scientific and logistic matters, Counsel on clinical and technical matters and operational logistic matters, Provide initial advice based on standard operating policies and procedures, Collaborate with laboratory leadership to consider patients, health care providers, and the organization in creating new directions, Collaborate with organization leadership to consider patients, health care providers, and the microbiology laboratory in creating new directions, Educational and professional qualifications, Provide proof of education and professional qualifications, Request and maintain copies of transcript or diploma, Maintain up-to-date records for each staff member, Request and maintain copies from each staff member and acknowledge receipt, Provide copy and record of annual renewal, Request and maintain records at the time of hiring, Request and maintain records of previous work experience at the time of hiring, Contribute to the creation of microbiology job descriptions, Perform job responsibilities as described, Assign job descriptions to each staff member, Introduction of new staff to the laboratory environment, Create and maintain records of orientation to the institution, Develop the orientation program for the microbiology laboratory, Participate in the orientation of new laboratory staff, Orient new staff to the microbiology laboratory (e.g., checklist orientation), Maintain records of microbiology orientation, Evaluate effectiveness of the orientation plan, Contribute to the development of the training program, Competently complete training in current job tasks, Create and update training checklist for each job task, Create competency assessments for microbiology personnel, Complete competency assessments for assigned job, Evaluate testing personnel for their competency for their assigned job tasks in the laboratory, Maintain records of competency assessments, Records of continuing education and achievements, Facilitate educational activities and achievements, Identify gaps and interests in microbiology, Maintain documentation of staff performance, Participate in peer or manager performance review as applicable, Reports of accidents and exposure to occupational hazards, Maintain individual records of accident and exposure for human resources and/or occupational health, Maintain records of accidents and exposures, Report any incidents or exposures to microbiology laboratory management and occupational health, Complete an incident report for any laboratory accident or exposure, Track accidents or exposures and retrain employees where applicable, Immunization status, relevant to assigned duties, Maintain individual records in human resources and/or occupational health records, Ensure that laboratory staff are aware of pertinent vaccines, such as, Maintain immunization status per institutional policies, Require evidence of vaccination where applicable to the task, Provide engineering controls to limit access, Provide work environment with clean, well-maintained floor, ceiling, and walls and adequate lighting, water, ventilation, power, and communication, Advise as to accommodations and environmental-condition requirements, Inform when accommodations and environmental conditions are unsatisfactory or unsafe, Report accidents, incidents, or near misses, Provide resources and oversight for institutional safety program, Designate biosafety and safety officer(s), Develop a comprehensive safety program to meet all requirements, Provide adequate safety supplies in close proximity, Be aware of and advise as to safety requirements and appropriate engineering controls, Utilize appropriate personal protective equipment and engineering controls, Provide appropriate safe engineering controls, Inform when supplies or engineering controls are unsafe, inadequate, or unusable, Provide occupational health services adequate for level of services provided, Advise as to necessity for baseline immunity testing and provide vaccinations, Monitor for exposures and recommend prophylaxis or treatment as required, Receive vaccinations, prophylaxis, or treatments as recommended, Determine the need for service agreements, Provide the method to enter into a service agreement, Review operations to determine what service agreements are needed, Provide data to drive the decision for service agreements, Maintain the system that allows procurement of service agreements and good relationships with providers, Work with business analyst to facilitate development of appropriate service agreements, Maintain detailed records of services provided, Identify expense budget for providing the services to ensure continuation of service agreements across fiscal years and budget periods, ensuring uninterrupted service coverage, Identify requirements to be provided by the service agreement, Ensure that service agreements are kept current, renewed, or cancelled, Review the service agreement to make certain that terms are met, Understand and adhere to the terms of the service agreement, Analyze data on the performance of the service agreement, Monitor the performance of the service agreement, Before decision to purchase products or services or renewal of an agreement, Negotiate best price, terms, and conditions, Establish criteria for the selection of quality products and services, Provide input into the level of quality required for products and services, Inform users of backorders or unavailability of products, Inform management of incomplete orders or lack of service, Monitor quality of the products and services received, May provide a template for official documents, Establish a document control system that meets any institutional requirements, Inform supervisor if a new or revised document is needed. Each LSP shall be updated and approved at least annually, or as often as tasks change, by the laboratory management and the LSO. Mandated data archiving greatly improves access to research data. 1994. Microbiology laboratory management should contribute to the development of these relevant documents for all microbiology personnel. PDF General Laboratory Safety Manual - University of Houston When everything came to a standstill due to the lockdown imposed due to the Covid-19 Pandemic, Technology came in as a savior. It makes a strong connection between the Documents, so it is also helpful in Collaborations [17]. Frequent communication encourages input from all levels of the laboratory staff and helps to provide a platform for shaping organizational culture, building trust within a team, and engaging and empowering staff. Organization Personnel Equipment Purchasing & Inventory Individuals shall never share their personal access code with others. When the LIS is upgraded or the system is replaced, the laboratory shall have a process in place to ensure that previously entered data can be retrieved in its entirety and unaltered. 9. 12. Dr. Salfinger received his M.D. Each laboratory has a unique organizational structure. The role of the clinical microbiology laboratory is rapidly evolving as the delivery of health care undergoes drastic changes. Whenever possible, airflow should be in an inward direction from corridors into the laboratory space. This chapter aims to provide the solutions to common problems in paper data and electronic data archiving and management. Regul Toxicol Pharmacol. The latter two may be captured in course evaluations that specifically ask about the participant's satisfaction and how likely the course would change their practice. If specimens or isolates are sent off-site for disposal, there may be additional requirements from a waste management company. If the occurrence is inside the laboratory, the specific laboratory section shall be designated. The performance specifications should be included in the test information in the SOP. Accessibility The laboratory quality standards are divided into three overarching areas: the infrastructure of the quality system, the laboratory operations, and the activities under quality assurance and continual improvement (CI). The laboratory shall develop and implement a comprehensive safety program. Incorrectly collected or mislabeled specimens are significant errors that may lead to misinterpretation or, worse, reporting of results for the wrong patient. Handout 2: Suggested Format for Maintenance/QC Log (502), Job Aid 3: Equipment Inventory Form (507), Homework- Creating A Maintenance and QC Log Quiz, Institute for Healthcare Improvement (IHI), Strengthening Laboratory Management Toward Accreditation. e - records provide distinct benefits and time saving in data storage and transmission while overcoming human errors at every stage and under required security. To arrange transfer of records with historical value to the archives, contact Sara Mouch, Curator/University Archivist, at 419 . Responsibilities for meeting the quality objectives shall be clearly defined within the laboratory organization. Clear and timely communication of this information is essential for successful consultation in microbiology. attach to your lab notebook loose notes, emails, letters, graphs, figures and charts containing any part of conception of an idea or result of an experiment; title, sign and date each attachment, as well as each laboratory notebook page; record the objective of an experiment as well as the results obtained in as much detail as possible It secures the data of different types of studies/researches and assures the retention and retrieval period having proper documentation practices. There are four main activities under the analytical process: test verification, test validation, writing and reviewing SOPs, and establishing the measurement of uncertainty for tests with quantitative results. LABORATORY DESIGN AND MAINTENANCE - World Health Organization 16-1: Introduction Documents provide written information about policies, processes and procedures. The laboratory shall ensure that purchased consumables are not used until they have been inspected or otherwise verified as complying with standard specifications or defined requirements. How a laboratory refrigerator is different from a household refrigerator? Suggested roles and responsibilities for key activities are listed in Table 2. He has held academic appointments at Thomas Jefferson University, the University of South Florida, and the University of Iowa. Examples of quality indicators for the total testing process, Examples of nonanalytical quality indicators, Example of a quality indicator activities form. Results shall be graded, and performance shall be documented. Grainger LA, Ferries R. Lab design best practices-design document. For example, calculations made electronically in the LIS shall be verified periodically and after software updates to ensure that they are working as intended.