Project Proposal Form
Project Submission Date: 26 March 2014 Submitter contact information: Name: Debra Kuehl Organization: Centers for Disease Control and Prevention Phone number: 404.498.0098 E-mail:
[email protected] Proposed Title: How to Implement, Verify, and Maintain Laboratory Equipment and Instruments Proposed product will be (check one):; Click here for explanation of the product types (insert hyperlinks) Consensus standard Consensus guideline Report Other (please describe) Level of intended user: ☒ Novice ☐ Intermediate Advanced Part 1A: Proposed Project Is this proposal for a new document or a revision? New Revision Other (please describe) Provide a rationale for the project and describe its potential impact on health care: Whereas CLSI guideline GP37, Quality Management System: Equipment provides a comprehensive overview of the requirements for an equipment management program, this revised guideline will provide detailed “how to” information for implementing, verifying, and maintaining specific types of medical laboratory equipment and instruments. This guideline and any accompanying products will provide a systematic and easy-to-follow format for developing and documenting a maintenance program for laboratory equipment and instruments. Although many manufacturers and providers offer assistance in the selection, verification, and maintenance of equipment and instruments, the laboratory director is ultimately responsible for adequately verifying and maintaining equipment and instruments used in the production of laboratory examination results. CLSI could package QMS13-A, Quality Management System: Equipment (which overviews equipment requirements and provides “why”-type information) with this guideline (which provides “how-to” information) since both are needed by laboratory management and technical staff to maintain an effective equipment management program.
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Project Proposal Form Please provide answers to the following: 1. How does this proposed project meet CLSI’s mission? Click here to review CLSI’s mission. This project will provide guidance for laboratorians to ensure implementation of best practices for verification of laboratory equipment. This guideline may be of particular interest in resource-constrained settings. 2. Describe why this project would be of interest to one or more of CLSI’s three constituencies (government, industry, professions). Please identify the constituency along with the reason it would be of interest/value to that group. This document will be of particular interest to the professions constituency as it will provide detailed “how to” information for implementing, verifying, and maintaining specific types of medical laboratory equipment and instruments. 3. Describe whether there are any related standards or guidelines already in existence or under development by another organization. None known 4. Describe whether there are any strategic opportunities available for the proposed document. For example, does the document fit into a strategic growth area identified in CLSI’s strategic plan? (NOTE: The CLSI Board has identified five focus areas for the organization which include Method Evaluation, Microbiology, Newborn Screening, Point-of-Care Testing, and Quality Management Systems.) Is this a document that could be developed in collaboration with an important partner (eg, ISO, WHO), or with funding from another group? This document fits into the quality management systems area. There is no particular group with which collaboration would be particularly beneficial. Provide other important factors that should be considered when evaluating this proposal: See rationale provided above. Part 1B: Proposed Users Check the boxes to indicate which potential users this document would apply to: ☒ ☒ ☒ ☒
Medical laboratory Veterinary laboratory Research laboratory Public health laboratory Manufacturer Regulatory or accreditation organization. Other (please describe)
Part 1C: Scope Briefly describe what the document will and will not include. This document is intended to provide useful tools and forms that can be used to plan, record, and track instrument implementation, verification, and maintenance for specific types of laboratory equipment and instruments. This guideline is applicable to medical laboratories of any size, complexity, or specialty, including point-of-care testing. However, since the types of equipment and instruments are not unique to medical laboratories, this guideline can be used by other types of laboratories, such as Page 2 of 7
Project Proposal Form public health, research, food, environmental, and veterinarian laboratories. This guideline can be used in laboratories that use equipment and instruments in the delivery of preexamination, examination and/or postexamination phases of the laboratory’s path of workflow. Part 1D: Process(es) Covered in This Document Check boxes to indicate the type of process this document will cover: ☒ Preexamination (preanalytical) processes: Test order through sample receipt and accessioning ☒ Examination (analytical) processes: Test method, validation, quality control, automated analyzer platform, laboratory results, interpretation ☒ Postexamination (postanalytical) processes: Reporting results, archiving results, archiving samples Quality System Essential (QSE) (or part of a QSE) Information technology: Laboratory information system, interfacing, laboratory records, etc. Manufacturing Other (please describe): Part 1E: Existing Products List applicable CLSI and other related publications that should be considered during the development of this document. CLSI document QMS13, Quality Management System: Equipment This document will consume and update the contents of the following CLSI documents: •
ASI-1: Preparation of Manuals for Installation, Operation, and Repair of Laboratory Instruments
•
I2-A2: Temperature Calibration of Water Baths, Instrument, and Temperature Sensors
•
ASI-5: Power Requirements for Clinical Laboratory Instruments for Laboratory Power Sources
•
I6-A: Service of Clinical Laboratory Instruments
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Project Proposal Form Part 1F: Draft Outline Provide a DRAFT outline of the chapter headings and topics that follows the document outline template for the process(es) that will be described in this document. Click here for information on the document outline template.
Foreword Chapter 1 Scope Introduction Terminology Definitions Abbreviations / Acronyms Chapter 2: Process flow Chapter 3: Overview of Recommendations for a Laboratory Equipment and Instrument Implementation, Verification, and Maintenance Program (GP31 section 5) [Briefly links this document to QMS13] 3.1 Manufacturer recommendations 3.2 Service Contracts 3.3 Documentation and Records Keeping (with appendixes) 3.3.1 Package inserts 3.3.2 Manuals 3.3.3 Maintenance schedules 3.3.4 Maintenance logs and function checks 3.3.5 Repair logs 3.3.6 Verifications Chapter 4: Unpacking equipment (ASI-1 section 2) (QMS13 Appendix F) Chapter 5: Power requirements for equipment and instruments (4.1.2 and ASI-05; refer to QMS04, formerly GP18) 5.1 Standard 5.2 Electrical grounding 5.3 Emergency Power Chapter 6: Environmental requirements 6.1 Physical 6.1.1 Noise (OSHA requirements) 6.1.2 Temperature 6.1.3 Humidity 6.1.4 Light 6.1.5 Air flow 6.2 Biological contaminants (eg, dust spores)
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Project Proposal Form Chapter 7: Basic laboratory equipment and instruments This document will be linked with QMS 13 by including Table 1 from QMS13, with the specific equipment and instruments covered in the GP31 revision in bold font. GP37-A, Table 1. General laboratory equipment and specific laboratory instrumentation. Laboratory Equipment Laboratory Instruments Autoclave Osmometer Automated tissue Pipettor Automated Oven stainer • Mechanical coverglass/cassettes pH meter Blood cell analyzer • Automated instrumentation Photometers/lightBlood chemistry Thermal cycler Balance/scale based analyzer Thin layer Biological cabinet device Blood gas analyzer chromatograph Centrifuge Polarimeter Blood typing Urine analyzer Refractometer equipment • General purpose Rotator Centrifuge • Microhematocrit Shaker • Automated cell (dedicated, fixed Temperaturewashing RPM) controlled Co-oximeter • Refrigerated equipment Densitometer • Stand-alone • Refrigerator Electrode-based Fume hood instrument • Freezer Glassware washer Electrophoresis • Incubator Laboratory system Flow thermometer • Water bath cytometer Light box • Blood bank Ion-selective Manual pipettor transport electrode Microscope container Mass spectrometer Microtome Timer Microbial Tissue processor identification Water purifier instrumentation Nephelometer 7.1 Centrifuges (QMS13 Appendix N) 7.1.1 Low speed 7.1.2 High speed 7.1.3 Refrigerated 7.1.4 Dedicated RPM, such as microhematocrit 7.2 Pipettors and Dilutors 7.2.1 Manual 7.2.2 Automated 7.3 Glassware 7.3.1 Glassware (cleaning issues and what can’t be used) 7.3.2 Glassware washers 7.4 Biosafety cabinets, fume hoods, and glove boxes 7.5 Shakers and rotators 7.6 Scales and balances 7.7 Temperature-regulated equipment 7.7.1 Thermometers (Appendixes: Log and Levey-Jennings chart) 7.7.2 Water baths and heat blocks 7.7.3 Refrigerators and freezers Page 5 of 7
Project Proposal Form 7.7.4 Incubators 7.8 pH meters Chapter 8: Specialized laboratory instruments (include POCT) 8.1 Minimum requirements for documentation (QMS13) 8.2 Refer to manufacturer’s instructions Chapter 9: Microscopes Chapter 10: Uncertainty of Measurement (CLSI documents C51, C59, ISO Technical Report) 10.1 Variability by instrument 10.2 Sum measure of uncertainty Chapter 11: Quality System Essentials Important issues for each of the other QSEs will be discussed as applicable Chapter 12: Conclusion Chapter 13: Supplemental material Part 2: Recommended Timeline How much time is anticipated for completing the writing phase for a working draft for voting? 6 months ☒ 8 months ☐ 10 months Other, justify: Part 3: Proposed Companion Products Check the companion products listed below that could be developed with this proposed document. Note that companion products may or may not be developed by the document writing group. ☒ Quick Guides (Handy reminders that put information at the user’s fingertips, such as quick guides and wall charts) Checklists (For use in reporting completed required activities and/or assessments) Video/DVD (Instructional video presentation) ☐ Toolkits (eg, electronic document templates) Software (eg, databases) ☒ Educational presentations ☒ Article in a professional journal(s) (List names of appropriate journals) ☐ Presentations/Workshops at professional meetings (List appropriate professional organizations and associated meetings) ☒ Web/audio conference Other
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Project Proposal Form Part 4: Document Attributes Answer the following questions: What are the key features included in this document? ☒ Updated information New methods or technologies Proven process ☒ Provision of guidance Other, describe: Please expand on any selected items: See rationale provided in Part 1A; see also document outline provided in Part 1F What are the benefits of using this document? ☒ Meet regulatory or accreditation requirements ☒ Meet quality or organizational objectives ☒ Satisfy customers Other (please describe): Please expand on any selected items: See rationale provided in Part 1A Part 5: Document Development Committee Membership • Describe specific expertise needed for development of this proposed document. Laboratory professionals in both the public and private sectors with expertise in maintaining and monitoring equipment performance. Include a global perspective to capture cultural, economic, and other needs and differences. • Suggest possible participants and whether they have been contacted regarding potential interest. Potential Chairholder Name: Debra Kuehl
Contacted? ☒ Yes
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No
