Project Proposal Form Project Submission Date: 26 March 2014

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.
Page 1 of 7 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
Page 3 of 7 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)
Page 4 of 7 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
Page 6 of 7 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
Page 7 of 7 No