Policy
● Statement or memo
○ Outline the institution’s position on an administrative or operational issue
Procedure
● Instructional document
○ Provides explanations and step-by step directions on how to perform a task, test,
or process
● Also referred to as SOP - Standard Operating Procedure
Manual
● Handbook
○ Contains information and instructions about the operation or how to do something
Types of Manuals
● Policy Manual
○ Contains policies that apply to the general and overall operations of the institution
■ Administrative organization
■ Employment and personnel process
■ Adherence and enforcement of safety and health procedures
■ Disaster plans
■ Confidentiality and release of patient information
■ Security and access to facilities
■ Dress codes
■ Food and smoking rules
■ Telephone use
■ Safety rules
■ Absences and late arrival notifications
■ Vacation and holiday requests
■ Supply requisition
● Procedure Manual
○ Standardize the way tasks and tests are performed
○ Ensure that all work is performed according to criteria set
○ Assist in problems which require troubleshooting
○ Contains procedures that apply to specific work tasks and duties
■ Technical manuals - contains procedures for performing test, operating
instruments, or processing quality control information.
● Objective of these manuals
○ To ensure effective communication between the members of the organization
○ To remove any ambiguities
○ To allow uniform and consistent application of the laboratory’s policies and
procedures
● Issues of these manuals
○ Responsibility and control
○ Performance appraisals
○ Completion of tasks and duties
○ Quality standards and monitoring indexes
○ Job descriptions
○ Workflow and job analysis
○ Financial accountability
Types of Policy and Procedure Manuals
● External manuals - Directed for the users of laboratory services
○ Specimen Collection Manual
■ Contains detailed instruction for patients and health care providers for
collecting, labeling, storing, rejecting, transporting, and delivering
specimens to the laboratory
○ Laboratory Service Manual
■ Covers policies and procedures concerning operational factors:
● Business hours
● Services provided
● Specimen submission requirements
● Billing practices
● Internal manuals - Designed for workers of the laboratory
○ Administrative manuals
■ Addresses policies that apply to the entire laboratory
● Work schedules
● Vacation and holiday staffing
● Dress codes
● Telephone use
● Changes in schedule
● Delegation
● Disaster plans
● Procedures for supply requisitions
○ Technical manuals (organized according to discipline)
■ Contains information and step-by-step instructions:
● Operating instruments
● Performing individual tests
● Tasks and duties
● Procedures for calibration
● Quality Control
● Safety
● Troubleshooting
● Releasing of results
○ Safety manuals
■ Dedicated to specific safety concerns present in facility
■ Covers physical, chemical, fure, natural disaster, and blood borne
dangers
■ Contains the chemical and exposure control plan as dictated by OSHA
● OSHA - Occupational Safety and Health Administration
○ Quality management manuals
■ Contains overall policies, procedures, and rules for ensuring the quality of
laboratory services
■ Deals with…
● Specimen acceptability
● Administrative and technical review of quality data
● Ensuring the quality standards and goals are achieved
Writing Policy and Procedure Manuals
● Ensures
○ CONSISTENCY - serves as a checklist
○ ACCURACY - Accurate results > relying on memory
○ QUALITY - consistent and reliable results is primary goal of the laboratory
● Policy Manual Format
○ Organized BY TOPIC, present using an OUTLINE MODEL with subject
headings
○ Policy can range from a one-sentence statement to more extensive discussion
■ “Example: All staff will present a professional appearance at all times”
● Procedure Manual Format
○ Regulatory agencies have specific guidelines governing the information provided
in procedure manual format
○ Regulatory agencies require that the laboratory maintain specific procedures
relating to the work done in its facility
○ Examples of REGULATORY AGENCIES *REMEMBER THESE*
■ JCAHO - Joint Commission on Accreditation of Healthcare Organizations
■ CAP - College of American Pathologists
■ AABB - American Association of Blood Banks
■ CLIA ‘88 - Clinical Laboratory Improvement Amendment of 1988
■ OSHA - Occupational Safety and Health Administration
■ NCCLS - National Committee for Clinical Laboratory Standards
● Factors in selecting Format and Style
○ Skill and technical ability of the user
○ Manual’s use as a ready resource for checking performance criteria
○ Performance and behavior expectations of the laboratory
Items found in Technical Procedure Manual
● Name of test, procedure, task or duty
● Effective date and any changes
● Short summary of the main elements of the procedure
● Principle of the test
● Specimen requirements
● Instrumentation, equipment needed
● Reagent preparation
● Calibration
● QC procedures
● Interferences
● Step-by-step instructions
● Calculations and interpretations of results
● Reference ranges
● Troubleshooting suggestions
● References
● Authorization and schedule for review
Document Control
● Ensures that the more current version of any documents is the one that is in use
● Ensure availability and ease of use when a document is needed
● Provide for the appropriate archiving of documents when they need to be replaced
Elements of Document Control
● Uniform format
○ Includes a numbering system and method for identifying the version (date)
document
● Process for formal approval for each new document and procedure for updating and
revising laboratory documents
● Master log or inventory of all documents of the laboratory
● Process to ensure that the documents are available
● Method for archiving documents that get outdated but used for future reference
Controlled Documents
● SOPs
● Texts, articles, and books
● Documents of external origin
Developing the Document Control System
● Create a system for standardizing the format and/or numbering
○ Indicates document version
● All pages of the documents must contain an appropriate number
● Approval, distribution, and revision process
● Master log
● Accessibility
● System for archiving
Implementing Document Control
● Collect, review and update all existing documents and records
● Determine the additional needs
○ New process or procedure descriptions
● Develop or obtain example of documents
● Involves stakeholders
Common issues for Document Control
● Outdated documents in circulation
● Distribution Problems
● Failure to account for documents of external origin
Importance of Records
● Continuous monitoring
● Tracking of samples
● Evaluating problems
● Management
Examples of Laboratory Records
● Sample logbook, registers
● Laboratory workbooks or worksheets
● Instrument printouts—maintenance records
● Quality control data
● External quality assessment or proficiency testing records
● Patient test reports
● Personnel records
● Results of internal and external audits
● Continuous improvement projects
● Incident reports
● User surveys and customer feedback
● Critical communications
Records that are Easily Forgotten
● Information on the management and handling of rejected samples
● Data needed on any sample referred to another laboratory; to include when the sample
was transported, where it was sent and when the report was issued.
○ The sample should be able to be tracked throughout the referral process
● Information about adverse occurrences or problems
● Include all information that is pertinent, such as the results of any investigation of the
problem
● Inventory and storage records. These helps keep track of reagents and supplies
● Equipment records
Test Report Content
● Identification of test
● Identification of laboratory
● Unique identification and location of patient, where possible, and destination of the
report
● Name and address of requestor
● Date and time of collection, and time of receipt in laboratory
● Date and time of release of report
● Primary sample type
● Results reported in SI units or units traceable to SI units, where applicable
● Biological reference intervals, where applicable
● Interpretation of results, where appropriate
● Applicable comments relating to quality or adequacy of sample, methodology limitations
or other issues that affect interpretation
● Identification and signature of the person authorizing release of the report
● If relevant, notation of original and corrected results
Storing of Records - PAST
● Permanence - how long records last
● Accessibility - how easily available the information is
● Security - maintains patient confidentiality
● Traceability - record of all the processes
Electronic System - PST
● Permanence - backup systems
● Security - access codes
● Traceability - input and availability of record
Record Retention
● Length of time the laboratory will need to have access to its records
● Government requirements or standards that dictate record retention times
● Whether laboratory is engaged in ongoing research requiring many years of data
● Time interval between the laboratory’s assessments
KEY POINTS
● INFORMATION is the product of laboratory
● DOCUMENTS are essential for assuring accuracy and consistency in the laboratory