Using and Maintaining Documents and Records

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Using and Maintaining Documents and Records

• Finding the information
• when you need it

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Document Control Goals

• Provide current procedures easily understood by
  lab personnel
• Provide basic information to evaluate, verify and
  maintain quality of procedures
• Improve quality of laboratory testing
• Meet standards

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Problem Scenario

• You are the laboratory supervisor in a public
  health laboratory. You have a report of a
  patient who had a confirmed positive rapid HIV
  test one month ago and today had a negative HIV
  rapid test.
• What documents or records would you review to
  find the source of the problem? What additional
  information would you request from the doctor?

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Outline

• Definitions
• Importance of documents
• Document types
• Document preparation
• Document and record control

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Definitions

• Documents WRITTEN policies, process
  descriptions, procedures, and blank forms
• Used to communicate information
• Records worksheets, forms, charts, labels
• Used to capture information, activities, or
  results when performing a procedure
• May be paper or electronic

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Documents
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Hierarchy of Documents
what to do
Policies
how it happens
Processes
how to do it - (SOPs)
Procedures/ Work Instructions
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Policies

• The WHAT TO DO
• Statements of the organization's mission, goals
  and purpose
• Quality laboratory services to support disease
  prevention and treatment
• Framework for the organizations Quality Manual
• There shall be a Quality Planning Process
  established and managed by the laboratory
  administration to assure that the quality goals
  for laboratory testing are successfully met

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Responsibilities of Director

• Ensures sufficient qualified personnel with
  documented training and experience to carry out
  required laboratory work
• Monitors work to determine that medically
  reliable data are being provided
• Identifies problems and develop corrective
  actions
• Ensures documentation is complete and timely

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Responsibilities of Supervisors

• Assist in development of documents and document
  control
• Direct implementation and ensure documentation is
  performed
• Ensure technologists understand responsibilities
  and functions
• Keep Director apprised of problems and oversee
  corrective action

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Responsibilities of Technologists

• Carry out assigned documentation functions at
  their properly scheduled time
• Carry out maintenance activities, and detect
  deficiencies and problems
• Document maintenance and corrective actions
• Maintain ability to correct deficiencies within
  responsibilities
• Keep Director and Chief Technologist apprised of
  activities

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Processes

• The HOW IT HAPPENS
• Describes what is involved in carrying out
  quality policies
• Easily represented in flow charts
• Involves a series of stages, usually occurring
  over a period of time
• Usually involves more than one person

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Example of a Process

• The pre-analytical testing process
• Evaluating and selecting methods and equipment
• Training new employees
• Responding to requests for test results
• Assessing operation of process and requirements
  for changes

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Procedures / Work Instructions

• The HOW TO DO IT
• The step-by-step instructions for performing a
  single activity
• A sequential list of tasks in a procedure

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Processes Lead to Procedures
Process
Stage 1 Phlebotomist collects specimens
Stage 2 Orderly transports specimens to lab
Stage 3 Technologist performs testing
Procedure
Specimen Collection Step 1. Prepare collection
tubes and supplies Step 2. Confirm patient
identity. Step 3. Label tubes. Step 4.
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Why Do Labs Need Documents?

• Tell people what should and should not be done
  communicate to customers (Policies)
• Perform consistent methods (Procedures)
• Track workflow find problems (Records)
• Quality Manual overall monitoring of the total
  testing process
• References - available to share or access
• Required to meet formal laboratory standards

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Why do labs need documents?

• Verbal instructions often are
• Not heard
• Misunderstood
• Quickly forgotten
• Ignored

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Standard Operating ProceduresCommon Elements

• Title
• Purpose
• Procedure instructions
• Pre-analytic
• Analytic
• Post-analytic
• References
• Author
• Approval signature (s)
• Date in use/version number

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Good Documents Are

• Clear
• Concise
• User friendly

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A Good SOP

• Provides an easy, efficient means to document
  complicated techniques
• Communicates what is done in the laboratory
• Is the basis of training
• Is easily understood by new personnel
• Is approved by management

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A Poorly Written Procedure

• Uses more words than necessary
• Is complex and difficult to read
• Requires frequent updates and corrections
• Does not follow a standard outline
• Is not reviewed by QA Manager and Director

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Job Aid
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Records
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Why are Records Essential?

• For continuous monitoring of quality system
• For specimen tracking throughout process
• To identify failures in equipment
• To revisit information reference
• For use as a management tool

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Examples Quality Assurance Records

• Specimen log book, registers
• Laboratory workbooks/sheets
• Instrument printouts, maintenance records
• QC logs, plots
• EQA / PT records
• Patient test reports

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Other Examples Quality Assurance Records

• Personnel files
• Results of internal audits
• Results of external audits
• Continuous improvement projects
• User surveys and customer feedback

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Things You Might Forget to Record!

• Disposition of rejected specimens
• Referral of specimens to another laboratory
• Records of adverse occurrences or problems
• Inventory and storage records
• Instrument purchase data, preventive maintenance,
  troubleshooting

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Test Report Contents

• Laboratory name
• Name of person authorizing the report
• Name and lot number of kit or reagent
• QC for the test run

• Date and time
• Any patient identifiers
• Date and time of sample collection
• Date and time sample received in the lab
• Person performing test
• Biological reference intervals
• Interpretative comments

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Document / Record Control
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Document Control

• Advantages
• Assures that the most current version is used
• Ensures availability when needed
• Organizational tool

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Document Control Elements

• A system for formatting and maintaining documents
• Uniform format
• Legible and identifiable
• Approval, distribution, and revision process
• Reviewed and updated
• Master log
• Availability
• Relevant versions at point of use
• Archive

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Documents of External Origin

• Include in your document control system
• Instrument service manuals
• Industry regulations
• ISO standards
• References used for your documentation

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Implementation Steps

• Collect existing documents and records
• Review and update
• Determine additional needs
• Develop or obtain
• Documents, forms, worksheets, logbooks, reports
• Involve stakeholders

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Summary Document Preparation and Control Process
Preparation
Approval
Revision
Issue / Distribution
Review
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Where will you keep your documents and records?
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Paper Systems

• Permanence
• books bound
• pages numbered
• permanent ink
• controlled storage
• Security
• controlled distribution confidentiality
• safe from environmental hazards

• Ability to attribute
• all retained records should be signed and dated,
  periodically signed by supervisor

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Electronic Systems

• Permanence
• system maintenance, e.g., backups
• Security
• Access
• Confidentiality
• Ability to attribute

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Factors Affecting Retention Times

• Review of the testing process
• National legislation and regulation
• Research purposes
• Time intervals between assessments or audits

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Common Problems

• Timely Approval
• Distribution
• Too many documents are distributed. The system
  cannot be maintained.
• Lack of control of documents of external and
  internal origin
• Avoid these problems by planning ahead.....

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And all the pieces will fall in place.
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Take home Messages

• Written policies and procedures are the backbone
  of the quality system
• Reliable and timely reports of results can save
  lives
• Complete quality assurance records make quality
  management possible

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Back to Problem Scenario

• Were all of the records you needed to review part
  of your current documentation system?
• How can some of the records suggested here help
  you find the source of the problem?
• What improvements do you need to make to your
  records and documentation system?