Documents and

Records

1
 Learning Objectives
At the conclusion of this session, you will be able
to:
 explain the difference between documents and
records;
 describe the hierarchy of documents and the
role of each level;
 outline the contents of a quality manual;
 outline the content that should be included in a
standard operating procedure;
 explain the important steps, or elements, of a
laboratory document management system;
 describe methods and tools to properly store
documents and records.

Documents and Records - Module 16 2

Scenario
You have found all these papers lying on a desk.
Which of these are documents and which are
records?
 testing algorithm  report of corrective actions
 safety manual  temperature log (blank
 client test results form)
 quality control record (blank
 standard operation
procedures (SOPs) for an form)
approved HIV rapid test  daily maintenance log
 manufacturer test kit (completed)
inserts  stock cards and stock book
 summary of findings from (completed)
on-site evaluation visit  EQA specimen transfer log
(completed)

Documents and Records - Module 16 3

 The Quality Management System

Organization Personnel Equipment

Purchasing Information
Process
& Management
Control
Inventory

Documents Occurrence
& Management Assessment
Records

Process Customer Facilities

Improvement Service &
Safety

Documents and Records - Module 16 4

 Why do laboratories need to manage
documents and records?

To find information
whenever it is needed!

Documents and Records - Module 16 5

 Documents and Records—How do they differ?

Documents Records
 communicate  capture information
information via on worksheets,
policies, processes, forms, labels, and
and procedures charts
 need updating  permanent, do not
change
RECORDS

Documents and Records - Module 16 6

 Information is the
major product
of the laboratory

Documents and Records - Module 16 7

 Policies

Laboratory
Documents
Procedures Processes

Documents and Records - Module 16 8

Policies - The “WHAT TO DO”
“A written statement of overall intentions
and directions defined by those in the
organization and endorsed by
management.” (CLSI HS1-A3)
Policies:
 tell “what to do” in a broad and general way
 include the organizational mission, goals, and
purpose
 serve as the framework for the quality system
 should always be specified in the quality
manual

Documents and Records - Module 16 9

Processes - The “HOW IT HAPPENS”
A “set of interrelated or interacting activities
that transform inputs into outputs.” (ISO 9000
4.3.1)
Processes:
 describe the steps involved to carry out quality
policies
 easily represented in flow charts
 involve a series of steps, usually occurring over
a period of time

Documents and Records - Module 16 10

 Procedures - The “HOW TO DO IT”
Standard operating procedures (SOP)
 step-by-step instructions for performing
a single activity

Job aid
 a shortened version of the SOP
 does not replace the SOP

Documents and Records - Module 16 11

Hierarchy of Documents

“How to do it”

“How it happens”

“What to do”

Documents and Records - Module 16 12

Why are documents important?
 essential guidelines for laboratory
 quality manual
 SOPs
 reference materials

 required by formal laboratory standards

Documents and Records - Module 16 13

Documents are the communicators
of the quality management system

Verbal instructions often are:

 not heard
 misunderstood
 quickly forgotten
 difficult to follow

Documents and Records - Module 16 14

 Documents are a reflection of
the laboratory’s organization
and its quality management.

A good rule to follow is:

“Do what you wrote and
write what you are doing.”
Documents and Records - Module 16 15
Good Documents are:

 clear
 concise
 user-friendly
 explicit
 accurate
 up-to-date

Documents and Records - Module 16 16

 Documents for work processes should
be accessible to staff at the work site :
 instructions on handling incoming samples
 SOPs for each test
 quality control charts
and trouble-shooting
instructions
 safety manuals
and precautions

Documents and Records - Module 16 17

 The Quality Manual
is a document describing the
quality management system
of an organization
(ISO 15189)

Documents and Records - Module 16 18

 Quality Manual
 communicates information
 serves as a framework or roadmap
for meeting quality management
system requirements
 demonstrates management
commitment to quality

Documents and Records - Module 16 19

Writing a Quality Manual

Documents and Records - Module 16 20

Writing a Quality Manual
Form a Steering Committee

Describe how
the related
quality
t p ol i cy for
Se processes occur
12 QS
essentials Reference
procedures

Documents and Records - Module 16 21

Key Points: Quality Manual

 only ONE official version

 never “done”, always being improved
 read and accepted by everyone
 use the best-adapted language

Very big job, but very useful

Documents and Records - Module 16 22

 Standard Operating Procedures
(SOPs) are documents that:
 describe how to perform a test using
step-by-step instructions

 written SOPs help ensure:

consistency
accuracy
quality

Documents and Records - Module 16 23

A Good SOP
 provides detailed, clear, and concise
direction for testing techniques
 is easily understood by new
personnel
 is reviewed and approved by
management
 is updated on a regular basis

Documents and Records - Module 16 24

Standardized SOP Format

 Computerized procedure
J Johnson,
RB Smith
 Standardization:
 Header
 Version/chapter/reference
 Author/reader/validator
 Recipients
 Version date/Application
date
 Typical outline
 Updating and storage of
different versions is easy

Documents and Records - Module 16 25

Complete Standardized Header

Use at the top of the first page only

Documents and Records - Module 16 26

Reduced Standardized Header

 other pages of every procedure

 use at the top of all other pages

Documents and Records - Module 16 27

 When Preparing SOPs
determine
determine
procedure
procedure
to
touse
use
establish
establish assess
assess
means
meansforfor scientific
scientific
updating
updating validity
validity

gather
gatherall
all include
include
documents
documents each
eachstep
step
Documents and Records - Module 16 28
Suggested Outline for SOPs
 Title: Name of Test
 Purpose: Medical use
 Instructions:
 Preexamination
 Examination
 Postexamination
 References to verify the method is established
 Author’s name
 Approval signature(s)–initial and date

Documents and Records - Module 16 29

Avoid Drowning in Detail…..
 BAD EXAMPLE: “The purpose of
this procedure is to document
the aforementioned activities,
herin after referred to as the
prescribed tasks in terms that
preclude their execution in an
inconsistent manner, wherin such
inconsistency may potentially
result in the prescribed tasks
delivering a result that is not
repeatable or reproducible”…

Documents and Records - Module 16 30

Do not rely solely on manufacturer
product inserts
Inserts do not provide specific
information for test sites,
such as:
 materials required, but not in kit
 specific safety requirements
 external quality control requirements

Documents and Records - Module 16 31

Job Aids
 shortened version of SOPs
 hand written or printed
 visible location at testing site
 useful tool to assure all testing steps
are correctly performed

Documents and Records - Module 16 32

Job Aids

Documents and Records - Module 16 33

Job Aids

Documents and Records - Module 16 34

Document Control ensures availability
when needed
assures that the
most current
version is used

organizational tool
Documents and Records - Module 16 35
 Document Control Elements
 system for organizing, such as
numbering or coding system
 approval, distribution, and revision
process
 master log that describes which
documents are in circulation
 accessibility of documents at the point
of use
 system for archiving

Documents and Records - Module 16 36

 regulations
and SOPs
standards

Controlled
documents

equipment texts,
service articles,
manuals reference
books

Documents and Records - Module 16 37

Documents of External Origin
 Include in the laboratory document
control system:
 instrument service manuals
 industry regulations
 ISO standards
 references used for documentation

Documents and Records - Module 16 38

Numbering System
 need uniform numbering system
 do not change a current system that works
 one system: letter for the type of document
and then an incremented number: B1, B2,
B3 for books and T1, T2 for official texts
 number all pages of document
 reference by document code, pages,
location code: Book number 2, pages 188-
200, on bookshelf 1: B2,188-200, BS1

Documents and Records - Module 16 39

 Document Preparation and
Control Process

Preparation
Issue
Distribution
Review

Revision Approval
Documents and Records - Module 16 40
Implementing Document Control
 collect existing documents and records
 review and update
 determine additional needs
 develop or obtain documents, forms,
worksheets, logbooks, reports
 involve stakeholders

Documents and Records - Module 16 41

Common Document Control Problems

 outdated documents
 too many documents are
distributed and the system
cannot be maintained
 lack of control of documents
of external and internal origin

Documents and Records - Module 16 42

Why are records essential?
Continuous
Sample
monitoring
tracking
of
throughout
quality
process
system

Management Identify
tool problems

Documents and Records - Module 16 43

 Sample
Sample
log
logbook
book
Patient
Patient ororregister
register Workbooks
Workbooks
test
testreports
reports Worksheets
Worksheets

Laboratory
EQA
EQA// Records Instrument
Instrument
PT
PTrecords
records printouts
printouts

Quality
Quality Maintenance
Maintenance
control
control records
records
data
data

Documents and Records - Module 16 44

 Personnel
Personnel
records
records Internal
Internal
Critical
Critical
communications
audits
audits
communications
results
results

More External
External
Customer
Customer
feedback
feedback Records audits
audits
results
results

User
User Continuous
Continuous
surveys
surveys improvement
improvement

Documents and Records - Module 16 45

 Keep the Things You Might
Forget!
 disposition of rejected samples
 referral of samples to another
laboratory
 records of adverse occurrences or
problems
 inventory and storage records
 equipment purchase data, preventive
maintenance, and troubleshooting

Documents and Records - Module 16 46

Test Report Contents ISO 15189
 test identification  primary sample type
 laboratory identification  results (SI units)
 patient unique  biological reference
identification and location intervals
 name and address of  interpretive comments
requestor
 person authorizing
 date and time of
collection release, with signature
when possible
 time of receipt in lab
 date and time of release
 note if reporting a
of report corrected result

Documents and Records - Module 16 47

Paper Systems
 Permanence  Security
 bind books  maintain
 number pages
confidentiality
 keep safe from
 use permanent ink
environmental hazards
 control storage

 Traceability
 Accessibility  allow for tracking of a
 use system that will specimen throughout
allow ease of access all processes

Documents and Records - Module 16 48

Documents and Records - Module 16 49
Electronic Systems

 permanence
 computer system maintenance, backups
 security
 access
 confidentiality
 traceability

Documents and Records - Module 16 50

 National
National
legislation
legislation
and
and
regulation
regulation

Testing Factors
Testing Research
process
process affecting Research
purposes
purposes
review
review retention
times

Time
Time
between
between
assessments
assessments
-audits
-audits
Documents and Records - Module 16 51
Summary
Documents:
 include written policies, processes, and procedures
 need to be updated and maintained
Records:
 include information captured in processes
 are permanent, do not require updating
A good document control program:
 most current version used
 availability and ease of access

Documents and Records - Module 16 52

Key Messages

 Information is our product.

 Documents are essential for assuring
accuracy and consistency in the
laboratory.

Documents and Records - Module 16 53

Scenario
You have found all these papers lying on a desk.
Which of these are documents and which are
records?
 testing algorithm  report of corrective actions
 safety manual  temperature log (blank
 client test results form)
 quality control record (blank
 standard operation
procedures (SOPs) for an form)
approved HIV rapid test  daily maintenance log
 manufacturer test kit (completed)
inserts  stock cards and stock book
 summary of findings from (completed)
on-site evaluation visit  EQA sample transfer log
(completed)

Documents and Records - Module 16 54

Scenario
You have found all these papers lying on a desk.
Which of these are documents and which are
records?
 testing algorithm  report of corrective actions
 safety manual  temperature log (blank
 client test results form)
 quality control record (blank
 standard operation
procedures (SOPs) for an form)
approved HIV rapid test  daily maintenance log
 manufacturer test kit (completed)
inserts  stock cards and stock book
 summary of findings from (completed)
on-site evaluation visit  EQA sample transfer log
(completed)

Documents and Records - Module 16 55

 Organization Personnel Equipment

Purchasing
&
Process Information Questions?
Control Management
Inventory

Comments?
Documents Occurrence
& Management Assessment
Records

Process Customer Facilities

Improvement Service &
Safety

Documents and Records - Module 16 56