THE BASICS OF DOCUMENT
CONTROL IN THE LABORATORY
Jen Schuler
Director of Laboratory Services
Fairbanks Memorial Hospital
Laboratories
Introductions
Name and Title
•Your Experience with Document Control
•
Objectives
1.
2.
3.
4.
Describe how document control has changed
over time.
Discuss regulatory requirements as well as
some accrediting agency requirements for
document control.
Understand the basic requirements for
document control in the Laboratory.
Understand the basics of writing a procedure.
What is Your Definition of
Document Control?
Is it really “Document Control”?

Overall organization on how we deal with all
documents within our laboratories to ensure
they are:
 Current
 Approved
prior to use
 Reviewed as required
 Correct
 Available for end user

With all parts and pieces it really becomes
“Document Control Management”
Some History

Around 2003, AABB and CAP began adding
requirements to ensure laboratories had
document control systems and that ALL
laboratory documents were subject to
document control. (Paxton, Anne. Bedeviled by Documents, Labs Seek
Control. CAP Today. July 2009.)

Think back to those old procedures that you run
into now and then. How do you see they have
changed over time?
CLIA Requirements
From: Interpretive Guidelines for Laboratories, Appendix C, Survey Procedures and Interpretive Guidelines for
Laboratories and Laboratory Services, downloads for Subpart J and Subpart K Part 1.
www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html
Subpart K--Quality System for Nonwaived Testing
 493.1200 (a)
 Must
establish/maintain policies/procedures to
implement and monitor quality systems for all phases of
testing processes.

493.1251 (a-e)Standard: Procedure Manual.
 Must
have manuals for all test/assay/exams performed
available to all staff.
CLIA Requirements
From: Interpretive Guidelines for Laboratories, Appendix C, Survey Procedures and Interpretive Guidelines for
Laboratories and Laboratory Services, downloads for Subpart J and Subpart K Part 1.
www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html

Must include:
 All
pre analytical variables, i.e. patient prep,
specimen collection/labeling/processing/rejection,
etc.
 Prep of all materials, reagents, etc.
 Control, calibration and cal ver procedures
 Reportable Range/Normal Values/Critical Values
 Corrective Action
 References
 Reporting Results including critical values
 Downtime procedures
CLIA Requirements
From: Interpretive Guidelines for Laboratories, Appendix C, Survey Procedures and Interpretive Guidelines for
Laboratories and Laboratory Services, downloads for Subpart J and Subpart K Part 1.
www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html
 May
use manufacturer’s instructions/operator
manuals if meet requirements
 Must be approved (dated/signed) by lab
director before use (new and changed)
 Must maintain copy with date of initial
implementation and archive.
CLIA Requirements
From: Interpretive Guidelines for Laboratories, Appendix C, Survey Procedures and Interpretive Guidelines for
Laboratories and Laboratory Services, downloads for Subpart J and Subpart K Part 1.
www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html
Subpart J--Facility Administration for Nonwaived
Testing
 493.1105 (a)(2)Standard: Retention requirements.
Test procedures.
 Typically
2 years.
 Blood Bank/Transfusion Service 5 years
CAP Requirements
From: “Laboratory General” and “All Common” Checklists, CAP Accreditation Program, 9/25/12.

GEN.20375 – The Laboratory has a document
control system
 Policy/procedure
current
 Staff has read those relevant to job
 Authorized by lab director prior to implement
 Reviewed biennially by director/designee
 Archived are quarantined for 2 years or 5 for
transfusion med.
 Electronic is OK.
CAP Requirements
From: “Laboratory General” and “All Common” Checklists, CAP Accreditation Program, 9/25/12.

COM.10200 New Procedure Review
 Lab
Director review/approve all new and substantial
changes before implementation

COM.10300 Knowledge of Procedures
 All
staff are knowledgeable about the contents of
manuals relevant to their scope of practice. This
includes changes

COM.10400 New Director Procedure Review
 New
lab director must review manuals within
reasonable period of time.
AABB Requirements
Taken From: Standards for Blood Banks and Transfusion Services, 28th Edition, AABB, effective Nov. 1,2012.

Standard 6.1 – Documents. The blood bank or
transfusion service shall have a process for
document control that includes the following
elements:
 Master
List of documents (policies, processes,
procedures, labels and forms) (6.1.1)
 Use of standardized format for documents (6.1.2)
 Review and approval of new and revised documents
before use (6.1.3)
AABB Requirements
Taken From: Standards for Blood Banks and Transfusion Services, 28th Edition, AABB, effective Nov. 1, 2012.




Review by authorized individual (minimum every 2
years) (6.1.4)
Use only valid and current documents (6.1.5)
Identification and archival of obsolete documents
(6.1.6)
Storage to preserve legibility and protect from
accidental or unauthorized access, destruction or
modification.
COLA Requirements
From: Organization section of the COLA Laboratory Accreditation Manual, COLA, June 2012.



ORG 12 R – Does the procedure manual include all
the tests offered by the laboratory?
ORG 13 R – Is the procedure manual easily
accessible to your personnel?
ORG 15 R – Are all the test procedure reviewed,
approved, and signed annually by the lab director?
COLA Requirements
From: Organization section of the COLA Laboratory Accreditation Manual, COLA, June 2012.

ORG 16 R – ORG 18 R – Does the laboratory
director sign and date:
 Each
new procedure
 Any changes
 Entire manual if he/she is new director


ORG 19 R – Are procedures dated when they are
initially put into use and when they are
discontinued?
ORG 20 R – Are discontinued procedures kept for
at least 2 years beyond the discontinued date?
Why Is Document Control Important
and Necessary?
CLIA and our Accrediting Agencies tell us so
 Sets expectations
 Consistency among staff/everyone on same
page
 Guidelines for when things don’t go right

CONSISTENT, QUALITY PATIENT
CARE!

Who is Responsible?
Ultimately – the Laboratory Director
 Typically…

 Managers
 Supervisors
 Section

Leads
Consider having bench level staff work on
procedures and document control.
Do We Have To?

Leaders have probably heard questions such as:
 Do
we have to follow all these steps?
 Can I skip this?
 I really need my cheat sheet.
 Why can’t we just…?



Having an in depth, clear, concise, and as easy as
possible process in place is important
It can be difficult to keep track on paper as it is
easy to miss steps.
Make sure you have a point person
It’s Where?
It is very important to have the right
information at the right place at the right time.
 Control of documents will help make sure the
errant copies of old procedures do not
suddenly appear after 5 years because
someone kept a copy in a drawer.
 Utilize staff who will use the document to
figure out where information needs to go.

Resources to Use
CLSI Documents such as: Laboratory
Documents: Development and Control;
Approved Guideline – 5th Edition; GP2-A5.
 Accrediting Agencies
 Teleconferences, webinars, etc.
 Vendors that offer electronic document control
management systems
 Specialized procedure writing programs
 Colleagues – Do not be afraid to ask!

Document Control and Management at
FMH Laboratories
Our system was originally developed by
management and staff in our Blood
Bank/Transfusion Service.
 In 2010, we modified our existing lab-wide
document control system by expanding the
Blood Bank system throughout the rest of the
lab.
 Change control is a large part of our document
management system.

Definitions from FMH Labs




Policy – Describes why something happens. A written
statement of overall intentions and directions defined by those
in the organization and endorsed by management.
Process – Describes the sequence of specific activities that
take place across time and identifies the specific
organizational units and individuals involved.
Procedure- A set of instructions that describe the stepwise
actions to be taken to complete activities identified in
processes.
Form – A paper or electronic document on which the results
from the performance of a procedure or other information are
captured. When the form is completed, it will become a
record.
Definitions from FMH Labs



Attachment – A document that aids in the process,
policy, or procedure and may include important
information needed by the reader to make decisions.
This may be created or may be from a reference.
Substantial Change(s) – Any change(s) to a policy,
procedure, or process that is assessed “High Risk” by
the Change Control procedure.
Revision – Any changes to a policy, procedure, or
process that is assessed Medium or Low Risk by the
Change Control procedure.
FMH Change Control
(Flow Chart)
*Any staff member can submit.
•*For use for any changes to process, policy, procedure to
include forms and attachments.
•
FMH Change Control
*Manager reviews, logs, assigns number and passes it on
to appropriate person.
•*Change is discussed as needed and either accepted,
rejected or amended.
•
•
Decision is passed along to submitter.
FMH Change Control
Designee completes:
*The rationale as to why we are implementing
•
*Risk Assessment
•
*Plan for Implementation
•
FMH Change Control
Risk
Assessment
Next Steps
Assign Document Number using Master List of
Documents
 Create or Revise Document (See Template)

 Include
Lab Name/location
 Title
 Document
Location
 Document number
 Related Documents
 Approval Information
 Revision Information
Next Steps
Document Sections (See Template)









Purpose/Principle/ Policy
Responsibility
Materials/Equipment
Attachments/Job
Aids/Appendices
Procedure
Interpretation/ Reporting
Results
References
Attachments/Job
Aids/Appendices
Annual Review












Background
Specimen Requirements
Reagents
Reagent Preparation
Safety
Calculations
QC or Calibration
Maintenance
Limitations
Notes
Definitions
Before You Begin
Next Steps
Major Changes
New test implementation (see New Test
Implementation Checklist)
 Complete all validation and method
verification studies as indicated

Next Steps
Have staff review document (SOP Validation
Checklists)
 Designee will check for regulatory compliance
 Make edits if indicated
 Get required approval

 Lab
Director for New and Substantially Changed
documents
 Medical Director and supervisor/manager assigned
to area
Next Steps
Train Staff
 Staff review new/revised SOP
(SOP Change and Review Form)
 Implement SOP
 Archive as needed
 Don’t forget to update the Master List of
Documents
 “Records Management Checklist”
 Annual Review as required.

Now It Is Your Turn

Volunteer Needed...
Details
Change Request submitted to create an SOP
for Making a Peanut Butter and Jelly Sandwich
for lunch.
 Change Request is amended because we
realize we do not have a manual for making
lunch.
 New Manual to be created with title “Home
Lunch”
 Procedure number assigned HL.001.00.

Writing the Procedure as a Group
Volunteer to
make a
sandwich
•
Use
template to
write as a
group
•
THANK YOU!
Questions?