THE BASICS OF DOCUMENT CONTROL IN THE LABORATORY

Jen Schuler

Director of Laboratory Services

Fairbanks Memorial Hospital Laboratories

•Name and Title•Your Experience with Document Control

Introductions

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Objectives

1. Describe how document control has changed over time.

2. Discuss regulatory requirements as well as some accrediting agency requirements for document control.

3. Understand the basic requirements for document control in the Laboratory.

4. 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 proceduresReportable Range/Normal Values/Critical

ValuesCorrective ActionReferencesReporting Results including critical valuesDowntime 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 RequirementsFrom: “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 RequirementsFrom: “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 RequirementsTaken 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 RequirementsTaken 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 RequirementsFrom: 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 RequirementsFrom: 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 StepsDocument 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?