# Presentation: 284218

## Using and Maintaining Documents and Records

- Finding the information
-  when you need it

## Outline

- Definitions
- Importance of documents
- Document types
- Document preparation
- Control of Document and records

## Problem Scenario

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

## 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

## Documents

## Hierarchy of Documents 

**Policies**

**Processes**

**Procedures /**
** ****Work Instructions**

**“****what to do”**

- “**how** **it happens”**

- “**how** **to do it”** -  (**SOPs**)

## Policies

- The “WHAT TO DO”
- Statements of the organization's intent
- Framework for the organization’s Quality Manual

## Processes

- The “HOW IT HAPPENS”
- Describes the steps involved to carry out quality policies
- Easily represented in flow charts
- Involves a series of steps, usually occurring over a period of time

## Gen-Probe

**Gen-Probe**
**MTD test**

**No **
**request**

- Smear
- Report
- 24-36 h

- Report
- 5-60 days

**Negative**

- Final
- negative
- 90 days

- Final
- negative
- 60 days

- for smear positive

- Contamin
- 14-40 days

- Report
- 24-72
- hours

**Direct **
**susceptibility**
**plates**

- Report
- 21 days

**Special **
**request **

**Indirect susceptibilities**
**and biochemical ID**

**Bactec susceptibilities 5 drugs **

- 28 days

- 28 days

- 7 -14
- days

- 21 d
- + time to
- grow

- 1 -10

## Procedures / Work Instructions

- The “HOW TO DO IT”
- The step-by-step instructions for performing a single activity

## Slide 11

## Why Do Labs Need Documents?

- Policies  - communicate to customers
- Quality Manual for monitoring the total testing process
- Procedure manuals – consistent methods
- References  - available to share or access
- Required to meet formal laboratory standards

## Why do labs need documents?

- Verbal instructions often are:
- Not heard
- Misunderstood
- Quickly forgotten
- Ignored

## Standard Operating ProceduresCommon Elements:

- Title
- Purpose
- Procedure instructions
- Pre-analytic
- Analytic
- Post-analytic
- References
- Author
- Approval signature (s)

## Good Documents Are:

- Clear
- Concise
- User friendly

## 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”

## And Poorly Written Procedures

- Why use ten words when one will do?
- “The items hereinunder referenced in some cases fell excessively outside normal parameters.”
- “The procedures contained herin are applicable to all operations in the following departments within their functional ambit”

## Job Aid

## Slide 19

## Records

## 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

##  Examples:   Quality Assurance Records 

- Specimen log book, registers
- Laboratory workbooks/sheets
- Instrument printouts –maintenance records
- QC
- EQA / PT records
- Patient test reports

## Slide 23

## Other Examples:   Quality Assurance Records

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

## 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

## Test Report Contents

- 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

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

## Document / Record Control

## Document Control

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

## 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

## Documents of External Origin

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

## Implementation Steps

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

## Summary:  Document Preparation and Control Process

**Approval**

**Issue / **
** ****Distribution**

**Review**

**Revision**

**Preparation**

## Where will you keep your documents and records?

## 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

## Slide 35

## Slide 36

## Electronic Systems

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

## Factors Affecting Retention Times

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

## Common Problems

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

## And all the pieces will fall in place.

## “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

## A1

**A1**

## Problem Scenario

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

## Problem Scenario	

- Were all of the steps you needed to review the problem part of your current documentation system?
- Do you see how some of the records suggested here could help you find the source of the problem?
- Would you start keeping more records than you did before?