Documents and Records in Organization and Planning of a Medical Laboratory

Reception :

This is the part of the laboratory which is the link between the patient and the laboratory. It is the

first point of patient care services of the laboratory. Registration of patients/samples take place at

the reception.

This registration involves receiving requisition and other office formality. For example, in a

blood bank pretransfusion testing of samples, issue of crossmatched blood or products ,donor

recruitment, selection, screening is done.

Proper documentation and recording is must however be ensured in a reception.

Reagents/Consumable storage is another important facility required in a laboratory.

- A store must not be far from the laboratory

- It must be managed by a store keeper and a laboratory quality control officer.

- Reagents release should be first come first go and also based on their expiry dates.

- Proper documentation is also very important in a laboratory store.

USE OF DOCUMENTS AND RECORD IN ORGANIZATION / PLANNING OF A

MEDICAL LABORATORY.

DOCUMENTS provide written information about policies, processes and procedures. It

includes all the written policies, processes and proceduresof the laboratory. In order to develop

laboratory documents, it is important to understand each of these elements and how they relate to

each other.

1. Policies: A policy is “a documented statement of overall intentions and direction defined

by those in the organization and endorsed by management”.

and general way;include a statement of the organizational mission, goals and purpose;serve as

the framework for the quality system, and should always be specified in the quality manual.

Although there are national policies that affect laboratory operations,each laboratory will

develop policies specific to its own operations.

2. Processes are the steps involved in carrying out quality policies. ISO 9000 [4.3.1]

defines a process as a “set of interrelated or interacting activities that transform inputs into

outputs”.

Some examples of laboratory inputs include test requests, samples, and requests for information.

Examples of laboratory outputs include laboratory data and reports of results. Using these

examples, one process might be how to transform a test request (input) into a test result (output).

Another way of thinking about a process is as “how it happens”.Processes can generally be

represented in a flow chart, with a series of steps to indicate how events should occur over a

period of time.

3. Procedures are the specific activities of a process (ISO 9000 [3.4]). Procedures are very

familiar to laboratorians—a procedure is easily described as the performance of a test.

A procedure tells“how to do it”, and shows the step-by-step instructions that laboratory staff

should meticulously follow for each activity.

The term standard operating procedure (SOP) is often used to indicate these detailed instructions

on how to do it.

Characteristics of documents.

i. They communicate information to all persons who need it including laboratory staff,

users and laboratory management personnel;

iii. They must be changed when a policy, process or procedure changes;

iv. There must be established formats for recording and reporting information by the use of

standardized forms—once the forms are used to record information, they become records.

Some examples of documents include a quality manual, standard operating procedures and

job aids.

RECORDS are the collected information produced by the laboratory in the process of

performing and reporting a laboratory test.

Characteristics of records

i. Should be easily retrieved or accessed;

ii. They should contain information that is permanent, and does not require updating.

Many kinds of records are produced in a laboratory. Some examples include:

sample logbook, registers, laboratory workbooks or worksheets, instrument printouts—

maintenance records, quality control data, external quality assessment or proficiency testing

records, patient test reports, personnel records, results of internal and external audits, continuous

improvement projects, incident reports, user surveys and customer feedback, critical

communications (e.g. letters from regulatory agencies, government or administrative offices

within the health care system).

A method to record any information that must be kept should be established. The following type

of records could be easily forgotten.

Information on the management and handling of rejected samples.

Data needed on any sample referred to another laboratory; to include when the sample was

transported, where it was sent and when the report was issued.
The sample should be able to be tracked throughout the referral process.

The management of documents and records is one of the 12 essential elements of the

quality system which are ;

1. Organization,

2. Personnel,

3. Equipment,

4. Purchasing and inventory,

5. Process control,

6. Information management,

7. Occurrence management,

8. Assessment,

9. Facilities and safety,

10. Customer service,

11. Process improvement,

12. Documents and records.

The management system addresses both use and maintenance of documents and records.

A major goal of keeping documents and records is to find information whenever it is needed.

1. JOB AIDS or work instructions are shortened versions of SOPs that can be pasted at the

bench for easy reference on performing a procedure. They are meant to supplement, not

replace, the SOPs.

2. THE QUALITY MANUAL

The quality manual is a document that describes the quality management system

of an organization (ISO 15189). Its purpose is to:

 serve as a framework for meeting quality system requirements

 convey managerial commitment to the quality system.

As the quality manual is an important guide or roadmap, all persons in the laboratory should be

instructed on its use and application. The manual must be kept up to date, and responsibility for

the updating should be assigned.

The quality manual should state policies for each of the twelve essentials of the

quality system. It also describe how all the related quality processes occur, and

make note of all versions of procedures (SOPs) and where they are located.

The key points to remember about the quality manual are:

i. There is only one official version

ii. The quality manual is never finished—it is always being improved

iii. It should be read, understood and accepted by everyone

iv. It should be written in clear, easily understood language

v. The quality manual should be dated and signed by the management.

Developing a quality manual is a very big job, but it is also very rewarding

and useful for the laboratory.

3. Standard operating procedures (SOPs)

SOPs are documents that contain written step-by-step instructions that laboratory staff should

meticulously follow when performing a procedure.

A laboratory will have many SOPs, one for each procedure conducted in the laboratory.

Written SOPs ensure the following qualities.

can be expected from all staff. Consistency enables people who use laboratory results to observe

changes in a particular patient’s results over time. If different laboratories use the same SOPs,

comparisons of their results can be made; it should be emphasized that all laboratory staff must

follow the SOPs exactly.

Accuracy—following written procedures helps laboratory staff produce more

accurate results than relying on memory alone because they will not forget

steps in the process.

Quality—consistent (reliable) and accurate results are primary goals of the

laboratory, and could be considered as the definition of quality in the laboratory.

A good SOP should be:

detailed, clear and concise, so that staff not normally performing the procedure will be able to

do so by following the SOP—all necessary details (e.g. ambient temperature requirements and

precise timing instructions) should be included;

easily understood by new personnel or students in training;

reviewed and approved by the laboratory management—approval is indicated

by a signature and a date (this is important to ensure that the procedures being

used for testing in the laboratory are those that are up to date and appropriate);

updated on a regular basis.It is a good idea to standardize the formats of SOPs so staff can

easily recognize the flow of the information.

Headers are a very important part of the format.

Content of SOPs

SOPs should include the following information:

-purpose—include information about the test (why it is important, how it is used,

and whether it is intended for screening, to diagnose, or to follow treatment

and if it is to be used for public health surveillance);

-instructions—detailed information for the entire testing process, including pre-

examination, examination and post-examination phases;

-name of the person preparing the SOP;

-signatures of approving officials and dates of approval—it is necessary to follow

the laboratory’s quality policy and regulatory requirements.