Dr.T.V.Rao MD

SPECIMEN MANAGEMENT IN

DIAGNOSTIC MICROBIOLOGY

DR.T.V.RAO MD 1

NABH STANDARDS FOR HOSPITALS

• The programme is made to fulfill major

objectives of the AAC.7 Clause C

on Policies and procedures guide

collection, identification, handling safe

transportation, processing and disposal of

Microbiology Specimens

DR.T.V.RAO MD 2

HOW DO WE ACHIEVE EXCELLENT

PERFORMANCE IN THE LABORATORY?

Dependent on quality

systems

DR.T.V.RAO MD 3

• The specimens are

collected and handled may

directly affect the outcome

of microbiological analysis,

appropriate specimen

management is critical to

ensuring laboratory

effectiveness and an

acceptable turnaround

time. Specific guidelines on

specimen collection are

necessary for optimal use

of microbiology services.

WHY SPECIMEN MANAGEMENT IS A

IMPORTANT FACTOR

DR.T.V.RAO MD 4

• Microbiology

laboratory results

that are accurate,

significant, and

clinically relevant

depend almost

entirely on the

specimen

management

process

ACCURATE RESULTS DEPENDENT ON

QUALITY MANAGEMENT OF SPECIMENS

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The Quality Assurance Cycle

•Data and Lab

Management

•Safety

•Customer

Service

Patient/Client Prep

Sample Collection

Sample Receipt

and Accessioning

Sample Transport Quality Control

Record Keeping

Reporting Personnel Competency

Test Evaluations

Testing

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• Support from the top level

of the organization

• Involve all persons in the

organization

• Conform with any

regulatory requirements

ORGANIZATION

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• Request forms

• Specimen - identification throughout process

• collection (including patient preparation)

• receipt and accessioning

• rejection criteria

• processing

• transport

• storage

PROCESS CONTROL:

SPECIMEN MANAGEMENT

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The result of any laboratory test is only as good as the sample

received in the laboratory

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• Specimen Collection

• Specimen Transport

• Specimen Handling

• Specimen Referral

• Specimen Storage

• Specimen Disposal

SPECIMEN MANAGEMENT

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Purchasing

& Inventory

Assessment Occurrence

Management

Information

Management

Process

Improvement

Customer

Service

Facilities &

Safety

THE QUALITY SYSTEM

Organization Personnel Equipment

Documents

& Records

Process

Control

(QC & EQA) &

Specimen

Management

DR.T.V.RAO MD 11

• Sample management strategies

vary among organizations.

Overall, the goal of an SMS is for

the organization to leverage

assets (samples) for future

research, eliminate costly

development time, ensure

informed consents are properly

associated with the appropriate

samples, and build an

organization-wide sample library

to pull samples with multiple data

points

WHAT IS A SAMPLE/SPECIMEN

MANAGEMENT STRATEGY (SMS)?

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IMPACT OF SPECIMEN MANAGEMENT

ON PATIENT CARE

• Essential to accurate laboratory diagnosis

• Directly affects patient care and patient outcome

• Influences therapeutic decisions

• Impacts patient length of stay, hospital costs, and

laboratory costs

• Influences laboratory efficiency

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SPECIMEN COLLECTION:

LABORATORY RESPONSIBILITIES

• Verify completeness of test request

• Verify integrity of the specimen

• Determine adequacy of specimen

• Appropriately labeled, legible identification

• Determine if appropriate specimen was submitted for requested test

• Identifier of the collector, e.g., phlebotomist, patient

• Enforce procedures for handling sub-optimum specimens

• Specimen rejection criteria

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SPECIMEN COLLECTION PROCEDURES

• Should include instructions for: • Positively identifying the patient before

collecting a specimen • Required specimen for each requested test • Preparation of patient • Type of collection container, required volume,

timing • Preservation of specimen, e.g., transport media • Proper specimen labeling • Special handling instructions, e.g., refrigeration

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SWABS FOR SPECIMEN COLLECTION

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• Bacteria, aerobic - cotton, Dacron, or alginate is usually

acceptable

• Bacteria, anaerobe - tissue or aspirate is recommended. Resist

placing swabs into Surgery. Use only anaerobe transport.

• Chlamydia - Dacron or alginate but not cotton. Cytobrush is

specimen of choice. No wooden shafts

• Fungi - swabs not recommended

• Viruses - cotton or Dacron but not alginate. No wooden shafts

or charcoal.

LABORATORY HANDBOOK

• Compilation of documents that must be made available to all specimen collection areas

• Must be understood by all laboratory staff

• Includes:

• Name and address of laboratory

• Contact names and telephone numbers

• Hours of operation

• List of available tests

• Specimen collection procedures

• Specimen transport procedures

• Expected turn around times (TAT)

• How stat requests are handled

• May be referenced in the Quality Manual

DR.T.V.RAO MD 17

• This occurs mainly because

laboratorians either are

afraid or have no support to

say “no” to a physician or

to reject the specimen

that was inappropriately

selected, collected, or

transported. This indicates

that there is little support

for promoting quality in

microbiology and that

someone other than the

microbiology-

ACCEPTING EVERY SPECIMEN ???.

DR.T.V.RAO MD 18

• A swab is not the collection device of

choice for many specimens, and

for some specimens special

swabs will be necessary. The

laboratory must receive a

specimen that is representative

of the disease process.

Specimens submitted for the

diagnosis of otitis media should

not be sent on swabs since the

flora on the swab will likely be

that of the external ear canal.

The specimen of choice is an

aspirate from a tympanocentesis

ACCEPTING EVERY TRANSPORT

DEVICE.

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SITES OF INFECTION WHERE THE SPECIMEN IS

LIKELY TO BECOME CONTAMINATED DURING

COLLECTION

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• Middle ear ……………. External ear canal

• Lower respiratory tract. Oropharynx

• Nasal sinus…………….Nasopharynx

• Bladder……………..… Urethra and perineum

• Endometrium…………. Vagina

• Superficial wounds…… Skin and membranes

• Fistulae………………… GI tract

SPECIMEN TRANSPORT

• Train personnel in appropriate safety and packaging procedures

• Package and preserve specimens appropriately

• Transport specimens at appropriate temperature

• Determine acceptable transport time

• Determine mode of transport • Courier, ambulance, clinic/lab staff

• Adhere to the International Air Transport Association (IATA) regulations

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• Establish policy

• What should be stored?

• Determine retention time

• Determine storage location

• Consider ease of access

• Assure proper storage conditions

• Indexing of specimens

• By day of receipt or accession number

SPECIMEN STORAGE

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SPECIMEN STORAGE

Serum Banks:

• Establish tracking

procedures

• Encourage use of

information technology

• Maintain an organized,

accessible storage system

• Monitor freeze/thaw cycles

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SPECIMEN REJECTION CRITERIA:

• Unlabeled specimen

• Insufficient patient information

• Hemolyzed specimen

• Wrong tube drawn

• Wrong specimen submitted

• Inadequate volume for the amount of preservative

• Insufficient quantity

• Prolonged transport

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• Specimen management

manual - spend the time to write

what you really need; then follow

it!

• QC policy - remember,

specimens can be out of control.

You should never report out-of-

control results!

• References - document your

position!

• Read-Read-Read! - budget time

to keep up!

BE PREPARED TO SAY “NO”

(PROFESSIONALLY)

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• Handle all specimens as if

infectious

• Use tracking system for all

specimens:

• Accession / logging process

• Confirm actual receipt of

specimens

• Date and time of specimen

receipt

• Track aliquots – traceable to

the original sample

SPECIMEN HANDLING

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SPECIMEN HANDLING

• Establish procedures for handling:

• Stat / urgent requests

• Delayed testing, e.g., storage, separation of

serum/plasma from cells

• Leaking containers

• Contaminated forms

• Preservation of specimens

DR.T.V.RAO MD 27

• Providing appropriate

support in the

preanalytical, analytical,

and postanalytical

phases of the

laboratory testing

process in microbiology

requires working only

with appropriate

specimens

WORKING WITH IDEAL SAMPLE ????

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• Patient Identification

• Phlebotomy Technique

• Test Collection Procedures

• Specimen Transport

• Specimen Processing

TYPES OF COLLECTION ERRORS

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BLOOD SPECIMEN TRANSPORT

ERRORS

• Transport of blood specimens in the proper manner after collection ensures the quality of the sample

• Timing

• Some specimens must be transported immediately

after collection, for example Arterial Blood Gases.

• Specimens for serum or plasma chemistry testing should be centrifuged and separated within two hours

TRANSPORT ERRORS

• Temperature • Specimens must be transported at the appropriate temperature for the required test

• On ice—ABGs, Ammonia

• Warmed --98.6 degrees (37 C), cryoglobulins

• Avoid temperature extremes if transported from via vehicle from other collection site

• Transport Container • Some samples need to be protected from light, for example,

bilirubin

• Transport in leak-proof plastic bags in lockable rigid containers

• Covers:

• Packaging

• Labelling Packages

• Packing Instructions

• Documentation

• Training

• Are updated annually by

IATA

THE DANGEROUS GOODS

REGULATIONS

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SPECIMEN REFERRAL • Record:

• Tests / specimens referred

• Date of referral

• Name of person referring test

• Monitor / Track, and Record:

• Turnaround time

• Results delivery (from referral lab, to requestor)

• Problems with referral

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SPECIMEN DISPOSAL

• Develop policy for disposal of medical waste

• Establish and follow disinfection procedures

• Comply with local regulations

• Include policy of disposal of rejected specimens

• Appoint someone with oversight responsibilities

• Establish a schedule to review all stored

specimens

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• Managing incoming and outgoing information

• Standardization of information capture

• Privacy and confidentiality of patient information

• Competency in relevant computer skills

• Word processing

• Spreadsheet

• Database

INFORMATION MANAGEMENT

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• IMS is an compliant system that

performs integrated control and

operation system, from order

receipt entry to report writing.

With the use of computer

networks, it deals with a large

number of samples in a speedy

and precise manner. It also

supports e-mail distribution to

customers and realizes customer

request with higher satisfaction

through appropriate delivery

management system.

LABORATORY INFORMATION MANAGEMENT

SYSTEM ( LIMS) AND COMPUTER SYSTEM

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• Remember good laboratory practice

• Patients first!

• Train all personnel responsible for collecting, handling, storage, transport of specimens

• Monitor rejection log

• Routinely communicate with customers

• Update handbook, procedures when methods change

SUMMARY: AVOIDING PITFALLS

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ERROR PREVENTION

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• Phlebotomy Education

• Phlebotomists should have completed a standard academic course in phlebotomy and undergo thorough on-the-job training under the supervision of a senior phlebotomist

• Continuing Education

• Phlebotomists should participate in regular educational competency assessments (written and observational)

• Professional Licensure

• Phlebotomy Staffing

• Adequate staffing to maintain collection standards • Technology

• Use of barcode scanners for patient identification

The process of dealing

with laboratory

problems and errors as

they occur

• Perform in a timely

manner

• Provide information to

those affected by the

problem or error

OCCURRENCE MANAGEMENT

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• Collect information

about systematic

problems

• Establish a process to

detect all problems

• Analyze the problem,

take corrective action

• Keep records

OCCURRENCE MANAGEMENT:

HOW?

DR.T.V.RAO MD 40

• We are responsible for

all phases of the testing

cycle

• Our Job Is To Educate

Clinicians Using Our

Services

• In pre analytic phase of

testing cycle: selection,

collection and transport

WE MICROBIOLOGISTS ARE RESPONSIBLE

MAJOR ISSUES ………..

DR.T.V.RAO MD 41

IMPACT OF SPECIMEN MANAGEMENT

ON PATIENT CARE

• Key to accurate laboratory diagnosis

• Directly affects patient care and patient outcome

• Influences therapeutic decisions

• Impacts hospital infection control

• Impacts patient length of stay, hospital costs, and

laboratory costs

• Influences laboratory efficiency

• EVERYONE IN THE

LABORATORY!

• Laboratory

management must

commit to meeting

quality needs

• Laboratory personnel

must follow all quality

assurance procedures

WHO IS RESPONSIBLE FOR

QUALITY?

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• When errors occur at any

point in this specimen

management process,

regardless of who might be

responsible for the error,

the result can be a

negative outcome for the

patient, such as

misdiagnosis, extended

length of stay and/or

inappropriate therapy

CONSEQUENCES OF LABORATORY ERRORS

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• The microbiology laboratory

needs the support of its client

physicians, not just that of

laboratory management, to

optimize the information coming

from it. Laboratorians must be

charged with the critical task of

evaluating specimen quality and

this report must be transmitted to

the submitting physician in order

for an accurate interpretation of

specimen results to be

accomplished

LABORATORIES NEED THE SUPPORT OF

PHYSICIANS FOR A GREATR SUCCESS

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MOTIVATION TO SAY “NO”

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• Good laboratory practice - patients first!

• Following the law - CLIA „88

• 493.1211 - The procedure manual must include

requirements for specimen collection and

processing, and criteria for rejection.

• 493.1109 - Must indicate on the report any

information regarding the condition and disposition

of specimens that do not not meet the laboratory

criteria for acceptability.

SPECIMEN DISPOSAL IMPORTANT PART

OF SPECIMEN MANAGEMENT

BIOSAFETY PRECAUTION

• All the

Technical staff should follow the Universal and other Biosafety Precautions while

handling and Disposing the Microbiology Specimens

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SOURCES OF LABORATORY QA

GUIDANCE AND INFORMATION

• World Health Organization (WHO)

• International Organization for Standardization (ISO)

• NCCLS

• CDC guidelines

• Professional & accrediting organizations

• National standards & regulations

DR.T.V.RAO MD 49

PROGRAMME CREATED BY DR.T.V.RAO MD

FOR LABORATORY PERSONAL IN THE

DEVELOPING WORLD

Email

doctortvrao@gmail.com

DR.T.V.RAO MD 50