GUIDELINES FOR HANDLING FOMEMA SPECIMEN...2015/07/28 · Page 2 of 13 FOMEMA SPECIMEN Document No....

GUIDELINE FOR HANDLING FOMEMA SPECIMEN

QUALITY PROCEDURE

QP2-OP02-02

MASTER COPY

Prepared by Approved by

Signature :……………………………... Signature :……………………………...

Name : Ong Keh Seen Name : DR. Lily Manorammah

A/P V.J.Samuel

Designation : Quality Manager Designation : Laboratory Director

Date : 28th

July 2015 Date : 28th

July 2015

GLENMARIE BRANCH

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Document No. QP2-OP02-02

B.P. CLINICAL LAB SDN. BHD. Level: 2

(Company No.: 152314-H) Issue No. 02

Revision No. 00

GUIDELINE FOR HANDLING Effective Date: 28th

July 2015

FOMEMA SPECIMEN

Guideline for Handling FOMEMA specimen Table of Contents

Contents A FACILITIES .................................................................................................................................................. 3

B. STAFF ......................................................................................................................................................... 4

C ORGANISATION/ SERVICES ....................................................................................................................... 4

D. EQUIPMENT .............................................................................................................................................. 5

E. PRE-ANALYTICAL ....................................................................................................................................... 5

F. SPECIMEN RECEPTION AND REGISTRY ..................................................................................................... 6

G. TRACEABILITY OF SPECIMENS .................................................................................................................. 7

H. SPECIMEN TUBES ..................................................................................................................................... 7

I REJECTION OF SPECIMENS ......................................................................................................................... 8

J. BARCODES .................................................................................................................................................. 8

K.METHODOLOGY ......................................................................................................................................... 9

L. REAGENT .................................................................................................................................................. 9

M. CONFIRMATORY TEST FOR APPEAL CASES ............................................................................................ 10

N. QUALITY ASSURANCE ............................................................................................................................. 10

O. POST ANALYTICAL .................................................................................................................................. 10

P. MONITORING OF RESULT TURNAROUND TIME ...................................................................................... 11

Q. RETENTION OF SPECIMENS .................................................................................................................... 11

R. HEALTH AND SAFETY .............................................................................................................................. 12

S. TRAINING AND CONTINUING MEDICAL EDUCATION (CME) .................................................................. 12

APPENDIX .................................................................................................................................................... 13

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FOMEMA SPECIMEN

RECORD OF AMENDMENTS

Date Section Page

No.

Line

No

Description of changes Approved by:

Name & Designation

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Minimum requirement:

1. Workbench for

sample reception,

sorting and

Centrifugation

2. Fridge for sample

storage (temperature

record)

3. Storage space for

reagents,

consumables

4. Hand washing

facilities

5. Waste disposal (

rubbish bin)

6. Space for recording

and documentation.




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FOMEMA SPECIMEN

Objective: The purpose of this procedure is to ensure that the assigned BP collecting centres and Panel laboratory

adhered to the Standard Operating Procedure (SOP)

REQUIREMENTS

A FACILITIES 1. The laboratory shall operate during the operational hours

2. Operational hours of the facility must be displayed in a signboard.

3. There should be designated area for handling specimens:-

a. Sorting and checking the specimens b. Centrifuging and aliquoting the specimens

c. Packing the specimens for transport to the main lab

d. Recording and administrative work area (table). 4. The Floor and bench tops should be of material which facilitates easy

cleaning. 5. The laboratory should have adequate hand washing facilities and toilet.

6. The laboratory should have adequate storage space for specimens, reagents, consumables and

others materials. 7. There should be facility for appropriate disposal of waste (clinical, non-clinical and sharps.)

8. The laboratory should well ventilated and have sufficient lightings.

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FOMEMA SPECIMEN

B. STAFF

1. The laboratory shall have a list of its staff and their roles and responsibilities.

2. The laboratory should have sufficient qualified staff to perform the tests and the

minimum qualification should be a diploma in Medical Laboratory Technology

or it equivalent.

3. The number of dispatch and administrative should commensurate with the workload of the lab.

4. The lab should collect specimens from allocated clinics on a regular basis. Prior written approval

from FOMEMA Sdn Bhd shall be obtained on any other form of arrangement.

5. Appropriate transport must be available for dispatch staff to collect the specimens from the

allocated clinics.

C. ORGANISATION/ SERVICES

The Organisation chart of the laboratory shall be available and displayed for inspection.

The services handbook and list of tests should be available in the laboratory.

The Flow Chart on processing of specimens should be available in the laboratory.

Refer Appendix 1: Process Flow for FOMEMA Test Request at Collection Centre

Laboratory

Manager

MLT

Courier Personnel

(despatch)

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FOMEMA SPECIMEN

D. EQUIPMENT

a. Suitable refrigerator shall be used for the storage of specimens. The specimens shall be kept at

20C

to 8

0C .

b. Monitor the temperature of fridge daily. Please keep manual records in the temperature record

form (appendix 14) and as IT records.

c. DO NOT KEEP FOOD, DRINK OR PHARMACEUTICALS in the

same fridge as the specimens

d. Use of expired specimen tubes is strictly prohibited.

e. Regular scheduled maintenance and calibration should be done for all equipment and records

maintained and shall be made available upon request

f. Operating and service manuals should be available for all equipment.

E. PRE-ANALYTICAL Specimen Collection

Before initiating collection of blood and urine Specimen, patient identity must be verified by the person.

For urine collection, a collector is assigned to monitor the urine collection process. Only conduct one

collection for one foreign worker at a time. Maintain personal control over each specimen throughout the

collection process. The Urine specimen should be immediately handed to the collector. The collector

shall reject any diluted urine, “detergent smell” urine, suspicious urine, contaminated urine directly and

instruct the worker to re-collect a fresh specimen.

a) Specimen shall be transported in appropriate containers and at appropriate temperatures from the

clinics to the facility and from the facility to the testing laboratory.

b) Transportation and Packaging

a. Specimen carrier Bag

A Proper biohazard bag must be used for specimen transportation.

Carrier bag used for transportation of specimens must be equipped with enough ice packs to

maintain the temperature inside the bag.

b. Packaging ( Triple packaging system)

Primary package - Clinical/biological samples should be placed in a sealed container, for

example a vacutainer or a specimen container.

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FOMEMA SPECIMEN

Secondary package – labelled, watertight, leak-proof container which would be sufficient to

contain all the liquid content if the primary container breaks. ( Biohazard bag)

Tertiary Package- A rigid sealed, secured container e.g.: Styrofoam box, dispatch bag

(Temperature controlled) to house the secondary package. (Refer Appendix 5 : proper and correct

ways of packaging the samples)

F. SPECIMEN RECEPTION AND REGISTRY Refer attached Registration guideline

The laboratory shall maintain a specimen register itemising

the following:

- Date of time of receipt of specimen

- Name of Foreign worker (eg: Rup Ronahama)

- Worker Code (eg : W8ERXXXXXX)

-Source of Specimen (registered doctor of FOMEMA)

-Name of despatch person

-Name of staff receiving specimen

The laboratory MUST NOT ACCEPT foreign workers urine and blood specimens for laboratory

investigations from unauthorised personnel claiming to represent clinics.

However, in the event that there is receipt of specimens from any other source, the name and

identity card number of the individual and the clinic from which the person is said to be

representing, shall be duly recorded and must forthwith inform FOMEMA.

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G. TRACEABILITY OF SPECIMENS

a. The laboratory must ensure the specimens are collected from the assigned clinics within twenty

four (24) hours from time of specimen collection.. b. The following records must be maintained :

Traceability from clinic to dispatch

Number of Samples

Clinic stamp

Date and Time received

Traceability from dispatch to laboratory

Signature of lab personnel / Person in charge of SR

Date and Time received

c. The Specimen collection record must be recorded and acknowledge by despatch and lab

personnel.Refer to attached appendix of FR3-PM04d.

d. Despatch shall acknowledge record and chop for clinics visited, check and record the total

number, types of specimen collected from clinics.

e. The lab personnel shall acknowledge signed and record the date and time of receiving samples

from despatch at the collecting centres.

f. The specimens registered at collecting centres, an Internal Transfer form (FR3-OP01a) will be

generated with the number and type of specimens received for each request indicated.

H. SPECIMEN TUBES

All tubes used for sample collection shall not be expired.

EDTA

Plain

Gel tube

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FOMEMA SPECIMEN

I REJECTION OF SPECIMENS a. The laboratory shall not accept and reject the following specimens:

b. Refer attached appendix of specimen rejection criteria and photos, specimen volume requirement,

and haemolysis guideline.

Unlabeled specimen

Sample without 2 patient identifier

Wrongly labeled specimens

Improperly labeled specimens

Hemolysis sample

Diluted specimen

Substituted specimen

Insufficient quantity of sample ( 3ml

Plain,2ml EDTA,30ml Urine)

Leakage of specimens

Usage of expired tubes

Usage of incorrect tube

c. Laboratory Manager/ Person in charge verified

the rejection and contact the requester for necessary advice and corrections.

d. The lab shall not proceed above and must contact the doctor for a repeat specimen. The

examining doctor required to recall the foreign worker and collect a repeat sample to fulfil the

above requirement.

e. All rejected specimens shall not be returned to the clinic and shall be kept in the laboratory or

collection center.

f. In the case of either on specimen (Blood or urine) being rejected, a new set of specimens shall be

requested from the clinic (blood and urine).

g. The laboratory or collection centre shall not proceed with any tests until the whole set of

specimens are received from the clinic.

h. Only the original FOMEMA Medical Examination Form (Laboratory„s copy) shall be returned to

the clinic when specimens are rejected. The Laboratory or collection centre shall retain a

photocopy of the FOMEMA Medical Examination Form for future reference.

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J. BARCODES

a. The laboratories are recommended to use barcode labels for all its specimens and secondary tubes

in order to ensure minimum human error in transmission.

b. A Laboratory number and a pre-printed barcode shall be assigned to each request form. Barcode

stickers with prefix E for EDTA, G for fluoride, U for urine and blank either for Plain or others

are pasted on every sample approximately 2cm away from the base of the tube.

Plain specimen EDTA specimen Urine Specimen

K.METHODOLOGY

Anti-HIV 1 & II Screening ( Architect CI8200,CMIA)

HbsAg ( Architect CI8200,CMIA)

Serum Beta-HCg ( Architect CI8200,CMIA)

ABO Grouping ( Antibody-Antigen Reaction)

Urine Pregnancy test (Hormone , Rapid Test Kit)

Morphine (Architect CI8200, Enzyme Immunoassay)

Level of detection for Morphine – 300 ng/ml

Cannabinoid (Architect CI8200, Enzyme Immunoassay)

Level of detection for Cannabinoids- 50 ng/ml

FEME ( Urinalysis Strip, Microscopic)

Syphilis TP ( Architect CI8200,CMIA)

VDRL ( manual method)

Malaria Parasite ( Abbott Cell Dye Ruby, Atypical Depolarization)

10 % of negative Slides and 100 % of positive slides should be sent to Vector Borne Disease Unit

of Ministry of Health State level for quality Check (Pahang/Sabah/Johor).

L. REAGENT a. All Reagents used shall stored in acceptable condition (not expired, not

deteriorate, stability maintained)

b. Must maintain a temperature record of all fridges used to store reagents.

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FOMEMA SPECIMEN

M. CONFIRMATORY TEST FOR APPEAL CASES - HIV test- Western Blot

- HbsAg confirmation test

- Urine Drugs ( Opiate and Cannabinoid confirmation test)

- Urine Pregnancy- Serum Beta HCG

- VDRL- TPHA test

A confirmatory test shall be conducted after obtaining approval from FOMEMA.

N. QUALITY ASSURANCE Laboratory shall follow Standard Operating procedure to ensure the laboratory delivers

reliable and valid test results.

Internal Quality Control Assessment ( IQA)

External Quality Assessment (EQA)

RCPA

CAP

IQC must be conducted prior testing patients samples

O. POST ANALYTICAL a. The laboratory shall attempts to automate all its analytical processes and transfer of results to the

laboratory information system and subsequent linkage to the FOMEMA on-line system to

minimise human error during transmission of result. Refer appendix 15 guideline for result

transmission.

b. The laboratory must key in the date of receipt of specimens in the laboratory.

c. The lab must carry out the test within 24 hours and transmit the results within 48 hours of receipt

of specimens.

d. Facilities must be available for all reports to be transmitted electronically to FOMEMA. A

hardcopy of each report must be sent to clinic as soon as possible the softcopy is to be submitted

to FOMEMA on a monthly basis.

e. The laboratory is responsible for the accuracy of the test results before transmission of the

laboratory results

f. All results shall be checked and verified by a second person before transmission to FOMEMA.

g. Every staff entering results into the laboratory system shall have individual username and

passwords.

h. Any manipulation of results should be traceable.

i. All records must be treated with strict confidentiality.

j. Records of specimens and results should be kept for at least two years.

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FOMEMA SPECIMEN

P. MONITORING OF RESULT TURNAROUND TIME

a. Result TAT shall be monitored to ensure lab results are delivered in timely manner and meet

stipulated TAT parameters. Monthly TAT reports shall be generated from the LIS system to

monitor on result TAT.

b. The data shall be analyse monthly by calculating the percentage of compliance :

Total number of FOMEMA test reported within stipulated TAT

Total number of FOMEMA test requested

c. Laboratory shall identify the root cause on delay TAT and taken corrective action to improve the

turnaround time.

d. Root cause analysis shall be done to identify the contributing factors.

e. Action shall be taken to improve the turnaround time.

Q. RETENTION OF SPECIMENS Laboratory shall keep specimens at appropriate temperature according to the following retention Period.

Assay Normal / Negative /

Non-Reactive Cases

Abnormal / Positive /

Reactive Cases

HIV 7 days 8 weeks

HBsAg 7 days 8 weeks

Malaria Parasite (Slides) 2 weeks 8 weeks

VDRL 7 days 8 weeks

Urine Drug Test 3 days 8 weeks

Urine Pregnancy Test 3 days 8 weeks

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FOMEMA SPECIMEN

R. HEALTH AND SAFETY

a. The staff should have easy access to the Laboratory Safety Manual and laboratory hazards

(MSDS) . Refer attached guideline for hazardous and chemical spill handling.

b. The lab should be regularly cleaned and disinfected.

c. Hand Hygiene facilities must be available and hand washing should be perform by staffs.

Refer attached Guideline for Hand washing

S. TRAINING AND CONTINUING MEDICAL EDUCATION (CME)

a. Record of all training programs and on-going continuing medical education (C.M.E) undertaken

for all technical staff of laboratory should be available.

b. New staff should be given the opportunity to undergo a minimum of one month orientation

program before being posted a specific section.

c. Opportunities should be made available for the staff to attend training courses, seminar and

conferences on a regular basis as part of continuing medical education and continuous

improvement.

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APPENDIX

Appendix 1: Process Flow for FOMEMA Test Request at Collection Centre

Appendix 2: Photo of Specimen volume requirement

Appendix 3: Photo of Specimen rejection

Appendix 4 : Rejection criteria

Appendix 5: Guideline for specimen packaging and transportation

Appendix 6: Guideline for hazardous and chemical handling

Appendix 7: Guideline for haemolysis

Appendix 8 : Guideline for Hand washing

Appendix 9: Guideline for Registration

Appendix 10: Specimen collection form format

Appendix 11: Specimen Rejection Record

Appendix 12 : Sample Rejection form

Appendix 13: IT form format

Appendix 14 : Fridge Temperature Record Form

Appendix 15 : Guideline for FOMEMA‟s result transmission

Appendix 16 : Process Flow for FOMEMA tests processing and Result TAT monitoring.

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