GLENMARIE BRANCH GUIDELINE FOR HANDLING 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 : 28 th July 2015 Date : 28 th July 2015
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 Page 1 of 13
RECORD OF AMENDMENTS Date Section Page No. Line No Description of changes Approved by: Name & Designation Page 2 of 13
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. 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. Page 3 of 13
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. Laboratory Manager MLT Courier Personnel 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 Page 4 of 13
D. EQUIPMENT a. Suitable refrigerator shall be used for the storage of specimens. The specimens shall be kept at 2 0 C to 8 0 C. 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. Page 5 of 13
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. Page 6 of 13
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 Page 7 of 13
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. Page 8 of 13
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. Page 9 of 13
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. Page 10 of 13
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 Page 11 of 13
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. Page 12 of 13
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. Page 13 of 13