KAN TECHNICAL NOTES ON MEDICAL LABORATORY IN THE FIELD OF CLINICAL CHEMISTRY. Issue Number: 3 April 2016

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1 \\\ 11 1"/'1,\\ \ I fl1... " ~/...,. ~,......//,. '~;:. Vi WC MffA _ KAN... ~:f Komite Akreditasi Nasional ~...,./. ~ ;:.._-.' '1/ /'"""'\ :\'' '''"I"''' KAN-TN-LM 01 KAN TECHNICAL NOTES ON MEDICAL LABORATORY IN THE FIELD OF CLINICAL CHEMISTRY Issue Number: 3 April 2016 Komite Akreditasi Nasional National Accreditation Body of Indonesia Gedung I BPPT Lt. 14 JI. M.H. Thamrin No. 8, Kebon Siri h, Jakarta Indonesia Tel. : Fax. : Website : laboratorium@bsn.qo.id; labmedik kan@yahoo.com :

2 -KAN-TN-LM 01 Issue Number: 3 7 April 2016 APPROVAL SHEET Reviewed by ~, Quality Manager of National Accreditation Committee of Indonesia (KAN) Approved by : ~ J, 7 Director of National Accreditation Committee of Indonesia (KAN)

3 - KAN-TN-LM 01 Issue Number: 3 7 April 2016 LIST OF AMENDMENT No. Date Number Brief Description of Changes Revision Revised Number Clause 2 Clause 3 Clause 2 was revised as a whole Clause 3: "Accommodation And Environmental Conditions" was changed to " Reagents And Standard Solution" 1 January 2008 Om itting Clause 5.1 to 5.3, 5 (b), 5 (d), 1 Clause 5 5 (e}, 5 (f) point 3-6 and 8, 5 (h) - 5 (k), and 5 (m) 2 7 April 2016 Clause April 2016 Clause 1 a 4 7 April 2016 Clause 1 b Clause 6: "Reagents And Reference Materials" Was Changed To "Reference Materials And Working Reference Material" ldentificatio n document Identification document changed to KAN-R-LM KAN-TN-LM Replace "SNI ISO 15189:2009 into "SNI ISO 15189:2012" Replace "...., as in a hospital laboratory including the area of pathology that is generally concerned with analysis of bodily fluids." into "..., examined in a medical laboratory from materials derived from the human body for the purpose of providing information for the diagnosis, prevention and treatment of disease in, or assessment of the health of human beings." - Delete "... physiologically significant.." and "... tissue.. " - Add "... faeces.. " - Replace ".... with application to the 5 7 April 2016 Clause 1 c diagnosis or therapy of disease. 1 That are taken to include:" into ".. and other material derived from the human body and include:" - Detailed classification for common clinical chemistry tests (i until iv) ii

4 -KAN-TN-LM 01 Issue Number: 3 7 April 2016 No. Date 6 7 April 2016 Number Revised Clause 2 Brief Description of Changes Add "a A competent and experienced (for at least two years) medical technologist should be appointed as supervisor of the clinical chemistry department." Revision Number 7 7 April 2016 Clause 2 a Replace "a Technical Manager, Laboratory Supervisors and chem ical laboratory analysis shall possess a basic education in chemistry vocation or a related science." into "b Technical manager and supervisor shall possess a basic education in diploma of medical laboratory analyst. " 8 7 April 2016 Clause 2 b Replace "A clinical pathologist is a physician, a pharmacist or a veterinarian responsible for the interpretation data derived from body flu ids such as blood, urine, and tissue aspirates. clinical pathologist shall works in close collaboration with medical technologists." into "c A clinical pathologist is a physician with a degree of clinical pathologist and has the competency and the authority to manage a medical laboratory, validate, interpret and expertise data from the examination specimen derived from of human body such as blood, urine, faeces, other body fluids and other material derived from the human body. Clinical pathologist shall works in close collaboration with medical technologists." 9 7 April 2016 Clause 2 c Delete ".. such as medical technologists." April 2016 Clause 2 f Add "g... Employment training should cover more than job tasks alone, because staff has additional responsibilities in the areas, ethics, and quality." 11 7 April 2016 Add "k Clinical pathologist I medical doctor should be appointed to give consultation and expertise to patients when needed." iii

5 No. Date Number Brief Description of Changes Revision Revised Number Delete ".. and in sound condition so 12 7 April 2016 Clause 3 f there are no tripping hazards." April 2016 Clause 3 g Delete "g" 1 Replace "h Sample receiving and storage is conducted in designated areas which are separate from the main part of the laboratory." into "g 14 7 April 2016 Clause 3 h Sample receiving is conducted in 1 designated areas which are separate from the main part of the laboratory. Sample was stored in place that meets the requirements." 15 7 April 2016 Add clause 3 h until 3 m 1 Replace "EXAMINATION 16 7 April 2016 Clause 4 PROCEDURES" into "PRE- 1 ANALYTICAL" 17 7 April April 2016 Clause April 2016 Clause 5 m - Change "4 EXAMINATION PROCEDURES", "5 EQUIPMENT AND MEASUREMENT TRACEABILITY", and "6 REAGENTS AND REFERENCE Clause 4, 5, MATERIALS" as part of "5 and 6 ANALYTICAL PROCEDURES" 1 - Content of the examination procedures is more structured based on SNI ISO 15189:2012, i.e. validation method, verification process, etc. Delete "5 I Laboratory shall have of ph standards at least two buffer to cover the range of ph needed in the tests methods for ph meter" Change "5 m Laboratory shall checked and recorded regularly of temperatures for Ovens, Refrigerators, Water baths, that used in the tests methods" into "5.2.4 I Laboratory shall checked and recorded regularly of temperatures for freezer, refrigerators, water baths, that is used in test methods and humidity value of hygrometer, that is used in work area." 1 1 iv

6 -KAN-TN-LM 01 Issue Number: 3 7 April 2016 No Date 7 April 2016 Number Revised 7 April 2016 I Clause 6 f 7 April 2016 I Clause 6 g 7 April 2016 I Clause 7 7 April April 2016 I Clause Brief Description of Changes Add "A quality check and water treament system maintenance should be done." Change "6 f Distilled or de-ionized water systems are monitored for conductivity and total chlorine periodically. Heavy metals analysis, water quality test and use test are performed annually on the water systems." into "5.3.5 Distilled or deionized water systems are monitored for conductivity and microbial contain periodically." Change "6 g Chemical, standards and reference materials and cultures are stored separately from samples." into "5.3.6 Reagents, solutions, controls, calibrators and standards are stored separately from samples." Add "6 a The chemistry laboratory has a written quality management and quality control (QM/QC) Program. ii i The program must ensure quality throughout the pre-analytic, analytic, and post-analytic (patient identification, specimen collection, preparation and preservation, specimen identification, transportation, processing and timely result reporting). The program must be capable of detecting problem in the laboratory's systems, and identifying opportunities for system improvement. The laboratory must be able to develop plans of corrective/preventive action based on data from its QM system. " Add "6 d There is documentation of quality control corrective action when control results exceed defined acceptability limits. " 7 I Delete: Revision Number v

7 No. Date Number Brief Description of Changes Revision Revised Number part 3 a In applying the criteria for measurement traceability, not all items of equipment used need to be calibrated April April April 2016 Clause 7 part 4 Only those items of equipment having a significant effect on the accuracy or validity of the results need to be calibrated. Add "6 h Whenever appropriate laboratory should establish uncertainty of measurement of the method used in the laboratory." Change Clause 7 part 4 into Clause 9 1 Change "i iv... ISO/IEC Guide 43-1 :,, Clause into "... ISO/IEC part 5 d 17043: ,, April 2016 Delete "7 5 e Accuracy and precision control charts are used to determine if Clause 7 the measurement system process is in part 5 e control and whether the results generated by the measurement system are acceptable." 30 7 April 2016 Add "7 POST ANALYTICAL" April 2016 Add "8 PATIENT SAFETY" 1 1 vi

8 - KAN-TN-LM 01 Issue Number: 3 7 April 2016 KAN TECHNICAL NOTES ON MEDICAL LABORATORY IN THE FIELD OF CLINICAL CHEMISTRY 1 INTRODUCTION a This technical notes are an interpretation of the general requirements of SNI ISO 15189:2012 and those technical notes of accreditation applicable to a clinical chemistry field, testing technology, type of test, or specific test, as an extra information to the already generally stated requirements in each of the clauses SNI ISO 15189:2012. b Clinical chemistry or clinical biochemistry or chemical pathology is the chemistry of human health and disease, chemistry in connection with the management of patients, examined in a medical laboratory from materials derived from the human body for the purpose of providing information for the diagnosis, prevention and treatment of disease in, or assessment of the health of human beings. c Clinical chemistry tests are demonstrating the presence of substances in the blood, urine, faeces, other body fluids and other material derived from the human body and include: Cardiac marker e.g :CK, CKMB, Troponin, LDH, Hs CRP. ii Liver Function test e.g: AST, ALT, GGT, ALP, Bilirubin total, Bilirubin Direct, CHE. iii Lipid profile e.g: Total Cholesterol, Triglyceride, LDL, HDL, Lp(a), Apo A, Apo B, sd-ldl. iv Renal functions e.g: Urea/BUN (Blood Urea Nitrogen), Creatinin, Uric acid, Cystatin C. v Metabolic disease e.g: Glucose, HbA1c, ketone bodies. vi Proteins e.g albumin, globulin. vii Blood gas analysis, including CO-oximetry, ph, PC02, P02, 02. saturation and other analytes performed on a blood gas analyser, etc. viii Electrolyte: Ca, Ca++, Na, K. ix Trace elements and Mineral: Mg, Ca, Ca++, Fe, Phosphate. x Therapeutic Drugs Monitoring e.g digoxin, phenitoin, etc. 1 of 12

9 xi Toxicology and Drug of Abuse e.g amphetamine, barbiturat, cocain, etc. xii Vitamin and specific protein assays: Vitam in 812, Folate, transferin,ferritin etc. xiii Faeces examination e.g faecal occult blood, the rest of digestion, etc. xiv Calculi. d In some cases the applications will be quite limited, applying only to a given test method or to a group of test methods. In other cases the applications may be quite broad, applying to the testing of various products or items or to entire fields of testing. 2 PERSONNEL a A competent and experienced (for at least two years) medical technologist should be appointed as supervisor of the clinical chemistry department. b Technical manager and supervisor shall possess a basic education in diploma of medical laboratory analyst. c A clinical pathologist is a physician with a degree of clinical pathologist and has the competency and the authority to manage a medical laboratory, validate, interpret and expertise data from the examination specimen derived from of human body such as blood, urine, faeces, other body fluids and other material derived from the human body. Clinical pathologist shall works in close collaboration with medical technologists. d Laboratory analysis I examination must be carried out by, or under the supervision of a qualified, experienced and competent analyst. e Laboratory management shall ensure that all laboratory personnel have the knowledge, skills, and abilities based on education, experience, demonstrated skills, and training to perform their duties. f Laboratory shall establish and define an internal training program and ensure the competency of all laboratory personnel. g Laboratory shall have training procedure that used to ensure that training has taken place with each employee for procedures and methods that the employee performs. The procedure applies to on-the-job training, in-house training and newhire training. Employment training should cover more than job tasks alone, because staff has additional responsibilities in the areas, ethics, and quality. 2of12

10 h The training is verified and documented. The training procedure is applicable to new employees, for the introduction of new procedures and methods, for retraining of employees, and for re-verification of employee performance. The laboratory shall maintain an up-to-date record of the training that each member of staff has received. Before starting any work related duties, the employee should be familiar with all work related documents. These documents include procedures, work instructions, applicable manuals and regulations. k Clinical pathologist I medical doctor should be appointed to give consultation and expertise to patients when needed. 3 ACCOMODATION AND ENVIRONMENTAL CONDITIONS a The laboratories are designed to provide space, engineering controls, and proper environmental conditions for optimal sample and reagent storage, sample handling, and analysis, in accordance with general laboratory practices. b Laboratory facilities meet the required environmental conditions, including any needed separation of work areas to ensure that analyses will not be adversely affected within resources provided. c Laboratory storage areas provide proper storage of samples, reagents, chemicals, standards and reference materials, and radioactive wastes and hazardous waste. d The temperature and humidity within the laboratory are maintained within limits for the proper performance of each test or analysis and maintained according to the manufacturer's specifications for the proper operation of instruments. e Floors in the laboratories are constructed from a material that is resistant to most chemical spills and easily disinfected. f Labs are designed to minimize areas with cracks or fibers that could serve to accumulate debris and serve as an area for growth of microorganisms. Floors are clean and dry. g Sample receiving is conducted in designated areas which are separate from the main part of the laboratory. Sample was stored in place that meets the requirements. h Laboratory should provide facilities or procedures for disables. Laboratory should have uninterrupted, stable and appropriate power/ electricity. 3of12

11 Laboratory shall provide other utilities to support analyzing sample process, such as light, wash basin. k Laboratory should assess any potential hazards exposure and develops a hazard exposure prevention, monitoring and management procedure. Use of personal protective equipment (PPE) in collecting sample, analyzing and dispose specimen according to the potential hazard. m Laboratory should have procedure in handling and storing toxic, flammable material. 4 PRE-ANALYTICAL a Laboratory should verify that patient is already prepared accordingly to the test requested. b Phlebotomist must confirm the identity of the patient by a minimal of two positive identifications. c In special situations such as tests for alcohol, drug abuse or other tests of medicolegal importance, establishment chain of custody should be done. Another identification might be required. d Spesimen collection: Privacy. e Specimen are transported in a decided time, temperature and other transport condition as to maintain sample quality. Transportation of infectious material should follow current regulation. f Laboratory should have policy I procedures to verify that spesimen preparation (centrifuging) is done properly. 5 ANALYTICAL PROCEDURES a Examination procedure ii There should be a method validation or verification process for a new method used. If laboratory has more than 1 instrumen fo r the same test, laboratory should perform and evaluate the comparison study between those instruments. 4 of 12

12 - KAN-TN-LM 01 Issue Number: 3 7 April 2016 iii There shall be procedures for the conduct of all examinations that include &/or refer to, as applicable, the following (with regard to clause 5.5 SNI ISO 15189:2012). iv All current examination procedures shall be readily available in relevant sections of the laboratory. b Equipment and Measurement Traceability Laboratory management shall ensure that there is equipment to provide a service that meets the needs & requirements of the customer. ii The laboratory should define and document the policy and procedures to purchase equipment, consumables and disposable material, which may affect the quality of analytical services. iii Laboratory management shall establish a procedure for the procurement & management of equipment that includes: a) assessment & justification of need, b) selection, c) acceptance, d) training, e) maintenance, service & repair, f) decontamination, g) record of instrument fai lure & subsequent corrective action, h) planned replacement & disposal, i) adverse incident & vigilance reporting. iv There shall be an inventory of equipment that includes: a. name of manufacturer, contact person & telephone number b. serial number & condition when received c. date of purchase or acquisition d. record of contracted maintenance & calibration services e. record of equipment performance v Laboratory shall have equipment records containing description of the instrument, critical accessories and software, manufacturer's name, contact person & telephone number, type identification and serial number condition when received, date of purchase or acquisition ; Laboratory number ; 5of 12

13 installation qualification (IQ) and operational qualification (OQ) records obtained from the installer or manufacturer; and other related material such as instrument service and repair, warranty information, service contract conditions and specifications. vi Laboratory shall have a procedure specifies the schedule and requirements for maintenance, performance, calibration, and verification of laboratory testing equipment that meet the criteria of the maintenance and calibration parameters needed to achieve the accuracy of instruments used for analytical testing. vii Equipment that is scheduled to be maintained and calibrated periodically is tagged as above, except that instead of the calibration dates, it is documented. viii Laboratory shall have operating instructions for each instrument, including starting and shutting down the instrument. ix Small equipment with insufficient space to record the information on the label such as need only be identified with their unique identification number. x Equipment Maintenance, performance checks and record of equipment performance - Laboratory equipment maintenance and performance checks are conducted on a scheduled basis. - Instrument Maintenance Evaluation. There is documentation of periodically evaluation of instrument maintenance and function, including temperature of refrigerators/freezers in which reagent or patient specimens are kept. -A schedule, identifying and procedure for trouble shooting, is established for the servicing of laboratory equipment. - Maintenance and performance checks are documented to demonstrate that the program is being followed according to schedule. - Manufacturer's instructions are used for guidance in performing equ ipment maintenance. In the absence of manufacturer's instructions, instructions are provided in the instrument operation procedure. -Volumetric equipment such as class A glassware, mechanical and automatic pipettes shall completed by manufacturer's certificate of graduation accuracy. - Volumetric equipment, including mechanical and analytical pipettes shall calibrated by the laboratory's procedure. 6 of 12

14 - Some instrumentation, such as chromatographic systems. Latitude is provided to address such systems at the method application level as long as traceability is maintained with specified method performance criteria, which includes a certified reference or in-house reference material, and system suitability checks. - Rapid test kits Test shall checks the performance by in-house kit+/ controls for each lot and test run. - Spectrophotometers and Spectrometers (AA, UVNis, Mass etc) should have verification of performance annually for overall system o Wavelength e.g : accuracy, precision, stability o source stability, detector performance e.g resolution, selectivity, stability, linearity, accuracy, precision o signal-to-noise e.g mass, ppm, wavelength, frequency, absorbance, transmittance, bandwidth, intensity xi Equipment is operated by authorized personnel; authorized personnel are identified per laboratory. xii The overall program for calibration in the chemical laboratory shall be designed to ensure that all measurements that have a significant effect on test or calibration results are traceable to a measurement standard, preferably a national or international measurement standard such as a reference material. xiii New or newly acquired equipment must be checked by the laboratory before use to ensure conformity with specified design, performance and dimension requirements. xiv Instruments such as chromatographs and spectrometers, which require calibration as part of their normal operation, shall be calibrated. xv Procedures for performing calibrations shall be adequately documented, either as part of specific analytical methods or as a general calibration document. The documentation should indicate how to perform the calibration, how often calibration is necessary, action to be taken in the event of calibration failure. Frequency intervals for recalibration of physical measurement standards should also be indicated. xvi Laboratory shall checked and recorded regularly of temperatures for freezer, refrigerators, water baths, that is used in test methods and humidity value of hygrometer, that is used in work area. 7 of 12 Dokumen ini tidak dikendalikan iika diunduh/ Uncontrolled when downloaded

15 - KAN-TN-LM 01 Issue Number: 3 7 April 2016 xvii Equipment that is not operating properly is clearly marked to show that it is out of service. When an instrument is discovered to be improperly operating, it is tagged and taken out of service xviii Equipment is not returned to service until performance checks and verification have been performed and documented. xix Each instrument has an established schedule specifying performance checks, including the testing frequency and acceptable performance specifications. These performance checks ensure the instrument is operating properly and consistently prior to analysis. xx A quality check and water treament system maintenance should be done. c Reagents and Reference Materials Reagents, supplies and consumable goods are obtained from approved suppliers. The quality supervisor shall maintain a data base file of durable and disposable material suppliers. ii Reagents, solutions, controls, calibrators and standards are properly labeled, as applicable and appropriate, with the following element: content and quantity, concentration, storage requirements, date prepared or reconstituted by laboratory, expiration date and identity of person who prepared. iii Reagents, solutions, controls, calibrators and standards shall be stored under appropriate cond itions and in a secure manner to ensure the separation of incompatible materials. iv Disposed of reagents, solutions, controls, calibrators and standards appropriately followed to National and or local reg ulation. v Distilled or de-ionized water systems are monitored for conductivity and microbial contain periodically. vi Reagents, solutions, controls, calibrators and standards are stored separately from samples. 6 ASSURING THE QUALITY OF EXAMINATION PROCEDURES a The chemistry laboratory has a written quality management and quality control (QM/QC) Program. 8 of 12

16 The program must ensure quality throughout the pre-analytic, analytic, and post-analytic (patient identification, specimen collection, preparation and preservation, specimen identification, transportation, processing and timely result reporting). ii The program must be capable of detecting problem in the laboratory's systems, and identifying opportunities for system improvement. iii The laboratory must be able to develop plans of corrective/preventive action based on data from its QM system. b Laboratory Quality Control is an essential aspect of ensuring that data released is fit for the purpose determined by the quality objectives. c Approach of quality control is the principal recourse available for ensuring that only qualified data is released. d There is documentation of quality control corrective action when control results exceed defined acceptability limits. e Laboratory shall adopt an appropriate set of quality control procedures suitable to the range of work done. Comprehensive programmed of internal quality control is essential to ensure the quality of all laboratory examinations. ii The laboratory should participate in at least one proficiency testing programmed annually for each discipline iii When developing new examination procedures, the laboratory shall consider carefully their quality control requirements. iv This should be documented as part of the quality assurance plan for those examination procedures. v Where necessary, the existing quality control procedures should be extended to cover the new work or new procedures. vi The adequacy of the quality control procedures will be examined critically during assessments. vii The quality control plan, together with the acceptable criteria & actions to be taken in out of control situations, shall be documented. viii Quality control material are commercial or control samples. Commercial control shall be done normal, low and/or high level. Control sample shall be done relevant levels, duplicates or blanks. 9 of 12

17 ix Quality control material shall be of a similar matrix as the patient samples. Correlation of results in a sample shall be reviewed, where relevant. x Internal quality control, external proficiency testing & other alternative performance assessment samples shall be examined using exactly the same procedures as for patient samples & analyzed by personnel who routinely examined patient samples f There shall be procedures for Internal Quality Control (IQC) of all exam inations which verify that the intended quality is achieved. These shall include: Records of date, source & storage requirements of IQC material. ii The process of validation of IQC material prior to routine use. iii Appropriate statistical procedures. iv Where applicable, acceptance criteria for results obtained on IQC material in use. g All IQC results shall be recorded, regularly evaluated & subsequent corrective &/or preventive actions taken recorded. h Whenever appropriate laboratory should establish uncertainty of measurement of the method used in the laboratory External quality assessment ii iii iv v There shall be participation in External Quality Assessment Scheme appropriate to the Exam inations & interpretations provided. A record of results against the agreed performance criteria in approved EQA Schemes shall be maintained. The record of the performance in EQA shall be reviewed by staff & any problems or deficiencies identified shall be recorded & acted upon. EQA schemes should be in substantial agreement with SNI ISO/IEC 17043:2010 Conformity assessment - General requirements for proficiency testing, if available. If EQAS is not available laboratory shall perform interlaboratory comparison with a minimum of two laboratories and cover the clinical significance decision level. 7 POST ANALYTICAL 10 of 12

18 a Laboratory shall have a reference value b Result reporting Laboratory shall have a procedure for reporting critical result and ensure that the result is given to the right person in as soon as possible 8 PATIENT SAFETY a Laboratory shall develop an approach to improve accuracy of patient identifications. The procedures require at least two positive ways to identify a patient, such as the patient's name, identification number, birth date, or other ways. b Laboratory develops an approach to improve the effectiveness of communication among caregivers. Effective communication is a communication which is timely, accurate, complete information, unambiguous, and understood by the recipient, reduces errors and results in improved patient safety. Communication can be electronic, verbal, or written. Laboratory shall develops a policy and/or procedure for verbal and telephone orders that includes the writing down the test result by the receiver of the information; the receiver reading back the order or test result; and the confirmation that what has been written down and read back is accurate. c Laboratory shall develop a procedure that verify correct tube, correct preparation, correct analysis, correct reporting. There should be clear communication among staff, including the use of abbreviations. d Laboratory shall develops an approach to reduce the risk of health care- associated infections (proper hand hygiene, use of personal protective equipment, sample collection, sharps disposal, disinfectants). 9 INTERNAL AUDITS OF EXAMINATION PROCESSES a b There shall be internal audit of the pre examination, examination & post examination processes. The internal audit process shall be: planned & scheduled, 11 of 12