A) TECHNICAL REQUIREMENTS:a.
Personnel Personnel competency is assessed in 4 categories which are, technical personnel, clinical personnel, management personnel and supervisory personnel. A technical personnel that perform scientific and technical work of laboratory shall be accredited with Bachelor of Science or Biomedical Science Degree or Diploma in Medical Laboratory Technology with at least 6 months of supervised training in the suitable aspect and records of evaluation of competence in the duty given. Technical work may also be done by trainee technical personnel with direction and supervision of a technical personnel having the accreditation mentioned. For technical assistants that is not having the qualifications mentioned but possess suitable practical experience and specialized training, they are only to do job of repetitive nature that does not involve analysis of testing or result. Laboratories management are the one that behold accountability to entrust tasks in a way that guarantees result validity and laboratory safety when it comes to personnel with mental or physical challenges. As for clinical personnel that deliver clinical interpretations for the aim of medical diagnosis or treatment, such professional judgement requires the clinical personnel to have qualifications, training and experience appropriate to the pathology category that they practice.
In order to be accredited, laboratories must have suitable requirement for personnel with interpretive or consultative credentials. Clinical interpretations or consultations of laboratory test outcome must only be given by medically qualified pathologist specifically in the fields that they are qualified in. The qualification must be backed by post graduate qualification in pathology approved by Government of Malaysia, accompanied by at least 3 years of training or working experience before or after acquiring the post graduate qualification. Clinical interpretations can also be delivered by medical practitioners working in the laboratory following direction and supervision of medically qualified pathologist in the area.
In specific conditions, results interpretations might be given by technical personnel having the appropriate training and working experience. The interpretation however is only on prepared text or comment based on generally accepted aspects or algorithm but not on clinical diagnosis and management advice. These exceptions are stated within the Specific Technical Requirements (STRs).
The person that provide clinical interpretations, being laboratory director or not, are of the power to make decisions on laboratory operations when it comes to clinical interpretations. Certain clinical personnel can also act as key personnel or designees of laboratory director. To take on management and supervisory roles, some aspects must be considered.
Firstly, the qualifications and experience that one have with management and supervisory. Next, the workload of laboratory and types of tests present and technical complexity and nature of the testing included. Contact that managers and supervisors have with subordinate staffs is also put into equation and lastly, the involvement of managers and supervisors in the improvement of methods and practice on new methods in the laboratory. Management team should be comprised of all laboratory directors and minimum one medically qualified pathologist that can be a visiting pathologist.
There shall be a statement of sufficient authorities, skills and experience to train and supervise subordinate personnel for persons with supervisory roles. Laboratory should ensure that a contracted personnel that will be used, meet the requirements for staff competence no matter the personnel will work on part-time or full-time basis. Records on the competency evaluation of personnel shall be kept. Training should be given where needed especially in the areas they will work on. Initially, they might need to be supervised directly to ensure their competence in carrying out their tasks.
Visiting pathologists are pathologist with medical qualification that visits laboratory periodically to perform tasks in areas no one else can carry out. The tasks might be supervisory or clinical interpretation of test result provision or other services. They shall have qualifications in field they are serving for and shall still comply with the requirements of clinical personnel competency. Between the laboratory director and the visiting pathologist, a written and formal arrangement shall be documented to ensure productive working relationship and the visiting pathologists instructions are acted upon appropriate timeframe. It is also to ensure prevalence and length of visits are suitable to the mass and area of task that is appointed to the visiting pathologist and might take into considerations the availability of electronic connections which still able a remote supervision of laboratory outcome.
Besides, the functions, roles and practice of visiting pathologist should be defined transparently where records of each visits in details are kept and a proper mean of contacting the pathologist is set up. It must also be as effective of a system to give way to provision of clinical advice including signing of tests reports and the liabilities of the test outcome and intentions are clearly stated. Competence assessment of personnel should be done at least in every two years. Personnel that have been absent from work for a long period also needs to be reassessed and retraining if necessary. Administration of training and competency accomplished must be done both trainer and trainee.
A regular refresher training should be given in situation where personnel are to work in areas they don’t normally work in. To maintain competence of clinical and technical personnel, continuing education and professional development is highly significant. External activities and use of suitable reference texts and journals can be considered as part of it. Examples of external activities includes attendance at professional conferences, seminars and lectures or educational attachment or field trips to other laboratories and to partake in training workshops and courses. On the other hand, internal activities that can be done, comprises of regular educational presentations, reviewing journal article, presenting cases, QAP educational material reviewing and unique case reviews.
b. Accommodation ; Environmental Conditions The laboratory design shall guarantee comfortable and secure functional environment referring to WHO Laboratory Biosafety Manual, College of Pathologists, Academy of Medicine Malaysia guidelines; guidance documents from other accreditation bodies, Occupational Safety and Health (Regulation 2000 and 2013) and the Guidelines on Chemical Management in Health Care facilities Ministry of Health. Safety wise, all practicable standards and guidelines that identifies to medical laboratories in Malaysia, and recognized best practice shall be administered. Any hazardous practices must be paid attention to. Safety manual listing policies and procedures in laboratory in relative to health and safety should be available at all time for staffs.
Certain procedures should be separated to ensure workers’ safety and environment protection. For examples, procedures that may be hazardous towards other staffs, ones that are sensitive if not segregated and when silent, uninterrupted working environment is needed. “Clean” and “dirty” areas shall also be separated accordingly. c. Laboratory equipment, reagents, and consumables Generally, when having to share specialized equipment that is not of a laboratory’s continuous control, there must be calibration and maintenance record of an equipment and its performance must be verified every time it is being used.
When it comes to equipment calibration and metrological traceability, test or calibration tools that can affect result must be calibrated according to Standards Malaysia accredited calibration laboratories and/or Standards Malaysia Mutual Recognition Agreement accredited calibration laboratories as it is laboratories’ accountability to provide transparent proof that its system of calibrating and maintenance brings assurance. In aspect of reagents and consumables, they shall all be labeled at least minimum of name, prepared date and opened date as well as concentration, solvent and any specific hazards and/or precaution. Highly hazardous substances shall also be stored separately.
d. Pre-examination processes Proper collection and transportation should be prioritized. Every three years, collection centers shall be accessed. Laboratory must ensure proper instruction and monitoring even if the laboratory personnel are not involved directly with sample collection.
Samples must be identified uniquely while being matched to its accompanying request form. In case of more than one samples are requested, the sample must be able to be differentiated by the labels and request forms. Access of safety precautions instructions must be available for personnel responsible of sample collection.
Collector shall positively identify patients and label the samples with the minimum of two unique identifiers, its type and date of collection. Sample reception includes uniquely identifying samples throughout the testing, for example, by using unique laboratory numbers, the most practical option for differentiating specimens or by using at least two of patients’ identifiers. The best option are ones that can distinguish samples even after a long haul.
e. Examination processes In general, each process must be endorsed, dated and documented by accountable key personnel. Inspection must be done for new batches for any procedural changes and inserted in the manual if any and relevance of products update must be reviewed. Measurement of uncertainty of measured quantity value is as stated in ISO 15189 and SAMM Policy 5.
f. Ensuring quality of examination results As for quality control, person responsible for quality control activities shall be identified and conducted by including all analytical or analysis concentrations featured. All values control must be done daily or by batch of analysis and specifically for special stains, positive controls must be done and the control materials must be matrix matched. The controls must not be manufacturers’ products while means and standard deviation given by them must be verified.
Appropriate material shall be used when doing calibration and acceptable spectrum must be outlined. Document any quality control that is outside acceptable range and action taken to it and also any internal QC done; acceptance or rejection criteria shall be established. Early detection of trends can be done by having graphical presentation of quantitative QC results.
Long term monitoring of internal quality control results system must be possessed by laboratories for assessment purposes. Interlaboratory Comparison (ILC) programs can give info of any uncertainties regarding patient samples, including personnel competence. Their participation records must be kept for the purpose of performance evaluation.
ILC may also challenges personnel for professional development thus each laboratories must be subscribed to at least one current and sustained ILC program per test or per related group of tests. Risk based approach is best done to decide on suitable ILC frequencies. g. Post-examination processes Samples should be obtained in congruence to the national guidelines.h.
Reporting of results Transcriptions of data or result are best to not be done manually or when there is no other option, there should be a way to check transcriptions accuracy and entries that is performed, by an independent operator.?B) RECOMMENDED CALIBRATION AND/OR PERFORMANCE CHECK INTERVAL FOR MEDICAL TESTING LABORATORIESAutomatic burettes, dispensers and pipettors needs 3 monthly intermediate check in order to ensure accuracy of and repeatability at volumes in use. On the other hand, balances should be initially calibrated every time, such as every repair, moving of equipment. On each weighing, zero check must be done, while every month calibration is done by one point check procedure using a known mass close to balance capacity and every 6 months, calibration using traceable certified masses or using statistical process control (SPC) by using repeatability checks at the upper and lower ends of the scale. Masses should have initial calibration and 5 years recalibration by an accredited calibration laboratory. Biological Safety Cabinets, Laminar Flow and Fume Hood/Cabinet requires Yearly certification by a certified body or according to manufacturer’s instruction but Intermediate check or performance check must still be done.
Centrifuges should be calibrated following manufacturer’s instruction by an accredited calibration laboratory. Calibration equipment for centrifuges includes tachometer (mechanical, stroboscope or light cell type, or by other approved means) where operating speed is specified and calibration of the timing device and, where appropriate, the temperature measurement device will also be required. Sterilizers and autoclaves also requires initial calibration by an accredited calibration laboratory followed by 15 months calibration or as required by DOSH certification By Department of Safety and Health (DOSH). However, monthly intermediate check must be done with the use of biological indicator. After each use, use physical indicator to ensure device calibration. In the case of hot air sterilizing ovens it needs to be calibrated before use and after each use by an accredited laboratory using physical indicator.
pH meter shall be calibrated using at least two appropriate standard buffers for intended purposes after each usage. Refrigerators, chillers, freezer and cold room need minimum of daily calibration and monitoring of temperature using calibrated thermometer. Thermometers need 5 years, 6 months and initial checking by accredited calibration laboratory, by checking ice point and at points of use and by checking against reference thermometer or thermocouple across working range or at points of use respectively.
Thermostatically controlled equipment such an incubator or water baths and oven requires initial calibration by an accredited calibration laboratory and working days checking to monitor temperature using calibrated thermometer. Volumetric glassware, for examples, flasks, pipettes and burettes only needs initial check using distilled water at critical graduations. For timing devices like stop watch, clock, and timers, 6 months check has to be done against Malaysia standard time by having 2 measurements separated by an appropriate interval.