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Process control and method evaluation in medical laboratories

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  • Process control and method evaluation in medical laboratories

    Process control and method evaluation

    Process control (PC) in the clinical laboratory encompasses يشمل each step of the chain of events from the preparation of patient and collection of the specimen to the delivery of the result to the clinician الطبيب ألسريري. Every action in the chain of events must be scrutinized يدقق to ensure that optimal patient care is achieved.
    Interlinked items included in process control (PC):
    - Training and experience of technical and clinical laboratory personnel.
    - Level of supervision of the clinical laboratory.
    - Training and experience of phlebotomists.
    - Patient preparation.
    - Collection, preservation, transportation, and handling of specimen.
    - Storage of specimen of analysis is delayed.
    - Times between collection and reporting (i.e., the turnaround time).
    - Instrument maintenances and checks on instrument function.
    - Quality of reagent, kits, and analytical materials, quality of standards and control materials.
    - Through evaluation of any new methods and procedures, including comparison with current methods, linearity checks, preparation of suitable reference range and so on
    - Adequacy ملائمة of procedures manual, within the laboratory environments, equipments and materials.
    - Assessment تقييم of analytical variability by an adequate reference specimen methods.
    - Participation مشاركة of external control surveys فحص.
    - Policy of extreme أقصى values for patients (I.e. panic ذعر value).
    - Optimum الدرجة المثلي result reporting and delivery, including electronic reporting.
    - Correctness of reference (normal) range stratified يطابق by age and gender الجنس when possible.
    - Record keeping of patients data.
    - Long – term storage of patients and control data and timely retrieval استرجاع of same medical record information, pharmacy, dietary, radiology, and other functions that help the laboratory personnel interpret يفسر findings نتائج بحث.
    - Ongoing continuing education of entire كامل professional staff.
    - A published ينشر "كتاباً laboratory guide for users of the laboratory that includes services, policies, reference range. Telephone numbers, locations of services and so on.
    - Well established safety procedures.


    Training and experience of laboratory personnel

    A well – educated and experience staff is the most important asset موجودات that a laboratory has. Laboratory personnel must have the necessary technical skills, more important, they must have good judgment استخدام ملكة التميز, رأي.
    Pieces to Good judgment:
    - Recognizing يميز, يدرك that the specimens are from patient and that erroneous غير صحيح laboratory data can have unpleasant كريه and sometimes serious consequences أهمية for the patient, such as unnecessary diagnostic procedures, extra days in the hospital and the attendant cost, mistaken or missed diagnoses and so forth.
    - Being able to communicate to other providers of health care in a professional and helpful way to further patient care.
    - Identifying and correcting lapses زلة in laboratory performance, such as mistaken values
    - Alerting ينبه physicians at once when extremely abnormal results are observed in the laboratory and identifying a possible life – threatening ينذر بـ situation.
    - Having a willingness راغب في العمل, إرادي to provide extra effort and time when the situation demands مطلب it with ill patients and unusual استثنائي cases.
    - Recognizing the need to keep professionality alert and informed on new developments in the field.
    Within – laboratory process control:
    More sensitive and specific laboratory tests have simplified diagnostic medicine and provided signals of disease earlier في وقت مبكر in their course.
    Process – control programs provide a mechanism by which the analytic performance of clinical laboratories may be evaluated, ********ed and improved.
    Process – control programs: should contain at least the elements:
    - The precision ضبط of the method over the entire dynamic rang of normal and abnormal results are known.
    - Control materials are used that mimic يسخر منه , المقلد patients specimens as closely as possible.
    - Simple statically calculations are made on the control results to give means, standards deviations (SD), and coefficients المعامل
    درجة of variation (CV) of all analytical procedures.
    - Control charts (the control charts contain warring limits and action limits to assist the technical staff in decision making) …eg, levery – Jennings charts.
    - The limits on the control charts are largely defined in a pragmatic واقعي way and with a view toward medical needs and the regulatory environment.
    - Continuous monitoring of analytical performance is carried out by introducing of analytical performance is carried out by introducing fictitious زائف, مفترض patient specimen into the laboratory staff in addition to the control specimen known to the analysts .
    - The entire laboratory staff is responsible for the entry of process – control data into a computerized process – control system.
    - Certain individuals are responsible for collation of data for preparing charts.

    The reference sample method of Process – control:
    Controls that mimic patient specimen are analyzed repeatedly مرة بعد مرة within and between days.
    Commercially available controls:
    Purchased شراء control have the advantage of convenience شيء ملائم.they cannot used uncritically; criteria for selection must include qualitative characteristic, concentrations, stability, cost and matrix effects.

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