The Importanec Of Internal Audit Program Control As A Part Of The System Management

Patient safety is the major concern particularly in clinical laboratories. Accreditation can become more accountable in terms of better quality system and less dependent on external supports. Efforts to achieve laboratory accreditation also improve the overall laboratory management network such as staff training, instrument maintenance and supply chain. Role of quality manager require a comprehensive knowledge in ISO 15189 and ISO/IEC 17025, external relationship including complaints and advisory service, people, sample and technical management as well as system maintenance. In this article, we focus on the control of internal audit program which is part of the system management.

Introduction

Laboratory accreditation is mandatory requirement for pathology testing operation in Australia. An accredited laboratory must regularly assess by National Association of Testing Authorities (NATA) in order to maintain their accreditation. Moreover, Medicare rebate in Australia only available to NATA/RCPA accredited pathology. All facilities are expected to continually comply NATA accreditation criteria and assessment cycle every three years. Criteria to determine competency based on ISO 15189, 17025 and 17020 which included the assessment of qualification, staff training and experience staff, correct equipment used in laboratory is calibrated and maintained properly, obtained an adequate quality assurance (QA) procedure, ensure appropriate sampling practices etc.

ISO 15189 is the human pathology international standard accreditation for laboratories to develop their own quality management system (QMS) and to assess their own competency. The best example is Sunshine Pathology is NATA/RCPA accredited to ISO 15189 in chemical, haematology, microbiology and reproductive technologies. Frequency of error and reliable test result can be enhance by monitor and implement a comprehensive laboratory quality management system which included proficiency testing (PT) and participate in accreditation program. Internal audit program is conducted by personnel from Quality Assurance Unit. Quality manager is responsible to plan a schedule of internal audit or monitoring plan that encompasses both management and technical elements of QMS.

Quality manager is also responsible in consultation with Chief Executive Officer (CEO) into implement, maintain and continually improve QMS to ensure the organization effectively compliance with accreditation, regulatory and industry or professional standards, upgrade QMS documentation, monitoring, review and audit QMS, provide feedback, suggesting and improvement to describe the effectiveness of the system to CEO, ensure the promotion of awareness of client needs, training and evaluating organization internal auditor, ensuring review feedback from client, staff training record during internal audit and assist training recommendation to advance competence to all staff. As the assistant of quality manager, it is important to assists quality manager and the quality unit to maintain the regulatory accreditation requirement.

Internal audit is a systemic, independent and documented process that for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Internal audit must have a clear understanding of NATA requirement and company QMS. Audits also enable the effectiveness of a process and potential problem or weakness of area that need to be identified for improvement. There are several types of audit that available in Dorevitch pathology including compliance, system, process or vertical, procedure or horizontal, traceability, raw data and study set-up audits (only used in clinical trial). Internal audit in Sunshine pathology are conducted at least once a year or more frequent if require to monitored laboratory compliance to QMS and regulatory accreditation requirement. The schedule of internal audit that cover all areas is determined using the internal audit workbook. For example, the internal quality control audit will be conducted on November whereas laboratory equipment audit conducted in June each year.

Discussion

There are two particular requirements to assess the competence and the quality of a medical testing in a clinical laboratory which is technical and management that part of the NATA assessment. The management commitment of ISO 15189 to ensure the laboratory is legally identified and meet the requirement of the standard, ensure quality system implemented by establish quality policy, establish communication processes and communicate to laboratory personnel regarding regulatory and accreditation requirement as well as appoint a quality manager. The management aspects for medical laboratories requirement for internal standard ISO 15189 for quality and competence including organisation and management responsibility, QMS, document control, service agreement, examination by referral laboratories, external services and supplies, advisory visit, resolution of complaints, identification of non-conformities, corrective and preventative action, continual improvement, control records, evaluation and audit and management review.

Internal audit of organisation responsibility should include laboratory supervision, communication, quality focus meeting and staffing. For instance, Sunshine pathology is under category B laboratories where the supervising or on-site pathologist is a specialist in anatomical pathology. The hours of supervision and complete supervision should be documented and the frequency of staff meeting documented using corporate meeting minutes template. Current laboratory organisation chart and the arrangement for staff member to have contact with routine and supervisory staff should include in the audit. The document control internal audit is required by QMS and to prevent any unintended use of obsolete document. Audit checklist should include all methods in use authorised appropriately, reviewed within required time frame, source or reference for procedure is included, do senior staff demonstrate understanding of external document that form part of quality system, are superseded and absolete document retained in accordance with NPAAC requirement included verification any document that have hand written amendment, ensure forms used in current version, all procedures, work procedure, forms appropriately document and displayed on walls and in laboratory control document. Dorevitch pathology use Q-pulse as the document control management system across the business unit.

The document hierarchy of Dorevitch pathology to demonstrate the translation of quality policy to routine operation and the content of document reflect the use of Q-pulse. The technical aspects of medical laboratory requirement included personnel, accommodation and environment condition, laboratory equipment and consumable and reagents, pre-examination process. examination process, ensuring quality of examination results, post-examination process, reporting result, release of result and laboratory informatic system (LIS). The personnel audit of Dorevitch pathology is to ensure the competence of all staff for the function they perform and maintain records for all personnel to indicate whether they compliance to the requirement including WHS requirement. The training record for a representative selection should include name, position, highest academic qualification where obtained, copy of training record, curriculum vitae present, completed employment record, a signed current position description, completed induction training, records of participation in internal and external continuing education, return worker following a period of extended absence, completed training checklist and competency assessment.

Next, laboratory equipment, reagent and consumable requirement ensuring all equipment is adequately selected and tested, fit for purpose, only operate by adequately trained personnel, appropriate operating instruction available, appropriately calibrated, maintained and repaired and all necessary records involve performance is maintained. General criteria internal audit checklist for equipment should include copies or access operator manual for the item of equipment, available equipment inventory and documented, instruction and maintenance of equipment document, records of all external service, identified faulty equipment to prevent inadvertent use, blood bank refrigerator monitored with maximum and minimum thermometer daily and maintain record, corrective action taken and recorded if temperature fall outside the acceptable limits and monthly review of all equipment maintenance charts. Equipment such as balances check performed with record maintain follow by NATA calibration done in three yearly, biological safety cabinet service annually, weekly maintenance of centrifuge, stability and level of ESR tube rack monitor during test, microscope service at least biennial, pipette in use have NATA calibration certificate and regular check at a frequency consistent with application and thermometer check either at operating temperature or ice point at six month interval. The pre-examination process describe the pre-analytical phase and all take place prior to the sample receipt by testing laboratory. There are four dimension process required to ensure right specimen collected from the right person at right time, right transport condition and result attributed to right patient and deliver to right requestor. Internal audit in the specimen collection centre requirement include premises, equipment, personnel, documentation, collection and blood bank procedure. For instance, current approval certificate in the premises should displayed in public area with list expiry date, where refrigeration require storage temperature must be maintained between two to eight degree with a monitoring chart record daily, specimen stored for least possible time courier run arranged to minimise storage times, staff identification worn all time, staff acknowleage the procedure for release patient result, patient positively identified by collector without prompting, specimen labelled must be in presence of the patient and confirmed identifier with the patient, specimen labelled at least three identifiers include name, date of birth and UR number etc.

Transportation and specimen reception audit included transportation of samples been monitored to ensure they are transported within appropriate time frame and temperature, document procedure available to cover criteria for acceptance or rejection of unsuitable specimen such as container leaking. Specimen are transported in compliance with local regulatory requirement to ensure safety for the courier, the public and the receiving laboratory. Courier run are design to ensure the timely delivery of specimen and the document procedure for handling urgent specimen are available. Audit also need to include how are the action taken to assure the identity of specimen recorded, such as unlabelled specimen should be discard or rejected for those that is not suitable for testing and all record of specimen receipt should be kept.

The laboratory also needs to defined the time limit for request additional testing or further testing on the same primary sample. For example, Sunshine pathology kept EDTA, citrate and serum blood sample maximum for a week, frozen plasma for coagulation assay for three weeks, one week for urine sample and CSF for two weeks. The examination procedure describe the process ensure all test method use are adequately validated and verified, have appropriate reference interval and decision limit and have measure of uncertainty when applicable. The example of require audit should have included the policy for introduce new instrument and the record of instrument qualification or method validation studies retained. Reference interval are established for each new test, the source of information should documented and review periodically. The assuring quality of examination result under section 5. 6 is important take into account when establish internal quality control (IQC) procedure. Quality control provide laboratory with the confident of patient result.

Each laboratory has their own systemic IQC in place and it is the responsibility of the manager to ensure appropriate IQC are establish and follow. Require audit for IQC should cover the analytical range of IQC material in use and indicate whether it is high, low, positive or negative etc, QC must performed on each day of patient testing, appropriate material used as calibrator when require, the acceptable range for all IQC material such as +/- 2SD, documentation of QC procedure and protocol when QC result fall outside acceptable range, QC result plotted to assist in early detection of trends and establish a system of long review of IQC to assess method performance. On the other hand, participate in external quality assurance program (QAP) or proficiency testing (PT) under section 5. 6 also important to assisting in overall control of testing in the laboratory. The objective for external QAP is to establish intra-laboratory comparability. Proper record must be kept of the result obtained by the laboratory and the finding must be discussed with the staff involved in the test. All laboratory should should participate QAP to cover the range of the test performed. Alternative measure should be consider where QAP is not available. Moreover, analyser that located outside laboratory such as blood gas analyser should have a seperate enrolment for QAP. As far as practical, all QAP sample should be treated as the same way as patient sample. Laboratories also not allow to communicate with other participate about sample data until after the date for submission and any ongoing poor performance in QAP should discuss at quality focus meeting and preventive action table where require.

In conclusion improvement in the quality of medical testing always set as the high priority across the country to ensuring safety and the well-being of patient. Laboratory accreditation as the recognized framework that accepted international and nationally for better test quality and minimize the frequency of laboratory error. Both management and technical aspect is important to drive improvement in the management and laboratory network as well as the positive effect of overall performance. Hence, establish an effective internal audit to implement the system to govern patient safety is prioritise and giving a sense in being in control.