Safety and health programs help businesses:. Home Safety Management. Recommended Practices for Safety and Health Programs. A safe workplace is sound business. Safety and health programs help businesses: Prevent workplace injuries and illnesses Improve compliance with laws and regulations Reduce costs, including significant reductions in workers' compensation premiums Engage workers Enhance their social responsibility goals Increase productivity and enhance overall business operations.
QC logs must document control results assayed with each test to determine the acceptability of the QC run and to aid in detection of shifts and trends in control data [28,30].
QC records must be readily available to the staff performing the test. Results of controls must be recorded or plotted in real time e. Laboratory personnel who perform QC runs, record results, and plot data on graphs must record their initials, date, and time as testing is performed.
QC records should contain detailed information to reconstruct establishment of ranges for each QC material used for monitoring analytic performance. Information should include, but is not limited to: Package insert containing material name, manufacturer, concentration, lot numbers, etc. All QC materials and reagents currently in use must be prepared and stored as required by the manufacturer. If ambient temperature is indicated for storage or use, there must be documentation that the defined ambient temperature is maintained and that corrective action is taken when tolerance limits are exceeded [23].
An expiration date must be assigned to QC materials and reagents that do not have a manufacturer-provided expiration date or an expiration date that changes upon reconstitution or use. The manufacturer should be consulted should this situation arise.
Exception: Microbiological organisms—storage and sub-culturing techniques will determine time of use [32]. Deteriorated or outdated expired QC materials and reagents must not be used because this may jeopardize the quality of collected data [23].
For each new lot, batch or kit of reagents, the laboratory must document that samples, manufacturer-provided reference materials or proficiency testing materials are tested in parallel with both the current lot and the new lot to assess test comparability before or concurrently with being placed into service [34]. For quantitative tests, parallel testing should be performed by assaying the same samples or reference materials with both the old and new lot numbers to assess comparability.
Quality control materials should also be tested when comparing old and new lots. For qualitative tests, parallel testing must include re-testing at least one known positive or abnormal and one known negative or normal sample. The laboratory must document evidence of corrective action taken when water testing does not meet defined tolerance limits [23]. Validation of manufacturer provided performance specifications, or the development of such specifications can be challenging.
The assay development and approval status defines what parameters are required in a formal validation study. The standards below offer guidance on how to validate an assay. The laboratory must verify and document optimal performance of non-waived CLIA tests used to acquire study-participant results following pre-defined specifications that are equivalent to the ones provided by the manufacturer. The laboratory must also include a correction factor for each test to account for systematic errors that occur between tests.
The inclusion of correction factors ensures data comparability when multiple tests are conducted to measure the same analyte in support of study-participant results. Documentation of experiment results and approval should be readily accessible [36].
Methods that are defined as waived by CLIA do not require method validation, unless otherwise instructed by the sponsor.
Laboratories are not required to verify or establish performance specifications for any analytical test system used by the laboratory before April 24, [36]. Verification and documentation of normal responses for each test system including the Analytical Measurement Range AMR and the Clinically Reportable Range CRR and normal range s must be established to determine the usable and reliable range of results produced by that system [37].
These include accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference intervals, and any other parameter required for test performance. If the test is modified, or not FDA-approved, the reference range must be established [36]. The specimens should be representative of the population age, gender, genetics, geographic area etc.
An appropriate number of specimens must be evaluated to establish reference ranges. Typically, the minimum number of specimens required to establish reference ranges is specimens per demographic group e. Reference intervals must be evaluated at the following times: Upon introduction of a new analyte to the test offerings by a laboratory, with a change of analytic methodology, or with a change in study-participant population [42].
Correction factors represent adjustments made to compensate for constant and proportional errors when more than one assay format is being used to report study participant data. To ensure interchangeability of the data from any assay used, a correction factor must be incorporated into the relevant test procedure and reflected in the appropriate SOPs if the laboratory has determined the need for correction factors based on the validation exercises.
The laboratory must define and maintain a system to provide and retain all clinical trial data records and reports for a period of time to troubleshoot potential problems, or if it is necessary to reconstruct the study for auditing purposes. These records may include specimen tracking forms, laboratory requisitions, chain-of-custody documents, laboratory reports, equipment service and maintenance records, and instrument printouts [31]. Adequate manual or electronic systems must be in place to ensure assay results and other study participant specific data e.
Assay results must be released only to authorized persons and, if applicable, the individual responsible for requesting the test s [43]. The laboratory director must define alert or critical values in consultation with study-related clinicians [43]. The laboratory must, upon request, make available a list of test assays employed by the laboratory and, as applicable, the performance specifications established or verified [43].
When the laboratory cannot report study-participant test results within the time frames established by the laboratory, the laboratory must notify the appropriate individual s of the delays [43].
Reports generated by the Laboratory Information System LIS , and those created by other means, must be concise, readable, standardized in format, and chronological. It is important to replicate all of the previous information test results, interpretations, reference intervals for comparison with the revised information and to clearly indicate that the result has been corrected [43].
Additionally, the laboratory must have a system that identifies the analyst performing and completing the test result modification, along with the date and time. A log or other appropriate record must be kept for result modifications. The laboratory must maintain copies of the original report as well as the corrected report [43].
Proper error correction techniques e. All clinical trial data records and reports must be safely and securely e. The laboratory may archive test reports or records either on- or off-site. The environment in which laboratory testing is performed must be conducive to efficient operations that do not compromise the safety of the staff or the quality of the pre-analytical, analytical and post-analytical processes.
The laboratory design must account for equipment placement, proper ventilation, and have a designated area for reagent storage as well as archiving of data in a secure fire-proof preferred , fire-resistant, or fire-protected environment with access to only authorized personnel. Laboratory work areas must have sufficient space so that there is no hindrance to the work or employee safety [45,46].
Laboratory room ambient temperature and humidity must be controlled so that equipment and testing is maintained within the tolerance limits set forth by the manufacturer [23]. Ambient temperature logs should be utilized to document the acceptable ambient temperature range, record daily actual temperatures, and allow for documentation of corrective action taken should the acceptable temperature ranges be exceeded [47]. All floors, walls, ceilings, and bench tops of the laboratory must be clean and well maintained [48].
Molecular amplification procedures within the laboratory that are not contained in closed systems must have a uni-directional workflow. This must include separate areas for specimen preparation, amplification, detection, and as applicable, reagent preparation to avoid contamination and mix-ups between test and control articles.
The accuracy of all laboratory test results depends on the identity and integrity of the specimen submitted. The establishment of a sound specimen chain of custody from collection through to reporting of test results is paramount in ensuring quality data. The laboratory must have documented procedures for collection, transportation, and receipt of specimens because the accuracy of all laboratory tests in dependant on specimen quality [23].
A laboratory can only ensure specimen integrity when following appropriate specimen management and transportation procedures. A properly completed request form must accompany each study-participant sample to the laboratory.
The specimen inspection process must involve verification of the specimen container label information with the request form or log sheet [50]. Any discrepant or missing information must be verified promptly, before specimens are processed or stored by laboratory personnel. The laboratory must maintain an audit trail for every specimen from collection to disposal or storage. Audit trails must verify the date and time an activity was performed and the personnel responsible for that activity.
All audit trails must be documented [51]. A shipping procedure must be documented that addresses preparing shipments by following all federal and local transportation of dangerous goods regulations e.
The safety of all laboratory staff is paramount to avoid laboratory accidents that may jeopardize acquisition of infectious agents through handling of blood, as an example. Although exposure cannot always be avoided, every precaution must be taken to provide a safe work environment. The employer must assess the workplace to determine if hazards are likely to be present which necessitate the use of Personal Protective Equipment PPE and provide access to PPE to all laboratory staff at risk [55].
All laboratory employees must use PPE if there is a potential for exposure to blood or other potentially infectious material through any route e. All laboratory staff must receive safety training. Safety training must be documented and maintained.
Safety training must be completed before any employee begins working in the laboratory and on a regular basis thereafter. Ongoing safety training must take place each calendar year.
Documentation of this training must be signed and dated by the employee. Safety-related incidents must be documented, submitted, reviewed, and signed by the Laboratory Manager or designee on a regular basis, not to exceed one month from time of submission. Safety reports must be incorporated into the Quality Management QM program allowing the laboratory to note trends and correct problems to prevent recurrence [58].
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