[The external evaluation of study quality: the role in maintaining the reliability of laboratory information].

The external evaluation of quality of clinical laboratory examinations was gradually introduced in USSR medical laboratories since 1970s. In Russia, in the middle of 1990 a unified all-national system of external evaluation quality was organized known as the Federal center of external evaluation of quality at the basis of laboratory of the state research center of preventive medicine. The main positions of policy in this area were neatly formulated in the guidance documents of ministry of Health. Nowadays, the center of external evaluation of quality proposes 100 and more types of control studies and permanently extends their specter starting from interests of different disciplines of clinical medicine. The consistent participation of laboratories in the cycles of external evaluation of quality intrinsically promotes improvement of indicators of properness and precision of analysis results and increases reliability of laboratory information. However, a significant percentage of laboratories does not participate at all in external evaluation of quality or takes part in control process irregularly and in limited number of tests. The managers of a number of medical organizations disregard the application of the proposed possibilities to increase reliability of laboratory information and limit financing of studies in the field of quality control. The article proposes to adopt the national standard on the basis of ISO 17043 "Evaluation of compliance. The common requirements of professional competence testing".

Implementation of a configurable laboratory information management system for use in cellular process development and manufacturing.

BACKGROUND AIMS: Regulatory requirements for the manufacturing of cell products for clinical investigation require a significant level of record-keeping, starting early in process development and continuing through to the execution and requisite follow-up of patients on clinical trials. Central to record-keeping is the management of documentation related to patients, raw materials, processes, assays and facilities. METHODS: To support these requirements, we evaluated several laboratory information management systems (LIMS), including their cost, flexibility, regulatory compliance, ongoing programming requirements and ability to integrate with laboratory equipment. After selecting a system, we performed a pilot study to develop a user-configurable LIMS for our laboratory in support of our pre-clinical and clinical cell-production activities. We report here on the design and utilization of this system to manage accrual with a healthy blood-donor protocol, as well as manufacturing operations for the production of a master cell bank and several patient-specific stem cell products. RESULTS: The system was used successfully to manage blood donor eligibility, recruiting, appointments, billing and serology, and to provide annual accrual reports. Quality management reporting features of the system were used to capture, report and investigate process and equipment deviations that occurred during the production of a master cell bank and patient products. CONCLUSIONS: Overall the system has served to support the compliance requirements of process development and phase I/II clinical trial activities for our laboratory and can be easily modified to meet the needs of similar laboratories.

[Medical biology accreditation at EFS]. / Accréditation des laboratoires de biologie médicale au sein de l'Établissement français du sang.

The medical biology laboratory accreditation according to the Iso 15189 standard, which main lines are mentioned in the article, is henceforth becoming a statutory obligation in France. All laboratories must apply, at least partly, to the COFRAC, by 31(st) October 2012. The EFS has largely anticipated the necessary steps to reach this objective and has developed an approach based on six basic processes. To date, 24 laboratories of various technical fields are accredited and several other submissions are pending. The Iso 15189 standard requirements match those already implemented at the EFS with the Certification. The trade standard operating procedures are almost included in the risk control management. Through the involvement of all the EFS members following precision action plans based on the sharing of successful experiences and the harmonization of trade practices, this compulsory objective will be reached and the deadline respected.

Pathology consultation on reporting of critical values.

Among the most important functions of a pathology or laboratory medicine service is the clear, accurate, and rapid communication of critical test results (critical values) to patient care providers. Pathologists and laboratory professionals are often confronted with many obstacles in the reporting of such critical values, including establishing clinically relevant criteria for critical values, resolving difficulties in locating an ordering provider when a critical value is obtained, and ensuring that the provider understands the severity and implications of a critical result when he or she has questions. This article presents a hypothetical (yet fairly common) clinical case scenario regarding critical values and then provides an up-to-date discussion and review of the literature on the reporting of critical results.

[Guidelines concerning sample reception and request recording of laboratory tests]. / Recommandations concernant l'accueil et l'enregistrement des échantillons de biologie médicale.

The process is described to help to achieve the requirements of the ISO 15189 standard. The precautions to be respected for a correct recording of the request are specified. The criteria for traceability are formalized. A logogram illustrates the propositions of attitude to be followed when occurs nonconformities. Then, we propose guidelines for the treatment of the identification uncertainties of the primary sample. An algorithm is proposed to formalize the process and treat the situations which can be met with an irreplaceable or critical sample.

[Management of pre-analytical nonconformities]. / Outils pour la gestion et la maîtrise des non-conformités pré-analytiques.

The main nonconformities enumerated to facilitate consensual codification. In each case, an action is defined: refusal to realize the examination with request of a new sample, request of information or correction, results cancellation, nurse or physician information. A traceability of the curative, corrective and preventive actions is needed. Then, methodology and indicators are proposed to assess nonconformity and to follow the quality improvements. The laboratory information system can be used instead of dedicated software. Tools for the follow-up of nonconformities scores are proposed. Finally, we propose an organization and some tools allowing the management and control of the nonconformities occurring during the pre-examination phase.

[Self assesment grid for pre-examination phase]. / Proposition de grille d'auto-évaluation de la phase pré-analytique.

This document is a proposal of questionnaire for self-assessment of pre-analytical phase referring to the different steps described in the document SG1-01. The questions are aimed at verifying that what is examined fulfills ISO 15189 standard requirements or in general tends towards client satisfaction. This questionnaire has been elaborated using 5 M risk assessment tool for exhaustiveness purpose. This document may be useful to develop internal audit grids.

[Analytical validation of the results]. / Validation analytique des résultats.

The results obtained using automatic analysers have to be reviewed before release to the laboratory information system (LIMS) for definitive validation by the authorised person. The objective of such a review is to ensure that quality indicators are in agreement with the defined requirements and that the procedures have been carefully fulfilled.

Point-of-care testing: the impact of CLIA regulations on your testing program.

Competitive pressures drive physician offices toward on-site clinical laboratory testing programs to streamline service, generate revenue, and make better decisions during patient visits. The Clinical Laboratory Improvement Amendments continue to govern all laboratory tests performed for patient diagnosis, monitoring, or treatment. However, new diagnostic tools reduce regulatory hassles previously associated with point-of-care testing. Of course, regulatory consequences are still an important consideration when commencing a testing program or adding to an existing one. Here we focus on the regulatory restraints surrounding physician office laboratories to help you determine whether or not it makes sense to test in your setting.

Laboratory services regulations carry HIM implications.

This is Part 1 of a two-part article on national coverage and policies for clinical diagnostic laboratory services payable under medicare Part B. Part 1 concentrates on the administrative policies. Part 2, which will appear in the October issue of the Journal, will focus on the national coverage policies developed for individual clinical diagnostic laboratory tests. For additional information regarding the new administrative policies, see the Centers for Medicare & Medicaid Services (CMS) Program Memorandum AB-02-030, which was issued to all Medicare contractors on March 5, 2002.