Advanced Search

Amendment Of The Cabinet Of Ministers Of 20 January 2009 Regulation No 60 Of The "provisions On The Minimum Requirements For Medical Institutions And Their Departments"

Original Language Title: Grozījums Ministru kabineta 2009.gada 20.janvāra noteikumos Nr.60 "Noteikumi par obligātajām prasībām ārstniecības iestādēm un to struktūrvienībām"

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
Cabinet of Ministers Regulations No 1183 year 2010 in Riga on December 21st (Mon. No 74 85) amendment of the Cabinet of Ministers of 20 January 2009 the Regulation No 60 "provisions concerning minimum requirements for medical institutions and their departments ' Issued in accordance with article 55 of the law on medical treatment, the second part 1. make the Cabinet of 20 January 2009 the Regulation No 60" provisions concerning minimum requirements for medical institutions and their departments "(Latvian journal, 2009, 2010, 23 No; 41. No.) and complement the provisions of the amendment to subsection 3.10 the following : "3.10. Requirements for medical laboratories 39.2 medical laboratory is a therapeutic institution or body, which carried out biological, microbiological, immunological, chemical, imūnhematoloģisk, haematological, biophysical, cytological, pathological or other material derived from human studies.
39.3 laboratory work organisation provides the necessary resources and the agenda to provide laboratory services required and appropriate quality, including studies outside the laboratory premises at the patient's bedside and ekspresdiagnostik.
the laboratory developed 63.3 staff management policy and organisational structure of the laboratory, defines employee responsibilities, responsibilities, powers, as well as the work provided for the necessary staff resources and expertise.
63.4 staff resources correspond to the specific tasks and quality requirements: 1. laboratory 63.4 management personnel have the appropriate competence in organizational, administrative, educational, advisory and technical operations, and quality control services in the field;
63.4 2. laboratory technical staff have the appropriate competence in the areas related to the objectives of the investigation procedure, action, evaluation and professional opinions.
the laboratory maintains a 63.5 following information for staff compliance with specific tasks: 63.5 1. education copies of supporting documents;
2. the specialization of 63.5 or improvement of professional qualification in a given specialty, copies of the supporting documents;
3. training, 63.5 experience and expertise in the production of supporting documents;
4. post descriptions 63.5;
5. training of 63.5 plan or programme;
63.5 6. safety training, copies of the supporting documents.
63.6 laboratory or its departments are located in rooms that can take laboratory investigations, without affecting the quality of the examination results, quality control procedures, personnel safety and patient care services. These conditions are met the primary sample collection and investigation sites outside the permanent laboratory work areas, sampling and collection points.
63.7 indoor climate requirements and environmental conditions define and maintain the premises, taking into account the actions to be taken and the appropriate specifications, if this may affect the quality of the examination results.
63.8 adjacent work areas that are not compatible actions are mutually separated to prevent contamination.
the laboratory shall document and 39.7 control room and work area availability and usage to protect laboratory technical resources, documents and material consideration from unauthorised access.
63.10 Laboratory is provided with the appropriate communication systems required for the effective transmission of the message, depending on the volume and nature of work.
63.11 laboratory are devices that provide laboratory services: 63.11 1. investigation equipment and measuring tools (hereinafter equipment);
63.11 2. reagents, reference materials, calibration materials (reagents);
63.11 3. investigation system, the laboratory sampling devices and accessories.
63.12 (installing and using them everyday) displays the ability to achieve the required results. In accordance with the manufacturer's instructions, the laboratory shall develop and document the following: 1. installation of 63.12 technical supervision program;
2. equipment 63.12 metrological inspection programme;
63.12 3. equipment maintenance program.
used in the analytical Laboratory 63.13 facilities include laboratories in the list of devices and their use of the site ensure that the staff concerned equipment used, understandable way formulated the following documentation: 1.63.13 laboratory equipment operating instructions;
2.63.13 safety rules for working in the laboratory;
63.13 3. instructions for maintenance of the laboratory devices.
63.14 per machine, which is used in the study, is the original technical documentation and records containing the following information: 1. the machine name 63.14;
2. equipment manufacturer 63.14, identification of the type and serial number;
63.14 3. manufacturer's representative or the supplier's contact and telephone number;
63.14 4. commissioning date;
63.14 5. current location;
63.14 6. position at the time of receipt (new, used, refurbished);
63.14 7. data for calibration or verification;
8. technical data 63.14 surveillance;
9. equipment damage 63.14, malfunction, modification or repair.
63.15 reagent catalog contains the following information about their compliance with the intended use: 1. the name, 63.15 code, serial number, quantity;
2. the supplier 63.15;
63.15 3. period of validity;
63.15 4. storage conditions;
63.15 5. terms of use;
6. use 63.15 start and end date.
63.16 With equipment working in personnel, who are trained in the use and maintenance of equipment and has the mandate of the head of the laboratory working with the equipment.
document the procedure in the laboratory of 63.17 handling for appropriate laboratory equipment, identifying the persons responsible for the following areas: 1. marking and isolation 63.17;
2. evaluation of damage to 63.17 and next steps;
3. compulsory examinations 63.17 and;
63.17 4. decision on the resumption of the operation;
63.17 5. impact on the examination conducted and patient information, if necessary.
If the data collection study 63.18, processing, recording, reporting, storage or repair are used in laboratory information systems or automated equipment, the laboratory shall ensure that: 1. computer programs 63.18 and patient databases are protected to prevent unauthorized persons from accessing them, changes in the program or their destruction;
2. computer and automated 63.18 examination facilities are maintained to appropriate environmental conditions, guaranteeing their proper functioning.
63.19 according to the services provided by the laboratory, the laboratory shall document the information material regarding the sample collection and handling them. The laboratory shall ensure that the information material is available to patients and laboratory personnel in sight. Material information shall specify: 1. the laboratory used 63.19 investigation methods;
2. requirements for patient 63.19 preparation prior to sample collection and the factors which can affect the results of the study;
3. term of 63.19 being carried out examinations;
63.19 4. period during which may require repeated and additional studies;
63.19 5. the sample collection, sampling, labeling, storage conditions and the sampling devices and laboratory use;
6. in the target sample 63.19 atraidīšan criteria and procedure, if it is rejected;
63.19 7. specific action and the conditions for transport of the sample under investigation;
63.19 8. study request form;
9. the study consent 63.19 certificate form, if necessary.
development of a Laboratory study 63.20 request form, which shall contain the following information: 1. identification of the patient, 63.20;
2. the doctor's 100 or other personal identification, which is empowered to request the study and use of the information obtained;
63.20 3. investigation reports sending address;
4. the sample of 100 type and anatomical site of origin (if necessary);
5. the requested 100 studies;
63.20 6. clinical information about the patient;
7. the 100 sample collection date and time;
8. imūnhematoloģisk 100 examinations AB0 blood group system;
9. the 100 sample receipt date and time in the laboratory;
10. in the sample received 100 conformity assessment.
used in the laboratory investigation of 63.21 methods that satisfy the needs of users of laboratory services and are suitable for the study to be carried out. Investigation procedures, including sampling, is documented and available to the appropriate personnel in the workplace. Enter the manufacturer instructions (user guide, Agent inserts) can be used as part of the procedure, if those instructions are laboratory workers in plain language. Description of the method of inquiry include the following minimum information: 1. the purpose of the study 63.21;
63.21 2. principle of the method used in the investigation;
63.21 3. the performance specification is a method of investigation;
63.21 4. investigation applied the sample type;
63.21 5. necessary equipment and reagents or accessories;
63.21 6. calibration procedure;
7. procedure of 63.21 progress;

63.21 8. quality control procedures;
9. examination results 63.21 contributing factors;
10. examination results 63.21 calculation principles;
11. the study results 63.21 biological reference interval;
12. examination results 63.21 critical sizes (where appropriate);
63.21 13. interpretation of results of the study.
If the laboratory intends to change 63.22 investigation method and can therefore vary considerably, test results or their interpretation, the possible consequences of changes explains the patients before the investigation methods.
laboratory procedures documented 63.23 investigation process for quality assurance: 63.23 1. internal quality control;
63.23 2. external quality control.
According to the Laboratory 63.24 scope document the internal quality control system, including: 1. the programme, 63.24
2. responsible 63.24;
3.63.24 control criteria;
63.24 4. assessment of control results;
63.24 5. corrective and preventive action implementation and effectiveness evaluation.
63.25 in its laboratory activity participate in the external quality control programs, documenting: 63.25 1. plan;
2. control results 63.25 evaluation;
3. corrective and preventive 63.25, and assessment of the effectiveness of their enforcement.
If there is no available 63.26 external quality control programs, the lab developed and used in other investigations of external quality control mechanisms through exchange with other laboratories.
the laboratory shall document receipt of 63.27 examination results are comparable (correlation) clinically acceptable within the interval of the study carried out using different methods of investigation, action, performing in different places or with a different technical support.
the laboratory shall document such 63.28 post procedures: 1. the procedure for the conduct of 63.28 with examination results protocols that define the protocol design, changes them and staff responsibility. The Protocol contains a study and patient identification, all measurements, original observations, calculations, and calculations in the survey results, date of investigation, as well as the identification of the person who carried out the investigation;
2. the procedure for the examination of 63.28 reporting results, which determine the authorized and competent personnel for the systematic review of examination results, assessing their compliance with the clinical information available about the patient and examination results and notification approval of examination results, the method including the notification of examination results by phone, and the time limit within which the results of the investigation, notify;
63.28 3. procedure that determines the action with a vital study results of critical intervals and notification procedures.
the results of the investigation of 63.29 reports contain the following information: 1. identification of the laboratory 63.29, which prepared the report;
2. identification of the study of 63.29;
3. the identification of 63.29;
4. study of the principal 63.29 identification and address;
5. sample collection 63.29 date and time if this is essential;
6. in the target sample 63.29 type;
63.29 7. study results;
8. biological 63.29 reference intervals;
9. the study results 63.29 interpretation, if necessary;
10. responsible 63.29 identification and signature;
11. review of 63.29;
12. the marks of the investigated 63.29 sample investigation of non-compliance.
laboratory procedure documented 63.30 biological, chemical and other hazards. The laboratory management shall determine the hazard identification, the dangerous zones and labelling, as well as the use of the marks is responsible for regular review of hazard identification system and updating and staff information. The laboratory shall determine any action in case of accidents and adverse atgadījumo and documentation (detailed description of the incident, the agent assessment, corrective and preventive action).
63.31 staff personal protection measures have been applied and are used in the work.
the laboratory shall determine the procedure of 63.32 cooperation with laboratories for patients, including the handling of complaints.
63.33 laboratory provides the following consultancy services: 63.33 1. participate in the laboratory the patient educational meetings;
63.33 2. provide advice on studies and the choice of laboratory;
63.33 3. establish procedures for the laboratory can visit and get the information you need, and provide it.
the laboratory shall document 63.34 remedial action procedures, determining: 1 63.34. the person in charge of selection and corrective action;
63.34 2. procedures carried out an analysis of the causes of non-compliance;
63.34 3. remedial action choices in relation to the importance of the problem and possible risks;
63.34 4. remedial action plan;
63.34 5. corrective actions monitoring and evaluation of the effectiveness of actions identified problems.
This rule 3.10 63.35 subdivision of such requirements do not apply to medical laboratories accredited according to the standard LVS EN ISO 15189:2008 "medical laboratory. Particular requirements for quality and competence "."
2. the rules shall enter into force on January 1, 2011.
The Prime Minister, regional development and local Government Minister v. dombrovsky Health Minister j. Bārzdiņš