Академический Документы
Профессиональный Документы
Культура Документы
2nd Edition
Goals
The following is a list of all goals. They are presented here for your convenience without their requirements, intent statements, or measurable elements. For more information about these goals, please see the next section in this chapter, Goals, Standards, Intents, and Measurable Elements.
IPSG.1 IPSG.2 IPSG.3 IPSG.4 IPSG.5 IPSG.6
Identify Patients Correctly Improve Effective Communication Not applicable for laboratories Ensure Correct-Site, Correct-Procedure, Correct-Patient Surgery Reduce the Risk of Health CareAssociated Infections Not applicable for laboratories
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Standards
The following is a list of all standards. They are presented here for your convenience without their requirements, intent statements, or measurable elements. For more information about these standards, please see the next section in this chapter, Standards, Intents, and Measurable Elements.
Planning
MGT.1
and reference laboratory services, including services that provide blood and blood products.
Contract Laboratory Services
MGT.1.2.1
The laboratory director is responsible for assuring the consistent performance of contract laboratory services.
The laboratory director is responsible for assuring the consistent performance of reference laboratory services.
Resource Planning
MGT.1.3 The leaders are responsible for providing adequate resources for the provision of
Responsibilities for administrative direction and clinical direction of the laboratory are defined in writing. In addition, other leadership roles are also defined.
MGT.2.1 The directorship of the laboratory is effective. MGT.2.2 The laboratory director is responsible for requiring practices that respect the needs of
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JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CLINICAL LABORATORIES, SECOND EDITION
Laboratory leaders provide for communication and coordination throughout the laboratory and with outside customers.
MGT.3.1 Leaders communicate to laboratory staff the priority of meeting the needs of clinicians,
Laboratory leaders are responsible for planning, documenting, implementing, and monitoring a quality management and improvement program.
MGT.4.1 The laboratorys program for process design and quality measurement, analysis, and
improvement is systematic and addresses the goals of the quality management and improvement system; all of the quality management and improvement systems components; the methodology used to measure and improve processes and services; and the systems used for quality control of laboratory testing and other services.
MGT.4.1.1 MGT.4.1.2 MGT.4.1.3 MGT.4.1.4
Laboratory leaders ensure that the program is coordinated and an appropriate individual(s) is appointed to implement and manage the process. The leaders assign adequate resources to quality management and improvement activities. Leaders communicate the key elements of the quality management and improvement program to employees. The leaders define performance and quality control activities used to monitor the laboratorys processes and the systems used to ensure proper operation and control of these processes.
The laboratory designs new and redesigns existing systems and processes according to quality improvement principles. The leaders prioritize which processes are to be measured and which improvement activities will be implemented.
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Quality measurement includes those aspects of the following that are selected by leaders: a) The laboratorys safety and infection control programs b) The laboratorys quality control programs c) Preanalytic processes, including patient preparation; specimen quality processes (collection, labeling, preservation, transportation, and rejection); and completeness of requisitions.
d) Postanalytic processes, including efficient transfer of information; timeliness of reporting test results; adequacy of documentation; and accuracy of reports.
MGT.4.2.2
Managerial measurement includes aspects of the following that are selected by leaders: a) The needs, expectations, and satisfaction of individuals and organizations served b) The appropriateness of tests offered c) Key aspects of the procurement of routinely required supplies and equipment essential to provide laboratory services d) Those aspects of laboratory employee expectations and satisfaction selected by the leaders e) Those aspects of financial management selected by the leaders f ) Those aspects of the prevention and control of events that jeopardize the safety of patients, families, and staff selected by the leaders, including the International Patient Safety Goals
laboratory requirements.
MGT.4.5 The analysis process includes comparisons internally, with other laboratories when avail-
Improvement
MGT.4.7 Improvement in quality and safety is achieved and sustained. MGT.4.8 Improvement and safety activities are undertaken for the priority areas identified by the
laboratorys leaders.
MGT.4.9 An ongoing program of identifying and reducing unanticipated adverse events and safe-
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Standards
The following is a list of all standards. They are presented here for your convenience, without their requirements, intent statements, or measurable elements. For more information about these standards, please see the next section in this chapter, Standards, Intents, and Measurable Elements.
DCP.1
The requirements for developing and maintaining the laboratorys policies and procedures are defined in a written protocol.
Policies and procedures are developed to provide step-by-step specimen collection protocols for each type of specimen submitted to the laboratory. Policies and procedures are developed to guide how specimens are accessioned and processed in the laboratory.
The laboratory has current written descriptions and instructions for performing test methods and procedures.
The laboratory has defined a process for immediate notification of the responsible clinician when specific critical results indicate that the patients situation is life-threatening. The laboratory has defined the process of measuring turnaround times. The laboratory has a defined process for correcting reported results.
A written protocol defines the storage and maintenance requirements for records, including retained specimens, slides, tissues, and blocks.
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Standards
The following is a list of all standards. They are presented here for your convenience, without their requirements, intent statements, or measurable elements. For more information about these standards, please see the next section in this chapter, Standards, Intents, and Measurable Elements.
Provision of Resources
RSM.1
The leaders provide sufficient resources to support the ongoing, uninterrupted operation of the laboratory.
RSM.1.1 Personnel policies and procedures are described in writing and are followed.
Human Resources
Staff Qualifications
RSM.1.2 Pathology and clinical laboratory services are directed by one or more qualified
professionals.
RSM.1.3 Supervisory staff and other leaders have the appropriate training and expertise to per-
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JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CLINICAL LABORATORIES, SECOND EDITION
InfrastructureBasic Facilities
RSM.3
Laboratory leaders have planned for basic facilities, including adequate space, utilities, and equipment.
RSM.3.1 There is sufficient space for all areas under control of the laboratory. The laboratory
Laboratory Space
leaders have planned and provided for appropriate space for all laboratory areas.
RSM.3.1.1 Spaces for specific laboratory areas are adequate.
Utilities Management
RSM.3.2 A plan for providing and maintaining necessary utilities is defined and implemented. RSM.3.2.1 There is a system to inspect, test, and maintain critical operating compo-
nents for utility systems and to investigate and correct utility system problems.
Laboratory leaders ensure that analytic and other equipment, as well as other material resources required for the provision of services, are adequate, appropriate, and available.
RSM.4.1 Laboratory equipment is maintained, tested, and inspected. RSM.4.1.1 A historical record is maintained for each analytical instrument and piece
There is a plan to ensure that laboratory services and facilities are secure.
The laboratory has a plan for inventory, handling, storage, and use of hazardous materials and the control and disposal of hazardous waste.
RSM.6.1 The laboratory uses a coordinated process to reduce the risks of infection as a result of
The laboratory designs a safe, accessible, effective, and efficient environment consistent with its mission, services, and law and regulation.
RSM.7.1 Laboratory leaders address fire safety. RSM.7.1.1 The laboratory conducts fire drills regularly. RSM.7.2 Adequate safety devices and equipment are provided. RSM.7.3 When a laboratory performs electron microscopy, the laboratory has processes to ensure
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Standards
The following is a list of all standards. They are presented here for your convenience, without their requirements, intent statements, or measurable elements. For more information about these standards, please see the next section in this chapter, Standards, Intents, and Measurable Elements.
Quality control processes are established for each test method, and data from these processes are available and used to monitor and ensure the stability of test systems.
QCP.1.1
The laboratory has a program of external graded interlaboratory comparison testing or proficiency testing for analytes for each specialty and subspecialty for which such testing is available.
QCP.1.1.1 QCP.1.1.2
Proficiency sample testing is performed in the same manner as patient sample testing. The laboratory uses a system for verifying the accuracy and reliability of test results obtained for those tests not included in the formal proficiency testing program.
The laboratory uses a system to evaluate and correlate the relationship between results for the same test performed with different methodologies or instruments or at different sites. The laboratory performs initial validation for new instruments and analytical systems to verify that the method(s) will produce accurate and reliable results. The laboratory validates electronic or internal monitoring systems prior to using them for routine quality control. Calibration, linearity checks, and other function checks are performed on instruments and analytic systems used for patient testing. The quality control processes of the laboratory include a coordinated review of patient results, quality control results, and instrument function checks. The laboratory takes remedial action for deficiencies identified through quality control measures or authorized inspections and documents such actions.
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JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CLINICAL LABORATORIES, SECOND EDITION
There are quality control processes in place for surgical pathology and autopsy services.
QCP.2.1
The laboratory has implemented processes for ensuring the proper identification, preservation, and documentation of receipt of surgical specimens sent for analysis.
QCP.2.1.1
When immunohistochemistry is performed, the laboratory has appropriate quality control processes.
QCP.2.2
The laboratory implements quality control and assurance processes for evaluating the ongoing qualifications of individuals who perform gross analysis of tissue and microscopic analysis of tissue. There are defined processes to document the ongoing proficiency of individuals who perform microscopic analysis of tissue. The laboratory has implemented processes to ensure access to required patient information and to cross-reference such information to assist in providing a complete and proper diagnosis.
QCP.2.3 QCP.2.4
Cytopathology
QCP.3
A pathologist or physician qualified in cytology maintains the quality of the cytopathology service through direct supervision.
QCP.3.1
The cytology laboratory has a process to measure, assess, and improve quality.
The laboratory leaders have defined quality control processes for all clinical chemistry, hematology, and coagulation tests.
QCP.4.1
For tests that produce quantitative results (such as many clinical chemistry, hematology, and coagulation analyses), laboratory quality meets certain requirements. The laboratory defines and follows certain quality control guidelines. The laboratory has quality control processes in place for blood film evaluation and differential counts.
QCP.4.2
Microbiology
QCP.5
The laboratory has quality control processes when performing bacteriology, mycobacteriology, and mycology.
QCP.5.1 QCP.5.2
Antimicrobial, antimycobacterial, and antifungal susceptibility testing systems are verified with approved reference organisms. All stains are tested with appropriate controls.
There are adequate quality control procedures when molecular microbiology testing is performed.
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Parasitology
QCP.6
If the laboratory is performing parasitology, appropriate reference materials, equipment, and methods are used.
Virology
QCP.7
If the laboratory performs tests for identifying viruses, records detailing the systems used and the reactions observed are maintained.
QCP.7.1
The laboratory uses controls that will identify erroneous results in tests for identifying viruses.
The laboratory ensures the quality of tests performed in urinalysis and clinical microscopy.
The laboratory runs serologic tests on unknown specimens, including those for syphilis, concurrently with a positive control serum of known titer and a negative control, or controls of graded reactivity, to ensure specificity of antigen reactivity.
QCP.9.1
Equipment, glassware, reagents, controls, and techniques for syphilis tests conform to manufacturers specifications.
procedures and implementing practices that ensure the safety of patients being transfused.
Donor Selection and Testing
QCP.11.1 There are defined procedures and practices for blood donor selection and blood collec-
tion. Staff are trained and assessed as competent to perform these procedures.
QCP.11.1.1 A detailed history of a donor is performed prior to selection for blood
donation.
QCP.11.1.2 An adequate physical examination is performed prior to approving the
protocol.
QCP.11.1.4 Written guidelines are implemented when autologous blood is collected. QCP.11.2 Blood and related donor records are properly identified, and the identification is main-
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JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CLINICAL LABORATORIES, SECOND EDITION
QCP.11.3 Donor blood undergoes routine testing before being used for transfusion. In addition,
process controls are used to ensure appropriate tracking and prevent blood from being released prematurely.
Blood Component Preparation or Modification
QCP.11.4 When components are prepared or modified by the organization, there are defined
procedures for their processing and storage, and appropriate quality control measures are taken.
Whole Blood
QCP.11.4.1 Tests and processes are used to maintain the quality of whole blood. This
includes whole blood from which components and products are to be processed.
Red Blood Cells
QCP.11.4.2 Defined processes are implemented to maintain the quality of red blood
cells.
Platelets
QCP.11.4.3 Defined processes are used to ensure the quality of platelets.
Plasma
QCP.11.4.4 Defined processes are used to ensure the quality of plasma.
Cryoprecipitated AHF
QCP.11.4.5 Defined processes are used to ensure the quality of cryoprecipitated AHF.
Blood and Component Storage Requirements (for Donor Facility and Blood Transfusion Services)
QCP.11.5 The blood bank director ensures that blood and components are stored in a secure and
quately reactive cells of a known type to determine the correct ABO blood group and Rh type.
QCP.11.7.1 The potency and reliability of reagents used for ABO grouping, Rh typ-
ing, antibody detection, and compatibility determinations are tested for reactivity.
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QCP.11.8 Before blood is administered, appropriate compatibility testing and antibody testing
(except in an emergency) are performed. In addition, other procedural controls are implemented.
Selecting Blood and Components for Transfusion
QCP.11.9 Specific procedures are followed when selecting blood and components for transfusion.
before transfusion.
QCP .11.10.2 Specific policies and practices are required before and during blood
administration.
Recognizing Suspected Transfusion Reactions
QCP .11.10.3 The director has defined criteria for recognition of transfusion reactions,
and/or components, and/or issues blood for transfusion, there are specific records that must be maintained.
Histocompatibility Testing
QCP.12 When performing histocompatibility testing, the laboratory uses appropriate screening techniques
and donors using the most reactive and recent sera, as appropriate to the study or individual procedure performed.
QCP.12.4 The laboratory uses reagents and antisera that are specific and verified with appropriate
available, or develops an exchange system with another laboratory to validate interlaboratory reproducibility.
QCP.12.6 Storage of records and specimens is addressed.
Cytogenetics Testing
QCP.13 Laboratory procedures and practices in cytogenetics provide for accurate results.
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JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CLINICAL LABORATORIES, SECOND EDITION
QCP.13.1 Laboratory records identify the media used, the reactions observed, and the details of
information.
QCP.13.3 The laboratory maintains individual sample identification during all phases of testing
and reporting.
Molecular Testing
QCP.14 The laboratory follows written policies and procedures for molecular testing. QCP.14.1 Validation studies include representatives from each specimen type expected to be tested
quality controls.
QCP.14.4 Molecular testing reports include specific testing information.
Molecular Genetics
QCP.14.5 The laboratory follows written policies and procedures for molecular genetic testing. QCP.14.6 Molecular genetic testing reports include specific testing information.
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