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Joint Acreditacion de Laboratorios
Joint Acreditacion de Laboratorios
JOINT COMMISSION
INTERNATIONAL
ACCREDITATION STANDARDS FOR
CliniCAl lAborAtoriEs
1 April 2010
Management and
Leadership (MGT)
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 The leaders are responsible for laboratory planning.
MGT.1.1 The leaders plan the type and scope of services to be provided after communicating
contract
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
patient preparation;
specimen quality processes (collection, labeling, preservation,
transportation, and rejection); and
completeness of requisitions.
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MANAGEMENT AND LEADERSHIP (MGT)
laboratorys leaders.
MGT.4.9 An ongoing program of identifying and reducing unanticipated adverse events and safety
risks to patients and staff is defined and implemented.
Quality Management and Improvement Program Review
MGT.4.10 Leaders manage the quality and improvement process and periodically review the
effectiveness,
adequacy, and relevance of the monitoring and improvement activities.
Development and
Control of Policies and
Procedures (DCP)
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.
procedures.
when specific critical results indicate that the patients situation is life-threatening.
DCP.4.2 The laboratory has defined the process of measuring turnaround times.
DCP.4.3 The laboratory has a defined process for correcting reported results.
Resource Management
and Laboratory
Environment (RSM)
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.
Human Resources
RSM.1.1 Personnel policies and procedures are described in writing and are followed.
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 perform
all responsibilities.
RSM.1.4 The director of the laboratory provides an adequate number of qualified staff.
Staff Orientation and Education
RSM.1.5 All new staff members are oriented to the organization and the laboratory area(s) where
RSM.1.6 In-service or other education and training maintain and improve staff competence.
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InfrastructureBasic Facilities
RSM.3 Laboratory leaders have planned for basic facilities, including adequate space, utilities, and
equipment.
Laboratory Space
RSM.3.1 There is sufficient space for all areas under control of the laboratory. The laboratory
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 components
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
of equipment used by the laboratory.
RSM.4.2 Maintenance and inspection ensure that equipment is safe.
RSM.4.3 There are defined processes in place for validating and maintaining computer software
and information, when they are used by the laboratory.
Reagents and Other Supplies
RSM.4.4 The laboratory follows written guidelines for the periodic evaluation of all reagents,
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RESOURCE MANAGEMENT AND LABORATORY ENVIRONMENT (RSM)
Quality Control
Processes (QCP)
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.
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 Proficiency sample testing is performed in the same manner as patient
sample testing.
QCP.1.1.2 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.
QCP.1.2 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.
QCP.1.3 The laboratory performs initial validation for new instruments and analytical systems to
verify that the method(s) will produce accurate and reliable results.
QCP.1.4 The laboratory validates electronic or internal monitoring systems prior to using them
for routine quality control.
QCP.1.5 Calibration, linearity checks, and other function checks are performed on instruments
and analytic systems used for patient testing.
QCP.1.6 The quality control processes of the laboratory include a coordinated review of patient
results, quality control results, and instrument function checks.
QCP.1.7 The laboratory takes remedial action for deficiencies identified through quality control
measures or authorized inspections and documents such actions.
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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.
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.
QCP.4.2 The laboratory has quality control processes in place for blood film evaluation and differential
counts.
Microbiology
QCP.5 The laboratory has quality control processes when performing bacteriology, mycobacteriology,
and mycology.
QCP.5.1 Antimicrobial, antimycobacterial, and antifungal susceptibility testing systems are verified
with approved reference organisms.
QCP.5.2 All stains are tested with appropriate controls.
Molecular Microbiology Testing
QCP.5.3 There are adequate quality control procedures when molecular microbiology testing is
performed.
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QUALITY CONTROL PROCESSES (QCP)
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
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.
Radiobioassay and Other Tests Using Radioisotopes
QCP.10 The laboratory uses written quality control procedures that provide diagnostic reliability and
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 collection.
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
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
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 typing,
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
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
for donors and recipients.
QCP.12.1 The laboratory performs mixed lymphocyte cultures or other recognized methods to
detect cellular-defined antigens according to defined methods.
QCP.12.2 The laboratory performs HLA serologic typing of both donor and recipient, as appropriate
to the study or individual procedure performed.
QCP.12.3 Before transplantation is performed, the laboratory crossmatches potential recipients
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
controls, when available.
QCP.12.5 The laboratory participates in at least one national or regional cell-exchange program, if
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.
QCP.13.1 Laboratory records identify the media used, the reactions observed, and the details of
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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