JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CliniCAl laboratories 2nd Edition Effective 1 April 2010
International Patient Safety Goals (IPSG) 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 Care Associated Infections Not applicable for laboratories 29
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 with customers regarding their needs. Contract and Reference Laboratory Services MGT.1.2 The laboratory director and other leaders define the process for selecting and approving 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 of contract laboratory services. Reference Laboratory Services MGT.1.2.2 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 planned laboratory services. Responsibility and Authority MGT.2 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 MGT.2.2 The directorship of the laboratory is effective. The laboratory director is responsible for requiring practices that respect the needs of patients and other customers. 33
JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CLINICAL LABORATORIES, SECOND EDITION Communication and Coordination MGT.3 Laboratory leaders provide for communication and coordination throughout the laboratory and with outside customers. MGT.3.1 MGT.3.2 Leaders communicate to laboratory staff the priority of meeting the needs of clinicians, patients, and other users of laboratory services. Necessary policies are developed for communicating with clinicians who order tests. Quality Management and Improvement Process Planning and Coordination of the Quality Management and Improvement Program MGT.4 Laboratory leaders are responsible for planning, documenting, implementing, and monitoring a quality management and improvement program. MGT.4.1 The laboratory s 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 system s 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 Design of New Processes MGT.4.1.5 MGT.4.1.6 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 laboratory s 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. Data Collection for Quality Measurement MGT.4.2 The laboratory s leaders identify key measures (indicators) to measure clinical and managerial structures, processes, and outcomes. 34 MGT.4.2.1 Quality measurement includes those aspects of the following that are selected by leaders: a) The laboratory s safety and infection control programs b) The laboratory s quality control programs c) Preanalytic processes, including patient preparation; specimen quality processes (collection, labeling, preservation, transportation, and rejection); and completeness of requisitions.
MANAGEMENT AND LEADERSHIP (MGT) 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 Analysis of Measurement Data MGT.4.3 Individuals with appropriate experience, knowledge, and skills systematically aggregate and analyze data in the laboratory. MGT.4.4 MGT.4.5 MGT.4.6 The frequency of data analysis is appropriate to the process being studied and meets laboratory requirements. The analysis process includes comparisons internally, with other laboratories when available, and with published scientific standards and desirable practices. Data are analyzed when undesirable trends and variation are evident from the data. Improvement MGT.4.7 Improvement in quality and safety is achieved and sustained. MGT.4.8 MGT.4.9 Improvement and safety activities are undertaken for the priority areas identified by the laboratory s leaders. 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. 35
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 laboratory s policies and procedures are defined in a written protocol. Preanalytic Policies and Procedures DCP.2 Procedures for ordering tests are defined in writing. DCP.2.1 DCP.2.2 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. Analytic Policies and Procedures DCP.3 The laboratory has current written descriptions and instructions for performing test methods and procedures. Postanalytic Policies and Procedures DCP.4 The laboratory develops policies, procedures, and controls for the postexamination processes. DCP.4.1 DCP.4.2 DCP.4.3 The laboratory has defined a process for immediate notification of the responsible clinician when specific critical results indicate that the patient s situation is life-threatening. The laboratory has defined the process of measuring turnaround times. The laboratory has a defined process for correcting reported results. Record and Specimen Retention Requirements DCP.5 A written protocol defines the storage and maintenance requirements for records, including retained specimens, slides, tissues, and blocks. 57
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 RSM.1.4 Supervisory staff and other leaders have the appropriate training and expertise to perform all responsibilities. 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 they are assigned, as well as to their specific job responsibilities. RSM.1.6 In-service or other education and training maintain and improve staff competence. Competence Assessment and Performance Evaluation RSM.1.7 Following orientation and/or training, and periodically thereafter, the competence of each staff member to perform assigned tasks is assessed. Documented Personnel Information RSM.2 Documented personnel information is maintained for each staff member. 67
JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CLINICAL LABORATORIES, SECOND EDITION Infrastructure Basic 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 for utility systems and to investigate and correct utility system problems. Laboratory Equipment and Other Materials RMS.4 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 of equipment used by the laboratory. RSM.4.2 RSM.4.3 Maintenance and inspection ensure that equipment is safe. 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, including water, to provide for accuracy and precision of results. RSM.4.5 Laboratory records include documentation of required information for reagents, and reagents are completely and accurately labeled. Safety and Security RSM.5 There is a plan to ensure that laboratory services and facilities are secure. Hazardous Materials and Waste RSM.6 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 exposure to biohazardous materials and waste. RSM.6.2 RSM.6.3 The laboratory follows defined guidelines for handling and disposing of hazardous chemicals and waste (including chemotherapeutic materials and waste). If radioactive materials are used in the laboratory, there are processes for safe handling and monitoring of them. 68
RESOURCE MANAGEMENT AND LABORATORY ENVIRONMENT (RSM) Work Environment Laboratory Safety RSM.7 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 RSM.7.3 Adequate safety devices and equipment are provided. When a laboratory performs electron microscopy, the laboratory has processes to ensure safety and quality. 69
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. Quality Control Common to All Areas of Testing QCP.1 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. QCP.1.2 QCP.1.3 QCP.1.4 QCP.1.5 QCP.1.6 QCP.1.7 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. 89
JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CLINICAL LABORATORIES, SECOND EDITION Specialty Quality Control Histopathology QCP.2 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 QCP.2.3 QCP.2.4 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. 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. Clinical Laboratory Testing Clinical Chemistry, Hematology, and Coagulation QCP.4 The laboratory leaders have defined quality control processes for all clinical chemistry, hematology, and coagulation tests. QCP.4.1 QCP.4.2 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. 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. Molecular Microbiology Testing QCP.5.3 There are adequate quality control procedures when molecular microbiology testing is performed. 90
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 reactions observed are maintained. QCP.7.1 The laboratory uses controls that will identify erroneous results in tests for identifying viruses. Urinalysis and Clinical Microscopy QCP.8 The laboratory ensures the quality of tests performed in urinalysis and clinical microscopy. Diagnostic Immunology and Serology QCP.9 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. Radiobioassay and Other Tests Using Radioisotopes QCP.10 The laboratory uses written quality control procedures that provide diagnostic reliability and patient and staff safety when it uses in vitro radioisotopes. QCP.10.1 Any laboratory performing in vivo testing uses an appropriate quality control system for such testing and equipment performance checks. Blood Bank and Transfusion Services Director Responsibility QCP.11 The director of the blood bank or transfusion services is responsible for developing policies 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. 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 individual as a blood donor. QCP.11.1.3 Donor blood is collected safely and aseptically according to a defined 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 maintained from collection through the time the unit is transfused. 91
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 Red Blood Cells Platelets Plasma 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. QCP.11.4.2 Defined processes are implemented to maintain the quality of red blood cells. QCP.11.4.3 Defined processes are used to ensure the quality of platelets. 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 appropriate fashion in order to prevent damage or deterioration. QCP.11.5.1 Storage areas used for blood and components are appropriate for the volume and variety of components stored. QCP.11.5.2 Storage areas for blood and components are monitored to ensure that appropriate temperatures are maintained. QCP.11.6 The laboratory maintains identification and traceability of specimens; reagents; test results; and blood, blood components, and products. Blood Transfusion Services Testing of Blood Prior to Transfusion QCP.11.7 The laboratory tests donor blood and recipient blood with potent typing sera and adequately 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. 92
QUALITY CONTROL PROCESSES (QCP) 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. Blood Issuance and Transfusion QCP.11.10The director of the blood transfusion services provides policies and procedures to guide acceptable practices for blood and component transfusion. QCP.11.10.1 There are defined processes for checking blood out of the blood bank 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, as well as steps to take when symptoms occur. Blood Donor and Transfusion Services Record Requirements QCP.11.11When the laboratory draws donor blood, prepares blood components, stores blood 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. 93
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 each step of the identification procedure. QCP.13.2 The laboratory obtains and includes in the interpretative report all required clinical 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 in the assay and specimens representing the scope of reportable results. QCP.14.2 The laboratory establishes quality control limits, reference ranges, and reportable ranges. QCP.14.3 The laboratory verifies each test run of patient samples in molecular pathology, using 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. 94