JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR Clinical Laboratories

7/30/2019 JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR Clinical Laboratories

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2d Ed

JOINT COMMISSION INTERNATIONAL

ACCREDITATION STANDARDS FOR

CliniCAl lAborAtoriEs

Effecve

1 Ap 2010


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International Patient SafetyGoals (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 Identify Patients Correctly

IPSG.2 Improve Effective Communication

IPSG.3 Not applicable for laboratories

IPSG.4 Ensure Correct-Site, Correct-Procedure, Correct-Patient Surgery

IPSG.5 Reduce the Risk of Health CareAssociated Infections

IPSG.6 Not applicable for laboratories

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Management andLeadership (MGT)

Standards

The following is a list of all standards. They are presented here for your convenience without their require-ments, intent statements, or measurable elements. For more information about these standards, please see the

next section in this chapter, Standards, Intents, and Measurable Elements.

PlanningMGT.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 per-

formance of contract laboratory services.

Reference Laboratory Services

MGT.1.2.2 The laboratory director is responsible for assuring the consistent per-

formance 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 AuthorityMGT.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 The directorship of the laboratory is effective.

MGT.2.2 The laboratory director is responsible for requiring practices that respect the needs of

patients and other customers.

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Communication and CoordinationMGT.3 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,

patients, and other users of laboratory services.

MGT.3.2 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 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 Laboratory leaders ensure that the program is coordinated and an appro-

priate individual(s) is appointed to implement and manage the process.

MGT.4.1.2 The leaders assign adequate resources to quality management and

improvement activities.

MGT.4.1.3 Leaders communicate the key elements of the quality management and

improvement program to employees.

MGT.4.1.4 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.

Design of New Processes

MGT.4.1.5 The laboratory designs new and redesigns existing systems and processes

according to quality improvement principles.

MGT.4.1.6 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 laboratorys leaders identify key measures (indicators) to measure clinical and man-

agerial structures, processes, and outcomes.

MGT.4.2.1 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.

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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 select-ed by leaders:

a) The needs, expectations, and satisfaction of individuals and organi-

zations 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 jeopard-

ize 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 The frequency of data analysis is appropriate to the process being studied and meets

laboratory requirements.

MGT.4.5 The analysis process includes comparisons internally, with other laboratories when avail-

able, and with published scientific standards and desirable practices.

MGT.4.6 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 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-

ty 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 effec-tiveness, adequacy, and relevance of the monitoring and improvement activities.


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Development andControl of Policies and

Procedures (DCP)

Standards

The following is a list of all standards. They are presented here for your convenience, without their require-ments, intent statements, or measurable elements. For more information about these standards, please see the


DCP.1 The requirements for developing and maintaining the laboratorys policies and procedures are

defined in a written protocol.

Preanalytic Policies and ProceduresDCP.2 Procedures for ordering tests are defined in writing.

DCP.2.1 Policies and procedures are developed to provide step-by-step specimen collection pro-

tocols for each type of specimen submitted to the laboratory.

DCP.2.2 Policies and procedures are developed to guide how specimens are accessioned andprocessed in the laboratory.

Analytic Policies and ProceduresDCP.3 The laboratory has current written descriptions and instructions for performing test methods and

procedures.

Postanalytic Policies and ProceduresDCP.4 The laboratory develops policies, procedures, and controls for the postexamination processes.

DCP.4.1 The laboratory has defined a process for immediate notification of the responsible clini-

cian 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.

Record and Specimen Retention RequirementsDCP.5 A written protocol defines the storage and maintenance requirements for records, including

retained specimens, slides, tissues, and blocks.

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Resource Managementand Laboratory

Environment (RSM)

Standards

The following is a list of all standards. They are presented here for your convenience, without their require-ments, intent statements, or measurable elements. For more information about these standards, please see the


Provision of ResourcesRSM.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.1.2Pathology and clinical laboratory services are directed by one or more qualifiedprofessionals.

RSM.1.3 Supervisory staff and other leaders have the appropriate training and expertise to per-

form 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

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 InformationRSM.2 Documented personnel information is maintained for each staff member.

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InfrastructureBasic FacilitiesRSM.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 compo-

nents 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 resourcesrequired 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 SuppliesRSM.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 SecurityRSM.5 There is a plan to ensure that laboratory services and facilities are secure.

Hazardous Materials and WasteRSM.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 The laboratory follows defined guidelines for handling and disposing of hazardous

chemicals and waste (including chemotherapeutic materials and waste).

RSM.6.3 If radioactive materials are used in the laboratory, there are processes for safe handling

and monitoring of them.

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RESOURCE MANAGEMENT AND LABORATORYENVIRONMENT(RSM)

Work EnvironmentLaboratory 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 Adequate safety devices and equipment are provided.

RSM.7.3 When a laboratory performs electron microscopy, the laboratory has processes to ensure

safety and quality.


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Quality ControlProcesses (QCP)

Standards

The following is a list of all standards. They are presented here for your convenience, without their require-

ments, intent statements, or measurable elements. For more information about these standards, please see thenext section in this chapter, Standards, Intents, and Measurable Elements.

Quality Control Common to All Areas of TestingQCP.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 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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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 appropri-

ate 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 micro-

scopic analysis of tissue.

QCP.2.3 There are defined processes to document the ongoing proficiency of individuals who

perform microscopic analysis of tissue.

QCP.2.4 The laboratory has implemented processes to ensure access to required patient informa-

tion and to cross-reference such information to assist in providing a complete and prop-er 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 For tests that produce quantitative results (such as many clinical chemistry, hematology,

and coagulation analyses), laboratory quality meets certain requirements. The laborato-

ry defines and follows certain quality control guidelines.

QCP.4.2 The laboratory has quality control processes in place for blood film evaluation and dif-

ferential 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 veri-

fied 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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QUALITYCONTROL PROCESSES (QCP)

Parasitology

QCP.6 If the laboratory is performing parasitology, appropriate reference materials, equipment, and meth-

ods 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, concur-

rently 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 ResponsibilityQCP.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 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

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 main-

tained from collection through the time the unit is transfused.


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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 measuresare 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 BloodTransfusion 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 vol-

ume 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 TransfusionQCP.11.7 The laboratory tests donor blood and recipient blood with potent typing sera and ade-

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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QUALITYCONTROL 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 todetect cellular-defined antigens according to defined methods.

QCP.12.2 The laboratory performs HLA serologic typing of both donor and recipient, as appro-

priate 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 indi-

vidual 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, ifavailable, or develops an exchange system with another laboratory to validate interlabo-

ratory 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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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.13.3The laboratory maintains individual sample identification during all phases of testingand 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.


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JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR Clinical Laboratories