JCI

The standards and measurable elements (MEs) related to Medical Laboratory services are primarily detailed in the Assessment of Patients (AOP) chapter and the Prevention and Control of Infections (PCI) chapter of the JCI Accreditation Standards for Hospitals, 8th Edition.

Standard AOP.03.00: Availability and Compliance Laboratory services must be available to meet patient needs, and all laboratory services must meet applicable local and national standards, laws, and regulations.

• ME 1: Laboratory services, including outside sources of laboratory services, meet applicable local and national standards, laws, and regulations.

• ME 2: Laboratory services meet the needs of the patients and other services the hospital provides, including a process to access laboratory services after hours and for emergency needs.

• ME 3: Experts in specialized diagnostic areas are contacted when needed.

Standard AOP.03.01: Leadership and Staff Qualifications A qualified individual(s) must be responsible for managing the clinical laboratory or pathology service, and all laboratory staff must be qualified to perform tests and interpret results.

• ME 1: The clinical laboratory and other laboratory services throughout the hospital are under the direction and oversight of one or more qualified individuals.

• ME 2: Responsibilities of the qualified laboratory leader include developing, implementing, and maintaining policies and procedures; providing administrative oversight; maintaining quality control programs; developing and implementing a staffing program; recommending outside sources; and monitoring and reviewing all services.

• ME 3: All laboratory staff have the required qualifications to perform and interpret tests.

• ME 4: A laboratory staffing program is implemented so staff can perform tests promptly and provide staffing during all hours of operation and emergencies.

• ME 5: Laboratory supervisory staff are identified and have the proper qualifications and experience for the role.

Standard AOP.03.02: Point-of-Care Testing (POCT) Oversight The hospital has defined requirements for the oversight and supervision of the point-of-care testing program.

• ME 1: The person responsible for managing laboratory services, or a designee, provides oversight and supervision of the POCT program.

• ME 2: Staff performing POCT have the required qualifications and training and are competent to perform POCT.

• ME 3: The POCT program includes a defined process for reporting abnormal test results, including reporting critical results.

• ME 4: The POCT program includes requirements for quality control performance and documentation.

• ME 5: The POCT program is monitored, evaluated, and included in quality improvement activities.

Standard AOP.03.03: Turnaround and Reporting Times Laboratory results are reported within time frames defined by hospital policy.

• ME 1: The hospital has a written policy establishing expected reporting times for routine and urgent (stat) test results.

• ME 2: The hospital monitors whether stat tests are reported within the expected time frame.

• ME 3: The hospital monitors whether routine laboratory results are reported within the expected time frame.

• ME 4: Corrective actions are taken when laboratory results are not reported within the expected time frame.

Standard AOP.03.04: Equipment Management All laboratory testing equipment is regularly inspected, maintained, and calibrated, and appropriate records are maintained.

• ME 1: The laboratory manages equipment with a written process for selection and acquisition.

• ME 2: There is an inventory of all laboratory equipment.

• ME 3: Equipment is inspected and tested when new and according to manufacturers’ guidelines, with documented inspections.

• ME 4: Equipment is calibrated and maintained according to manufacturers’ guidelines, and these activities are documented.

• ME 5: The hospital monitors and acts on equipment hazard notices, recalls, reportable incidents, problems, and failures.

Standard AOP.03.05: Reagents and Supplies Essential reagents and supplies are available, and all reagents are evaluated to ensure accuracy and precision of results.

• ME 1: Essential reagents and supplies are identified and available, with a process to address shortages.

• ME 2: All reagents are stored and dispensed according to manufacturers’ instructions.

• ME 3: The laboratory establishes and follows a written policy to evaluate all reagents for accuracy and precision.

• ME 4: All reagents undergo quality control testing as required by the manufacturer.

• ME 5: Reagent records include the identity of the reagent, date of receipt/preparation, lot number, expiration date, and date put into use.

Standard AOP.03.06: Specimen Management Procedures for collecting, identifying, handling, safely transporting, and disposing of specimens are established and implemented.

• ME 1: Procedures are established and implemented for the ordering of tests.

• ME 2: Procedures are established and implemented for the collection and identification of specimens.

• ME 3: Procedures are established and implemented for the transport, storage, and preservation of specimens.

• ME 4: Procedures are established and implemented for the receipt and tracking of specimens.

• ME 5: Procedures are established and implemented for the disposal of specimens.

• ME 6: These procedures are also followed when contracted laboratory services are used.

Standard AOP.03.07: Norms and Ranges Established norms and ranges are used to interpret and to report clinical laboratory results.

• ME 1: The laboratory establishes reference ranges for each test performed.

• ME 2: The range is included in the medical record at the time test results are reported.

• ME 3: Ranges are provided when tests are performed by contracted laboratory services.

• ME 4: Ranges are appropriate to the hospital’s geography and patient demographics.

• ME 5: The laboratory reviews and updates ranges as needed.

Standard AOP.03.08: Quality Control and Proficiency Testing The hospital has implemented processes for quality control and proficiency testing of laboratory services.

• ME 1: The hospital establishes and implements a written quality control program for the clinical laboratory.

• ME 2: The program includes validating test methods for accuracy, precision, and reportable range.

• ME 3: The program includes daily surveillance and documentation of test results.

• ME 4: The program includes rapid correction and documentation of deficiencies.

• ME 5: The laboratory participates in a proficiency testing program (or an alternative peer exchange for all laboratory tests when external assessments are unavailable).

• ME 6: The laboratory’s proficiency testing results meet satisfactory performance criteria in accordance with laws and regulations.

Standard AOP.03.09: Contracted Laboratory Services The hospital ensures the quality of services provided by contracted laboratories.

• ME 1: The hospital maintains a copy of the license, certificate, or letter of accreditation from a recognized authority for all contracted laboratories.

• ME 2: The hospital maintains documentation that contracted laboratories participate in a proficiency testing program.

• ME 3: The hospital determines the frequency and type of performance expectation data from contracted laboratories.

• ME 4: The individual responsible for the laboratory (or a designee) reviews performance data from contracted laboratories and takes action based on the results.

• ME 5: An annual report of the data from contracted laboratories is provided to leaders responsible for contract management and renewal.

Standard PCI.02.01: Laboratory Infection Prevention and Biosafety The laboratory implements a process to reduce the risks of infection resulting from exposure to infectious diseases and biohazardous materials and waste.

• ME 1: The laboratory implements written policies and procedures to reduce the risks of infection.

• ME 2: The hospital reports infections acquired in the laboratory as defined in policy and in compliance with laws and regulations.

• ME 3: The laboratory follows biosafety rules, including: controlling aerosol/droplet exposures; wearing appropriate coats/gowns; using biosafety cabinets as required; implementing procedures for accident handling and decontamination; safe specimen collection and handling; specific prohibitions in technical areas (e.g., no eating, smoking, or mouth pipetting); training staff on bloodborne pathogens; and managing exposure risks to highly infectious diseases.

• ME 4: The hospital takes corrective actions, which are documented and reviewed, when problems with practice are identified or accidents occur.

The survey process and guide for the medical laboratory are structured around the Laboratory Tracer activity, which evaluates how laboratory services are provided and integrated into the hospital's overall quality and safety programs.

Purpose of the Laboratory Tracer The tracer visit to the laboratory aims to address several key areas:

• Section-specific policies and technical procedures.

• Documentation of preventive maintenance and quality control.

• Infection prevention, control, and safety practices.

• Practices for specimen collection and processing.

• Review and evaluation of the point-of-care testing (POCT) program.

• Adequacy of staff numbers and their overall competence.

• Review of blood bank practices, if applicable.

What Will Occur During the Survey The tracer takes place in the laboratory department as well as any areas outside the department where laboratory tests or point-of-care testing occur. Participants usually include the laboratory director, the laboratory safety officer, the individual overseeing POCT, technicians, and other staff providing laboratory services.

During the visit, surveyors will:

• Assess the implementation of all elements of the laboratory safety program.

• Review the hospital’s list of critical results, the process for managing them, the turnaround time (TAT) for critical results, and the TAT monitoring process for emergent/stat tests.

• Discuss the POCT program, focusing on its scope, oversight management, performance data collection, and improvements made based on that data.

• Review documentation for equipment inspection, testing, and maintenance.

Sample Survey Questions (How to Prepare) To prepare for the tracer, hospital staff should be ready to answer the following sample questions used by surveyors to assess compliance with specific standards:

• Scope of Services & Contracted Labs (AOP.03.00): What is the scope of services and how is this documented? What tests are performed in outsourced laboratories? Can you provide the contract and the process for how these services are selected?.

• Leadership & Staffing (AOP.03.01): What are the qualifications and responsibilities of the individual who oversees the laboratory, including the oversight of the POCT program? How does the hospital ensure adequate staffing of the laboratory?.

• Point-of-Care Testing (AOP.03.02): Who supervises the POCT program? Is there a documented list of point-of-care tests that take place in the hospital? Which staff are allowed to perform POCT, and what is the process for determining their qualifications and competency? What is the process for reporting POCT critical results? Who does the daily quality control of the POCT devices?.

• Turnaround Times & Ordering (AOP.03.03): How are turnaround times (TATs) for internal laboratory tests and outsourced laboratory tests tracked? What is the process for ordering laboratory tests?.

• Equipment Maintenance (AOP.03.04): How is the equipment maintenance program documented? How do staff document all equipment failures or problems?.

• Reagents (AOP.03.05): How are reagents evaluated (internal quality control)? Do all reagents undergo quality control testing as required by the manufacturer?.

• Quality Management & Proficiency (AOP.03.08): Describe the laboratory’s quality management system. Who surveys the test results daily, and how/for what length of time are the samples preserved for peer comparison? What criteria are used to determine that proficiency testing results are satisfactory?.

• Blood Bank (AOP.04.00, AOP.04.01): What services does the blood bank provide? What are the applicable laws and regulations? What are the qualifications for people who can donate blood?.

• Biosafety & Infection Control (PCI.02.01): How is the laboratory part of the overall infection prevention and control program of the hospital? What reports are provided to the governing entity? What is the policy related to addressing staff’s risk of developing a laboratory-acquired infection? How is information associated with staff-related injuries (e.g., needlestick injuries, major spills, toxic agent exposure, TB transmission) tracked, analyzed, and used to make improvements?.

•  Blood centre KPIs

• Laboratory KPIs