Joint Commission Laboratory Standards and Quality Management Systems A laboratory can demonstrate that it follows a quality approach to provide high reliability diagnostic results for patient care without having a specifically named quality management system (QMS) or QMS accreditation in place. The key is for the laboratory to incorporate quality concepts and processes into its day-to-day work, rather than viewing regulatory and accreditation requirements as rules that must be followed to achieve licensure or accreditation. The Joint Commission Laboratory Standards The Joint Commission’s laboratory accreditation standards (Joint Commission Standards)1 include all the information a laboratory needs for continual operational improvement within a quality management environment, organized in a specified relational structure. First, a Joint Commission standard statement broadly defines performance expectations, structures, and processes that must be in place for the laboratory to provide safe, quality services. Second, where additional explanation is needed, a rationale statement provides background, justification, or information about the purpose of a standard. Third, Elements of Performance (EPs) detail specific performance expectations, structures, or processes that 1) must be in place; 2) demonstrate compliance with the standard, and 3) enable the laboratory to provide safe, quality services. The Joint Commission uses a system and process approach to quality through its long standing and well-defined tracer methodology—an approach that clearly shows how laboratory services are incorporated into and support patient care. Tracer patients are first chosen from the period since the last survey, and then orders for laboratory tests are traced from the test order in the patient’s medical record through sample collection; receipt in the laboratory; testing, with all related quality activities that support testing; and delivery of results back through the laboratory’s paper or electronic information system to the patient’s medical record. Particular emphasis is placed on the communication of alert or critical values to the primary clinician(s) and to the management of these results. The tracer approach is distinctly different from that of reviewing discrete quality activities within a laboratory’s subspecialty testing areas because it more closely represents the relationship of laboratory work processes to patient care. ISO 15189 There is now a burgeoning interest in laboratory accreditation concerning the international laboratory quality management standard, ISO 15189.2 This standard differs from the U.S. national laboratory regulation, CLIA ’883, in that ISO 15189 requires a laboratory to have a documented quality management system—that is, a written description of how the laboratory organizes and integrates specific management processes to support preanalytic, analytic, and postanalytic technical activities. In the

2 U.S., a laboratory must demonstrate compliance with CLIA requirements to maintain an operating license. Accreditation to ISO 15189:2007 does not meet the requirements of the Centers for Medicare & Medicaid Services CLIA regulation at this time, but can be used as a quality management tool. The QSEs For over a decade, managerial and technical requirements for blood banks and laboratories have been categorized into Quality System Essentials (QSEs).4-5 The requirements expressed in the 12 laboratory QSEs were identified from regulations, accreditation requirements, checklists, and standards for medical laboratories and transfusion services, including those of the Joint Commission standards and ISO 15189. Each QSE contains all the published requirements for a particular area of laboratory activity, such as equipment management, personnel, documents and records, and continual improvement. The underlying philosophy is that the requirements represent activities necessary for providing quality laboratory services that support patient care. The QSEs allow a laboratory to organize and implement managerial and technical processes to ensure that all the requirements for a particular area are met. Table 1 is a listing of the 12 QSEs, the order of which logically follows the areas a laboratory should consider when starting a new laboratory discipline (e.g., molecular testing), implementing new testing services, or making major changes. The Quality System Essentials provide a road map that guides external assessments, such as the Joint Commission survey, through the key components of a good quality system. Table 1. The Clinical and Laboratory Standards Institute Quality System Essentials5

CLSI QSE5 Organization Customer Focus Facilities and Safety Personnel Purchasing and Inventory Equipment Process Management Documents and Records Information Management Nonconforming Event Management Assessments Continual Improvement

3 QMS accreditation Why might a laboratory seek accreditation of the QMS represented by the ISO 15189 standard? Whereas in other countries, ISO 15189 has served as that nation’s laboratory requirements, in the U.S., accreditation to ISO 15189 is an additional assessment process. By achieving ISO 15189 accreditation, a laboratory demonstrates its willingness to step above CLIA’s minimum quality control and quality assurance-based laboratory requirements to the philosophy of creating an ongoing systematic relationship between a laboratory’s management and technical activities. The Joint Commission standards already began that journey several years ago by moving from surveying discrete activities within the different laboratory specialties to evaluating, through the tracer survey methods, how the laboratory manages its extradepartmental, as well as intradepartmental, processes with evidence of improving patient care. Of important note, though, is that the current Joint Commission standards are not intended for a laboratory to achieve accreditation to ISO 15189, but rather align the organization to provide for systematic quality throughout the health care facility. The importance of leadership-driven quality processes that disseminate throughout the organization is a continuous element of The Joint Commission standards and its survey process. The Joint Commission, like ISO, sets its standards above the minimum CLIA requirements in order to establish the system and its components for process integrity and improvement. Are the Joint Commission Standards a QMS? The Joint Commission’s patient care-oriented, systematic approach to health care activities embeds many important elements that can be used in implementing a laboratory QMS including consistency in standards organization throughout a health care facility, including the laboratory. The chapters are organized by activities that span laboratory areas to drive greater process uniformity and system thinking. Through a comparison analysis, the Joint Commission laboratory standards statements were shown to align in concept with specific QSEs and/or clauses of ISO 15189. When viewed at the EP level, many additional elements from the QSEs and ISO 15189 also align. Figure 1 depicts a high-level overview of the cyclical nature of quality management and demonstrates the location of major clauses of the Joint Commission standards, the CLSI QSEs and the major clauses of ISO 15189:2007.

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Laboratory accreditation standards showing Joint Commission standards, CLSI QSEs and ISO 15189:2007 in an ISO 9001 style

Continual improvement of the laboratory JC: PI CLSI QSE: Cont Impr ISO 15189: 4.12

Organization, Management, and QMS JC: LD CLSI QSE: Org ISO 15189: 4, 4.1, 4.2, 4.15

Resource management

Measurement and analysis JC: APR, NPSG CLSI QSE: Nonconform, Assmt ISO 15189: 4.8, 4.9, 4.14

JC: HR, EC CLSI QSEs: Facil/Safety, Pers, Purch, Equip ISO 15189: 4.4, 4.5, 4.6, 4.7, 5.1, 5.2, 5.3

Laboratory user Requirements

Laboratory user

Examination Processes Request

JC: CLSI QSE: Customer ISO 15189:

Report JC: EM, QSA, DC, IC, IM, TS, WT CLSI QSEs: Prcs Mgmt, Docs & Recs, Info Mgmt ISO 15189: 4.3, 4.13, 5.4. 5.5, 5.6, 5.7, 5.8

Level of satisfaction JC: CLSI QSE: Customer ISO 15189:

Figure 1. A Quality Management System View of Laboratory Accreditation Standards In future revisions of the Joint Commission laboratory accreditation standards, more specific references to Quality Management Systems will be considered as appropriate to continue supporting a laboratory approach towards processes rather than tasks. The CLSI guideline that describes the QSEs was updated in 20115 and the revision to the ISO 15189 standard6 is currently moving through final review processes. The Joint Commission is closely following the evolving updates and changes so that future versions of the laboratory accreditation standards will incorporate and maintain quality management elements as a strong component. Table 2 shows how the 12 CLSI QSEs and the major clauses of ISO 15189:2007 align with the major sections of the Joint Commission laboratory accreditation standards. Table 2. Crosswalk of Joint Commission Laboratory Accreditation Standards (JCLAS) to Clinical and Laboratory Standards Institute Quality System Essentials (CLSI QSE) and Clauses of ISO 15189:2007 JC-LAS1

Accreditation Participation Requirements (APR)

CLSI QSE5 (not in order) Assessment

Clauses of ISO 15189:20072 (not in order) 4.8 Complaints 4.9 Nonconformities 4.14 Internal Audit

5 Document and Process Control (DC)

Document and Records

Environment of Care (EC)

Facilities and Safety

Emergency Management (EM) Human Resources (HR) Infection Prevention and Control (IC) Information Management (IM) Leadership (LD)

Process Management

National Patient Safety Goals (NPSG) Performance Improvement (PI)

Assessment

Quality System Assessment for Nonwaived Testing (QSA)

Assessment Process Management

Transplant Safety (TS) Waived Testing (WT)

Process Management Process Management

Personnel Process Management Information Management Organization

Continual Improvement

4.3 Document Control 4.13 Quality and Technical Records 5.2 Accommodation and environmental conditions

5.1 Personnel

4.1 Organization and management 4.2 Quality management system

4.10 Corrective action 4.11 Preventive action 4.12 Continual improvement 5.4 Preexamination procedures 5.5 Examination Procedures 5.6 Assuring quality of examination procedures 5.7 Post examination procedures 5.8 Reporting of results 5.4 Preexamination procedures 5.5 Examination Procedures 5.6 Assuring quality of examination procedures 5.7 Post examination procedures 5.8 Reporting of results

6

Thus, a laboratory that follows current and future editions of the Joint Commission standards will be building quality management into its processes—in a manner that directly supports improved patient care.

References 1. The Joint Commission. Laboratory Accreditation Standards. Oakbrook Terrace, IL: Joint Commission Resources, 2011. 2. ISO. ISO 15189: Medical laboratories—Particular requirements for quality and competence. Geneva: International Organization for Standardization, 2007. 3. Centers for Medicare & Medicaid Services. Department of Health and Human Services. Code of Federal Regulations, Title 42, Part 493—Laboratory Requirements: Clinical Laboratory Improvement Amendments of 1988. U.S. Government Printing Office. Published annually. 4. AABB. Standards for Blood Banks and Transfusion Services, 27th edition. Bethesda, MD: AABB Press, 2011. 5. CLSI. Quality Management System: A Model for Laboratory Services; Approved Guideline GP26-A4—Fourth Edition. Wayne, PA: Clinical and Laboratory Standards Institute, 2011. 6. ISO. ISO/DIS 15189: Medical laboratories—Particular requirements for quality and competence. Geneva: International Organization for Standardization, 2011.