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New quality guidelines for laboratories.

A quality system is becoming the current standard for today's laboratory. New quality system models provide comprehensive, uniform programs to meet most regulatory requirements.

What's new in quality these days? Currently, there is a movement in the national and international arenas to provide guidance for blood banks, laboratories, and healthcare organizations on upgrading their quality control and quality assurance programs to the next stage--that of quality systems. Whereas quality assurance monitors the performance of individual aspects of a lab's operations, a quality system applies universal quality elements across all of a lab's operations. This article will review 3 documents that are applicable to the healthcare and laboratory settings and describe the features of a quality system.

Three documents on quality systems We begin our discussion with a look at the origins, development, and publication of 3 different guidelines for quality systems.

The blood banks begin. US blood centers and transfusion services began adopting the concepts of quality systems into their operations in the mid-1990s, based on direction provided by a 1993 Food and Drug Administration quality assurance guideline. [1] The American Association of Blood Banks quickly followed suit and published its quality program in 1994. [2] Three years later, the AABB simplified that program by publishing 10 quality system essentials (QSEs). [3] The 10 QSEs have now been incorporated as blood bank standards into the most recent edition of the AABB's Standards for Blood Banks and Transfusion Services. [4] In addition, the AABB has revised its accreditation program to assess a blood bank's or transfusion service's implementation of the QSEs, as well as the status of their technical operations. Most blood centers and transfusion services are now well into carrying out their quality systems. The AABB QSEs are shown in the first column of the table.

The laboratories follow. Quality coordinators in hospital-based transfusion services quickly realized that the QSEs proposed for blood banks were applicable to the entire clinical laboratory as well. The QSEs represent many regulatory requirements in the Clinical Laboratory Improvement Amendments of 1988 as well as accreditation requirements for laboratories of the Joint Commission on Accreditation of Healthcare Organizations and the College of American Pathologists. Uniformity of these quality activities across the laboratory disciplines of chemistry, hematology, microbiology, transfusion services, and surgical pathology improves the efficiency and effectiveness of laboratory operations and the likelihood of fewer deficiencies on accreditation inspections.

Recognizing this, the NCCLS (formerly known as the National Committee for Clinical Laboratory Standards) convened a subcommittee to write a guideline for a quality system for the medical laboratory. The NCCLS subcommittee used the AABB QSEs, with only minor modifications, as the basis for a quality system model that was recently published as GP26-A, A Quality System Model for Health Care, [5] an approved guideline. The 10 QSEs used in the NCCLS quality system are shown in the middle column of the table.

The scene worldwide. Since 1988, the worldwide standard for a quality system in business and industry has been the ISO 9000 guidelines published by the International Organization for Standardization. Countries trading their products across international boundaries realized the benefit of having standardized requirements that improved quality and reduced the cost and time involved in multiple, international quality inspections. The ISO 9000 quality standards have been the stepping-stone to the development of more specific quality standards for selected applications, such as the QS 9000 standards used in our country's automotive industry.

The US-based NCCLS has been functioning as the secretariat for the US Technical Advisory Group 212 (US-TAG for ISO/TC 212), in which the Technical Committee's Work Group 1 (TC 212,WGl) has spent the past 3 years drafting international standard (DIS) #15 189, Quality Management in the Medical Laboratory. [6] This document is currently in the draft international stage and is being circulated worldwide for comments and approval before recognition as a final draft international standard, which is expected sometime in 2000. The 21 management system, resource, and technical requirements are matched with their respective QSE counterparts of the AABB and NCCLS GP26-A in the third column of the table.

The NCCLS model

The NCCLS GP26-A model of a quality system identifies universal quality elements and applies them to a healthcare service's operations (see Figure). The 10 NCCLS quality system essentials are almost identical in both name and content to the AABB QSEs. Ideally, the QSEs should be practiced uniformly across all operations in the laboratory's workflow path, which represents activities that precede, are part of, and take place after analytical testing.

One way to look at the QSEs is as a grouping of all related CLIA '88 sub-clauses, CAP checklist items, and JCAHO standards for that topic. Indeed, that's how they were first outlined. [7] By collecting all the like requirements together under universal headings such as personnel and equipment that are applicable to any healthcare organization, the QSEs offer a way to standardize policies, processes, and procedures for these activities in other clinical services, as well as in the laboratory. The NCCLS GP26 subcommittee filled any gaps in current laboratory regulations and accreditation requirements with quality elements from the original ISO 9000 quality standards.

The advantage of organizing a laboratory's quality program using QSEs is that the activities can proceed uniformly in all the clinical subspecialties, including the transfusion service, which must comply with the QSEs to maintain its AABB accreditation. Logically, if the QSEs contain the regulations and accreditation requirements, then a laboratory that organizes itself around the QSEs will be prepared for all regulatory and accreditation inspections. Wouldn't it be helpful to eliminate all the last-minute hassles and anxiety just before the CAP, AABB, or JCAHO visits?

The following offers a brief summary of each NCCLS QSE. A more complete outline of the contents of the QSEs can be found in the tables in Section 7 of NCCLS GP26-A.

QSE 1: Organization. The laboratory's executive management, administrative directors, medical directors, managers, and supervisors must all support and participate in the laboratory's quality system. They should demonstrate this support and participation by developing policies for the QSEs, providing resources for the processes needed to implement the policies, and removing barriers to implementation. The management team must also conduct periodic reviews of the quality system, review the findings, take corrective actions on identified problems, and plan for quality improvements. More information on management's role in quality planning can be found in NCCLS GP22-A, "Continuous Quality Improvement: Essential Management Approaches." [8]

QSE 2: Personnel. People are the most valuable asset of the laboratory. They should be provided with clearly defined job qualifications and job descriptions. Staff members' success on the job increases with uniform processes for employee orientation, training, competence assessment, and performance review. Training should be provided when employees are new, when new procedures are implemented, when procedures are changed, and when training needs are identified.

QSE 3: Equipment. Lab equipment should be installed, calibrated, maintained, and used in accordance with the manufacturer's instructions. All additional accreditation and regulatory requirements must be followed. The laboratories should have consistent processes for installing, calibrating, using, maintaining, and troubleshooting equipment as well as obtaining service when needed.

QSE 4: Purchasing and inventory. Laboratories must identify the critical supplies and services they use and define the criteria to be met by vendors for each critical supply and service. Collaboration with the organization's purchasing function is essential to ensure that the needs of the organization, the laboratory, and the vendor are met. There should be processes for receiving, inspecting and testing (where necessary) purchased materials and for managing inventory.

QSE 5: Process control. Each laboratory should identify the processes in its respective operations. Flow charts that identify current processes will aid in visualizing how the operations occur. New or changed processes should be validated to ensure they work as expected and meet the end user's needs. There must be well-written instructions that are understood and used by the laboratory and non-laboratory staff who perform tasks in the laboratory's workflow path. These documents communicate important requirements that ensure consistency and successful performance. Quality control and proficiency testing programs ensure that test methods work as expected and provide accurate results.

QSE 6: Documents and records. Written policies, process descriptions (flowcharts of lab operations), and standard operating procedures are documents that communicate information to those who perform laboratory tasks. Uniformity in appearance and content for standard operating procedures and forms increases staff understanding and consistency in performance. Records are the completed worksheets, forms, computer printouts, labels, and tags that capture the information obtained, activities performed, or results achieved when a procedure is done. Both documents and records need to be managed and archived.

QSE 7: Occurrence management. When variances to expected activities occur, the laboratory's ability to be of useful service to its customers is compromised. The laboratory should detect, document, and analyze these incidents to determine the underlying problems they represent and take subsequent actions to correct those problems. Occurrence management is an important part of the larger organization's risk management program.

QSE 8: Internal assessment. Quality assurance indicators should be identified and measured for all major processes in laboratory operations. Action should be taken when the information from the indicators demonstrates unacceptable performance. Periodic audits of operations and the quality system can demonstrate various gaps and weaknesses that occur between the laboratory's documents and its actual operating practices.

QSE 9: Process improvement. Information that identifies needed improvements in laboratory operations will come from sources such as complaints, external inspections, internal audits, benchmarking, and customer feedback. The laboratory should select and use a problem-resolution process that includes the elements of problem identification and prioritization, problem analysis, root cause determination, generation and selection of a solution, and monitoring for effective solution to the problem.

QSE 10 Service and satisfaction. Each laboratory should actively seek and measure the satisfaction of its internal (employee) and external (physician, patient, other) customers with its services. When problems are identified, the problem resolution processes are used to improve those operations.

The laboratory's workflow path. The second half of the NCCLS GP26-A guideline discusses how to implement a quality system using the clinical laboratory as an example. A list of key elements for the operations in the laboratory's workflow path, condensed from CLIA '88 regulations and CAP and JCAHO laboratory accreditation requirements, are given in the figure (p. 48). The laboratory can use this checklist to determine if all its clinical subspecialties meet technical requirements.

Other features of GP26-A. In addition to suggesting a sequence for implementing a quality system, the guideline includes examples of laboratory quality policies, processes, and procedures. Sample formats for technical operating procedures are given. Suggestions are provided for what to include in the laboratory's employee training program, along with a reporting form for occurrences and a list of quality indicators to monitor.

Raising the bar

In the past, laboratories were leaders in quality operations in healthcare because of their quality control and interlaboratory-comparison programs. Now, after 10 years of quality assurance, the bar is being raised. To keep pace with the advances in quality in the world around us, we need only note that an international standard for a quality system in the medical laboratory is close to realization. Only one US laboratory, Quest Diagnostics, Inc., Nichols Institute, in San Juan Capistrano, CA, has achieved international recognition of its ISO 9001 quality system (in 1998). This model for quality assurance in design, development, production, installation, and servicing [9,10] used by car manufacturers and other industries to build quality products was the only guidance available when Quest developed its system. With these new guidelines written in laboratory language, implementing a quality system in our nation's laboratories is realistic and achievable.

Lucia Berte is a quality systems consultant in Elmhurst, IL.


(1.) Food and Drug Administration, Center for Biologics Evaluation and Research. Guideline for quality assurance in blood establishments. Rockville, MD; Food and Drug Administration; 1995. Docket No. 91N-0450.

(2.) American Association of Blood Banks. The quality program. Bethesda, MD; American Association of Blood Banks; 1994.

(3.) American Association of Blood Banks. Association Bulletin 97-4: Quality System Essentials. Bethesda, MD; American Association of Blood Banks; 1997.

(4.) American Association of Blood Banks. Standards for blood banks and transfusion services. 19th ed. Bethesda, MD; American Association of Blood Banks; 1999.

(5.) NCCLS. A quality system model for health care; Approved Guideline GP26-A. Wayne, PA; NCCLS; 1999.

(6.) International Organization for Standardization. Quality management in the medical laboratory, ISO/DIS 15189. Geneva, Switzerland; International Organization for Standardization; 1998.

(7.) Nevalainen DE, Berte LM. Pounding the drum for quality: A new beat. CAP Today. 1997; 11(3):10-20.

(8.) NCCLS. Continuous quality improvement: Essential management approaches; Approved Guideline GP22-A. Wayne, PA; NCCLS; 1999.

(9.) International Organization for Standardization. ISO 9001: Quality assurance in design, development, production, installation and servicing. In: ISO 9000 Quality Management-ISO Standards Compendium. 6th ed. Geneva, Switzerland; International Organization for Standardization; 1996.

(10.) Nevalainen DE. ISO 9000 quality system and accreditation. Lab Med. 1999;30(11):732-735.
 AABB, NCCLS, and ISO/DIS 15189 quality system models
 This table provides a comparison of 3 models for
 quality systems; each row (between rules)
 represents or is related to 1 quality system essential.
Organization Organization
Personnel Personnel
Equipment Equipment
Agreement review Purchasing and inventory
Process control Process control
Documents and records Documents and records
Incidents, errors and Occurrence management
Internal and external Internal assessment
Process improvement Process improvement
Facilities and safety Service and satisfaction
AABB QSEs [1] ISO/DIS 15189 [3]
Organization 4.1 Organization and management
 4.2 Quality management system
 4.4 Referral of examinations to other laboratories
 4.12 Management review
Personnel 5.1 Personnel
Equipment 5.3 Laboratory equipment
Agreement review 4.5 External services and supplies
Process control 5.2 Accommodation and environmental conditions
 5.4 Pre-examination procedures
 5.5 Examination procedures
 5.6 Assuring the quality of examination procedures
 5.7 Post-examination procedures
 5.8 Reporting results
 5.9 Alternations and amendments of reports
Documents and records 4.3 Document control
 4.10 Quality records and technical records
Incidents, errors and 4.6 Control of nonconformities
Internal and external 4.11 Internal audits
Process improvement 4.8 Preventive actions
 4.9 Corrective actions
Facilities and safety 4.7 Consultative services and resolution of complaints

(1.)American Association of Blood Banks. Standards for Blood Banks and Transfusion Services. 19th ed. Bethesda MD; American Association of Blood Banks; 1999.

(2.)NCCLS A Quality System Model for Health Care, Approved Guideline GP26-A. Wayne PA; NCCLS; 1999.

(3.)International Organization for Standardization/TC 212/WG 1. ISO/DIS 15189 Quality Management in the Medical Laboratory. Geneva, Switzerland; International Organization for Standardization; 1998.

QSE = quality system essentials; AABB = American Association of Blood Banks; NCCLS = National Committee for Clinical Laboratory Standards; ISO/DIS = International Organization for Standardization/Draft International Standard.

Laboratory workflow path


Patient assessment

Test request

Specimen collection

Specimen transport

Specimen receipt





Results reporting

Post-test specimen management

Information management

Laboratory information system

Information management

Clinical application/consultation

10 QSEs apply to all stages of workflow path
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Article Details
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Author:Berte, Lucia M.
Publication:Medical Laboratory Observer
Geographic Code:1USA
Date:Mar 1, 2000
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