Quality Management for Laboratory and Ancillary Services
Lucia M. Berte
President, Laboratories Made Better! P.C.
16575 Ellingwood Drive
Broomfield, CO 80023-8324
T: 303-487-1135
E: lmberte@comcast.net
Submission for Advance for Administrators of the Laboratory on behalf of the ASQ-QIHC
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Introduction
A medical laboratory in the United States is one of the most highly regulated health care
services because it is subject to so many national and international requirements. The
challenge for laboratories of any size, scope, and specialty is how to have a single quality
management system that 1) meets all these requirements, as well as those of customers
and users; 2) improves patient safety; 3) saves money; and 4) provides a competitive
advantage.
A T-shaped model exists that condenses all the applicable requirements into a quality
management system (QMS) framework (1, 2), as illustrated in Figure 1. The vertical stem
of the “T” represents 12 management activities critical to the success of any type of entity
and are known as “quality system essentials” (QSEs). Each QSE is a compilation of all
the regulatory and accreditation requirements for that topic from a wide variety of
documents and organizations. (3-13) QSE contents are arranged in the order in which
they occur in the laboratory. For example, all the requirements on the topic of personnel
management have been condensed into the following short list:

Personnel qualifications

Job descriptions

Staff orientation to the organization

Staff training in quality, safety computer systems, and assigned work processes

Initial and ongoing assessments of staff competence

Continuing education
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
Professional growth and development
From this list, any health care service can easily develop the policies, processes, and
procedures needed to meet the personnel requirements in any QMS.
Quality System Essentials—Management’s Responsibility
Laboratory management is responsible for developing and implementing policies,
processes, and procedures for its management and technical operations. The 12 QSEs that
represent management operations are described in Table 1.
The QSEs are not laboratory-specific; they represent the generic management
infrastructure of any type, size, scope, or specialty of any health care service. The QSEs
support the success of the service’s operational workflow processes; that is, when one or
more QSE is not implemented or functioning effectively, ramifications will manifest as
problems in the operational workflow. For example, when laboratory management does
not have an equipment management programs in place that includes at least the
manufacturer’s required calibration and maintenance programs, problems will arise with
the laboratory’s instruments, analyzers, and computer systems. Such problems lead to
inefficiency, waste and miscommunication, and can adversely affect patients.
The Path of Workflow—Health Care Service Specific
The crossbar of the “T” represents the workflow of any particular health care service. For
example, the medical laboratory has clearly defined processes for transforming the input
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of a clinician’s order through sample collection, sample transport, sample receipt, testing,
interpretation, and follow-up, to the output of release of testing and examination results
and reports. Healthcare services such as respiratory therapy, rehabilitation services,
pharmacy, and diagnostic imaging all have their own paths of workflow. For example,
the inpatient medication path of workflow (ie, pharmacy) is similar to that for the
laboratory transfusion service’s blood components in that drugs/blood are ordered by a
clinician; the drug/blood is prepared for issue; the drug/blood is issued to the patient’s
location; the blood/drug is administered; and the patient is carefully monitored for any
adverse reaction to the drug/blood. The challenge is for all health care services to design
and implement effective path of workflow processes and procedures that meet relevant
requirements, document the workflow, measure and monitor quality, and make
improvements where needed.
Both bars of the “T” are necessary for successful QMS implementation and service
performance.
Improving Patient Safety
Every health care service should ask the question, “What can we do to improve patient
safety?” Although there is a wealth of literature on this subject, the simplest answer for
how a laboratory can make its best contribution to patient safety is to understand,
document, train to, monitor, and improve its path of workflow and QSE processes and
procedures. Such an approach is achievable by working within and outside the
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laboratory’s walls, process by process. The preanalytic processes of test ordering and
sample collection are performed, for the most part, by clinicians, nurses, and nonlaboratorians such as clerks and aides. These personnel need current, complete, correct,
and accessible information on ordering, collecting, handling and transporting laboratory
samples. The analytic processes of test performance, result review, and interpretation are
performed by laboratory professionals who need documented processes and procedures in
which they’ve been trained and determined competent to perform. Reliable postanalytic
processes are necessary to ensure that accurate patient result reports get to the proper
health care professionals in a timely manner.
Saving Money
Quality improvement tools and techniques such as Lean and Six Sigma can be applied to
these processes to improve efficiency and effectiveness. Efficient processes performed by
trained, competent staff reduce or eliminate rework and errors that consume resources to
correct. Effective processes ensure that customer, regulatory, and accreditation
requirements are always met, so that few or no costly deficiencies exist or need
correction.
The Laboratory as a Model for Ancillary Services
The laboratory service is well-positioned to model the QSEs and path of workflow for the
entire health care organization. Once the QSE policies, processes, and procedures are
developed by the laboratory, they can be broadened for use by the entire organization or
adjusted to another service within the organization. Laboratorians could serve as internal
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consultants to help other services map their particular technical requirements to their path
of workflow and function as facilitators for documenting the service’s work processes.
These actions offer visibility for the laboratory to lead in the quest for improving patient
safety and continual improvement.
Lucia Berte is president of Laboratories Made Better! Berte teaches laboratories how to
implement a quality management system for improving patient safety, efficiency, and
effectiveness, and for meeting accreditation requirements. In addition to being an ASCP
certified medical technologist and a specialist in blood banking, she is an ASQ Certified
Quality Manager and Quality Auditor. Lucia will present a workshop entitled
“Innovative QM for Lab and Ancillary Services” at the Quality Institute for Healthcare,
May 16-18th in Pittsburgh, PA. For more information, visit http://qihc.asq.org
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References
1. CLSI/NCCLS. A Quality Management System Model for Health Care; Approved
Guideline—Second Edition. CLSI document HS01-A2. Wayne, PA: Clinical and
Laboratory Standards Institute; 2004.
2. CLSI/NCCLS. Application of a Quality Management System Model to Laboratory
Services; Approved Guideline—Third Edition. CLSI document GP26-A3. Wayne,
PA: Clinical and Laboratory Standards Institute; 2004.
3. ISO. Medical laboratories—Particular requirements for quality and competence. ISO
15189. Geneva, Switzerland: International Organization for Standardization; 2007.
4. Centers for Medicare and Medicaid Services. Department of Health and Human
Services. Part 493Laboratory Requirements: Clinical Laboratory Improvement
Amendments of 1988. Code of Federal Regulations, Title 42, Parts 430 to end. US
Government Printing Office. Published annually.
5. The Joint Commission. Comprehensive Accreditation Manual for Pathology and
Laboratory Services. Oakbrook Terrace, IL: JCAHO. Published annually.
6. CAP. Laboratory Accreditation Program Accreditation Checklists. Northfield, IL:
College of American Pathologists; Published annually.
7. COLA. Laboratory Accreditation Manual. Columbia, MD. COLA, 2010.
8. AABB. Standards for Blood Banks and Transfusion Services. 26th ed. Bethesda, MD:
American Association of Blood Banks; 2009.
9. US Department of Labor. Occupational Safety and Health Administration.
Bloodborne pathogens contains the requirements for a bloodborne pathogen
program. 29 CFR 1910.1030. US Government Printing Office. Published annually.
Submission for Advance for Administrators of the Laboratory on behalf of the ASQ-QIHC
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10. Department of Transportation. Hazardous material. Infectious Substances. 49 CFR
171-180. US Government Printing Office. Published annually.
11. Department of Health and Human Services, Food and Drug Administration. Current
Good Manufacturing Practice for Finished Pharmaceuticals. 21 CFR 211. US
Government Printing Office. Published annually.
12. Department of Health and Human Services, Food and Drug Administration. General
Biological Products Standards. 21 CFR 606. US Government Printing Office.
Published annually.
13. Department of Health and Human Services, Food and Drug Administration. Good
Laboratory Practice for Nonclinical Laboratory Studies. 21 CFR 58. US Government
Printing Office. Published annually.
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Table 1. The 12 Quality Systems Essentials
QSE
Organization
Description
Organizational structure, planning for quality, and
management review
Customer Focus
Identification of external and internal customers, their
expectations, and their satisfaction with products and
services
Facilities and Safety
Organization’s physical work environment and safety
practices
Personnel
Management and development of staff to competently
perform assigned work processes
Purchasing and Inventory
Processes for acquiring, receiving, inspecting, and
managing materials used in provision of products and
services
Equipment
Qualification, operation, and maintenance of equipment
and computer systems critical to the quality of the
organization’s product or service
Process Management
Design, implementation, control, and change of the
service’s management and technical work processes
Documents and Records
Development and control of documents and the
management and control of records
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Table 1, continued.
Information Management
Management and use of patient information and results
and reports in paper and electronic information systems
Nonconforming Event
Collection and analysis of information about
Management
nonconformances and referral to corrective action and
continual improvement
Assessments
Participation in external assessments, and programs for
internal assessments such as monitoring and auditing
Continual Improvement
Application of tools and processes to reduce failure and
waste and improve performance
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Quality Management System Model
Service's Path of Workflow
Pre-service
Service
Post-service
Quality System Essentials
Organization
Customer Service
Facilities and Safety
Personnel
Purchasing & Inventory
Equipment
Process Management
Documents and Records
Information Management
Nonconforming Event Management
Assessments
Continual Improvement
Adapted from CLSI/NCCLS HS01 and GP26
Figure 1. Any health care service can develop a quality management system from a
generic model that incorporates generic management requirements with its technical
operations.
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