Quality Management for Lab and Ancillary Services

A medical laboratory in the United States is one of the most highly regulated healthcare 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; and
  • professional growth and development.

From this list, any healthcare 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 representing management operations are described in Table 1.

The 12 Quality Systems Essentials
QSE 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


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


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

Information Management

Management and use of patient information and results and reports in paper and electronic information systems

Nonconforming Event Management

Collection and analysis of information about nonconformances and referral to corrective action and continual improvement


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

The QSEs are not laboratory-specific; they represent the generic management infrastructure of any type, size, scope or specialty of any healthcare 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 including 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-Healthcare Service Specific

The crossbar of the “T” represents the workflow of any particular healthcare service. For example, the medical laboratory has clearly defined processes for transforming the input 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 healthcare services to design and implement effective path of workflow processes and procedures meeting relevant requirements, documenting the workflow, measuring and monitoring quality, and making improvements where needed.

Both bars of the “T” are necessary for successful QMS implementation and service performance.

Improving Patient Safety

Every healthcare 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 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 non-laboratorians 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 accurate patient result reports get to the proper healthcare professionals in a timely manner.

Saving Money

These processes can apply quality improvement tools and techniques such as Lean and Six Sigma 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 customer, regulatory and accreditation requirements are always met, so 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 workflow path for the entire healthcare organization. Once the laboratory develops QSE policies, processes and procedures, they can be broadened for use by the entire organization or adjusted to another service within the organization. Laboratorians could serve as internal 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

See page 2 for 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 493¾Laboratory 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.

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.

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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