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The Laboratory Advisory Committee, in collaboration with the Practice Guidelines Committee, has been charged by the ASC to address the issue of patient safety and reduction of medical error in the practice of cytopathology. On November 29, 1999, the Institute of Medicine (IOM) released its report on medical error and patient safety in America, To Err is Human: Building a Safer Health System.1 The implications for pathology have been summarized by Sirota.2

The profession of pathology strives to provide quality care. Competency to practice anatomic and clinical pathology is measured by the certification examination of the American Board of Pathology. Competency to practice Cytotechnology is measured by the American Society of Clinical Pathology’s Board of Registry examination. Professional organizations such as the College of American Pathologists, American Society of Cytopathology, and American Society for Cytotechnology have developed practice guidelines, laboratory accreditation programs and continuing medical education programs in order to provide quality patient care. Although these mechanisms provide a level of safety in pathology practice, they do not necessarily provide for overall safety and error reduction in patient care.

In the IOM’s report, safety is defined as “freedom from accidental injury” and error is defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.” Preventing errors requires designing the health care system at all levels to make it safer. Safety must be built into processes of care to reduce medical error and to improve quality. To establish such a model a “team approach” is required. The IOM’s committee members recognized that a major force for improving patient safety is intrinsic motivation by health care professionals and organizations; however, they focused on external environment forces that can be employed to encourage the implementation of a specific set of actions within these groups. Therefore, it would serve us well as a profession to develop strategies for a systems approach to patient safety and error reduction.

The ASC can serve as a model to other professional societies in improving patient safety and reducing medical error by (1) defining practice guidelines that include patient safety issues in collaboration with other pathology organizations; (2) sponsoring and conducting intersociety meetings and seminars on patient safety as they relate to the practice of cytopathology; (3) encouraging a clinical team approach to patient management; (4) promulgating the education of medical students, residents, fellows and technologists in patient safety and error reduction; (5) serving as an advocate for change by working with lay and information technology organizations, government agencies and regulatory commissions; (6) and promoting and sponsoring research into error reduction and safety improvement.

Processes in the pathology laboratory are divided into three phases: (1) Pre-Analytical, (2) Analytical, and (3) Post-Analytical.

The Pre-Analytical Phase has the potential to be fraught with the most medical errors in pathology since it is clinically driven. Numerous health care professions completing a myriad of hand-written forms at times with incomplete or inaccurate patient demographics compounds the problem. In order to streamline the process, enhance workflow in the laboratory and reduce error, the following are proposed:

A. Use of bound and on-line specimen procurement and submission manuals made available to all health care providers to ensure standardized collection and submission.

B. Institute computerized patient registration and order entry to minimize human error by transferring identical patient demographics to all subsequent reports.

C. Institute use of computer constraints for required data fields so that the pathology laboratory receives the appropriate clinical information.

D. Encourage the use of bar coding from the time of patient registration to receipt of the specimen in the laboratory.

E. Streamline and standardize test requisition forms sent to health care providers.

F. Provide in-service training on specimen procurement and submission to health care providers as part of the team approach to patient care.

G. Promote inclusion of the patient as part of the team in safety design and the process of care.

H. Upon request, provide clinics and health care providers with statistical feedback regarding the adequacy of specimen labeling, completion of accurate demographic data and inclusion of pertinent clinical information on the requisition. Encourage clinics and health care organizations to collect this information to detect undesirable trends related to inaccurate or absent information and to assimilate this data when planning process improvements in accordance with JCAHO guidelines for the support of patient safety and medical error reduction.

I. Endorse definitive laboratory specimen rejection policies to prevent further
processing of and interpretation of specimens with potential demographic mismatches or pertinent clinical information.

The Analytical Phase is laboratory driven. Methods to reduce error and improve patient safety include:

A. Development and implementation of an ongoing quality assurance/total quality improvement program that includes error reduction and continuous safety improvement directly related to the practice of pathology.

B. Use of standardized reporting systems, cancer protocols, checklists and reporting templates that are endorsed by professional organizations.

C. Participation in laboratory testing and accreditation programs.

D. Utilization of intra and extra-departmental consultation or prospective/retrospective quality assurance review on high-risk cases.

E. Ensure adequate staffing and streamline workflow in the laboratory to improve laboratory turnaround time for diagnoses.

F. Ensure an environment conducive to the accurate interpretation of patient specimens.

G. Implementation of the team approach to patient management.

H. Participation of laboratory personnel and pathologists in continuing medical education courses as they relate to the practice of pathology.

The Post-Analytical Phase is outcomes driven. Resolution of issues within the Pre-Analytical and Analytical Phases will result in error reduction and improvements in patient safety. Communication between the cytopathology laboratory and health care providers is a must for this to occur. Methods to reduce error and improve patient safety include:

A. Feedback to providers regarding specimen adequacy and rejection statistics.

B. Collection of data showing adverse patient outcome or “near misses” for review at morbidity and mortality conferences.

C. Monitoring data for trends in error with subsequent implementation of new quality assurance indicators.

Although this list is by no means exhaustive, the members of each setting in which pathology is practiced must develop and implement team approach strategies to improve patient safety and reduce medical error.


1. Kohn LT, Corriga JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press; 1999.

2. Sirota RL. The Institutes of Medicine’s Report on Medicine: Implications for Pathology. Arch Pathol Lab Med 2000; 124:1674-1678.


Submitted by the ASC Laboratory Advisory Committee; approved by the ASC Executive Board 4/2002.