Patient Safety in Anatomic Pathology
Moderator: Peter Furness
Section 1 -
Overview of Medical Error and Patient Safety in the USA
Ronald L. Sirota
Lutheran General Hospital
Department of Pathology
Park Ridge , IL USA
Overview of Medical Error and Patient Safety in the USA 
The modern patient safety movement in the United States began in late 1999 with the publication of the
Institute of Medicine's report on medical error in the United States, To Err is
Human: Building a Safer Health System
. This landmark report documented that between 44,000 and 98,000 annual deaths in the United States were
due to medical errors, many of which were preventable, and it outlined specific steps that could be taken
to improve patient safety and reduce medical error. These steps included the establishment of a national
focus to create leadership, creation of research tools and protocols to enhance the knowledge base about
patient safety, identification and learning from errors through mandatory and voluntary error reporting
systems, the enactment of tort reform so that physicians could report medical error without fear of
lawsuits and monetary and criminal reprisals, and the use of a system approach rather than personal
approach to reduce medical error and improve patient safety. The report called for a 50% reduction in
medical error in the five-year period following the report.
The IOM report immediately caught the attention of the national media, federal and state governments,
regulators, healthcare providers and the general public. It spawned numerous initiatives to achieve the
its goals. Throughout the years following the report improving patient safety has become a major focus
of almost all healthcare organizations in the USA, has become the focal point of quality assurance
programs in hospitals throughout the country and has become a major part of the programs of leading
healthcare organizations, including the Joint Commission on Accreditation of Healthcare Organizations
(JCAHO), the College of American Pathologists (CAP) and others. It has additionally become the subject
of both federal and state legislation and has also been the subject of numerous professional publications
and research awards .
The JCAHO has made improvement of patient safety in its accredited organizations a primary goal since
at least 2003. It has done this primarily in two ways: through the creation of its National Patient
Safety Goals (NPSGs) and through revamping of its accreditation standards.
In 2003 the JCAHO published its first set of NPSGs. Their purpose "is to promote specific
improvements in patient safety. The Goals highlight problematic areas in health care and describe
evidence and expert-based solutions to these problems. Recognizing that sound system design is intrinsic
to the delivery of safe, high quality health care, the Goals focus on system-wide solutions, wherever
possible."  The JCAHO has outlined specific goals for
various parts of the healthcare organization, such as Ambulatory Care and Office Based Surgery, Assisted
Living, Behavioral Health Care and others, and the Laboratory is included as one of the specific areas.
Since the publication of the first set of goals, they have been amended and added to each year since
The 2007 set of NSPGs for the Laboratory are as follows, including requirements to meet these goals :
|Goal 1 ||Improve the accuracy of patient identification.|
|1A ||Use at least two patient identifiers when providing care, treatment or services.|
|1B ||Prior to the start of any invasive procedure, conduct a final verification process, (such as a "time out,") to confirm the correct patient, procedure and site using active-not passive-communication techniques.|
|Goal 2 ||Improve the effectiveness of communication among caregivers.|
|2A ||For verbal or telephone orders or for telephonic reporting of critical test results, verify the complete order or test result by having the person receiving the information record and "read-back" the complete order or test result.|
|2B ||Standardize a list of abbreviations, acronyms, symbols, and dose designations that are not to be used throughout the organization.|
|2C ||Measure, assess and, if appropriate, take action to improve the timeliness of reporting, and the timeliness of receipt by the responsible licensed caregiver, of critical test results and values.|
|2E ||Implement a standardized approach to "hand off" communications, including an opportunity to ask and respond to questions.|
|Goal 7 ||Reduce the risk of health care-associated infections.|
|7A ||Comply with current Centers for Disease Control and Prevention (CDC) hand hygiene guidelines.|
|7B ||Manage as sentinel events all identified cases of unanticipated death or major permanent loss of function associated with a health care-associated infection.|
|Goal 13 ||Encourage patients' active involvement in their own care as a patient safety strategy.|
|13A ||Define and communicate the means for patients and their families to report concerns about safety and encourage them to do so.|
In addition to its NSPGs, the JCAHO has revamped most of its Accreditation Standards in order to focus
on patient safety. Almost every major section of the standards address patient safety issues, including
the creation of an organizational culture of safety throughout the organization and a system focus of
prevention of errors. The Standards also mandate that untoward or unanticipated events and medical
errors be disclosed to patients and their families.
College of American Pathologists
The CAP has also focused on patient safety issues. Similar to the JCAHO, it has used a two-pronged
approach, establishing in 2006 its own set of Laboratory Patient Safety Goals (LPSGs) and substantially
modifying its Laboratory Accreditation Program to focus on patient safety. The objectives of the CAP are
to improve patient safety and reduce errors throughout the testing cycle, focus on patient safety issues
in the pre-analytic and post-analytic phases of testing, explicitly integrate patient safety activities
into the LAP process and require each laboratory to create its own Laboratory Patient Safety Plan  .
The CAP LPSGs are as follows  :
- Improve Patient and Sample Identification
- At the time of specimen collection
- At the time of analysis
- At the time of result delivery
- Improve the verification and communication of life threatening or life altering information regarding
- HIV and infectious disease
- Cytogenetic abnormalities
- Critical values
- Improve identification, communication
and correction of errors
- All inaccuracies documented and communicated as soon as inaccuracy becomes known
- Errors that cause material injury must be disclosed to the patient
- If a pathologist is directly involved, the
pathologist should discuss the matter with the physician who ordered the consultation to determine how
best to communicate the result to the patient
- Improve integration
and coordination of laboratory patient safety role within Healthcare Organization and operations
- Point of care testing personnel
- Exchange of information and review by relevant parties
The CAP has also substantially modified its accreditation Checklists to focus the LPSGs. The
introduction to the General Laboratory Checklist states "Laboratories should emphasize these goals in
their quality management activities. Approaches include monitoring activities related to the goals (for
example, number of mislabeled specimen containers), with corrective/preventive action as necessary;
investigation of sentinel events, with corrective/preventive action as necessary; and evaluation and
revision of processes and procedures affecting the goals, to optimize laboratory performance. The
laboratory should document how it addresses these goals. The inspector should pay particular attention
to checklist questions that address the above patient safety goals, and communicate any findings to the
inspection team leader, who will address patient safety goal issues with the laboratory director." 
Specific Checklist questions related to patient safety have also been added. The most important of
these is in the General Checklist, GEN.20365: "Does the laboratory address the current CAP Laboratory
Patient Safety Goals?"  Failure to meet this standard is a Phase II Deficiency requiring immediate
correction for accreditation.
The Patient Safety and Quality Improvement Act of 2005, P.L. 109-41
was approved by Congress by a near unanimous vote and was signed into
law by the President on July 29, 2005 . Its goal is to provide for the improvement of patient safety and
reduce the incidence of events that adversely effect patient safety. It enables providers to contract
voluntarily with Patient Safety Organizations (PSO's) to help them to identify and analyze threats to
patient safety and other quality of care problems, change health care structures and processes to improve
health outcomes without fear that data will be disclosed or used in legal or administrative proceedings
against them and provides privilege and confidentiality protections to patient safety data (patient
safety work products (PSWPs) so that it can be collected without fear of legal implications. PSOs are
organizations that have contracted with HHS to perform patient safety functions and PSWPs are sets of
data that healthcare providers submit to the PSOs for evaluation. As previously stated, PSWPs are
confidential and not subject to discovery except under certain circumstances such as criminal
proceedings. The bill has many other definitions, clauses and exclusions related to its mission beyond
the scope of this summary.
On September 28, 2005 Senators Bararck Obama (Dem-IL) and Hiliary Clinton (Dem-NY) proposed the
National Medical Error Disclosure and Compensation Bill (MEDiC)
It intent is to promote
the confidential disclosure to patients of medical errors in an effort to improve patient safety systems.
At the time of disclosure, compensation for the patient or family would be negotiated and procedures
would be implemented to prevent a recurrence of the problem that led to injury. The bill provides
certain protections from liability within the context of the program in order to promote a safe
environment for disclosure. It is designed to promote open communication between patient and providers,
reduce rates of preventable medical errors, ensure patient access to fair compensation for medical injury
negligence or malpractice, reduce the cost of medical liability insurance and provide grant support and
technical assistance for providers that disclose medical errors and problems with patient safety and
offer fair compensation to patients for injuries or harm. As of this writing, the bill has not yet
Since the Institute of Medicine report on medical error, patient safety and error reduction have
become a major focus of healthcare in the United States . Although some of the goals of the IOM report
remain unrealized, a great deal of effort and attention at every level of healthcare in the United States
has been paid to the goals set out in the report. The patient safety movement stands today as probably
the single most dominant healthcare movement in the United States .
- Abstracted from a larger article on this subject by the author, in preparation.
- Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Washington , DC : National Academy Press; 1999.
- Sirota RL. The Institute of Medicine 's report on medical error: implications for pathology. Arch Pathol Lab Med. 2000;124:1674-1678.
- Stelfox HT, Palmisani S, Scurlock C, Orav EJ, Bates DW, The "To Err is Human" report and the patient safety literature. Qual Saf Health Care. 2006;15:174-178.
- Joint Commission on Accreditation of HealthCare Organizations Introduction to National Patient Safety Goals. Available at: http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/npsg_intro.htm. Accessed June 21, 2006.
- Joint Commission on Accreditation of HealthCare Organizations 2007 Laboratory Services National Patient Safety Goals. Available at: http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/07_lab_npsgs.htm?print=yes. Accessed June 21, 2006.
- College of American Pathologists Laboratory Patient Safety Plan. Available at: http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt%7BactionForm.contentReference%7D=patient_safety%2Flaboratory_patient_safety_plan.html&_state=maximized&_pageLabel=cntvwr. Accessed June 21, 2006.
- Commission on Laboratory Accreditation Laboratory Accreditation Program General Checklist. Available at: http://www.cap.org/apps/docs/laboratory_accreditation/checklists/laboratory_general_april2006.pdf Accessed June 16, 2006.
- P.L.109-41. Available at: http://www.utsystem.edu/ogc/newsletter/PtSafetyQualAct.pdf. Accessed June 16, 2006
- Public Law 109-41 July 29, 2005. Available at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_public_laws&docid=f:publ041.109.pdf. Accessed June 16, 2006.
- The Patient Safety and Quality Improvement Act of 2005. Available at: http://www.ahrq.gov/qual/psoact.htm. Accessed June 16, 2006 .
- 109th Congress First Session S.1734. Available at: http://www.govtrack.us/data/us/bills.text/109/s/s1734.pdf. Accessed June 20, 2006.
- Clinton H, Obama B, Making patient safety the centerpiece of medical liability reform. N Engl J Med 2006; 354:2205-2208, May 25, 2006 .