Laboratory of Pathology - Staff

LABORATORY OF PATHOLOGY QUALITY MANAGEMENT PROGRAM

Quality Systems

Quality Systems in pathology can be described as quality control (QC), quality assurance (QA), and quality improvement (QI) activities that the organization undertakes with the ultimate goal of ensuring the highest quality of diagnostic anatomic pathology interpretation and reporting. The overall process of the QC, QA and QI program is defined as the Quality Management (QM) Program. LP's QM Program incorporates active participation of administrative staff, technologists/technicians, technical supervisors, clinical residents/fellows, and attending pathologists into a interdepartmental, interdisciplinary quality program that aims to identify, track, improve and monitor quality systems that ensures the highest level of quality in clinical services.

Quality Control activities address the ways in which laboratories accession, process, interpret, report and retain submitted specimens. Quality control monitors are typically designed to compare the actual performance of a test or function as compared with the process set for in department procedures¹. Examples of quality control activities in anatomic pathology include items such as:

• Instrument Checks and Daily Maintenance
• Maintaining Temperature Logs of Water Baths and Cryostats
• Controls for Special Stains
• Maintaining Procedures for Obtaining Specimens
• Determining the Quality of Sectioning and Staining

Quality Assurance is a term used for internal quality checks, and activities often monitor such things as report timeliness or diagnostic error rates¹. Examples of quality assurance monitors in anatomic pathology might include:

• Frozen Section Accuracy
• Frozen Section Turnaround Time
• Rate of Specimen Identification Errors
• Diagnostic Accuracy
• Completeness of Tumor Staging

Quality Improvement activities seek to improve the outcomes of failures in quality control or quality assurance activitites. The Laboratory of Pathology's Quality Management Program aim to identify, track and report on quality indicators, and identify interventions and monitor effectiveness of corrective actions. Typical steps in the Quality Improvement cycle include:

• Identify the Indicators or Processes to Improve (LP's Quality Indicators)
• Measure Current Levels of Performance for the Process (Monitoring)
• Determine Target or Desirable Levels of Performance (Benchmarks)
• Design and Implement an Intervention (LP incorporates expertise of technologists, Residents and Attending Pathologists in this exercise)
• Re-evaluate Levels of Performance(Monthly QM Reports)
• Repeat Steps, as necessary, to Achieve Desired Level of Performance.

Each clinical section must establish and maintain written policies and procedures that implement and monitor quality systems for all phases of the total testing process (i.e., preanalytic, analytic, and postanalytic) as well as general laboratory systems. Each section’s quality system must include an assessment component that ensures continuous improvement of the lab’s performance and services through ongoing monitoring that identifies, evaluates, and resolves problems. Under the direction of the Medical Director, LP's integrated intradepartmental Quality Management Program monitors and addresses several preanalytic, analytic, and postanalytic quality indicators established at the beginning of each year.

The Medical Director has overall responsibility to ensure that the quality program:

• Has a QM Plan that is implemented as designed
• Covers all clinical areas of the laboratory and all beneficiaries of service
• Includes monitoring key indicators of quality in the preanalytic, analytic and postanalytic phases
• QM Plan is reviewed annually for effectiveness

Pre-Analytic Variables

The Laboratory of Pathology (LP) defines preanalytic variables of quality as those activities that occur prior to the cases being presented to the Pathologist for diagnostic interpretation. These variables include elements such as: specimen collection, specimen identification, slide (secondary container) labeling, reagent preparation, quality control, instrument maintenance and function checks, and specimen quality.

Analytic Variables

LP defines analytic variables as those activities involving quality control review, requests for repeat stains, diagnostic interpretation by the pathologist, accuracy of diagnostic interpretation (e.g. frozen sections to permanent), and turnaround time from accession to pathologist signing out the final or supplemental report in the Laboratory Information System (LIS).

Post-Analytic Variables

LP defines postanalytic variables as those activities that occur after a final report is signed out. Activities could include review of report completeness, review of corrected reports, turnaround time for returning submitted materials, and customer satisfaction.

Quality Management Committee 

As a part of the Laboratory of Pathology’s ongoing Quality Management Program, the quality and appropriateness of laboratory services are monitored objectively and evaluated systematically to pursue opportunities to improve patient care and to resolve identified problems. The QM Committee will meet at least bimonthly to review and discuss quality indicators, status of QM projects, safety and environment of care issues, and incident (error) reports. The Chair of the Quality Management Committee leads the committee reviews, discussion and ensures action items are addressed. The Clinical Manager maintains all documents related to the Quality Management Program.

Sentinel Events

A Sentinel Event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk therefore, requiring immediate attention and investigation. Serious injury specifically includes loss of limb or function. The phrase, “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of serious adverse outcome. Such events are called “sentinel” because they signal the need for immediate investigation and response. Sentinel events include an unanticipated death or major permanent loss of function, not related to the natural course of the patient’s illness or underlying condition, or one of the following events (even if the outcome was not death or major permanent loss of function):

• Suicide of a patient in a setting where the patient receives around-the-clock care;

• Infant abduction or discharge to the wrong family;

• Rape; or

• Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities.

If the occurrence is determined to be a sentinel event, the Clinical Chief and responsible practitioner will follow reporting procedures outlined in the Sentinel Event Policy (see Medical Administrative Series M00-2), including notifying the Laboratory of Pathology (LP) Chief and the Deputy Director for Clinical Care (DDCC), NIH Clinical Center (CC) within 24 hours.

Occurrence reporting and analysis are intended to prevent damage/risk from occurring, to reduce damage when adverse events have already occurred, and to prevent future adverse events. See Medical Administrative Series, M88-3 for more details and procedures for reporting an occurrence. A password and training on the ORS is required to initiate a report. The Clinical Manager can initiate a report for anyone who does not yet have a password for using the system.

Note: Printing or distribution of hard copies of individual occurrence reports or of summary documents that contain occurrence-specific information is strictly limited to instance when the documents will facilitate formal discussions at peer review or clinical quality meetings. If hard copies are used for this purpose, the copies will be numbered for tracking purposes, collected at the end of each peer review/clinical quality meeting, and destroyed after the meeting.

Disclosure of Medical Errors to Patients

This section addresses the important topic of medical errors and how they relate to our responsibilities as health care providers. The NIH Clinical Center has gone to great effort to reduce medical errors, including developing our computerized ordering system with built-in safeguards (CRIS, soon to be replaced by CRIS with enhanced safeguards), the Occurrence Reporting System, a process for a root-cause analysis of serious unexpected patient outcomes, and the continual establishment and review of patient safety policies by the Medical Executive Committee. Further, many institutes have initiated monthly Quality Management Rounds with their clinical staff to discuss occurrences, review practices and policies, and consider ways of preventing errors.

When medical errors do occur, they may not only result in physical harm but also be emotionally devastating to the patient and family. The Medical Executive Committee has approved Medical Administrative Series policy, M03-3, "Disclosure of Information to Patients Following the Occurrence of an Unanticipated Outcome Associated with a Harmful Medical Error," to guide medical staff in informing patients of medical errors that result in harm.

A brief outline of the policy is as follows:

• Upon detecting a medical error, whether or not harm resulted from the error, the Occurrence Reporting System (ORS) should be used to initiate a review of the error, with the aim of determining why it happened and preventing recurrence of the error;

• Medical errors that cause harm must be disclosed to patients;

• The patient care team, including the attending physician and/or principal investigator, should meet as soon as possible to determine the facts of the error and decide who will discuss the error with the patient (and family members, where appropriate);

• The need for additional staff should be identified (e.g., patient representative);

• The clinical director should be notified;

• The medical error should be discussed with the patient as soon as possible following its recognition;

• Should the patient prefer to speak to a different health care professional from the one chosen by the team, a substitute, in consultation with the patient, should be provided;

• A witness should be in attendance during the discussions with the patient;

• The disclosure discussion must be documented in the patient's medical record.

Errors that qualify as serious adverse events in the course of a research protocol must be reported to the Institutional Review Board (IRB).

Device-Related Adverse Patient Events

A medical device is any item that is used for the diagnosis, treatment, or prevention of a disease, injury, or other condition and is NOT a drug or biologic. The Food and Drug Administration (FDA) requires health care facilities to report patient deaths or serious injuries whenever the facility become aware of information that reasonably suggests a medical device has or may have caused or contributed to the adverse event. Information that reasonably suggests that a medical device has caused or contributed to a reportable event includes any information such as professional, scientific, or medical facts and observations or opinion that a device has caused or may have caused or contributed to a reportable event. These requirements are covered under the FDA Safe Medical Devices Act (SMDA).

The FDA defines "serious patient injury" as one that is life threatening, or results in permanent impairment of a body function or permanent damage to a body structure; or necessitates medical or surgical interventions to preclude permanent impairment or damage.

Device malfunctions or problems that are reportable may relate to any aspect of a test, including hardware, labeling, reagents or calibration- or, to user error. Note: an adverse patient event that may have resulted from inherent limitations in an analytic system (e.g. limitations of sensitivity, specificity, accuracy, and precision) is not reportable.

Laboratory staff must:

1. Ensure the device is removed from service and not used for patient care until further notification from the Technical Director.
2. Immediately notify the sections' Technical Director, Clinical Manager, and Medical Director of any suspected or notified incident of an adverse patient event.
3. Complete an LP Occurrence Report.

The Clinical Manager will immediately establish notify the NIH Clinical Center's Safety Officer, and initiate a comprehensive Root Cause Analysis.

The NIH Clinical Center (CC) takes overall responsibility for addressing adverse patient events and submitting annual repot of device-related deaths or injuries annually to the FDA, if any such event was reported.

The CC uses its Occurrence Reporting System (ORS) Safety Tracking and Reporting System (STARS) to monitor patient incidents and identify events that meet reporting requirements for the SMDA. It is critical to enter information in the ORS in a timely manner, so that the CC can investigate and report serious events within 10 work days. The CC Safety Officer, under the direction of the Deputy for Clinical Care, submits mandatory reports to the FDA.

Voluntary reports (problems with products only) can be submitted by any department such as the Laboratory of Pathology (LP), Department of Laboratory Medicine (DLM), Department of Transfusion Medicine (DTM), Materials Management Department (MMD), Outpatient Department (OPD), etc. For example, if you believe there are problems with the controls provided with a commercially available diagnostic kit or reagent, you can submit a voluntary SMDA report to the FDA.

For more information, refer to the CC Medical Administrative Policy M88-3, the FDA Website, or contact the CC Safety Office at (301) 496-5281.

Notification from Vendors

This policy addresses how the Laboratory of Pathology manages notifications from vendors of defects or issues with reagents, supplies, instruments, equipment, or software that may affect patient care or client services.

Medical Device Recall: a mandatory notice that addresses a problem with a medical device issued by a government regulatory agency, such as the FDA, or a manufacturer or professional institute or association. Further information about recalls can be obtained at the FDA List of Device Recalls External Link Icon.

Notifications may take the form of product recalls, market withdrawals, or software patches and upgrades. The laboratory must take action on those that are required by the manufacturer, or issues that have the potential to affect testing results or laboratory services.

Whenever notified from vendors of defects or issues with supplies or software that may affect patient care, the recipient section will immediately notify the LP Clinical Manager and initiate an LP Occurrence Report. The Clinical Manager will subsequently report the device notification to the NIH Clinical Center (CC) in accordance with Medical Administrative Policy S-006.

The Clinical Center (CC) monitors and takes appropriate actions in response to a recall or alert for medical devices that is in use in the CC. These actions include measures to meet reporting requirements in the Safe Medical Devices Act issued by the U.S. Food and Drug Administration (FDA). 

1. If a recall or alert notice has been received from a manufacturer or is warranted as a result of surveillance of CC incidents, the LP Clinical Manager will do the following:
2. Notify the Materials Management Department at CC-MMD Feedback (mmdfeedback@cc.nih.gov ) in the event they are not aware of the recall or alert.
3. As required by the recall or alert, implement and document response actions outlined by the issuing office as soon as feasible, ensuring patient care issues are addressed. Actions may include:
   1. Removal or quarantine of the device.
   2. Changing procedures, e.g., approved clinical interventions, that include staff education or reinforcing existing recommendations for use.
   3. Modifying equipment or programming by authorized persons.
   4. If there is any industry notification about the integrity of a clinical analyzer or methodology currently in use by the Laboratory of Pathology, that procedure or instrument will be immediately quarantined until a full investigation has been completed. Retesting can only resume when there is concrete evidence of procedure integrity.
   5. If a software upgrade is mandated, the laboratory section or technical representative from the manufacturer will install the upgrade and perform a full system validation with quality control to ensure proper operation.
4. Distribute the recall or alert notice to other departments or clinical service areas that may also have the product in their inventory.
5. File an incident report in the CC Safety Tracking and Reporting System (STARS) for any medical device known or suspected to cause serious injury, illness or death and/or is associated with an alert or recall.

Patient Safety and Clinical Quality Office monitors the STARS in order to identify adverse events that meet the mandatory reporting requirements outlined in the Safe Medical Devices Act.

The Environmental Safety Officer facilitates and/or submits and maintains mandatory reports filed with the FDA for medical devices known or suspected to cause serious injury, illness or death.

Summaries of surveillance and response actions are submitted to the CC Safety Committee for review and comment. This activity is part of the Information Collection, Evaluation and Surveillance (ICES) activities for environment of care functions overseen by the CC Safety Committee.

Healthcare Communications

Communication Among Healthcare Workers

Laboratory employees are responsible for communicating information about pending specimens, tests, and patient care issues, such as at a change in shift, or when the responsibility for a case is transferred between pathologists, technologists, or other healthcare workers. Employees should be aware of potential communication issues or barriers (e.g., hierarchical, organizational, cultural, fears, short staffing, etc.). To improve the effectiveness of communication among caregivers and teams when handing off information, always provide an opportunity for asking and responding to questions. Patient care is delivered through the collective knowledge of multidisciplinary teams; therefore, skills such as collaboration, debriefing, team work and conflict resolution should be emphasized. Practices for effective communication are:

• Listen without judgment
• Be open to all options
• Listen without thinking about what you will say next
• Do not be invested in being right--it is not the point
• Ask for repetition
• Repeat back what is heard and ask if it is correct
• Pay attention to body language
• Be honest, truthful, polite, respectful, and sincere
• Get comfortable with gray areas when things are not black and white
• Demonstrate integrity and build trust

The LP enforces a "zero tolerance" policy for abusive behavior. If you encounter persons who cannot control their anger or someone who exhibits aggressive or intimidating behavior, please discuss it with your Supervisor, the Clinical Manager, or the LP Chief. Maintaining effective communication among staff members is critical for the quality of patient care. If problems arise individual mentoring, coaching, or training may be helpful.

Staff-Patient Communication

The NIH Clinical Center (CC) fosters open communication among healthcare workers, the patient, and the patient's family. The CC has created a Speak Up for Your Safety brochure that is available to patients and their families. Copies of this brochure are available in the office of the Clinical Laboratory Manager.

Reference:

¹ Nakhleh, R., & Fitzgibbons, P. (2005). Quality Management in Anatomic Pathology: Promoting Patient Safety Through Systems Improvement and Error Reduction. College of American Pathologists: Illinois.