Laboratory of Pathology - Staff

Reporting and Addressing Quality and Safety Concerns

Reporting Quality and Safety Concerns

Patients and employees are encouraged to communicate quality and safety concerns to the Laboratory of Pathology's leadership. Each section must readily provide contact information to the Clinical Manager, Branch Chief and/or Medical Director to any staff or employee who wishes to report a quality or safety concern.

Employees are encouraged to communicate any concerns or complaints with respect to the quality of patient testing and safety to management. The investigation and analysis of employee complaints and suggestions, with corrective and/or preventive action as appropriate, must be documented in each section. An employee is encouraged to report issues to their direct supervisor, but may report issues to any supervisor, manager, Chief, Safety Officer, CC Safety Office, or through the ORS (see Occurrence Reporting System).

Each section must prominently post the the official College of American Pathologist (CAP) sign (see attachment) regarding reporting of quality concerns to the College of American Pathologist. Official CAP signs may be obtained by calling 800-323-4040, option 1#. Employees should report quality or safety concerns to laboratory management. However, anyone may communicate with CAP directly if they have a concern not addressed by laboratory management, and that CAP holds such communications in strict confidence. The laboratory prohibits harassment or punitive action against an employee in response to a complaint or concern made to CAP or other regulatory organization regarding laboratory quality or safety. The dedicated, confidential CAP telephone line for quality or safety concerns is 866-236-7212.

Each section must document all complaints and problems in the section for all phases of the total testing process (that is, pre-analytic, analytic, and post-analytic) as well as general laboratory systems, safety problems, and instances when breakdown in communications occur between the laboratory and an authorized individual who orders or receives test results.

Scope and Extent of Investigation and Corrective Action

All errors must be addressed by each sections' head or designee, and corrective actions implemented and communicated to staff as necessary to ensure the same or similar events do not recur. The section should conduct investigations of complaints, when the section head deems an investigator is appropriate. Each section head, or designee, determines appropriate documentation procedures and problem resolution for his/her section. The Clinical Section Head, or designee, defines the scope and extent of investigation required for events that represent a risk to patients, employees, or health and safety.  The section head or designee performs comprehensive investigations and addresses corrective actions and prevention of future incidents related to the error, and determines if any issue should be forwarded to the LP Chief, the Quality Management Committee, Surgical Administrative Committee, and/or ORS (see above), based on the criteria of the associated policies. An employee or supervisor may use forms internal to your Section Q/I Tracking Forms if they meet the CLIA and CAP requirements for Quality Assessment; however, they should be submitted to the Clinical Manager on a monthly basis, to be included in the monthly QI summary. The monthly QI summaries are available through the Clinical Manager.

The Quality Management Assessment Log and the Quality Management Tracker can be used according to the following guidelines:

• Detecting Errors: Laboratory errors have no limit with the ways they can be identified, or by whom can identify an error. Errors can be reported by patients, treating clinicians, nurses, technicians/technologists, pathologists, administrative or technical staff, or other health professionals. As soon as an error is identified, it must be reported to the section head who will determine an appropriate investigation and corrective action plan. Some common error detection methods include:
  • Quality control or maintenance checks failures
  • Proficiency surveys
  • Instrument failure or error
  • Patient or clinician notification or complaint
  • Pre-analytic errors such as patient identification, specimen labeling or processing errors
  • Variances reported on quality management reports
• Record the following types of deviations on the Quality Management Assessment Log, as determined by your supervisor:
  • Pre-Analytical (occurs prior to accessioning) deviations: Requisition, order, specimen collection, transportation, identification, etc.
  • Analytical (occurs during accessioning, processing, analysis, sign-out): Accessioning error, test systems, equipment, instruments, reagents, calibrations, controls, material, supplies, technical analysis, test performance, sign-out, frozen section discrepancies, excessive TAT (e.g., >2X expected TAT), etc.
  • Post-Analytical (occurs after sign-out of case): Data handling, report, report processing, release/notification of results, reference labs, consults, report revision, etc.

• Record the following types of deviations on the Quality Management Tracker:
  • Revised report due to a technical error.
  • Persistent unresolved problem after multiple attempts at correction.
  • A serious incident (including near misses or minor problems) with the following features:
    • Care deviates beyond safe limits of practice, and
    • Deviation had a direct, indirect, or potential effect on the eventual (or potentially) adverse outcome of the patient.
• Corrective and Preventive Action Plan (CAPA): 
  • Corrective actions are processes taken to resolve a problem and preventive actions are those actions that keep the problem from recurring. After identifying an error, it is vital to determine the most appropriate actions to correct the current incident and implement a system plan to prevent similar events from recurring.
  • A Corrective and Preventive Action Plan will be implemented to address resolution to the current issue or error, and include processes to prevent the same or similar incident or error from recurring. This can be accomplished by policy or procedure revision, education of staff, or establishing new systems, for example. 
  • The CAPA must be clearly identified by the section head, and communicated with the laboratory or office staff. If a system or procedure was amended, all staff are responsible for reviewing and acknowledging comprehension of the revised procedure. The section head is responsible for ensuring all staff have acknowledged the CAP and policy/procedure revision, and for revisiting the effectiveness of the corrective action plan.

Sentinel Events and Non-Conforming Events (e.g. Near Misses)

The attached template is for an Intensive Root Cause Analysis (RCA) which is a process for identifying and investigating specifics of an event or error that is defined as a non-conforming event, such as near misses or events that represent a risk to patients, employees or the general public - or a sentinel event that resulted in death, permanent harm or severe temporary harm.  The RCA is more than just a thorough examination, but is a planned and organized approach toward finding not only the superficial causes of a problem, but also the deeper, or core  problems. The focus of an RCA is primarily on systems and processes, not individual performance, and can aid the investigator with identifying the basic or causal factors that underlie variation in performance that leads to an error or system failure. It progresses from special causes in clinical processes to common causes in organizational processes and identifies potential improvements in processes or systems that would tend to decrease the likelihood of such events in the future, or determines, after analysis that no such improvement opportunities exist. 

An overview of the RCA process provides a description of each step and element of the RCA.

All non-conforming events are reported to the Medical Director and Quality Management Committee via the Monthly QM Reports for peer review and educational purposes. All sentinel events must be immediately reported using the STARS system and communicated with the Clinical Center's Office of Patient Safety and Quality, which will conduct an intensive root-cause-analysis by engaging LP Staff, Patient Care Providers, and any ancillary support staff throughout the NIH that would be involved in the event.

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