9. QSE Nonconforming Event Management

According to CLSI GP26-A4, “QSE Nonconforming Event Management describes processes to detect and document nonconformances, manage products and services that do not meet specified requirements, classify nonconformances for analysis, and correct the problems they represent ”.[1]

As such, Nonconforming Event (NCE) Management plays a very important role in the Quality Management System of any clinical laboratory. This is the mechanism that investigates patient incidents and near misses to make sure that the system is operating as effectively and efficiently as possible to avoid any future or ongoing harm to the patient. According to the Canadian Standards Association, Non-Conformance Management “is the foundation of all other procedures that lead to error identification, error correction, and continual improvement. This clause, more than any other, ties the medical laboratory directly to patient safety”.[2]

A non-conformance is any action that is not consistent with established procedure. It can be described as an opportunity to improve and should be used as a learning tool.[3] In order to clearly understand the role of Occurrence Management in the organization, it is imperative that students understand the terminology that is frequently used when describing the occurrence management processes.

Common Terms

Nonconformances

 

Trending

 

Risk Management

 

Root Cause

Corrective action

Sentinel event

Near miss

There are 3 main policies associated with Occurrence Management that give an overview of its purpose:

  1. The identification, documentation and investigation of complaints and nonconforming events
  2. Classification, analysis, and trending the data to gain meaningful data
  3. Root cause analysis and process improvement (quality improvement)

Processes and procedures fall out from each of these policies.

Some examples of processes and procedures that would fit into this QSE include

Processes

  • Standardized reporting mechanisms for any nonconformances that may occur
  • Mechanisms for managing recalls of materials, equipment, or software
  • Mechanism for receiving, reviewing, classifying, analyzing information, and filing reports
  • Process for reviewing data and information from reports on a regular basis to look for trends and to initiate corrective action when they are found
  • a mechanism for referral to process improvement for root cause analysis and for corrective action to occur

Procedures

  • to identify and report deviations from the norm, nonconformances, unusual occurrences, and unexpected or adverse outcomes
  • to identify staff responsible for NCE investigations
  • to define responsibilities of staff for purchasing/materials management and laboratory staff for handling recalls
  • to classify NCEs regarding their severity
  • for tracking and trending information
  • for reporting of analyses to management
  • for identifying and referring opportunities for performance improvement

When NCE’s do happen it is required by most organizations’ executive management that reports be submitted describing the event or incident because “these risks are a major concern because they introduce levels of unnecessary and inappropriate risk” (PLUS 15189, p 24) [4]

On occasions when the event is very serious or has caused significant harm to a patient, then a full investigation must occur and a root cause analyze must be performed. Once the root cause has been fully identified, a plan for corrective action can occur. Sometimes this plan may affect only one Department of the organization but often, when major issues are being investigated, it will result in comprehensive changes that may impact the whole organization, or a large piece of it.

Problems, or NCEs, can be identified in a variety of ways:

  • from physician, patient, or customer complaints
  • from QC or calibration issues and external proficiency results
  • from non-conforming patient examination results and reports
  • from reagent and consumable issues
  • from staff comments
  • from findings of internal or external audits and from management reviews

Non-conforming event management is linked with the organizations’ risk management program. This is because the risk management program provides information on systemic laboratory problems that can impact patient care.

What are some examples of nonconforming events?

The reporting of nonconforming events is very important in the laboratory environment and so it is imperative that open lines of communication are practiced within the laboratory. Open communication is more easily achieved once staff understand that most NCEs are caused by process deficiencies and reporting them can aid in process improvement and reduction of NCEs overall. They are not intended to assign blame to individual workers or departments. More mistakes are caused from systemic process issues than from people.

A standard format to follow when completing an NCE report would include the following the information.[5]

Components of a Non-Conformance Report

Who
  • Identity of reporting person(s)
  • Identity of any involved individuals who committed, compounded, discovered, investigated, or initiated immediate action
  • Patient or donor identification
  • Reviewer of report
What
  • Brief description of the event
  • Effects on, and outcome to, the patient or donor
When
  • Date of the report
  • Date and time the event occurred
  • Date and time the event was discovered
  • Date and time that immediate action was taken
Where
  • Physical location of the event
Why and How
  • Explanation of how the event occurred
  • Contributing factors to the event
  • Root cause(s)
Follow-up
  • Corrective action taken
  • Implementation date
  • Effectiveness of action taken
  • Reports or notifications to physician, patient, laboratory management, etc.

When blood and/or blood products are involved in an NCE, additional information is required in the report with regard to donor information, site of process event, whether or not the arm preparation was performed correctly, the number of units used, and any other transfusion specific information that may be relevant to the event.

Investigation of NCEs includes documenting individual incidences of problems, classifying the type of problem it is, taking remedial action where possible, and investigating and applying corrective action in all other incidences. Once a problem has been identified and the reason for it has been determined, it is much easier to set up a process to avoid future occurrences.

The activities that must occur to address NCEs include

  • consideration of the medical significance of the event
  • notification of the proper health care professional(s)
  • stoppage of the procedure until a review and revision of the process can take place to correct the issue
  • definition of further actions to take and designation of personnel to resolve the problem
  • definition of the responsibility for resuming the examination once the issue has been resolved

All NCEs must be documented and stored in order to have valid records of the actions taken and the persons responsible.

Classification, analysis, and trending of the data and information collected is a vital part of the Quality Management System to ensure that process improvement occurs. Through these processes, trends and patterns of recurring issues can be identified. As well, root cause analysis can occur and the process can be improved so that the same or similar events do not continue to happen.

There are a number of tools and processes that can be used for performing root cause analysis that leads to process improvement. The process for performing root cause analysis can be as simple as a conversation with involved parties, or it can require more in depth analysis.

Some of the common tools used in Root Cause Analysis include

  • Process mapping
  • Cause and effect diagrams (Fish bone)
  • Pareto charts
  • Failure modes and effects analysis (FMEA)

Because of the legal implications of NCE reports, it is very important that they be written concisely and clearly so that they can be easily understood.

Rules for writing NCE Reports

  1. Be factual
  2. Do not offer opinions – of either the possible chain of events or of the person you assume made the error
  3. Print (not write) in a concise, complete, unbiased, easy to read manner
  4. Complete the report in a timely manner so that follow up actions can be taken

Scenario

You are working alone on the evening shift. You pick up a package from the bench that contains a patient requisition and accompanying specimens. The requisition is labelled with the following information:

Patient: Smith, John M.
HIS#: 01234567
DOB: Feb.28, 1967
Ordering Physician: Dr. Peter Brennan

The Specimens are labelled with this information:

Patient Name: Smith, Jane M.
His#: 0123567
DOB: Fe. 28, 1967

Describe how you would write up a report to describe this nonconforming event.

Other examples of events that would require an NCE report

  • A specimen is found lying on the counter in the washroom. It is not in a bag and there is no accompanying requisition. The blood specimen is dated and labelled with the name Charles Burton Weatherby and a MRN.
  • A report is given on a patient’s tests that you later realize was not the patient who the results were requested on.
  • A biohazard bag was placed on the counter in the lab. When you looked into the bag, you found a requisition requesting a PTT and blood sample in a sodium citrate anticoagulated tube. The date on the requisition was 10/11/2010. Today is 12/11/2010.
  • You receive a call from the Orthopaedic Unit asking why you sent them a test report for Troponin on Mary Jane Smith. They claim that they didn’t order that test and their patient was certainly not exhibiting any signs of having had a cardiac event. Upon investigation, you discover that there was an error made in specimen processing. A patient test request had come into the lab about the same time as the orthopaedic patient specimen. The patient was from the Emergency department and her name was Mary Jean Smith. She had a troponin test requested. When you checked the ordering requisition for the orthopaedic patient, her test request was for electrolytes.

Think about how these occurrences may have happened and describe how you would address each one.

Review Questions

  1. List the 3 main policies for NCE Management.
  2. When would a full investigation and root cause analysis be performed?
  3. What is one of the main causes of Nonconforming Events?
    1. Human error
    2. Process issues
    3. Broken equipment
    4. Budget cuts
  4. Describe the 6 components of an NCE report.
  1. Berte, L. (2019). A quality management system model for laboratory services [GP26-A4] (5th ed.) p.101. Wayne, PA: Clinical and Laboratory Standards Institute. ↵
  2. Canadian Standards Association. (2010). The ISO 15189:2007 essentials – A practical handbook for implementing the ISO 15189:2007 standard for medical laboratories. Mississauga, ON: Canadian Standards Association. p. 24 ↵
  3. Quinley, E.D. (2011). Immunohematology principles and practice (3rd ed.). Baltimore, MD: Lippincott, Williams & Wilkins. ↵
  4. Canadian Standards Association. (2010).  The ISO 15189:2007 essentials - A practical handbook for implementing the ISO 15189:2007 standard for medical laboratories.  Mississauga, ON: Canadian Standards Association. ↵
  5. Roback, J., Grossman, B., Harris, T., & Hillyer, C. (eds). (2011). Technical manual (17th ed.). Bethesda, MD: AABB. p.21 ↵

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