Vol. 24 • Issue 3 • Page 34
The College of American Pathologists (CAP) requires the tracking and trending of Nonconforming Events (NCEs). The FDA requires blood product deviations reporting. Laboratories are also required to develop Key Indicators of Quality (KIQs) metrics – essential components of a Quality Plan. Done effectively in a “Just Culture” setting, NCE and BPD reporting can be the cornerstone of an effective quality program. Done ineffectively, NCE and BPD reporting can be time consuming and contribute to low morale.
To help administrators implement an effective program, the following is a review of NCE and BPD reporting regulatory requirements – how to conduct effective root-cause analysis (RCA) in a “Just Culture” setting, how NCE trending can help guide selection of KIQs and the benefits of NCE-reporting software.
Regulatory Requirements for NCE, BPD and KIQ Reporting
CAP GEN.20208 QM Patient Care Services – Phase II
• The QM system includes a program to identify and evaluate errors, incidents and other problems that may interfere with patient care services.
CAP GEN.20325 Employee & Patient Quality Communication – Phase II
• The lab has a procedure for employees and patients to communicate concerns about quality and safety to management.
CAP GEN.20316 QM Indicators of Quality – Phase II
• The QM program includes the monitoring of key indicators of quality in the pre-analytic, analytic and post-analytic phases.
FDA Guidance for Industry – Biological Product Deviation Reporting for Blood & Plasma Establishments
• Must investigate any errors that have the potential to impact blood safety, purity or potency.
• If involved component left control of the laboratory, electronic report must be filed with FDA within 45 days of discovery.
• BPDs discovered prior to distribution – i.e., “near misses” must still be investigated, but do not have to be reported.
Joint Commission Standard 04.04.05
• Must proactively explore potential system failures to analyze and take action on problems that have occurred, and encourage the reporting of adverse events and near misses, both internally and externally.
• E08: The organization conducts thorough and credible root-cause analyses in response to sentinel events that include:
– Development of an action plan designed to implement improvements to reduce risk
– Implement the improvements
– Monitor the effectiveness
– Should focus on systems and process, not individual performance
What to Report
In the general laboratory, NCE reporting should include anything that, if undetected, could potentially adversely impact patient care and/or accuracy of test results. Reports should capture errors in all phases of testing – i.e., pre-analytic, analytic and post-analytic. NCE reports are also an effective way to capture safety concerns or violations and all complaints from both external customers and laboratory employees regardless of validity.
In the blood bank, any error that, if undetected, would have the potential to compromise blood component safety, purity or potency must be investigated. Blood bank errors that occur prior to product distribution (near misses) must also be investigated, but don’t have to be reported to FDA. Our NCE information system allows employees to report concerns anonymously, satisfying CAP GEN.20325.
Effective Root-cause Analysis
To effectively impact quality, NCE reporting must be timely and include thorough RCA with concise documentation of all relevant facts, immediate corrective actions taken and sufficient detail for follow-up and risk assessment. Critical to success is the development of a “just culture,” where emphasis is placed on the NCE as an opportunity to review and improve systems rather than an occasion to “write-up” colleagues.
RCA aims to uncover the fundamental reason(s) that allowed the error to occur. Discussing the incident with the employee involved is often critical to the root cause determination. Did they know what to do, i.e., was it simple human error or a competency problem? If they don’t recall what happened, as is often the case, have them explain their normal process to assess competency. Were there other contributing factors or did more than one error contribute – i.e., the “Swiss-cheese model,” where several “holes” in the process line up, allowing the error to get through?
The “5 Whys” method can help determine root cause – as this simple example demonstrates:
My car won’t start!
1. Why? The battery is dead.
2. Why? The alternator is not functioning.
3. Why? The alternator belt has broken.
4. Why? The alternator belt was well beyond its useful service life and not replaced.
5. Why? The vehicle was not maintained according to the recommended service schedule.
Reviewing an NCE report can help improve SOPs. Did your SOP cover the step in question? If yes, review the SOP with your team. If no, rewrite or revise before closing out the report.
NCE Reporting in a ‘Just Culture’
At our facility, we have evolved from a “blame free” culture that suggests no individual accountability to the development of a “just culture,” which emphasizes open reporting, systems analysis and prevention of recurrence while still maintaining performance accountability. Establishment of a just culture begins by assuming good intentions. With rare exceptions, lab employees are trained professionals who want to do things correctly. Use your NCE review session to restore confidence, relieve anxiety and reiterate the goal: Identification of systems problems and potential improvements to help prevent recurrence. Remind them how many times they do things right. In short, be positive, not punitive, and treat near misses the same as actual events.
Communication is critical. We alert the entire blood bank staff to all BPDs via email, detailing vulnerable steps in the process, how to prevent recurrences and soliciting suggestions. Error prevention has become a “game” with open exchange of ideas for improvement and prevention.
There should be no automatic link between NCE reports and discipline, which only encourages cover-ups and leads to low morale. The obvious question becomes, “Is discipline ever indicated as a result of errors?” Clearly, disciplinary action is indicated in certain circumstances: impairment due to drugs or alcohol, intentional disregard of policy, falsification of records, failure to report (including self-reporting) and repeated errors of the same type. Don’t use employee evaluations as an error review session. We only discuss error rates during evaluations if they are very high, or very low.
Employees must know that the NCE reports don’t go into a black hole. Staff can submit prevention suggestions via a field in our OTIS reporting system, and all suggestions are acknowledged. Share successes. For instance, when Hoag went live with CPOE, numerous ordering errors resulted in extra work in the lab. We simply created a CPOE incident category in OTIS, trended the data and provided reports to the nurse managers. Error reduction data is shared with the staff so that they can see results from their reporting efforts. Lastly, we use NCE data to let staff how well they’re doing. Our reportable BPD rate of .048 percent with no adverse patient outcomes becomes a cause for celebration and pride.
Randy German is blood bank and laboratory quality manager at Hoag Memorial Hospital, a 600-bed, two-campus, not-for-profit hospital in Newport Beach, Calif. For further details on the “Use of a Nonconforming Events Information System in the Laboratory to Select Key Indicators of Quality, and Meet AABB and CAP Requirements for Quality Management,” see http://otisnow.com/blood-bank-qa-webinar-randy-german-hoag-hospital/.