Laboratory Administration & Management of Pathology Practices

Safety

Patient safety



Last author update: 6 June 2022
Last staff update: 6 June 2022

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PubMed Search: Patient safety

Anoshia Afzal, M.D.
Lewis A. Hassell, M.D.
Page views in 2021: 7
Page views in 2022 to date: 200
Cite this page: Afzal A, Hassel LA. Patient safety. PathologyOutlines.com website. https://www.pathologyoutlines.com/topic/labadminmanagementpatientsafety.html. Accessed December 9th, 2022.
Definition / general
  • Per WHO: “protection of patients by preventing and reducing errors and adverse effects during health care provision” (WHO: Patient Safety [Accessed 27 April 2022])
  • Promoting a just culture; preventing / reducing pre-analytic, analytic and postanalytic errors; using tools and technology to evaluate and improve patient safety
  • Building a highly reliable team in the laboratory; encouraging laboratory staff and healthcare professionals to prioritize patient safety, learn from errors and prevent them in the future
  • It is imperative to deliver quality health care, which is safe, effective, timely and people centered, to patients
Essential features
  • Prevention of errors and adverse effects
  • Promoting a safe and just culture
  • Classifying and monitoring errors in the laboratory, in addition to proper error reporting and follow up
  • Addressing human factors to enhance patient safety in the laboratory
  • Building high reliability teams in the laboratory
  • Using automation and technology to prevent human error
  • Promoting fail safe communication practices
Terminology
  • Patient safety culture in the laboratory: preventing errors and reducing adverse effects in the laboratory in order to improve quality and patient safety
  • Just culture: foundation for promoting a laboratory culture of patient safety
    • Just culture is a learning culture where an individual is not blamed for an error or adverse event; instead, the whole system is analyzed and errors are perceived as an opportunity to learn from the mistake and improve
  • Patient safety initiatives: include a patient centered care system, increase accountability, create a just culture, evaluate system failures and focus on proper communication and teamwork
  • References: Arch Pathol Lab Med 2005;129:1252, Ergonomics 2015;58:33, Nakhleh: Error Reduction and Prevention in Surgical Pathology, 2nd Edition, 2019
Diagrams / tables
  • Spaghetti diagrams or workflow charts can be created in order to maximize the utility and efficiency of work space (see Lean workflow)
  • Root cause analysis (RCA): problem → ask why (and then why again and again and again) → root cause → corrective action

Images hosted on other servers:

Workflow examples

Histology specimen workflow

Fishbone diagram of RCA

Key practices
  • Developing a patient safety focused culture:
    • Taking proper initiatives to prevent errors and adverse effects
    • Classifying errors in order to monitor and prevent them
    • Reporting errors in an appropriate and timely fashion
    • Taking appropriate actions; for instance, performing a root cause analysis (RCA) or implementing a Plan, Do, Study, Act (PDSA) or failure mode and effects analysis (FMEA) to address and prevent those mistakes in the future
      • RCA is a process of identifying the root cause of an error or an adverse event in order to discover potential solutions and prevent the same error from happening in the future; RCA tends to be a systematic approach where the processes are examined and analyzed and then proper techniques and protocols are implemented for future patient care
      • PDSA is a process of testing a change that was implemented and analyzing its efficacy in order to improve and repeat the process again, if needed
      • FMEA is a process where all the possible components of system failure are identified in order to remove the causes behind them; FMEA can be both qualitative and quantitative and is intended to identify areas that need improvement and change
        • Ideal for preimplementation evaluation
  • References: Health Serv Res 2006;41:1690, JAMA 2005;293:1359, Sesok-Pizzini: Patient Safety in Anatomic and Clinical Pathology Laboratories, 1st Edition, 2017
Classification of errors
  • Laboratory errors are divided into pre-analytic, analytic and postanalytic phases, depending on the phase during which the error / adverse event occurs:
    • Pre-analytic errors in anatomic pathology (Arch Pathol Lab Med 2013;137:1798, Am J Clin Pathol 2006;126:833):
      • Errors in specimen identification (which may be related to unintended workaround of barcoded tracking system), patient misidentification and specimen mix up
      • Wrong / unreliable clinical information
      • Delayed requisitions
      • Amended reports in the electronic medical record by physicians / clinicians
    • Analytic errors in anatomic pathology (Arch Pathol Lab Med 2008;132:181):
      • Mistakes in gross examination of specimens
      • Inappropriate dissection and sectioning of the specimen
      • Problems in histologic processing and staining of slides
      • Mistakes in interpretation by pathologists under the microscope
      • Tissue contamination
      • Failure to obtain expert opinion when needed
    • Postanalytic errors in anatomic pathology:
      • Incomplete reports / mistakes in reports, wrong diagnosis, misdirected reports, failure to report critical values
    • Pre-analytic errors in clinical pathology (Clin Chim Acta 2009;404:28):
      • Wrong physician orders (inappropriate selection of test, duplicate order, wrong test ordered)
      • Mistakes in patient preparation sites
      • Mislabeled specimens, inaccurate wrist bands, specimens collected from site of IV infusion
      • Certain patient conditions that affect specimen quality (hemolysis, icterus, lipemia, clotting, etc.)
      • Requisition not matching the label
      • Specimen collected in the wrong tube
      • Specimen contamination (e.g., skin flora in blood culture)
      • Inappropriate specimen transport medium and temperature
    • Analytic errors in clinical pathology (Clin Chem 2000;46:746):
      • Instrument malfunction
      • Reagent carryover, especially in random access instruments that use dedicated probes
      • Instrument validation errors and quality control failure
      • Random errors caused by the instrument
      • Frozen specimen thawing and coagulation errors
    • Postanalytic errors in clinical pathology (Arch Pathol Lab Med 2005;129:1252):
      • Errors in reporting of results
      • Wrong data entered into the system
      • Results reported to wrong provider or delayed results
      • Incorrect reference ranges
      • Delay in receiving results from the clinical teams
      • Data integrity failures in the electronic health record
    • Monitoring errors in clinical and anatomic pathology (Arch Pathol Lab Med 2005;129:1252):
      • Pneumatic tube systems need to be regularly checked and validated
      • Proper identification, accurate accessioning of the specimen and using high quality barcoded labels before sending specimens to the automated machine
      • Certain analytic errors can be easily avoided by preventing reagent carryover, specimen carryover, proper calibration and verification of the instruments and appropriate quality control
      • There should be a backup plan for reporting critical values, etc., in case the system fails (downtime procedure)
      • Reference ranges need to be periodically monitored and updated
      • Lower limit of detection for certain molecular assays needs to be reviewed regularly, for accuracy
      • There should be accountability at both ends (the laboratory and the clinical team)
      • Ordering physician should be vigilant enough to follow unusual trends (e.g., gradually increasing cell counts and critical values, etc.)
      • Point of care testing should be carefully implemented in critically ill patients, as this patient population often requires urgent laboratory support and can experience wide fluctuations in blood levels of different gases and electrolytes
Additional useful tools
  • A quality indicator portfolio has been offered by College of American Pathologists (CAP), which is called the Q probes program, including the Q track program
    • Created in 1999 as a subscription service for quality monitoring; the main objectives were the establishment of quality benchmarks, monitoring performance over time and identification of practices associated with better performance
  • References: Arch Pathol Lab Med 2014;138:1003, Arch Pathol Lab Med 2014;138:1139
Error reporting, risk management and implementation of patient safety program
  • Identification of risks and implementation of certain interventions to prevent and decrease those risks
  • Medical errors should be disclosed directly to the patient, in order to gain patient trust and avoid lawsuits
  • Information should be compiled from resources, such as incident reports, chart reviews and patient complaints, in order to have a comprehensive overview of errors
  • Reporting should be followed by an RCA to investigate the incident, define risks and prevent the same incident from happening in the future
  • Local system hazards should be identified and worked on as well
  • References: Arch Pathol Lab Med 1998;122:231, JAMA 2003;289:1001, JAMA 2005;293:1359
Addressing human factors to prevent error and enhance patient safety in the laboratory
  • Transparency and a team approach should be encouraged whenever an error occurs
  • Just culture promotes the concept of holding the system (instead of an individual) responsible for an incident and emphasizes the importance of evaluating system design as opposed to blaming an employee
  • Addressing stress, fatigue, call schedule, communication, handoffs and transitions in the laboratory staff and healthcare professionals is extremely important to avoid blunders that are due to burnout or lack of communication
  • Effective communication, written documentation and proper hand off between pathology and clinical teams, during daytime and on call
  • Implementation of read back culture after each result is called out (frozen section results, critical values and during patient handoffs)
  • Phonetic spelling and clarification of questions whenever a result is called out
  • Implementation and incorporation of a patient safety curriculum for residents / fellows
    • Patient safety education should be mandatory for accreditation purposes before resident physicians enter independent practice
    • Quality assurance (QA) and quality improvement (QI) activities should be incorporated in resident and fellow curriculum, to minimize the chances of human error by increasing awareness and understanding the importance of lab safety culture
  • References: Health Serv Res 2006;41:1690, Acad Pathol 2021;8:2374289521998046
Technology and tools to improve laboratory patient safety
  • Rigorous staff orientation / training / competency assessment programs to elevate skills of laboratory staff
  • Use customized charts and graphs in the work area
  • Use robotics for hazardous and repetitive activities to minimize human error
  • Deploy automation and information technology, such as laboratory information system (LIS), to the individual benches and workstations for laboratory personnel
  • Lab automation decreases the risk of human errors, at the cost of its own errors and shortcomings
  • Flagging of critical values / results by automated systems
  • Computerized provider order entry (CPOE) improves order entry lab orders and avoids downstream human errors at multiple levels
  • Many laboratory functions such as quality control, inventory, data verification and reporting can be automated and help to decrease the workload and fatigue among the laboratory staff
  • Lab automation increases reliability by standardizing processes
  • References: Clin Leadersh Manag Rev 2007;21:E3, Ergonomics 2015;58:33
Videos

Root cause analysis (RCA)

Plan, Do, Study, Act (PDSA) cycle

Failure mode and effects analysis (FMEA)

Root cause analysis techniques

Board review style question #1
A healthy, safety oriented lab culture will consistently do which of the following?

  1. Assign a lab safety officer that is responsible for all things safety in the lab
  2. Collect data on quality practices without ever reporting or reviewing the collected data
  3. Focus error reduction efforts on all the pre-analytic problems identified by clinical colleagues
  4. Quickly identify the individual responsible for an error or defect and release or retrain them
  5. Seek to learn from errors or mishaps through efforts such as open reporting, root cause analysis and failure mode effects analyses, so that errors are not repeated
Board review style answer #1
E. Seek to learn from errors or mishaps through efforts such as open reporting, root cause analysis and failure mode effects analyses, so that errors are not repeated. Healthy lab safety cultures seek to learn from mistakes and value them as an opportunity to improve. They see the system, rather than the individual, as the locus of intervention and source of problems. They are continually reviewing their experience to search for ways to improve and balance their focus between internal and external sources of errors, within the lab and beyond. They empower all employees to participate in making their work safer for their patients and themselves.

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Reference: Patient safety
Board review style question #2
Your lab is now handling an increased number of prostate biopsies after 2 large local urology practices severed ties with a large national lab. Patient J from one of these practices had a total prostatectomy, following a report that 4/6 sextant biopsies showed a Gleason score 7 carcinoma; however, his prostatectomy contained no evidence of carcinoma. Genotyping of this prostatectomy and the biopsy tissues do not show evidence of a match. When you meet to disclose the error with the patient and the surgeon, the patient asks you: “Who got the wrong report for my likely benign biopsies?” The most likely place to look for this kind of error and the type of error most likely responsible for this will be among which of the following?

  1. All patients with prostate biopsies accessioned in your lab on that day (pre-analytic within the lab)
  2. All prostate biopsies dictated by the GU pathologist the day patient J was reported (analytic)
  3. All prostate biopsy reports distributed the day patient J was reported (postanalytic)
  4. All prostate biopsy reports sent to the same clinic the day patient J was reported (postanalytic, outside the lab)
  5. Patients seen in the same clinic as Patient J on the day of his biopsies (pre-analytic outside the lab)
Board review style answer #2
E. Among patients seen in the same clinic as Patient J the day of his biopsies (pre-analytic outside the lab). Most pre-analytic errors occur outside the laboratory. Although the “other” patient in this sort of paired error will likely be present in all of the groups mentioned above, the smallest number of other considerations to be evaluated will be within the cohort in option E; therefore this is the most fruitful place to start. Such errors, due to faulty or incorrectly followed labeling procedures, are much more common than accessioning, interpretive, transcription or reporting / filing errors alluded to in the other choices.

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Reference: Patient safety
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