Laboratory Administration & Management of Pathology Practices

• Define the adverse event or undesired outcome
  • Adverse event example: laboratory test resulted to incorrect patient
  • Near miss example: labeling error identified and corrected by pathologist before test resulted to patient
• Identify all involved or knowledgeable personnel
  • In the laboratory: frontline staff, support personnel, technologist, resident trainees, supervisors, managers and pathologists
  • Nonlaboratory stakeholders: physicians or service lines involved (e.g., radiology, surgery), operating room (OR) staff, transport / courier staff, nurses
• Identify equipment, processes and policies that may be linked to the incident
• Gather information:
  • Document objective information (who, what, where, when); question of "why" reserved for next step
  • Interview and gather data from all personnel involved
• Create tools to help visually describe the components of the event (process map)
• References: Proc (Bayl Univ Med Cent) 2001;14:154, Appl Immunohistochem Mol Morphol 2019;27:329

5 "why's" method

• Iterative technique used to discover a problem source: ask "why" 5 consecutive times, each time using the previous answer as the starting point for the next question
• By the fifth "why", the root cause is often revealed
• Effective method to use when the root cause is likely internal to the laboratory (or organization)
• Example 1:
  • I was late for work → why?
    1. Because I did not know about the accident on the highway → why?
    2. Because I did not turn on the radio while getting dressed → why?
    3. Because I woke up late and was rushing → why?
    4. Because I did not hear the alarm go off → why?
    5. Because I was out too late last night
• Example 2:
  • The H&E stain has been suboptimal lately → why?
    1. Because the reagents have not been changed daily over the past week → why?
    2. Because the histology lab staff did not know daily routines → why?
    3. Because new histology staff did not receive adequate onboarding or supervision → why?
    4. Because there was no new staff orientation → why?
    5. Because the histology supervisor was absent and current operational policies and procedures do not specify who should supervise staff onboarding and orientation when the histology supervisor is absent

Fishbone or Ishikawa diagram

• Diagram used to identify possible causes of a problem and sort them into useful categories for investigation
• Problem to be addressed is the "head" of the fish and the categories of possible causes form the "bones," with various specific details along each of the bones
• Effective method to use when the root cause(s) is (are) deemed multifactorial or originating outside of the laboratory or department
• Example:
  • During review of quality metrics, it was noted that the number of mislabeled specimens being received from the OR was above the metric threshold
  • Because these specimens are critical, the standard re-education of OR staff regarding labeling was considered an insufficient measure to correct the problem
  • Full RCA was undertaken
  • Working group of stakeholders was convened to review the current processes; this included a pathologist, histotechnologist, specimen accessioning tech, nurse educator for the OR, circulating nurse and general surgeon
  • Group implemented a fishbone diagram to review the processes and 5 areas of importance were investigated:
    • Procedures: procedures for both the OR and the anatomic pathology department were reviewed and 2 major areas of potential weakness were identified
      • Time out procedures for the OR required identification of the patient and procedure (operation) but did not include identification and confirmation of specimens for pathology
      • Laboratory OR procedures did not detail the labeling and handoff process at each stage in relocating specimens from the OR, to the specimen drop off site, to collection of specimens, to accessioning
    • Processes: a review of the OR processes showed that some staff were using shortcuts to "make things run more smoothly" or were not completing room turnover per protocol
      • Specimen bottles were labeled with patient identifiers at the start of the surgery, rather than when specimens were acquired
        • Prelabeled and unused bottles were not always discarded after patient surgery
        • Therefore, these prelabeled bottles were at risk of being used incorrectly for a subsequent patient case
      • Specimen label sheets were printed out for use at the start of a case and were not always discarded after the surgery
        • Therefore, unused prelabeled specimen sheets were at risk of being used incorrectly for a subsequent patient case
    • Personnel:
      • Surgeons did not always perform a complete specimen count after case completion and did not sign the anatomic pathology requisition per protocol
      • New personnel in the OR were not trained with standard procedures and practices
    • Education:
      • Onboarding of new staff in the OR and pathology required to understand the labeling and logging process for patient safety was incomplete
      • Training OR staff and environmental care staff to identify material to be discarded during room turnover did not include empty labeled specimen containers or patient labels
    • Equipment:
      • Equipment limitations were encouraging staff to "prelabel" requisitions and containers as "shortcuts"
      • Many specimen label printers were either inconveniently located outside the OR or not in working order
  • All the above factors discovered during RCA contributed to specimen mislabeling; as a result, the following actions were taken:
    • Procedures for specimen labeling, handoff and transfer were revised and clarified; all staff was retrained
    • Procedures for room turnover were rewritten to emphasize items which must be discarded after case completion
      • Unused patient labels and labeled specimen containers must be discarded at case completion
    • Surgeons were mandated to review and sign laboratory specimen sheets at the end of a case
    • IT was engaged to routinely round in the OR to check printer functionality
    
    Contributed by Moira P. Larsen, M.D., M.B.A.
    
    

    Fishbone diagram example

    
    

Cause map analysis

• Cause and effect diagram, similar to a fishbone diagram but organized from left to right on the page
• Start with the problem, then draw an arrow to the next box that answers the question of "why" or "was caused by"
• Continue with iterations until the root cause is revealed
• Example:
  • Multiple medical technologists in the core laboratory reported to occupational health over the course of 2 days with symptoms including headaches and nausea
    • Symptoms, which developed at work, were reported to laboratory leadership
    • Investigation regarding the illnesses began and was conducted by the occupational health nurse, chemistry supervisor and laboratory administrative director
    • Medical technologists were interviewed and all reported an odd odor in the walk-in freezer
  • As the investigating team checked the freezer, they also noted the odor and began developing symptoms
    • Chemistry supervisor discovered that there were twice as many reagent supply boxes in the walk-in as usual and when opened and inspected, all of the boxes contained dry ice
    • Team suspected that excessive dry ice was leading to high levels of CO2 in the enclosed space and producing the symptoms
    • Dry ice was removed and an RCA investigation was conducted
  • Facilities were asked to check and confirm the high levels of CO2, then address the CO2 alarm
    • Functional CO2 alarm should sound when CO2 levels are dangerously elevated
    • Investigation revealed that the alarm had not sounded and was not functioning
    • Alarm was repaired
  • Chemistry supervisor contacted the vendor to determine why the standing reagent order had been doubled
    • Investigation found an error in lab ordering
    • Lab ordered the supplies, as inventory had not been appropriately checked
    • To prevent recurrence of this error, additional logs and inventory management were implemented
    
    Contributed by Moira P. Larsen, M.D., M.B.A.
    
    

    Cause map analysis example

Which of the following scenarios is least likely to benefit from a root cause analysis?

1. Addressing the cause of blood product administration to the wrong patient
2. Daily monitoring of personnel punctuality to ensure adequacy of shift coverage
3. Explaining the reason for difficulties in personnel recruitment and retention
4. Increased turnaround time for surgical pathology reports
5. Investigating a complaint regarding frequent specimen mislabeling

B. Daily monitoring of personnel punctuality to ensure adequacy of shift coverage. RCA is most practical when used as an investigative tool to uncover and address the chief underlying reason(s) for an undesired event, trend or outcome. It has less utility as a proactive surveillance tool. The daily monitoring of personnel punctuality to ensure adequacy of shift coverage is an ongoing surveillance activity; unless a negative trend is discovered, RCA is not likely to be directly applicable. The underlying reason (root cause) for increased turnaround time in surgical pathology, specimen mislabeling or incorrect blood product administration may originate from systemic issues beyond what may be immediately visible and thus these scenarios may benefit from RCAs. Similarly, difficulties in personnel recruitment and retention may be due to reasons other than labor market forces (such as institutional / departmental reputation, conflicting personalities, safety concerns, onboarding problems, human resource conflicts) and as such, may benefit from RCA.

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Reference: Causal analysis