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Laboratory Administration
Operations
Phases of the "Loop"

Reviewer: Richard E. Horowitz, M.D. (see Reviewers page)
Revised: 15 June 2013, last major update June 2013
Copyright: (c) 2012-2013, PathologyOutlines.com, Inc.

Requirements of the Test Ordering Phase
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  1. Physician Education: physicians and house staff should know what tests are available, what they might be used for, their sensitivity, predictive value and diagnostic efficiency and their turn-around time; this requires:
    1. A user manual available online and in the doctor's office
    2. Formal conferences, CPC's, curbside consults in the doctor's dining room
    3. An available pathologist to assist clinicians in ordering appropriately
  2. Hospital and Office Staff Education: nurses, ward clerks and office staff should know what tests are available, when and how they may be ordered; this requires:
    1. A user manual
    2. Nursing in-service education, seminars for office personnel
  3. Laboratory Personnel Education: receptionists, telephone operators and phlebotomists:
    1. Must have intimate knowledge of the user manual
    2. Need special training in telephone and inquiry triage
  4. Requisition design is very influential in the Ordering Phase
    1. Design of paper requisitions or computer screen requisitions is the responsibility of pathologists working with clinicians to obtain optimum usable formats
    2. The format determines ordering patterns, suggests test algorithms and guides clinicians in the use of the laboratory
    3. The ideal requisition merely lists the clinician's problem(s) and requests the pathologist to determine what tests are needed (this is usually the case in anatomic pathology where the surgeon submits a surgical pathology requisition asking for a diagnosis; it is up to the pathologist to determine how that will be achieved, what sections to take, what special stains or molecular studies to do; a similar approach is being used by Laposata in solving coagulation problems - the clinician requests help to solve a problem; the lab determines which tests are needed, in what order, to solve the problem)
    4. Some essential elements of a good requisition:
      1. Clear patient demographics
      2. Precise insurance (or billing) information
      3. Name and contact information of ordering physician - especially for STAT tests requests, knowing to whom to report the result is critical!
      4. Pertinent clinical history
  5. Computer Interface: orders may come to the laboratory on paper, from doctors' offices, via the internet or via dedicated terminals, from the Hospital Information System (HIS) of from a variety of other sources, many with different computers, all of which must interface seamlessly and accurately with the Laboratory Information System (LIS); it is the responsibility of the laboratory to periodically monitor these interfaces to make certain they are transmitting orders and other data accurately, such as patient identification, patient demographics, location and billing data

Requirements of the Specimen Acquisition Phase
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  1. Patient and specimen identification system (bar code, RFID)
  2. Hospital computer system that has the capability for duplicate name check
  3. Laboratory computer system that has capability for duplicate test order checking
  4. Personnel training for proper specimen acquisition; phlebotomists, nurses, couriers - all need training - particularly nurses and orderlies who are responsible for specimen acquisition, e.g., sputum or urine or ICU specimens from IV lines
  5. Special training for personnel outside the hospital, particularly doctor's office personnel, surgicenter personnel, remote outpatient phlebotomy sites, etc.
  6. Equipment: computer, cars, pneumatic tubes, bar code printers, phlebotomy carts, robots for specimen transport must all be checked for proper functioning; for example, does the car used by the courier service have appropriate refrigeration for specimens? Does the pneumatic tube system cause hemolysis?
  7. Specimen triage in the laboratory's Central Receiving and Processing area is often the source of errors, it requires fail-safe systems and protocols for:
    1. Test ordered lists (on paper or on computer)
    2. Specimen receipt list
    3. Specimen splitting and distribution
    4. Work lists
    5. Send-out list
    6. Overdue test lists
    7. Re-draw lists

Requirements of the Testing Phase
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  1. Test development and selection requires assessment of clinical utility, cost analysis and comparison, technology assessment, impact on workload, need for information management and employee education and test validation
  2. Test performance is dependent on: competent personnel, functioning equipment, adequate space and proper reagents
  3. A Standard Operating Procedure (SOP) for every test needs detailed descriptions of:
    1. Purpose and principles of the test
    2. Specimen requirements
    3. Reagents and equipment
    4. Testing procedure
    5. Calibration
    6. Quality control
    7. Calculations
    8. Interpretation
    9. References
    10. History of the test in the laboratory
  4. Quality assurance (encompassing QA, QC, quality management, proficiency testing, performance measurement, process improvement, outcomes management, etc.) is an essential component of the Testing Phase
  5. Point of care and ancillary testing is generally the responsibility of the laboratory and needs special attention with regard to:
    1. Justifying the point of care testing
    2. Developing simple methods for non-lab personnel
    3. Acquiring fail-safe instruments
    4. Selecting methods and equipment
    5. Training personnel
    6. Quality management and proficiency testing
    7. Billing
    8. Transfer of result data from POC to LIS
  6. Pathologist's interpretation and verification is required on all anatomic and selected clinical pathology tests

Billing Subsystem
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Requirements of the Reporting Phase
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  1. Computer interface identical to that described above
  2. A report which may be paper, computer screen, verbal or other
    1. Pathology is an information business; our product is information in the form of reports, numbers, graphs, pictures, descriptions and diagnoses
    2. Our various report formats are the "gift wrap" for our product; this includes the classical paper report, the telephone report and the report appearing on the computer screen
    3. The design of the various report formats is the responsibility of the laboratory working with the clinicians and other customers, e.g., nurses, ward clerks
    4. Essentials of a good form
      1. Visual appeal - include logo - get design help
      2. Easy data entry and readability
      3. Customized report formats for different customers
      4. Zoning, spacing, sequencing, emphasizing and elimination of unnecessary data
    5. Establish a system of forms control
      1. If there are too many forms, too much paper, poor readability, filing problems
      2. Collect all forms, index and classify them, analyze the need for each form, eliminate, consolidate and redesign the essential forms
    6. Pathologists' special reporting functions - the TELEPHONE
      1. Call the surgeon and attending physician on all malignant, interesting or strange surgical diagnoses
      2. Call attending physician about all new panic values or unusual clinical laboratory test results
    7. STAT and critical values reporting
      1. Criteria for inclusion and ranges by clinicians
      2. Reporting methods: phone, computer, text message
      3. Hierarchical escalation of reporting
    8. HIPAA
      1. Privacy protection standards

Additional references
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End of Laboratory Administration > Operations > Phases of the "Loop"


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