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Result Validation: Information Systems

I. PRINCIPLE:

Result Validation is a procedure used to "validate" results entered and released in the LIS are identical to those displayed or printed on other information systems linked to the LIS via an interface. (e.g.: hospital information systems (HIS), physician office systems (POS) and/or other laboratory systems) The procedure is performed annually with a predefined battery of tests. It will also be performed:

  1. anytime a new test configuration is established
  2. anytime an established test configuration is modified in such a way as to directly affect the reporting of results for that configuration
  3. at the discretion of the Technical Director/CIO, LIS Director or the LIS Project Coordinator.

II. PROCEDURE:

  1. Annual Result Validation:
    1. Order the following tests on the interfaced information system (HIS, POS etc.…) test patient, with a priority of routine and for the current date/time if date/time is not otherwise specified:
      1. Hemogram
      2. Urinalysis with Micro
      3. Comprehensive Metabolic Panel
      4. Myoglobin
      5. Troponin I
      6. Rapid Strep Antigen
      7. Digoxin
    2. Issue the appropriate credits for the interfaced information system and change the price of the ordered tests in the LIS to $0.00.
    3. After the requisitions print on the LIS requisition printer, enter the results in the LIS, via Manual Results Entry screen, as follows:
      1. Hemogram
        1. WBC: 5.0
        2. RBC: 4.5
        3. HGB: 13.8 (abnormal if test patient is male)
        4. HCT: 43
        5. MCV: 86
        6. MCH: 28
        7. MCHC: 32
        8. PLAT: CT: 200
        9. RDW: 13.5
        10. MPV: 8.5
      2. Urinalysis with Micro
        1. Color: Yellow (Yel)
        2. Appearance: Hazy (Haz)
        3. Glucose: Negative (N)
        4. Bilirubin: Negative (N)
        5. Ketone: Negative (N)
        6. Specific Gravity: 1.010
        7. Hemoglobin: Negative (N)
        8. pH: 6.5
        9. Protein: Trace (T)
        10. Urobilinogen: 0.1
        11. Nitrite: Negative (N)
        12. Leukocyte Esterase: Negative
        13. RBC: 0
        14. WBC: 15
        15. Bacteria: 1+
      3. Comprehensive Metabolic Panel
        1. BUN: 23
        2. Glucose: 210
        3. Creatinine: 0.8
        4. Calcium: 10.2
        5. Total Bilirubin: 0.2
        6. Alkaline Phosphatase: 108
        7. AST(SGOT): 22
        8. ALT(SGPT): 53
        9. Albumin: 3.7
        10. Total Protein: 7.60
        11. Sodium: 134
        12. Potassium: 3.0
        13. Chloride: 109
        14. CO2: 28
      4. Myoglobin: 90
      5. Troponin I: 0.02
      6. Rapid Strep Antigen: Not Detected
      7. Digoxin: < 0.2
    4. Release results in the LIS via the Transcription Review/Release screen.
    5. Gather the Temporary Reports from the interfaced system and compare the reported results to those entered in step 1.C.
      Note: Results listed in italic are abnormal and are to appear as flagged (#) results on the Temporary Report copy generated by the HIS, with the exception of CKMB with Index.
    6. Gather the Cumulative Reports, which print on the LIS and compare the reported results to those entered in step 1.C.
      Note: Results listed in italic are abnormal and are to appear highlighted on the Cumulative Report generated by the LIS.
    7. Record the results of the validation test on the Result Validation Report.
  1. Result Validation for New or Modified Test Configurations:
    1. Place two orders of the new or modified Test Configurations through the interfaced system on the system test patient Assign the priority level as routine and place the orders for the current date/time.
    2. Issue the appropriate credits for the interfaced information system and change the price of the ordered tests in the LIS to $0.00.
    3. Gather the requisitions that print on the LIS and enter results in the LIS via Manual Results Entry screen:
      1. Using the accession number and Test Configuration Code on one of the duplicate orders, enter the appropriate result. If the result is numeric, enter a result that represents the upper limit of normal; if the result is a text value enter a normal text value.
      2. Using the accession number and Test Configuration Code on the other duplicate order, enter the appropriate result. If the result is numeric, enter a result that represents the lower limit of abnormal; if the result is a text value enter an abnormal text value.
    4. Release the results entered via Transcription Review/Release screen.
    5. Check the LIS Inquiry screen for appropriate indication as normal or abnormal results.
    6. Gather the Temporary Report from the interfaced system and compare the reported results to those entered in step 2.C.
      Note: Check that abnormal results are flagged with a "#" sign on the Temporary Report.
    7. Gather the Cumulative Report from the LIS and compare the reported results to those entered in step 2.C.
      Note: Check that abnormal results are highlighted on the Cumulative Report.
    8. Record the results of the validation test on the Result Validation Report.
    1. M. English
    2. M. English (Revised: replaced Chem 13 with Comp. Met. Panel)
    3. M. English (Revised: Note following 1.E; added CO2 to CMP)
    4. 2000 M. English (Revised: CMP config & changed to annual testing)
    5. 2001 M. English (Revised: replaced cardiac protocol with current testing regimen)
    6. 2007 M. English (Revised: replaced card. Markers with Myoglobin & Troponin I, added RDW and MPV to hemogram)

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