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Outcomes of Poor Quality Control

The following examples emphatically demonstrate the terrible adverse outcomes that patients may experience if the laboratory reports patient results when quality control is out of range.

  • A 54 year old man has a PSA ordered as part of his annual physical exam. The laboratory reports out a PSA result of 6.3 ng/mL. The patient is referred to an urologist for further evaluation. Six prostate needle biopsies are taken, all of which are reported as normal. A repeat PSA level is 3.5 ng/mL. The primary physician calls the laboratory to asks the laboratory to repeat the PSA on the original specimen. The result is 3.8 mg/dL.
  • A 38 year old female complains of fatigue and aching joints. A comprehensive metabolic profile is performed as part of her laboratory workup. The ALT is reported as 84 IU/L. The physician refers the patient to a gastroenterologist who orders more liver function tests including a hepatitis profile, ANA, smooth muscle antibody, mitochrondrial antibody, iron and transferrin saturation, and a ceruloplasmin. All of these tests are normal. The gastroenterologist orders a repeat ALT prior to performing a liver biopsy. The result is 54 IU/L. He calls the laboratory to inquire why there is so much variability in this patients’ ALT values over a 2 week period?
  • A 28 year old pregnant woman who is at 26 weeks gestation comes to the outpatient clinic for a 50 g oral glucose tolerance test. The laboratory reports a value of 150 mg/dL. The obstetrician orders a confirmatory 100 g oral glucose tolerance test. After drinking the Glucola, the patient becomes extremely nauseated. The results of the OGTT are normal. The obstetrician calls the laboratory and asks why the 50 g OGTT was abnormal, if the 100 g test was normal? The laboratory repeats the glucose on the original specimen and the result is 130 mg/dL.
  • An 81 year old woman is hospitalized for a broken hip. The admission coagulation profile reveals a Protime of 23.3 seconds and an INR of 2.1. The orthopedic surgeon orders 2 units of FFP for transfusion prior to surgery. The next day the laboratory realizes that its quality control had been out of range and that the patient’s Protime was probably within the normal range. Unfortunately, the FFP had already been transfused. One week after surgery the patient develops encephalitis and tests positive for the West Nile Virus. A transfusion reaction workup includes reporting the encephalitis to Community Blood Center. Their investigation reveals that the donor of one of the units of FFP had been bitten by a mosquito one week prior to donation and had experienced a flu-like illness. The patient recovers after one month in the ICU and then files a malpractice suit against the surgeon, hospital, and blood center.
  • A 36 year old woman complains of easy bruising. Her physician orders a CBC and the lab reports a platelet count of 69,000/uL and a Hb of 12.0 g/dL. She is referred to a hematologist who orders a platelet antibody, a CT scan of the abdomen and performs a bone marrow aspirate and biopsy. All of the tests are normal. He then orders a repeat platelet count, which is 160,000/uL. He calls the laboratory to determine if a platelet count can vary this much during a two week interval.
  • A 71 year male is hospitalized for pneumonia. A basic metabolic panel is ordered and all of the electrolytes are reported as normal except for the potassium, which is reported to be 3.2 mEq/L. The following day, the patient is treated with an intravenous potassium drip. Shortly thereafter, he develops an arrhythmia and has a cardiac arrest. During the code blue, electrolytes are ordered and the potassium is 7.9 mEq/L. The nursing unit asks the laboratory to repeat the potassium on the original specimen and the result is 4.6 mEq/L. An incident report is filed with risk management.
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