Description of Event or Problem · 1
IN OUR INTERNAL MEDICINE OFFICE, WE USE (B) (6) DIAGNOSTICS FREQUENTLY FOR OUR LAB WORK. WE HAVE HAD SEVERAL SKEWED RESULTS RECENTLY THAT HAVE AFFECTED THE HEALTH OF OUR PTS. WE HAVE SPOKEN WITH THE MEDICAL DIRECTOR OF (B) (6) WHO ACKNOWLEDGES THAT THEY HAVE HAD SOME PROBLEMS WITH THEIR LAB MACHINES BUT THEY HAVE NEVER REPORTED THEM. HERE ARE A FEW SPECIFIC EXAMPLES: PT WITH A RADICAL PROSTATECTOMY HAS A PSA THAT COMES BACK AS 0.6. THIS SHOULD BE AN UNDETECTABLE READING. WHEN ASKED TO REPEAT THE TEST, (B) (6) SAYS THAT THEY DID REPEAT IT, BUT WE ARE GIVEN THE EXACT SAME LAB RESULT. WHEN REPEATED WITH A DIFFERENT SPECIMEN FROM THE SAME PT, AGAIN THE PSA CAME BACK AS 0.6 AND NOT UNDETECTABLE. THIS IS AN INCORRECT READING. PT HAD A CA 125 DRAWN IN OUR OFFICE AND CA 125 WAS REPORTED AS 125 WHICH IS AN EXTREMELY HIGH READING INDICATIVE OF POSSIBLE OVARIAN CANCER. WHEN WE REPEATED THE BLOOD TEST WITH (B) (6), IT CAME BACK AS 8. PT'S SODIUM LEVEL WAS REPORTED AS 165 AND AGAIN 165 WHEN THEY SAID THEY REPEATED IT. THIS PROMOTED AN ER VISIT FOR THIS PT WHEN THE SODIUM WAS IN FACT NORMAL. ON THAT SAME DAY, WE LATER NOTICED THAT SEVERAL SODIUM LEVELS ON DIFFERENT PTS WERE ELEVATED AND WE IMMEDIATELY CALLED (B) (6) TO REPORT THIS, AND THEY ACKNOWLEDGED THAT THERE WAS A PROBLEM WITH THE MACHINE THAT THEY RAN THE BLOOD ON. THESE ARE JUST A FEW EXAMPLES OF PROBLEMS THAT WE HAVE HAD WITH (B) (6) AND AS YOU CAN SEE OUR PTS ARE REALLY BEING AFFECTED BY THE INACCURACY OF THEIR RESULTS. THIS IS UNACCEPTABLE AND REALLY NEEDS FURTHER INVESTIGATION TO ENSURE PT SAFETY.