Description of Event or Problem · 0
ON THE (B)(6) 2021 MY FATHER WENT TO THE (B)(6) COMPLAINING OF CHEST PAIN, NECK PAIN, AND HEADACHE PAIN ON THE LEFT SIDE OF HIS HEAD. HE WAS DISCHARGED AS HAVING GERD AND AN EPISODIC TENSION -TYPE HEADACHE THAT WAS NOT RESISTANT TO TREATMENT OR POORLY CONTROLLED. HE DIED (5) DAYS LATER OF CARDIAC ARREST WHILE COMPLAINING TO A WITNESS OF THE SAME PAIN HE HAD AT THE EMERGENCY ROOM BUT THAT THEY HAD ALREADY RAN TESTS AND IT WAS JUST ACID REFLUX. THE CONCERN I HAVE IS REGARDING THE DECISION TO MAKE A SINGLE TROPONIN DRAW AND NOT ORDER FOLLOW UP TESTING. IN THE BECKMAN COULTER INSTRUCTIONS FOR USE (IFU) FOR HSTNL HIGH SENSITIVITY TROPONIN I TESTING FOR THE ACCESS 2 ANALYZER IT STATES: "CARDIAC TROPONIN SHOULD BE MEASURED UPON ADMISSION, AND THEN SERIALLY AT REGULAR INTERVALS TO DEMONSTRATE A RISE AND/OR FALL IN CTN VALUES." I EMAILED THE MANUFACTURER OF THE DEVICE IF THEY INTEND FOR SERIAL DRAWS TO BE DONE IN THE IFU AND THEY SIMPLY RESPONDED IN THEIR E-MAIL WITH THAT SAME TEXT HIGHLIGHTED. AFTER FILING A REQUEST FOR AN INTERNAL INVESTIGATION INTO MY FATHER'S DEATH, AND EXPRESSING THIS CONCERN, THE RESPONSE FROM (B)(4) OF QUALITY RELEASED ON 3/7/2022 WAS: "SERIAL TROPONINS AND FURTHER CARDIAC TESTING ARE NOT ALWAYS INDICATED IF SURROUNDING TESTS ARE NEGATIVE AND OTHER INTERVENTIONS ARE EFFECTIVE IN IMPROVING THE PATIENT SYMPTOM(S) THAT LED TO ANOTHER NON-CARDIAC DIAGNOSIS." MY UNDERSTANDING THAT IFU'S FOR EQUIPMENT SHOULD BE FOLLOWED. OTHER BRANDS OF ANALYZER COULD HAVE DIFFERENT OPERATING PROCEDURES, SOFTWARE, REAGENT CARTRIDGES ETC. THE TERM "SHOULD" IN THE IFU'S IS NOT USED IN THE LEGAL SENSE OF "SHOULD VS. SHALL" I THINK THERE IS NO INDECISION IN THE IFU FOR THE MACHINE WHEN THE WORD SHOULD IS USED REGARDING CALIBRATION, MACHINE USE OR MAINTENANCE. IE: "IF YOU USE THE ACCESS 2 SYSTEM TO PROCESS THE VITAMIN B12 ASSAY, YOU SHOULD ALSO RUN THE SPECIAL CLEAN ROUTINE AT THE END OF EVERY DAY OR WHENEVER YOU WILL NOT USE THE INSTRUMENT TO PROCESS SAMPLES FOR 8 HOURS OR MORE." I BELIEVE DECH AND THE LAB IGNORES THE MANUFACTURER'S INSTRUCTIONS FOR SERIAL TESTING. MY OTHER CONCERN IS BOTH BECKMAN COULTER AND THE FDA PUT OUT BULLETINS WARNING PHYSICIANS AND LABS THAT EXCESS LEVELS OF BIOTIN (B7) IN THE FORM OF MULTIVITAMINS AND DIETARY SUPPLEMENTS, HAIR/NAIL GROWTH PRODUCTS CAN CAUSE FALSELY LOW ASSAY RESULTS IN REPORTING TROPONIN. THIS IS PREVALENT IN SANDWICH ASSAYS. WHEN I INQUIRED IF THE NURSE/LAB HAD SCREENED FOR BIOTIN THE RESPONSE FROM (B)(4) RELEASED ON 4/4/2022 WAS: "IN TERMS OF CONCERNS WITH BIOTIN, WE NOTED NURSING DOCUMENTED THE HOME MEDICATION LIST AS REPORTED. THIS IS A STANDARD PART OF OUR TRIAGE PROCESS, AND IT WAS COMPLETED. BIOTIN WAS NOT REPORTED AS A HOME MEDICATION." THIS LEADS ME TO BELIEVE THE HOSPITAL (AND I'M SURE THE LAB WAS INVOLVED IN THE INVESTIGATION) IS AWARE THAT BIOTIN CAN INTERFERE WITH THE ASSAYS, OTHERWISE THE RESPONSE WOULD HAVE BEEN "OUR LAB, AND NURSES HAVE NO KNOWLEDGE THAT BIOTIN HAS AN IMPACT ON OUR TROPONIN ASSAYS". AND IT'S TRUE... THE NURSE DID SCREEN FOR HOME MEDICATIONS. THEY ALWAYS DO WHENEVER I'VE BEEN TO A HOSPITAL. AND I WOULD HAZARD A GUESS UNDER OATH THE NURSE WOULD PROBABLY SAY THEY ARE ASKING PATIENTS IF THEY ARE ON ANY MEDICATIONS, IF THEY ARE SCREENING FOR SUPPLEMENTS SUCH AS FISH OIL, MAGNESIUM, FLINTSTONE VITAMINS, CENTRUM SILVER OR BIOTIN HAIR OR NAIL GROWTH PRODUCTS I WOULD BE EXTREMELY SURPRISED. IF THE LAB KNOWS A TROPONIN ASSAY IS GOING TO BE DONE, DOES IT ASK OR ENSURE THE PATIENT IS ASKED "ARE YOU CURRENTLY TAKING A SUPPLEMENT CONTAINING BIOTIN?" SUPPLEMENTS DO NOT CURE AN ILLNESS OR A DISEASE BY DEFINITION, MEDICATION DOES. I BELIEVE THIS HOSPITAL/LAB KNOW OF THE RISKS OF BIOTIN BUT ARE UNWILLING TO ADMIT THEY DO NOT PROPERLY SCREEN FOR IT. I HAVE RECEIVED NO DOCUMENTATION SHOWING HOW THEY SCREEN FOR THAT SUPPLEMENT. CLIA WILL NOT SPEAK TO THE IFU ON THE DEVICE AND OF COURSE CANNOT WEIGH IN ON THE BULLETINS REGARDING BIOTIN. I HAVE TALKED TO MANY PEOPLE NEAR THIS TOWN AND FOLLOW UP CARDIAC ISSUES ARE A KNOWN PROBLEM BUT THERE ARE NO OTHER HOSPITALS NEARBY. THE HOSPITALS LACK OF CORRESPONDENCE DURING MY COMPLAINT PROCESS AND (B)(6) RELUCTANCE TO EVEN GO TAKE A LOOK ARE JUST BIZARRE TO ME WHEN HUMAN LIVES ARE INVOLVED. CAN'T WE JUST MAKE SURE THE T'S ARE CROSSED AND THE I'S DOTTED? THAT'S ALL I'M ASKING FOR. ACCORDING TO THEIR LETTER THEY THINK THEY ARE SCREENING FOR BIOTIN BY ASKING "ARE YOU TAKING HOME MEDICATIONS". I DON'T THINK THAT'S GOOD ENOUGH. AS I STATED ABOVE, A SUPPLEMENT ISN'T A MEDICATION AND IF I'M RUNNING THE LAB TEST I WANT TO KNOW AND BE SURE. THEIR LAB DIRECTOR WORKS FOR A 3RD PARTY COMPANY OUT OF (B)(6). I'M NOT SURE HOW OFTEN HE GETS TO THE LAB? MAYBE IT'S FREQUENT. FDA SAFETY REPORT ID# (B)(4).