The Department of Health & Human Services, Centers for Medicare & Medicaid Services, Atlanta Regional Office (“CMS”) has provided written notice that “effective December 9, 2018, the agreement between Vanderbilt University Medical Center … and the Secretary of Health and Human Services, as provider of Hospital Services in the Health Insurance for the Aged and Disabled Program (Medicare) is to be terminated. Vanderbilt University Medical Center does not meet the following conditions of participation: 42 CFR 482.13 Patient Rights 42 CFR 482.23 Nursing Services. The Centers for Medicare and Medicaid Services has determined that Vanderbilt University Medical Center is not in compliance with the conditions of participation. The Medicare program will not make payment for hospital services to patients who are admitted after December 9, 2018.” Source
CMS’ proposed termination action resulted from an unannounced onsite survey conducted from October 31, 2018 to November 8, 2018, to investigate a complaint regarding “Patient #1.” CMS’ Statement of Deficiencies and Plan of Correction dated November 8, 2018 stated, in part: “Medical record review for Patient #1 revealed the patient was admitted to the hospital on 12/24/17 with diagnoses of Intraparenchymal Hematoma of the Brain, Headache, Homonymous Hemianopia (vision field loss of both eyes)-Left, Atrial Fibrillation, and Hypertension … the patient was awake, alert and oriented and spent time shopping prior to hospitalization … Patient #1 was transported to Radiology for a PET (Positron Emission Tomography) scan on 12/26/17 for a full body scan.”
“The procedure was scheduled for 2:00 PM. There was no documentation in the medical record the time the patient arrived in Radiology. Patient #1 was alert and oriented. While in Radiology Patient #1 requested something for anxiety before the PET scan procedure due to being claustrophobic … the physician ordered Versed 2 milligrams (mgs) intravenously for the patient’s anxiety during the PET scan procedure … Registered Nurse (RN) #1 took the medication Vecuronium 10 mgs (a neuromuscular blocking agent which causes paralysis) from the ADC located in the Neuro Intensive Care Unit (ICU) using the override feature, instead of taking the Versed medication that was ordered for Patient #1. There was no physician order for Patient #1 to receive Vecuronium. The override was not verified by Pharmacy. There was no documentation in the patient’s medical record the RN had administered the Vecuronium to the patient.”
“Review of a physician note dated 12/26/17 at 3:45 PM revealed the physician documented, “Called for code in PET scanner, patient was pulseless and unresponsive on arrival. patient was emergently intubated and retrieved ROSC [return of spontaneous circulation] after 2 – 3 rounds of chest compressions. Patient transferred to Neuro ICU”.”
“Review of the Nurse Practitioner’s (NP) note dated 12/26/17 revealed the NP documented, “Patient was doing well and transferred to the stepdown unit. On 12/26/17, patient was readmitted to NCU [neuro critical care] after suffering cardiac arrest while off the unit to undergo PET scan…””
“Review of the physician’s note dated 12/27/17 revealed the physician documented, “I discussed the case with the neurology team and it is felt that these changes in exam likely represent progression towards but not complete brain death…very low likelihood of neurological recovery, we made the decision to pursue comfort care measures. [Patient #1] was made a DNR [do not resuscitate]…” The physician documented the patient was extubated (removed from mechanical ventilation) on 12/27/17 at 12:57 AM and expired on 12/27/17 at 1:07 AM.” …
“RN #1 stated he/she searched for the Versed under her profile in the ADC and he/she couldn’t find it. The RN stated he/she then chose the override setting on the ADC and searched for the Versed. RN #1 stated she was talking to the Orientee while he/she was searching the ADC for the Versed and had typed in the first 2 letters of Versed which are VE and chose the 1st medication on the list. RN #1 stated he/she took out the medication vial out of the ADC, and looked at the back of the vial at the directions for how much to reconstitute it with. RN #1 verified he/she did not re-check the name on the vial. RN #1 stated he/she grabbed a sticker from the patient’s file, a handful of flushes, alcohol swabs, a blunt tip needle. RN #1 stated he/she put the medication vial in a baggie and wrote on the baggie, “PET scan, Versed 1-2 mg” and went to Radiology to administer the medication to Patient #1.” …
“RN #1 stated, went into Patient #1’s room and informed Physician #2, and the NP that he/she had made a mistake and administered Vecuronium to Patient #1 instead of Versed. RN #1 was asked if it was documented he/she had administered the Vecuronium in Patient #1’s medical record. RN #1 stated, “I did not. I spoke with [Named Nurse Manager] and he/she told me the new system would capture it on the MAR [Medication Administration Record]. I asked and [the Nurse Manager] said it would show up in a special area in a different color.”” …
“RN #1 was asked if he/she talked to anyone at the hospital in the days after the event, and the RN stated, “I did have some conversations with risk management. I don’t remember all I said. It was on the phone. I came back on the 3rd [January] and saw [Named Nurse Manager]. That is when I was terminated. They sent me to an employee resource counsellor for my own personal wellbeing.””
CMS surveyors stated that “[t]he patient has the right to be free from all forms of abuse or harassment” and that this standard was met because “the hospital failed to ensure patients were free from all forms of abuse when a Critical Care Registered Nurse (RN) neglected to administer medication as ordered to 1 of 5 (Patient #1) sampled patients review for medication errors and failed to monitor for any untoward effects as the patient experienced respiratory/cardiac arrest. The hospital failed to report this incident to the Tennessee Department of Health as mandated. The failure of the nurse to administer the medication as ordered and to ensure the patient was monitored for untoward effects resulted in a SERIOUS and IMMEDIATE THREAT to the health and safety of all patients and placed them in IMMEDIATE JEOPARDY and risk of serious injuries and/or death … the hospital failed to ensure that the Quality Assurance and Performance Improvement (QAPI) program thoroughly analyzed a critical adverse event and all the causes, and implement preventive actions that included adding additional safety parameters associated with overriding paralytics and other High Alert medications from an automated dispensing cabinet (ADC) to ensure that a similar critical adverse event could not reoccur. This failed practice had the potential to affect the safety and health of all patients receiving care in the critical care areas in this hospital … the hospital failed to ensure all physicians followed policies, and rules and regulations for reporting unusual and unexpected deaths to the County Medical Examiner for 1 of 1 (Patient #1) patient deaths reviewed … Medical record review for Patient #1 revealed Physician #1 called the Medical Examiner (ME) to report Patient #1’s death. There was no documentation in the record of the medication error being communicated to the ME per facility policy. There was no documentation in the medical record of the disclosure to the family documenting the Date, time, and place of disclosure; Names of those present; Nature of the discussion and areas covered; Offers of assistance, including bereavement support; Questions addressed in the discussion; or Plan for continued communications … There was no documentation in Patient #1’s medical record how much Vecuronium he/she received, nothing in the medical record reflected he/she was declining. The medical record documented Patient #1 was improving, he/she was stable and was waiting for a floor bed.”
The CMS surveyors further concluded: “the hospital failed to ensure nursing services administered the correct medications, monitored the patient for any adverse reactions following the administration of a medication and prevented a preventable death … The failure of the hospital to ensure all nurses implemented standards of practice, policies and procedures pertaining to the supervision and evaluation of all patients resulted in a fatal medication error for Patient #1 and placed all patients in a SERIOUS and IMMEDIATE THREAT of their health and safety and placed them in IMMEDIATE JEOPARDY for risk of serious injuries and/or death … There was no documentation in Patient #1’s
medical record that Vecuronium or Versed was administered to her on 12/26/17.”
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