The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

VANDERBILT UNIVERSITY MEDICAL CENTER 1211 MEDICAL CENTER DRIVE NASHVILLE, TN 37232 Jan. 17, 2020
VIOLATION: NURSING SERVICES Tag No: A0385
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on policy review, document review, medical record review, and interview the facility failed to ensure nursing services administered Heparin, according to facility protocols and physician's orders for 1 of 3 (Patient #1) sampled patients receiving Heparin.

The findings included:

Investigation of the facility-reported incident revealed Patient #1 was admitted to the facility on [DATE] following emergent placement of an intra-aortic balloon pump in an effort to address his Congestive Heart Failure. Patient #1 was placed on a continuous Heparin infusion to decrease his risks of blood clot formation. The patient was monitored for therapeutic effects of the medication which included periodic Partial Thromboplastin (PTT) levels, a blood test that looks at how long it takes for blood to clot. The therapeutic parameters for Patient #1's PTT were 60-80 seconds. The facility's Heparin protocol in place at the time, had measures in place to address PTT levels less than 40, 40-59, 60-80, 81-110, and Greater than 110. Patient #1's PTT levels remained sub-therapeutic (less than 40) from the time of his admission on 8/26/19 until 9:36 AM on 8/28/19. Patient #1 received Heparin boluses and infusion rate changes based on his PTT levels. On 8/28/19 at 9:36 AM, Patient #1's PTT level was 37 seconds and his Heparin was infusing at a rate of 28 units/kg/hr. On 8/28/19 at 10:30 AM, Patient #1 was given a Heparin bolus of 3,672 units and his infusion rate had been increased to 32 units per kilogram per hour (units/kg/hr) at 11:00 AM. On 8/28/19 at 5:50 PM, Patient #1's PTT level had increased to greater than 200 seconds (supra-therapeutic) and the Heparin infusion was paused. The PTT level was redrawn and was still greater than 200 seconds at 5:50 PM. The Heparin infusion was restarted on 8/28/19 at 6:00 PM at a rate of 32 units/kg/hr instead of 29 units/kg/hr as required in the protocol. On 8/28/19 at 6:32 PM, the PTT level was checked; remained critically high and the Heparin infusion was paused from 7:00 PM until 8:00 PM. The Heparin infusion was restarted at a rate of 29 units/kg/hr per protocol. Nursing staff continued following the protocol checking the PTT levels and decreasing the Heparin infusion rates. On 8/29/19 at 2:00 AM, Patient #1 developed a sudden, severe headache and his condition rapidly declined. A computerized tomography (CT) scan of his head revealed Patient #1 had a subdural hematoma (bleeding in the brain). Patient #1 did not recover and expired in the facility on 8/29/19 at 5:32 PM.

The facility was requested to investigate the cause of Patient #1's death by his wife. The facility discovered the Heparin rate had been programmed into the infusion pump incorrectly on 8/28/19 from 10:14 AM until 2:54 PM. During this time, Patient #1 should have received Heparin at a rate of 32 units/kg/hr; a rate of 1,960 units per hour and instead received Heparin at a rate of 52 units/kg/hr; a rate of 3200 units per hour. The facility determined the programming error resulted in a medication error that may have contributed the development of Patient #1's subdural hematoma.

During a conference on 1/16/2020 at 2:35 PM with the facility's Senior Director of Quality, Safety and Risk Prevention, Regulatory Officer; the Senior Quality and Patient Advisor; and the Assistant Director of Accreditation and Standards, the facility was informed of an Immediate Jeopardy under 42 CFR 482.23 Condition of Participation, Nursing Services. The facility was provided a copy of the Immediate Jeopardy Template at 3:15 PM following the conference.

During a conference on 1/17/2020 at 9:27 AM with the facility's Senior Quality and Patient Advisor; the Assistant Director of Accreditation and Standards; and the Chief Nursing Officer of the Adult Hospital, the facility presented an Immediate Action Plan for the Immediate Jeopardy which included:

1. The current "Lower dose Nurse Managed heparin protocol" was revised to include "...PTT value Greater than 199 Stop heparin and repeat PTT q [every] 2h until < [less than] 100. Once PTT < 100 resume infusion at rate 4 units/kg/hour less than previous rate. Repeat PTT 6 hours after rate change. If contaminated sample suspected, repeat PTT STAT [immediately]. If contamination is ruled out, notify house staff immediately of high PTT levels." The policy change was implemented on 1/14/2020.

2. A requirement for 2 nurses to sign off Heparin rate changes was added to the current policy requiring 2 nurses to sign off Heparin boluses and bag changes. The requirement for dual sign-off of the Heparin rate changes was implemented on the morning of 1/17/2020.

3. The Action Plan developed by the facility contained additional actions for on-going monitoring and implementation that would further increase patient safety; however, those actions are planned to be implemented at a later date.

Review of the Immediate Action Plan revealed immediate actions were implemented by the facility and the Immediate Jeopardy was removed on 1/17/2020. The facility remains out of compliance at 42 CFR 482.23 Condition of Participation, Nursing Services.

Refer to A-0395.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on document review, policy review, medical record review, and interview the facility failed to ensure nursing services administered Heparin, according to facility protocols and physician's orders for 1 of 3 (Patient #1) sampled patients receiving Heparin.

The findings included:

1. On 11/4/19, the hospital's Patient Relations Director received a letter from Patient #1's wife which requested an investigation into the cause of Patient #1's death that occurred on 8/28/19 after the patient developed a Subdural Hematoma, bleeding in the brain. Patient #1 had a past medical history that included a heart transplant in April of 2018. Patient #1 was admitted on [DATE]. During the hospitalization , the patient received heparin therapy to prevent the formation of blood clots after an Intra-aortic Balloon Pump (IABP), a mechanical device placed in the aorta to help the heart pump blood more efficiently, was inserted for the treatment of Congestive Heart Failure.
The letter from Patient #1 ' s wife requesting the investigation was forwarded to the Risk Management department on 11/7/19. The hospital ' s investigation revealed the Heparin rate had been programmed into the infusion pump incorrectly resulting in a medication error that may have contributed to the development of Patient #1's subdural hematoma.

2. The facility's "High Alert Medications" policy approved November 2018 showed , "...High Alert Medications - Medications that bear a heightened risk of causing significant patient harm when used in error. Independent Double-Check - A safety procedure in which two qualified individuals ...separately check (alone and apart from each other, then compare results) each component of prescribing, dispensing, and verifying the medication before administering to the patient. Components include the following where applicable...Right dose...Right concentration and volume...Right infusion rate...Right pump setting...Independent Double-Check where electronic clinical systems prompt dual signoff..."

3. The facility's "High Alert Medications Chart: Adult Patients" revised December 2019 revealed, "...Heparin IV [intravenous] bolus and infusion...Specific Safety Strategies...A standard concentration (100 units/mL [milliliters]) is used for IV infusion, Heparin advisor offers dosing recommendations and appropriate monitoring orders, Independent Double Check prior to administration, where electronic clinical systems prompt dual sign off for bolus doses and upon the following for infusions: Initiation of infusion; Change of container; Handover..." The policy did not include a Double Check off to be performed when the infusion rate was changed.

4. The hospital's Medication Administration policy showed, "...staff validate the five rights of medication administration to minimize medication errors...Right patient; Right medication; Right dose; Right route...Right time to adhere to the prescribed frequency and time of administration...Document medication administration in the electronic medical record to include, at a minimum, the following...Date and time of administration; Medication name and strength; Dosage of medication administered...Route of administration..."

5. The hospital's "Lower dose Nurse Managed Heparin Protocol" for IV infusion showed, Heparin 25,000 units in 0.45% (percent) Normal Saline (NS) 250 ml infusion premix, "...Target PTT [Partial Thromboplastin Time] 60-80," with the following instructions, "PTT value Less than 40 Increase infusion by 4 units per kilogram per hour [units/kg/hr]; order bolus of 60 units/kg, Repeat PTT 6 hours after rate change....PTT Greater than 110 Decrease infusion by 3 units/kg/hr; Stop heparin infusion for 1 hour; Repeat PTT 6 hours after rate change."

6. Medical record review for Patient #1 showed the patient was admitted on [DATE] following emergent insertion of an IABP with diagnoses that included [DIAGNOSES REDACTED][DIAGNOSES REDACTED]. Patient #1 weighed 135 pounds upon admission.

A physician's order dated 8/26/19 showed Patient #1 was to receive Heparin 25,000 units in 250 ml of Normal Saline (NS) bolus for infusion of 3,672 units and initiate Heparin Drip Protocol.

Review of the Patient Care Timeline showed Patient #1's PTT levels remained sub-therapeutic (less than 40) from the time of his admission on 8/26/19 until 9:36 AM on 8/28/19. Patient #1 received Heparin boluses and infusion rate changes based on his PTT levels per the facility's Heparin protocol.

The Patient Care Timeline showed Patient #1's PTT was 37 seconds (sub-therapeutic) on 8/28/19 at 9:36 AM. Patient #1 received a bolus of 3,672 units of Heparin per protocol at 10:30 AM. The continuous infusion rate was increased to 32 units/kg/hr at a rate of 19.6 ml/hr at 11:00 AM.

The facility provided document titled, "Alaris pump data" showed Patient #1's Heparin infusion was incorrectly programmed to administer 32 ml/hr, a rate of 3,200 units of Heparin per hour instead of 32 units/kg/hr as ordered per protocol which would have been a rate of 19.6 ml/hr, a rate of 1,960 units of Heparin per hour from 10:13 AM on 8/28/19 until 2:54 PM on 8/28/19. The pump data further revealed the nurse over-road the pre-programmed alert on the pump 2 different times during the time period.

The Patient Care Timeline showed the continuous Heparin infusion was "...Paused d/t [due to] elevated PTT [on 8/28/19 at 5:15 PM] CCU [critical care unit] Team notified...and lab redrawn..." There was no documentation of the PTT results at the time the infusion was paused.

The Patient Care Timeline showed Patient #1's PTT was greater than [>] 200 seconds (critically high) on 8/28/19 at 5:50 PM. Patient #1's continuous Heparin infusion was restarted at 6:00 PM (less than an hour after being stopped, which was a deviation from the facility's protocol.) Patient #1 had a repeat PTT drawn at 6:32 PM, and the continuous Heparin infusion was stopped again at 7:00 PM. Patient #1's PTT was >200 seconds (critically high) at 7:42 PM. Patient #1's continuous Heparin infusion was restarted at 8:00 PM at 29 units/kg/hr, a rate of 17.7 ml/hr per protocol.

The Patient Care Timeline showed Patient #1's PTT remained critically high at > 200 seconds on 8/28/19 at 10:14 PM. The continuous Heparin infusion was decreased to 26 units/kg/hr, a rate of 15.9 ml/hr at 11:00 PM.

The Patient Care Timeline on 8/29/19 at 2:00 AM showed, "...Communication/Event Note: ccu resident notified and at bedside. no neurological deficits noted at this time, stat labs sent...Oriented...Obeys commands...patient c/o [complained of] 10/10 pressure headache..." The Heparin infusion was stopped at 2:01 AM. At 2:25 AM, Patient #1 was noted to be "lethargic." On 8/29/19 at 2:39 AM, Patient #1 was taken to radiology for a computerized tomography (CT) scan of his head. At 3:00 AM, the time line showed, "...Communication /Event Note: CCU present, patient posturing, pupils 8 and fixed..." At 3:15 AM, the time line showed, "...Communication/Event Note: Airway team met patient in CT, patient intubated..." On 8/29/19 at 3:42 AM, Patient #1's PTT level remained critically high at >200 seconds. Patient #1 received a bolus of hypertonic solution of 3% Sodium Chloride IV at a rate of 1,000 ml/hr at 3:35 AM. The patient was given 31 milligrams (mg) IV of Protamine, a medication used to reverse the effects of Heparin, at 3:45 AM.

A progress note written by Physician #1 dated 8/29/19 at 4:09 AM revealed, "...Around 2 am on morning he developed severe headache, stat CT scan ordered. On route to CT scan, had abrupt neurologic decline and became unresponsive; was subsequently intubated. CT scan demonstrated 2.3 cm [centimeters] left convexity subdural hematoma with 2 cm of midline shift to the right and evidence of uncal herniation...I/P [Impression/Plan] 1. Catastrophic subdural hemorrhage with uncal herniation. discussion with neurosurgery and neurology with no meaningful recovery of Function..."

A neurology consult note dated 8/29/19 at 12:34 PM showed, "...cerebral hemorrhage. Had large subdural with herniation. Is on max medical therapy. Prognosis for good recovery is poor. If he survives he will be left with devastating damage...Recommendations: Given findings on physical exam, uncal herniation is likely complete. Patient unfortunately has no significant chance of meaningful neurologic recovery. Would not pursue further imaging, workup, or treatment. Family at bedside..."

The Patient Care Timeline on 8/29/19 at 4:40 PM showed orders were written to reflect Patient #1's family wishes for comfort care only and do not resuscitate. Patient #1 was taken off of the ventilator and his oral airway access was removed.

The Report of Death dated 8/29/19, revealed Patient #1 expired on [DATE] at 5:23 PM with the preliminary cause of death listed as a "Subdural hematoma." Further review revealed there was no autopsy requested and the Medical Examiner was not notified.

The facility provided Summary file (a transcript of e-mail correspondence) revealed Patient #1's wife contacted the Patient Relations Director via telephone on 9/16/19 wanting questions to be answered and wanted to know the cause of her husband's death. Physician #1, Patient #1's attending physician, was informed of her request by the Patient Relations Director on 9/16/19 and was asked if he would be willing to talk with her regarding the cause of death. Physician #1 agreed to make the phone call. On 9/17/19, Patient #1's wife called the Patient Relations Director back and requested to meet with Physician #1 in person. She also informed him that she had questions regarding the nursing care her husband received on the night of 8/28/19.

The Summary file included a summary of the meeting that was held between Patient #1's wife and Physician #1 on 10/15/19 and indicated Patient #1's wife voiced concerns about the amount of blood noted on her husband's gown, and Physician #1 informed her it was "...not unusual for there to be bleeding when the nurses change the ports..." The note further indicated Patient #1's wife questioned the physician about the difficulty regulating his anticoagulant level on the day he passed. The physician responded to her question by going over the frequency of the PTT tests and the results. Patient #1's wife asked Physician #1 if that played a part in her husband's brain bleed. Physician #1 informed her that it "could have played a part in the amount of blood, and then asked her if Patient #1 had fallen in the last couple of weeks. The patient's wife informed him that the patient had fallen earlier in the year, but not in the last 2 weeks. Physician #1 informed her that it was possible that Patient #1 had suffered a small brain bleed at the time of the fall "and explained that would be a weak point in the brain and possibly was the location of the brain bleed that he experienced the early morning of this death..."

The Summary file showed the Patient Relations Director received a letter from Patient #1's wife on 11/4/19 that stated, "...as I explained to you over the phone prior to our meeting, I want to know what happened with my husband in the hands of those in CICU [CVICU] who were attending to him. [Named Patient #1] was in CICU [CVICU] and on heparin...I am not convinced that [Patient #1] received that type of care from those who were attending to him directly. I read through the copy of [Patient #1]'s records...Afterwards, I realized that the help of a medical professional was needed. Such help was enlisted...I am requesting an investigation into this most serious and significant matter..."

The Summary file showed the Patient Relations Director forwarded the letter to the Risk Management department on 11/7/19.

During an interview on 1/13/2020 at 3:19 PM, Pharmacist #1 stated she had been asked by Risk Management to review Patient #1's medical record regarding his Heparin usage and PTT levels. The pharmacist then stated she pulled the data from the pump used for the Heparin and found an "unintended rate" for 8/28/19. Pharmacist #1 stated, the order was to increase the dose to 32 units/kg/hr and the data showed the pump was programmed to deliver 3200 units/hr instead of the intended 1960 units/hr. The pharmacist stated, "The number 32 was placed in the milliliters per hour instead of units/kg/hr... [Patient #1] received the increased dosage from about 10:15 in the morning and it was resolved around 3:00 PM. There was certainly an unintended overage from what was ordered..."

During an interview on 1/13/2020 at 4:45 PM, Physician #2 was asked what she could recall regarding Patient #1. Physician #2 stated they were having difficulty achieving therapeutic PTT levels and then all of a sudden it (PTT) jumped to over 200. Patient #1's level was double checked and remained high. Physician #2 stated, "It appears misprogramming of the pump; it delivered way higher dose for about 4 hours...I'm struggling to understand why his body didn't respond to the lower doses... [Patient #1's] PTT really should have dropped. [Patient #1] went 11 hours on the corrected dose... [Patient #1 ' s] bleed occurred after that... [Patient #1's] final PTT, still over 200 occurred after he had been on the lower rate of Heparin..."

During an interview on 1/13/2020 at 4:55 PM, the Chief Nursing Officer (CNO) of the Adult Hospital stated, "In this case [Patient #1] the Heparin Protocol was not the issue; it was a programming error."

During an interview on 1/14/2020 at 8:43 AM, Pharmacist #1 brought in a pump used to administer the Heparin drip and showed the surveyor the alert screen that had been over-ridden by the nurse twice on 8/28/19. The screen display showed the following message, "Dose of 3200 units/hr exceeds Guardrails limit of 3000 units/h. [Do you want to] Proceed? Press Yes or No." When the pharmacist was asked what the purpose of the alert screen was, she stated it basically asks the nurse, "Are you sure you want to run at this rate?" The pharmacist stated, "High alert meds are meds more likely to cause patient harm when something unintended occurs; whether in prescribing or administration." The pharmacist stated, they relied on the "double check" system in which the nurses checked for errors in programming, and stated "currently, the rate change is not part of the double check system." The pharmacist stated having the rate change be included in the double check system was under consideration, but it was "an enterprise level decision and requires a lot of vetting...you have to make sure it's feasible and see if the work flow could support that change."

During an interview on 1/14/2020 at 11:45 AM, RN #1 was asked to explain the process to administer Heparin infusions. He stated they followed the protocol that showed what to do based on the patient's PTT levels. RN #1 stated the order and doses were verified by another nurse when the bag was changed and when a bolus was given, but not when there was a dosage change. RN #1 was asked what he would do if the pre-programmed alert on the pump alerted him the dose exceeded the 3000 unit limit. RN #1 stated, "It would prompt me to make sure I didn't make a mistake and to double check whether the dose is correct because there may be times when it is appropriate...the protocol doesn't go above that..."

During an interview on 1/14/2020 at 11:00 AM, RN #2 verified a double check was not required when changing the Heparin infusion rate.

During a telephone interview on 1/14/2020 at 11:45 AM, Physician #1 was asked what he recalled regarding Patient #1. Physician #1 stated he had known the patient for a long time and had cared for him since before the patient's cardiac transplant. The physician stated Patient #1 had developed CAV (Cardiac Allograft [DIAGNOSES REDACTED] - an accelerated form of coronary artery disease) leading to recurrent hospitalization s for Congestive Heart Failure and the patient was getting sicker and sicker. A balloon pump (IABP) was inserted and that was helping his heart. He was started on Heparin which is standard protocol when you have a pump to prevent blood clotting. The physician stated he was notified early in the morning on 8/29/19 that Patient #1 complained of a severe headache. CT scan was performed and showed a Subdural Hematoma. He stated Heparin increased the risks of bleeding but the pump would have clotted if it hadn't been used. Physician #1 was asked when he was informed that Patient #1 had received excessive doses of Heparin. He stated, "I didn't know that until we've had several interrogations...his family was asking questions so we took a deeper dive into it...The whole pump issue seemed to be the problem as well as his co-morbidities." Physician #1 was asked if the excessive doses of Heparin were the cause of Patient #1's hemorrhage and ultimately his death. Physician #1 stated, "I think it possibly aggravated or accelerated his demise along with other co-morbidities that were going on. The higher levels [Heparin] probably did affect his PTT and why he spontaneously bled...It did contribute, but I don't know that it's the sole reason. We see these high levels and people don't always bleed. Looking at the whole person, he was in trouble before this dose incident."

During an interview on 1/14/2020 at 4:00 PM, RN #3 was asked what she recalled regarding Patient #1 and the Heparin infusion. RN #3 stated, "I came in and his PTT was not therapeutic. I had to do a rate change and I had not done a rate change by myself at that point so I went to my preceptor [named RN #5] and he walked me through it and we did it together. He went in the room with me and did it with me. I re-drew it [PTT] 6 hours after the rate change and it [PTT] was over 200 seconds. I stopped the drip and told the team and they asked me to straight stick him and keep the Heparin off and that's when shift change happened." RN #3 was asked if she was aware the rate had been programmed into the machine incorrectly. RN #3 stated, she was informed just recently the dose was entered incorrectly.

During an interview on 1/15/2020 at 8:20 AM, RN #4 was asked what she recalled regarding Patient #1. RN #4 stated Patient #1's PTT was supra therapeutic when she started the shift and was redrawn to verify the rate was actually that high since he had been sub-therapeutic earlier. When it was determined the PTT was actually that high (greater than 200 seconds) the doctor was notified seeking guidance on what to do. RN #4 stated, "At 2:00 AM another nurse answered his call light and let me know he complained of a headache. I went into his room to check on him. I knew he had Tylenol ordered. He had no other neuro complaints at that time. I let the provider know and got some Tylenol. I went back in and gave Tylenol; either when giving the Tylenol or on a recheck and he seemed more lethargic. I let the provider know. He was still alert and answering questions. He pretty fastly became more lethargic. I discussed it with the provider and we sent him down for a stat CT..." RN #4 was asked if she was aware at any time the Heparin had been run at an excessive rate, and she shook her head "No."

During an interview on 1/15/2020 at 4:34 PM, Pharmacist #1 confirmed the Heparin error was discovered on 11/14/19.

During a telephone interview on 1/16/2020 at 10:15 AM, RN #5 was asked what the role of preceptor entailed. He stated, "Observe and make sure the nurse is performing everything to the proper protocol." RN #5 was asked if he was aware Patient #1 received excessive doses of Heparin administered by the nurse he had been the preceptor for (RN #3). RN #5 stated, "That's what I was told...I don't recall verifying the rate." RN #5 was asked when he was informed of the Heparin error, and stated, "I was probably told in December."