Mod 5 Steps:
INSTRUCTIONS:
1.
Read
Chapter 6 Introduction to Criminal Aspects of Healthcare (p. 164-174) in our textbook, Legal and Ethical Issues for Health Professionals by George D. Pozgar (5th Edition).
2.
Read
· The booklet “A Roadmap for New Physicians: Avoiding Medicare Fraud and Abuses by OIG” posted on D2L or Go to the Link below and select the Audio Narration for a narrated PowerPoint Presentation (the transcript is also available at this link under Speaker Notes):
https://www.oig.hhs.gov/compliance/physician-education/intro.asp
·
3
Click the links and review the reports:
· “When a Nurse is Prosecuted for a Fatal Medical Mistake, Does it Make Medicine Safer?” (see link below)
https://www.npr.org/sections/health-shots/2019/04/10/709971677/when-a-nurse-is-prosecuted-for-a-fatal-medical-mistake-does-it-make-medicine-saf
· The RaDonda Vaught case is confusing. This timeline will help (see link below)
https://www.msn.com/en-us/news/crime/the-radonda-vaught-case-is-confusing-this-timeline-will-help/ar-BB10EVFV
· CMS Report re: VU Nurse Fatal Medication Error (see link below)
Assess the facts and issues for yourself. Decide who should be at fault. Be prepared for a lively discussion!
This module is dedicated to criminal aspects of healthcare and advocacy cause practice.
At the conclusion of this module, you should be able to:
· Describe the five major fraud and abuse laws that apply to physicians.
· Analyze the VU nurse medication error, the criminal charges, and predict the outcome of the criminal case.
· Create draft advocacy cause/capstone slide: Finalize Logic Model spreadsheet, Program Budget. Begin to prepare your PowerPoint slides with a visual aid to present your proposed project.
· At the beginning of Class 5, you will take Exam 2 covering modules 4 and 5.
These outcomes correspond to the following course objectives as stated in your syllabus:
· Identify a variety of key legal responsibilities, civil and criminal liability, perspectives and rights of major stakeholders, including selected healthcare organizations, providers, and patients, in the U.S. healthcare system.
· Evaluate and debate resolutions to current healthcare legal issues and ethical dilemmas by applying ethical and legal frameworks and reasoning.
· Creatively formulate and persuasively communicate your strategic recommendations to solve pressing health care problems with ethical and legal solutions.
Book: https://books.google.com/books?hl=en&lr=&id=j7J5DwAAQBAJ&oi=fnd&pg=PP1&dq=Legal+and+Ethical+Issues+for+Health+Professionals&ots=vMqsTnjhzu&sig=v_eGtmtjpSj1LUQwkxVISxwC79U#v=onepage&q=Legal%20and%20Ethical%20Issues%20for%20Health%20Professionals&f=false
MODULE #5 ASSIGNMENT Criminal Aspects of Healthcare and Advocacy Cause
INSTRUCTIONS: This written assignment will not be separately graded but is your ticket to participate in class and receive a grade for Class Preparation and Participation.
Copy the questions for Parts I – II below into a Word document. Type and save the questions and your answers in the Word document, using Times New Roman 12 point font, 1 inch margins. Upload your Word file to the Dropbox by the due date and times posted in D2L.
There is no partial credit for preparing but not attending class or vice versa.
Part I: Legal Issues with Fraud and Abuse
a Briefly describe the False Claims Act and its purpose. Give one example of a violation of this law.
b Briefly describe the Anti-Kickback Statute and its purpose. Give one example of a violation of this law.
c Briefly describe the Physician Self-Referral Law and its purpose. Give one example of a violation of this law.
d Briefly describe the Exclusion Authorities and its purpose. Give one example of when the government may apply this authority.
e Briefly describe the Civil Monetary Penalties Law and its purpose. Give one example of when the government may assess monetary penalties.
Part II: Legal Issues with Criminalizing Human Errors
a. Discuss whether or not you agree that the Vanderbilt nurse should have been indicted for reckless homicide? Why or why not?
b. Considering the NPR article, your experience and research, do you believe criminal indictments of healthcare providers will make healthcare safer or less safe.
BLAW 6500 MOD 5 Assignment Updated 5/11/21 Page 1
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 000 INITIAL COMMENTS A 000
An unannounced onsite survey was conducted
10/31/18 to 11/8/18 to investigate complaint #
TN00045852.
An entrance conference was held with the
Regulatory Officer, Accreditation Specialist and
the Senior Quality and Patient Advisor. They were
informed of the nature of the complaint.
A telephone exit conference was held on 11/8/18
at 2:00 PM. The Regulatory Officer, Accreditation
Specialist and the Senior Quality and Patient
Advisor, and the Accreditation Regulatory
Specialist were notified of Immediate Jeopardy in
the areas of 482.13 Patient Rights, 482.23
Nursing Services. They were afforded the
opportunity to ask questions of the survey team.
A 115 PATIENT RIGHTS
CFR(s): 482.13
A hospital must protect and promote each
patient’s rights.
This CONDITION is not met as evidenced by:
A 115
Based on policy review, medical record review,
and interview, the hospital failed to ensure
patients’ rights were protected to receive care in a
safe setting and implemented measures to
mitigate risks of potential fatal medication errors
to the patients receiving care in the hospital.
The failure of the hospital to mitigate risks
associated with medication errors and ensure all
patients’ received care in a safe setting to protect
their physical and emotional health and safety
placed all patients in a SERIOUS and
IMMEDIATE THREAT and placed them in
LABORATORY DIRECTOR’S OR PROVIDER/SUPPLIER REPRESENTATIVE’S SIGNATURE TITLE (X6) DATE
Any deficiency statement ending with an asterisk (*) denotes a deficiency which the institution may be excused from correcting providing it is determined that
other safeguards provide sufficient protection to the patients . (See instructions.) Except for nursing homes, the findings stated above are disclosable 90 days
following the date of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plans of correction are disclosable 14
days following the date these documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite to continued
program participation.
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 1 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 115 Continued From page 1 A 115
IMMEDIATE JEOPARDY and risk of serious
injuries and/or death.
The findings included:
1. The hospital failed to ensure all patients
received care in a safe setting and staff followed
standards of practice and utilized their nursing
skills and training to ensure the correct
medications were administered to all patients.
Refer to A-0144
2. The hospital failed to ensure patients were free
from neglect.
Refer to A-0145
A 144 PATIENT RIGHTS: CARE IN SAFE SETTING
CFR(s): 482.13(c)(2)
The patient has the right to receive care in a safe
setting.
This STANDARD is not met as evidenced by:
A 144
Based on standards of practice, document
review, review of hospital policies and
procedures, medical record review, and interview,
the hospital failed to ensure all Critical Care
Registered Nurses (RN) implemented medication
policies and procedures pertaining to the
administration and monitoring of medications,
including high-risk medications, and patients
received care in a safe setting for 1 of 5 (Patient
#1) patients reviewed for medication errors.
The failure of the hospital to ensure all nurses
followed medication administration polices and
procedures resulted in a fatal medication error for
Patient #1 and placed all patients in a SERIOUS
and IMMEDIATE THREAT of their health and
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 2 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 144 Continued From page 2 A 144
safety and placed them in IMMEDIATE
JEOPARDY for risk of serious injuries and/or
death.
The findings included:
1. Review of the Lippincott Manual of Nursing
Practice 10th Edition documented, “…Watch the
patient’s reaction to the drug during and after
administration. Be alert for major adverse effects,
such as…respiratory distress…NURSING
ALERT…The nurse is ultimately accountable for
the drug administered…”
Review of the hospital’s High Alert Medications
policy documented, “…High Alert Medications –
Medications that bear a heightened risk of
causing significant patient harm when used in
error…Medication orders are reviewed by a
pharmacist prior to removal from floor stock or an
automated dispensing cabinet unless…A delay
would harm the patient (including sudden
changes in a patient’s clinical status…Additional
strategies are followed for a specified list of High
Alert Medications…Higher level decision
support…Independent Double-Check where
electronic clinical systems prompt dual signoff …”
The medication Vecuronium (a neuromuscular
blocking medication that causes paralysis and
subsequent death if not monitored accordingly)
was listed in the policy as a high alert medication.
There was no documentation in this policy
detailing any procedure or guidance regarding the
manner and frequency of monitoring patients
during and after medications were administered.
Review of the document ISMP List of High-Alert
Medications in Acute Care Settings…ISMP 2018
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 3 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 144 Continued From page 3 A 144
documented, “…High-alert medications are drugs
that bear a heightened risk of causing significant
patient harm when they are used in
error…Classes/Categories of
Medications…moderate sedation agents, IV
[Intravenous] (e.g.[for example]…midazolam
[Versed]…neuromuscular blocking agents
(e.g…rocuronium, vecuronium)…”
Review of document Paralyzed by Mistakes:
Reassess the Safety of Neuromuscular Blockers
in Your Facility documented, “…Neuromuscular
blocking agents are high-alert medications
because of their well-documented history of
causing catastrophic injuries or death when used
in error…Because neuromuscular blockers
paralyze the muscles that are necessary for
breathing, some patients have died or sustained
serious, permanent injuries if the paralysis was
not witnessed by a practitioner who could
intervene. After a patient receives a
neuromuscular blocker, progressive paralysis
develops, initially affecting the small muscle
groups such as the face and hands, then moving
to larger muscle groups in the extremities and
torso until all muscle groups are paralyzed and
respiration ceases. However, full consciousness
remains intact, and patients can experience
intense fear when they can no longer breathe.
They can also sense pain. The experience can be
horrific for patients…The most common type of
error with neuromuscular blockers appears to be
administration of the wrong drug…Practitioners
thought they were administering a different drug,
so patients may not have been supported with
mechanical ventilation…”
Review of document titled Joint Commission eyes
overrides of dispensing cabinets dated May, 2018
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 4 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 144 Continued From page 4 A 144
in the American Journal of Health-System
Pharmacy documented, “…vice president at the
Institute for Safe Medication Practices (ISMP)
said her organization has long considered ADC
[automated dispensing cabinet] overrides
potentially problematic. One of the big problems
with automated dispensing cabinets is that
sometimes staff are overriding without having an
order.” she said. “There’s no verbal order written
down, or they’re anticipating an order, so they get
a drug from the cabinet”…”
Review of the document titled Evaluation of
Medications Removed from Automated
Dispensing Machines [ADMs] Using the Override
Function Leading to Multiple System Changes
documented, “…The override function allows a
nurse to remove a medication from the machine
before a pharmacist reviews the order. The
purpose of the override function is to allow
access to medications in urgent/emergent
situations…Administering medications prior to a
pharmacist review increases the risk of
medication errors…The challenge with ADMs is to
prevent medication overrides in nonurgent
settings and to avoid administering medications
from orders that have not been reviewed by a
pharmacist…”
Review of the document titled The Drug
Summary for Midazolam Hydrochloride (Versed).
Retrieved from PDR, 2018, http://www.pdr.net
documented, “…CLASSES Anxiolytics
Benzodiazepine Sedative/Hypnotics Other
General Anesthetics…Administration of
midazolam requires an experienced clinician
trained in the use of resuscitative equipment and
skilled in airway management…Monitor patients
for early signs of respiratory insufficiency,
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 5 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 144 Continued From page 5 A 144
respiratory depression, hypoventilation, airway
obstruction, or apnea (i.e., via pulse oximetry),
which may lead to hypoxia and/or cardiac arrest.
Review of the Centers for Medicare and Medicaid
(CMS) Interpretive Guidelines documented,
“…Hospital policies and procedures are expected
to address how the manner and frequency of
monitoring, considering patient and drug risk
factors, are determined, as well as the
information to be communicated at shift changes,
including the hospital’s requirements for the
method(s) of communication. Policies and
procedures related to IV medication
administration must address those medications
the hospital has identified as high-alert
medications and the monitoring requirements for
patients receiving such drugs intravenously…”
Review of the hospital’s policy titled Medication
Administration documented, “[Named Hospital]
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…” There
was no documentation in this policy detailing any
procedure or guidance regarding the manner and
frequency of monitoring patients during and after
medications were administered.
2. Medical record review for Patient #1 revealed
the patient was admitted to the hospital on
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 6 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 144 Continued From page 6 A 144
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 record revealed the patient
was awake, alert and oriented and spent time
shopping prior to hospitalization.
The record revealed 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.
Review of the medication order #60651186 dated
12/26/17 at 3:00 PM revealed the physician
ordered Versed 2 milligrams (mgs) intravenously
for the patient’s anxiety during the PET scan
procedure.
Review of the Automatic Dispensing Cabinet
(ADC) detail report revealed the order was
entered on 12/26/17 at 2:47 PM. Pharmacy had
verified the order at 2:49 PM.
Review of the ADC detail report dated 12/26/17
revealed at 2:59 PM 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
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 7 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 144 Continued From page 7 A 144
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 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.
3. Telephone interview with RN #1 on 11/5/18
beginning at 4:41 PM, RN #1 was asked to
describe the circumstances leading up to Patient
#1’s death beginning on Tuesday 12/26/17. RN
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 8 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 144 Continued From page 8 A 144
#1 stated, “I was in a patient care role, I was the
help-all nurse. A help-all nurse is a resource
nurse and I had an Orientee”
RN #1 stated that RN #2 had asked her to go
downstairs to Radiology PET scan and administer
the medication Versed to Patient #1 because the
patient was not able to tolerate the PET scan
procedure or they would have to send the patient
back and reschedule it.
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 was asked how long it took her to get to
the Radiology department PET scan, and RN #1
stated, “5 minutes or less, it was my first time to
go to PET scan, I had to ask for directions”. RN
#1 stated, “I saw one patient [who was Patient
#1] on one of our beds, I checked the patient for
his/her identity, and told her I was there to give
him/her something to help him/her relax”.
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 9 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 144 Continued From page 9 A 144
RN #1 stated, “I reconstituted the medication and
measured the amount I needed”
The RN stated Radiology Technician #1 was
there at the time he/she administered the
medication IV to Patient #1. RN #1 stated he/she
left the Radiology PET scan area after he/she
had administered the medication to Patient #1.
RN #1 was asked how much medication did
he/she administer to Patient #1, and the RN
stated, “I can’t remember, I am pretty sure I gave
[him/her] 1 milliliter.
RN #1 was asked what was done with any left
over medication, and the RN stated, “I put the left
over in the baggie and gave it to [Named RN
#2]…”
RN #1 was asked what he/she did after
administering the medication to Patient #1, and
the RN stated he/she left Patient #1 in Radiology.
RN #1 confirmed that he/she did not monitor
Patient #1 after the medication was administered.
RN #1 was asked what happened next and the
RN stated, “Patient #1’s family was standing
outside in the hallway…we heard a rapid
response call for PET scan. That was a red flag
since the patient was ours, so [Named RN #2]
called down there [to the PET scan] but there was
no answer. The family looked at us and said
“ours?” [Named RN #2] said “we are going to
make sure.” We tried to call PET scan again, we
were being responsible to go to see if it was our
patient”.
RN #1 stated that he/she and RN #2 went to PET
scan and when they arrived Patient #1 was
intubated and had regained a heart rate. The RN
stated he/she, Physician #2, and the Charge
Nurse moved Patient #1 back to the ICU.
RN #1 stated, “I told [Named Physician #2] that I
had given [Patient #1] Versed a few minutes
ago…I reminded the Nurse Practitioner that
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 10 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 144 Continued From page 10 A 144
Patient #1 was awake but unmonitored when I
gave the Versed”.
RN #1 stated RN #2 approached him/her and
asked, “Is this the med you gave [named Patient
#1]?” and RN #1 responded “yes”. RN #1 then
stated RN #2 said, “This isn’t Versed, It’s
Vecuronium.”
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 could remember how
much Vecuronium she administered to Patient
#1, and RN #1 stated, “I would have given 1
milligram.”
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.”
RN #1 was asked about the “help-all nurse” role
and was there documentation of what was done
while working a shift, and the RN stated, “If you
do something, you just chart it for that patient”.
The RN stated there was not an actual job
description for the role of a “help-all nurse”
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 11 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 144 Continued From page 11 A 144
4. Interview with Radiology Technician (RT) #2
on 11/2/18 at 1:30 PM the RT was asked about
the events surrounding [Named Patient #1’s]
medication error in December. RT #2 stated,
“[Patient #1] was an inpatient brought down by
Transport, and was dropped off in a hallway. Me
and another girl went to get the patient and put in
an injection room. [Patient #1] said he/she was
claustrophobic so the other girl called the
patient’s nurse…a transporter walked by the
patients room and noticed he/she was
unresponsive. We were in the control room, we
have cameras that we can view but not to the
point of seeing if they are breathing.”
RT #2 was asked how long the patient was in the
room by him/herself before the transporter
noticed him/her. RT #2 stated, “If I was going to
guess, maybe 30 minutes. I don’t know
specifically. I ran to call the code and [Named RT
#1] started CPR…”
Telephone interview on 11/5/18 at 9:29 AM with
RN #2 (Patient #1’s primary care nurse prior to
the Event) the RN #2 was asked to describe the
events surrounding Patient #1’s death. RN #2
stated, “…[Patient #1] was scheduled for a PET
scan and was nervous…PET scan called me and
told me the doc [doctor] had ordered an IV med
[medication] for anxiety…I relayed to the help all
nurse and [Named RN #1] agreed to go and
administer it. I don’t remember the timing, I heard
the code, they brought [Patient #1] back to an
ICU room. I went over to ICU to give report to the
nurse taking care of the patient and [Named RN
#1] handed me a vial in a bag…I went back to my
desk to do some charting and then I realized it
[Vecuronium had been administered instead of
Versed] I went and told my charge nurse and I
gave the bag to him/her. That was the end of my
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 12 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 144 Continued From page 12 A 144
involvement.”
RN #2 was asked how long he had the bag with
the vial in it before he/she realized it was the
wrong medication. RN #2 stated, “It was less than
15 minutes…”
Telephone interview with RT #1 on 11/5/18
beginning at 1:15 PM he/she was asked about
the events that lead up to Patient #1’s death, and
RT #1 stated, “Transportation brought [Patient #1]
in and I talked to [Patient #1] about the scan.
He/She said he/she needed some medication for
anxiety and he/she had gotten some when he/she
had an MRI. I called [Patient #1’s] nurse to let
him/her know and the doctor that she could not
go through the scan, so the doctor ordered
Versed. We had a busy day that day, it was a full
schedule. We were going to send [Patient #1]
back if they couldn’t come and give him/her the
med. [Patient #1’s] nurse asked if our nurses
could give it, so I asked them and they said no
because the patient would need to be monitored.
I then asked [the patient’s] nurse if he/she would
need to be monitored and he/she said no and
he/she would send another nurse. I injected the
[radioactive] tracer for the scan knowing she was
going to get the medication. We can’t do the PET
scan for an hour after the tracer is injected so it
can circulate throughout the body. Two nurses
came down and he/she asked if this was the
patient that needed the med. [The nurse] gave
the med and then we put [the patient] into our
patient room. That is where they wait the hour. I
went back into the scan room. Sometime later,
the transporter was there to pick up [Named
Patient #1], he found him/her unresponsive, we
called the rapid response, I started chest
compressions and [Named RT #2] got the crash
cart…”
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 13 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 144 Continued From page 13 A 144
RT #1 was asked about how long Patient #1 was
in the room after the nurse came and
administered the medication, and RT #1 stated, “I
had briefly 30 minutes of uptake time left. We
could see him/her through the camera from
where we were. He/She had her eyes closed the
entire time, we thought it was a light issue with
her eyes. The camera isn’t sharp enough to pick
up breathing. [rise and fall of the chest]”
RT #1 was asked if Patient #1 was monitored
after receiving the medication for anxiety, and RT
#1 stated that the RN #1 did not stay and monitor
the patient after he/she administered the
medication.
A 145 PATIENT RIGHTS: FREE FROM
ABUSE/HARASSMENT
CFR(s): 482.13(c)(3)
The patient has the right to be free from all forms
of abuse or harassment.
This STANDARD is not met as evidenced by:
A 145
Based on standard of practice, document review,
review of hospital policies and procedures,
interpretative guidances, Review of Tennessee
Code Annotated, medical record review and
interview, 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
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 14 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 145 Continued From page 14 A 145
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 findings included:
1. A review of the “Lippincott Manual of Nursing
Practice 10th Edition” documented, “…Watch the
patient’s reaction to the drug during and after
administration. Be alert for major adverse effects,
such as…respiratory distress…NURSING
ALERT…The nurse is ultimately accountable for
the drug administered…”
A review of the “ISMP List of High-Alert
Medications in Acute Care Settings…ISMP 2018”
documented, “…High-alert medications are drugs
that bear a heightened risk of causing significant
patient harm when they are used in
error…Classes/Categories of
Medications…moderate sedation agents, IV
[Intravenous] (e.g.[for example]…midazolam
[Versed]…neuromuscular blocking agents
(e.g…rocuronium, vecuronium)…”
2. Review of “Paralyzed by Mistakes: Reassess
the Safety of Neuromuscular Blockers in Your
Facility” documented, “…Neuromuscular blocking
agents are high-alert medications because of
their well-documented history of causing
catastrophic injuries or death when used in
error…Because neuromuscular blockers paralyze
the muscles that are necessary for breathing,
some patients have died or sustained serious,
permanent injuries if the paralysis was not
witnessed by a practitioner who could intervene.
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 15 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 145 Continued From page 15 A 145
After a patient receives a neuromuscular blocker,
progressive paralysis develops, initially affecting
the small muscle groups such as the face and
hands, then moving to larger muscle groups in
the extremities and torso until all muscle groups
are paralyzed and respiration ceases. However,
full consciousness remains intact, and patients
can experience intense fear when they can no
longer breathe. They can also sense pain. The
experience can be horrific for patients…The most
common type of error with neuromuscular
blockers appears to be administration of the
wrong drug…Practitioners thought they were
administering a different drug, so patients may
not have been supported with mechanical
ventilation…”
3. A review of the hospital’s “High Alert
Medications” policy documented, “…High Alert
Medications – Medications that bear a heightened
risk of causing significant patient harm when
used in error…Medication orders are reviewed by
a pharmacist prior to removal from floor stock or
an automated dispensing cabinet unless…A delay
would harm the patient (including sudden
changes in a patient’s clinical status…Additional
strategies are followed for a specified list of High
Alert Medications…Higher level decision
support…Independent Double-Check where
electronic clinical systems prompt dual signoff …”
Vecuronium was listed as a high alert medication.
There was no documentation in this policy
detailing any procedure or guidance regarding the
manner and frequency of monitoring patients
during and after medications were administered.
Review of the facility’s “Medication
Administration” documented, “[Named Hospital]
staff validate the five rights of medication
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 16 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 145 Continued From page 16 A 145
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…”
There was no documentation in this policy
detailing any procedure or guidance regarding the
manner and frequency of monitoring patients
during and after medications were administered.
Review of the hospital’s “Interpretive Guidelines
for Reportable Events” revised July 2009
revealed, “Effective May 27, 2009, the Health
Data Reporting Act of 2002 was amended by
Public Acts of 2009, Chapter 318. The new law
provides that all licensed health care
facilities…shall only report incidents of abuse,
neglect, and misappropriation that occur at the
facility to the Department. For state licensure
purposes, the facility is required to make the
report within seven (7) business days from the
date that the facility identifies the incident…
Definitions… ‘Neglect’ means the failure to
provide goods and services necessary to avoid
physical harm…”
4. Review of State Operations Manual, Appendix
A Survey Protocol, Regulations, and Interpretative
Guidelines for Hospitals revealed, “…482.13(c)
(3)… The intent of this requirement is to prohibit
all forms of abuse, neglect (as a form of abuse)
and harassment whether from staff… The hospital
must ensure that patients are free from all forms
of abuse, neglect, or harassment… Neglect… is
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 17 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 145 Continued From page 17 A 145
considered a form of abuse and is defined as the
failure to provide goods and services necessary
to avoid physical harm, mental anguish, or mental
illness. The following components are suggested
as necessary for effective abuse protection…
Report/Respond. The hospital must assure that
any incidents of abuse, neglect or harassment
are reported and analyzed, and the appropriate
corrective, remedial or disciplinary action
occurs…”
The “RULES OF TENNESSEE DEPARTMENT
OF HEALTH BOARD FOR LICENSING HEALTH
CARE FACILITIES CHAPTER 1200-08-01
STANDARDS FOR HOSPITALS ” documented
on page 31, “…(6) Pharmaceutical Services…(d)
Adverse drug events, both adverse reactions and
medication errors, shall be reported according to
established guidelines to the hospital
performance improvement/risk management
program and as appropriate to physicians, the
hospital governing body and regulatory
agencies…”
5. The “Tennessee Code Annotated Title
71…Chapter 6…Part 1…” documented,
“…71-6-103…Any person, including, but not
limited to, a physican, nurse…having reasonable
cause to suspect that an adult has
suffered…neglect…shall report or cause reports
to be made in accordance with this part. Death of
the adult does not relieve one of the responsibility
for reporting the circumstances surrounding the
death…If a hospital…or any other organization or
agency responsible for the care of adults has a
specific procedure, approved by the director of
adult protective services for the department, or
the director’s designee, for the protection of
adults who are victims of…neglect…any member
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 18 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 145 Continued From page 18 A 145
of its staff whose duty to report under this part
arises from the performance of the staff
member’s services as a member of the staff of
the organization may, at the staff member’s
option, fulfill that duty by reporting instead to the
person in charge of the organization or the
organization head’s designee who shall make the
report in accordance with this chapter…An oral or
written report shall be made immediately to the
department upon knowledge of the occurrence of
suspected…neglect…of an adult…”
The “Tennessee Code Annotated Title
68…Chapter 11…Part 2…” documented,
“…68-11-211…Reporting incidents of abuse,
neglect…As used in this section…”Department”
means the department of health…”Facility” means
any facility licensed under this part…”Neglect”
means the failure to provide goods and services
necessary to avoid physical harm…each facility
shall report incidents of…neglect…that occur at
the facility to the department within seven (7)
business days from the facility’s identification of
the incident…Nothing in this section shall be
construed to eliminate or alter in any manner the
required reporting of…neglect…or any other
provisions of…title 71, chapter 6, part 1…”
6. Patient #1 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.
Patient #1 was transported to Radiology for a
P.E.T. (Positron Emission Tomography) scan on
12/26/17 for a full body scan. The procedure was
scheduled for 2:00 PM. Patient #1 was alert and
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IDENTIFICATION NUMBER:
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(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 145 Continued From page 19 A 145
oriented to person, place, time and situation.
While in Radiology, Patient #1 requested
something for anxiety before the PET scan
procedure due to being claustrophobic.
Review of medication order #60651186 order
details dated 12/26/17 at 3:00 PM, revealed
Versed (Midazolam) 2 mg. (milligrams)
intravenous one time. Administration instructions
documented, “For PET scan if first milligram
insufficient, can give 1-2mg additional if
needed…” Review of the Automatic Dispensing
Cabinet (ADC) detail report revealed the order
was entered on 12/26/17 at 2:47 PM. Pharmacy
verified the order at 2:49 PM. Versed was not
removed from the Automated Dispensing Cabinet
(ADC).
Review of medication order #60651187 order
details dated 12/26/17 at 3:00 PM, revealed
Versed (Midazolam) 1 mg. intravenous one time.
Administration instructions documented, “For
PET scan” Review of the Automatic Dispensing
Cabinet (ADC) detail report revealed the order
was entered on 12/26/17 at 2:47 PM. Pharmacy
verified the order at 2:49 PM. Versed was not
removed from the ADC.
Review of the ADC detail report dated 12/26/17
revealed Vecuronium (a paralytic drug) 10 mg.
injection was pulled at 2:59 PM from the ADC
located in the Neuro ICU using the override
feature. There was no physician order for Patient
#1 to receive this drug. The order was not verified
by Pharmacy.
Review of the time line for the medication error
event that occurred on 12/26/17 revealed the
following:
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A. BUILDING ______________________
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(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 145 Continued From page 20 A 145
Patient #1 was scheduled for a PET scan at 2:00
PM.
No documentation when Patient #1 arrived in
Radiology.
An order for Versed was entered into the
computer at 2:47 PM and was verified by
Pharmacy at 2:49 PM. (Versed was available at
2:49 PM under Patient #1’s profile)
An override pull for Vecuronium was documented
at 2:59 PM.
There is no documentation of the administration
time or amount of Vecuronium to Patient #1.
RN #1 stated it took about 5 minutes to get to
Radiology before he/she administered it.
Patient #1 was found unresponsive and pulseless
in the Radiology Department prior to the PET
scan.
A rapid response (Hospital term for emergency
resuscitation) was called overhead at 3:29 PM.
(30 minutes between the time the drug was pulled
from the ADC in Neuro Unit and the time the rapid
response was called.
Interview with the Regulatory Officer (RO) and the
Senior Quality and Patient Advisor (SQPA) on
10/31/18 at 1:40 PM, they were asked why this
event wasn’t reported to the state. The RO
stated, “I will ask Risk about that because it was a
death and it should have been reported.”
Interview with the SQPA on 10/31/18 at 3:02 PM,
the SQPA stated, “I talked to Risk Management
about reporting to the state, and [he/she] stated
we [Risk Management] follow the 2009 state rules
on reporting and it includes abuse, any,
exploitation, fire with disruption of service, strikes,
external disasters, misappropriation and injury of
a patient in a nursing home of unknown nature.
[He/She] said for you to see the state regs
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A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 145 Continued From page 21 A 145
[regulations], page 31, 6d.”
Interview with the Manager of Adult Patient Safety
Team (MAPST) on 11/1/18 at 4:23 PM, the
MAPST stated, the hospital had performed an
Event Analysis with the findings are
“…The timeline was:
12/26/17 – 2 PM: PET scan scheduled.
12/26/17 – 2:47 PM: 2mg. of Versed was ordered.
12/26/17 – 2:59 PM: Vecuronium override in
Acudose. VE was entered in the Acudose and the
machine defaults to generic medications –
Vecuronium popped up. Versed [brand name] did
not show on the screen. A warning in red box was
visible for an override stating that is should be for
STAT orders.
12/26/17 – RN #1 gave the medication – it’s
unknown what time she got to Radiology.
12/26/17 – RRT was called at 15:29 [3:29 PM].
STATS go overhead. As a group [leaders, risk
etc] what can we do to fix it…Action plan: The bar
code scanning implementation in Radiology – this
is pending. A Multi-disciplinary team meeting
regarding the override med list. Vec [Vecuronium]
was removed from override status…”
Telephone interview with RN #2 (Patient #1’s
primary care nurse prior to the Event) on 11/5/18
beginning at 9:29 AM, RN #2 was asked to
describe the events surrounding [Named Patient
#1’s] death. RN #2 stated, “…[Patient #1] was
scheduled for a PET scan and was nervous…I
was watching another nurse’s patients because
[the patient’s nurse] had gone to lunch. PET scan
called me and told me the doc [doctor] had
ordered an IV med for anxiety and could I come
down and give it to her. I told them I could not
come down and could their nurses give it. They
said they didn’t feel comfortable administering it
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A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 145 Continued From page 22 A 145
and needed a nurse from our floor to come down.
I relayed to the “help all nurse” and [Named RN
#1] agreed to go and administer it. I don’t
remember the timing, I heard the code, they
brought her back to an ICU room…”
Telephone interview with the Director of
Investigations (DOI) at the Medical Examiner’s
Office on 11/5/18 at 10:01 AM, the DOI was
asked about (Named Patient #1) and what was
reported to them regarding [Patient #1’s] death.
The DOI stated, “The date of death was 12/27/17
and was called in by [Named Physician #1].
He/she stated that maybe there was a medication
error but that was just hearsay, and nothing has
been documented in the medical record. There
was no named drug in the notes. The death
certificate says [Patient #1] had a bleed. We
declined jurisdiction because there was an MRI
that confirmed the bleed…”
Telephone interview with RN #1 on 11/5/18
beginning at 4:41 PM, RN #1 was asked to
describe the circumstances leading up to Patient
#1’s death on Tuesday 12/26/17. RN #1 stated, “I
was in a patient care role, I was the “help-all
nurse”. A help-all nurse is a resource nurse and I
had an Orientee… [Named RN #2] asked me to
go downstairs to PET scan and give [Named
Patient #1] Versed because [the patient] was not
able to tolerate it [the PET scan procedure] or
they would have to send her/him back and
reschedule it. We were already heading to ER to
do a swallow study on a patient. I went and
searched for the med under [the patient’s] profile
[in the ADC] and it was not there. I chose the
override setting and I searched for it. I was talking
to the Orientee about why we do swallow studies
in the ER…I typed in the first 2 letters [VE] and
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A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 145 Continued From page 23 A 145
that’s how I hit it, I chose the 1st one on the list. I
took out the vial and I looked at the back at the
directions for how much to reconstitute it with, I
did not re-check the name on the vial… I saw 1
patient on one of our beds, I checked the patient
for his/her identity, and told [the patient] I was
there to give him/her something to help him/her
relax… I reconstituted it and measured the
amount I needed… One of the techs [Radiology
Technician #1] came out, I gave the med, flushed
it and we left. [Radiology Technician #1] took the
patient back. We went straight to the ER from
there… I am not sure if I drew up and gave
him/her what she needed… heard a rapid
response call for PET scan. That was a red flag
since out patient was ours… we were being
responsible to go to see if it was our patient…
when we got there they had intubated him/her
and got a pulse back. [Named Physician #2,
Named Charge Nurse] myself and the team, we
collectively moved him/her bed back to the unit. I
told [Named Physician #2] that I had given [the
patient] Versed a few minutes ago…I reminded
the Nurse Practitioner that Patient #1 was awake
but unmonitored when I gave him/her the Versed.
We spent probably about 45 minutes getting labs
and things. I had drawn several tubes of blood for
labs when [Named RN #2] came up to me and
he/she said, “Is this the med you gave him/her?” I
said yes, we need to waste it. RN #2 stated, “This
isn’t Versed” I said what is it? He/she said, “It’s
Vecuronium” and I went back into the room
[Patient #1’s] and [Named Physician #2], a couple
of residents, and [Named Nurse Practitioner]
were in the room discussing what was happening.
I told them right then it was my mistake. I told
them I gave Vecuronium. They all knew it right
then. [Named Nurse Practitioner] said, “I’m so
sorry” and I left the room. I am not sure where I
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A. BUILDING ______________________
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IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 145 Continued From page 24 A 145
went but I ended up in the educators office. I
spoke to management – different people. I filled
out the “Veritas” [Hospital’s reporting system].
This was around four-ish [4:00 PM]. I gave both
my phones to the charge nurse and the Orientee
was assigned to someone else. It was after 8:00
PM when I left.” RN #1 was asked if he/she
documented 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]. RN #1 stated
that he/she left Patient #1 in Radiology. RN #1
confirmed that he/she did not monitor Patient #1
after the medication was administered.
A 286 PATIENT SAFETY
CFR(s): 482.21(a), (c)(2), (e)(3)
(a) Standard: Program Scope
(1) The program must include, but not be limited
to, an ongoing program that shows measurable
improvement in indicators for which there is
evidence that it will … identify and reduce
medical errors.
(2) The hospital must measure, analyze, and
track …adverse patient events …
(c) Program Activities …..
(2) Performance improvement activities must
track medical errors and adverse patient events,
analyze their causes, and implement preventive
actions and mechanisms that include feedback
and learning throughout the hospital.
(e) Executive Responsibilities, The hospital’s
governing body (or organized group or individual
who assumes full legal authority and responsibility
for operations of the hospital), medical staff, and
A 286
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IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 286 Continued From page 25 A 286
administrative officials are responsible and
accountable for ensuring the following: …
(3) That clear expectations for safety are
established.
This STANDARD is not met as evidenced by:
Based on standards of practice, document
review, review of hospital policies and
procedures, medical record review, and interview,
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 findings included:
1. Review of the hospital’s High Alert Medications
policy documented, “…High Alert Medications –
Medications that bear a heightened risk of
causing significant patient harm when used in
error…Medication orders are reviewed by a
pharmacist prior to removal from floor stock or an
automated dispensing cabinet unless…A delay
would harm the patient (including sudden
changes in a patient’s clinical status…Additional
strategies are followed for a specified list of High
Alert Medications…Higher level decision
support…Independent Double-Check where
electronic clinical systems prompt dual signoff …”
Vecuronium was listed as a high alert medication.
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A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 286 Continued From page 26 A 286
There was no documentation in this policy
detailing any procedure or guidance regarding the
manner and frequency of monitoring patients
during and after medications were administered.
Review of the document ISMP List of High-Alert
Medications in Acute Care Settings…ISMP 2018
documented, “…High-alert medications are drugs
that bear a heightened risk of causing significant
patient harm when they are used in
error…Classes/Categories of
Medications…moderate sedation agents, IV
[Intravenous] (e.g.[for example]…midazolam
[Versed]…neuromuscular blocking agents
(e.g…rocuronium, vecuronium)…”
The hospital’s document titled High Alert
Medications Chart: Adult Patients Revised May
2018 did not list any moderate sedation agents
such as Versed.
Review of “Paralyzed by Mistakes: Reassess the
Safety of Neuromuscular Blockers in Your
Facility” documented, “…Neuromuscular blocking
agents are high-alert medications because of
their well-documented history of causing
catastrophic injuries or death when used in
error…Because neuromuscular blockers paralyze
the muscles that are necessary for breathing,
some patients have died or sustained serious,
permanent injuries if the paralysis was not
witnessed by a practitioner who could intervene.
After a patient receives a neuromuscular blocker,
progressive paralysis develops, initially affecting
the small muscle groups such as the face and
hands, then moving to larger muscle groups in
the extremities and torso until all muscle groups
are paralyzed and respiration ceases. However,
full consciousness remains intact, and patients
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A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 286 Continued From page 27 A 286
can experience intense fear when they can no
longer breathe. They can also sense pain. The
experience can be horrific for patients…The most
common type of error with neuromuscular
blockers appears to be administration of the
wrong drug…Practitioners thought they were
administering a different drug, so patients may
not have been supported with mechanical
ventilation…”
Review of the document titled Joint Commission
eyes overrides of dispensing cabinets dated May,
2018 in the American Journal of Health-System
Pharmacy documented, “…vice president at the
Institute for Safe Medication Practices (ISMP)said
her organization has long considered ADC
overrides potentially problematic. “One of the big
problems with automated dispensing cabinets is
that sometimes staff are overriding without having
an order.” she said. “There’s no verbal order
written down, or they’re anticipating an order, so
they get a drug from the cabinet”…”
Review of the document titled Evaluation of
Medications Removed from Automated
Dispensing Machines (ADMs) Using the Override
Function Leading to Multiple System Changes
documented, “…The override function allows a
nurse to remove a medication from the machine
before a pharmacist reviews the order. The
purpose of the override function is to allow
access to medications in urgent/emergent
situations…Administering medications prior to a
pharmacist review increases the risk of
medication errors…The challenge with ADMs is to
prevent medication overrides in nonurgent
settings and to avoid administering medications
from orders that have not been reviewed by a
pharmacist…”
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 28 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 286 Continued From page 28 A 286
2. Observations in Neuro Critical Care Unit
(NCU) on 11/1/18 beginning at 1:38 PM revealed
the ADC that was used to withdraw medications
in the Neuro Unit. The NCU Pharmacist was at
the ADC and demonstrated how medication is
withdrawn. The NCU Pharmacist was asked to
show how the paralytic drug Rocuronium is
stored and how to remove it through the override
function. The ADC was accessed by the
pharmacist’s fingerprint. The Pharmacist entered
“RO” and Rocuronium was displayed on the
screen. He/She chose that drug and the drawer
opened. There were 3 vials of Rocuronium in the
bin. The bin was labeled with an orange sticker
that documented, “WARNING: Paralyzing Agent
Causes Respiratory Arrest.” The Pharmacist was
asked if Rocuronium could be overridden.
He/She confirmed Rocuronium could be
overridden because of the emergent need of the
drug during a rapid response.
3. Interview with the Manager of the Adult Patient
Safety Team (MAPST) on 10/31/18 beginning at
3:15 PM, in conference room 167, the MAPST
was asked about his/her role regarding the
events associated with Patient #1, and the
MAPST stated, “We facilitate Event Analysis here
– it used to be called Root Cause Analysis,
regarding the medication error, we [a
multidisciplinary group] did the root cause
analysis. We learned the nurse and the Orientee
were called to Radiology for a patient that was
having some anxiety. [Patient #1] was in the
Neuro stepdown unit but waiting for a floor bed.
[RN #1] pulled the med from ICU. He/She went
into the system and picked the patient and typed
“VE” for Versed and did a search. He/She chose
Vecuronium because it was the first that came
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 29 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 286 Continued From page 29 A 286
up. The window popped and alert up notifying that
drug was not in the patient’s profile and she over
rode that, which can be done due to possible
emergencies. This drug was a powder and had to
be reconstituted, Versed did not [have to be
reconstituted]. Reconstitution was a question of
where was it done. He/She gives the drug to the
patient and left the patient unattended. The
radiology team called her down to help and give
the Versed.”
The MAPST was asked how long was [the
patient] was left unattended, and the MAPST
stated, “They found her in arrest, called the code.
I don’t know how long it was between when the
med was given and the code was called…We
looked at the medications that are on override
and took Vecuronium out of override status.
[Named Quality Pharmacist] was part of this
meeting.” The MAPST was asked if any
education was done for the nursing staff. The
MAPST stated, “Safe transport education –
making sure if a patient needs meds, they have
the appropriate staff with them and Neuro added
a sedation review to their annual competencies’.
Interview with the Provider Support Services
Representative (PSSR) on 10/31/18 at 3:30 PM,
in conference room 167, the PSSR was asked if
there was any discussion at any meeting after the
event occurred in December, 2017. As the PSSR
reviewed the minutes for each monthly meeting
Med Executive Meeting from January through
October 2018, the PSSR stated, “We do the
credentialing for all the providers and we
coordinate the minutes for the Med Executive
Meeting. [Medical Center Medical Board]. The
review of the minutes on January 11, 2018
revealed a new policy called Medication Ordering
was presented at this meeting. The process for
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A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 286 Continued From page 30 A 286
removing meds from the Acudose [Automated
Dispensing Cabinet] was not listed on the
minutes meeting agenda for January through
October [2018].” The PSSR was asked if there
was any discussion during any of the Executive
Committee meeting minutes regarding the
process for obtaining medications from the ADC.
The PSSR reviewed the monthly meeting minutes
from January through August 2018, and the
PSSR stated, “There was a Medication
Administration policy updated at the May meeting
and was discussed, approved and passed
unanimously in the June meeting.”
There was no evidence or documentation this
medication error was discussed in the Med
Executive meetings or the Executive Committee
meetings.
Interview with Pharmacist #1 (Medication Safety
Program Director) on 11/1/18 at 4:00 PM, in
conference room 167, Pharmacist #1 was asked
if he/she knew where the vial of Vecuronium was
that was used when the medication error
occurred in December, 2017, and he/she stated,
“It’s my understanding the vial was not
quarantined in time. We cannot tell how much
she got, that’s my understanding.”
He/She was asked if reversing agents are readily
accessible, and Pharmacist #1 stated,
“Sugammadex [a neuromuscular reversal drug]
we have that on formulary, it’s available in the
ORs [Operating Rooms] where paralytics are
used the most. In an ICU area, that would have
paralytics, it would have to come through
Anesthesia…We no longer use Vecuronium for
RSI [Rapid Sequence Intubation]. There was a
global review and we now use Rocuronium.”
He/She was asked if Rocuronium is still available
on override in Neuro ICU, and the Pharmacist
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 31 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 286 Continued From page 31 A 286
stated, “Yes, the decision was made to continue,
it has that level of access and because of the
urgency of the need.” He/She further stated, “We
rolled out EPIC, our new system for
documentation last year in November [2017]. We
did an expansion with the bar code scanners to
the ED [Emergency Department], PACU [Post
Anesthesia Care Unit], Holding Rooms and
Radiology is next. It was already on the list [roll
out].”
Interview with the MAPST and the SQPA on
11/1/18 at 4:23 PM, the MAPST stated, “We use
the Safety Event Decision Algorithm as part of our
methodology…overview of the EA: He/She had a
lengthy intolerance to lengthy procedures. The
Neuro Primary Nurse asked the help-all nurse to
administer the medication. The med was
administered without being scanned into the
patient’s EMR [Electronic Medical Record]. The
time frame between administering the Vec
[Vecuronium] in Radiology and the time the RRT
[Rapid Response Team] was called remains in
question. [Named RN #1] made her way back to
[Named Primary Nurse’s] assignment. He/She
handed him the bag with the vial in it. The RRT
phone went off announcing for patient in PET
1251. [Named RN #1 and RN #2] went to the
PET area and found the patient she had given the
med to. [Named RN #1] helped the team
transport him/her back to NCU. After he/she got
back, [Named RN #2] asked him/her if this
[holding the bag] was what he/she gave the
patient. He/She confirmed it was. [Named RN #1]
asked [Named RN #2] to give it [the bag and the
med in it] to the charge nurse to address the
issue. We don’t know who the charge nurse was
or what he/she did with the medication. [Named
RN #1] notified the team [team of doctors, NP] in
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A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 286 Continued From page 32 A 286
[Patient #1’s] room what had occurred. He/She
also notified the charge nurse, the CSL [Clinical
Staff Leader] and went to the educator’s office.
He/She notified [Named Neuro Nurse Manager]
and Risk Management…The timeline was:
12/26/17 – 2 PM: PET scan scheduled.
12/26/17 – 2:47 PM: 2mg. of Versed was ordered.
12/26/17 – 2:59 PM: Vecuronium override in
Acudose. VE was entered in the Acudose and the
machine defaults to generic medications –
Vecuronium popped up. Versed [brand name] did
not show on the screen. A warning in red box was
visible for an override stating that is should be for
STAT orders.
12/26/17 – RN #1 gave the medication – it’s
unknown what time she got to Radiology.
12/26/17 – RRT was called at 15:29 [3:29 PM].
STATS go overhead.
As a group [leaders, risk etc] what can we do to
fix it…Action plan: The bar code scanning
implementation in Radiology – this is pending. A
Multi-disciplinary team meeting regarding the
override med list. Vec [Vecuronium] was removed
from override status. Roc [Rocuronium] was left
on [the override list] for emergencies. We
weighted the risks versus the benefits and left it
on. We met on January 19. The meeting on
February 2, it was approved. The meeting on
February 23 was the Pharmacy Policy
Committee. The meeting on March 3 it was
completed…We also did education of local [NCU]
and global nursing team members regarding
sedative administration and monitoring…”
Interview with SQPA on 11/2/18 at 9:22 AM, she
stated, “…we wanted to make sure the Patient
Safety Alert from the Safety Team went to
operational leaders and [Named VUH CNO] was
a recipient of this alert and she sends out the
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A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 286 Continued From page 33 A 286
information to her reports…”
Review of the time stamp on the “Patient Safety
Notification Serious Safety Event Notification
revealed the notification was distributed on
Wednesday, 1/3/18 (8 days after the event
occurred). The notification documented, “[Patient
#1’s Initials], was a 75 y.o. [year old] female
admitted for ICH [Intracerebral Hemorrhage].
Versed 1 mg IV ordered to assist with patient
comfort during PET scan. Vecuronium 1 mg IV
inadvertently retrieved and administered by RN.
Due to neurological sequelae, pt. placed on
comfort care by family and died later that day. A
serious safety event analysis (SSEA) is in
progress of being convened. Please contact the
QSRP Safety Team, at [telephone number], if you
need additional information.”
4. Interview with the Director for Clinical Risk
Management (DCRM) on 11/2/18 at 12:35 PM, in
conference room 167, the DCRM produced the
baggie with the medication in it. She stated, “My
understanding is this is the actual baggie…” The
DCRM was asked if he/she spoke to RN #1 and
was he/she able to explain the contents. The
DCRM stated, “He/She took this with him/her
[holding up the baggie]. The nurse stated this was
the syringe with the drug in it that that was
administered to the patient in PET. [holding up
the syringe with the 1.5 mL clear liquid in
it]…He/She was distraught and it was a small
window to get the information…We are not sure
what is in each syringe, this package was the
waste possibly [holding up the baggie]…the level
of granularity in our investigation, 2 things were
happening, the patient’s clinical needs, during the
arrest we identified the wrong drug. The family
was told immediately of a possible med error. On
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A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 286 Continued From page 34 A 286
our end, we put the med in a secure place. We
also try to give the employee assistance. By the
time they pronounced [Patient #1], they thought it
was the VEC [Vecuronium] and we will get back
with you [the family]. There was a med error that
likely impacted her breathing. We are very up
front early on. Then Risk and Quality began to
look at the Pyxis [ADC], looking to see if
something is wrong with the machine. In the end,
there were so many things the nurse did – the 5
rights, basic nursing care. I had reached out to
the family and they had already obtained an
attorney – and the rest is
confidential…assessment before [medication
given], 5 rights give med and assess after” The
DCRM was asked about the lack of
documentation in the chart. He/She stated,
“Everyone was focused on resuscitation. The
code team was called, they treated only the
resuscitation. The investigation was after she was
dead. He/She was worked on and at no time was
he/she stable. There was no opportunity for her
[RN #1] to chart about the med.”
Observations in conference room 167 on 11/2/18
at 12:35 PM revealed one (1) clear zip lock
baggie with an orange biohazard label. There was
handwriting on the baggie in a pink color marker
that documented, “Versed 1mg 2mg PET
1251.” Inside the baggie was a vial with a few
drops of clear liquid remaining in the vial. The vial
was labeled Vecuronium Bromide 10mg. 1mg/mL
when reconstituted to 10mL. Reconstitute with
Bacteriostatic water. The vial had a red top that
documented, “WARNING: PARALYZING
AGENT.” There was one (1) 10 mL syringe
labeled “Normal Saline” with a capped needle
attached. The syringe had 8 mL of a clear liquid
remaining in it. There was one 10 mL syringe
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 35 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 286 Continued From page 35 A 286
labeled “Normal Saline” with 1.5 ml of a clear
liquid remaining in it and capped with a white cap
with no needle. There was also a 2″ alcohol prep
pad in the baggie.
There was no way to tell what was Vecuronium
and what was normal saline and no way to
determine how much of the drug Patient #1
actually received.
5. Interview with the Regulatory Officer (RO) on
11/6/18 at 12:57 PM, in conference room 167,
he/she was asked what is the process for
incidents, and the RO stated, “The occurrence
happens, then its logged into the system [Veritas
II- reporting software], a review is made with Risk
and Quality, if there is a chance it is serious, it
goes to the executive leadership for review, then
if it is, a serious safety event is released and sent
down to all staff. In the background we are doing
the investigative portion – the event analysis [EA].
We took and take immediate action on all events.
He was asked why Rocuronium is still available in
the Acudose for override, and the RO stated, “An
analysis was done for each drug looking at the
risks versus the benefits and Rocuronium was left
on the override list.”
He/she was asked what process has been put in
place to ensure this won’t happen with
Rocuronium, and the RO stated, “Let’s get the
pharmacist in here to answer that…EA is
considered a QAPI”
Interview with the Pharmacy Manager,
Pharmacist #2, and the RO on 11/6/18 at 3:06
PM, in conference room 167, he/she was asked
what process has been put in place to ensure this
won’t happen with Rocuronium. The Pharmacy
Manager stated, “We felt we had appropriate
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A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 286 Continued From page 36 A 286
safety measures in place. We did a
comprehensive review of the override list and
removed some of the drugs in a few specific
places. Rocuronium has a quicker onset in the
body.”
The RO stated, “A full analysis was done and
there were more safety concerns of putting more
safety restrictions due to the need of immediate
access. The risk of delay of accessing Roc could
lead to negative patient outcomes. Those
potentials outweigh the need for additional safety
mechanisms.”
The Pharmacy Manager stated, ” Rocuronium is
a generic name which would default on the
Acudose machine when putting it in, making it
visible on the screen, whereas Versed is a name
brand and putting in VE would not display unless
the nurse physically pushed the brand name
selection.”
The RO stated, “The number of safety points this
nurse went through was numerous.” The RO was
asked why was there a delay in nursing
education.
The RO stated, “We see the issue and we
probably should have educated sooner. We
wanted to make sure we did a root cause
analysis before we trained on it. We got the alerts
out immediately to all staff.”
The RO was asked if he looked at the “Help-all
nurse’s” role, and what areas would he/she be
pulled to, and also orienting a new nurse at the
same time.
The RO stated, “I have never heart that term, that
is not a [Named Hospital] wide term. But believe
me, we are going to look at it.”
The RO was asked about the process for QAPI
and where does the analysis begin and does it
get to the system level for review.
The RO stated that each hospital [Adult,
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A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 286 Continued From page 37 A 286
Children’s, Behavioral] has committees that meet
and review all events. Those committees roll up
to each hospital QAPI committee that is chaired
by the CEO of that hospital. [see system
flowsheet] Each of those committees meet and
those meeting minutes are funneled up to the
System’s Quality Steering Committee which is
chaired by the Hospital System’s CEO”.
The Pharmacy Manager stated, “Drug errors are
forwarded to QSRP [Quality, Safety , Risk
Prevention]. The errors that happened in October
will be reported to ADE [Adverse Drug Events]
Committee. They meet monthly and will review
the October errors this Friday. They meet the
second Friday of every month.”
6. Review of the education records revealed the
education began in March 2018, more than 2
months after the event.
A 364 AUTOPSIES
CFR(s): 482.22(d)
The medical staff should attempt to secure
autopsies in all cases of unusual deaths and of
medical-legal and educational interest. The
mechanism for documenting permission to
perform an autopsy must be defined. There must
be a system for notifying the medical staff, and
specifically the attending practitioner, when an
autopsy is being performed.
This STANDARD is not met as evidenced by:
A 364
Based on document review, review of hospital
policies and procedures, medical record review,
and interview 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
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 38 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 364 Continued From page 38 A 364
(Patient #1) patient deaths reviewed.
The findings included:
1. Review of the hospital’s Deaths Requiring
Reporting to the Medical Examiner policy
documented, “…The Davidson County ME
[Medical Examiner] is notified of all deaths
occurring at [Named Hospital System] that
require reporting to the ME prior to discussions
with the patient’s family regarding an autopsy for
a reportable death, as stated in Section
IIIA…Deaths reportable under Tennessee law and
[Named Hospital] policy include ALL those due to,
apparently due to, related to, or admitted for the
following (regardless of the interval between
event and time of death)…Any suspicious,
unusual or unnatural death…Death during or as a
result of a…medication error…It is the
responsibility of the physician completing the
Report of Death…to notify the Davidson County
ME when a death falls within any of the
categories described above. In case of
uncertainty of the need to report a death, the ME
is consulted regarding whether or not the death is
reportable. The ME makes the final determination
of case acceptance for examination…”
Review of the hospital’s Medical Staff Rules and
Regulations documented, “…Deaths…[Named
Hospital System] complies with all applicable
state and local law regarding certification of
death…and the reporting of deaths to the medical
examiner under circumstances required by state
law to facilitate the performance of inquests in
accordance with hospital policy…Medical
Examiner Cases…The physician…in charge of the
patient’s care for the…condition that resulted in
the patient’s death shall report any death due to,
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 39 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 364 Continued From page 39 A 364
apparently due to…regardless of the interval
between event and time of death to the…Medical
Examiner’s Office…”
Review of the hospital’s House Staff Agreement…
signed by Physician #3 documented, “…In
accepting this appointment, I hereby agree
to…Abide by the applicable Medical Staff Bylaws,
Rules and Regulations…Demonstrate and
understanding and acceptance of my personal
role in…accurate reporting of patient outcomes
and clinical experience data…”
Review of the document titled 2017 Tennessee
Department of Health Office of the State Chief
Medical Examiner County Medical Examiner
Handbook documented, “…Tennessee Code
requires that any death which is suspicious,
unusual or occurs under unnatural
circumstances is to be reported to the county
medical examiner. The mandatory reporters of
such deaths are listed as “any physician,
undertaker, law enforcement officer, or other
person having knowledge of the death.” T.C.A. §
38-7-108. Specifically, the county medical
examiner of the county in which the death
occurred is to be notified in all cases of:…Deaths
in any suspicious/unusual/unnatural manner…The
first decision point for the county medical
examiner receiving a report of death occurring in
a healthcare facility is to determine the probable
manner of death. In cases of death in persons
with a medical history of a disease process which
could reasonably account for death and there is
no non-natural process contributing in any way to
the death, the physician treating the patient for
that disease should complete and sign the death
certificate…The manner of death [listed on the
death certificate] represents the county medical
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 40 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 364 Continued From page 40 A 364
examiner ‘ s opinion as to which category the
death best fits into and is based on the
circumstances surrounding the death…The five
options for completion of the manner of death in
Tennessee are Natural, Accident, Suicide,
Homicide, and Could Not Be Determined…All
deaths should be classified as to manner, and
only one manner of death is to be
chosen…Natural deaths are those due exclusively
(100%) to disease and/or the aging process. A
death in which a discrete, unnatural act
contributes in any way towards the death,
regardless of the interval elapsed between the
event and demise, cannot be considered a
natural death…Accident is defined as an
unnatural death resulting from an inadvertent
chance happening…The National Center for
Health Statistics assigns ICD-10 codes to death
certificates for vital statistics. As such, it is
important to list each drug felt to be contributory
to death on the death certificate [e.g., “acute
combined drug toxicity (heroin, alprazolam, and
ethanol)]” for improved data collection. Use of the
terms “toxicity”, “intoxication”, “overdose”,
“ingested”, “injected” or “inhaled” will be assigned
a statistical code indicating that the event was
non-natural…Standard Language for Cause of
Death: Examples…Accidental…Acute drug/mixed
drug (names of drug(s) intoxication…Standard
Language for How Injury Occurred. These
phrases should satisfy the purposes of item 34 on
death certificate in the majority of non-natural
deaths…injected prescription
medications…38-7-108. Death under suspicious,
unusual or unnatural circumstances. (a) Any
physician, undertaker, law enforcement officer, or
other person having knowledge of the death of
any person from… deaths in any
suspicious/unusual/unnatural manner, found
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 41 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 364 Continued From page 41 A 364
dead…shall immediately notify the county medical
examiner or the district attorney general, the local
police or the county sheriff, who in turn shall notify
the county medical examiner. The notification
shall be directed to the county medical examiner
in the county in which the death occurred…”
Review of the hospitals Disclosure of
Unanticipated Outcomes policy documented, “…
[Named Hospital System] clinicians share
information with patients or their authorized
representatives about their medical care,
including information regarding unanticipated
outcomes, whether arising as a result of
pathologic process, complication of treatment or
medical error…Unexpected Outcome –
Unexpected change in patient’s condition
generally worse that what had been intended or
hoped for, as a result of a…medical
error….Medical Error – The failure of a planned
action to be completed as intended…The
Attending of Record has the ultimate
responsibility for…Informing patients or their
authorized representatives about unanticipated
outcomes, including those associated with
medical error…Discussions concerning sharing of
unanticipated outcomes and/or medical errors are
documented in patients’ charts…Guidelines for
Sharing Information about Unanticipated
Outcomes (“Disclosure”)…Documentation of
disclosure in the medical record includes: 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; Plan for continued
communications…”
Review of the hospital’s Occurrence Reporting:
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 42 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 364 Continued From page 42 A 364
Patient and Visitor policy documented, “…When a
serious or significant Event involving a patient or
visitor occurs, immediately notify the Office of
Risk and Insurance Management and the
Administrative Coordinator…Event for the
purposes of this policy is any of the following:
Sentinel Event; Serious Reportable
Event…Unanticipated outcome or occurrence
involving a patient…Other terms which fall under
the meaning of Event under this policy
include…Medication Error, or adverse drug
reaction…Medication Errors and Adverse Drug
Events are the unintended, undesired, and
unexpected effects of prescribed medications…or
Medication Error requiring discontinuing a
medication…supportive treatment, or resulting in
temporary or permanent disability…a life
threatening condition, death…Sentinel Event is a
term established by The Joint Commission for an
unexpected occurrence involving death…Serious
Injury is unanticipated death…Serious Reportable
Event is a term established by the National
Quality Forum [NQF] that refers to 29 serious and
largely preventable adverse Events…”
Review of NQF’s document titled Serious
Reportable Events in Healthcare – 2011 Update…
documented, “…Patient death or serious injury
associated with a medication error (e.g., errors
involving the wrong drug, wrong dose, wrong
patient, wrong time, wrong rate, wrong
preparation, or wrong route of administration)…”
2. 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
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 43 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 364 Continued From page 43 A 364
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.
3. Interview with the Accreditation Regulatory
Specialist (ARS) on 11/1/18 at 9:10 AM, in
conference room 167, the ARS was setting up the
computer to review Patient #1’s medical record.
There was a discussion regarding the death
certificate and the manner of death. The ARS
stated that you cannot make a medication
administration accusation on the death certificate.
Telephone interview with Physician #1 on 11/2/18
at 9:56 AM, He/She was asked if he/she met with
the family regarding Patient #1’s event. He/She
stated, “No, I did not. I met with [Named
Physician #2]” Physician #1 was asked because
he/she received a paralytic that directly
contributed to his/her death, would you have
marked “accidental” on the death certificate.
Physician #1 stated, “I have always thought of
accidents as…I have never marked that, but this
does make sense with this case…”.
Interview with the Senior Quality and Patient
Advisor (SQPA) on 11/2/18 at 10:05 AM, (just
after the above interview with Physician #1)
he/she stated, “He/She [Physician #1] was led to
say something 11 months later and I don’t think
that was accurate. We don’t know, he/she
[Patient #1] got such a small dose, and he/she
was anxious about the test, so we can’t say it
contributed to his/her demise. Things can be
disclosed after the fact [death]…”
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 44 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 364 Continued From page 44 A 364
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.
Interview with Physician #2 on 11/2/18 at 11:24
AM, he/she was asked about the event
surrounding Patient #1, and he/she stated, “I
went down [to PET scan] when I heard it [Rapid
Response] overhead. What was his/her clinical
picture prior to the event? [He/She] had been
stable and moved to stepdown. [His/Her] type of
bleed was related to a suspected mass behind it.”
He/She was asked what he/she thought caused
the event, and he/she stated, “Our leading cause
was the medication error contributed to it, he/she
became hypoxic…They had just completed CPR
and he/she was intubated. After he/she was back
in ICU, procedures were done…”
Physician #2 was asked if he/she talked to the
family and were they told about the medication
error, and Physician #2 stated, “Just the husband,
I don’t remember if they asked any questions.”
Interview with Physician #3 on 11/2/18 at 1:15
PM, in conference room 167 , he/she confirmed
he/she called the office of the Medical Examiner
to report Patient #1’s death. Physician #3 was
asked if he/she informed the Medical Examiner
that Patient #1 was given a paralytic drug by
mistake that contributed to his/her death.
Physician #3 stated that he/she could not
remember. Physician #3 further stated that
he/she answered the questions the Medical
Examiner asked him/her but he/she could not
remember the questions or the answers.
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 45 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 364 Continued From page 45 A 364
Physician #3 was asked if he/she had any
communication with the family regarding the
event. Physician #3 stated that he/she talked to
someone, distant relatives. He/She stated that
he/she did not talk to the immediate family.
Telephone interview with the Director of
Investigations (DOI) in the Medical Examiners
office on 11/5/18 at 10:01 AM, the DOI was asked
about (Named Patient #1) and what was reported
to them regarding Patient #1’s death, and the DOI
stated, “The date of death was 12/27/17 and was
called in by [Named Physician #1]. The death
certificate says he/she had a bleed. We declined
jurisdiction because there was an MRI that
confirmed the bleed…”
The DOI was asked to describe the process
when a physician reports a death, and the DOI
stated, “We have a set of questions we ask such
as admission, date and time of death, reason for
the admission, what were they treated for.”
The DOI was given the information for Patient #1
and he/she looked up his/her case. The DOI was
asked if administering a paralytic in error that
caused a death would be something the Medical
Examiner’s office should be notified of, and the
DOI stated, “Yes…The information shows he/she
died of an Intracerebral bleed. We released
jurisdiction because there was an MRI that
confirmed the bleed. [Named Physician #1] stated
maybe there was a medication error, but that was
hearsay, nothing has been documented. Since
there was no documentation and he/she said it
was just hearsay, we didn’t see any red flags…”
The name of the drug was not disclosed to the
ME.
A 385 NURSING SERVICES
CFR(s): 482.23
A 385
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 46 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 385 Continued From page 46 A 385
The hospital must have an organized nursing
service that provides 24-hour nursing services.
The nursing services must be furnished or
supervised by a registered nurse.
This CONDITION is not met as evidenced by:
Based on policy review, document review,
medical record review and interview, 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 mitigate risks
associated with medication errors and ensure all
patients’ received the correct medications to
protect their physical and emotional health and
safety placed all patients 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 findings included:
1. The hospital nursing services failed to ensure
the correct medication was administered.
Refer to A-0395
A 395 RN SUPERVISION OF NURSING CARE
CFR(s): 482.23(b)(3)
A registered nurse must supervise and evaluate
the nursing care for each patient.
This STANDARD is not met as evidenced by:
A 395
Based on standards of practice, document
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 47 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 395 Continued From page 47 A 395
review, review of hospital policies and
procedures, medical record review, and interview,
the hospital failed to ensure all Critical Care
Registered Nurses (RN) implemented policies
and procedures pertaining to the supervising and
evaluating the nursing care that was provided for
each patient for 1 of 1 (Patient #1) patients
reviewed who received the wrong medication.
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.
The findings included:
1. Review of Lippincott Manual of Nursing
Practice 10th Edition documented, “…Watch the
patient’s reaction to the drug during and after
administration. Be alert for major adverse effects,
such as…respiratory distress…NURSING
ALERT…The nurse is ultimately accountable for
the drug administered…”
Review of the hospital’s High Alert Medications
policy documented, “…High Alert Medications –
Medications that bear a heightened risk of
causing significant patient harm when used in
error…Medication orders are reviewed by a
pharmacist prior to removal from floor stock or an
automated dispensing cabinet unless…A delay
would harm the patient (including sudden
changes in a patient’s clinical status…Additional
strategies are followed for a specified list of High
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 48 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 395 Continued From page 48 A 395
Alert Medications…Higher level decision
support…Independent Double-Check where
electronic clinical systems prompt dual signoff …”
Vecuronium was listed as a high alert medication.
There was no documentation in this policy
detailing any procedure or guidance regarding the
manner and frequency of monitoring patients
during and after medications were administered.
The Drug Summary for Midazolam Hydrochloride
(Versed). Retrieved from PDR, 2018,
http://www.pdr.net documented, “…CLASSES
Anxiolytics Benzodiazepine Sedative/Hypnotics
Other General Anesthetics…Administration of
midazolam requires an experienced clinician
trained in the use of resuscitative equipment and
skilled in airway management…Monitor patients
for early signs of respiratory insufficiency,
respiratory depression, hypoventilation, airway
obstruction, or apnea (i.e., via pulse oximetry),
which may lead to hypoxia and/or cardiac arrest.
The facility’s “High Alert Medications Chart: Adult
Patients Revised May 2018” did not list any
moderate sedation agents such as Versed.
Review of the hospital’s Medication
Administration documented, “[Named Hospital]
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…”
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 49 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 395 Continued From page 49 A 395
There was no documentation in this policy
detailing any procedure or guidance regarding the
manner and frequency of monitoring patients
during and after medications were administered.
There was no documentation in Patient #1’s
medical record that Vecuronium or Versed was
administered to her on 12/26/17.
Review of the hospital’s RN 2CC Job Description
documented, “…CORE
COMPETENCIES…Fulfills Safety and Regulatory
Requirements: Understands all aspects of
providing a safe environment and performs
routine safety checks to prevent safety hazards
from occurring…”
2. 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.
A physician progress note written on 12/25/17 at
1:32 PM, by Physician #2 documented, “…no
acute events since admission…encourage out of
bed activity…DISPO [Disposition] no further
critical care issues. likely going to the floor
today…”
Review of medication order #60651186 order
details dated 12/16/17 at 3:00 PM revealed
Versed 2 milligrams (mgs) intravenous one time.
Administration instructions documented, “For
PET scan if first milligram insufficient, can give
1-2mg additional if needed…”
Review of the Automatic Dispensing Cabinet
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 50 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 395 Continued From page 50 A 395
(ADC) detail report revealed the order was
entered on 12/26/18 2:47 PM. Pharmacy verified
the order at 2:49 PM. Versed was not removed
from the Automated Dispensing Cabinet (ADC).
Review of the ADC detail report dated 12/26/17
revealed Vecuronium (a neuromuscular paralytic
drug) 10 mg. injection vial was taken by RN #1 at
2:59 PM from the ADC located in the Neuro ICU
using the override feature. There was no
physician order for Patient #1 to receive this drug.
The override was not verified by Pharmacy.
Interview with the Nurse Manager of Neuro Unit
on 11/1/18 at 12:36 PM in conference room 167
the Nurse Manager was asked if there was
documentation anywhere in Patient #1’s medical
record that he/she received Vecuronium and how
much and when he/she received it. The Nurse
Manager stated, “No…”
A physician progress note written on 12/26/17 at
6:28 PM by an Advance Practice Registered
Nurse (APRN) and co-signed by Physician #2
documented, “…Received patient to NCU [Neuro
Critical Care Unit] after cardiac arrest in PET
scan. Per report, ROSC [Return of Spontaneous
Circulation] received after approximately 2 rounds
of ACLS [Advanced Cardiac Life Support]. Patient
was intubated during event…Current
Facility-Administered
Medications…Vecuronium…” No dose, route or
frequency was documented.
A physician progress note written on 12/26/17 at
6:36 PM, by Physician #2 documented, “…After a
couple of hours in the ICU, [he/she] began
displaying myoclonic jerks w/stimulus
interspersed with posturing…pt’s neuro exam is
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 51 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 395 Continued From page 51 A 395
very concerning. after d/w [discussion with]
neurology team, they suspect that [his/her] exam
is c/w [consistent with] what would be seen after
anoxic brain injury – CT [Computerized
Tomography] head showed some increase in
swelling, but area of bleed not worsened – initially
suspected worsening hemorrhage as reason for
arrest, however after further discussion, it is
suspected that [he/she] may have received an
incorrect medication which contributed to the
event…DISPO: pt’s course is very concerning.
Given myoclonic jerks there is high concern for
anoxic brain injury…”
A physician progress note written on 12/27/17 at
12:27 AM, by a physician and cosigned by
Physician #2 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…[He/She] was made a DNR/DNI [Do Not
Resuscitate/Do Not Intubate]. Palliative
extubation was performed 12/27/17 at 12:57 AM.
Vasoactive infusions were then discontinued.
Time of cardiopulmonary death was 1:07 AM by
pulselessness on [his/her] arterial line…”
Interview with the Manager of the Adult Patient
Safety Team (MAPST) on 10/31/18 beginning at
3:15 PM, in conference room 167, the MAPST
was asked about his/her role regarding [Named
Patient #1]. The MAPST stated, “…We learned
the nurse and [his/her] Orientee were called to
Radiology for a patient that was having some
anxiety…[He/She] [RN #1] pulled the med from
ICU. [He/She] went into the system and picked
the patient and typed “VE” for Versed and did a
search. [He/She] chose Vecuronium because it
was the first that came up. The window popped
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 52 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 395 Continued From page 52 A 395
and alert up notifying that drug was not in the
patient’s profile and [He/She] over rode that,
which can be done due to possible emergencies.
This drug was a powder and had to be
reconstituted, Versed did not [have to be
reconstituted]. Reconstitution was a question of
where was it done. [He/She] gives the drug to the
patient and left the patient unattended.” The
MAPST was asked how long was Patient #1 left
unattended. The MAPST stated, “They found
[him/her] in arrest, called the code. I don’t know
how long it was between when the med was
given and the code was called…”
Telephone interview with RN #1 on 11/5/18
beginning at 4:41 PM, RN #1 was asked to
describe the circumstances leading up to Patient
#1’s death beginning on Tuesday 12/26/17. RN
#1 stated, “I was in a patient care role, I was the
help-all nurse. A help-all nurse is a resource
nurse and I had an Orientee”
RN #1 stated that RN #2 had asked (him/her) to
go downstairs to Radiology PET scan and
administer the medication Versed to Patient #1
because the patient was not able to tolerate the
PET scan procedure or they would have to send
him/her back and reschedule it.
RN #1 stated he/she searched for the Versed
under Patient #1’s profile in the ADC and RN #1
couldn’t find it. RN#1 stated that he/she then
chose the override setting on the ADC and
searched for the Versed.
RN #1 stated he/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 the medication vial out
of the ADC, and looked at the back of the vial at
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 53 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 395 Continued From page 53 A 395
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 was asked how long it took him/her to get
to the Radiology department PET scan, and RN
#1 stated, “5 minutes or less, it was my first time
to go to PET scan, I had to ask for directions”.
RN #1 stated, “I saw one patient [who was
Patient #1] on one of our beds, I checked the
patient for [his/her] identity, and told [him/her] I
was there to give [him/her] something to help
[him/her] relax”.
RN #1 stated, “I reconstituted the medication and
measured the amount I needed”
The RN stated Radiology Technician #1 was
there at the time he/she (RN #1) administered the
medication IV to Patient #1. RN #1 stated he/she
left the Radiology PET scan area after he/she
had administered the medication to Patient #1.
RN #1 was asked how much medication did
he/she administer to Patient #1, and the RN
stated, “I can’t remember, I am pretty sure I gave
[him/her] 1 milliliter.
RN #1 was asked what was done with any left
over medication, and the RN stated, “I put the left
over in the baggie and gave it to [Named RN
#2]…”
RN #1 was asked what he/she did after
administering the medication to Patient #1, and
the RN stated he/she left Patient #1 in Radiology.
RN #1 confirmed that he/she did not monitor
Patient #1 after the medication was administered.
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 54 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 395 Continued From page 54 A 395
RN #1 was asked what happened next and the
RN stated, “Patient #1’s family was standing
outside in the hallway…we heard a rapid
response call for PET scan. That was a red flag
since the patient was ours, so [Named RN #2]
called down there [to the PET scan] but there was
no answer. The family looked at us and said
“ours?” [Named RN #2] said “we are going to
make sure.” We tried to call PET scan again, we
were being responsible to go to see if it was our
patient”.
RN #1 stated that he/she and RN #2 went to PET
scan and when they arrived Patient #1 was
intubated and had regained a heart rate. The RN
stated he/she, Physician #2, and the Charge
Nurse moved Patient #1 back to the ICU.
RN #1 stated, “I told [Named Physician #2] that I
had given him/her Versed a few minutes ago…I
reminded the Nurse Practitioner that Patient #1
was awake but unmonitored when I gave him/her
the Versed”.
RN #1 stated RN #2 approached him/her and
asked, “Is this the med you gave [him/her]?” and
RN #1 responded “yes”. RN #1 then stated RN #2
said, “This isn’t Versed, It’s Vecuronium.”
RN #1 stated he/she then 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 he/she 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
he/she said it would show up in a special area in
a different color.”
RN #1 was asked if he/she could remember how
much Vecuronium he/she administered to Patient
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 55 of 56
A. BUILDING ______________________
(X1) PROVIDER/SUPPLIER/CLIA
IDENTIFICATION NUMBER:
STATEMENT OF DEFICIENCIES
AND PLAN OF CORRECTION
(X3) DATE SURVEY
COMPLETED
PRINTED: 11/19/2018
FORM APPROVED
(X2) MULTIPLE CONSTRUCTION
B. WING _____________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
440039 11/08/2018
C
STREET ADDRESS, CITY, STATE, ZIP CODENAME OF PROVIDER OR SUPPLIER
1211 MEDICAL CENTER DRIVE
VANDERBILT UNIVERSITY MEDICAL CENTER
NASHVILLE, TN 37232
PROVIDER’S PLAN OF CORRECTION
(EACH CORRECTIVE ACTION SHOULD BE
CROSS-REFERENCED TO THE APPROPRIATE
DEFICIENCY)
(X5)
COMPLETION
DATE
ID
PREFIX
TAG
(X4) ID
PREFIX
TAG
SUMMARY STATEMENT OF DEFICIENCIES
(EACH DEFICIENCY MUST BE PRECEDED BY FULL
REGULATORY OR LSC IDENTIFYING INFORMATION)
A 395 Continued From page 55 A 395
#1, and RN #1 stated, “I would have given her 1
milligram.”
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.”
RN #1 was asked about the “help-all nurse” role
and was there documentation of what was done
while working a shift, and the RN stated, “If you
do something, you just chart it for that patient”.
The RN stated there was not an actual job
description for the role of a “help-all nurse”
Refer to A 144 and A145.
FORM CMS-2567(02-99) Previous Versions Obsolete NVYT11Event ID: Facility ID: TNP53127 If continuation sheet Page 56 of 56
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Anti-Kickback Statute [
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Exclusion Statute [42 U�S�C� § 1320a-7] ������������������������������������������������������������� 7
Civil Monetary Penalties Law [42 U�S�C� § 1320a-7a] ���������������������������������������
8
I� Physician Relationships With Payers ���������������������������������������������������������������������� 9
Accurate Coding and Billing �������������������������������������������������������������������������������� 9
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Enrolling as a Medicare and Medicaid Provider With CMS ����������������������������� 12
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II� Physician Relationships With Fellow Providers: Physicians,
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16
Physician Investments in Health Care Business Ventures ��������������������������������� 16
Physician Recruitment ���������������������������������������������������������������������������������������
19
Tips for Medical Directors ��������������������������������������������������������������������������������� 20
III� Physician Relationships With Vendors����������������������������������������������������������������
21
Free Samples ������������������������������������������������������������������������������������������������������ 21
Relationships With the Pharmaceutical and Medical Device Industries ������������
22
Transparency in Physician-Industry Relationships ��������������������������������������������
24
Conflict-of-Interest Disclosures ������������������������������������������������������������������������� 24
Continuing Medical Education ��������������������������������������������������������������������������
25
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26
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28
What To Do If You Have Information About Fraud and
Abuse Against Federal Health Care Programs ������������������������������������������������������
29
Table of Contents
Introduction
Most physicians strive to work ethically, render high-quality medical care to their
patients, and submit proper claims for payment. Society places enormous trust in
physicians, and rightly so. Trust is at the core of the physician-patient relationship.
When our health is at its most vulnerable, we rely on physicians to use their expert
medical training to put us on the road to a healthy recovery.
The Federal Government also places enormous trust in physicians. Medicare, Medicaid,
and other Federal health care programs rely on physicians’ medical judgment to treat
beneficiaries with appropriate services. When reimbursing physicians
and hospitals for services provided to program beneficiaries, the
Federal Government relies on physicians to submit accurate
and truthful claims information.
The presence of some dishonest health care providers
who exploit the health care system for illegal personal
gain has created the need for laws that combat fraud and
abuse and ensure appropriate quality medical care. This
brochure assists physicians in understanding how to comply
with these Federal laws by identifying “red flags” that could lead
to potential liability in law enforcement and administrative actions. The information
is organized around three types of relationships that physicians frequently encounter
in their careers:
I. Relationships with payers,
II. Relationships with fellow physicians and other providers, and
III. Relationships with vendors.
The key issues addressed in this brochure are relevant to all physicians, regardless
of specialty or practice setting.
CAUTION
2
Most physicians strive to work ethically, render high-quality medical care to their
patients, and submit proper claims for payment. Society places enormous trust in
physicians, and rightly so. Trust is at the core of the physician-patient relationship.
When our health is at its most vulnerable, we rely on physicians to use their expert
medical training to put us on the road to a healthy recovery.
The Federal Government also places enormous trust in physicians. Medicare, Medicaid,
and other Federal health care programs rely on physicians’ medical judgment to treat
beneficiaries with appropriate services. When reimbursing physicians
and hospitals for services provided to program beneficiaries, the
Federal Government relies on physicians to submit accurate
and truthful claims information.
The presence of some dishonest health care providers
who exploit the health care system for illegal personal
gain has created the need for laws that combat fraud and
abuse and ensure appropriate quality medical care. This
brochure assists physicians in understanding how to comply
with these Federal laws by identifying “red flags” that could lead
to potential liability in law enforcement and administrative actions. The information
is organized around three types of relationships that physicians frequently encounter
in their careers:
I. Relationships with payers,
II. Relationships with fellow physicians and other providers, and
III. Relationships with vendors.
The key issues addressed in this brochure are relevant to all physicians, regardless
of specialty or practice setting.
Fraud and Abuse Laws
The five most important Federal fraud and abuse laws that apply to physicians are the
False Claims Act (FCA), the Anti-Kickback Statute (AKS), the Physician Self-Referral
Law (Stark law), the Exclusion Authorities, and the Civil Monetary Penalties Law
(CMPL). Government agencies, including the Department of Justice, the Department
of Health & Human Services Office of Inspector General (OIG), and the Centers for
Medicare & Medicaid Services (CMS), are charged with enforcing these laws. As you
begin your career, it is crucial to understand these laws not only because following
them is the right thing to do, but also because violating them could result in criminal
penalties, civil fines, exclusion from the Federal health care programs, or loss of your
medical license from your State medical board.
False Claims Act [31 U.S.C. §§ 3729–3733]
The civil FCA protects the Government from being overcharged or sold shoddy
goods or services. It is illegal to submit claims for payment to Medicare or
Medicaid that you know or should know are false or fraudulent. Filing false
claims may result in fines of up to three times the programs’ loss plus $
11
,000 per claim
filed. Under the civil FCA, each instance of an item or a service billed to Medicare or
Medicaid counts as a claim, so fines can add up quickly. The fact that a claim results
from a kickback or is made in violation of the Stark law also may render it false or
fraudulent, creating liability under the civil FCA as well as the AKS or Stark law.
Under the civil FCA, no specific intent to defraud is required. The civil FCA defines
“knowing” to include not only actual knowledge but also instances in which the
person acted in deliberate ignorance or reckless disregard of the truth or falsity of
the information. Further, the civil FCA contains a whistleblower provision that allows
a private individual to file a lawsuit on behalf of the United States and entitles that
whistleblower to a percentage of any recoveries. Whistleblowers could be current or
ex-business partners, hospital or office staff, patients, or competitors.
There also is a criminal FCA (
18
U.S.C. § 287). Criminal penalties for submitting false
claims include imprisonment and criminal fines. Physicians have gone to prison for
submitting false health care claims. OIG also may impose administrative civil monetary
penalties for false or fraudulent claims, as discussed below.
3
Anti-Kickback Statute [42 U.S.C. § 1320a-7b(b)]
The AKS is a criminal law that prohibits the knowing and willful payment of
“remuneration” to induce or reward patient referrals or the generation of business
involving any item or service payable by the Federal health care programs (e.g., drugs,
supplies, or health care services for Medicare or Medicaid patients). Remuneration
includes anything of value and can take many forms besides cash, such as free
rent, expensive hotel stays and meals, and excessive compensation for medical
directorships or consultancies. In some industries, it is acceptable to
reward those who refer business to you. However, in the
Federal health care programs, paying for
referrals is a crime. The statute covers the payers
of kickbacks—those who offer or pay remuneration—
as well as the recipients of kickbacks—those who
solicit or receive remuneration. Each party’s intent is a
key element of their liability under the AKS.
Criminal penalties and administrative sanctions for
violating the AKS include fines, jail terms, and exclusion
from participation in the Federal health care programs. Under the CMPL,
physicians who pay or accept kickbacks also face penalties of up to $50,000
per kickback plus three times the amount of the remuneration.
Safe harbors protect certain payment and business practices that could otherwise
implicate the AKS from criminal and civil prosecution. To be protected by a safe harbor,
an arrangement must fit squarely in the safe harbor and satisfy all of its requirements.
Some safe harbors address personal services and rental agreements, investments in
ambulatory surgical centers, and payments to bona fide employees.
For additional information on safe harbors, see “OIG’s Safe Harbor Regulations”
available at http://oig.hhs.gov/fraud/safeharborregulations.asp.
As a physician, you are an attractive target for kickback schemes because
you can be a source of referrals for fellow physicians or other health care providers
and suppliers. You decide what drugs your patients use, which specialists they see, and
what health care services and supplies they receive.
4
http://oig.hhs.gov/fraud/safeharborregulations.asp
Many people and companies want your patients’ business and would pay you to send
that business their way. Just as it is illegal for you to take money from providers and
suppliers in return for the referral of your Medicare and Medicaid patients, it is illegal
for you to pay others to refer their Medicare and Medicaid patients to you.
The kickback prohibition applies to all sources
of referrals, even patients. For example, where the
Medicare and Medicaid programs require patients to
pay copays for services, you are generally required to collect that money from your
patients. Routinely waiving these copays could implicate the AKS and you may not
advertise that you will forgive copayments. However, you are free to waive a copayment
if you make an individual determination that the patient cannot afford to pay or if your
reasonable collection efforts fail. It is also legal to provide free or discounted
services to uninsured people.
Besides the AKS, the beneficiary inducement statute (42 U.S.C. § 1320a-7a(a)(5)) also
imposes civil monetary penalties on physicians who offer remuneration to Medicare
and Medicaid beneficiaries to influence them to use their services.
The Government does not need to prove patient harm or financial loss to the programs
to show that a physician violated the AKS. A physician can be guilty of violating
the AKS even if the physician actually rendered the service and the service was
medically necessary. Taking money or gifts from a drug or device company
or a durable medical equipment (DME) supplier is not justified by the
argument that you would have prescribed that drug or ordered that
wheelchair even without a kickback.
Kickbacks in health care can lead to:
B Overutilization
B Increased program costs
B Corruption of medical decisionmaking
B Patient steering
B Unfair competition
5
Physician Self-Referral Law [42 U.S.C. § 1395nn]
The Physician Self-Referral Law, commonly referred to as the Stark law, prohibits
physicians from referring patients to receive “designated health services” payable by
Medicare or Medicaid from entities with which the physician or an immediate family
member has a financial relationship, unless an exception applies. Financial relationships
include both ownership/investment interests and compensation arrangements. For
example, if you invest in an imaging center, the Stark law requires the resulting
financial relationship to fit within an exception or you may not refer patients to the
facility and the entity may not bill for the referred imaging services.
“Designated health services” are:
• clinical laboratory services;
• physical therapy, occupational therapy, and outpatient speech-language
pathology services;
• radiology and certain other imaging services;
• radiation therapy services and supplies;
• DME and supplies;
• parenteral and enteral nutrients,
equipment, and supplies;
• prosthetics, orthotics, and prosthetic
devices and supplies;
• home health services;
• outpatient prescription drugs; and
• inpatient and outpatient hospital services.
The Stark law is a strict liability statute, which means proof of specific intent to
violate the law is not required. The Stark law prohibits the submission, or causing
the submission, of claims in violation of the law’s restrictions on referrals. Penalties
for physicians who violate the Stark law include fines as well as exclusion from
participation in the Federal health care programs.
For more information, see CMS’s Stark law Web site available at
http://www.cms.gov/physicianselfreferral/.
6
http://www.cms.hhs.gov/physicianselfreferral/
Physician Self-Referral Law [42 U.S.C. § 1395nn]
The Physician Self-Referral Law, commonly referred to as the Stark law, prohibits
physicians from referring patients to receive “designated health services” payable by
Medicare or Medicaid from entities with which the physician or an immediate family
member has a financial relationship, unless an exception applies. Financial relationships
include both ownership/investment interests and compensation arrangements. For
example, if you invest in an imaging center, the Stark law requires the resulting
financial relationship to fit within an exception or you may not refer patients to the
facility and the entity may not bill for the referred imaging services.
“Designated health services” are:
• clinical laboratory services;
• physical therapy, occupational therapy, and outpatient speech-language
pathology services;
• radiology and certain other imaging services;
• radiation therapy services and supplies;
• DME and supplies;
• parenteral and enteral nutrients,
equipment, and supplies;
• prosthetics, orthotics, and prosthetic
devices and supplies;
• home health services;
• outpatient prescription drugs; and
• inpatient and outpatient hospital services.
The Stark law is a strict liability statute, which means proof of specific intent to
violate the law is not required. The Stark law prohibits the submission, or causing
the submission, of claims in violation of the law’s restrictions on referrals. Penalties
for physicians who violate the Stark law include fines as well as exclusion from
participation in the Federal health care programs.
Exclusion Statute [42 U.S.C. § 1320a-7]
OIG is legally required to exclude from participation in all Federal health care
programs individuals and entities convicted of the following types of criminal offenses:
(1) Medicare or Medicaid fraud, as well as any other offenses related to the delivery of
items or services under Medicare or Medicaid; (2) patient abuse or neglect; (3) felony
convictions for other health-care-related fraud, theft, or other financial misconduct;
and (4) felony convictions for unlawful manufacture, distribution, prescription, or
dispensing of controlled substances. OIG has discretion to exclude individuals and
entities on several other grounds, including misdemeanor convictions related to
health care fraud other than Medicare or Medicaid fraud or misdemeanor
convictions in connection with the unlawful manufacture, distribution,
prescription, or dispensing of controlled substances; suspension,
revocation, or surrender of a license to provide health care for reasons
bearing on professional competence, professional performance,
or financial integrity; provision of unnecessary or substandard
services; submission of false or fraudulent claims to a Federal health
care program; engaging in unlawful kickback arrangements; and
defaulting on health education loan or scholarship obligations.
If you are excluded by OIG from participation in the Federal health
care programs, then Medicare, Medicaid, and other Federal health care
programs, such as TRICARE and the Veterans Health Administration,
will not pay for items or services that you furnish, order, or prescribe.
Excluded physicians may not bill directly for treating
Medicare and Medicaid patients, nor may their services be
billed indirectly through an employer or a group practice. In
addition, if you furnish services to a patient on a private-pay basis, no
order or prescription that you give to that patient will be reimbursable by
any Federal health care program.
For more information, see OIG’s Special Advisory Bulletin entitled “The Effect of
Exclusion From Participation in Federal Health Care Programs” available at
http://oig.hhs.gov/fraud/docs/alertsandbulletins/effected.htm.
7
http://oig.hhs.gov/fraud/docs/alertsandbulletins/effected.htm
You are responsible for ensuring that you do not employ or contract with excluded
individuals or entities, whether in a physician practice, a clinic, or in any capacity
or setting in which Federal health care programs may reimburse for the items or
services furnished by those employees or contractors. This responsibility requires
screening all current and prospective employees and contractors against OIG’s List of
Excluded Individuals and Entities. This online database can be accessed from OIG’s
Exclusion Web site. If you employ or contract with an excluded individual or entity
and Federal health care program payment is made for items or services that person or
entity furnishes, whether directly or indirectly, you may be subject to a civil monetary
penalty and/or an obligation to repay any amounts attributable to the services of the
excluded individual or entity.
For more information, see OIG’s exclusion Web site available at
http://oig.hhs.gov/fraud/exclusions.asp.
Civil Monetary Penalties Law [42 U.S.C. § 1320a-7a]
OIG may seek civil monetary penalties and sometimes exclusion for a wide variety of
conduct and is authorized to seek different amounts of penalties and assessments based
on the type of violation at issue. Penalties range from $
10
,000 to $50,000 per violation.
Some examples of CMPL violations include:
B presenting a claim that the person knows or should know is for an item or service
that was not provided as claimed or is false or fraudulent;
B presenting a claim that the person knows or should know is for an item or service
for which payment may not be made;
B violating the AKS;
B violating Medicare assignment provisions;
B violating the Medicare physician agreement;
B providing false or misleading information expected to influence a decision to
discharge;
B failing to provide an adequate medical screening examination for patients
who present to a hospital emergency department with an emergency medical
condition or in labor; and
B making false statements or misrepresentations on applications or contracts to
participate in the Federal health care programs.
8
http://oig.hhs.gov/fraud/exclusions.asp
I. Physician Relationships With Payers
During residency, you probably are not focused on who pays for your patients’ care.
Once you start practicing, it is important to understand who the payers are. The U.S.
health care system relies heavily on third-party payers, and, therefore, your patients
often are not the ones who pay most of their medical bills. Third-party payers include
commercial insurers and the Federal and State governments. When the Federal
Government covers items or services rendered to Medicare and Medicaid
beneficiaries, the Federal fraud and abuse laws apply. Many States also
have adopted similar laws that apply to your provision of care under State-financed
programs and to private-pay patients. Consequently, you should recognize that the
issues discussed here may apply to your care of all insured patients.
Accurate Coding and Billing
Payers trust you, as a physician, to provide necessary, cost-effective, and quality care.
You exert significant influence over what services your patients receive, you control the
documentation describing what services they actually received, and your documentation
serves as the basis for bills sent to insurers for
services you provided. The Government’s
payment of claims is generally based solely
on your representations in the claims
documents.
Because the Government invests so
much trust in physicians on the front end,
Congress provided powerful criminal, civil,
and administrative enforcement tools for
instances when unscrupulous providers abuse that trust. The Government has broad
capabilities to audit claims and investigate providers when it has a reason to suspect
fraud. Suspicion of fraud and abuse may be raised by irregular billing patterns or
reports from others, including your staff, competitors, and patients.
9
When you submit a claim for services performed for a Medicare or
Medicaid beneficiary, you are filing a bill with the Federal Government
and certifying that you have earned the payment requested and complied
with the billing requirements. If you knew or should have known that the submitted
claim was false, then the attempt to collect unearned money constitutes a violation. A
common type of false claim is “upcoding,” which refers to using billing codes that
reflect a more severe illness than actually existed or a more expensive treatment than
was provided. Additional examples of improper claims include:
B billing for services that you did not actually render;
B billing for services that were not medically necessary;
B billing for services that were performed by an improperly supervised or
unqualified employee;
B billing for services that were performed by an employee who has been excluded
from participation in the Federal health care programs;
B billing for services of such low quality that they are virtually worthless; and
B billing separately for services already included in a global fee, like billing for an
evaluation and management service the day after surgery.
Upcoding
Medicare pays for many physician services using Evaluation and Management
(commonly referred to as “E&M”) codes. New patient visits generally require more
time than follow-up visits for established patients, and therefore E&M codes for
new patients command higher reimbursement rates than E&M codes for established
patients. An example of upcoding is an instance when you provide a follow-up office
visit or follow-up inpatient consultation but bill using a higher level E&M code as
if you had provided a comprehensive new patient office visit or an initial inpatient
consultation.
Another example of upcoding related to E&M codes is misuse of Modifier 25.
Modifier 25 allows additional payment for a separate E&M service rendered on the
same day as a procedure. Upcoding occurs if a provider uses Modifier 25 to claim
payment for an E&M service when the patient care rendered was not significant,
was not separately identifiable, and was not above and beyond the care usually
associated with the procedure.
CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION
CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION
10
Case Examples of Fraudulent Billing
• A psychiatrist was fined $400,000 and
permanently excluded from participating in the
Federal health care programs for misrepresenting
that he provided therapy sessions requiring
30 or 60 minutes of face-to-face time with the
patient, when he had provided only medication checks for
15
minutes or less. The psychiatrist also misrepresented that he provided
therapy sessions when in fact a non-licensed individual conducted the sessions.
• A dermatologist was sentenced to 2 years of probation and 6 months of home
confinement and ordered to pay $2.9 million after he pled guilty to one count of
obstruction of a criminal health care fraud investigation. The dermatologist admitted
to falsifying lab tests and backdating letters to referring physicians to substantiate
false diagnoses to make the documentation appear that his patients had Medicare-
covered conditions when they did not.
• A cardiologist paid the Government $435,000 and entered into a 5-year Integrity
Agreement with OIG to settle allegations that he knowingly submitted claims for
consultation services that were not supported by patient medical records and did
not meet the criteria for a consultation. The physician also allegedly knowingly
submitted false claims for E&M services when he had already received payment for
such services in connection with previous claims for nuclear stress testing.
• An endocrinologist billed routine blood draws as critical care blood draws. He
paid $447,000 to settle allegations of upcoding and other billing violations.
11
Physician Documentation
Physicians should maintain accurate and complete medical records and documentation
of the services they provide. Physicians also should ensure that the claims they submit
for payment are supported by the documentation. The Medicare
and Medicaid programs may review beneficiaries’ medical
records. Good documentation practice helps ensure that
your patients receive appropriate care from you and
other providers who may rely on your records for
patients’ past medical histories. It also helps you address
challenges raised against the integrity of your bills. You may have
heard the saying regarding malpractice litigation: “If you didn’t
document it, it’s the same as if you didn’t do it.” The same can be
said for Medicare and Medicaid billing.
For more information on physician documentation, see CMS’s Documentation
Guidelines for Evaluation and Management Services available at
http://www.cms.gov/MLNEdWebGuide/25_EMDOC.asp.
Enrolling as a Medicare and Medicaid Provider
With CMS
CMS is the Federal agency that administers the Medicare program and monitors the
Medicaid programs run by each State. To obtain reimbursement from the Government
for services provided to Federal health care program beneficiaries, you must:
1. Obtain a National Provider Identifier (NPI). An NPI is a unique health
identifier for health care providers. You may apply for your NPI at
https://nppes.cms.hhs.gov/NPPES/Welcome.do.
2. Complete the appropriate Medicare Enrollment Application. During the
enrollment process, CMS collects information to ensure that you are qualified
and eligible to enroll in the Medicare Program. Information about Medicare
provider enrollment is available at
http://www.cms.gov/MedicareProviderSupEnroll/.
3. Complete your State-specific Medicaid Enrollment Application.
Information about Medicaid provider enrollment is available from your State
Medicaid agency.
Once you become a Medicare and/or Medicaid provider, you are responsible for
ensuring that claims submitted under your number are true and correct.
12
http://www.cms.gov/MLNEdWebGuide/25_EMDOC.asp
https://nppes.cms.hhs.gov/NPPES/Welcome.do
http://www.cms.gov/MedicareProviderSupEnroll/
For tips you can share with your patients on how they can protect themselves from
medical identity theft, see OIG’s brochure entitled “Tips to Avoid Medical ID
Theft” available at
http://oig.hhs.gov/fraud/IDTheft/OIG_Medical_Identity_Theft_Brochure .
Prescription Authority
The Drug Enforcement Administration (DEA) is a Department
of Justice agency responsible for enforcing the Controlled
Substances Act. When you prepare to enter practice, you
probably will apply for a DEA number that authorizes you
to write prescriptions for controlled substances. You also
will apply for your State medical license and any additional credentials your State
requires for you to write prescriptions. You must ensure that you write prescriptions
only for lawful purposes.
Case Examples of Misuse of Physician Provider and
Prescription Numbers
• A physician was ordered to pay $50,000 in restitution to the Government for
falsely indicating on his provider number application that he was running his own
practice when, in fact, a neurophysiologist was
operating the practice and paying the physician a
salary for the use of his number.
• An osteopathic physician was sentenced to 10
years in prison and ordered to pay $7.9 million in
restitution after she accepted cash payments for signing preprinted
prescriptions and Certificates of Medical Necessity for motorized wheelchairs for
beneficiaries she never examined. More than 60 DME companies received Medicare
and Medicaid payments based on her fraudulent prescriptions.
• An internal medicine physician pled guilty to Medicare fraud and to conspiring
to dispense oxycodone, morphine, hydrocodone, and alprazolam. The physician
allowed unauthorized and non-medical employees at his pain center to prescribe
drugs using his pre-signed blank prescription forms. Prescriptions were issued in
his name without adequate physical exams, proper diagnoses, or consideration of
alternative treatment options. He paid $3
17
,000 in restitution to the Government.
13
http://oig.hhs.gov/fraud/IDTheft/OIG_Medical_Identity_Theft_Brochure
Assignment Issues in Medicare Reimbursement
Most physicians bill Medicare as participating providers, which is referred to as
“accepting assignment.” Each year, Medicare promulgates a fee schedule setting the
reimbursement for each physician service. Once beneficiaries satisfy their annual
deductible, Medicare pays 80 percent of the fee schedule amount and the beneficiary
pays 20 percent. Participating providers receive the Medicare program’s
80 percent directly from the Medicare program and bill the beneficiary
for the remaining 20 percent. Accepting assignment means that the
physician accepts the Medicare payment plus any copayment or
deductible Medicare requires the patient to pay as the full payment
for the physician’s services and that the physician will not seek any
extra payment (beyond the copayment or deductible) from the
patient. Medicare participating physicians may not bill Medicare
patients extra for services that are already covered by Medicare.
Doing so is a violation of a physician’s assignment agreement and
can lead to penalties.
The second, less common, way to obtain Medicare reimbursement is to bill as a non-
participating provider. Non-participating providers do not receive direct payment
from the Medicare program. Rather, they bill their patients and the patients seek
reimbursement from Medicare. Although non-participating providers are not subject to
the assignment rules, they still must limit the dollar amount of their charges to Medicare
patients. Generally, non-participating providers may not charge Medicare beneficiaries
more than 15 percent in excess of the Medicare fee schedule amount. It is illegal to
charge patients more than the limiting charge established for physicians’ services.
You may see advertisements offering to help you convert your practice into a “boutique,”
“concierge,” or “retainer” practice. Many such solicitations promise to help you work
less, yet earn more money. If you are a participating or non-participating
physician, you may not ask Medicare patients to pay a second time for
services for which Medicare has already paid. It is legal to charge patients
for services that are not covered by Medicare. However, charging an “access fee” or
“administrative fee” that simply allows them to obtain Medicare-covered services
from your practice constitutes double billing.
Excluded providers may not receive
Medicare payment either as participating
or non-participating providers.
DO NOT
ENTER
14
Case Example of a Physician Violating an Assignment
Agreement by Charging Beneficiaries Extra Fees
• A physician paid $107,000 to resolve potential
liability for charging patients, including Medicare
beneficiaries, an annual fee. In exchange for
the fee, the physician offered: (1) an annual
physical; (2) same- or next-day appointments;
(3) dedicated support personnel; (4) around-the-clock
physician availability; (5) prescription facilitation; (6) expedited and
coordinated referrals; and (7) other amenities at the physician’s discretion. The
physician’s activities allegedly violated the assignment agreement because some of
the services outlined in the annual fee were already covered by Medicare.
15
II. Physician Relationships With Fellow
Providers: Physicians, Hospitals,
Nursing Homes, Etc.
Any time a health care business offers something to you for free or at below fair market
value, you always should ask yourself, “Why?” For example, if a DME supplier offers to
give you cash or to pay for your summer vacation, you should suspect that the supplier
is trying to induce you to refer your patients to that vendor. If a laboratory offers to
decorate your patient waiting room, you should suspect that it is trying to induce you
to send your lab business its way.
For more information on physician relationships with:
fellow providers, see OIG’s “Compliance Program Guidance for Individual and
Small Group Physician Practices” available at
http://oig.hhs.gov/authorities/docs/physician ;
hospitals, see OIG’s “Supplemental Compliance Program Guidance for Hospitals”
available at http://oig.hhs.gov/fraud/docs/complianceguidance/01
27
05HospSupplem
entalGuidance ; and
nursing homes, see OIG’s “Supplemental Compliance Program Guidance for
Nursing Facilities” available at
http://oig.hhs.gov/fraud/docs/complianceguidance/nhg_fr .
Physician Investments in Health Care
Business Ventures
Some have observed that physicians who invest in health care business ventures with
outside parties (e.g., imaging centers, labs, equipment vendors, or physical therapy
clinics) refer more patients for the services provided by those parties than physicians
who do not invest. Maybe this disproportionate utilization partly reflects the physicians’
belief in the value of the services or technology, prompting the investments in the
first place. However, there also is a risk that the physicians’ belief in the value of
the services or technology is less a cause than an effect of the investment interest.
The physician investors’ disproportionate utilization may be motivated partly by the
physicians’ ability to profit from the use of the ancillary services. These business
relationships can sometimes unduly influence or distort physician decisionmaking
and result in the improper steering of a patient to a particular therapy or source of
services in which a physician has a financial interest. Excessive and medically
unnecessary referrals waste Government and beneficiary money and
16
http://oig.hhs.gov/authorities/docs/physician
http://oig.hhs.gov/fraud/docs/complianceguidance/012705HospSupplementalGuidance
http://oig.hhs.gov/fraud/docs/complianceguidance/012705HospSupplementalGuidance
http://oig.hhs.gov/fraud/docs/complianceguidance/nhg_fr
can expose beneficiaries to harm from unnecessary services. Many of these
investment relationships have serious legal risks under the AKS and Stark law.
If you are invited to invest in a health care business whose products you might order or
to which you might refer your patients, you should ask the following questions. If the
answer is “yes” to any of them, you should consider carefully whether you are investing
for legitimate reasons.
V Are you being offered an investment interest for a nominal capital contribution?
V Will your ownership share be larger than your share of the aggregate capital
contributions made to the venture?
V Is the venture promising you high rates of return for little or no financial risk?
V Is the venture or any potential business partner offering to loan you the money to
make your capital contribution?
V Are you being asked to promise or guarantee that you will refer patients or order
items or services from the venture?
V Do you believe you will be more likely to refer more patients for the items and
services provided by the venture if you make the investment?
V Do you believe you will be more likely to refer to the venture just because you
made the investment?
V Will the venture have sufficient capital from other sources to fund its ongoing
operations?
17
For more information on physician investments, see:
OIG’s Special Fraud Alert entitled “Joint Venture Arrangements” available at
http://oig.hhs.gov/fraud/docs/alertsandbulletins/121994.html;
OIG’s Special Advisory Bulletin on contractual joint ventures available at
http://oig.hhs.gov/fraud/docs/alertsandbulletins/04
23
03SABJointVentures ; and
OIG’s “Supplemental Compliance Program Guidance for Hospitals”
available at http://oig.hhs.gov/fraud/docs/complianceguidance/012705HospSupplem
entalGuidance .
Case Examples Involving Kickbacks for Referrals
and Self-Referrals
• Nine cardiologists paid the Government over
$3.2 million for allegedly engaging in a kickback
scheme. The cardiologists received salaries
under clinical faculty services agreements
with a hospital under which, the Government
alleged, they did not provide some or any of the services.
In exchange, the cardiologists referred their patients to the hospital for
cardiology services. Two of the physicians also pled guilty to criminal embezzlement
charges involving the same conduct.
• A physician paid the Government $203,000 to settle allegations that he violated the
physician self-referral prohibition in the Stark law for routinely referring Medicare
patients to an oxygen supply company he owned.
18
http://www.oig.hhs.gov/fraud/docs/alertsandbulletins/ 121994.html
http://www.oig.hhs.gov/fraud/docs/alertsandbulletins/042303SABJointVentures
http://oig.hhs.gov/fraud/docs/complianceguidance/012705HospSupplementalGuidance
http://oig.hhs.gov/fraud/docs/complianceguidance/012705HospSupplementalGuidance
Physician Recruitment
A hospital will sometimes provide a physician with a recruitment incentive to induce
the physician to relocate to the hospital’s geographic area, become a member of its
medical staff, and establish a practice that helps serve that community’s medical needs.
Often, such recruitment efforts are legitimately designed to fill a “clinical gap” in a
medically underserved area to which it may be difficult to attract physicians in the
absence of financial incentives. However, as you begin planning your professional
future and perhaps receiving recruitment offers, you need to be aware that in some
communities, especially ones with multiple hospitals, the competition for patients can
be fierce. Some hospitals may offer illegal inducements to you, or to the established
physician practice you join in the hospital’s community, to gain referrals. This means
that the competition for your loyalty can cross the line into illegal arrangements for
which both you and the hospital can be liable.
Recruitment arrangements are of special interest to graduating residents and fellows.
Within very specific parameters specified in the Stark law and subject to compliance
with the AKS, hospitals may provide relocation assistance and practice support under
a properly structured recruitment arrangement to assist you in
establishing a practice in the hospital’s community. Alternatively, a
hospital may pay you a fair market value salary as an employee or pay
you fair market value for specific services you render to the hospital
as an independent contractor. However, the hospital may not
offer you money, provide you free or below-market rent for
your medical office, or engage in similar activities designed
to influence your referral decisions. You should admit
your patients to the hospital best suited to care for
their particular medical conditions or to the
hospital your patient selects based on his or her
preference or insurance coverage. As noted, if a hospital
or physician practice seperately or jointly is recruiting you as a
new physician to the community, you may be offered a
recruitment package. But, you may not negotiate for benefits in
exchange for a promise—implicit or explicit—that you will
admit your patients to a specific hospital or practice setting
unless you are a hospital employee. You should seek
knowledgeable legal counsel if someone with whom you are
entering into a relationship requires you to admit patients to a
specific hospital or practice group.
19
Case Examples of Medical Directorship Issues
• A physician group practice paid the Government
$1 million and entered into a 5-year Corporate
Integrity Agreement to settle alleged violations of
the AKS, FCA, and Stark law related to medical
directorships with a medical center. Allegedly,
the agreements were not in writing, the physicians were
paid more than fair market value for the services they rendered, and the
payment amounts were based on the value of referrals the physicians sent to the
medical center.
• Two orthopedic surgeons paid $450,000 and $250,000 to settle allegations related
to improper medical directorships with a company that operated a diagnostic imaging
center, a rehabilitation facility, and an ambulatory surgery center. The company
allegedly provided the physicians with valuable compensation, including free use
of the corporate jet, under the medical directorship agreements, which required the
physicians to render limited services in return. The agreements with the physicians
allegedly called for redundant services and served to encourage the physicians to
refer their patients to the facilities operated by the company.
Tips for Medical Directors
If you choose to accept a medical directorship at a nursing home or other facility,
you must be prepared to assume substantial professional responsibility for the care
delivered at the facility. As medical director, patients (both your own patients and the
patients of other attending physicians) and their families count on you, and State and
Federal authorities may hold you accountable as well. To do this job well, you should:
• actively oversee clinical care in the facility;
• lead the medical staff to meet the standard of care;
• ensure proper training, education, and oversight for physicians, nurses, and other
staff members; and
• identify and address quality problems.
Free Samples
Some physicians welcome visits from pharmaceutical salespeople, while other
physicians prefer not to directly engage with industry representatives. If you decide to
make your practice accessible to salespeople, you probably
will be offered product samples. Many drug and biologic
companies provide physicians with free samples that
the physicians may give to patients free of charge. It
is legal to give these samples to your patients
for free, but it is illegal to sell the samples.
The Government has prosecuted physicians
for billing Medicare for free samples. Opinions
differ on whether sampling practices ultimately
increase or decrease patients’ long-term drug costs. If
you choose to accept samples, you will need reliable systems in place to safely store the
samples and ensure that samples are not commingled with your commercial stock.
20
III. Physician Relationships With Vendors
Free Samples
Some physicians welcome visits from pharmaceutical salespeople, while other
physicians prefer not to directly engage with industry representatives. If you decide to
make your practice accessible to salespeople, you probably
will be offered product samples. Many drug and biologic
companies provide physicians with free samples that
the physicians may give to patients free of charge. It
is legal to give these samples to your patients
for free, but it is illegal to sell the samples.
The Government has prosecuted physicians
for billing Medicare for free samples. Opinions
differ on whether sampling practices ultimately
increase or decrease patients’ long-term drug costs. If
you choose to accept samples, you will need reliable systems in place to safely store the
samples and ensure that samples are not commingled with your commercial stock.
Case Example Involving Drug Samples
• Several urologists pled guilty to charges of conspiracy, paid restitution in the tens
of thousands of dollars, and received sanctions against their medical licenses for
billing Medicare for injectable prostate cancer
drugs they received for free from two
pharmaceutical companies. The pharmaceutical
companies paid $1.4 billion for their part of the
alleged scheme to give urologists free samples
and encourage them to bill Medicare at an inflated
price. The pharmaceutical companies also provided urologists with
additional inducements to use their drugs over the competitor’s products, including
drug rebates, education grants, volume discounts, free goods, and debt forgiveness.
21
Relationships With the Pharmaceutical and Medical
Device Industries
Physician-industry collaboration can produce important medical advances. However,
some pharmaceutical and device companies have used sham consulting agreements
and other arrangements to buy physician loyalty to their products. Such illegal
arrangements induce physicians to prescribe or use products on the basis of that loyalty
to the company or to get more money from the company, rather than because it is the
best treatment for the patient.
As a practicing physician, you may have opportunities to work as a consultant or
promotional speaker for the drug or device industry. For every financial relationship
offered to you, evaluate the link between the services you can provide and the
compensation you will receive. Test the propriety of any proposed relationship by
asking yourself the following questions:
V Does the company really need my particular expertise or input?
V Does the amount of money the company is offering seem fair, appropriate, and
commercially reasonable for what it is asking me to do?
V Is it possible the company is paying me for my loyalty so that I will prescribe its
drugs or use its devices?
A good discussion that assists in distinguishing between legitimate and
questionable industry relationships is located in the OIG’s “Compliance Program
Guidance for Pharmaceutical Manufacturers” available at
http://oig.hhs.gov/authorities/docs/03/050503FRCPGPharmac .
22
http://www.oig.hhs.gov/authorities/docs/03/050503FRCPGPharmac
If your contribution is your time and effort or your ability to generate useful ideas and
the payment you receive is fair market value compensation for your services without
regard to referrals, then, depending on the circumstances, you may legitimately serve
as a bona fide consultant. If your contribution is your ability to prescribe a
drug or use a medical device or refer your patients for particular services
or supplies, the proposed consulting arrangement likely is one you should
avoid as it could violate fraud and abuse laws.
For example, if a drug company offers to pay you and a hundred other
“thought leaders” to attend a conference in the Bahamas without
requiring preparatory work on your part or information about
your expertise in the field (other than the fact that you are a
licensed physician), you should be suspicious that the company
is attempting to influence you to prescribe its drug.
Case Example of Kickbacks in the Device Industry
• Four orthopedic device manufacturers paid $311 million to settle kickback and
false claims allegations that the companies bribed surgeons to recommend their hip
and knee surgical implant products. The companies
allegedly would award physicians with vacations,
gifts, and annual “consulting fees” as high as
$200,000 in return for the physicians’
endorsements of their implants or use of them in
operations. Many of the individual orthopedic
surgeons at the receiving end of the kickbacks are the subject of
ongoing investigations by the Government. One orthopedic surgeon recently paid
$650,000 to resolve allegations that the surgeon accepted payments from device
manufacturers to use their hip and knee implants.
23
Transparency in Physician-Industry Relationships
Although some physicians believe that free lunches, subsidized trips, and gifts do
not affect their medical judgment, research shows that these types of perquisites can
influence prescribing practices. Recent pharmaceutical company settlements with
the Department of Justice and OIG require “transparency” in physician-industry
relationships, whether by requiring the pharmaceutical company to provide the
Government with a list of physicians whom the company paid and/or by requiring
ongoing public disclosure by the company of physician payments. The public will
soon know what gifts and payments a physician receives from industry.
The Patient Protection and Affordable Care Act of 2010 requires drug, device, and
biologic companies to publicly report nearly all gifts or payments they make to
physicians beginning in 2013.
Academic institutions also may impose various restrictions on the interactions
their faculty members or affiliated physicians have with industry. These and other
considerations may factor into your decision about whether you want to conduct
industry-sponsored research; serve as a consultant or director for a drug, biologic,
or device company; apply for industry-sponsored educational or research grants; or
engage in other relationships with industry.
Both the pharmaceutical industry (through PhRMA) and the medical device
industry (through AdvaMed) have adopted codes of ethics for their respective
industries regarding relationships with health care professionals. Both codes are
available online.
Conflict-of-Interest Disclosures
Many of the relationships discussed in this brochure are subject to conflict-of-interest
disclosure policies. Even if the relationships are legal, you may have an obligation
to disclose their existence. Rules about disclosing and managing conflicts of interest
come from a variety of sources, including grant funders, such as States, universities,
and the National Institutes of Health, and from the Food and Drug Administration
(FDA) when data are submitted to support marketing approval for new drugs, devices,
or biologics. To “manage” your conflicts of interest, consider the conflicts policies that
affect your professional activities, candidly disclose any industry money subject to
these policies, and adhere to restrictions on your activities. If you are uncertain whether
a conflict exists, ask someone. You always can apply the “newspaper test” and ask
yourself whether you would want the arrangement to appear on the front page of your
local newspaper.
24
Continuing Medical Education
After finishing your formal graduate medical training,
you will assume greater responsibility for your continuing
medical education (CME) to maintain State licensure,
hospital privileges, and board certification. Drug and device manufacturers sponsor
many educational opportunities for physicians. It is important to distinguish
between CME sessions that are educational in nature and sessions that
constitute marketing by a drug or device manufacturer. Industry satellite
programs that occur concurrently with a society meeting are generally promotional,
even if the primary speaker is a physician who is well known in the field. You should
be circumspect about a discussion that focuses on a particular brand drug or device, as
opposed to all the treatment alternatives for a specific condition.
For example, if speakers recommend use of a drug to treat conditions for which
there is no FDA approval or use of a drug by children when FDA has approved
only adult use, you should independently seek out the empirical data that support
these recommendations. Note that although physicians may prescribe
drugs for off-label uses, it is illegal under the Federal Food, Drug,
and Cosmetic Act for drug manufacturers to promote off-label uses
of drugs.
Advertisements and other promotional materials for drugs, biologics, and medical
devices must be truthful, not misleading, and limited to approved uses. FDA is
requesting physicians’ assistance in identifying misleading advertisements through
its Bad Ad Program. If you spot advertising violations, you should report them to
FDA by calling 877-RX-DDMAC (877-793-3622) or by emailing badad@fda.gov.
If you are invited to serve as faculty for industry-sponsored CME, ask yourself the
following questions:
V Does the sponsor really need my particular expertise or input?
V Does the amount of money the sponsor is offering seem fair and appropriate for
the educational value I will add to the presentation?
V Is it possible the sponsor is paying me for my loyalty so that I will prescribe its
drugs or use its devices?
V Does the sponsor prepare a slide deck and speaker notes, or am I free to set the
content of the lecture?
25
Compliance Programs for Physicians
Establishing and following a compliance program will help physicians avoid fraudulent
activities and ensure that they are submitting true and accurate claims. The following
seven components provide a solid basis upon which a physician practice can create a
voluntary compliance program:
1. Conduct internal monitoring and auditing.
2. Implement compliance and practice standards.
3. Designate a compliance officer or contact.
4. Conduct appropriate training and education.
5. Respond appropriately to detected offenses and develop corrective action.
6. Develop open lines of communication with employees.
7. Enforce disciplinary standards through well-publicized guidelines.
With the passage of the Patient Protection and Affordable Care Act of 2010, physicians
who treat Medicare and Medicaid beneficiaries will be required to establish a
compliance program.
For more information on compliance programs for physicians, see OIG’s
“Compliance Program Guidance for Individual and Small Group Physician
Practices” available at http://oig.hhs.gov/authorities/docs/physician .
Where To Go for Help
When you are considering whether or not to engage in a particular billing practice;
enter into a particular business venture; or pursue an employment, consulting, or other
personal services relationship, it is prudent to evaluate the arrangement for potential
compliance problems. The following is a list of possible resources that can help you.
Ј Experienced health care lawyers can analyze your issues and provide a
legal evaluation and risk analysis of the proposed venture, relationship, or
arrangement.
26
http://www.oig.hhs.gov/authorities/docs/physician
Ј The Bar Association in your State may have a directory of attorneys in your area
who practice in the health care field.
Ј Your State or local medical society may be a good resource for issues affecting
physicians and may have listings of health care lawyers in your area.
Ј Your specialty society may have information on additional risk areas specific to
your type of practice.
Ј CMS’s local contractor medical directors are a valuable source of information
on Medicare coverage policies and appropriate billing practices. The contact
information for local contractors is available at
http://www.cms.gov/MLNGenInfo/30_contactus.asp.
Ј CMS’s “Medicare Physician Guide: A Resource for Residents, Practicing
Physicians, and Other Health Care Professionals” available at
http://www.cms.gov/MLNProducts/downloads/physicianguide , provides an
overview of the Medicare program and information on Medicare reimbursement
and payment policies.
Ј The OIG’s Web site, available at http://oig.hhs.gov, provides substantial
fraud and abuse guidance.
Ј As discussed above, OIG issues Compliance Program Guidance documents that
include compliance recommendations and discussions of fraud and abuse risk
areas. These guidance documents are available at
http://oig.hhs.gov/fraud/complianceguidance.asp.
Ј OIG issues advisory opinions to parties who seek advice on the application of the
AKS, CMPL, and Exclusion Authorities. Information on how to request an OIG
advisory opinion and links to previously published OIG advisory opinions are
available at http://oig.hhs.gov/fraud/advisoryopinions.asp.
Ј CMS issues advisory opinions to parties who seek advice on the Stark law.
Information on how to request a CMS advisory opinion and links to previously
published CMS advisory opinions are available at
http://www.cms.gov/PhysicianSelfReferral/95_advisory_opinions.asp.
27
http://www.cms.gov/MLNGenInfo/30_contactus.asp
https://www.cms.gov/MLNProducts/downloads/physicianguide
http://oig.hhs.gov/fraud/complianceguidance.asp
http://oig.hhs.gov/fraud/complianceguidance.asp
http://oig.hhs.gov/fraud/advisoryopinions.asp
http://www3.cms.gov/PhysicianSelfReferral/95_advisory_opinions.asp
What To Do If You Think You Have a Problem
If you are engaged in a relationship you think is problematic or have been following
billing practices you now realize were wrong:
Ј Immediately cease filing the problematic bills.
Ј Seek knowledgeable legal counsel.
Ј Determine what money you collected in error from your patients and from the
Federal health care programs and report and return overpayments.
Ј Unwind the problematic investment.
Ј Disentangle yourself from the suspicious relationship.
Ј Consider using OIG’s or CMS’s self-disclosure protocols.
OIG Provider Self-Disclosure Protocol
The OIG Provider Self-Disclosure Protocol is a vehicle for physicians to voluntarily
disclose self-discovered evidence of potential fraud. The protocol allows providers
to work with the Government to avoid the costs and disruptions entailed in a
Government-directed investigation. For more information on the OIG Provider
Self-Disclosure Protocol, see http://oig.hhs.gov/fraud/selfdisclosure.asp.
Case Examples of Physician Liabilities Resolved Under
the OIG Provider Self-Disclosure Protocol
• A Minneapolis physician paid $53,400 and
resolved liability for violating his Medicare
assignment agreement by charging patients a
yearly fee for services, some of which were
covered by Medicare.
• A Florida physician paid $100,000 and resolved liability related to
referring patients to a lab owned by his brother.
• A neurosurgery practice paid $10,000 and resolved liability for employing an
individual who was excluded from participation in the Federal health care programs.
28
http://www.oig.hhs.gov/fraud/selfdisclosure.asp
What To Do If You Have Information About
Fraud and Abuse Against Federal Health
Care Programs
If you have information about fraud and abuse against Federal health care programs,
use the OIG Fraud Hotline to report that information to the appropriate authorities. The
Hotline allows the option of reporting anonymously.
Phone: 1-800-HHS-TIPS (1-800-447-8477)
Fax: 1-800-223-8164
Email: HHSTIPS@oig.hhs.gov
TTY: 1-800-377-4950
Mail: Office of Inspector General
Department of Health & Human Services
Attn: HOTLINE
P.O. Box 23489
Washington, DC 20026
For additional information about the Hotline, visit the OIG Web site at
http://oig.hhs.gov/fraud/hotline/.
29
http://www.oig.hhs.gov/fraud/hotline/
This publication is available on the OIG Web site. You may reproduce, reprint,
and distribute this publication for educational purposes. You may not charge a
fee for this publication. http://oig.hhs.gov/fraud/PhysicianEducation/
http://oig.hhs.gov/fraud/PhysicianEducation/
-
Introduction
- I. Physician Relationships With Payers
- II. Physician Relationships With Fellow Providers: Physicians, Hospitals, Nursing Homes, Etc.
- III. Physician Relationships With Vendors
- What To Do If You Have Information About Fraud and Abuse Against Federal Health Care Programs
Fraud and Abuse Laws
Anti-Kickback Statute [42 U.S.C. §§ 1320a-7b(b)]
Physician Self-Referral Law (Stark law)
[42 U.S.C. §§ 1395nn]
Exclusion Statute [42 U.S.C. §§ 1320a-7]
Civil Monetary Penalties Law [42 U.S.C. §§ 1320a-7a]
Physician Documentation
Enrolling as a Medicare and Medicaid Provider
With CMS
Prescription Authority
Assignment Issues in Medicare Reimbursement
Physician Recruitment
Tips for Medical Directors
Relationships With the Pharmaceutical and Medical Device Industries
Transparency in Physician-Industry Relationships
Conflict-of-Interest Disclosures
Continuing Medical Education
Compliance Programs for Physicians
Where To Go for Help
What To Do If You Think You Have a Problem
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