2567 UMMC Inspection 1-8-21

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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED

CENTERS FOR MEDICARE & MEDICAID SERVICES OMB NO. 0938-0391
STATEMENT OF DEFICIENCIES (X1) PROVIDER/SUPPLIER/CLIA (X2) MULTIPLE CONSTRUCTION (X3) DATE SURVEY
AND PLAN OF CORRECTION IDENTIFICATION NUMBER: COMPLETED
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NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE
510 W TIDWELL
UNITED MEMORIAL MEDICAL CENTER
HOUSTON, TX 77091
(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

PREFIX (EACH DEFICIENCY MUST BE PRECEDED BY FULL PREFIX (EACH CORRECTIVE ACTION SHOULD BE COMPLETION
REGULATORY OR LSC IDENTIFYING INFORMATION) CROSS-REFERENCED TO THE APPROPRIATE DATE
TAG TAG
DEFICIENCY)
A 000 INITIAL COMMENTS A 000
Note: The CMS 2567 is an official, legal

document. All information must remain
unchanged except for entering the plan of
correction, correction dates, and the signature
space. If information is inadvertently changed by
the provider, you should notify the state Survey
Agency. If the SA notices any discrepancy in the
information, the Regional Office will make a
referral of possible fraud to the Office of the
Inspector General (OIG).
An entrance conference was held at 9 p.m. on

12/31/2020 with the administrative house
supervisor. The purpose, scope and process of
the CMS COVID-19 infection control survey &
complaint investigation survey was explained and
an opportunity for questions and discussion was
provided.
Appendix A-Survey Protocol, Regulations and

Interpretive Guidelines for Hospitals was utilized
to determined hospital's compliance with 42 CFR
482 Conditions of Participation (CoP) for
Hospitals regarding: Governing Body, Patient
Rights; Medical Staff; Nursing Services,
Pharmacy Services, Physical Environment; and
Infection Prevention & Control.
An exit conference was held in the afternoon of

01/07/2021 with key administrative personnel.
Preliminary findings of the survey were
discussed. The facility was provided an
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 Event ID: GRBN11 Facility ID: 810305 If continuation sheet Page 1 of 72
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A 000 Continued From page 1 A 000

opportunity to submit further information related
to the findings; none was offered. The process for
submitting a Plan of Correction was reviewed.
Discussion was held; all questions were
answered.
The survey exit date was extended to 01/08/2021

due to the need to obtain additional information.
The following CONDITIONS were not met:
Governing Body- CFR 482.12
Patient Rights - CFR 482.13
Pharmaceutical Services -CFR 482.25
Infection Prevention and Control -CFR 482.42
TX 00369179 was substantiated

GLOSSARY:
ABG: arterial blood gas
cc : cubic centimeter
CDC: Centers for Disease Control
CEO: Chief Executive Officer
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CFR : Code of Federal Regulations
CMS : Centers for Medicare and Medicaid

Services
CV: curriculum vitae
F.D.A.: Food & Drug Administration
HCP: healthcare personnel
HIPAA : Health Insurance Portability and

Accountabiity Act
HR: Human Resources
hr : hour
ICP: infection control practitioner
IV: intravenous
MAR: medication administration record
mcg : microgram
mg: milligram
ml: milliter
NG: nasogastric
OGT : orogastric tube
PICC: peripherally inserted central catheter
RN: registered nurse
RT: respiratory therapist

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SARS-CoV-2 : severe acute respiratory

syndrome coronavirus 2
Levophed (norepinephrine bitartrate)- is a

vasoconstrictor, similar to adrenaline, used to
treat life-threatening low blood pressure
(hypotension) that can occur with certain medical
conditions or surgical procedures. Levophed is
often used during or after CPR (cardio-pulmonary
resuscitation).
A 021 COMPLIANCE WITH LAWS A 021
CFR(s): 482.11(a)
The hospital must be in compliance with

applicable Federal laws related to the health and
safety of patients.
This STANDARD is not met as evidenced by:

Based on record review, observation and
interview it was determined that the facility failed
to be in compliance with applicable Federal laws
related to the health and safety of patients. The
locked exterior entrance door to the emergency
room had an 8.5 x 11 sign posted in English
instructing persons needing assistance to call the
emergency department (ED) by phone, but the
phone was not working.
Findings:
Record review of the facility EMTALA policy

revised 04/19, stated, II. DEFINITIONS "Comes
to the emergency department" or "comes to the
hospital" means when:
1. An individual presents anywhere in the

Hospital or on the Hospital property, even if the
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individual presents at a location other than the
emergency department. An individual in a
non-hospital owned ambulance on hospital
property is considered to have come to the
Hospital's emergency department.
Based on observation on 01/05/2021 at

approximately 1240 patient (patient ID #9) was
seen talking to EMS staff after she had called 911
because she could not contact the ED personal
or other hospital personal that she need to be
seen in the ED via the telephone outside of the
ED. Patient (ID#9) stated the phone was not
working. The EMS staff walked the patient to the
ED.
On 01/06/2021 at 11:06 am and 11:08 am a call

was made to the ED to the telephone number
listed. Both calls appeared to ring for
approximately 3 times, then phone call went
dead.
Interview on 01/06/2021 at 0915 with the ED staff

(ID# Z) who stated the phones were not working.
The staff had received an email from their IT
department stating that the phone service would
not be working properly. She also stated the
EMS staff called the front desk to alert them
about the patient, so she could be seen. She
also stated additional signage should be placed
so patients can access the ED if the phone is not
working.
Phone interview with patient (ID# 9) on

01/07/2021 at 14:30 confirmed she did go to
United Memorial Medical Center Hospital
Emergency Room on 1/05/2021. Patient (ID#9)
stated she went to the Emergency Room door
and saw the sign that said to call the Emergency
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Room number listed. Patient (ID#9) stated she
called the number three times with no answer and
no one said "hello" on the phone, she also
confirmed she not see the red button on side of
door to ring bell. Patient (ID#9) stated that she
also banged on the door and no one would open
the door, and that she returned to her car and
began having chest pain and called 911.
Based on observation and interview the facility

failed to post any notices related to human
trafficking in the emergency department.
On a tour of the emergency department on

01/06/2021 between 1:00 p.m.- 1:30 p.m.
revealed a 12-bed unit, with a census of 11.
Room 7-11 were designated for COVID positive
patients and sealed off. The empty rooms 4, 5 as
well as the patient bathrooms, and bulletin boards
did not have any notices related to human
trafficking.
Interview on 01/6/2021 with the charge nurse (ID#

T) who said we do not have any signs for human
trafficking. This collaborated by the administrator
(ID#A).
A 043 GOVERNING BODY A 043
CFR(s): 482.12
There must be an effective governing body that is

legally responsible for the conduct of the hospital.
If a hospital does not have an organized
governing body, the persons legally responsible
for the conduct of the hospital must carry out the
functions specified in this part that pertain to the
governing body ...
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This CONDITION is not met as evidenced by:

Based on observation, interview, and record
review, the Governing Body failed to effectively
discharge its oversight responsibilities in the total
operation of the hospital.
Findings:
The Governing Body :
1. Failed to ensure Patient ID # 9 had timely

physical access to the emergency department on
01/05/2021. Cross refer to Tag A-0021
2. Failed to review and approve an international

medical student "observer program" to include
program description & curriculum; signed
agreements with medical schools; and an
established vetting process for all students.
Cross- refer to Tag-0049
3. Failed to ensure nursing staff who worked the

COVID IMU / ICU units had access to direct
communication with the attending physician per
policy. This deficient practice caused a serious
delay in treatment for Patient ID # 18 .
Cross-refer to Tag A-0067
4. Failed to ensure the patient's right to be

involved in the decision-making process by failing
to obtain properly executed informed consent for
procedures in 10 of 10 medical records reviewed.
Cross-refer to A-0131
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5. Failed to protect thirty-one (31) patient's right to
privacy by: allowing media presence in the
facility's COVID IMU/ICU unit to take pictures and
videos of patients and staff without ensuring
patient and staff consent, without executing a
business agreement, without ensuring signed
HIPAA agreements were in place, and without
ensuring proper vetting and infection control
training of media staff. Cross-refer to A-0143
6. Failed to ensure the patient's right to receive

care in a safe setting by: not having defibrillators
charged and readily available for staff use, failing
to ensure cardiac monitoring equipment and
systems for critically ill patients were functioning
properly and that exterior access doors were
closed and secure. Cross-refer to A-0144
7 . a. Failed to ensure investigational drug

protocols were reviewed / approved by the facility
Pharmacy & Therapeutics Committee; Medical
Executive Committee; and the Governing Body
prior to administration of the medications to 66
patients (Patient IDs: 39 through 104, and #181 );
and
b. Failed to develop & implement policies related

to investigational drugs that included: review
process; approval; supervision; monitoring; and
pharmacy control of: storage; dispensing;
labeling, and distribution. Cross-refer to A-0491
8. Failed to ensure drugs and biologicals were

stored per facility policy and in a manner to
prevent access by unauthorized individuals for
both controlled and non-controlled drugs.
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9. Failed to employ methods for preventing and

controlling the transmission of infections per
facility policies and professional infection
prevention guidelines. Cross-refer to A-0749
10. Leadership failed to:

a. ensure effective implementation of a
COVID-19 screening process for staff, visitors,
and vendors per CDC recommendations; and
b. ensure systems were in place to prevent

potential transmission of infectious diseases from
the use of single use glucometers on multiple
patients (patients 21-38). Cross-refer to A-0770
A 049 MEDICAL STAFF - ACCOUNTABILITY A 049
CFR(s): 482.12(a)(5)
[The governing body must] ensure that the

medical staff is accountable to the governing
body for the quality of care provided to patients.

Based on interviews and record review, the
governing body failed to ensure the medical staff
was accountable for the quality of care provided
to the patients.
An "observer program" that involved international

medical students was implemented by a
physician without documentation of the program
overview; copies of signed agreements with
medical schools; and established process for
vetting of all students.
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The facility and Chief of Medical Staff failed to
provide documentation to show this "observer
program" had been reviewed and approved by
the governing body prior to implementation.
Findings:
During an interview on 01/05/2021 at 1:00 PM

with Staff G, RN she stated that medical students
sometimes assessed patients during the night
shift when Staff C, physician was not on-site.
They checked vents and IV lines. The medical
students were on-site 24/7; they also wrote
orders.
During a confidential telephone interview on

01/04/2021 at 8:00 PM with a facility respiratory
therapist, she reported a medical student
performed a bronchoscopy on a patient with only
a nurse in the room and the physician available
by text. This respiratory therapist said she
remembered this because she offered to be in
the room during the procedure. The medical
student declined her presence but did ask her for
an adapter. She also said it was known in the
respiratory department that the medical students
had performed at least 2 difficult intubations (with
multiple attempts) with the ER physician.
Record review of facility document titled

"Governing Board Bylaws", review date
12/19/2019, showed:
The Governing Board's purpose was: "...to

establish and maintain a facility that provides
quality in-patient and out-patient care and
services meeting nationally accepted standards
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of clinical practice and care...The Board shall
work to ensure operations support consistent
standards of quality of care and patient safety..."
The Governing Board has "the responsibility for

the overall organization, management, control,
and operation of the Hospital...and has
established ...an effective mechanism for
communication and accountability between the
Board, the Medical Staff...and the Hospital
administration..."
Record review of facility document titled "Medical

Staff Rules and Regulations", review date April
19, 2019, showed a sole reference to "Observers"
and this was in relation to observation of surgical
procedures by students and technical
representatives.
During an interview on 1/4/2020 at 11: 15 AM with

Staff A, CEO, she was asked to provide all
information regarding the international medical
students: program description, and medical
executive committee / governing body review and
approvals. The CEO said the Chief of Staff, Staff
C, was responsible for this program. He would be
able to provide the information.
During an interview on 1/04/2021 at 2: 15 PM with

Staff C, Chief of Medical Staff, he stated he has
"had the program with the medical students for
many years. The students come from all over the
world : Mexico, New York. They are in their last
year of medical school. When they come, we
review a series of regulations: what they can do
and cannot do. The students have 8 hours of
HIPAA training."
"This is a teaching / learning experience for

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these students. They see patients with me on
day- to-day rounds. We do procedures; we write
papers. At the end of the training -I write a letter
of recommendation to their school. Every day, we
sit down together and go over the patients'
condition and labs. They are learning how to
describe and treat a patient's condition. The
students use templates and we review them
together."
He went on to say the criterion for selection to his

program was "grades; top 10 % of class."
Regarding the vetting process for the students
[professional & character references, criminal
background checks, verification of medical
education, etc], the Chief of Staff said he
conducted video reference checks. He was
unsure what details of the vetting process were
included in the medical school agreements.
The Chief of Staff was asked to speak to the

complaint intake allegations that medical students
were assessing patients by themselves and
performing procedures (a bronchoscopy &
intubations ) without him present. He stated: "No
student in my program can do procedures unless
I am with them. To my knowledge, no student has
ever intubated a patient with the ER physician or
done any other procedures without me."
The Chief of Staff was asked to provide a

program description and /or curriculum and
approvals by MEC and the governing body. He
said he had agreements with many medical
schools; he stated they were in Spanish. He was
asked to provide these. No further information
related to this program, including the medical
school agreements, was provided prior to the
survey team exit on 01/07/2021.
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On 01/04/2021, surveyor reviewed the list of

current medical students with the Chief of Staff.
This list was provided by Staff E, HR Manager
this same day. The Chief of Staff stated this list
was not current. He said only 2 of the 15 students
listed were still here. He said the students stayed
2 to 3 months.

with Staff E, HR Manager, she stated "the
medical students come from all over: Mexico,
Africa, New York. They are 'observers.' I make a
packet for them: there is a HIPAA test; they must
pass with an 80%. They also must take the
CARES program, which is a customer service
program. The doctor ( Chief of Staff) signs off on
how long the students will stay here. Generally it
is 6 months to a year. "When asked about
criminal background checks, drug screening, and
references; HR Staff said the doctor may have
information on this.
Record review on 01/04/2021 of the HR files for

four (4) medical students ID # : LL, MM, NN, OO
showed evidence of abuse / neglect training;
HIPAA/Confidentiality ; and CARES customer
service program. The files contained a copy of
the student's CV and passport, emergency
contact information, along with several signed
agreements.
Continued review of these same HR files failed to

show documentation of : criminal background
checks; drug screening, and professional and/or
personal references. There was no transcript of
current medical school education. There was no
documented training for: infection prevention
/control; fire safety / evacuation; and emergency
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preparedness.
Review of the HR checklist for these "Observer"

files did not include a reference to any of the
above-listed components.
A 067 CARE OF PATIENTS - MD/DO ON CALL A 067
CFR(s): 482.12(c)(3)
[ ...the governing body must ensure that the

following requirements are met:]
A doctor of medicine or osteopathy is on duty or
on call at all times.

Based on interviews and record review, the
facility failed to ensure nursing staff had direct
communication with the attending physician per
facility policies.
Nursing staff was directed to communicate any

patients' change in condition; critical lab results;
or need for clarification of orders through the
medical students. The medical students then
communicated the information to the physician.
This lack of providing nursing direct

communication with the physician resulted in an
almost 2 hour 'delay in treatment' of a serious
cardiac arrhythmia experienced by Patient # 18 .
Citing 4 of 4 sampled patients [Patient ID # 12,

14, 15, 18].
Findings:
The complaints included during this survey

showed that all were submitted by facility RNs. All
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of the complaints have various documented
concerns related to the facility's use of medical
students. All of the complaints had patient safety
concerns related to the to lack of nursing access
to direct communication with the MD.
The following are excerpts from the complaint

intakes related to the communication issue as
documented by the facility RNs:
a) "When I first arrived here-I was instructed

that the line of communication is to consult the
medical students, the medical students call the
doctor. If the doctor responds , he will notify the
students and the students notify us. The students
are here around the clock, they rotate and write
all of Staff C (MD) orders and sign his name...
when I have asked to speak to the doctor, the
students insist we communicate the way the
doctor wants..."
B) "When you first get to the facility ...they let

you know their protocol is to first talk with the
student and the students will communicate with
the physician (Staff C/ MD). I have been here for
3 weeks and last night was the first time I spoke
with the doctor. I had to beg the student for the
number and promise not to tell the doctor where I
got it. I had to speak with the doctor because my
patient was very unstable... One day I had a
patient who had a blood pressure in the high 180s
/ 100 and I requested medication for my patient.
The medical student told me the MD said he's not
concerned with it until it reaches the 200's ( via
text-- I never saw )....."
c) "I don't feel comfortable that I have to talk

to a medical student who has no license and is
here on a student visa. They text the MD and
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when he responds , they write the order as if they
are him. I had a student tell me that I could
increase the IV Versed for my patient beyond the
max dose. I had to tell him it was above the max
dose..."
d) " On my first day here--we were told Staff

C/MD's preference is for us to talk to his medical
students regarding any care or requests we may
need. The students contact the doctor and when
or if the doctor responds, he will notify the
students and then the students notify us. This
process has been questioned several times;
students are adamant we do not contact him
(MD)...".
e) "There is no Hospitalist here on nights--our

only way to get to the MD is his medical students.
It is confirmed that these students are
international students. We are not told what
college they attend. The students write orders
and sign the MD's name...I have been here 4
weeks--I work 5 to 6 days a week on nights.
Although I take care of Staff C/MD's patients, I
have never communicated with him: either in
person or over the telephone..."
f) " I have seen multiple times unlicensed

medical students writing orders without an MD
present. ..I have witnessed RNs and RTs having
to report critical lab values to an unlicensed
medical student...never in my career have I had
so much fear for my patient's safety..."
Record review of facility policy titled " Change in

Patient Condition: Notification of Physician," last
review date 04/19, showed: " Nursing will notify
the responsible physician of any significant
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change in patient condition immediately..."
Record review of facility policy titled "Critical

Results /Values Reporting," last revised 04/19,
read: "... Upon receipt of the critical result/value ,
the nurse will immediately begin to initiate contact
with the physician. If the nurse is unable to reach
the physician within sixty minutes of receiving the
result, the next Practitioner in the Chain of
Command should be contacted..."
During an interview on 1/04/2021 at 2: 15 PM with

Staff C, Chief of Staff, he was informed there
were allegations by multiple nursing staff that they
were only to communicate with him through the
medical students. If there was a serious change
in a patient's condition or a critical lab result-
nurses were to report to the medical students,
who would then contact him for orders, which
they write. The Chief of Staff said this was "totally
not true--false. I am so upset they would say this.
I am on call all the time--nurses are calling me all
the time. Many have my personal cell phone
number. There was a day when I got 39 phone
calls."
The Chief of Staff was asked why the medical

students were on-call 24/7 and available in-house
during the night? Staff C, MD said the reason was
the medical students were there to be an "extra
set of eyes and ears" and to assist the nurses
with proning the patients, if needed.
Medical Record Review:
Record review on 01/08/2021 of the medical

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records of Patients ID # 12, 14, 15, and 18,
showed numerous examples of nursing staff
documentation of informing the medical students
and not the physician of patients' change of
condition. In the case of Patient # 18, there was a
delay in treatment of almost 2 hours as a result of
the required communication process with the
medical students and not the physician.
Record review of the clinical records showed the

following:
Patient # 18:
Patient # 18 was a 79 year-old female

transferred to the facility on 11/20/2020 with a
diagnosis of acute COVID-19 pneumonia. She
expired on 11/29/20.
Nurse's Notes: 11/23/2020:
>Time 0440: "Change in Condition: "nurse notes

patient's heart rate in 170s, blood pressure
dropping significantly, nurse notified med student
(named) and refused to come to assess pt. Med
student (named) did not respond to nurse's call
three times. pt continued to decline, no help or
orders from medical student & medical student
still did not come to bedside after an hour."
>Time 0540 : "nurse noted pt heart rate at 177

and irregular rhythm, nurse placed a call to med
student (named). Administrator on call (AOS) on
the unit at the time and AOS started to go to the
ER to come (sic) for ER MD, no orders or
assistance received from med student or AOS. pt
continues to be in A fib (atrial fibrillation) at this
time."
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>Time 0630 : Amiodarone order received at this
time from (name of medical student) per MAR.
Amiodarone started per order... nurse continues
to monitor..."
Nurse's Notes: 11/24/2020:
>Time 0600: pt very restless at this time, Versed

increased to 30 cc/hr. pt having runny stool at this
time. Med student notified.
>Time 0630: morphine 2 mg IV given as ordered.
>Time 0700: pt still restless at this time. Med

student notified to inform doctor of patient's
condition.
Patient # 15:
Patient # 15 was an 83 year-old male admitted to

the facility on 12/15/2020 with a diagnosis of
acute COVID-19 pneumonia. He expired on
12/31/2020.
Nurse's Notes:
>12/22/20 (0801) : "NG clogged had to be

removed. Unable to insert another one due to
meeting resistance. MD student notified-he does
not want to try to reinsert NG..."
>12/22/20 (2030) : "...nurse attempted to insert

NGT/OGT with no success. Student (named)
notified of no oral medication access..."
>12/23/20 ( 0435) : "patient breathing from the

mouth also agonal breathing. Student notified and
ABG completed. Nursing also reported swelling of
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right arm where PICC line is placed..."
>12/24/20 ( 0800) : "critical lab values rec'd from

lab: hemoglobin 6.70- (named) medical student
informed...."
>12/25/20 (0611)-nurses note regarding

medication order for "Phenol" -the medication
dosage needed to be clarified:"doctor was notified
by medical student to please clarify the mg--no
response back..."
>12/26/19 (0002) : "nurse reported that patient's

OGT was clogged to student (name) who advised
to leave in place..."
Patient # 14:
Patient # 14 was an 51 year-old male admitted to

the facility on 12/02/2020 with a diagnosis of
acute covid-19 pneumonia. He expired on
12/16/2020.
Nurse's notes:
12/11/20 ( 0800) : "... spoke with (student

name)--interm ( sic) about patient is unable to
tolerate medication due to severe shortness of
breath and nausea..." patient unable to tolerate
earlier medication.
12/15/20 ( 0821) : "...due to patient constantly

dropping in oxygen saturation, medical student
(named) was informed and asked to order an
ABG. No new orders were ordered...."
Patient # 12:
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Patient # 12 was an 43 year-old female admitted

to the facility on 12/19/2020 with a diagnosis of
acute covid-19 pneumonia. She expired on
12/30/2020.
Nurse's note: dated 12/22/20 ( 0536): " Patient

attempting to reach for ET (endotracheal) tube
and fighting the ventilator. Student notified..."
A 115 PATIENT RIGHTS A 115
CFR(s): 482.13
A hospital must protect and promote each

patient's rights.

Based on record review and interview the facility
failed:
A.) to ensure the patient's right to be involved in

the decision-making process by failing to obtain
properly executed informed consent for
procedures in 10 of 10 medical records reviewed.
B.) to protect thirty-one (31) patient's privacy by:

allowing media presence in the facility's COVID
IMU/ICU unit to take pictures and videos of
patients and staff without ensuring patient and
staff consent, without executing a business
agreement, without ensuring signed HIPAA
agreements were in place, and without ensuring
proper vetting and infection control training of
media staff.
C.) to ensure the patient's right to receive care in

a safe setting by: not having defibrillators charged
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and readily available for staff use, failing to
ensure cardiac monitoring equipment and
systems for critically ill patients were functioning
properly and that exterior access doors were
closed and secure.
A 131 PATIENT RIGHTS: INFORMED CONSENT A 131
CFR(s): 482.13(b)(2)
The patient or his or her representative (as

allowed under State law) has the right to make
informed decisions regarding his or her care.
The patient's rights include being informed of his

or her health status, being involved in care
planning and treatment, and being able to request
or refuse treatment. This right must not be
construed as a mechanism to demand the
provision of treatment or services deemed
medically unnecessary or inappropriate.

Based on record review and interview the facility
failed to ensure the patient's right to be involved
in the decision making process by failing to obtain
properly executed informed consent for
procedures in 10 of 10 medical records reviewed
Patient ID (#2, #17, #18, #106, #107, #108, #109,
#110, #111, and #112).
Findings:
Record Review of facility policy titled: PATIENT

RIGHTS POLICY dated 04/19 showed the
following information:
A. In accordance with the Medicare Conditions of

Participation, the Texas Department of State
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Health Services, the Hospital Safety Code and
the CIHQ Standards, the Hospital will ensure the
provision of the following patient rights ...
5. The right of the patient, in collaboration with his

or her physician, to make decisions involving his
or her health care to include the following:
a. The right of the patient to accept medical care

or to refuse treatment to the extent permitted by
law and to be informed of the medical
consequences of such refusal.
5. The right of the patient to the information

necessary to enable him or her to make
treatment decisions that reflect his or her wishes.
Record Review of facility policy titled: Consent:

Informed dated 04/19 showed the following
information:
I. Outcome Standard
The Hospital recognized that consent is a

process which includes the provision of
information to the patient which is sufficient for
the patient to make an informed decision about
the proposed procedure. The process of the
informed consent will be recorded in the medical
record.
II. Process Standards
A. Generally accepted elements of an informed

consents include:
-The diagnosis and nature of the illness
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-The recommended treatment or procedure to be
performed
-The purpose of the treatment or procedure
-The likelihood of success
-The side effects of the treatment or procedure
-The inherent risks and potential hazards of the

treatment or procedure
-The alternative to this treatment or procedure
-The consequences of not treatment or alternate

treatments
-The name of the physician or other practitioner

who will be primarily responsible for the patient's
care
-The identity and professional status of any

individual responsible for authorizing and/or
performing procedures or treatments, if different
from the primary physician.
-Any professional relationship between the

organization and/or caregivers and other
healthcare providers or institutions, which might
be constructed as a conflict of interest.
-Any relationship between the organization and/or

caregiver to any educational institution involved in
the patient's care.
-Any business relationship between or among

individuals treating the patient and/or between or
among the organization and any other health
care, service, or educational institution involved in
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the patient's care.
B. Forms for Documentation of the Informed

Consent
...The consent form is the final step in the

process memorializing in writing that the
disclosure process has taken place to the
satisfaction of the patient and that the patient
authorizes the physician to perform the procedure
discussed. A signed consent form is the only
evidence of the consent and not a substitute for it.
C. Responsibility of the Physicians
1. The physician who is performing the procedure

should obtain the informed consent.
Record Review of facility Medical Staff Rules and

Regulations, dated 04/19 showed the following
information:
7. Informed Consent
All inpatient and outpatient medical records

must contain a properly executed and completed
written informed consent form. The process of
informed consent requires the treating physician
to discuss the proposed intervention with the
patient. The treating physician should make a
notation in the patient's medical record
documenting the occurrence of the discussion
and summarizing its contents.
The generally accepted elements of an informed

consent discussion should include:
1. The names of the persons who actually will

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perform the surgical procedure as well as the
names of the people other than the primary
surgeon who will perform important parts/ specific
surgical tasks of the procedure, even if these are
performed under the surgeon's supervision.
2. The nature of the proposed care, treatment,

service, medications, interventions, or
procedures.
3. Potential benefits, risks, or side effects,

including potential problems, related to
recuperation.
4. The likelihood of achieving care, treatment and

service goals.
5. Reasonable alternative to the proposed care,

treatment or service.
6. The relevant risks, benefits and side effects

related to alternatives, including the possible
results of not receiving care, treatment or
services.
7. When indicated, any limitations on the

confidentiality of information learned from or
about the patient.
A signed informed consent will be obtained in all

situations except when the patient's life is in
danger. In such cases the involved physicians
(e.g. surgeon, consultant, anesthesiologist)
should document the reasons.
Record review of patient's (ID#2) medical record

on 1/5/2021 at 1:35 showed operative report for
date of service 12/29/2020 for left common
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femoral arterial access, left common femoral vein
access, selective left and right coronary
angiography, left ventricular pressure, pressure
pull back, pulmonary angiogram with bilateral
pulmonary arteries, aortic root injection and
moderate sedation for 30 minutes. Further review
revealed no consent for this procedure.
During an interview with RN (ID UU) assigned to

patient (ID#2) at the time of observation when
asked by surveyor if patient (ID#2) had any heart
catheterization procedures, she stated "No, not
that I am aware of. That would have been
relayed to me during shift report." After reading
operative report listed above, she stated "I guess
he did have the procedure. I was not aware of it."
She confirmed that there was no consent for this
procedure in the medical record. She stated that
"any procedures require consent from the patient
or next of kin if the patient cannot give consent."
She also informed the surveyor that patients who
are on the COVID unit are still required to
physically sign the consent, the consent is
brought to and from the room in a plastic bag to
minimize contamination.
Record review of medical record for patient

(ID#106) showed consent form for computed
tomography scan of abdomen and pelvis, oral
contrast. The portion of the consent stating I (we)
voluntarily request Dr. ________ (left blank) as
my physician and such associates ...as they
deem necessary to treat my condition which has
been explained to me as: ________ (left blank). I
(we) consent and authorize MD (ID C) as the
physician who will actually perform the surgical,
medical, diagnostic procedure or important
aspects of the procedure. There was no patient
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signature, but printed information read: verbal
consent 2 nurse witness. Two nurse's signatures
were recorded as witnesses on 7/20/2020 12:20
PM, patient unable to sign was left blank and
there was no physician's signature, date or time.
Further record review showed a second consent
form for computed topography scan of chest with
intravenous contrast. The portion of the consent
stating I (we) voluntarily request Dr. ________
(left blank) as my physician and such associates
...as they deem necessary to treat my condition
which has been explained to me as: _______
was left blank. I (we) consent and authorize MD
(ID C) as the physician who will actually perform
the surgical, medical, diagnostic procedure or
important aspects of the procedure. There was
no patient signature, but written information read:
verbal consent 2 nurse witness. Two nurse's
signatures were recorded as witnesses on
7/31/2020 10:50 AM, patient unable to sign was
left blank and there was no physician's signature,
date or time.

(ID#107) showed consent form for peripheral
inserted central line. I (we) understand ...MD (ID
C) as the physician who will actually perform the
surgical, medical, diagnostic procedure. The
patient signature portion showed writing of verbal
consent and first name of patient (ID#107),
7/23/2020 1710. Patient unable to sign portion
was left blank. There were two RN signatures, no
physician signature, date or time.

(ID#17) showed consent form for peripherally
inserted central catheter to treat my condition
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which has been explained as: _________was left
blank. I (we) understand ... MD (ID C) as the
physician who will actually perform the surgical,
medical, diagnostic procedure. The patient
signature portion was left blank, Patient unable to
sign was left blank. There were two RN witness
signatures, no physician signature, date, or time.
Review of medical record for patient (ID #108)

showed consent form for peripherally inserted
central catheter, stating I (we) voluntarily ...to
treat my condition which has been explained as:
_______ was left blank. Dr._________ (left
blank) as the physician who will actually perform
the following .... was left blank. Patient Signature
showed printed name of patient (ID#23), Patient
unable to sign: COVID contact isolation was
written in, two RN witness signatures, and no
physician signature, time, or date.
Review of medical record for patient (ID #109)

showed consent form for peripherally inserted
central line. The form stated: I (we) consent and
authorize MD (ID C) as the physician who will
actually perform the surgical, medical, diagnostic
procedure or important aspects of the procedure.
There was no patient signature recorded, Patient
unable to sign was left blank, and there was no
physician signature, time or date.
Review of medical record for patient (ID#110)

showed consent form for computer tomography
scan of chest with intravenous contrast. The
consent form did not have a physician signature,
date, or time.
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revealed a consent form for a peripherally
inserted central line witnessed on 11/20/20 at
0700. The condition/diagnosis, physician
signature, date, and time was left blank. Further
review revealed a consent form for a
percutaneous endoscopic gastrostomy tube
placement witnessed on 11/25/20 at 2230. The
condition/ diagnosis, physician signature, date,
and time were left blank.

showed a consent form for a peripherally inserted
central catheter. Information left blank on this
consent for included: the physician that will
actually perform procedure, patient signature,
physician signature, date and time.

showed consent for a peripherally inserted central
catheter. Information left blank on the consent
form included: condition/diagnosis, the physician
that will actually perform the procedure, physician
signature, date and time. The patient signature
portion of the form had written in the same
handwriting as the RN completing the consent
form, portion stating patient unable to sign:
COVID isolation.
Further review of medical records for patient's

(#2, #17, #18, #106, #107, #108, #109, #110,
#111, and #112) showed all above listed
procedures were completed.
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During an interview with facility Director of
Nursing (ID B) on 1/6/2021 at 1:45 PM, she
acknowledged that there was no consent for
patient (ID#2) in the medical record. She also
stated that the only way to show that a physician
had explained the procedure, risks and benefits
to the patient would be by his or her signature on
the consent form. She stated that during the
current COVID crisis some nurses are getting
verbal consent for the patent and having two RNs
sign as witnesses. She acknowledged that MD
(ID C) would not be the physician actually
performing the procedures such at computed
tomography or placement of peripheral central
catheter as stated on the consents for patient's
(ID#s 17, 106, 107, and 109). When shown the
consents for patients (ID #17, #18, #106, #107,
#108, #109, #110, #111, and #112), she stated
they were not acceptable.
A 143 PATIENT RIGHTS: PERSONAL PRIVACY A 143
CFR(s): 482.13(c)(1)
The patient has the right to personal privacy.

review, the facility failed to protect patient's right
to privacy by: allowing media presence in the
facility's COVID IMU/ICU unit to take pictures and
videos of patients and staff without ensuring
patient and staff consent, without executing a
business agreement, without ensuring signed
HIPAA agreements were in place, and without
ensuring proper vetting and infection control
training of media staff.
Pictures available online via media company A &

B showing full unclothed body exposure from
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head to groin and full-face for patient (ID #113),
full face exposure and past medical diagnosis for
patient (ID #114) and face exposure for patient
(ID#115). Patients were identified by name.
Pictures available online via media company C

showing video essay of patient on the facility's
COVID IMU/ICU unit. Patients identified by name
and face photos include patients (ID# 106, 107,
108, 109, 111, 116, and 117).
Media photographer present on the COVID

IMU/ICU unit with camera having access to
patient information for patients (ID#s 1, 2, 4, 5,
111, 118, 119, 120, 121, 122, 123, 124, 125, 126,
127, 128, 129, 130, 131, 132, and 133).
Findings:
Record review of facility policy titled: MEDIA

RELATIONS, dated 4/19 showed the following
information:
D. Pictures and Tape Recordings
Media representatives will be required to show

proof of identity and must coordinate photography
or television coverage in advance with the
marketing director or administrator on call ...
Media representatives must always be escorted

while on hospital property and care should be
taken to ensure no patients other than the
subject, are included on photographs or on a TV
camera.
When the newspaper (or other media) requests

the privilege of photographing a pa patient, such
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permission can be given only:
1. News Media and Public Information Cases:
a. If, in the opinion of the attending

physician, the patient's condition will not be
jeopardized.
b. If the patient will give written permission

to have photograph taken.
c. If photographers use extreme caution to

avoid upsetting other patients.
d. If a release form is singed and placed in

the patient's medical record.
E. Media Access
The media representatives must always be
escorted while on hospital premises.
The media is prohibited from entering the

following areas:
5. Intensive Care Unit
Review of personnel file for Director of

Government Relations & Communications (ID
WW) showed a copy of resume, signed abuse &
neglect document and a consulting agreement
between her (ID WW) and the facility. The
personnel file failed to show documented duties
and obligations of the position for (ID WW).
Record review of patient's (ID#s 1, 2, 4, 5, 106,

107, 108, 109, 111, 113, 114, 115, 116, 117, 118,
119, 120, 121, 122, 123, 124, 125, 126, 127, 128,
129, 130, 131, 132, and 133) medical records
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revealed no written permission to have
photographs or video taken and no release form
per facility policy.
Record review of pictures available online via

media company A & B show the following:
Two (2) photographs of patient (ID#113). In one

photo patient (ID#113) is showing full body
exposure form head to groin and full-face for
patient with six (6) people providing care (not
including photographer at the head of patient
bed). Caption along with this photo read:
HOUSTON, TEXAS-JULY 1, 2020-HOUSTON,
TEXAS-JULY 1, 2020-Putting a patient on a
ventilator is a last resort. Dr. (ID C), does
emergency treatment on patient (ID#113), age
65, after putting him on a ventilator assisted by
his team of nurses and medical students. At
(facility surveyed), Texas, Dr. (ID C) leads a team
to fight the increasing number of coronavirus
patients in the expanded Covid-19 ward on July
1, 2020. (media photographer (ID A2) /media
company A & B). In another photo of patient
(ID#113) shows five (5) persons providing care to
him with photographer being located at the head
of the bed. Patient's (ID#113) is in view showing
endotracheal tube in place. Caption along with
photo read: HOUSTON, TEXAS-JULY 1,
2020-Medical students under the direction of Dr.
(ID C) at United Memorial Medical Center work to
revive COVID-19 patient (Id#113), 65, after his
heart stopped while he was being placed on a
ventilator on Wednesday, July 1, 2020. At (facility
surveyed) in Houston, Texas, Dr. (ID C) leads a
team to fight the increasing number of
coronavirus patients in the expanded Covid-19
ward on July 1, 2020. (media photographer (ID
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A2)/media company A & B).
Photo of patient (ID# 114) is of him lying in his

hospital bed will full face exposure holding a
gloved hand of an unidentified person. Caption
for this photo reads: HOUSTON, TEXAS-JULY 1,
2020-Patient (ID #114), 59, already suffered from
cirrhosis before he contracted COVID-19, putting
him at added risk. He holds on to a nurse as he
received treatment at (facility surveyed) in
Houston, Texas. At (facility surveyed) in Houston,
Texas, Dr. (ID C) leads a team to fight the
increasing number of coronavirus patients in the
expanded Covid-19 ward on July 1, 2020. (media
photographer (ID A2)/media company A & B).
Photo of patient (ID#115) shows patient (ID#115)

wearing a surgical mask, receiving care at the
bedside. Caption for photo reads: HOUSTON,
TEXAS MAY 6, 2020 Medical student (ID A3),
age 27, treats COVID-19 patient, (ID#115), age
43, a restaurant worker and father of four from
Houston. In Houston, Texas at (facility surveyed),
Dr. (ID C) leads a team of nurses and medical
students in the COVID-19 unit. (media
photographer (ID A2)/media company A & B).
Review of online article from Media Company C

reveals names and faces of patients (ID#s 106,
107, 108, 109, 111, 116, and 117) along with
information regarding condition and diagnosis,
care and treatment of patient on ventilators, as
well as performing Cardiopulmonary
Resuscitation (CPR) and staff providing
post-mortem care for patients. This article is
accompanied by a 23-picture photo essay
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capturing care and treatment of patients by Dr.
(ID C) at (facility surveyed). (media photographer
A1/ Media company C)
Observation on 12/31/2020 at 9:25 PM an

individual (ID A1) with a camera, alone, on the
COVID IMU/ICU unit. She was not wearing any
identification and was asked to identify herself to
the surveyor. She refused to give her name and
employer information to the surveyor. She stated
that she was just trying to leave and that she did
not want to get the hospital or anyone in trouble.
With hesitation she confirmed that she was a
media photographer and provided the surveyor
her name. At that time, she left the unit.
Interview with RN (ID X) on 12/31/2020 at 9:23

when asked to identify person on the unit with the
camera, she stated "she was a media
photographer, I am not sure really who she is or
who she is with, they (media) are here all the
time".
Interview with RN (ID W) on 1/2/ 2021 at 6:30

AM, she stated that "On my first day of work, I
came in early to figure out supplies, etc. I heard a
code called, saw camera crew that followed Dr.
(ID C) and medical students. They stayed in there
a long time. Afterward the camera crew came into
my patient's room and stated ... that patient died,
what is next? I told them that I did not know why
they were there and did not have her permission
to film me and asked them to leave room."
During interview with RN (ID BB) on 1/4/2021 at

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3:00 PM she stated, "Camera crews are here all
the time in the patient care areas. We don't even
know who they are. There are way too many
people in here that shouldn't be".
During interview with RN (ID CC) on 1/4/2021 at

2:58 PM, she stated, "Patient (ID #1) was found
unresponsive in his room. After he was coded
and intubated he was brought to station 400.
Shortly after he coded again, there is no code
button, I started compressions and moments later
nurses, medical students, and camera person
arrived in the room." She also stated, "There was
an MD interview with a news crew at nurse
station, this area is way too crowded, too many
people are in that area where social distancing is
already limited. There was a camera man
recording another nurse on the phone with family
regarding a patient's death".
Interview with RN (A4) on 1/4/21 at 3:00 revealed

" Camera crews taking pictures and video
follow us into the patient care areas. I am unsure
of patients have signed consent; we certainly
haven't. They try to take pictures and film us all
the time; we have not consented.
Interview with RN (X) on 1/6/2021 at 7:00 PM,

she stated" the night the survey team was here
(12/31), that camera crew came back. They
wanted to film us working on New Year's Eve.
The camera person tried to follow me into my
patient's room. I had to put my hand up, palm out,
and I told them they cannot come in here and do
not have my permission to film me. I closed the
door on them."
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During an interview with facility Chief Executive

Officer (CEO) (ID A) on 1/5/2021 at 10:50 AM,
when asked about media presence in the facility
she stated "Chief of Staff, (ID C), oversees all
that. To my knowledge, the media and camera
crews are not to go into patient rooms, they are
just to be at the nurse's station. You will have to
speak with Dr. (ID C) to get all of the information."
During an interview with Chief of Staff, (ID C), on

1/6/2021 at 4:30 PM, he stated "There are rules
in place regarding media presence at the
hospital. All the media must schedule
appointments through the Director of Government
Affairs and Communications (ID WW). She
oversees what media staff is here and when.
There are HIPAA agreements that the media
signs and strict guidelines they must follow, she
(ID WW) handles all of that. They must first
request to be here with her and she schedules it.
The media is present only when I am here. There
have been several major news channels covering
what is going on here at our hospital including:
CNN, BBC, KPRC, Univision, Fox26, Sky News
Europe and NHK7 from Japan. He stated that
patient give consent via video, if a patient doesn't
give consent, the media will stay out." When
asked to speak to the allegation of camera crews
following a nurse into a patient's room during a
Code Blue, he stated that "the camera crew may
have been following me, not the nurse." He also
stated that the nurses must sign a release and
give consent to be interviewed by the media.
During an interview with Director of Government

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Affairs and Communication (ID WW) on 1/6/2021
at 5:00 PM she stated the initial appointment with
Chief of staff (ID C) and the media takes place
through her. After that, they schedule directly with
him. I do not have knowledge of who is
scheduled to be here because it is usually
scheduled with him. Once they develop a
relationship they contact him directly. I am not
aware of HIPAA forms being signed, any
agreements that may be in place, vetting process
or infection control training. Dr. (ID C) is usually
in charge of all of this. She also stated that there
is nothing on file to show who from the media can
be at the facility and it is not tracked to her
knowledge.
A 144 PATIENT RIGHTS: CARE IN SAFE SETTING A 144
CFR(s): 482.13(c)(2)
The patient has the right to receive care in a safe

setting.
Based on observation, interviews, and record
review the facility failed to ensure the patient's
right to receive care in a safe setting by: not
having defibrillators charged and readily available
for staff use, failing to ensure cardiac monitoring
equipment and systems for eight (8) critically ill
patients (ID#s 111, 124, 131, 132, 134, 135, 136,
and 137) were functioning properly, and that
exterior access doors were closed and secure.
Findings:
Record review of facility policy titled: Equipment

and Supplies: Availability, dated 10/2014, showed
the following information:
I. Outcome standards:
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There will be maintenance of appropriate levels

and types of equipment and supplies in the
critical care unit to be identified needs.
II. Process standards
To facilitate the attainment of outcome standards,
A. An emergency card will be maintained in the

critical care unit for easy access:
1. The emergency cart will be stocked according

to approved medications and equipment.
2. The emergency card will be checked daily to

ensure proper functioning of equipment and
integrity of locked medication system with
documentation of these checks.
3. The emergency cart will be restocked by

pharmacy and other appropriate departments as
required and immediately following use of the
cart.
C. There will be establish guidelines for procuring

essential equipment and for ensuring available
back up equipment in the event of equipment
breakdown.
Record review of facility policy titled Crash Carts,

Checking, and Restocking/Exchange Crash
Carts, dated 04/19 showed the following
information:
I. Outcome standards
All emergency carts available to the nursing units

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will be checked on a routine basis to ensure that
required equipment is present, functional, and
supplies are available and current.
II. Process standards
A 2. The defibrillator will be checked by charging

to manufactures guidelines and discharged into
the system both plugged and unplugged. This is
to ensure that the battery is fully charged for use
away from an electrical outlet.
H. Exchange Crash Cart/Back up After Pharmacy

Hours
Exchange crash card to be used during the hours

the pharmacy is closed.
The exchange crash cart or identical to the adult

crash carts with all stock and equipment
provided.
The exchange crash cars are clearly marked with

large block letters to identify them as exchange
cards on the front of the cart.
United Memorial Medical Center will have to

exchange cards each assigned for after
pharmacy hour use.
Record review of facility policy titled:

Telemetry-floor Patient, Department Critical Care
Unit, dated 02/19.
I. Outcome standards
There will be establish guidelines to provide

nursing care to patient on the medical floor who
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require telemetry monitoring.
A licensed nurse or unit telemetry technician who
has completed the basic electrocardiogram
course will be assigned to observe telemetry 24
hours a day
Record review of facility IT tickets for monitors

from December 1 to current date, 1/6/2021,
showed the following information:
12/10/20 12:40 PM- the nurses are saying the

monitors that they switched out yesterday I've
gone off line again on a more critical patient.
12/14/20 9 AM- we have four (4) monitors that

are off-line station 4
12:18/20 10:55 AM-we have eight (8) patients

that are off-line on station 4
12/23/20 10:35 AM- we have patient monitors

that are going off line on station 4
12/28/20 8:55 AM- we have about nine (9)

patients off the monitor on station 4 and station 5
1/5/21 11:40 AM- we have monitors that are

off-line
1/6/21 9:35 AM- we four (4) have patients that are

off-line
Observation on 12/31/20 at 9:30 PM on the 400

hallway showed the unit to be cluttered and dirty.
There was equipment including one (1)
defibrillators on the floor with cords wrapped
around it not charging. There was an unidentified
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cart in the hallway which contained one (1)
defibrillator on top upside down with cords
tangled and wrapped around the cart, not plugged
in
Interview with RN (X) at the time of observation

confirmed that these were the defibrillators that
were available for use in emergent situations. I
don't know who is responsible for checking the
defibrillators.
Observations on 12/31/20 at 10:00 PM showed

an emergency cart located at the nurse's station,
none of the equipment was plugged in charging.
Interview with RN (X) at the time of observation

stated yes that is the crash cart it is supposed to
be on the unit plugged in and charging. There
was a code earlier and it has not been returned to
its proper place yet.
Observation on 12/31/20 at 10:15 PM at the

nurse's station for the 400 and 500 units revealed
two computer monitors that displayed cardiac
monitoring for each patient. Eight (8) of the
patient's (ID#s 111, 124, 131, 132, 134, 135, 136
and 137) monitors read "this monitor is off-line".
RN (W) stated at the time of observation that the

monitors were frequently off-line and there is not
a monitor tech on the unit. She stated that the
nurses are required to monitor all their patients
while providing patient care.
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During an interview with RN (DD) on 1/2/21 at

6:30 AM, she stated monitors off line A LOT."
Interview with Unit Secretary (A6) for Units

400/500 on 1/4/2020 revealed that she is only
there three days each week. She is responsible
for contacting IT if the monitors go off-line. She
stated that the tickets usually get put in when she
is there. The nurses do not always have time to
put in a ticket, I don't know if they all know how to
do it.
Interview with confidential RN (A4) on 1/4/2021 at

3:00 PM revealed that defibrillators don't always
work, a couple of weeks ago we had a code and
had to run to other parts of the hospital to find
one that worked. The central monitors are often
off-line. If we have a patient on a critical drip, we
have to go all the way back to the patient room to
check. My current patient is on a levophed drip
right now.
During an interview with confidential RN (A5) on

1/4/2021 at 3 PM, she stated "When we first
started working here the crash carts and
defibrillators were not be in checked. Sometimes
we find the defibrillators not plugged in. We check
them."
During an interview with RN (CC) on 1/4/2021 at

3:05 PM, she stated that "The monitors are
off-line a lot. My main concern is patient safety.
For example, I have a patient on an insulin drip.
This patient is fluid overloaded as many are. I
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think the monitors have two ways of connecting
but each time my monitor goes off-line, I have to
restart it and move it farther away from the vent in
order for it to pick up at the nurse's station."
Interview with RN (G) 1/4/2021 at 3:1, she states

"the defibrillators do not always work, or it's not
plugged in. One time recently we had to go in the
hospital, off the unit, to find one during a code.
During an interview with IT Systems Network

Administrator (VV) on 1/4/2021 at 1:30 PM, he
stated that the cardiac monitoring system was a
wireless system that worked from Wi-Fi. He
acknowledged that the monitors do sometimes go
off-line. He stated that sometimes it is a simple
ethernet switch that needs to be reset, or it can
be too much Internet traffic. He stated that they
have contacted the vendor and the connection
problems have gotten better. He stated that if the
nurses or the unit secretaries don't call to let us
know the monitors are off-line, we don't know to
fix it. He also stated that there are two different
systems covering the critical care COVID units.
He stated that sometimes when one of the pieces
of equipment isn't working properly the staff will
exchange it with another that is only compatible
with the other system. This creates problems
which includes the monitoring to be off-line. He
stated that he is responsible for training staff on
how to submit tickets and about the system. He
said that there is new staff every day, making the
situation more difficult. He also stated that there
were not any planned upgrades at this time to
address the issue.
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Unsecured access door to the facility
Observation of 10 exterior exits doors of the

facility revealed one exterior door that provided
direct access to the 500 Intermediate Care
COVID hallway was held open by a brick on the
following dates and times:
12/31/2020 at 22:04 along with Registered

Nurses Employee ID #s W & X.
01/04/2021 at 14:00 along with Employee ID #I,

Engineering Maintenance and Employee ID #V,
Administrative Assistant.
01/05/2021 at 08:27 observed by surveyor.
01/06/2021 at 11:00 was observed with Employee

ID #I, Engineering Maintenance.
Interview on 1/06/2021 at 11:00 with Employee ID

#I, Engineering Maintenance confirmed the door
should have been closed and locked and not
propped open to prevent unauthorized access to
the hospital's COVID unit.
A 489 Condition of Participation: Pharmaceutical Se A 489
CFR(s): 482.25
§482.25 Condition of Participation:

Pharmaceutical Services.
The hospital must have pharmaceutical services

that meet the needs of the patients.
The institution must have a pharmacy directed by
a registered pharmacist or a drug
storage area under competent supervision. The
medical staff is responsible for
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developing policies and procedures that minimize
drug errors. This function may
be delegated to the hospital's organized
pharmaceutical service.
Based on record review and interviews, facility
failed to:
A) ensure investigational drug protocols were

reviewed / approved by the facility Pharmacy &
Therapeutics Committee; Medical Executive
Committee; and the Governing Body prior to
administration of the medications to 66 patients
(Patient IDs: 39 through 104, and #181 );
B) provide effective nursing education regarding

the investigational drug protocols;
C) develop & implement policies related to

investigational drugs that included: review
labeling, and distribution.
Cross refer: A-0491

review, the facility failed to ensure drugs and
biologicals were stored per facility policy and in a
manner to prevent access by unauthorized
individuals for both controlled and non-controlled
drugs.
A 491 PHARMACY ADMINISTRATION A 491
CFR(s): 482.25(a)
[§482.25 Condition of Participation:
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Pharmaceutical Services
.....The medical staff is responsible for developing
policies and procedures that
minimize drug errors. This function may be
delegated to the hospital's organized
pharmaceutical service.]
§482.25(a) Standard: Pharmacy Management

and Administration
The pharmacy or drug storage area must be
administered in accordance with
accepted professional principles.
Based on record review and interviews, the
hospital's pharmacy services failed to ensure safe
and appropriate administration of investigational
drug protocols related to COVID-19. The facility
failed to:
A) ensure investigational drug protocols were

reviewed / approved by the facility Pharmacy &
Therapeutics Committee, Medical Executive
Committee, and the Governing Body prior to
administration of the medications to 66 patients
(Patient IDs: 39 through 104, and #181 );
B) provide effective nursing education regarding

the investigational drug protocols that included:
patient consent process, and drug administration
to include side effects and patient monitoring;
C) develop & implement policies related to

investigational drugs that included: review
process, approval, supervision, monitoring,
pharmacy control of storage, dispensing, labeling,
and distribution.
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Findings for A):
Record review of facility policy titled "Pharmacy &

Therapeutics Committee, "review date 2/05, read:
"Functions of the Committee....establish
standards concerning the use and control of
investigational drugs..."
During an interview on 1-07-2021 at 10 AM with

Staff D, Pharmacy Director, he said the facility
had three (3) different investigational drug trials
that had been approved by the P & T Committee
on 9-24-20 and forwarded to the MEC and
governing body and approved.
Review of the P & T committee minutes, dated

9/24/20 showed :
a. DAS-181 :" a novel recombinant sialidase"-

[given by nebulizer tx per Pharmacy director]
b. Regeneron: "a monoclonal antibody

combination"-[given by IV per Pharmacy director]
c. BGB-311: "protein kinase (BTK) inhibitor

inhibitor"-[given by capsule per Pharmacy
director]
" All presentations were reviewed and approved

to include P & P " [*see letter "C Findings" below]
Pharmacy Director went on to say there was

another investigational drug study "FIS/
Losamopid" study which will be presented to the
P & T Committee next month (February 2021)."
This study belonged to Staff C, MD's study.
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Staff D said that there was a outside Institutional
Review Board (IRB) and a "study coordinator" for
the drug studies. They work closely with the
physicians and help gather the research data.
Side effects and adverse drug reactions were
documented the same as any other drug. The
physicians were in charge of the protocols. The
DAS-181, Regeneron, and BGB-311 were Staff
YY, MD 's studies.
The Pharmacy director was asked about stem

cell research trials for COVID-19. He said there
was some of this done in the summer: in
June/July--maybe 2 or 3 times-unsure exact
amount. He said, the pharmacy had no
involvement with the stem cell study. Stem cells
were brought in on dry ice directly to the unit. He
was unable to state who brought the stem cells
into the facility or provide the names of the
patients who received them. He said maybe the
physicians would have a list.
During an interview on 01/06/2021 at 4: 15 PM

with Staff C, Chief of Staff, he presented an
overview of the investigational drug study
process. He said there was a centralized IRB.
Once the IRB approved all components of the
drug study, it was OK to begin. There was
established criteria for patient for inclusion and
exclusion; and consents were obtained. If a
patient was on a ventilator, the next of kin
consented.
Record review on 01/07/2021 of a report provided

by Director of Pharmacy showed the total number
of the investigational drugs that had been
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administered since the beginning of the
pandemic. The report, [dated March 2020 thru
January 5, 2021] included: patient name; name of
drug; ordering physician, and number of doses.
Review of the report showed all of the

investigational drug studies had been
implemented prior to approval by P & T
Committee. The FSI /Losamopid drug protocol
had not been presented to P & T Committee or
MEC, Governing Body, as yet. None of the 4
investigational drug studies had been approved
by the MEC and Governing Body.
*Regeneron (monoclonal antibodies):began

on 08/08/2020: 5 patients ( ID #s 39-43)
*DAS-181 investigational drug study: began

on 05/22/2020 : 41 patients ( ID# s 44- 83 and
#181)
*BGB-3111 investigational drug study began

on 09/05/2020: 10 patients ( ID #s 84-93)
*FSI/Losamopid investigational study began

on 11/06/2020: 10 patients (ID #s 94-104)
Record review on 01/07/2021 of facility "draft"

MEC and Governing Body meeting minutes dated
09/24/2020 showed Regeneron, DAS-181, and
BGB-311 investigational protocols were reviewed.
The meeting minutes did not state the
investigational drug studies had been approved.
Findings for B):
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with Staff C, Chief of Staff, he said all of the
nurses received training regarding the
investigational drug studies: " what does the drug
do and what are the side effects ? For example,
for DAS-181, you have to watch the liver function
studies and the cardiac QT wave."
During interviews on 01/05/2021 between 1:30

PM and 2:30 PM with staff RNs who worked the
300 & 400 COVID Units, they said:
RN Staff JJ : said we "learn as we go...there

were some stem cells given this past summer.
There are other drugs now. Nurses role with the
studies is sometimes we draw blood or collect
sputum. No special training on side effects or
specific patient monitoring."
RN Staff GG : said she gave the drug

FIS-Losamopid last week to a patient. She knew
it was part of a drug study. Staff GG was not
given any specific training related to this drug but
she looked it up. She said she was unsure who
obtained the consent-thought maybe the
physicians did.

with Staff B, CNO, she was asked what specific
training did the nursing staff receive related to the
investigational drug studies? The CNO provided
surveyor a 2 page form titled " Protocol
FIS-001-2020 Infusion/Exclusion Checklist."
Review of this document showed 11 yes/no
criteria screening questions for "Inclusion" and 12
for "Exclusion." The CNO said "This is all we
have."
Immediately prior to survey team exit on

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01/07/2021 , an unnamed staff person provided
surveyor a copied booklet titled "LOSVID Pocket
Protocol." This unnamed staff person told
surveyor this was found in a nursing unit.
Findings for C):
Record review of facility policy titled "Pharmacy &

Therapeutics Committee,"review date 2/05,
included a section labeled: "Investigational Drug
Usage Policy" that read: 'The use of
investigational drugs at this facility is prohibited
unless the prescribing physician is the authorized
investigator designated by the F.D.A. or the
National Institute of Health. The study has to be
approved by the hospital's Investigational Drug
Review Board. In that case, the physician must
administer the medication himself or authorize
the patient to do so.'

with Staff D, Pharmacy Director, he was asked to
explain the above referenced policy. The
Pharmacy Director said "prior to COVID-19, we
did not allow the use of investigational drugs. We
wanted the doctor to be in charge." Staff D was
asked if the pharmacy had 'investigational drug'
policies that addressed the following: review
labeling, and distribution. The Pharmacy Director
said the facility did not have polices that
addressed these issues.
A 502 SECURE STORAGE A 502
CFR(s): 482.25(b)(2)(i)
§482.25(b)(2)(i) - All drugs and biologicals must
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be kept in a secure area,
and locked when appropriate.
review, the facility failed to ensure drugs and
biologicals were stored per facility policy and in a
manner to prevent access by unauthorized
individuals. The facility failed to ensure :
A) the medication storage room was secure

[key-pad entry code was written on a paper
posted on the med room door];
B) controlled drugs were secure [narcotic cabinet

keys were easily accessible on the unit counter;
and known to staff without authorized access];
C) medications kept in the floor stock cart were

secured [code to med cart was written on the
cart];
D) vials of medications used for rapid intubation

were not accessible in the patient hallway;
E ) IV medications were properly discarded after

administration : labeled for Patient IDs # 6, 7, and
8; all were accessible in the general unit hallway.
[citing 1 of 2 hallways observed - 400 hallway]
Findings:
Record review of facility policy titled: "Security

and Theft: Controlled Substances," dated 8/98
showed:" Security as Applies to
Nursing":"Schedule II drugs are stored in locked
medication cabinets...Only one person per shift is
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responsible for the security of the scheduled
drugs in each medication center."
Record review of facility policy titled: "Medication

Use Processing: Dispensing, Handling, and
Storage of Medications," revised date 02/2005,
showed: '"Hospital-Wide Medication Security:
nursing medication carts are locked at all times
assuring medication security...all floor stock
medications are locked up to prevent theft and
tampering with medication."
Findings for A ):
Observation on 12/31/20 at 9:30 PM during the

initial tour of the 400 hall / COVID unit showed a
room near the nurse's station with a key pad
entrance. A paper was taped to the door with a
listing of "high alert meds" and other medications.
At the top left of the page in large numbers &
circled was the number "452."
During an interview at the time of observation with

Staff W, RN she was asked the significance of
"452" ? She said it was the key pad code to the
door, and then opened the medication room.
Observation inside the medication room showed
a locked wall-mounted cabinet in the back corner
of the room. Staff ID W said those were the
controlled drugs.
When asked who had access to the controlled

drug cabinet, RN W said "anyone who can get the
keys from the orange cup sitting on the counter at
the nurse's station." A orange-colored metal cup
was located in plain view on the counter,
accessible to anyone. RN W took a set of keys
on a leather key ring from the cup.
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Staff W, RN unlocked the controlled drug cabinet.

Observed inside the cabinet were the following
Schedule II controlled drugs (approximate
counts) :
two (2) boxes injectable fentanyl citrate vials

10 mcg/ 2 ml
twelve (12) + vials: meperidine (Demerol): 25

mg/ ml
one (1) box of midazolam (Versed) injectable:

2 mg/ml
two (2) boxes: morphine sulfate carpujets: 2

mg/ml vials
two (2) boxes: morphine sulfate carpujets : 4

mg/ml vials
six (6) hydromorphone (Dilaudid) injectables

plus 1 box of Dilaudid 1 mg/ml
one (1) 10 ml / multidose vial Versed (50

mg/10 ml) connected to small bag of IV fluid
Findings for B) :
Observation at the nurse's station on 1/04/2021 at

1:15 PM in the 400 hall/ COVID unit showed
Staff ID SS, unit secretary, sitting at the desk.
Surveyor was reviewing medical records at the
nurses' station.
Continued observation showed the same orange

metal cup located on the counter that was
observed on 12/31/20. It contained a couple of
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pens and the leather key ring.
Surveyor picked up the leather key ring and

asked the unit secretary: "what are these for?"
The Unit secretary replied: "Those are the
narcotic keys."
Findings for C) :
Observation in the 400 hallway on 12/31/20 at

9:45 PM showed a medication cart labeled as
"Station 4 floor stock" medications. Medications
listed on the cart's drawer labels included :
cymbalata; heparin; Imitrex; phenergan; robaxin;
solumedrol; and toprol XL (not all inclusive). The
cart was locked ; it had an numerical key pad
entry numbered 0-9.
Interview at the time of observation with Staff X,

RN, she was asked the meaning of the
handwritten numbers "2080" written on the front
of the cart ? Staff X said: "that is the code to
unlock the cart."
Findings for D) :
Observation on the 400 hallway on 12/31/20 at

approximately 9:40 PM showed an unsecured
bag of medication located on top of a cart. The
bag was labeled "RSI Kit" (rapid sequence
intubation). The bag contained the following
drugs: rocuronium, etomidate, atropine,
lidocaine--total of 7 medication vials. At time of
observation, RN Staff X said those drugs should
not have been left there and accessible.
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Findings for E) :
Continued observation on the 400 hallway on

12/31/20 at approximately 9:45 PM showed the
following medications left in the hallway:
Patient ID # 6 : IV medications left hanging on an

electronic IV pump included : solumedrol;
ascorbic acid; and magnesium sulfate.
Patient ID # 7 : IV medication-ascorbic acid:

located in a wire basket on a vital sign machine.
Patient ID # 8 : IV medication- solumedrol:

located in a wire basket on a vital sign machine.
A 747 INFECTION PREVENTION CONTROL ABX A 747
STEWARDSHIP
CFR(s): 482.42
The hospital must have active hospital-wide

programs for the surveillance, prevention, and
control of HAIs and other infectious diseases, and
for the optimization of antibiotic use through
stewardship. The programs must demonstrate
adherence to nationally recognized infection
prevention and control guidelines, as well as to
best practices for improving antibiotic use where
applicable, and for reducing the development and
transmission of HAIs and antibiotic resistant
organisms. Infection prevention and control
problems and antibiotic use issues identified in
the programs must be addressed in collaboration
with the hospital-wide quality assessment and
performance improvement (QAPI) program.
review, the facility failed to employ methods for
preventing and controlling the transmission of
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infections per facility policies and professional
infection prevention guidelines.

review, facility leadership failed to:
a. ensure effective implementation of a

COVID-19 screening process for staff, visitors,
and vendors per CDC recommendations; and
b. ensure systems were in place to prevent

patients (patients 21-38).
A 749 INFECTION CONTROL PROGRAM A 749
CFR(s): 482.42(a)(2)
The hospital infection prevention and control

program, as documented in its policies and
procedures, employs methods for preventing and
controlling the transmission of infections within
the hospital and between the hospital and other
institutions and settings;
review, the facility failed to employ methods for
preventing and controlling the transmission of
infections per facility policies and professional
infection prevention guidelines.
Citing 2 of 2 patient care units observed [400 &

500 halls].The facility failed to :
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A) ensure proper disinfection and storage of
patient care equipment [hallways];
B) keep clean patient equipment and dirty

supplies separate ;
C) maintain a sanitary environment to prevent the

spread of infection ;
D) keep biohazard sharps container emptied per

policy to prevent staff exposure to contaminated
needles /syringes;
E) store linen in a manner to prevent

contamination;
F) keep hallways uncluttered to facilitate proper

cleaning of floors.
Findings:
Record review of facility policy titled: "Infection

Control Program," dated 1/19, showed 'Program
Elements' included periodic observation of patient
care areas to assure maintenance of standard
and contact precautions....and review of
hazardous waste management and disposal
throughout the facility....
"Plant Operations will collaborate with ICP...to

ensure that all aspects of the environment related
to infection prevention and control are met..."
Observations on 12/31/2020 between 9:20 PM

and 10:30 PM in the 400 and 500 hallways
showed the following:
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A) Proper disinfection / storage of patient care
equipment :
Record review of facility policy titled: "Cleaning

and Disinfection Equipment," revised date 10/18,
showed the purpose of the policy was to minimize
risk of infection to patients, employees and
visitors through cleaning/disinfection of
environmental surfaces, patient care items, and
equipment. Hospital approved disinfectants must
be used:
"...IV pumps: disinfected daily and as needed.

Between patients-thoroughly disinfect and cover
with clear trash bag and return to designated
storage area.
* wheelchairs and stretchers at least weekly;

between patients and as needed with
disinfectant.
* Bedside commodes:between patients

thoroughly disinfect, cover with clear trash bag
and return to designated storage area. Do not
store dirty commodes in hallways.
*any moveable patient equipment: disinfected

between patients and as needed.
* Floors (general patient care, ICU): disinfect

daily, between patient use and as needed when
visibly soiled....floors will be cleaned on a regular
basis...."
Observations 400 hallway:
*one (1) portable bedside commode was located

outside a patient room in the hallway. A red
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biohazard bag was visible under the toilet seat
[used instead of a bucket].
*one(1) contaminated electronic IV pump

machine with IV fluids/medication still attached
(labeled for for Patient ID 6).
*one (1) hypothermia machine (Zoll "Thermogard

XP") with a bag of IV fluid attached to the
machine. The machine was uncovered; and had
dust, dirt and debris observed on the top and
sides of machine and the monitor.
*one (1) pulse oximeter machine [Nellcor

'Bedside SpO2 Patient Monitoring System']-this
machine was uncovered & had a white, splotchy
film and dust located over all the surfaces of the
machine.
Interview at the time of observation with Staff ID#

W. RN, she said all of the equipment in the
hallway had been used for current patients.
B) Separation of clean equipment and dirty

supplies:
In a large open room located at the end of the

400 hallway, the following was observed:
one (1) patient hospital bed with clean "linen

hamper "bags laying on top
seven (7) patient monitors-not covered
two (2) Bairhugger machines (used to warm

patients) -uncovered
multiple plastic bags of respiratory supplies.

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cart with opened plastic bag on top that contained

"clean" mop heads & cloths
multiple, biohazard cardboard boxes (folded

/unused)
dirty mop and broom
bottle of spray cleaner
open plastic wastebasket--with trash inside
one (1) open bottle of bleach laying on its side on

the floor; wet splashes noted across the floor
C) Maintenance of a sanitary environment to

prevent spread of infection:
Observation in the 500 hallway included:
*one (1) open bucket (approximately 5 gal) of

water draining from negative air pressure / air
handling machine. The unit and bucket were
located directly in the patient hallway between
patient rooms. The clear hose extending from the
machine to the bucket had visible blackish areas
noted in several places. The bucket was
approximately 1/2 full. A large amount of what
appeared to be dirt / soil was noted inside the
bottom of the bucket of drained water.
* observation showed a supply / work room with

trash on the counter alongside clean IV supplies
and extension tubing; some "clean" packaged IV
supplies on floor on floor; metal cart with blue pad
on top: contained IV supplies, tape--with 2 plastic
urinals hanging on side of the cart.
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*continued observation showed an open alcove to

the hallway that contained an IV pole; a
wheelchair with a linen bag in it; bucket with rags;
2 saniwipe containers with unknown contents ;
folded /unused biohazard boxes. Staff was
unable to state if this alcove was considered a
"clean or dirty" space.
Observation in the 400 hallway included:
*floors were very dirty and stained throughout;
*cart that contained styrofoam tray and cups

(patient food) . Food was located immediately
adjacent to medication & patient equipment;
* two(2) patient rooms had a wad of knotted

cables on the floor. These cables were located in
the doorways and extended into the hallway and
left dangling over the handrails. Interview at the
time of observation with Staff X, RN, she said
these were telephone cables.
D) Overfull biohazard sharps container:
Record review of facility policy titled "Bloodborne

Pathogen Exposure Control Plan", dated 1/25/98,
showed that "...sharps containers will be removed
by clinical staff when 3/4 full, the lid snapped and
placed into dirty utility room. Environmental
services will remove used sharps container from
dirty utility as part of their rounding.."
Observation in room 417 on 12/31/20 at 9:40 PM

showed an overfull biohazard sharps container
mounted to the wall. The container was filled
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well-past the designated "marked arrow" line to
empty. The container was locked. There were 3
to 4 syringes and plastic caps & tubing protruding
from the top "pull down handle."
During an interview at the time of observation with

RN Staff ID X, she reported the staff did not know
where the key was to unlock the sharps
containers in order to empty them.
E) Linen storage:
400 Hallway:
*observation showed two (2) "clean" sheets and

two (2) pillows -all stored uncovered on an
open-wire cart outside Room # 417. One pillow
was positioned directly on top of a plastic bin that
contained unknown items ; and the other pillow
was located underneath the bin.
* continued observation showed two (2) soiled

linen hampers --the tops were open on both.
F) Cluttered hallway:
Observation of the 400 hallway showed the floor

was very dirty and stained throughout. Patient
care equipment & supplies were stored on both
sides of the hallway. There was very little wall
space between patient room doors that did not
have something stored there, making effective
floor cleaning difficult.
Observations showed:
right side of hall:

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wire cart with linen and other supplies

two(2) soiled linen hampers (1 at each end of the
hall)
Hypothermia machine
wheelchair
electronic IV pump
portable bedside commode
unsecured oxygen tank
metal cart
left side of hall:
large plastic biohazard bin on the floor

three(3) large equipment/supply carts -located
immediately adjacent to each other
large negative air pressure/ air handling machine
electronic vital sign machine
A 770 LEADERSHIP RESPONSIBILITIES A 770
CFR(s): 482.42(c)(1)(i)
Standard: Leadership responsibilities
(1) The governing body must ensure all of the

following:
(i) Systems are in place and operational for the

tracking of all infection surveillance, prevention,
and control, and antibiotic use activities, in order
to demonstrate the implementation, success, and
sustainability of such activities.
A. Based on observation, interview, and record
review, the facility leadership failed to ensure
effective implementation of a COVID-19
screening process for staff, visitors, and vendors
per CDC recommendations. The facility failed to:
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Ensure multiple visitors and staff were screened
for COVID-19 prior to entry to the facility;
Develop and implement a policy or process that

addressed staff, visitor, and vendor screening for
COVID-19.
Findings:
Review of CDC "Interim Infection Prevention and

Control Recommendations for Healthcare
Personnel During the Coronavirus Disease 2019
(COVID-19) Pandemic," updated July 15, 2020,
recommended "...Screen everyone (patients,
HCP, visitors) entering the healthcare facility for
symptoms consistent with COVID-19 or exposure
to others with SARS-CoV-2 infection and ensure
they are practicing source control. Actively take
their temperature and document absence of
symptoms consistent with COVID-19. Fever is
either measured temperature =100.0°F or
subjective fever. Ask them if they have been
advised to self-quarantine because of exposure
to someone with SARS-CoV-2 infection...."
Review of facility policy titled "Hospital Planning

and Response Plan to Pandemic
Influenza,"revised date 4/19, showed Appendix V:
an established flow chart process to triage
patients who presented with "severe respiratory
illness without other diagnosis or radiographic
confirmed diagnosis " yes/no" algorithm : If
answered "yes" symptom questions were
triggered that included: fever, headache, fatigue,
sore throat, cough, difficult breathing..a "yes: to
symptoms triggers travel questions to "countries
with H5N1 [Avian Flu]"..and then questions
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related to contact with dead or living poultry? If
"yes": H5N1 strongly considered.. Appendix VI
flow chart is elated to patients who arrived by
ambulance: similar content to Appendix V.
The facility patient screening processes were not

specific to COVID-19 per CDC recommendations
but to H5N1 [Avian Flu].
The facility did not have a policy developed that

addressed COVID-19 screening of employees,
visitors, or vendors.
During an interview on 1/6/2021 at 2:15 PM with

Staff A, CEO, she stated COVID-19 screening
was done for everyone prior to entering the
hospital: staff, patients, visitors/vendors. The
person at the front desk asked the questions prior
to entry and directed them appropriately.
Observation on 12/31/2020 at approximately 9:

00 PM, a team of three (3) surveyors was allowed
access to the hospital with no COVID-19
screening conducted.
Observations on 1/4/2021 through 01/07/2021, a

team of six (6) surveyors was allowed daily
entrance to the hospital without any COVID-19
screening conducted.
Observation on 1/5/2021 at approximately 11:30

AM showed (2) two persons-who manually
opened the front entrance doors. They were
wearing scrubs and observed entering the
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hospital and went inside past the front desk. No
COVID 19 screening was observed.
Observation in the front lobby on 01/06/2021 at

1:15 PM showed a male in coveralls carrying a
large blue insulated bag. He had no visible name
tag on. He was given access through the
automatic secured doors by the front desk
person. No COVID 19 screening was observed.
Staff Screening:
On 01/5/2021 between 12:15 and 1: 15 PM,

surveyor interviewed six (6) Registered Nurses
(RN) on the 300, 400, and 500 hallways: staff RN
IDs: G; I, GG, JJ, HH, and KK. All six (6) RNs
said the facility did not screen staff for COVID 19.
During an interview on 1/5/2021 at 1245 PM with

Staff R, RN Employee Health Nurse she stated, "I
have been in this position for many years." When
informed that staff members were observed not
being screened upon entry into the hospital, Staff
R stated, "We have never done that." She
reported, "there are not any newly created or
updated policy and procedures regarding
COVID-19 and the need for the hospital to screen
staff" before their assigned work shifts. "The
employees know not to come to work sick."
Approximately "15" staff members have tested
positive for COVID since the "pandemic started."
The Employee Health Nurse stated, "I'm not
really sure because the scheduler keeps track of
that."
During an interview on the morning of 1/5/2021

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with Staff U, security guard at the hospital
information desk, he reported that he "never gets
screened" and "never sees any staff members"
being screened for COVID before their shifts. He
stated, "my security job told me to go get tested
to make sure I didn't have it a long time ago but
that's it."
Visitor/Vendor Screening :
During an interview on the morning of 1/04/2021

with Staff V, phone and information desk
operator, on the morning of 1/4/21 at the hospital
front entrance door, she reported that it was her
job to "greet the people at door," ask what they
are "coming to the hospital for," and direct them
to the right department. She stated that, "I just
ask them if they have a cough, congestion, and
fever or have been around anyone with COVID
symptoms." "If they need to go to the emergency
room and they do not have symptoms for COVID
I tell them to go to the registration desk." "If they
have symptoms of COVID, I have them call the
ER for help." Staff V said she did not take
patients' or visitors' temperature. "I just ask them
(patients and visitors) if they have a temperature."
"I was never given a thermometer."
B. Based on observation, review of the Contour

Blood Glucose Test Strips package insert
(revision 06/16), facility charge sheets and
confirmed in interview the facility leadership failed
to ensure systems were in place to prevent
patients (patients 21-38).
Findings:
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1. Observation in the Emergency Department,

ICU and Station 3 revealed the facility was using
the Contour Blood Glucose Monitoring System to
perform glucose testing of patients.
2. A review of the Contour Blood Glucose Test

Strips package insert (revision 06/16) revealed
the intended use was for
"self-testing by people with diabetes to monitor

glucose concentrations in whole blood";
"The meter and lancing device are for

single-patient use."
"Do not use on multiple patients!"
"All parts of the kit were to be "considered

biohazardous and can potentially transmit
infectious diseases, even after you have
performed cleaning and disinfection."
3. In an interview of Staff QQ on 1/7/2021 at 1205

hours in ICU revealed she used the Contour
Blood Glucose Meter ( serial number FB93784)
on multiple patients.
4. In an interview of Staff PP on 1/7/2021 at 1152

hours in ER revealed they used the Contour
Blood Glucose Meter (serial number FB52651) on
multiple patients.
5. A random review of facility charge sheets from

1019 and 2020 revealed glucometers were
documented as used on multiple patients daily.
A review February 26 2019 Glucometer charges

for Station 3 revealed 4 glucometer test
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performed on 2 different patients. (patients 33-34)
A review of July 13, 2020 Glucometer charges for

Station 3 revealed 8 glucometer tests performed
on 4 different patients. (patients 35-38)
A review August 05, 2020 Glucometer charges for

ER revealed 4 glucometer test performed on 4
different patients. (patients 29-32)
A review of October 13, 2020 Glucometer

charges for ICU revealed 25 glucometer tests
performed on 7 different patients. (Patients 21-
28).
6. In an interview of the Staff B on 1/7/2021 at

1600 hours she stated they had 1 glucometer
each of the 4 areas [ER, ICU, Station 3, Station
4/5] of the hospital.
7. In an interview with staff RR on 1/7/2021 at

1400 he stated that he was not consulted to
ensure the glucose test system used in the
hospital was appropriate for the testing
performed.

2567 UMMC Inspection 1-8-21

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PRINTED: 03/12/2021

DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

A 000 INITIAL COMMENTS A 000

Note: The CMS 2567 is an official, legal

An entrance conference was held at 9 p.m. on

Appendix A-Survey Protocol, Regulations and

An exit conference was held in the afternoon of

LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE TITLE (X6) DATE

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

A 000 Continued From page 1 A 000

The survey exit date was extended to 01/08/2021

The following CONDITIONS were not met:

Governing Body- CFR 482.12

Patient Rights - CFR 482.13

Pharmaceutical Services -CFR 482.25

Infection Prevention and Control -CFR 482.42

TX 00369179 was substantiated

ABG: arterial blood gas

CDC: Centers for Disease Control

CEO: Chief Executive Officer

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

A 000 Continued From page 2 A 000

CMS : Centers for Medicare and Medicaid

CV: curriculum vitae

F.D.A.: Food & Drug Administration

HCP: healthcare personnel

HIPAA : Health Insurance Portability and

HR: Human Resources

ICP: infection control practitioner

MAR: medication administration record

OGT : orogastric tube

PICC: peripherally inserted central catheter

RN: registered nurse

RT: respiratory therapist

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

A 000 Continued From page 3 A 000

SARS-CoV-2 : severe acute respiratory

Levophed (norepinephrine bitartrate)- is a

The hospital must be in compliance with

This STANDARD is not met as evidenced by:

Record review of the facility EMTALA policy

1. An individual presents anywhere in the

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

A 021 Continued From page 4 A 021

Based on observation on 01/05/2021 at

On 01/06/2021 at 11:06 am and 11:08 am a call

Interview on 01/06/2021 at 0915 with the ED staff

Phone interview with patient (ID# 9) on

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

A 021 Continued From page 5 A 021

Based on observation and interview the facility

On a tour of the emergency department on

Interview on 01/6/2021 with the charge nurse (ID#

There must be an effective governing body that is

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)

A 043 Continued From page 6 A 043

This CONDITION is not met as evidenced by:

The Governing Body :

1. Failed to ensure Patient ID # 9 had timely

2. Failed to review and approve an international

3. Failed to ensure nursing staff who worked the

4. Failed to ensure the patient's right to be

(X4) ID SUMMARY STATEMENT OF DEFICIENCIES ID PROVIDER'S PLAN OF CORRECTION (X5)