HospitalInspections.org

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 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 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).

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


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. Cross-refer to A-0502


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

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.

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 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 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.

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.

During an interview on 01/04/2021 at 1:20 PM 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 preparedness.

Review of the HR checklist for these "Observer" files did not include a reference to any of the above-listed components.

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 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 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 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 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."

>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 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:

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..."

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.
Cross-refer to A-0131

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.
Cross-refer to A-0143

C.) 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

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 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

-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 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 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 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 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.


Record review of medical record for patient (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.


Record review of medical record for patient (ID#17) showed consent form for peripherally inserted central catheter to treat my condition 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.


Review of medical record for patient (ID#18) 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.


Review of medical record for patient (ID#111) 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.


Review of medical record for patient (ID#112) 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.


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.

Based on observation, interview, and record 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 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 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 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 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 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 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."


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 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.

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:

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 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 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 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.


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 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.



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.

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 process; approval; supervision; monitoring; and pharmacy control of: storage; dispensing; labeling, and distribution.

Cross refer: A-0491

Based on observation, interview, and record 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.

Cross-refer to A-0502

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.



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.


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 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):

During an interview on 01/06/2021 at 4: 15 PM 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.

During an interview on 01/07/2021 at 2: 20 PM 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 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.'

During an interview on 01/07/2021 at 3:50 PM 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 process; approval; supervision; monitoring; and pharmacy control of: storage; dispensing; labeling, and distribution. The Pharmacy Director said the facility did not have polices that addressed these issues.

Based on observation, interview, and record 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 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.

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 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.


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.

Based on observation, interview, and record review, the facility 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


Based on observation, interview, and record 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 potential transmission of infectious diseases from the use of single use glucometers on multiple patients (patients 21-38).

Cross-refer to A-0770

Based on observation, interview, and record 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 :

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:

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 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.

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.

*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 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:

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. 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:

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 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 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.


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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 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."


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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 potential transmission of infectious diseases from the use of single use glucometers on multiple patients (patients 21-38).

Findings:

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 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.