HospitalInspections.org

Based on medical record reviews, review of hospital policies and procedures, interviews with administrative staff, tours of six patient care units, and review of related documentation, it was determined that the hospital failed to protect and promote the rights of each patient:

Findings include:

1. The facility failed to ensure that every patient was provided personal privacy. (Cross refer to Tag A 0143)

2. The facility failed to ensure that patients had the right to receive care in a safe setting. (Cross refer to Tag A 0144)

Based on a review of policy and procedure, a tour of one (1) of six (6) patient care units, and interviews with administrative staff, it was determined that a patient did not have physical privacy during a personal hygiene activity.

Findings include:

Reference: Policy and procedure titled "BOWEL AND BLADDER RETRAINING" states:
"I. POLICY:
Each patient who is incontinent or at risk of developing incontinence should be identified, assessed, and provided with individualized treatment and services to achieve and maintain as normal elimination function as possible.
II. DEFINITION:
Incontinence is defined as the inability to control the release of urine or stool.
.....
V. GENERAL CARE GUIDELINES:
.....
C. Provide privacy while still ensuring safety.
....."

1. A tour of the Kennedy Unit on September 9, 2021 was conducted, accompanied by Administrators #4 and #21. While passing Room A-125, a patient rest room, Staff #30, a Human Services Technician was observed assisting Patient #14 with toileting. The patient was standing in front of the toilet with with his/her pants and underpants down, exposing the patient from the waist down below his/her calves. The door to the room was fully open and there was a patient sitting in the common area across from the rest room, although his/her back was to the rest room.

2. Administrators #4 and #21 agreed with the findings.

A. Based on a tour of six (6) patient care units, interviews with administrative staff, and a review of policy and procedure, it was determined that ligature risk is not minimized.

Findings include:

Reference #1: Policy and procedure titled "SEARCH AND REMOVAL OF CONTRABAND IN THE ENVIRONMENT OF CARE" states:
"I. SCOPE OF AUTHORITY
A. AUTHORITY
Under the authority of the Chief Executive Officer and senior leadership of the Cabinet, all administrative, support, and clinical staff will assure that contraband and potentially dangerous objects will be identified and removed from the hospital environment in an expeditious manner.
B. STATEMENT
..... In order to reasonably assure and maintain healthy, safe, and secure conditions, it is essential that mandatory regular, random, and special contraband searches are conducted throughout the hospital when appropriate and that immediate action is taken to confiscate and secure items identified as contraband when they are found.
II. DEFINITIONS
A. CONTRABAND
Contraband is defined as any item/object that may threaten the health, safety and/or the security of patients or others in the hospital setting. For all patients in locked units' [sic] contraband includes the following:
.....
8. Any cord, string, rope, hand-made items (e.g., braided items, intertwined belts, pieces of cloth) that cannot be easily broken with minimal pulling apart in excess of 12 inches in length.
....."

Reference#2: Policy and procedure titled "RESPIRATORY EQUIPMENT -- C-PAP (Continuous Positive Airway Pressure) DEVICES - (CONTINUOUS POSITIVE AIR PRESSURE), and BI-PAP (Bilevel Positive Airway Pressure)" stated: ".....
E. Storage, Maintenance, and Repair:
All respiratory care equipment used in patient care will be stored in such a manner as to maintain the cleanliness of the equipment and following guidelines as established by the Manufacturer. Equipment should be labeled and cleaned equipment is stored in the Treatment Room when not in use, .....
....."

1. Administrator #1 stated that the above referenced policy and procedure is applicable to electrical oxygen concentrators as well as C-PAP and Bi-PAP machines.

2. During a tour of the Kennedy Unit on September 9, 2021, a positive behavior support unit which may house patients at risk for suicide, a patient bedroom was observed to have an electrical oxygen concentrator machine which had an approximately six (6) foot electrical cord attached to it. Interviews with Administrative revealed that one other patient presently in the hospital had a similar machine.

3. Administrators #1 and #2 agreed that the machine should not have been left in the patient's room.

On September 9, 2021, Staff #1 was notified that the above findings resulted in an Immediate Jeopardy (IJ). A copy of the completed IJ template was provided to Staff #1 at 4:17pm. An acceptable IJ removal plan was received from the facility on September 10, 2021 at 4:16pm.

On September 14, 2021, an onsite visit was conducted to assess facility compliance with the IJ removal plan. The onsite visit included:
Interviews with administrative staff;
Review of evidence of staff training;
Review of an attestation by administrative staff of the location of portable air purifiers in non-patient care areas; and
Review of documentation of psychiatrist or psychologist suicide screening of patients using a CPAP, BiPAP, or oxygen concentrator. If a patient using a CPAP, BiPAP, or oxygen concentrator had a roommate, review of a suicide screening of the roommate was also reviewed.
All air purifiers were determined to have been relocated to non-patient care areas.

The facility was in compliance with its IJ removal plan and the IJ was removed.

B. Based on a review of the medical record of one patient, review of policy and procedure, and review of related documentation, it was determined that the facility failed to provide protection for the patient's emotional health and safety.

Findings include:

Reference: Policy and procedure titled "SEARCH AND REMOVAL OF CONTRABAND IN THE ENVIRONMENT OF CARE" states:
"I. SCOPE OF POLICY
A. AUTHORITY
Under the authority of the Chief Executive Officer and senior leadership of the Cabinet, all administrative, support, and clinical staff will assure that contraband and potentially dangerous objects will be identified and removed from the hospital environment in an expeditious manner.
.....
II. DEFINITIONS
A. CONTRABAND
Contraband is defined as any item/object that may threaten the health, safety and/or the security of patients or others in the hospital setting. For all patients in locked units' [sic] contraband includes the following:
.....
20. Cell phones
.....
26. Cash, money, ..... and any other form of currency.
.....
Staff and visitors are prohibited from providing items to patients.
....."

1. A "New Jersey State Police Investigation Report" stated:
" .....
Division Case Number: ____-_____-_____
.....
Type of Premises: Health Care Facilities
Crime/Incident Location: TRENTON PSYCHIATRIC HOSPITAL / DRAKE BUILDING
Date & Time: At 16:50 - 2/17/2021
.....
Case Status: Investigation
Person Reporting Crime/Incident
Name: ______ _______ (first and surname of Patient #1)
.....
Crime/Incident Charges(s) & Statutes(s)
.....
(2C:30-2) - Official Misconduct
.....
Victims (Individuals)
Victim Name (First, Middle, Last): ______ ________ (first and surname of Patient #1)
.....
Suspects/Summoned
_______ _ _______ (first name, middle initial, and surname of Staff 18)
.....
Narrative
February 17, 2021 (Wednesday)
On the above date, at 1650 hours, Det. (Detective) _. _____ (Initial and surname) #____ and I responded to Trenton Psychiatric Hospital, Drake Building, Trenton City, Mercer County .....
.....
I then met with Drake Building _______ ________ (job title), _____ ______ (first and surname of Staff #46).
______ (surname of Staff #46) explained that _______'s (surname of Staff #18) position at Trenton Psychiatric is a Human Service Aid [sic], _______ (surname of Staff #18) is responsible for overseeing patients safety and well being and doing head counts. ______ (surname of Staff #46) explained that _______ (surname of Staff #18) worked in Drake West 1 and oversaw (surname of Patient #1) for approximately six months. .....
.....
Det. _____ (previously referenced surname) and I conducted a recorded Victim interview of in [sic] a private room in Drake West 1. .....
I concluded the interview at this time.
I responded to the office of _________ ________ __ _______ (Job title) ____ ________ (First and surname of Staff #13) office [sic]. ____ (first name of Staff #13) explained to me that after (surname of Staff #46) notified (him/her) of the incidents, (he/she) called _______ (surname of Staff #18) directly on February 16. ____ (first name of Staff #13) stated that _______ (surname of Staff #18) admitted to engaging in text message conversations with _______ (Patient #1) while off duty. _______ (surname of Staff #18) also admitted to engaging in video phone calls (FaceTime) with (surname of Staff #18) while off duty. _______ (surname of Staff #18) ..... _______ (surname of Staff #18) admitted that (he/she) had given _______ (surname of Patient #1) $100.00 at the "beginning". [sic] _______ (surname of Staff #18) was adamant to ____ (surname of Staff #13) that (he/she) had never engaged in any physical sexual activity with _______ (surname of Patient #1) and that it was all over the cell phone. ..... ____ (surname of Staff #13) stated that _______ (surname of Staff #18) was able to provide her two phone numbers for (surname of Patient #1), (___) ___-____ and (___) ___-____.
Det. _____ (previously referenced surname) and I responded to the residence of _______ (surname of Staff #18) ..... . Upon arrival, (surname of Staff #18) invited us in and (he/she) was asked to accompany us to Hamilton Station [sic] reference an interview regarding the incident and allegations occurring at work. (surname of Staff #18) obliged and was provided transport to Hamilton Station. Once at Hamilton Station, I escorted _______ (surname of Staff #18) into the interview room .....
A recorded audio/video interview was conducted by myself [sic] and Det. _____ (previously referenced surname). _______ (surname of Staff #18) admitted to engaging in cell phone text messages as well as video chats (FaceTime) with (surname of Patient #1). (He/She) admitted that (he/she) sent _______ (surname of Patient #1) of (him/her) pulling (his/her) shirt up, but never showed any intimate parts of (his/her) body in these messages. (He/She) explained that the messages were sexually suggestive, but did not reveal any intimate parts of (his/her) body. .....
I concluded the interview at this time.
....."
The report was electronically signed by "TPR. (Trooper) _ _ ________ " (initials and surname).

2. A "N.J. State Police Supplemental Investigation Report" stated:
" .....
Division Case Number: ____-_____-_____ (same numbers/letters as above referenced "New Jersey State Police Investigation Report.)
.....
Crime/Incident Location: TRENTON PSYCHIATRIC HOSPITAL / DRAKE BUILDING
Date & Time: At 16:50 - 2/17/2021
.....
Narrative
February 24, 2021 (Wednesday)
On the above date, cell phone search warrants for _______'s (surname of Staff #18) cell phone were drafted and approved by Mercer County J.S.C. Honorable _______ _. ________ (first name, middle initial, and surname).
.....
May 10, 2021
I retrieved all data extractions from Cyber Crimes and was able to review the results. I was able to examine a messaging thread through the application WhatsApp between _______ (surname of Staff #18) and _______ (surname of Patient #1). The content of the conversation was sexual in nature and contained recounts of past sexual acts between ______ (surname of Staff #18) and _______ (surname of Patient #1). Specifically on 12/05/2020 at 8:02pm, _______ (surname of Staff #18) messaged (Patient #1) "bathroom". [sic] This corroborated _______'s (surname of Patient #1) statement that they would meet in the bathroom for sexual intercourse. _______ (surname of Patient #1) states for _______ (surname of Staff #18) to let (him/her) know when. _______ (surname of Staff #18) then states that (he/she) can't make it to the meet up because (he/she) is on the board. On 12/07/2020 at 12:39am, _______ (surname of Patient #1) and _______ (surname of Staff #18) engage in a conversation where (he/she) states "i miss those lips too". [sic] _______ (surname of Staff #18) responds stating "oh, here we go again". [sic] _______ (Surname of Patient #1) states "you kiss so passionately". [sic] _______ (surname of Staff #18) states "o really". [sic] _______ (surname of Patient #1) states "yes" and _______ (surname of Staff #1) answers with a heart emoji. _______ (surname of Patient #1) then states "like nobody that ever kissed me". [sic] _______ (surname of Staff #18) states "please don't make yourself horny". [sic] _______ (surname of Patient #1) answers "Why" "I am always anyway" "You know that huh". [sic] _______ (surname of Staff #1) answers with "Thinking about those days". [sic] _______ (surname of Patient #1) answers "I always do" "I get excited then" "and go to my room". [sic] _______ (surname of Staff #18) then asks _______ (surname of Patient #1) "How often do you jerk off these days". _______ (surname of Patient #1) answers "pretty much every time I see u pretty much do" and _______ (surname of Staff #18) answers "oh ok". [sic] _______ (surname of Patient #1) states "I loved when you watched" "u was such a good (girl/boy)". [sic] _______ (surname of Staff #18) then states "mr big dick". _______ (surname of Staff #18) states "damn, it seems like I'm always on your mind". [sic] _______ (surname of Patient #1) answers "u r". [sic] _______ (surname of Staff #18) states, "because I was your recent I'm guessing". [sic] _______ (surname of Patient #1) answers, "and best". [sic] _______ (surname of Staff #18) states "now you are getting me excited". [sic] _______ (surname of Staff #18) asks _______ (surname of Patient #1) "so what are you doing right now". [sic] _______ (surname of Patient #1) answers "squeezing my dick sweetie". [sic] _______ (surname of Staff #18) states "I wish I was there in person". [sic] _______ (surname of Patient #1) states "rubbing it up and down" "pretending its in your mouth". _______ (surname of Staff #1) answers "I want to suck on it". [sic] _______ (surname of Patient #1) states "I would love that". [sic] _______ (surname of Staff #18) answers "I like it when you hit it from the back". [sic] _______ (surname of Patient #1) answers, "you're so tight" "it was really good". _______ (surname of Staff #18) answers "was it". {sic] _______ (surname of Patient #1) answers "yes". [sic] ________ (surname of Staff #18) answers "especially when you penetrated" "it was so good". _______ (surname of Patient #1) states "I really want to again" [sic] _______ (surname of Staff #18) answers " I felt it". _______ (surname of Patient #1) states, "I want to shoot a load inside you again". _______ (surname of Staff #18) answers "I like it when your dick is really hard" "and squeezing on my breast" "or sucking my nipples". [sic] This sexual conversation continues until they finally say goodnight at 0126 am.
.....
The report was electronically signed by "TPR. (Trooper) _ _ ________ " (previously referenced initials and surname).


40822

C. Based on review of four (4) patient medical records (#2, #8, #9, #10), facility policy and procedure, and staff interviews, it was determined that the facility failed to implement their policy and procedure for the safe and accurate administration of medication in three (3) of four (4) patients.

Findings include:

Reference: Facility policy titled, "Medication Administration" states, "... . II. Purpose: To ensure the safe and accurate administration of medication(s). ... . IV. Procedure: ... . K. Documentation of Medication Administered. 1. The nurse documents administration of a medication by entering his/her initials in the appropriate block on the Medication Administration Record (MAR) immediately upon administering any medication. a. Nurse must sign full name and initials on the back of the MAR, to identify the initials. This is necessary once for each page of the patient's MAR. ... . c. If the patient refuses to take the medication, or is not on the unit, initial the appropriate block, and circle the initial. ... . e. In addition, the nurse will describe in the Progress Notes and 24-Hour Report why any ordered medication was not given. If the patient refuses to take medication, the refusal shall be documented on the 24-Hour Report, and the Prescriber/MOD shall be notified immediately. ... . "

1. On 9/13/2021, a medical record review was conducted and the following was indicated:

a. The MAR of Patient #2, dated 8/5/21 through 8/19/21 was void of full signatures and initials on the back of the MAR, from all of the administering Nurses.

b. The MAR of Patient #9, dated 7/23/21 though 8/19/21 was void of full signatures and initials on the back of the MAR, from all of the administering Nurses.

c. The MAR of Patient #10, dated 6/25/21 through 7/22/21 was void of full signatures and initials on the back of the MAR, from all of the administering Nurses.

(i) Upon review of the MAR of Patient #10, on 6/21/21 a medication order entry states, "Vitamin D3 50,000 Units PO [by mouth] Q weekly [once per week] for six (6) weeks for Vitamin D deficiency; Hour-8 AM."

(ii) On 7/6/21, a Nurse initialed and circled his/her name in the 8 AM medication administration block.

(iii) On 7/20/21, a Nurse placed the letter "R" and circled the letter in the 8 AM medication administration block.

(iv) There was no documentation on the back of the MAR, in the patient progress note, nor on the 24-hour report to describe the reason the medication was not given and to indicate that this was reported to the prescriber or MOD for the above two dates.

2. On 9/13/2021 at 12:15 PM, Staff #25 stated that any nurse administering medications and documenting on the MAR, must provide their full signature, initial, and title as a means to identify who has administered the medication.
He/she further states that an initial with a circle or an "R" with a circle on the MAR indicates that the patient did not receive the medication, which should be reported to the Physician and also documented.

3. On 9/13/2021 at 3:00 PM, the above was confirmed by Staff #2.

Based on observation, facility documentation review, and staff interview, it was determined that the facility failed to ensure that an adequate infection control program that seeks to minimize infections and communicable diseases is implemented.

Findings include:

1. The facility failed to ensure that a qualified Infection Control Professional (ICP) was designated to oversee the facility's Infection Control Program. (Cross refer to Tag A 0748)

2. Based on staff interviews and review of personnel/education files, it was determined the facility failed to demonstrate that the individual(s) identified as the facility Infection Prevention Specialist(s) are appointed by the governing body. (Cross refer to Tag A 0748)

3. The facility failed to ensure an Infection Control program for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel is implemented. (Cross refer to Tag A 0749)

4. The facility failed to properly prevent and/or contain COVID-19 by adhering to screening protocols at facility entry points. (Cross refer to Tag A 0749)

5. The facility failed to properly prevent and/or contain COVID-19 through acceptable use of PPE in the care of a patient confirmed as COVID-19 positive or a PUI [Patient Under Investigation] for COVID-19. (Cross refer to Tag A 0749)

6. The facility failed to ensure implementation of policies and procedures addressing COVID-19 screening protocols. ( Cross refer to Tag A 0772)

7. The facility failed to ensure that manufacturer's instructions for use (IFUs) for its disinfectants are followed in accordance with the CDC [Centers for Disease Control and Prevention] guidelines. ( Cross refer to Tag A 0772)

8. The facility failed to ensure that manufacturer's instructions for use (IFUs) for its glucometer was readily available and followed in accordance with CDC [Centers for Disease Control and Prevention] guidelines. (Cross refer to Tag A 0772)

A. Based on staff interview and document review conducted on 11/12/2021, it was determined that the facility failed to ensure that a qualified Infection Control Professional (ICP) is designated to oversee the facility's Infection Control Program.

Findings include:

1. Review of the Infection Prevention Committee meeting minutes dated October 6, 2021, indicated that Staff #18 was the Infection Control Committee Chairperson.
Upon interview, Staff #2 stated that Staff #18 did not obtain CBIC certification or an Infection Control specialty certification through the American Board of Internal Medicine and/or recent specialized training in Infection Control.

2. The above finding was confirmed by Staff #2.


40822

B. Based on staff interviews and review of personnel/education files, it was determined the facility failed to demonstrate that the individual(s) identified as the facility Infection Prevention Specialist(s) are appointed by the governing body.

Findings include:

1. On 9/9/2021 at 11:45 AM, Staff #3 stated that he/she is the day to day Infection Control Preventionist Registered Nurse. He/she further stated that Staff #25 and Staff #11 assist him/her in the Infection Preventionist duties.

a. On 9/10/2021 at 12:30 PM, Staff #5 stated that their Infection Preventionist(s) are not appointed titles; The Infection Preventionist(s) role is more of a "functional title." The Infection Preventionist(s) were not appointed by the Governing Body.

2. On 9/10/2021 upon request to review the personnel/education files of Staff #3, Staff #11, Staff #25, and Staff #44, the following was indicated:

a. The personnel/educational file of Staff #3 was void of a job description identifying Staff #3 as the facility Infection Control Preventionist. This employee file indicted the employee's role as: Charge Nurse Full Time.

b. The facility was unable to produce the employee file of Staff #25 for review.

3. The above was confirmed by Staff #1, Staff #5, and Staff #6 on 9/14/2021 at 12:00 PM.

A. Based on observation, staff interviews, and document review conducted on 11/12/2021, it was determined that the facility failed to ensure an Infection Control program for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel is implemented.

Findings include:

1. Upon request of the Infection Control Program, Staff #2 provided a drafted document titled, "Infection Prevention Plan 2021." Staff #2 stated that the Infection Prevention Plan for the year 2021 was still in draft and had not been approved.

2. The above finding was confirmed with Staff #3.


40822


B. Based on observations of (2) two of (2) two patients (Patient #2 and Patient #3), staff interviews, nationally recognized infection control guidelines, and review of facility documents, the facility failed to properly prevent and/or contain COVID-19 through acceptable use of PPE in the care of a patient confirmed as COVID-19 positive or a PUI [Patient Under Investigation] for COVID-19.

Findings include:

Reference: "www.fda.gov/medical-devices/letters-health-care-providers/update", states, "Update: FDA [Food and Drug Administration] no longer authorizes use of non-NIOSH approved or decontaminated disposable respirators ... . June 30, 2021. The U.S. Food and Drug Administration (FDA) is revoking the Emergency Use Authorization (EUAs) for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021) ... . As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. These actions are in follow-up to the May 27, 2021 letter (/medical-devices-letters-health-care-providers ...), in which the FDA recommended a transition away from non-NIOSH approved disposable respirators ... ."

1. On 9/10/2021 upon staff interviews, the following was indicated:

a. At 10:15 AM, Staff #2 stated that no one in the facility has underwent N95 mask fit testing. The facility uses KN95 masks, which are universally fitted. There were hopes to get staff fit tested for N95 fit tested masks, however acquisition of the N95 masks was a challenge.

(i) Surveyor requested the IFU [Instructions for Use] for the KN95 masks that the facility has been using.

b. At 10:18 AM, Staff #3 stated that the facility is using CDC approved KN95 masks for their staff, who are working on quarantine units, where there are Covid-19 positive patients or PUI for COVID-19.

c. At 10:30 AM, Staff #26 stated that N95 masks are not required, as they are not intubating nor performing aerosol generating procedures. Staff #26 further stated that they are not able to implement fit testing, as they could not gain access to N95 masks in all the sizes to properly fit test all staff.

d. At 11:45 AM, Staff #31 stated the following vendors are used for medical supplies: Medline, Medical Express, JML Medical, and "sometimes Amazon." He/she stated he/she was unable to acquire N95 in various sizes. Sizes were limited. Staff #31 was asked if he/she could provide documentation of attempts to acquire N95 masks. Staff #31 was unable to provide the requested information.

e. At 12:00 PM, Staff #5 stated that at the onset of the COVID-19 pandemic (around March-April 2020), they were receiving PPE [Personal Protective Equipment] supplies from another hospital (Name of Hospital). He/she further stated that supply was short, and they were using any mask option they could get a hold of (Surgical masks, N95, KN95). They were unable to allocate N95 in multiple sizes, so continued to use KN95, under the EUA [Emergency Use Authorization] to current time.

2. Staff #2 provided the Product instruction insert for the KN95 masks that their staff have been using since the onset of the pandemic in 2020. In addition, a copy of their reference, titled, "Appendix A: Authorized Respirators; Updated May 28, 2020 was provided.

a. The Product instruction states, "Model: KN95 (earloop style). Item: KN95 Protective Mask (Non-Medical). ... . Manufacturer: Guangzhou Powecom Labor Insurance Supplies Co., ltd. ... China."

b. The Appendix A: Authorized Respirator reference the facility provided states, "The authorized respirators should be used in accordance with CDC's recommendations. ... . Please note that this list is updated on a rolling basis as new information becomes available for FDA to review. Authorized imported, Non-NIOSH approved respirators manufactured in China: ... . Guangzhou Powecom labor Insurance Supplies Co., LTD. ... ."

(i) Staff #2 and Staff #3 confirm that the above listed KN95 is the mask that all staff have been using since May 2020.

c. Staff #3, who was identified as the facility Infection Preventionist confirmed that he/she was not aware of the new June 30, 2021 FDA guidance outlining that non-NIOSH approved masks are no longer being authorized for use, effective July 6, 2021.

3. Upon tour of the following units, observation confirmed that staff are wearing KN95 masks on units where they are responsible in the care of Covid positive patients and UI patients.

a. On 9/9/2021, a tour of Drake East 1 at 12:49 PM was conducted.

(i) Staff #3 stated that this unit is separated into two distinct areas. One side of the unit was being use for PUI [Patient Under Investigation] for Covid and the other side for R and R [Recovery and Reintegration].

(ii) There was one PUI Patient (Patient #2) on the PUI side of the unit.

(iii) Staff #15 and Staff #16 were assigned to work with the patient on this unit.

(iv) In addition to the required PPE of a gown, gloves, and face shield, Staff #15 and #16 were wearing the facility supplied KN95 mask (non-NIOSH approved).

b. On 9/9/2021 at 3:35 PM, a tour of the Lincoln Complex-King Unit was conducted, and the following was indicated.

(i) Staff #3 stated that this is the facility designated COVID-19 unit.

(ii) There was one Covid-19 positive patient (Patient #3) on the unit.

(iii) Staff #27 and Staff #29 were assigned to work with the patient on the unit.

(iv) In addition to the required PPE of a gown, gloves, and face shield, Staff #27 and Staff #29 were wearing the facility supplied KN95 mask (non-NIOSH).

4. The above was confirmed by Staff #2, Staff #3, and Staff #5 on 9/10/2021 at 12:30PM.

A. Based on observations, staff interviews, and the review of facility policies, procedures, and documents, it was determined that the facility failed to properly prevent and/or contain COVID-19 by adhering to screening protocols at facility entry points.

Findings include:

Reference: Facility Policy and Procedure titled, "Thermal Scanning of Employees for Infection Prevention" states, "I. Policy: All (Name of Facility) employees and other individuals performing services on (Name of Facility) property will be screened for common symptoms of COVID 19 (SARs-COV-2 infection) before reporting to their work site each day and shift. This adheres to the statewide memo of April 21, 2020. "Those who will need to be screened include all staff, consultants, and others entering New Jersey's state psychiatric hospital, regardless of clinical contact." II. Purpose: To screen for possible, undetected symptoms of viral infection and transmission risk, temperature screening and symptom identification is designed to temporarily divert unwell staff members from the workforce and assist them in timely medical evaluation and care. ... . III. Responsibility: All Supervisors; (Name of Hospital) Security Force; Human Resources; Staffing Department. IV. Procedure: Before proceeding to assigned work area, all staff will be monitored for fever via "touchless" infrared temperature, and verbally surveyed for key symptoms common in COVID-19 cases. Questions are reinforced by reference to a visual (poster) pictorial guide."

1. On 9/9/2021 at 9:55 AM, upon entry to the facility (Parker Entrance), Staff #8 established identity of surveyors and linked surveyors with the Director of Public Safety as the escort into the facility. Surveyors entered the facility without being verbally surveyed for COVID-19 symptoms nor underwent a temperature check at this entrance.

a. On 9/9/2021 at 11:40 AM, Staff #2 stated that all visitors, contractors, and staff are to be screened for COVID-19 through a series of questions that are verbally asked, in addition to temperature checks. This is to be done for all buildings on the premises at the entry points. The initial start of entry would determine the location the screening should occur. Movement throughout the day between buildings, once a initial screening is completed does not warrant additional screening.

2. On 9/10/2021 at 2:30 PM, during a tour of the Travers Complex/Marquan Building, staff were observed entering the building and screening was inconsistent.

a. On 9/10/2021 at 2:35 PM, Staff #34 stated that upon his/her arrival to work, he/she is required to get his/her temperature checked at the Marquan Building before beginning his/her assignment.

b. On 9/10/2021 at 2:45 PM, Staff #36 stated that in the Marquan Building, he/she is required to get a temperature check before beginning his/her shift.

c. On 9/10/2021 at 2:55 PM, Staff #37 stated that before beginning the shift, employee COVID screening consists of a temperature check. He/she further stated that there was a staff member assigned to screen employees through symptom questions, but he/she has not been asked questions since the onset of summer.

3. The above findings were confirmed by Staff #2 on 9/10/2021 at 3:30 PM.

4. On 11/12/2021 at 10:01 AM, upon entry to the facility's Stratton building, this surveyor entered the facility without being verbally screened for key symptoms common in COVID-19.

a. When questioned about the screening process, Staff #2 stated that the screener should have asked signs and symptoms of COVID-19 at point of entry.

b. The above finding was confirmed with Staff #3.

B. Based on observation, staff interviews, and document review, conducted on 11/12/2021, it was determined that the facility failed to ensure that manufacturer's instructions for use (IFUs) for its disinfectants are followed in accordance with the CDC [Centers for Disease Control and Prevention] guidelines.

Findings include:

Reference: CDC [Centers for Disease Control and Prevention] Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 page 84 states, "Disinfect noncritical medical devices (e.g., blood pressure cuff) with an EPA-registered hospital disinfectant using the label's safety precautions and use directions. ... By law, all applicable label instructions on EPA-registered products must be followed. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability from any injuries resulting from the off-label use and is potentially subject to enforcement action under FIFRA."

1. During an observation in the Lincoln building on the lower level at 1:27 PM, in the presence of Staff #2 and Staff #4, PDI Super Sani-Cloth Germicidal Disposable Wipes and a spray bottle containing bleach solution were observed in the room.

a. Staff #11 was questioned regarding the use of the bleach containing spray bottle and PDI Super Sani-Cloth Germicidal Disposable wipes. Staff #11 stated that he/she used either the wipes or spray bottle solution to clean the patient care equipments in the room.

b. When questioned about the contact time of the PDI Super Sani-Cloth Germicidal Disposable wipes and the bleach solution, Staff #11 stated that there was no contact time.

2. During an observation in the Lincoln building cafeteria area at 12:30 PM, in the presence of Staff #2 and Staff #4, an unlabeled green bucket containing a clear liquid and a white rag was noted. Staff #12 stated that the unlabeled green bucket contained bleach solution that he/she had prepared. When questioned about the preparation and direction for use, Staff #12 stated that he/she "eyeballed and poured PureBright Germicidal Ultra Bleach solution and added hot water to the green bucket." Staff #12 stated that he/she would wipe the tables and chairs using the rag inside the green bucket and let it air dry. He/She did not know the contact time for the germicidal bleach solution.

a. Review of the 'PureBright Germicidal Ultra Bleach' states, "DISINFECTING: ...1. Use 3/4 cup of Bleach per gallon of water. ...3. Let stand 5 minutes, then rinse thoroughly and air dry."

b. At 12:31 PM, Staff #12 was observed spraying a table with a spray bottle and stated that the spray bottle contained "MARK E II cleaning solution." When questioned about the contact times for the MARK E II cleaning solution, Staff #12 stated that he/she did not know.

3. The facility failed to ensure all personnel responsible for the cleaning and disinfecting reusable patient care items are knowledgeable on the manufacturer's IFUs.

4. These findings were confirmed with Staff #2 and Staff #4.

C. Based on observation, staff interviews, and document review, conducted on 11/12/2021, it was determined that the facility failed to ensure that manufacturer's instructions for use (IFUs) for its glucometer is readily available and followed in accordance with CDC [Centers for Disease Control and Prevention] guidelines.

Findings include:

Reference #1: Center for Disease Control (CDC) website: http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html titled "Infection Prevention during Blood Glucose Monitoring and Insulin Administration" states, "...Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer's instructions. If the manufacturer does not specify how the device should be cleaned and disinfected, then it should not be shared."

Reference #2: CDC website: https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html titled, "2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in
Healthcare Settings" states, "... II.J. Patient Care Equipment and Instruments/Devices
Medical equipment and instruments/devices must be cleaned and maintained according to the manufacturers' instructions to prevent patient-to-patient transmission of infectious agents."

1. During an observation in the Lincoln building on the second floor at 12:45 PM, in the presence of Staff #2 and Staff #4, an Accu-Chek Inform II glucometer was found.
Staff #14 was questioned about the process of cleaning and disinfecting the Accu-Chek Inform II glucometer and he/she stated that "we use CaviWipes."

2. During an observation in the Lincoln building on the lower level where gynecological clinics are held, an Accu-Chek Inform II glucometer was found. Staff #11 was questioned about the process of cleaning and disinfecting the Accu-Check Inform II glucometer and he/she stated that "we use bleach solution spray or PDI Sani-Wipes."

3. The Accu-Chek Inform II glucometer IFU was requested and Accu-Chek Aviva Plus glucometer IFU was received.

4. The facility failed to ensure that the manufacturer's instructions for use for the Accu-Check Inform II glucometer was readily available. Therefore, it can not be determined if the glucometer is cleaned and disinfected in accordance with the manufacturer's IFU.

5. The above finding was confirmed with Staff #2.