HospitalInspections.org

The Condition of Participation for Basis and Scope has not been met.

Based on documentation review, interviews, and observations, it was determined that the hospital was not in compliance with the Medicare participatory requirements, including failing to operate as an Acute Care Hospital as defined in the Social Security Act Section 1867. The findings include:

The Social Security Act, Section §1861(e)(1) defines an acute care hospital as (1) primarily engaged in providing, by or under the supervision of physicians, to inpatients (A) diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons, or (B) rehabilitation services for the rehabilitation of injured, disabled, or sick persons. It also states that: "Notwithstanding the preceding provisions of this subsection, such term shall not, except for purposes of subsection (a)(2), include any institution which is primarily for the care and treatment of mental diseases unless it is a psychiatric hospital (as defined in subsection (f)."

On 5/8/23, a tour of this 38-bed hospital was conducted with the Hospital's President/CEO (Chief Executive Officer). The hospital consisted of two units and all 38 beds were designated for the care of psychiatric patients over 50 years of age with a primary diagnosis of mental illness. There were no beds designated for the provision of Acute Care hospital services.

Interview with the CEO on 5/10/23 at 9:00 AM identified that in 2005 the State of Connecticut granted the hospital a waiver to open a 23- bed psychiatric unit. Subsequently, in 2019, the hospital eliminated their 23-bed medical unit and on October 01, 2020, the State of Connecticut issued a license to operate as a Hospital for Mentally Ill patients. However, the hospital never submitted a request to CMS to terminate their certification as an Acute Care Hospital and apply for certification as a Psychiatric Hospital.

In order to participate in the Medicare program as a Psychiatric Hospital, a hospital must be (f) (1) primarily engaged in providing, by or under the supervision of a physician, psychiatric services for the diagnosis and treatment of mentally ill persons; (3) maintains clinical records on all patients and maintains such records as the Secretary finds to be necessary to determine the degree and intensity of the treatment provided to individuals entitled to hospital insurance benefits under part A; and (4) meets such staffing requirements as the Secretary finds necessary for the institution to carry out an active program of treatment for individuals who are furnished services in the institution. (The Social Security Act, Section §1861(f)(1)(3)(4)).

The CEO identified that the Centers for Medicare and Medicaid (CMS) continued to request information related to their Certification as an Acute Care Hospital with a PPS (Prospective Payment System) exempt psychiatric unit, but identified that the hospital does not provide those services. However, the Hospital is currently participating in the Medicare program as an Acute Care Hospital with a PPS exempt Psychiatric Unit.

The hospital failed to operate consistent with their certification as an Acute Care hospital with a PPS exempt psychiatric unit.

The Condition of Participation for Patient Rights has not been met.

Based on observations, medical record and documentation review, staff interviews and policy review, the facility failed to provide psychiatric patients care in a safe environment by failing to remove ligature risks and other hazards to behavioral health patients and failing to maintain the safety of a patient (patient #1) at risk for falls by placing the patient in seclusion without implementing safety measures to prevent falls including observation. In addition, the facility failed to consistently implement their restraint and seclusion policies to ensure that the use of restraints or seclusion is used to protect patients and others, by failing to obtain a physician's order for the use of seclusion (patient #1), failure to provide a face to face assessment by a Physician of a patient placed in seclusion (patient #1) and failed to insure that the use of physical restraint was discontinued at the earliest possible time (patient #7).

Cross reference:

482.13 (c)(2) Patient Rights: Care in a Safe Setting (A144);

482.13 (e)(5) Patient Rights: Restraint of Seclusions (A168);

482.13 (e)(9) Patient Rights: Restraint or Seclusion (A174)

482.13 (e)(10) Patient Rights: Restraint or Seclusion (A175)

482.13 (e)(12) Patient Rights: Restraint or Seclusion (A178)

Based on tour and observations, review of hospital documentation, staff interviews, and policy review, the hospital failed to ensure care in a safe setting by failing to remove ligature risks and other hazards to inpatient psychiatric patients and failed to provide constant supervision when one of three sampled patients (Patient #1) reviewed for falls was placed in seclusion, resulting in a fall with injuries. The findings include:

1. Observations during tours on 5/8/23 at 10:00 AM, 5/10/23 at 10:00 AM and on 5/11/23 at 9:45 AM noted the following:

'A' Wing
a. 12 of 12 dressers in Patient's bedrooms were observed not secured and easily moveable. 4 of 6 drawers in each of the 12 dressers did not have locks and could be opened creating a ligature point and access to drawer hardware;

b. 12 of 12 bathroom doors in patient's bedrooms were not able to be locked and did not have a slope area to prevent ligature risk.

c. Bathrooms and sleeping rooms doors had hinges and electrical cover plates that lacked institutional style, tamper resistant screws/fasteners that were not designed or maintained to psychiatric institutional standards or guidelines and posed a potential injury hazard.

d. 1 of 1 Patient bathrooms in the main hall was unlocked, had a door actuator, access to drain piping and standard barrel hinges on the door creating ligature points.

e. Patient sleeping rooms were with overhead lighting fixtures above the patients' dressers and accessible to patients, were breakable, and were not designed or maintained to psychiatric institutional standards, i.e. light lens and internal portions of these lamp units shall be properly safeguarded from patients as they posed potential injury hazard.

f. Windows within the patients rooms, common areas, and nurses's station were of tempered /laminate glass that if broken would break into small shards that posed a potential injury hazard and elopement risk and were not designed or maintained to psychiatric institutional standards or guides; i.e. no protective glazing or security screens.

g. In the Main Hall the cord for the patient phone was approximately 3 feet long, accessible to patients and posing a ligature risk to patients.

h. At the end of the hall a standpipe to attach a fire hose protruded from the wall creating a ligature point.

i. Night lights that were secured with ordinary fasteners, the lens covering the bulb appeared breakable and the lights were not maintained with institutional-style tamper resistant screws/fasteners and posed a potential injury hazard. The night lights were not designed or maintained to psychiatric institutional standards or guides. i.e., internal portions of lamp units shall be properly safeguarded from patients.

j. Windows within the patients' rooms and common areas that provided no privacy from the exterior i.e. no integral blinds or opaque window treatments on the exterior of the windows allowing passerby or workers to look directly into the room not maintaining patient dignity or privacy.

k. Observations on 5/10/23 at 10:00 AM with Quality Assurance Director noted upon entering the A unit, the dining room door was opened with 2 patients walking around inside the dining room without the supervision of staff. The Kitchenette door was noted to have two latex medical gloves inserted into the striker plate allowing the door to be opened without the use of the door handle or key. The same door handle was able to rotate 360 degrees when turned, was identified to be broken, and could not be used to open the door. Areas of ligature noted in the kitchen included, cabinets unlocked, drawers with plastic silverware including knives, cords observed from the steam table, microwave oven. The refrigerator was unlocked, and the garbage pail was noted with a plastic liner inside.
Further observation within the dining room noted cabinets on the wall were unlocked. One electrical outlet below the windows accessible to patients did not have a cover plate exposing wires and connection points.
Interview at that time with nursing stated that the kitchen door and cabinets are to be locked. Nursing further stated that they were unaware the door was broken.

l. Observations at the nursing station noted locked half doors, inside the station cords from phones and computers were accessible to patients.

m. Patient beds, although ligature approved, were surgical beds with ligature risks to include side rails with open bars and open frame.

Review of the 15-minute rounding book with PCAs #1, #2 and #3 identified a sheet of paper with the heading of "Identified Environmental safety risks" in the front of the book. The paper identified potential ligature risks. PCA #1, #2 and #3 stated they were not aware of the environmental safety risks checklist and were not documenting on the items listed on the Identified Environmental safety risks sheet. The PCAs further stated the 15-minute checks form they completed were patient specific and potential ligature risks were not identified as part of the 15-minute checks, just who completed the checks and the location of the patient.

'B' Wing
n. Night lights that were secured with ordinary fasteners, the lens covering the bulb appeared breakable and the lights were not maintained with institutional-style tamper resistant screws/fasteners and posed a potential injury hazard. The night lights were not designed or maintained to psychiatric institutional standards or guides. i.e., internal portions of lamp units shall be properly safeguarded from patients.

o. Windows within the patients' rooms and common areas that provided no privacy from the exterior i.e. no integral blinds or opaque window treatments on the exterior of the windows allowing passerby or workers to look directly into the room not maintaining patient dignity or privacy.

p. Observations during a tour on 5/10/23 from 10:00 AM to 10:50 AM an unlocked closet containing clothing, some with draw strings was identified as a ligature risk. Additionally, the unit had plastic bags lining the linen hamper and a standpipe used to connect a fire hose was noted at the end of the hall protruding from the wall creating a ligature point.

Interview with Director of Quality and Chief Executive Officer on 5/9/23 at 11:00 AM identified that environmental rounds are done once a month which includes checking the environment for damage and cleanliness however, they are not safety rounds. The Director stated hourly rounding is done by the nurses, but they are not documented. The Director further stated that 15-minute checks are completed by the PCA's which would include checking for ligature risks.

Interview with RN #4 and RN #5 on 5/10/23 at 10:15 AM stated that the PCA's do every fifteen-minute checks on the patients and they do hourly safety checks which included visualizing the patient; assessing for mood; pain; patient needs; if they are at risk for falling and if the patient has urges to hurt themselves. RN #4 and RN #5 stated that they do not conduct environmental rounding for ligature risks. RN #4 and RN #5 acknowledged they document in their patient shift charting about hourly rounding, but do not document on ligature risks in the environment.

Interviews with PCA #1, PCA #2 and PCA # 3 on 5/10/23 at 10:35 AM noted they round on patients every fifteen minutes and they are observing the resident; identifying if the Patient is sleeping or awake; checking to see if the top drawer of the bedroom dresser was locked; checking for contraband; checking if the bathroom is clean and checking patient belongings.

Interviews with RN #2 and RN #3 on 5/10/23 at 10:40 AM identified the RN does unit checks within 1 hour from the end of the shift. RN #2 and RN #3 stated that although they are doing checks and are looking for dangerous items or something that can be used as a weapon or as a ligature, there is no documentation that the checks were done.

Interview with the Director of Quality on 5/10/23 10:45 AM during tour acknowledged residents should not have been in the kitchen without supervision. Additionally, she acknowledged the kitchen door should not have been open, gloves should not have been in the striker plate, the door handle needed to be repaired, the cabinets should have been locked and the electrical outlet did not have a cover and all the areas identified represented a risk to patients.

Interview on 5/11/23 at 10 AM with the facility CEO and Director of Quality acknowledged the doors in patient bedrooms, the dressers in patient bedrooms, the phone cord in the main hall, the open patient bathroom in the main hall and the barrel hinges for various doors all represented a risk to the Patient as a potential ligature risk. The Director of Quality stated although the hospital does not have a policy on monitoring for ligature risks, nurses do hourly rounding.

An interview with the Administrator on 5/11/23 at 10:30 AM identified that the facility lacked a current environmental risk assessment for the Behavioral Health Nursing Units.

The hospital failed to ensure that Nursing Units on the 1st floor A & B wings were designed and maintained in a manner that promote the safety and well-being of patients.

Review of the hospital policy for Purposeful Hourly Rounding identified hourly rounding is to proactively assess and meet patient needs with the goal of reducing falls and improving patient satisfaction. The policy identified to assess the environment for safety.


2. Patient #1 was admitted to the hospital on 4/16/2023 from home for extreme agitation, threatening physical harm to caregivers, and paranoid behavior. The admission diagnosis was identified as dementia with behavioral disturbance.

The Initial Care Plan dated 4/16/2023 identified the patient was a high risk for falls related to poor safety awareness and an unsteady gate. Interventions directed the staff to provide assistance with ambulation, ensure appropriate footwear, provide a clutter free environment, and fifteen-minute checks for safety.

The Nurses Progress note dated 4/27/2022 on the 11:00 PM to 7:00 AM shift identified that the Patient was agitated and combative during the shift. The patient refused oral Trazadone and Ativan 0.5 milligrams (mg) was administered intramuscular (IM) at 2:30 AM with positive effect. Additionally, the note identified that the patient was non ambulatory and self-propelled in a wheelchair.

A Nurse's Progress note dated 4/27/2022 at 12:12 PM identified at 7:45 AM, a Nurses' aide (NA) called RN #20 to Patient #1's room. The RN assessment of the Patient identified diffuse scattered bruising on the right clavicle area extending to the right base of the neck. The Patient reported pain on movement and was unable to bend his/her right knee without assistance. X-rays were ordered for the right clavicle, hip and pelvis.

An Advance Practice Registered Nurse (APRN) progress note dated 4/27/2022 at 8:01 AM identified the Patient had significant bruising on the right shoulder. No documentation or report of a recent fall was noted in the clinical record. The Nurse Aide (NA) caring for the patient reported the bruising was not present on 4/26/2022, the morning before. The Patient complained of significant pain on movement and a decrease in range of motion was noted. A stat x-ray of the right clavicle and shoulder was ordered.

Radiology Reports dated 4/27/2022 identified no fracture of the right clavicle, hip and pelvis.

Further Review of Nurses progress notes identified the Patient was assessed every shift for the progression of injuries including pain and range of motion of the affected areas. The Patient often reported pain in the right clavicle and leg requiring the administration of Tylenol 1000 mgs. The Tylenol was effective for pain relief. The Care Plan was updated to include the use of a chair and bed alarm.

A Radiology Report dated 5/2/2022 identified a possible fracture of the right clavicle and no fracture of the right hip/pelvis.

A Physician's Progress note dated 5/2/2022 at 11:12 AM identified the Patient was seen for a follow up for ecchymosis of the right shoulder and hip. X-ray results were negative for fracture. CT scans would be more definitive. The Patient continued to complain of pain and has been unable to bear weight on the right leg. The plan was to discuss with the nurse manager and family about a transferring the Patient to the Emergency Department for CT scans of the affected areas.

A Nurse's Progress note dated 5/3/2022 at 8:20 PM noted Patient #1 had an unwitnessed fall and was observed lying on the floor next to the bed. A bed alarm was sounding. The patient was assessed, and no additional injuries were noted.

An APRN Progress note dated 5/4/2022 at 10:36 AM identified the Patient was examined after a reported unwitnessed fall and no new injuries were noted. The Patient was transferred to the ED for evaluation.

Patient #1 returned from the Hospital on 5/5/2022. A Physician Progress note dated 5/6/2022 at 12:06 AM identified CT imaging showed a proximal third clavicle fracture and a acetabular fracture on the right. The Patient was evaluated by orthopedic surgery and required no surgical intervention.

An Adverse Event Report dated 4/27/2022 identified that Patient #1 received Ativan 0.5 mg at 2:30 AM for combative behavior. At 8:00 AM ecchymosis noted on the right shoulder with pain and sensitivity. A fall or event was not reported by staff involved in overnight care. The Corrective Action Report dated 5/13/2022 identified the facility noted inconsistent implementation of the restraint and seclusion policy, the levels of observation policy, and management of escalating behavior policy.

Interview, review of the clinical record and the hospitals investigation into the injuries of unknown origin with the Director of Quality on 5/9/2023 at 1:30 PM identified that on 4/27/2022 during the 11:00 PM to 7:00 AM shift, Patient #1 was agitated and combative and was placed in the Seclusion room. A Physician's order was not obtained for the use of the seclusion room. A face-to-face assessment of the Patient was not conducted by a physician for justification for the use of the room. The Patient remained in the Seclusion room for approximately 15 minutes without the benefit of an RN assessment or one to one observation as directed in the policy. While unattended, a noise was heard coming from the seclusion room, staff ran to the room and found the patient on the floor. RN#20 failed to assess the Patient before injecting Ativan (at 2:30 am). The Patient was not exhibiting combative behavior at the time of the injection. The Patient was then lifted from the floor with the assistance of two staff members without an assessment for injury prior to lifting the patient. Although the Patient complained of right shoulder pain an assessment for injury was not conducted during the remainder of the shift. The Patient's injuries were not assessed until found by the oncoming shift. The Physician was then notified. Additionally, there was no documentation in the clinical record of the incident. Attempts to interview RN#20 were unsuccessful.

Review of Hospital's Restraints/seclusion policy directed, when seclusion is used, the assigned staff member will maintain Level 1 continuous observation and document in the Restraint/Seclusion observation form. A registered nurse will assess the patient every 30 minutes for discontinuation and maintaining of basic care needs.
The hospital failed to obtain physician's orders for the use of the seclusion room (restraint), failed to supervise the patient while in the seclusion room in accordance with policy, failed to assess the patient for injury subsequent to falling while in the seclusion room unattended, failed to notify the physician of the fall, and failed to report and document the incident in the clinical record.

Based on clinical record review, review of hospital policy, and interview for 1 of 4 patients reviewed for restraints (Patient #1), the hospital failed to obtain a physician's order for seclusion. The findings include:

a. Patient #1 was admitted to the hospital on 4/16/23 exhibiting extreme agitation, threatening physical harm of caregivers, and paranoid behavior. The admission diagnosis was identified as dementia with behavioral disturbance.

Review of the clinical record and hospital documentation identified that on 4/27/22 during the 11:00 PM to 7:00 AM shift, Patient #1 was agitated and combative and was placed in seclusion.

Interview and review of the clinical record with the Director of Quality on 5/9/2023 at 1:30 PM identified that that there was no physician order obtained for the use of seclusion.

The Hospital's Restraint/Seclusion policy directed physician orders be obtained for all restraint/seclusion episodes.

Based on clinical record review, review of hospital policy, and interview for 1 of 4 patients reviewed for restraints (Patient #1), the hospital failed to obtain a physician's order for seclusion. The findings include:

a. Patient #1 was admitted to the hospital on 4/16/23 exhibiting extreme agitation, threatening physical harm of caregivers, and paranoid behavior. The admission diagnosis was identified as dementia with behavioral disturbance.

Review of the clinical record and hospital documentation identified that on 4/27/22 during the 11:00 PM to 7:00 AM shift, Patient #1 was agitated and combative and was placed in seclusion.

Interview and review of the clinical record with the Director of Quality on 5/9/2023 at 1:30 PM identified that that there was no physician order obtained for the use of seclusion.

The Hospital's Restraint/Seclusion policy directed physician orders be obtained for all restraint/seclusion episodes.


b. Patient #7 diagnoses included schizophrenia, depression and suicidal ideation. Physician orders dated 4/18/23 at 3:00 PM directed to place the patient in a restraint chair for threatening and at risk of harming others.

Review of the face-to-face documentation dated 4/18/23 at 4:16 PM noted the patient was placed in the restraint chair due to physically threatening and attempting to bite, hit and kick staff, and the reason for discontinuation would be not a danger to others and exhibits calm behaviors. Review of the restraint/ seclusion observation form noted the patient was placed in the restraint chair at 3:15 PM, exhibiting kicking, hitting and biting behaviors. At 3:30 PM the patient was noted to be yelling while in the restraint chair, at 3:45 PM the patient was calm and at 4:00 PM no behaviors are documented.

The nurse's note dated 4/18/23 at 4:45 PM noted the patient was in a restraint at 3:03 PM, monitored per protocol and medicated at 3:22 PM. The clinical record lacked documentation of when the restraint was discontinued.
Review of the clinical record and facility violent restraint log and interview with the DON on 5/11/23 at 11:55 AM noted that patient #7's clinical record lacked documentation of when the restraint chair was discontinued, that the restraint log documentation was incomplete for date and time and total minutes in restraint chair. The DON stated that when a patient comes out of the restraint chair a debriefing note and the restraint log is to be completed.

Interview with MD #1 on 5/11/23 at 11:53 AM stated that the patient is to be removed from the restraint chair once the patient has stopped exhibiting the behaviors.

Review of the hospital policy for restraint/ seclusion guidelines noted patients need to be removed from the chair restraint as soon as possible.

Based on clinical record review, review of hospital policies, ad interview for 1 of 3 patients reviewed for restraint use (Patient #1), the hospital failed to ensure that the condition of the patient was monitored during seclusion in accordance with hospital policy. The findings include:

Patient #1 was admitted to the hospital on 4/16/23 exhibiting extreme agitation, threatening physical harm of caregivers, and paranoid behavior. The admission diagnosis was identified as dementia with behavioral disturbance.

Review of the clinical record, review of hospital documentation of an injury of unknown origin, and interview and with the Director of Quality on 5/9/2023 at 1:30 PM identified that that on 4/27/22 during the 11:00 PM to 7:00 AM shift, Patient #1 was agitated and combative and was placed in seclusion. The patient remained in the seclusion room for approximately 15 minutes without the benefit of a Registered Nurse (RN) assessment or one to one observation in accordance with hospital policy. While unattended, a noise was heard coming from the seclusion room, staff ran to the room and found the patient on the floor. On 4/28/22 at 8:00 AM ecchymosis was noted on the right shoulder with pain and sensitivity. The clinical record failed to identify that the patient fell or that an event occurred while in seclusion.

The Hospital's Restraint/Seclusion policy directed monitoring of patients during restraint/seclusion.

Based on clinical record review, review of hospital policies, ad interview for 1 of 3 patients reviewed for restraint use (Patient #1), the hospital failed to ensure that a face-to-face physician assessment was conducted. The findings include:

Patient #1 was admitted to the hospital on 4/16/23 exhibiting extreme agitation, threatening physical harm of caregivers, and paranoid behavior. The admission diagnosis was identified as dementia with behavioral disturbance.

Review of the clinical record and hospital documentation identified that on 4/27/22 during the 11:00 PM to 7:00 AM shift, Patient #1 was agitated and combative and was placed in seclusion.

Interview and review of the clinical record with the Director of Quality on 5/9/2023 at 1:30 PM identified that a face-to-face assessment of the patient was not conducted by a physician or other licensed independent practitioner after initiation of the seclusion.

The Hospital's Restraint/Seclusion policy directed face-to-face physician/LIP assessments for restraint/seclusion episodes.

Based on clinical record review, review of hospital documentation, policy review, and staff interview for 2 of 4 patients reviewed for restraints (Patients #7 & 20) the hospital failed to ensure that nursing staff evaluated the patients in a post event debriefing, in accordance with hospital policy. The findings include:

a. Patient #7's diagnoses included schizophrenia, depression and suicidal ideation. Physician orders dated 4/18/23 at 3:00 PM directed to place the patient in a restraint chair for threatening and at risk of harming others.
Review of the face-to-face documentation dated 4/18/23 at 4:16 PM noted the patient was placed in the restraint chair due to physically threatening and attempting to bite, hit and kick staff. Review of the restraint/seclusion observation form noted the patient was in the restraint chair from 3:15 PM until 4:00 PM.

Interview and review of Patient #7's clinical record with the DON on 5/11/23 at 11:45 AM failed to identify a post event debriefing was completed after the restraint was discontinued. The DON stated the debriefing is done with the clinical team to review the care during the use of the restraint.


b. Patient #20's diagnoses included Dementia and Delirium. Physician orders dated 4/13/23 at 7:12 PM directed to place Patient #20 into a restraint chair for at risk for self-harm, physically assaultive, and at risk for harm to others.
Review of the face-to-face documentation dated 4/13/23 at 7:05 PM noted the patient was agitated, trying to get up and walk, not redirectable, and striking out at staff and patients and was placed in a restraint chair. The note further identified the reason for discontinuation was not a danger to self or others and exhibits calm behaviors.

Review of the restraint/seclusion observation form dated 4/13/23 noted the patient was placed in the restraint chair from 7:00 PM until 10:15 PM at which time the patient was moved to a SOMA bed.

Interview and review of Patient #7's clinical record with the DON on 5/11/23 at 11:30 AM failed to identify a post event debriefing was completed after the restraint was discontinued. The DON stated the debriefing is done with the clinical team to review the care during the use of the restraint.

Review of the hospital policy for restraint/ seclusion guidelines noted post event debriefing is done with staff once the patient is secured.

Based on tour of the pharmacy, observations, review of hospital documentation and interview, the hospital failed to ensure that temperatures of the medication room were monitored. The finding includes:

Observations during a tour of the pharmacy department on 5/9/23 at 10:30 AM noted that the pharmacy lacked documentation of monitoring of temperature or humidity checks of the room. Subsequent to the surveyor's observation, a thermometer was brought to the pharmacy room and the temperature registered at 74 degrees Fahrenheit. The Director was unable to monitor the humidity at that time.

Interview with the Director of Pharmacy on 5/9/23 at 10:30 AM identified that the thermometer utilized to check the temperature and humidity of the room was broken for about a week. The Director stated she did not have a back-up thermometer and was waiting for a new one to arrive. The Director further stated it was not the practice to log the temperature or humidity of the room.

Review of the policy for medication management temperature storage noted all medications shall be stored at appropriate temperatures that do not exceed manufacturers recommendations or warnings and identified the temperature will be maintained between 68 degrees-77 degrees Fahrenheit.

Based on observations, clinical record review and staff interview for 1 of 3 patients reviewed for medication administration (Patient #19), the hospital failed to ensure medication used for the treatment of tardive dyskinesia was not expired. The finding includes:

Patient #19's diagnoses included depression and suicidal ideation. Review of the History & Physical dated 3/17/23 noted the patient was diagnosed with drug induced Tardive Dyskinesia.

The Physician orders dated 4/11/23 directed to administer Austedo 9 mg PO daily, a drug used to treat tardive dyskinesia.

Observations during a tour of the pharmacy on 5/9/23 at 10:45 AM noted 3 boxes of Austedo with an expiration date of 9/22.

Interview with the Director of Pharmacy on 5/9/23 at 10:50 AM identified that Patient #19 was currently receiving Austedo. The Director identified the medications were samples brought in by the MD and she was unaware that the medications were expired. The Director stated she checked medications for expiration monthly but must have missed that one.

The Condition of Participation for Infection Control has not been met.

Based on observations, review of clinical records, review of hospital policies and procedures, and interviews for eight (8) patients reviewed for infection control practices (Patients #2, 4, 5, 7, 8, 10, 11, and 13), the hospital failed to implement infection prevention measures to mitigate the spread of COVID-19 as evidenced by, failure to appropriately cohort confirmed and exposed COVID-19 patients, failure to implement testing of patients after prolonged exposure, failure to ensure staff donned appropriate personal protective equipment, failure to have appropriate room signage for COVID-19 positive and exposed patients, and failure to ensure that COVID-19 positive patients with wandering behaviors were cared for in a safe setting to reduce the risk of transmission to other patients, staff, and visitors consistent with the CDC guidelines resulting in a finding of Immediate Jeopardy.

Immediate Jeopardy was identified on 5/9/23 under 482.42 Infection Control for failure to ensure that the hospital followed appropriate infection control practices related to the management of COVID-19 infections.

The hospital provided an immediate corrective action plan that identified the following: Cohorting of infected patients, cohorting of exposed patients, relocation of COVID-19 positive patients to Unit B, wearing of appropriate PPE, testing all patients, and providing fit testing and education to staff.

On 5/10/23, the action plan was verified by observation, tour, review of documentation and interviews as implemented, and Immediate Jeopardy was removed.

CoP non-compliance for Infection Prevention and Control remains.

Cross reference:
482.42 (a) (2) Infection Control Program (A749)
482.42 (a) (3) Infection Control surveillance (A750)

Based on observations, review of clinical records, review of hospital policies and procedures, and interviews for 8 patients reviewed for infection control practices (Patient #2, 4, 5, 7, 8, 10, 11, 13), the hospital failed to implement infection prevention measures to mitigate the spread of COVID-19 evidenced by the failure to appropriately cohort confirmed and exposed COVID-19 patients, failure to implement testing of patients after prolonged exposure, failure to ensure staff donned appropriate personal protective equipment, failure to display appropriate room signage for COVID-19 positive and exposed patients, and failure to ensure that COVID-19 positive patients with wandering behaviors were cared for in a safe setting to reduce the risk of transmission to other patients, staff, and visitors consistent with CDC guidelines resulting in a finding of Immediate Jeopardy. The findings include:


1. During a tour of 'B' unit on 5/8/23 at 10:00 AM with the Director of nurses and MD #1 the following observations were made:

a. All staff donned surgical masks and were without the benefit of eye protection.

b. Signage posted on the doors to rooms of patients with COVID-19 positive diagnoses failed to identify N-95 or higher respirator mask as a requirement when entering the rooms.

c. Patient #4 (COVID-19 negative) and Patient #5 (COVID-19 positive as of 5/7/23) were identified as roommates.

d. Patient #2 (COVID-19 positive as of 5/7/23) was observed walking from the common TV room and into the hallway without the benefits of a mask covering nose and mouth while other patients were ambulating in the hallway.


2. During a tour of the 'A' unit of the Hospital on 5/8/23 at 12:30 PM the following observations were made:

a. Patient #7 (COVID-19 positive) was observed without a mask ambulating in the common area where other patients were gathering. Patient #7 was observed face to face with Patient #15 (COVID-19 negative). Patient #15 was observed with his/her mask below his/her mouth and nose as Patient #15 made physical contact by placing his/her lips to Patient #7's head. Staff Person separated the patients and escorted Patient #7 out of the common area to the hall and attempted to redirect #7. Patient #7 then lowered his/her pants and RN #7, who was wearing a surgical mask, ambulated Patient #7 to the common hallway restroom.

b. At 12:35 PM patient care assistant (PCA) #2 was observed with patient #7 (COVID-19 positive) in the patient's room. PCA #2 was observed wearing an isolation gown, gloves, face shield and a surgical mask while assisting Patient #7 with toileting and dressing. PCA #2 failed to don a N-95 (respirator) mask while providing care to patient #7 who was COVID-19 positive.

c. Patient #8 (COVID - 19 positive as of 5/6/23) and patient #13 (not tested) were identified as roommates.

d. Patient #10 (COVID -19 positive as of 5/2/23) and patient #11 (COVID-19 negative) were roommates.

e. Signage posted on the doors to rooms of patients with COVID positive diagnoses failed to identify N-95 or higher respirator mask as a requirement when entering the rooms.

Interview with MD#1, the Chief executive officer (CEO) and the Director of quality risk and safety on 5/8/23 at 9:45 AM identified that 36 % of the hospital's patients were diagnosed as COVID-19 positive. An interview with the CEO on 5/8/23 at 10:55 AM identified the hospital was treating all patients as COVID-19 positive with precautions to include extra handwashing, ensuring patients are wearing masks, and using bleach wipes.

Interview with MD #1 on 5/8/23 at 2:25 PM identified that regarding cohabitation, if two patients were roommates and one tested positive for COVID 19 and the other one was negative COVID 19, the patients were not necessarily separated, as the roommate was already exposed. MD #1 identified the hospital was testing only symptomatic patients.

In an interview with the hospital's Infection Preventionist (IP) on 5/9/23 at 11:20 AM the IP identified that with the unique patient population, patients were unable to remain in their rooms and identified cohorting was not feasible. The IP identified that to mitigate the spread of COVID-19 within the hospital, staff provided masks to roaming patients and identified it was the expectation that staff wore mask, gown, gloves and eye protection when in a room with COVID-19 positive patients. The IP identified that the hospital chose not to utilize N-95 masks and stated that staff have never been fit tested. The IP identified that staff were expected to wear eye protection when on the units with COVID-19 positive patients.

Review of the hospital's policy for, Working with Patients Who Test Positive for COVID 19, last updated on 8/2022, directed when entering the facility and at all times on the unit a surgical mask or KN-95 face mask is to be worn.

A review of the CDC guidance dated 9/23/22 recommended infection prevention and control practices when caring for a patient with suspected or confirmed SARS-COV-2 infection. The guidelines directed to cohort asymptomatic patients who have met the criteria for transmission-based precautions or who had close contact with someone with SARS-COV-2 infection, and patients with symptoms of COVID-19 (even before results of diagnostic testing) together. However, these patients should NOT cohort with patients with confirmed SARS-COV-2 infection unless they are confirmed to have SARS-COV2 infection through testing. The CDC guidance further directed to perform SARS-COV2 viral testing on asymptomatic patients with close contact with someone with SARS-COV-2 infection and should have a series of three viral tests for SARS-COV-2 infection. Testing is recommended approximately 24 hours after the exposure and if negative, again 48 hours after the first negative test and, if negative, again 48 hours after the second negative test. This will typically be, at day 1 (day of the exposure is day 0), day 3, and day 5.

The hospital's COVID-19 PPE policy failed to reflect current CDC guidelines.

Based on observation and staff interview for 1 of 2 patient refrigerators and steam table, the facility failed to ensure the refrigerators and steam table were maintained in a sanitary condition and failed to ensure that a comprehensive water management plan was in place to Reduce Legionella Risk in the Healthcare Facility's Water Systems to Prevent Cases and Outbreaks of Legionnaires' Disease (LD). The findings include:

1. Observations during a tour on 5/10/23 at 10:20 AM noted the shelves and door of the patient refrigerator in the kitchenette and the steam table were soiled with dried foods and liquids.

In an interview with the Director of nursing (DON) on 5/10/23 at 10:20 AM the DON stated that the refrigerator and steam table were to be clean daily. The DON further stated that although staff are to clean them daily, there was no log to identify when it was last done.

2. Review of hospital documentation identified the following:

a. The hospital lacked records identifying that the facility held water management team meetings and lacked records that identified the water management plan was reviewed.
b. The hospital lacked flushing logs for the first floor A & B wings.
c. The hospital's water testing records were reviewed and on 09/13/22 and six (6) samples were taken and sent to the lab with results reported on 05/23/22. The report identified two (2) samples of the six (6) were positive for Legionella species (sp). The facility lacked records of what was implemented to mitigate the risk to patients. Documentation identified Facility Compliance Services retested on 10/31/229, six (6) samples were sent to the lab with results reported on 11/10/22 identified three (3) of six (6) samples positive for Legionella sp. The facility lacked documentation that a remediation was conducted. All results were below action level as indicated by water testing documentation reviewed.
d. The hospital lacked documentation that identified the facility conducted annual review of the water management program i.e. no meeting attendance or a list of water management team members for the facility plan for water management was provided. And,

e. Documentation was not provided to indicate that the Water Management Committee had received education/training on a comprehensive water management plan.
Interview with the Administrator and review of Hospital documentation on On 05/11/23 at 10:30 AM failed to identify the hospital had a comprehensive water management plan in place as required by S&C 17-ALL.

The hospital failed to ensure that a comprehensive water management plan was in place to Reduce Legionella Risk in the Healthcare Facility's Water Systems to Prevent Cases and Outbreaks of Legionnaires' Disease (LD) as required by the Centers for Medicare and Medicaid Services Survey and Certification letter S&C 17-30-ALL issued June 2, 2017, and as required by 42 CFR §482.42 for hospitals.